http://www.safemedicines.org/ en-US Mon, 07 Mar 2016 06:52:00 -0800 http://www.typepad.com/ http://www.rssboard.org/rss-specification http://www.safemedicines.org/2016/03/health-emergency-in-texas-due-to-repeated-cases-of-disfiguring-counterfeit-beauty-treatments.html http://www.safemedicines.org/2016/03/health-emergency-in-texas-due-to-repeated-cases-of-disfiguring-counterfeit-beauty-treatments.html Texas authorities at both the regional and Federal level have combatting a rash of injuries and deaths caused by counterfeit cosmetic injections. From fake Botox and other counterfeit versions of filler treatments to industrial silicone injections sealed with superglue, these fake injectable cosmetic peddlers are putting the lives of Texas women at risk. <p><strong> <br /> <a class="asset-img-link" style="float: left;" href="http://www.safemedicines.org/BlackMarketBotox_singlepg_PRESS_pcis.pdf"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c81d817a970b img-responsive" style="margin: 0px 5px 5px 0px;" title="Black Market Botox" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c81d817a970b-320wi" alt="Black Market Botox" /></a>Texas authorities at both the regional and Federal level have combatting a rash of injuries and deaths caused by counterfeit cosmetic injections. From fake Botox and other counterfeit versions of filler treatments to industrial silicone injections sealed with superglue, these fake injectable cosmetic peddlers are putting the lives of Texas women at risk. </strong></p> <p>The Dallas case of Denise “Wee Wee” Ross and Jimmy “Alicia” Clarke began in 2015, when a client of the pair reported suffering pain and injuries as a result of treatment by them at their Deep Ellum salon, the <a href="http://www.dallasnews.com/news/crime/headlines/20150325-woman-jailed-in-deep-ellum-buttocks-shots-case.ece" target="_blank">Dallas Morning News</a> reports. Additionally, they report that the pair are being investigated in the death of Wykesha Reid, whose body was found last February at the abandoned salon.</p> <p>Ross and Clarke are accused of posing as medical professionals, and injecting customers with hydrogel, and sealing the injections with superglue, according to<a href="http://cw33.com/2015/03/19/backside-backlash-two-wanted-for-illegal-butt-injections/" target="_blank"> CW33</a> in Dallas.</p> <p>The <a href="http://crimeblog.dallasnews.com/2015/03/second-suspect-in-illegal-buttocks-injections-case-booked-into-jail.html/" target="_blank">Dallas Morning News Crime blog</a> notes that Ross faced similar charges in 2010, but the case never went to trial. Patricia Kelly, family member of the dead woman told the Crime blog, “They should’ve locked her up then and they didn’t. If they had, this wouldn’t have happened. My baby would still be alive.”</p> <p>The Dallas case follows on the heels of a successful federal prosecution of a similar black market cosmetic injectable practitioner. The <a href="http://www.fda.gov/ICECI/CriminalInvestigations/ucm465914.htm" target="_blank">Food and Drug Administration (FDA)</a> reports the sentencing of Maribel Quintero, who pleaded guilty to charges that she administered illegally imported silicone to unsuspecting Texas customers. Quintero is currently serving out her 16-month sentence for violating the Food, Drug and Cosmetics Act.</p> <p>According to the <a href="http://www.themonitor.com/premium/dangers-of-clandestine-cosmetic-procedures/article_1adb1d0c-6879-11e4-b9d4-4f2372a7996a.html " target="_blank">Monitor</a>,&nbsp;Quintero was administering a liquid form of Plexiglas to her unsuspecting customers. They also report her initial arrest came after she was caught crossing the border from Mexico with two large bottles labeled Remplissage that were filled with a thick, clear substance.</p> <p>These more recent cases follow a series of prosecutions in South Texas beauty salons. In 2014, <a href="http://www.safemedicines.org/2014/03/texas-experiences-rash-of-fake-botox-injuries-3-people-so-far-indicted-in-scam-3-26-14.html" target="_blank">individuals at 3 different beauty salons</a>, Elva Novarro, Nohemi Gonzalez, and Graciela Leon, all faced prosecution on allegations that they administered dangerous counterfeit cosmetic injections to clients. Those cases are all currently pending.</p> <p>The spate of injectable cosmetic injuries due to counterfeit treatments is not unique to Texas. To learn more about how counterfeit injectable cosmetics are a nationwide problem, please read <a href="http://www.safemedicines.org/BlackMarketBotox_singlepg_PRESS_pcis.pdf" target="_blank">Black Market Cosmetic Injectables in the U.S. 2005-2013</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 07 Mar 2016 06:52:00 -0800 http://www.safemedicines.org/2016/02/fake-pill-importer-last-of-the-texas-trio-sentenced-to-15-months-in-counterfeit-drug-case.html http://www.safemedicines.org/2016/02/fake-pill-importer-last-of-the-texas-trio-sentenced-to-15-months-in-counterfeit-drug-case.html On February 3, 2016, the Department of Justice (DOJ) announced that Catherine Nix had been sentenced to a year and three months in prison for her role in importing counterfeit medication into the U.S. Her sentence was the final chapter in the tale of the trio of Texans that were first indicted in 2014 for importing Chinese-made counterfeit drugs. <p><strong> <a class="asset-img-link" href="http://www.safemedicines.org/TexasTrio_infographic3.pdf" style="float: left;"><img alt="Texas Trio" class="asset asset-image at-xid-6a00e5550359d1883401bb08bd4b07970d img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08bd4b07970d-320wi" style="margin: 0px 5px 5px 0px;" title="Texas Trio" /></a>In 2014, Federal Prosecutors indicted 3 Texans on charges that they were importing counterfeit versions of prescription medications from China for resale in the United States. This month, the last of the 3 has been sentenced to 15 months in prison. </strong></p> <p>On February 3, 2016, the <a href="http://www.justice.gov/opa/pr/texas-woman-sentenced-prison-prescription-drug-smuggling-ring" target="_blank">Department of Justice (DOJ)</a> announced that Catherine Nix had been sentenced to a year and three months in prison for her role in importing counterfeit medication into the U.S. Her sentence was the final chapter in the tale of the trio of Texans that were first indicted in 2014 for importing Chinese-made counterfeit drugs.</p> <p>According to the DOJ, Nix pleaded guilty to one count of conspiracy to smuggle drugs into the United States. She and her co-conspirators smuggled “at least 43 known shipments, totaling approximately 106,000 pills, from China to Texas. The shipments contained unapproved, bogus versions of several FDA-approved drugs that, because of the health and safety risks associated with their use, require valid prescriptions to dispense. The prescription drugs seized included: Xanax®; Valium®; sibutramine; Cialis®; Viagra® and Stilnox®, marketed in the United States as Ambien®. <strong>None of the pills that were seized and tested were legitimate. Some were sub-potent, but most contained entirely different active ingredients from their legitimate, approved versions.</strong> The defendants attempted to hide their smuggling by using shipping labels that concealed the contents of their shipments and customs declarations falsely describing the contents as ‘gifts’ or ‘toys.’ They used multiple addresses in an effort to reduce the likelihood of seizures by U.S. Customs and Border Protection authorities.”</p> <p>According to the <a href="http://www.safemedicines.org/giddens_et_al_indictment.pdf" target="_blank">original indictment,</a> “The defendants were not in any way, (i) authorized by law, (ii) licensed in any state, or (iii) competent through any medical education and training to administer prescription drugs, professionally supervise the use of prescription drugs, dispense prescription drugs, hold prescription drugs for sale, fill a prescription for drugs, or make an oral or written prescription for drugs.”</p> <p>The indictment further reports that the 3 defendants originally faced 24 charges: 1 Conspiracy charge, 7 charges of Causing the Introduction of Misbranded Drugs into Interstate Commerce with the Intent to Defraud or Mislead, 5 charges of Causing the Introduction of Misbranded Drugs into Interstate Commerce (Imitation Drugs), 7 Smuggling charges, and 4 Tampering with a Witness, Victim, or Informant charges.</p> <p>The tampering charges were for both destroying evidence and for instructing a co-conspirator to destroy incriminating evidence, including the illegally imported drugs. The defendants were also accused of assaulting a co-conspirator in an attempt to insure that he would not assist law enforcement with their case.</p> <p>Nix’ co-defendants Thomas Giddens and Wanda Hollis pleaded guilty to a single count of conspiracy to smuggle drugs into the United States as well. Giddens and Hollis were sentenced to 15 months in prison in October 2015.</p> <p>This case was investigated by the FDA’s Office of Criminal Investigations and U.S. Immigration and Customs Enforcement’s Homeland Security Investigations. The case was prosecuted by Assistant U.S. Attorney Allen Hurst for the U.S. Attorney’s Office for the Eastern District of Texas and by Trial Attorney John W.M. Claud of the Civil Division’s Consumer Protection Branch.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 29 Feb 2016 06:26:00 -0800 http://www.safemedicines.org/2016/02/pakistani-businessman-extradited-charged-with-wholesale-counterfeit-drug-importation.html http://www.safemedicines.org/2016/02/pakistani-businessman-extradited-charged-with-wholesale-counterfeit-drug-importation.html The United States Department of Justice (DOJ) has announced that a Karachi native has been extradited from Germany to face counterfeit drug charges in the United States. According to the DOJ, Junaid Qadir appeared in a Federal courtroom in Denver to face charges that he and his Pakistani business partners were acting as prescription drug wholesalers, and offering bulk counterfeit medications to U.S. fake drugs resellers. <p><strong>After a 3-year effort to bring him to justice, Junaid Qadir has been indicted in Federal court on charges he illegally imported bulk counterfeit medications into the United States. </strong></p> <p>The<a href="http://www.justice.gov/usao-co/pr/pakistani-man-makes-appearance-us-district-court-denver-following-indictment-and-arrest" target="_blank"> United States Department of Justice (DOJ)</a> has announced that a Karachi native has been extradited from Germany to face counterfeit drug charges in the United States. According to the DOJ, Junaid Qadir appeared in a Federal courtroom in Denver to face charges that he and his Pakistani business partners were acting as prescription drug wholesalers, and offering bulk counterfeit medications to U.S. fake drugs resellers.</p> <p>The DOJ reports that Qadir was originally indicted in 2012 on counterfeit drug charges, and was charged with a superseding indictment in June 2015, after he travelled to Germany and was apprehended by authorities there. After fighting extradition, Qadir was finally brought to the United States and made his first appearance in Denver’s Federal Court in January of this year.</p> <p>According to the DOJ, Qadir faces the following charges: “Introduction and Delivery for Introduction of Unapproved New Drugs into Interstate Commerce, Introduction and Delivery for Introduction of Misbranded Drugs into Interstate Commerce, Sale of Counterfeit Drugs, Importation of Schedule IV Controlled Substances, Distribution of Scheduled IV Controlled Substances, Importation of Merchandise Contrary to Law, Conspiracy to Defraud the U.S. and Commit Offenses Against the U.S., Conspiracy to Import Schedule IV Controlled Substances and Conspiracy to Distribute and Possess with Intent to Distribute Schedule IV Controlled Substances. Penalties for these offenses range from not more than 3 years in federal prison per count, to not more than 20 years in federal prison per count. Each count also carries a penalty of up to a $250,000 fine.”</p> <p>The DOJ also reports that court documents describe Qadir and his brother as “principals of a family owned and operated business in Karachi, Pakistan known as JNS Impex. This company held itself out to be, among other things, a leading and long-standing exporter of branded and generic pharmaceutical drugs and surgical products. They wrongly claimed it had access to and could supply most brand name pharmaceutical products; that it was affiliated with many multinational pharmaceutical manufacturers; and that it was licensed to distribute and export over-the-counter, prescription and narcotic pharmaceutical drugs. At no time were they associated or registered with the DEA to import controlled substances into the U.S. or to distribute controlled substances in the United States.”</p> <p>According to the <a href="http://www.denverpost.com/business/ci_29460585/pakistani-man-charged-importing-fake-narcotics-viagra-us" target="_blank">Denver Post</a>, “JNS Impex took orders online, mostly from people operating Internet pharmacies that would sell the drugs to customers who did not have prescriptions. The orders were filled by suppliers in Pakistan, India, the U.K. and China. Often they were shipped loose in plastic vitamin and water bottles, or mailed without packaging, patient safety information or other written instructions.”</p> <p>U.S. Attorney John Walsh, as quoted by the DOJ, remarked that &quot;This case should be a reminder to everyone that buying counterfeit prescription drugs online from overseas pharmacies is playing with fire. An online buyer of such drugs has no idea what drug or substance they are actually receiving.”</p> <p>This case was investigated by Homeland Security Investigations, the Food and Drug Administration Office of Criminal Investigations, and the U.S. Postal Inspection Service. The case is being prosecuted by Assistant U.S. Attorney Kenneth M. Harmon.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 22 Feb 2016 06:54:00 -0800 http://www.safemedicines.org/2016/02/florida-businessman-pleads-guilty-to-selling-fake-misbranded-drugs.html http://www.safemedicines.org/2016/02/florida-businessman-pleads-guilty-to-selling-fake-misbranded-drugs.html Robert Lohr sold the fakes via a fake pharmacy known as either “American Drug Club of Bradenton” or “Canadian American Drug Club.” Lohr made over $1 million selling his counterfeit medication to unsuspecting patients. <p><strong>Robert Lohr sold the fakes via a fake pharmacy known as either “American Drug Club of Bradenton” or “Canadian American Drug Club.” Lohr made over $1 million selling his counterfeit medication to unsuspecting patients. </strong></p> <p>The <a href="http://www.justice.gov/usao-mdfl/pr/bradenton-man-pleads-guilty-selling-counterfeit-unapproved-and-misbranded-drugs" target="_blank">United States Department of Justice (DOJ)</a> reports that Bradenton, Florida resident Robert Lohr has pleaded guilty to conspiracy to smuggle goods into the United States. Lohr sold both counterfeit name-brand prescription medications and so-called herbal supplements that were in fact made up of prescription drugs, according to the DOJ.</p> <p>The counterfeits he sold ranged from counterfeits of Lipitor (a statin), Aciphex (an acid-reflux treatment) and various ED medications, as well as herbal dietary supplements made of real unlisted medicine ingredients that were offered for all manner of ailments.</p> <p>The DOJ notes that “At no time was Lohr ever licensed as a pharmacist, a drug importer, or drug wholesaler. Neither was American Drug Club a licensed pharmacy or licensed drug importer or wholesaler.”</p> <p>“Lohr generated more than $1.1 million in sales from these counterfeit drugs. The proceeds were deposited in the form of cash, third-party customer checks, and bank card transactions into business and personal bank accounts controlled by Lohr and others,” according to the DOJ.</p> <p>The <a href="http://www.bradenton.com/news/local/crime/article56900818.html" target="_blank">Bradenton Herald</a> reports, “Between March 21, 2014, and Sept. 15, several undercover purchases of misbranded, unapproved and counterfeit prescription drugs were made from Lohr's business.”</p> <p>U.S. Immigration and Customs Enforcement’s Homeland Security Investigations and the United States Food and Drug Administration have investigated this case and Assistant United States Attorneys Kelley Howard-Allen and Holly Gershow are acting as prosecutors in the case.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Wed, 03 Feb 2016 06:09:00 -0800 http://www.safemedicines.org/2016/01/death-in-la-county-highlights-the-dangers-of-counterfeit-medication.html http://www.safemedicines.org/2016/01/death-in-la-county-highlights-the-dangers-of-counterfeit-medication.html LA County officials warn public about the toxic threat that fake medications pose, and share a tragic story about a woman whose efforts to save money by using non-FDA approved treatments led to her death. An NBC News story shares... <script type="text/javascript" charset="UTF-8" src="http://www.nbcnewyork.com/portableplayer/?cmsID=366643001&videoID=8GSzFx8hlUbz&origin=nbcnewyork.com&sec=news&subsec=national-international&width=600&height=360"></script> <p><strong>LA County officials warn public about the toxic threat that fake medications pose, and share a tragic story about a woman whose efforts to save money by using non-FDA approved treatments led to her death. </strong></p> <p>An <a href="http://www.nbcnewyork.com/news/national-international/fake-pharmaceuticals-pills-danger-warning-la-county-health-toxic-death-366637811.html" target="_blank">NBC News</a> story shares the details of a counterfeit medication death in Los Angeles County. Esmeralda Mendez described for NBC News how her sister, suffering from chronic pain, purchased unlicensed medication. Instead of being cured by the administered injection, Ms. Mendez’ 40 year old sister died within a few hours of being treated.</p> <p>As Dr. Marv Shepherd, Partnership for Safe Medicines’ board member warns in a recent public service announcement, "Counterfeit pharmaceutical medication kills. These fake drugs are often made with toxic chemicals and are stored in filthy conditions."</p> <p>According to NBC News, non-FDA approved medications are often sought out as a “cheaper alternative” to genuine medication. Instead of submitting to unlicensed sources that sell potentially life threatening counterfeits, patients can turn to nonprofit organizations like www.NeedyMeds.org and www.Pparx.org that provide low-to-no-cost assistance for people who cannot afford their medicine.</p> <p>To find out how you can save on medication without endangering your health, please read <a href="http://www.safemedicines.org/save-money-safely-on-prescriptions-from-online-pharmacies.html" target="_blank">Save Money Safely on Prescriptions from Online Pharmacies</a>.</p> <p><span style="font-weight: 400;">To learn more about the dangers of counterfeit medication, please watch:</span></p> <iframe src="https://player.vimeo.com/video/152612452" width="500" height="281" frameborder="0" webkitallowfullscreen mozallowfullscreen allowfullscreen></iframe> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Marv D. Shepherd, PhD News Partnership News SafeMedicines Editor Wed, 27 Jan 2016 13:58:34 -0800 http://www.safemedicines.org/2015/12/when-buying-from-a-fake-online-pharmacy-iracm-wants-you-to-know-its-all-fake-12-16-15.html http://www.safemedicines.org/2015/12/when-buying-from-a-fake-online-pharmacy-iracm-wants-you-to-know-its-all-fake-12-16-15.html A new campaign by International Institute for Research Against Counterfeit Medicines (IRACM) aims to educate patients that anyone with access to the Internet can be exposed to counterfeit drugs via fake online pharmacies. Did you realize that of 331,430 websites... <p><strong>A new campaign by International <a href="http://www.iracm.com/en/" target="_blank">Institute for Research Against Counterfeit Medicines (IRACM)</a> aims to educate patients that anyone with access to the Internet can be exposed to counterfeit drugs via fake online pharmacies. </strong></p> <p>Did you realize that of 331,430 websites monitored by <a href="https://www.legitscript.com/" target="_blank">Legitscript</a>, a whopping 94.3% are selling pharmaceuticals illegally? The Wild West nature of online drug selling is what inspired IRACM to launch their <a href="http://www.iracm.com/en/2015/12/buying-drugs-on-internet-yes-but-not-just-anyhow/" target="_blank">“It’s All Fake!”</a> campaign.</p> <p>Watch the “It’s All Fake!” video to find out just how easy it is to get duped by a fake online pharmacy.</p> <iframe width="560" height="315" src="https://www.youtube.com/embed/cKcJsvzFKCs" frameborder="0" allowfullscreen></iframe> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Tue, 15 Dec 2015 09:57:16 -0800 http://www.safemedicines.org/2015/11/interchange-2014-highlights-mississippi-attorney-general-jim-hood-speaks-fights-counterfeits-at-the-12-14-15.html http://www.safemedicines.org/2015/11/interchange-2014-highlights-mississippi-attorney-general-jim-hood-speaks-fights-counterfeits-at-the-12-14-15.html Mississippi Attorney General Jim Hood, who has made significant contributions to state-based efforts to protect Americans from counterfeit products, offered an attorney general's perspective on working collaboratively with Federal agencies to fight counterfeit medicines. <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb089786b2970d-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401bb089786b2970d img-responsive" alt="Jim Hood 5" title="Jim Hood 5" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb089786b2970d-320wi" style="margin: 0px 5px 5px 0px;" /></a><p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Mississippi Attorney General Jim Hood, who has made significant contributions to state-based efforts to protect Americans from counterfeit products, was the first keynote speaker at PSM's 2014 Interchange. "By following up aggressively on all claims involving counterfeits," said PSM treasurer Tom Kubic, who introduced A.G. Hood, "Attorney General Hood has done something new and he showed us that the fight to protect consumers against counterfeit drugs is not just a Federal responsibility...Were the other 49 state attorney generals equally engaged in the fight against counterfeits, I believe the landscape would look significantly different today."</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Hood offered an attorney general's perspective on working collaboratively with Federal agencies to fight counterfeit medicines and spoke about confronting other illicit trade in his state. He also recounted the efforts of the National Association of Attorneys General (NAAG) to discourage the sale of black market medicines by pressuring the industries that create the infrastructure that supports the counterfeit drug trade. NAAG has been particularly successful in persuading banks to stop processing payments for fake drug distributors and continues to pressure companies such as Google, whose search engines lead consumers to dangerous fake online pharmacies, to be good corporate citizens: &nbsp;&nbsp;</span></p> <p><span style="font-weight: 400; font-family: arial, helvetica, sans-serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;They say, "you come tell us what you find out there." They want the government to carry the water for them. They want us in law &nbsp;&nbsp;&nbsp;&nbsp;enforcement to go out here and patrol everything they put up on the internet and tell them what’s wrong. Well, it doesn’t work &nbsp;&nbsp;&nbsp;&nbsp;that way. You know, they have a responsibility. &nbsp;&nbsp;&nbsp;</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Watch Attorney General Hood's keynote in its entirely:</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/hO8--S2-cBI?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" width="560"></iframe></span></p> <p>&nbsp;</p> <p><span style="font-weight: 400; font-family: arial, helvetica, sans-serif; font-size: 11pt;">Read about Google and illegal online pharmacies:</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><a href="http://www.safemedicines.org/2014/08/google-settles-with-shareholders-agrees-to-set-up-250-million-internal-program-to-weed-out-fake-onli-8-25-14.html" target="_blank"><span style="font-weight: 400;">Google Settles With Shareholders, Agrees To Set Up $250 Million Internal Program To Weed Out Fake Online Pharmacy Advertising</span></a><span style="font-weight: 400;"> (August 27, 2014)</span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><a href="http://www.safemedicines.org/2014/07/mississippi-attorney-general-targets-google-in-illicit-drug-ad-crackdown-7-30-14.html" target="_blank"><span style="font-weight: 400;">Mississippi Attorney General Targets Google in Illicit Drug Ad Crackdown</span></a><span style="font-weight: 400;"> (July 31, 2014)</span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><a href="http://www.safemedicines.org/2014/04/24-state-attorney-generals-talk-with-google-about-protecting-consumers-from-fake-online-pharmacies-4-18-14.html" target="_blank"><span style="font-weight: 400;">24 State Attorney Generals Talk with Google About Protecting Consumers from Fake Online Pharmacies</span></a><span style="font-weight: 400;"> (April 28, 2014)</span></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">&nbsp;</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></span></p> News Partnership News SafeMedicines Editor Mon, 14 Dec 2015 18:28:00 -0800 http://www.safemedicines.org/2015/12/psm-board-president-dr-marv-shepherd-explains-the-dangers-of-drug-importation-12-8-15.html http://www.safemedicines.org/2015/12/psm-board-president-dr-marv-shepherd-explains-the-dangers-of-drug-importation-12-8-15.html PSM Board member Dr. Marvin Shepherd was recently interviewed on a local Austin radio station. He described for listeners the realities of the counterfeit medication economy, and the dangers U.S. citizens face from imported medication. <p><strong> <br /> <a class="asset-img-link" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb089b9468970d-pi" style="float: left;"><img alt="MarvShepherd_778x707" class="asset asset-image at-xid-6a00e5550359d1883401bb089b9468970d img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb089b9468970d-320wi" style="margin: 0px 5px 5px 0px;" title="MarvShepherd_778x707" /></a>Dr. Shepherd was interviewed on a local Austin radio station and described for listeners the realities of the counterfeit medication economy, and the dangers U.S. citizens face from imported medication.</strong></p> <p>After William Scully, owner of the unlicensed pharmaceutical importer <a href="http://www.safemedicines.org/2015/11/new-york-man-who-ran-medical-device-king-convicted-in-prescription-drug-importation-scheme-11-24-15.html" target="_blank">Medical Device King/Pharmalogical</a>, was convicted on charges relating to his drug importation business, Bill Swail, host of the Austin radio program “<a href="http://www.talkradio1370am.com/Let-s-Get-Healthy-with-Bill-Swail/11925688" target="_blank">Let’s Get Healthy</a>” invited Dr. Marv Shepherd to come on the show and talk about the dangers of drug importation.</p> <p>In his interview, Dr. Shepherd, when asked about the size of the global counterfeit drug economy said, “It’s huge! It’s a $200 billion industry. Most of the fake medication is coming through rogue websites, which are spread all over the world. [They are fake] even though they look legitimate and look like they are U.S. or Canadian.”</p> <p>Dr. Shepherd also stated that the U.S. sees about 80 major drug counterfeiting cases a year.</p> <p>On being asked about elected officials who are advocating drug importation, Dr. Shepherd said “There are some candidates for president and some legislators that want to legalize drug importation…with the U.S.’ closed system, we have a closed distribution system, we pretty much filter out all those bad types of products.”</p> <p>Listen to Dr. Shepherd’s <a href="https://archive.org/details/peoplesrx_112315" target="_blank">entire interview here (starting at 13:43)</a>.</p> <p><a href="http://www.safemedicines.org/2009/02/what-you-dont-know-about-importing-drugs-from-canada.html" target="_blank">Learn more about why drug counterfeiters use Canada as a marketing ploy</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> <p>&#0160;</p> News Partnership News SafeMedicines Editor Tue, 08 Dec 2015 18:35:01 -0800 http://www.safemedicines.org/2015/11/interchange-2014-highlights-deputy-commissioner-howard-sklamberg-on-new-legislation-and-fdas-work-in-12-7-15.html http://www.safemedicines.org/2015/11/interchange-2014-highlights-deputy-commissioner-howard-sklamberg-on-new-legislation-and-fdas-work-in-12-7-15.html During PSM's 2014 Interchange, Howard Sklamberg, the FDA's Deputy Commissioner for Global Regulatory Operations and Policy gave an overview of the FDA's work in protecting the safe drug supply chain and of legislation enacted in 2012 and 2013. <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7f3621a970b-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c7f3621a970b img-responsive" alt="Howard Skalmberg Keynote 2" title="Howard Skalmberg Keynote 2" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7f3621a970b-320wi" style="margin: 0px 5px 5px 0px;" /></a><p>During PSM's 2014 Interchange, Howard Sklamberg, the Food and Drug Administration's Deputy Commissioner for Global Regulatory Operations and Policy and the conference's second keynote speaker, gave an overview of the FDA's work in protecting the safe drug supply chain. He introduced the audience to the <a href="http://www.fda.gov/downloads/newsevents/newsroom/factsheets/ucm349286.pdf" target="_blank">CD3</a>, a portable device which will be used by FDA investigators to detect counterfeit products, spoke about the agency's participation in <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398499.htm" target="_blank">Operation Pangea</a> and mentioned the <a href="http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/buyingmedicinesovertheinternet/besaferxknowyouronlinepharmacy/default.htm" target="_blank">BeSafeRx campaign</a>, an education effort that teaches Americans how to safely source their medicines.</p> <p>Sklamberg also spoke about legislation enacted in 2012 and 2013 which provides the FDA with greater power to protect the American public from fake medicines. The<a href="http://www.safemedicines.org/2014/08/deputy-commissioner-sklamberg-describes-fdas-new-powers-to-combat-fake-drugs-on-a-global-scale-8-6-14.html" target="_blank"> Food and Drug Administration Safety and Innovation Act (FDASIA)</a> expands FDA's authority to confiscate and destroy adulterated, misbranded or counterfeit drugs and requires companies working in the drug supply chain to communicate with the FDA about threats to supply chain security. A second law, <a href="http://www.safemedicines.org/track-and-trace-legislation-resource-page.html" target="_blank">the Drug Quality and Security Act (DQSA),</a> outlines steps to build an electronic system that will allow pharmaceutical companies, law enforcement and regulatory agencies to exchange information at the individual package level about where a drug has been in the supply chain. That specificity will enable supply chain actors to better check the legitimacy of medicines and make warnings and recalls more efficient.</p> <p>FDA's ongoing work, public education and improved regulation are "real successes, real skirmishes won in this overall battle," Sklamberg stated, but the challenge continues:</p> <p>The bad actors are all over the globe. They can get to our shores in numerous and devious ways and they can operate like ghosts, from a single computer terminal which a reach to millions of individuals, from every point of the compass...It’s difficult because what we’re dealing with here in many instances is international organized crime…and when you look at the cases we work on, you see actors in countries all over the globe involved in money moving around using the most sophisticated techniques that international organized crime uses.</p> <p>Watch Deputy Commissioner Sklamberg's speech in its entirety:</p> <iframe width="560" height="315" src="//www.youtube.com/embed/NIfirwrsz2Y?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" frameborder="0" allowfullscreen></iframe> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 07 Dec 2015 06:19:00 -0800 http://www.safemedicines.org/2015/12/letter-to-us-senate-opposing-drug-importation-12-1-15.html http://www.safemedicines.org/2015/12/letter-to-us-senate-opposing-drug-importation-12-1-15.html As a coalition whose outreach and operations involve educating health care workers and patients in all fifty states, and whose membership is comprised of more than 60 organizations committed to the safety of prescription drugs and protecting U.S. consumers against counterfeit, substandard or otherwise unsafe medicines, we are deeply concerned that importation proposals will undermine America’s existing and proposed drug safety protocols. <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Recently, conversations and debate about drug importation has reached a fever pitch. Partnership For Safe Medicines&#39; many coalition members want Congress to know about our concerns for the safety of American patients. The secure American drug supply chain protects American consumers from dangerous counterfeit, substandard and unsafe medicines. Any effort designed to bypass FDA controls tears open the safe, closed supply chain and exposes U.S. patients to serious risk.</span></strong></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">December 1, 2015</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Dear Senator,</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">As a coalition whose outreach and operations involve educating health care workers and patients in all fifty states, and whose membership is comprised of more than 60 organizations committed to the safety of prescription drugs and protecting U.S. consumers against counterfeit, substandard or otherwise unsafe medicines, we are deeply concerned that importation proposals will undermine America’s existing and proposed drug safety protocols.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Whether offered broadly or for a narrow set of medications, there’s never a good time to sacrifice safety. No patient is served well by a drug from an unknown source, that has been stored under unknown conditions, and which contains unknown ingredients because it passed through unlicensed, foreign middlemen who operate beyond U.S. law. Drug importation advocates believe that drugs purchased from countries such as Canada and the United Kingdom are safe because of their strict health regulations. Unfortunately, this is simply not true. There is no regulation for products trans-shipped through &quot;safe&quot; countries such as Canada and the United Kingdom and thus, Americans would be put at great risk.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Proposals allowing importation would undermine nearly two decades of drug safety policy. Large volume importation of prescription drugs could be permitted under current law only if the Health and Human Services (HHS) Secretary was willing to certify that imported drugs &quot;pose no additional risk to the public&#39;s health and safety, and result in a significant reduction in the cost of covered products to the American consumer.&quot; Recent HHS Secretaries have not been willing to make this certification of &quot;no risk.&quot; We urge you to focus on creating substantive programs that protect the nation’s drug supply to maintain access to safe medicines.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">With very best regards,</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Marv Shepherd, PhD President, Partnership for Safe Medicines,&#0160;Director of Pharmaeconomics, University of Texas School of Pharmacy</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Thomas T. Kubic President &amp; CEO, Pharmaceutical Security Institute Deputy Assistant Director, Criminal Division, FBI (Retired)</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Jim Dahl Assistant Director, FDA Office of Criminal Investigations (retired) Board member, Partnership for Safe Medicines</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Additional signers (alphabetical)</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Edith A. Rosato, RPh, IOM Chief Executive Officer, Academy of Managed Care Pharmacy</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Brian Kennedy Executive Director, Alliance for Patient Access</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Kelly Fine Ridgway, RPh. Chief Executive Officer, Arizona Pharmacy Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Todd Gillenwater Executive Vice President, Advocacy and External Relations California Life Sciences Association (CLSA)</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">John M. Gray President and Chief Executive Officer, Healthcare Distribution Management Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Steve Issenman Sr. Vice President, HealthCare Institute of New Jersey</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Mary R. Grealy President, Healthcare Leadership Council</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Garth K. Reynolds, RPh Executive Director, Illinois Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Michael R. Cohen, RPh, MS, ScD (hone), DPS (hon) Institute for Safe Medication Practices</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Bob Barchiesi President, International AntiCounterfeiting Coalition</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Robert L. McFalls Executive Director/CEO, Kentucky Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Todd Brown MHP, R.Ph. Executive Director, Massachusetts Independent Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Brandon Leonard, MA Director, Strategic Initiatives, Men&#39;s Health Network</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Larry Wagenknecht, Pharmacist Chief Executive Officer, Michigan Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Ron Fitzwater, CAE, MBA Chief Executive Officer, Missouri Pharmacy Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Rebecca P. Snead Chief Executive Officer, National Alliance of State Pharmacy Associations</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Carmen A. Catizone, MS, RPh, DPh Executive Director/Secretary, National Association of Boards of Pharmacy</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Tom O’Donnell Vice President, Federal Government Affairs, National Association of Chain Drugs Stores</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Charlie Cichon Executive Director, National Association of Drug Diversion Investigators</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Joe Trauger Vice President, Government Relations, National Association of Manufacturers</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Douglas Liptak President, National Biopharmaceutical Security Council</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Joni Cover, J.D. Chief Executive Officer, Nebraska Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Rich Sagall, MD President, NeedyMeds</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Elise M. Barry, M.S., CFRE Chief Executive Officer, New Jersey Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Ernest Boyd, Pharm.D (hon), MBA Ohio Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Debra Billingsley, JD Executive Director, Oklahoma Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Patricia A. Epple, CAE Chief Executive Officer, Pennsylvania Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Tim Dickson Executive Director, Pharmaceutical Industry Labor Management Association (PILMA)</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Thair Phillips President, RetireSafe</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Craig M. Burridge, M.S., CAE Chief Executive Officer, South Carolina Pharmacy Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Bruce Josten Executive Vice President, Government Affairs, US Chamber of Commerce</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Thomas J. Berger, Ph.D. Executive Director, The Veterans Health Council of Vietnam Veterans of America</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Timothy S. Musselman, Pharm.D. Executive Director, Virginia Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Richard Stevens, Executive Director, West Virginia Pharmacists Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Chester “Chip” Davis, Jr.,&#0160;President and Chief Executive Officer, Generic Pharmaceutical Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Louise F. Jones, Executive Director, &#0160;Alabama Pharmacy Association</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">William E. Arnold, Community Access National Network (CANN)</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">William P. Bro, President, CEO, and Patient-Survivor Coordinator, Kidney Cancer Association</span></p> News Partnership News SafeMedicines Editor Tue, 01 Dec 2015 09:23:14 -0800 http://www.safemedicines.org/2015/11/interchange-2014-highlights-eric-sampson-on-the-cdc-foundations-plans-to-combat-fake-drugs-11-30-15.html http://www.safemedicines.org/2015/11/interchange-2014-highlights-eric-sampson-on-the-cdc-foundations-plans-to-combat-fake-drugs-11-30-15.html Hear Senior Science Advisor Eric Sampson talk about the CDC Foundation's plans to study the impact of counterfeit drugs and educate the public health community about the black market. <p><strong> <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d16a8bde970c-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401b8d16a8bde970c img-responsive" style="margin: 0px 5px 5px 0px;" title="Panel 4 Eric Sampson 2" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d16a8bde970c-120wi" alt="Panel 4 Eric Sampson 2" /></a>Hear Senior Science Advisor Eric Sampson talk about the CDC Foundation's plans to study the impact of counterfeit drugs and educate the public health community about the black market. </strong></p> <p>At <a href="http://www.safemedicines.org/counterfeit-drug-conference-2014.html" target="_blank">PSM's 2014 Interchange</a>, Eric Sampson, Senior Science Advisor at the <a href="http://www.cdcfoundation.org/" target="_blank">CDC Foundation</a>, spoke about the CDC Foundation's plans to establish public/private partnerships to make the non-regulatory public health community aware of the pharmaceutical black market. Sampson said that the CDC is well-positioned to gather information about how many people are exposed to counterfeit medicines and about their health outcomes. "There is a very high risk of exposures that have been alluded to in today's meeting--heavy metals, harmful substances that have been substituted in prescription medicines," said Sampson, "and they will be asking questions like 'show me the most current list of those items.'"</p> <p>Watch Sampson's remarks in the embedded YouTube video below, or hear the whole panel, <a href="https://youtu.be/k_NeOtdwEQE" target="_blank">"How the Black Market Impacts Patients"</a> on PSM's YouTube channel. Eric Sampson remarks start at 18:42</p> <iframe width="560" height="315" src="//www.youtube.com/embed/k_NeOtdwEQE?start=1122 frameborder="0" allowfullscreen></iframe> <p>&nbsp;</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 News Partnership News SafeMedicines Editor Mon, 30 Nov 2015 07:15:00 -0800 http://www.safemedicines.org/2015/11/new-york-man-who-ran-medical-device-king-convicted-in-prescription-drug-importation-scheme-11-24-15.html http://www.safemedicines.org/2015/11/new-york-man-who-ran-medical-device-king-convicted-in-prescription-drug-importation-scheme-11-24-15.html Long Island drug importation kingpin convicted in case that exposed thousands of unsuspecting Americans to misbranded and counterfeit medication produced abroad. On November 12, 2015, William Scully, co-owner of a broad-ranging drug importation business called Pharmalogical Inc./Medical Device King was... <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401a3fd1c5bfb970b-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401a3fd1c5bfb970b img-responsive" alt="Medical Device King" title="Medical Device King" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401a3fd1c5bfb970b-800wi" border="0" style="margin: 0px 5px 5px 0px;" /></a><p><p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">Long Island drug importation kingpin convicted in case that exposed thousands of unsuspecting Americans to misbranded and counterfeit medication produced abroad. </span></strong></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">On November 12, 2015, William Scully, co-owner of a broad-ranging drug importation business called Pharmalogical Inc./Medical Device King was convicted of 66 charges related to his unsanctioned pharmaceutical wholesaling business. According to the <a href="http://www.safemedicines.org/MDK/Scully%20Jury%20Verdict.pdf" target="_blank">jury verdict</a> in his trial, Scully was convicted of wire and mail fraud, along with the introduction of misbranded drugs into interstate commerce and the resale of same. Scully was illegally importing prescription medication, and distributing it via sale to hundreds of doctors and clinics throughout the United States, according to a report in <a href="http://www.newsday.com/long-island/suffolk/william-scully-of-commack-convicted-of-distributing-unapproved-drugs-officials-say-1.11135936?qr=1" target="_blank">Newsday</a>. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">The case began in 2013, when the Food and Drug Administration (FDA) sent warnings out to <a href="http://www.fda.gov/downloads/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/UCM358844.pdf" target="_blank">781 doctors and clinics</a> in 48 states warning that Medical Device King (MDK) was an unlicensed pharmaceutical wholesaler. The <a href="http://www.fda.gov/drugs/drugsafety/drugintegrityandsupplychainsecurity/ucm358535.htm" target="_blank">warning letter states</a> “Prescription drugs distributed by MDK may be counterfeit drugs (not manufactured or distributed by the company indicated on their label); and/or may be drugs from foreign or unknown sources that are not approved for distribution in the United States. These drugs may have unknown ingredients, or may not have been manufactured, transported or stored under proper conditions as required by U.S. law, regulations, and standards.” </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">The FDA warning went on to explain that FDA lab tests on specific lots of vial labeled “Avastin,” and found that at least one contained no active ingredient at all. The warning went on to inform recipients that MDK was offering at least 30 other medications, including several cancer treatments for which there could be no guarantee of provenance. According to the FDA, “these drugs have not undergone scientific and regulatory review by FDA to ensure their safety and efficacy. While these drugs purport to have the same active ingredients as other drug products that have U.S. market approval, they are not legally marketed and have not been established by FDA to be therapeutically equivalent to or interchangeable with U.S. approved products that contain the same active ingredients.” </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;"><a href="http://www.safemedicines.org/MDK/Medical_Device_King_Superceding_Indictment_7-15.pdf" target="_blank">Scully’s indictment</a> claimed that Medical Device King was selling imported misbranded and counterfeit prescription drugs originally shipped from the United Kingdom, Turkey, the Cayman Islands, Canada, United Arab Emirates, Switzerland and India. The drugs were misrepresented as FDA approved drugs. According to the indictment, approximately 1,000 medical practices purchased the illegally imported pharmaceuticals from Medical Device King. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">MDK's overseas suppliers included <a href="http://www.safemedicines.org/2014/04/turkish-drug-manufacturer-accused-of-packaging-water-and-mold-in-cancer-drug-vials-4-3-14.html" target="_blank">Ozay Pharmaceuticals</a>, a Turkish company that sold Altuzan with no active ingredient to <a href="http://www.safemedicines.org/2013/07/british-owner-of-fake-cancer-drug-distributor-sentenced-in-federal-court-1.html" target="_blank">Richard Taylor</a>, a United Kingdom drug wholesaler who sold it to American medical practices. Two of <a href="http://www.justice.gov/usao-edmo/pr/two-turkish-nationals-indicted-smuggling-counterfeit-cancer-drug" target="_blank">Ozay's executives were indicted</a> in January 2014. They pleaded guilty in <a href="http://www.justice.gov/usao-edmo/pr/turkish-man-pleads-guilty-smuggling-counterfeit-cancer-drugs" target="_blank">July</a> and <a href="http://www.justice.gov/usao-edmo/pr/turkish-man-pleads-guilty-smuggling-adulterated-cancer-drugs" target="_blank">August 2014</a>, respectively. One, <a href="http://www.justice.gov/usao-edmo/pr/turkish-man-sentenced-smuggling-counterfeit-cancer-drugs" target="_blank">Okzan Semizoglu</a> was sentenced to 27 months in October 2014. </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 11pt;">According to the <a href="http://www.justice.gov/usao-edny/pr/two-officers-long-island-based-company-indicted-sale-17-million-worth-misbranded" target="_blank">Department of Justice press release</a> on the occasion of Scully’s indictment, Scully faces a maximum sentence of 20 years and fines of over $17 million.</span></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Tue, 24 Nov 2015 16:08:55 -0800 http://www.safemedicines.org/2015/11/interchange-2014-highlights-kimberly-new-explains-the-dangers-of-drug-diversion-in-hospital-settings-11-23-15.html http://www.safemedicines.org/2015/11/interchange-2014-highlights-kimberly-new-explains-the-dangers-of-drug-diversion-in-hospital-settings-11-23-15.html At the 2014 Interchange, New spoke about the risk that drug diversion poses to patients who may be treated with painkillers that have been contaminated by addicts, and about the scale of drug diversion in hospitals in the United States. <p><strong> <a class="asset-img-link" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08848358970d-pi" style="float: left;"><img alt="Panel 4 Kimberly New" class="asset asset-image at-xid-6a00e5550359d1883401bb08848358970d img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08848358970d-320wi" style="margin: 0px 5px 5px 0px;" title="Panel 4 Kimberly New" /></a>At the <a href="http://www.safemedicines.org/counterfeit-drug-conference-2014.html" target="_blank">2014 Interchange</a>, New spoke about the risk that drug diversion poses to patients who may be treated with painkillers that have been contaminated by addicts, and about the scale of drug diversion in hospitals in the United States.</strong></p> <p>Kimberly New, the current president of the Tennessee Chapter of the National Association of Drug Diversion Investigators, is a consultant and educator who helps protect patients by helping medical facilities establish and refine their drug diversion programs. At the 2014 Interchange, New spoke about the risk that drug diversion poses to patients who may be treated with painkillers that have been contaminated by addicts, and about the scale of drug diversion in hospitals in the United States. &quot;At the facility that I most recently left, a large academic institution with about 550 beds,&quot; New said, &quot;we have a nursing staff of about 1000 nurses. When we started our program, I was catching 3-4 nurses per month diverting medications within the facility. Even after we had a very established proactive program and everyone was aware of that, we still were having 1-2 per month.&quot; New also spoke about the role of nurses and other hospital staff in protecting patients.</p> <p>Listen to New&#39;s comments on <a href="https://youtu.be/k_NeOtdwEQE?t=11m40s" target="_blank">YouTube</a>, Kim speaks at 11:40</p> <p>(<iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/k_NeOtdwEQE?start=700" width="560"></iframe>)</p> <p>&#0160;</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 News Partnership News SafeMedicines Editor Mon, 23 Nov 2015 07:03:00 -0800 http://www.safemedicines.org/2015/11/rogues-gallery-comics-an-illustrated-guide-to-counterfeit-drug-crime-11-16-15.html http://www.safemedicines.org/2015/11/rogues-gallery-comics-an-illustrated-guide-to-counterfeit-drug-crime-11-16-15.html Ever wonder about what’s behind the news for counterfeit drug crime? The Rogues Gallery Comic Book Series tells the real-life stories of fake drug criminals and their cases. <p><strong> <a class="asset-img-link" style="float: left;" href="http://www.safemedicines.org/infographics/RoguesGallery2.pdf"><img class="asset asset-image at-xid-6a00e5550359d1883401bb088481f7970d img-responsive" style="margin: 0px 5px 5px 0px;" title="Rogues 2" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb088481f7970d-120wi" alt="Rogues 2" /></a>Ever wonder about what’s behind the news for counterfeit drug crime? The Rogues Gallery Comic Book Series tells the real-life stories of fake drug criminals and their cases. </strong></p> <p>In volume one, you can learn all about the Greedy Doctor that lied to patients with no hope of a cure and the Master Counterfeiter whose greed drove him straight into the arms of US investigators. You will also find out about the Black Marketer who sold fake drugs to US doctors, and the mystery Criminal Mastermind responsible for introducing counterfeit cancer medication to U.S. oncology practices.</p> <p>In volume two, you’ll see the stories of The Smooth Talker and his $150,000 car, the Canadian who pioneered the fake online pharmacy business model, and the Hero Nurses that were often all that stood between oncology patients and dangerous fake medications.</p> <p><strong>Download and share The Rogues Gallery Volumes one and two today. </strong></p> <p>Rogues Gallery Landing Page: <a href="http://www.safemedicines.org/fakecancerdrugcomics.html" target="_blank">http://www.safemedicines.org/fakecancerdrugcomics.html </a></p> <p>Volume One: <a href="http://www.safemedicines.org/infographics/RoguesGallery_All_5.pdf" target="_blank">http://www.safemedicines.org/infographics/RoguesGallery_All_5.pdf </a></p> <p>Volume Two: <a href="http://www.safemedicines.org/infographics/RoguesGallery2.pdf" target="_blank">http://www.safemedicines.org/infographics/RoguesGallery2.pdf </a></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 23 Nov 2015 06:56:00 -0800 http://www.safemedicines.org/2015/11/leading-patient-advocacy-group-applauds-conviction-of-illegal-drug-supply-operators-11-19-15.html http://www.safemedicines.org/2015/11/leading-patient-advocacy-group-applauds-conviction-of-illegal-drug-supply-operators-11-19-15.html The Partnership for Safe Medicines released the following statement regarding the verdict of William Scully for operating an illegitimate drug supply company called Pharmalogical Inc., which conducts business as Medical Device King. The defendant sold more than $14 million worth... <p>The Partnership for Safe Medicines released the following statement regarding the verdict of William Scully for operating an illegitimate drug supply company called Pharmalogical Inc., which conducts business as <a href="http://www.safemedicines.org/2013/02/new-counterfeit-avastin-found-medical-practitioners-advised-by-fda-to-be-wary-of-unfamiliar-wholesal-513.html" target="_blank">Medical Device King</a>. The defendant sold more than $14 million worth of illegal products including misbranded cancer medicine, unapproved birth control devices, and other medical products to physicians, clinics, and pharmacies in the U.S. In turn the products were administered to unsuspecting patients. PSM board member Jim Dahl testified in the trial.</p> <p>“PSM applauds the verdict finding William Scully guilty of 66 crimes for his role in operating an illegal medical supply company. Illicit suppliers and distributors of misbranded prescription medicines and medical devices jeopardize the health and safety of American citizens,” said PSM President Dr. Marv Shepherd. “Medical Device King distributed drugs that were unapproved and unregulated by the FDA, without regard for the laws and regulations meant to ensure the health and safety of the American public. As we have seen in many other instances, consumers who purchase medicines from unlicensed operators, in the U.S. or abroad, are putting themselves at great risk.”</p> <p>“Unlicensed distributors like Medical Device King, domestic or foreign, prey on the greed of unscrupulous persons in the supply chain and vulnerabilities in the system and put the public health at great risk. Medical Device King and thousands of other illicit online distributors commit their crimes without regard for patient safety, and have made billions of dollars. If we allow companies such as these to exist, we take a gamble on the security of the U.S. drug supply system and ultimately, the health of our nation. We must remain steadfast in shutting down these operations and bringing these criminals to justice.”</p> <p>For further comment or to arrange an interview with Dr. Shepherd or another PSM Board member, please contact demetrios@safemedicines.org.</p> <p><strong>About the Partnership for Safe Medicines:</strong> <em>Comprised of more than 70 non-profit organizations, the Partnership for Safe Medicines is a public health group committed to the safety of prescription medicines and protecting consumers against counterfeit, substandard or otherwise unsafe medicines. PSM can be found on Facebook (<a href="http://www.facebook.com/SafeMedicines" target="_blank">http://www.facebook.com/SafeMedicines</a>), Twitter (@safemedicines), and the web at <a href="http://www.safemedicines.org" target="_blank">www.safemedicines.org</a>.</em></p> Marv D. Shepherd, PhD News Partnership News SafeMedicines Editor Thu, 19 Nov 2015 09:46:13 -0800 http://www.safemedicines.org/2015/11/leading-patient-advocate-applauds-extradition-request-in-fake-drug-case-11-11-15.html http://www.safemedicines.org/2015/11/leading-patient-advocate-applauds-extradition-request-in-fake-drug-case-11-11-15.html “Canadadrugs.com and their co-conspirators are charged with shipping $78 million of counterfeit and unapproved medicines to unsuspecting patients across the United States,” said Thomas Kubic, PSM board member and former FBI Deputy Assistant Director who spent 30 years at our nation’s top law enforcement agency. “Yet to this day and since 2002, Canadadrugs.com has been listed as an “approved” and “safe” online pharmacy by a leading U.S. firm whose business model involves helping Americans unknowingly break the law and put their welfare at risk. <p>The Partnership for Safe Medicines, the leading advocate in the fight against counterfeit drugs, released the below statement following an extradition request by U.S. authorities to bring the leaders of a massive counterfeit importation scheme to justice:</p> <p>“Canadadrugs.com and their co-conspirators are charged with shipping $78 million of counterfeit and unapproved medicines to unsuspecting patients across the United States,” said Thomas Kubic, PSM board member and former FBI Deputy Assistant Director who spent 30 years at our nation’s top law enforcement agency. “Yet to this day and since 2002, Canadadrugs.com has been listed as an “approved” and “safe” online pharmacy by a leading U.S. firm whose business model involves helping Americans unknowingly break the law and put their welfare at risk.</p> <p>“PSM applauds the prosecutors who brought this case to light, and fully supports the extraditions to ensure those responsible for preying on our patients are brought to justice. However, this case has exposed broader issues that must be addressed by national policymakers. For example, why do some candidates for federal office, including the presidency, and others continue to advocate for prescription drug importation, when it is a recipe for disaster that effectively outsources patient safety to foreign governments? And why isn’t Canada doing anything to stop these operations before their tainted products infiltrate our borders?</p> <p>“After all the damning revelations of the CanadaDrugs.com indictment and the fact that one of the defendants in the case worked for the leading illegal online pharmacy “verification” company, it’s time for our elected representatives and policymakers to take this issue seriously, and stop playing politics with patient health. Neither HHS nor FDA have ever approved importation because they know the severe threat it poses to our secure drug supply chain. This case is the best example yet why importation is both bad policy and bad politics, and should be permanently rejected. The Partnership has an abundance of resources to explain how Americans who need medicines can get help.”</p> <p>For further comment or to arrange an interview with Mr. Kubic or another PSM Board member, contact media@safemedicines.org</p> <p><em><strong>About the Partnership for Safe Medicines:</strong> Comprised of more than 70 non-profit organizations, the Partnership for Safe Medicines is a public health group committed to the safety of prescription medicines and protecting consumers against counterfeit, substandard or otherwise unsafe medicines. PSM can be found on Facebook (<a href="http://www.facebook.com/SafeMedicines" target="_blank">http://www.facebook.com/SafeMedicines</a>), Twitter (@safemedicines), and the web at <a href="www.safemedicines.org" target="_blank">www.safemedicines.org</a></em></p> News Partnership News Thomas T. Kubic SafeMedicines Editor Wed, 11 Nov 2015 13:59:34 -0800 http://www.safemedicines.org/2015/11/interchange-2014-highlights-retired-fda-oci-assistant-director-jim-dahl-speaks-about-the-impact-of-t-11-9-15.html http://www.safemedicines.org/2015/11/interchange-2014-highlights-retired-fda-oci-assistant-director-jim-dahl-speaks-about-the-impact-of-t-11-9-15.html At PSM's 2014 Interchange, Jim Dahl, a 30 year veteran of Federal law enforcement, spoke about the scale of the counterfeit drug problem in the United States and how much risk Americans should be willing to accept. <p><strong> <a class="asset-img-link" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7e0a9db970b-pi" style="float: left;"><img alt="Panel 1 Jim Dahl 2" class="asset asset-image at-xid-6a00e5550359d1883401b7c7e0a9db970b img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7e0a9db970b-120wi" style="margin: 0px 5px 5px 0px;" title="Panel 1 Jim Dahl 2" /></a>At PSM&#39;s 2014 Interchange, Jim Dahl, a 30 year veteran of Federal law enforcement, spoke about the scale of the counterfeit drug problem in the United States and how much risk Americans should be willing to accept. </strong></p> <p>PSM board member Jim Dahl is a 30 year veteran of Federal law enforcement and spent his last nine years in government as the Assistant Director of the FDA&#39;s Office of Criminal Investigations. We were fortunate to have Jim moderate our fourth panel, &quot;How the Black Market Impacts Patients,&quot; at <a href="http://www.safemedicines.org/counterfeit-drug-conference-2014.html" target="_blank">PSM&#39;s 2014 Interchange,</a> where he discussed the scale of the counterfeit drug problem in the United States:</p> <p style="padding-left: 30px;">We certainly still have the gold standard of a drug delivery system here in the United States, but one in six Americans buys drugs on the Internet without a prescription, and that&#39;s a cause for danger as we&#39;ve heard from our previous panel...What is the acceptable risk? What should we be willing to accept? I would submit to you that when it comes to prescription drugs, the acceptable risk is 0. We shouldn&#39;t accept any risk.</p> <p>You can hear all of Jim&#39;s remarks, as well as the entire panel by watching the <a href="https://youtu.be/k_NeOtdwEQE" target="_blank">YouTube video</a> embedded below, and <a href="http://www.slideshare.net/SafeMedicines/14-20-panel-4-dahl-intro" target="_blank">see his presentation slides</a> in PSM&#39;s slideshare collection.</p> <p><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/k_NeOtdwEQE?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" width="560"></iframe></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 Jim Dahl News Partnership News SafeMedicines Editor Mon, 09 Nov 2015 06:52:00 -0800 http://www.safemedicines.org/2015/11/latest-prescription-drug-counterfeiting-scheme-illustrates-the-dangers-of-importation.html http://www.safemedicines.org/2015/11/latest-prescription-drug-counterfeiting-scheme-illustrates-the-dangers-of-importation.html The Partnership for Safe Medicines released the following statement on the sentencing of Daniel Sanchez for his role in an illegal online counterfeit medicines scheme based in Pittsburgh and Houston: “Drug counterfeiters take advantage of our vulnerable citizens on a... <p>The Partnership for Safe Medicines released the following statement on the sentencing of Daniel Sanchez for his role in an&#0160;<a href="http://www.post-gazette.com/local/city/2015/10/30/Counterfeit-drug-smuggler-under-indictment-in-Pittsburgh-headed-to-prison/stories/201510300160" target="_blank">illegal online counterfeit medicines scheme</a>&#0160;based in Pittsburgh and Houston:</p> <p>“Drug counterfeiters take advantage of our vulnerable citizens on a daily basis, and have grown globally into a multibillion dollar industry,” said PSM President Marv Shepherd. “This case only serves to reinforce the danger of illegal online pharmacies, domestic or foreign, and the harm they can cause to patients. We must never allow the security and effectiveness of the U.S. drug supply chain to be compromised, and this latest example proves our commitment to combat counterfeit medications must remain as strong as ever.”</p> <p>“Sadly, there remain members of Congress and candidates for President of the United States who support practices that would make it easier for counterfeit and non-FDA approved medicines to infiltrate our drug supply chain. Prescription drug importation would only benefit the vast criminal empires, while outsourcing patient health to foreign countries.</p> <p>For further comment or to arrange an interview with Dr. Shepherd or another PSM Board member, contact&#0160;<a href="mailto:demetrios@safemedicines.org" target="_blank">demetrios@safemedicines.org</a></p> Counterfeit Drugs News Partnership News Press Releases SafeMedicines Editor Fri, 06 Nov 2015 13:16:40 -0800 http://www.safemedicines.org/2015/11/is-your-oncologist-using-unsafe-black-market-cancer-drugs-11-2-15.html http://www.safemedicines.org/2015/11/is-your-oncologist-using-unsafe-black-market-cancer-drugs-11-2-15.html The FDA has been prosecuting doctors and unlicensed drug distributors for importing non-FDA approved cancer drugs. Some of those drugs have been counterfeits. Learn more about how to detect counterfeit medication by reading our 8-Step Checklist For Medicine Safety and about recent counterfeit cancer drug prosecutions by reading PSM's Black Market Cancer Drug Cases, 2007-2013. <p><strong> <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/BlackMarketCancer_singlepage2.pdf"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c7e0a84c970b img-responsive" style="margin: 0px 5px 5px 0px;" title="Black Market Cancer" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7e0a84c970b-320wi" alt="Black Market Cancer" /></a>The FDA has been prosecuting doctors and unlicensed drug distributors for importing non-FDA approved cancer drugs. Some of those drugs have been counterfeits. </strong></p> <p>In 2011, the FDA found counterfeit cancer medication, Avastin, in the American drug supply. The lifesaving medication used to treat late stage cancer patients contained mold and water, but no active ingredient. The fake drug reached patients after <a href="http://www.safemedicines.org/how-did-that-canadian-pharmacy-medicine-get-to-me.html" target="_blank">a circuitous round-the-world journey</a> that began in Turkey, moved through several different European Union pass-through distributors and was shipped to the United States. Since then, the FDA has prosecuted at least 17 doctors, pharmacists and distributors for importing non-FDA approved chemotherapy medicines. It has also has notified 145 medical practices in 29 states that they may have purchased a counterfeit cancer medications which were distributed by a fake online Canadian pharmacy.</p> <p>The doctors who purchased these discounted drugs generated a profit for themselves by billing insurance, Medicare and patients at the same price they would for legitimate treatments. Their pursuit of profit over safety denies patients safe, reliable medication and counterfeit medication can mean a death sentence for them. However, patients who receive treatments in medical offices can take steps to protect themselves. They should ask their doctors to see their medication’s packaging, examine the product for accurate labeling, good condition of the package, and the language of the labeling. All prescriptions approved for sale in the US should have product descriptions in English.</p> <p>Learn more about how to detect counterfeit medication by reading our <a href="http://www.safemedicines.org/safedrugs.html" target="_blank">8-Step Checklist For Medicine Safety</a> and about recent counterfeit cancer drug prosecutions by reading <a href="http://safemeds.typepad.com/BlackMarketCancer_singlepage2.pdf" target="_blank">PSM's Black Market Cancer Drug Cases, 2007-2013</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 02 Nov 2015 07:35:00 -0800 http://www.safemedicines.org/2015/10/5-secrets-canadian-pharmacies-dont-want-you-to-know.html http://www.safemedicines.org/2015/10/5-secrets-canadian-pharmacies-dont-want-you-to-know.html Aren't Canadian medicines they ordered online as safe as ours? Well, no. Buying medicines from online pharmacies that claim to be selling Canadian drugs is dangerous. <p><strong><br /> <a class="asset-img-link" style="float: left;" href="http://www.safemedicines.org/2015/08/us-attorney-unseals-indictment-in-usa-v-canadadrugscom-ltd-partnership8112015.html"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c7dcba95970b img-responsive" style="margin: 0px 5px 5px 0px;" title="CanadaDrugsIndictment_promo" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7dcba95970b-320wi" alt="CanadaDrugsIndictment_promo" /></a>Consumers looking for safe prescription medication often order drugs from "Canadian" online pharmacies. Aren't the Canadian medicines they order online as safe as ours? Well, no. Buying medicines from online pharmacies that claim to be selling Canadian drugs is dangerous.</strong></p> <p><strong>1. "Canadian" online pharmacies that sell to American consumers are often just shipping companies that pretend to sell medicines meant for Canadians.</strong> In fact, they may not even be located in Canada. <a href="http://www.safemedicines.org/2013/08/clandestine-pharmaceutical-distributor-in-virginia-that-posed-as-canadian-company-shuttered-11-indic.html" target="_blank">Gallant Pharma</a>, for example, claimed to be a Canadian company, but was actually selling unapproved foreign medications from Crystal City, Virginia.</p> <p><strong>2. Drugs shipped from Canada don't always come from Canada.</strong> They can't; there isn't enough supply in Canada to satisfy U.S. demand. If just half of elderly Americans shifted their purchases to Canadian sources, <a href="http://cph.sagepub.com/content/143/5/226.short" target="_blank">it would exhaust the supply of drugs in Canada in a few months</a>.&nbsp;</p> <p>In 2005, FDA found&nbsp;that nearly half the illegally imported drugs they seized from four foreign countries were falsely labeled Canadian. <a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108534.htm" target="_blank">85% of the medicines came from 27 countries around the globe, and some of the drugs the FDA tested were found to be counterfeit.</a></p> <p><strong>3. The drugs online "Canadian" pharmacies sell may be counterfeit, contaminated or substandard.</strong> In 2011, <a href="http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm" target="_blank">counterfeit cancer medication sold as Avastin was found and tested by the FDA</a>. The medication, used to treat late stage cancer patients, contained mold and water, but no active ingredient. The company that supervised the distribution of the medication was <a href="http://www.wsj.com/articles/SB10001424052702303879604577410430607090226#articleTabs%3Dinteractive" target="_blank">CanadaDrugs.com</a>, an online pharmacy headquartered in Winnipeg, Manitoba. Ultimately, the fake medicine came from <a href="http://www.wsj.com/articles/SB10001424052702303546204579435692215579758" target="_blank">Ozay Pharmaceuticals</a>, a Turkish company illegally exporting Turkish medicines of unknown quality.</p> <p><strong>4. "Canadian" pharmacies that sell drugs to Americans are not regulated by (or accountable to) authorities.</strong> As long as they are not selling medicines to Canadians, drug exporters can bypass Canada's safety regulations and mail fake or low-quality drugs to Americans using a Canadian mailing address. <a href="http://archive.hhs.gov/importtaskforce/Report1220.pdf" target="_blank">As one Canadian official put it</a>, “Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future.”</p> <p>But the FDA isn't overseeing the drugs, either. Canadian pharmacies are not subject to the FDA's jurisdiction, which means American customers aren't protected by the FDA's safety regulations. The FDA is explicit about this risk: "Medicine bought over the Internet from foreign sources, from storefront businesses that offer to buy foreign medicine for you, or during trips outside the United States, may not be safe or effective...<a href="http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/buyingmedicinefromoutsidetheunitedstates/default.htm" target="_blank">FDA cannot help you if you have problems with medicine you get from outside U.S. regulation and oversight."</a></p> <p><strong>5. Online pharmacies that claim to source their drugs from "Tier One" countries like Australia and the United Kingdom are not providing drugs that are any safer.</strong> Online pharmacies often assure customers that their medicines come from “Tier One” countries—Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or countries in the European Union. But the concept of a Tier One country for importation is a misreading of the <a href="http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVIII-sec382.htm" target="_blank">regulations</a>, confusing export countries and import countries. The FDA has never designated any country from which it is universally safe to import medicine.</p> <p>Criminal prosecutions show that once you break the supply chain, no promise about the source of medicine can be trusted. In the <a href="http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm" target="_blank">Avastin case,</a> counterfeiters bought and sold fake product repeatedly from country to country until it arrived at in the U.K. Licensed pharmacists in countries such as the U.K. are <a href="http://www.nhs.uk/chq/Pages/1011.aspx?CategoryID=73" target="_blank">not even allowed to fill overseas prescriptions from American doctors</a>, so you know these businesses can’t be legal pharmacies.</p> <p>The bottom-line is that when consumers import their drugs from Canada they have no way of knowing what they're buying. Americans who import drugs from Canada are gambling with their health and fake online pharmacies that sell these drugs are exploiting vulnerable patient populations such as minorities, seniors, and fixed income patients.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 26 Oct 2015 14:45:00 -0700 http://www.safemedicines.org/2015/10/drug-smuggling-charge-against-ram-kamath-dropped-5-22-15.html http://www.safemedicines.org/2015/10/drug-smuggling-charge-against-ram-kamath-dropped-5-22-15.html Ram Kamath has had a single charge of smuggling dropped and is now cooperating with the authorities. Kamath was one of 14 people charged in the case USA vs. CanadaDrugs. Kamath had been accused of participating in the international drug smuggling conspiracy allegedly perpetrated by CanadaDrugs. <p><strong>Kamath was one of 14 people charged in the case USA vs. CanadaDrugs. Kamath had been accused of participating in the international drug smuggling conspiracy allegedly perpetrated by CanadaDrugs. </strong></p> <p>Ram Kamath has reached an agreement with U.S. prosecutors, and will no longer face the drug smuggling charge he was originally indicted with, reports <a href="http://www.thestar.com/news/canada/2015/10/20/charges-dropped-against-us-man-accused-in-cancer-drug-smuggling-conspiracy.html" target="_blank">The Star</a>. According to The Star, “Prosecutors who made the deal with Ram Kamath of Downers Grove asked U.S. District Judge Dana Christensen to drop the charge of conspiracy to smuggle goods into the United States against him. Kamath had been accused of conspiring with an online Canadian pharmacy to smuggle mislabeled, unapproved and counterfeit prescription drugs into the U.S.”</p> <p>According to the <a href="http://m.washingtontimes.com/news/2015/oct/20/illinois-man-makes-deal-drug-smuggling-charge-drop/" target="_blank">Washington Times</a>, the “U.S. Attorney’s Office spokeswoman, Melissa Hornbein declined to say what specific requirements are in Kamath’s agreement. Kamath’s attorney, Max Davis, did not immediately respond to a call for comment on Tuesday.”</p> <p>Kamath is one of 14 people that have been charged in the CanadaDrugs prosecution, but according to the Washington Times, he is the only one of the 14 that has thus far appeared in U.S. Court.</p> <p>To find out the latest about the U.S. case against CanadaDrugs, please visit our informational page, US Attorney Unseals Indictment In &quot;<a href="http://www.safemedicines.org/2015/08/us-attorney-unseals-indictment-in-usa-v-canadadrugscom-ltd-partnership8112015.html" target="_blank">USA V. CanadaDrugs.Com Ltd. Partnership Case”</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Thu, 22 Oct 2015 15:42:43 -0700 http://www.safemedicines.org/2015/10/texas-oncologist-sues-drug-counterfeiter-for-selling-him-fake-drugs-5-20-15.html http://www.safemedicines.org/2015/10/texas-oncologist-sues-drug-counterfeiter-for-selling-him-fake-drugs-5-20-15.html Dr. Mohamad Ayman Ghraowi has filed suit against Canada Drugs subsidiaries Montana Healthcare Solutions and Rockeley Ventures, for supplying his practice with counterfeit cancer medication, the Courthouse News Service (CNS) reports. <p><strong>Dr. Mohamad Ayman Ghraowi has filed suit against Canada Drugs subsidiaries Montana Healthcare Solutions and Rockeley Ventures, for supplying his practice with counterfeit cancer medication, the <a href="http://www.courthousenews.com/2015/10/13/doctor-sues-firms-that-sold-him-bad-drugs.htm" target="_blank">Courthouse News Service (CNS)</a> reports. </strong></p> <p>Dr. Ghraowi’s South Texas Comprehensive Cancer Centers once offered service at five different clinics in and around Corpus Christi, Texas, but now all are shuttered after paying a $900,000 fine to the Food and Drug Administration (FDA).</p> <p>In April 2015, <a href="http://www.fda.gov/ICECI/CriminalInvestigations/ucm444644.htm" target="_blank">according to the FDA</a>, Dr. Ghraowi’s South Texas Cancer Centers settled with the FDA on charges that they caused “the introduction into interstate commerce of misbranded prescription cancer drugs worth more than $900,000, between Feb. 22, 2010, and Jan. 17, 2012. STCCC was a professional association existing under Texas state law with clinics located within the Southern District of Texas, which provided care and treatment for patients with cancer and blood diseases.”</p> <p>According to the CNS, Dr. Ghraowi insists that Montana Healthcare Solutions salesman Paul Bottomley assured him that the oncology drugs he was purchasing were FDA approved. As the result of the fines he has paid, Dr. Ghraowi has had to close all of his clinics and sell off all his business equipment to cover his debts. CNS goes on to report that “Ghraowi wants the defendants held liable for the $900,000 fine, lost wages and treble damages for RICO Act violations.”</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Tue, 20 Oct 2015 12:22:42 -0700 http://www.safemedicines.org/2015/10/fda-moves-to-destroy-counterfeit-misbranded-medications-shipped-into-the-us-10-19-15.html http://www.safemedicines.org/2015/10/fda-moves-to-destroy-counterfeit-misbranded-medications-shipped-into-the-us-10-19-15.html A change to current laws allows the Food and Drug Administration (FDA) to destroy misbranded medications blocked from entering the United States. Prior to this, the FDA was forced to return such drugs to the shipper. <p><strong>A change to current laws allows the Food and Drug Administration (FDA) to destroy misbranded medications blocked from entering the United States. Prior to this, the FDA was forced to return such drugs to the shipper. </strong></p> <p><a href="http://www.raps.org/Regulatory-Focus/News/2015/09/14/23193/Final-Rule-Allows-FDA-to-Destroy-Some-Drugs-Denied-Entry-into-US/" target="_blank">Regulatory Affairs Professionals Society (RAPS)</a> reports that the FDA has implemented administrative destruction of drugs refused entry into the United States. According to RAPS, for questionable drug shipments valued at $2,500 or less, the FDA has the discretion to destroy the shipments without notifying the shipper.</p> <p>According to the <a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM396240.pdf" target="_blank">FDA</a>, “The primary public health benefit from adoption of the proposed rule would be the value of the illnesses or deaths avoided because the Agency destroyed a refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that posed a public health risk. Additionally, the proposed rule may benefit firms through increases in sales, brand value, and investment in research and development if the destroyed drug is a counterfeit or an otherwise falsified version of an approved drug. The threat of destruction may also have a deterrent effect resulting in a reduction in the amount of adulterated, misbranded, or unapproved drugs (violative drugs) shipped into the United States in the future.”</p> <p>The regulation change as originally proposed is authorized by amendments made to the FD&amp;C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). In the <a href="http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm396073.htm" target="_blank">FDA’s initial announcement</a> of the regulation change, they noted that “this authority is intended to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.”</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 19 Oct 2015 07:43:00 -0700 http://www.safemedicines.org/2015/10/saint-louis-doctor-sentenced-for-illegally-importing-non-fda-approved-medications-defrauding-patient-10-12-15.html http://www.safemedicines.org/2015/10/saint-louis-doctor-sentenced-for-illegally-importing-non-fda-approved-medications-defrauding-patient-10-12-15.html A Missouri doctor was sentenced for misbranded drugs charges and his Patterson Medical Clinic was sentenced for false statements charges on September 2nd, 2015 related to the purchases of non-FDA approved osteoporosis treatments. Both the doctor and his clinic face 3 years probation. <p><strong>A Missouri doctor was sentenced for misbranded drugs charges and his Patterson Medical Clinic was sentenced for false statements charges on September 2nd, 2015 related to the purchases of non-FDA approved osteoporosis treatments. Both the doctor and his clinic face 3 years probation. </strong></p> <p>On Wednesday, September 2nd, the <a href="http://www.justice.gov/usao-edmo/pr/local-physician-and-clinic-sentenced-health-care-related-charges" target="_blank">U.S. Department of Justice (DOJ)</a> announced that Dr. Mel Lucas of Saint Louis Missouri has been sentenced to three years probation as a result of his misbranded medication purchases. According to the DOJ, “From April 2009 to September 2011, Dr. Lucas repeatedly purchased Aclasta, a non-FDA approved drug used for the treatment of osteoporosis, online from two Canadian companies, Canada Health Solutions and Global Health Supplies. Dr. Lucas paid about $749 for each bottle of Aclasta, which was several hundred dollars less than the price of a bottle of Reclast, which is an FDA- approved drug also used to treat osteoporosis. The bottles of Aclasta had Italian and Turkish language on them, which was a clear indication that the drug was not intended for use in the United States.”</p> <p>According to the DOJ, Lucas pled guilty in May to receiving misbranded prescription drugs via interstate commerce. Additionally, Lucas’ nurse practitioner, Robin Levy pled guilty in May to receipt in interstate commerce of misbranded prescription drugs. She is scheduled to appear for sentencing later this month.</p> <p>This case was investigated by the Department of Health and Human Services-Office of Inspector General and the FBI. Assistant United States Attorneys Reginald Harris and Suzanne Moore handled the case for the U.S. Attorney’s Office.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 12 Oct 2015 13:42:13 -0700 http://www.safemedicines.org/2015/10/dont-risk-your-safety-with-medicines-with-unsafe-sources.html http://www.safemedicines.org/2015/10/dont-risk-your-safety-with-medicines-with-unsafe-sources.html Medicine approved by the U.S. Food and Drug Administration’s (FDA) comprehensive drug approval process are considered the safest in the world. The U.S.’s closed distribution system keeps medicine counterfeiters and fakers out of pharmacies and away from patients. Medicines in... <div style="float: left;"><a class="asset-img-link" style="padding-right: 10px;" onclick="window.open( this.href, '_blank', 'width=640,height=480,scrollbars=no,resizable=no,toolbar=no,directories=no,location=no,menubar=no,status=no,left=0,top=0' ); return false" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d163c304970c-popup"><img class="asset asset-image at-xid-6a00e5550359d1883401b8d163c304970c img-responsive" title="Click on the infographic image to see it full size." src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d163c304970c-320wi" alt="Click on the infographic image to see it full size." /></a></div> <p>Medicine approved by the U.S. Food and Drug Administration’s (FDA) comprehensive drug approval process are considered the safest in the world. The U.S.’s closed distribution system keeps medicine counterfeiters and fakers out of pharmacies and away from patients.</p> <p>Medicines in countries without the systemic oversight of an agency like the FDA suffer from pervasive counterfeit and substandard drug problems. The&nbsp;<a href="http://www.who.int/mediacentre/factsheets/fs275/en/">World Health Organization</a>&nbsp;(WHO) estimates 10 percent of medicines worldwide – and up to 50 percent of the drugs consumed in developing nations – are counterfeit. &nbsp;FDA oversight and enforcement of laws protect patient safety; keeping dangerous counterfeits out of the U.S. &nbsp;</p> <p>It is possible to lower your prescription drug prices by <a href="http://www.safemedicines.org/save-money-safely-on-prescriptions-from-online-pharmacies.html">price comparing VIPPS pharmacies</a>, which are online pharmacies that only sell FDA-approved medication. Learn the <a href="http://www.safemedicines.org/consumer/safesavings.pdf">ways you can save safely from pharmacies that sell legitimate, safe medication in the US</a>.</p> <p>Click on the infographic to see it full size.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber</a></p> News Partnership News SafeMedicines Editor Tue, 06 Oct 2015 12:49:31 -0700 http://www.safemedicines.org/2015/09/owner-of-kenwood-pharmacy-sentenced-to-10-years-in-prison-in-misbranded-drugs-case-9-28-15.html http://www.safemedicines.org/2015/09/owner-of-kenwood-pharmacy-sentenced-to-10-years-in-prison-in-misbranded-drugs-case-9-28-15.html Michigan pharmacy owner and 18 of his employees face jail time for conspiracies that provided misbranded, returned, and out-of-date pharmaceuticals to nursing homes and adult foster care homes throughout the state. <p><strong>Michigan pharmacy owner and 18 of his employees face jail time for conspiracies that provided misbranded, returned, and out-of-date pharmaceuticals to nursing homes and adult foster care homes throughout the state.</strong></p> <p>Kenwood pharmacy owner Kim Duron Mulder was sentenced to 10 years in prison on August 27, 2015 for his pivotal role in supplying Michigan nursing homes and adult foster care homes with misbranded and recycled drugs, reports the<a href="https://www.fbi.gov/detroit/press-releases/2015/ceo-of-kentwood-pharmacy-sentenced-to-10-years-in-prison-for-health-care-fraud" target="_blank"> FBI</a>. According to the FBI press release, “The process by which Kentwood Pharmacy returned drugs to pharmacy stock resulted in the cross-contamination of drugs, improper labeling of drugs, the placement of different drug dosages into stock bottles, and the placement of the altogether wrong drugs into stock bottles. These practices also allowed Vice President Richard Clarke to remove returned controlled substances from the pharmacy, including Vicodin and OxyContin, and sell the drugs on the street in northern Michigan.”</p> <p>Mulder, along with 8 other employees of his Kenwood Pharmacy business were originally charged via Grand Jury in November 2013, reports the<a href="http://www.fda.gov/ICECI/CriminalInvestigations/ucm376799.htm" target="_blank"> FDA</a>. They were charged with conspiracy to misbrand drugs and conspiracy to create false prescription records. Mulder also faces a charge of structuring cash transactions in order to avoid bank-reporting regulations.</p> <p>Kenwood Pharmacy was in operation from 2004-2010, and ceased operations upon the execution of federal search warrants, reports the FBI.</p> <p>In February, the <a href="http://www.fda.gov/ICECI/CriminalInvestigations/ucm435503.htm" target="_blank">FDA reported</a> that Mulder and a co-conspirator pleaded guilty to charges that they illegally restocked and re-dispensed recycled pharmaceuticals via Kentwood Pharmacy. Mulder pled guilty to a conspiracy to commit healthcare fraud based on billing Medicare, Medicaid, and private insurance plans for misbranded and adulterated drugs.</p> <p>The FBI press release noted that the judge in the case cited the fact that public and private insurers paid more than $79 million for Kenwood Pharmacy’s misbranded medications, which were then sent to patients at more than 800 nursing homes throughout Michigan. Judge Jonker pointed to Mulder’s previous felony convictions and noted that the business was “conceived in fraud” and that Mulder “should never have received a [pharmacy] license.” He also said that Mulder “created a culture of chaos” and that “this was fraud, pure and simple, from the top” and “perpetrated by a person with a history of fraud.”</p> <p>Prosecuting U.S. Attorney Patrick Miles said, “The public must be able to rely on those who own and run pharmacies to operate in compliance with the federal and state laws regulating the handling, packaging, and distribution of drugs. When health care providers violate regulations meant to protect the public and then bill public and private healthcare insurers for such drugs, my office will pursue serious charges, including health care fraud.”</p> <p>The investigation of this matter involved the FDA, HHS-OIG, FBI, DEA, IRS, the Michigan Attorney General’s Office and the Michigan State Police. Assistant U.S. Attorneys Ray Beckering and Adam Townshend prosecuted the case on behalf of the United States.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 28 Sep 2015 06:25:00 -0700 http://www.safemedicines.org/2015/09/canadian-pharmaceutical-company-and-their-drop-shipper-pleaded-guilty-in-non-fda-approved-medication-9-21-15.html http://www.safemedicines.org/2015/09/canadian-pharmaceutical-company-and-their-drop-shipper-pleaded-guilty-in-non-fda-approved-medication-9-21-15.html A Canadian pharmaceutical company and their drop-shipper were fined $45 million, as well as forfeiting $30 million for smuggling Non-FDA approved medications into the U.S. 5 men from Canada and the United States have also pleaded guilty to a multi-year conspiracy to ship misbranded and non-FDA approved pharmaceuticals to U.S. Clinics and Doctors’ Offices. <p><strong>A Canadian pharmaceutical company and their drop-shipper were fined $45 million, as well as forfeiting $30 million for smuggling Non-FDA approved medications into the U.S. 5 men from Canada and the United States have also pleaded guilty to a multi-year conspiracy to ship misbranded and non-FDA approved pharmaceuticals to U.S. Clinics and Doctors’ Offices. </strong></p> <p>SB Medical Inc., and TC Medical Group of Toronto, Canada and St. Michael, Barbados pleaded guilty on May 7th 2015 to conspiracy to smuggle and sell misbranded prescription drugs in the United States and unlicensed wholesaling of prescription drugs, reports a <a href="http://www.fda.gov/ICECI/CriminalInvestigations/ucm446226.htm" target="_blank">Food and Drug Administration (FDA) press release</a>.</p> <p>According to the FDA SB Medical illegally imported “orthopedic injections, rheumatology infusions, cosmetic devices, opthomology products, and oncology drugs into the United States. The non-FDA approved prescription pharmaceuticals were sourced from other foreign countries including, India, Turkey, France, Italy, and other countries and included Lucentis, Mabthera, Botox, Dysport, Euflexxa, Remicade, Restylane, Synvisc, Prolia, Orencia, Orthovisc, and other products,” from 2011-2014.</p> <p>As part of the conspiracy, drop shippers in the United States received foreign shipments of medication, and relabeled them for resale, so that they would appear to have been shipped from the U.S., the FDA reports.</p> <p>In the press release, George M. Karavetsos, Director of the FDA Office of Criminal Investigations, stated that “Individuals who circumvent the FDA-regulated supply chain by distributing unapproved prescription drugs and medical devices put the health and safety of the American public at risk. The FDA has zero tolerance for those who participate in these illegal trafficking networks and, as we did in this case, we will continue to protect consumers by bringing such criminals to justice.”</p> <p>In addition to the massive fines, the FDA reports that 5 individuals have also pleaded guilty as part of the smuggling conspiracy:</p> <ul> <li>David Eli Burke, 34, of Thornhill, Ontario, Canada, director of sales</li> <li>Shlomo David Rabi, 25, of Toronto, Ontario, Canada, director of sales and marketing</li> <li>Asaf Akiva Ibrahimian, 24, of West Orange, New Jersey, sales representative</li> <li>Reuven David Mirlis, 23, of Passaic, New Jersey, sales representative</li> <li>Rivka Rabi, 26, of Lakewood, New Jersey, drop shipper</li> </ul> <p>This case was investigated by the FDA’s Office of Criminal Investigations, Homeland Security Investigations Washington, D.C., with the assistance of the United States Postal Inspection Service. Assistant U.S. Attorneys Alexander T.H. Nguyen, Kellen S. Dwyer, and Jay V. Prabhu are prosecuting the case.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 21 Sep 2015 15:55:05 -0700 http://www.safemedicines.org/2015/09/canadadrugs-indictment-narinder-kaulder-and-the-path-taken-by-fake-avastin-9-9-15.html http://www.safemedicines.org/2015/09/canadadrugs-indictment-narinder-kaulder-and-the-path-taken-by-fake-avastin-9-9-15.html The CanadaDrugs indictment lists Narinder Kaulder as the head of operations for a U.K. drug wholesaler called River East Supplies, LTD. River East was a subsidiary through which CanadaDrugs conducted its sales. The indictment alleges that “in order to ensure that the illegal shipments of clinical drugs were allowed into the United States without increased scrutiny from the FDA and United States Customs, River East systematically falsified customs declarations that accompanied illegal drug shipments.” <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d155bf88970c-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401b8d155bf88970c img-responsive" alt="Rivereast_supplies220" title="Rivereast_supplies220" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d155bf88970c-800wi" border="0" style="margin: 0px 5px 5px 0px;" /></a><p><strong>Among the 8 people facing charges as a result of the CanadaDrugs indictment is one Narinder Kaulder. He is alleged to have helped supply fake Avastin to U. S. doctors. </strong></p> <p>The <a href="http://www.safemedicines.org/2015/CanadaDrugs%20Indictment.pdf" target="_blank">CanadaDrugs indictment</a> lists Narinder Kaulder as the head of operations for a U.K. drug wholesaler called River East Supplies, LTD. According to the indictment, River East was a subsidiary through which CanadaDrugs conducted its “clinical sales.” The indictment alleges that “in order to ensure that the illegal shipments of clinical drugs were allowed into the United States without increased scrutiny from the FDA and United States Customs, River East systematically falsified customs declarations that accompanied illegal drug shipments.”</p> <p>According to the <a href="https://archive.org/stream/356775-bottomley-complaint/356775-bottomley-complaint_djvu.txt" target="_blank">2012 complaint filed against Paul Bottomley</a>, a British citizen that pleaded guilty to supplying fake cancer medications to U.S. doctors, the owner of one of the wholesale medication distributors located in the U.S. named Narinder Kaulder as one of the people he communicated with while purchasing the counterfeit Avastin from River East Supplies.</p> <p>The CanadaDrugs indictment alleges that Kaulder purchased pharmaceuticals including 82 units of Altuzan from an unidentified individual “A.” River East then sold these pharmaceuticals to US doctors. One of the doctors who purchased Altuzan from River East submitted his purchase for testing to the FDA, and it was found to be counterfeit.</p> <p>According to the indictment the UK Medicines Health Regulatory Agency (MHRA) conducted an interview with Kaulder where he confirmed purchasing the suspect Avastin and distributing it in the United States.</p> <p>Kaulder faces conspiracy to smuggle charges, smuggling charges, and conspiracy to commit money-laundering charges. If convicted, he could face up to 35 years in prison, and $1 million in fines.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Thu, 10 Sep 2015 13:06:43 -0700 http://www.safemedicines.org/2015/09/interchange-2014-madame-gu-and-psm-china-9-7-15.html http://www.safemedicines.org/2015/09/interchange-2014-madame-gu-and-psm-china-9-7-15.html Interchange 2014 was fortunate enough to have Madame LiHong Gu, director of the Partnership for Safe Medicines China join us and share her work. Madame Gu began her brief description of PSM China by pointing out that “China is another... <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7b2929b970b-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c7b2929b970b img-responsive" alt="Madame Gu 2" title="Madame Gu 2" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c7b2929b970b-320wi" style="margin: 0px 5px 5px 0px;" /></a><p>Interchange 2014 was fortunate enough to have Madame LiHong Gu, director of the Partnership for Safe Medicines China join us and share her work.</p> <p>Madame Gu began her brief description of PSM China by pointing out that “China is another large country with 1.3 billion people. They all need safe medicines.”</p> <p>She told the conference that PSM China was originally founded in November 2012, and that their efforts have been growing. In 2013, PSM China focused on the education of women and children. In 2014, PSM China sent a delegation to PSM India to learn from their organization. In February 2014, PSM China launched their website, and focused their education efforts on chronic diseases in the elderly.</p> <p>Madame Gu then invited all conference attendees to visit the new PSM China website: <a href="http://www.psmchina.cn/" target="_blank">http://www.psmchina.cn/ </a></p> <p>To learn more about PSM China’s accomplishments and future plans, please watch Madame Gu’s presentation in full below.</p> <p>Youtube:&nbsp;<a href="https://youtu.be/W5r-PJuxAq0?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK"> https://youtu.be/W5r-PJuxAq0?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK</a></p> <p>Madame Gu's slide presentation:&nbsp;<a href="http://www.slideshare.net/SafeMedicines/13-00-madame-gu">http://www.slideshare.net/SafeMedicines/13-00-madame-gu</a></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 News Partnership News SafeMedicines Editor Mon, 07 Sep 2015 07:21:00 -0700 http://www.safemedicines.org/2015/08/psm-psa-dont-buy-drugs-made-in-a-dirty-lab-8-31-15.html http://www.safemedicines.org/2015/08/psm-psa-dont-buy-drugs-made-in-a-dirty-lab-8-31-15.html The public service announcement from the Partnership for Safe Medicines Don’t Buy Drugs Made in a Dirty Lab! conjures images of the sort of filthy environs in which fake drugs are produced. PSM board member Tom Kubic notes “those online... <iframe width="560" height="315" src="https://www.youtube.com/embed/eKUdhBWHfYA?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" frameborder="0" allowfullscreen></iframe> <p>The public service announcement from the Partnership for Safe Medicines <a href="https://youtu.be/eKUdhBWHfYA?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" target="_blank"><strong>Don’t Buy Drugs Made in a Dirty Lab!</strong></a> conjures images of the sort of filthy environs in which fake drugs are produced. PSM board member Tom Kubic notes “those online Canadian pharmacies don’t sell real drugs.” Find out more about what fake online pharmacies are not telling you by reading <a href="http://www.safemedicines.org/2013/03/questions-and-answers-on-medicine-importation.html#1" target="_blank">Questions and Answers on Medicine Importation</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Jim Dahl News Partnership News SafeMedicines Editor Mon, 31 Aug 2015 06:45:00 -0700 http://www.safemedicines.org/2015/08/interchange-2014-bejon-misra-partnership-for-safe-medicines-india-8-24-15.html http://www.safemedicines.org/2015/08/interchange-2014-bejon-misra-partnership-for-safe-medicines-india-8-24-15.html The head of Partnership for Safe Medicines India shared with the conference what PSM India has done, and what its goals are. Bejon Misra, head of PSM India, took a few minutes to tell conference-goers about his organization. He pointed... <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb0856a5c4970d-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401bb0856a5c4970d img-responsive" alt="IMG_6332" title="IMG_6332" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb0856a5c4970d-320wi" style="margin: 0px 5px 5px 0px;" /></a><p><strong>The head of Partnership for Safe Medicines India shared with the conference what PSM India has done, and what its goals are.</strong></p> <p>Bejon Misra, head of PSM India, took a few minutes to tell conference-goers about his organization. He pointed out that he was “here on behalf of 1.2 billion consumers, and more than 10,000 pharmaceutical manufacturers.” The goal of PSM India is to protect consumers from “spurious medicine.”</p> <p>PSM India has been working closely with the Modi government in India to protect the Indian drug supply chain. Mr. Misra noted however that health is administered at the state level in India, and there are 36 distinct health administrations that must be brought into the PSM India fold. Thus far PSM India and Mr. Misra have had success with 8 health administrations, and hope to have all 36 health administrations involved with their goals within the next 2 years.</p> <p>Mr. Misra then posed the question: “How do you make sure that the consumer is empowered, that the generics as well as the branded (medications) need to be safe and of high quality?”</p> <p>To find out more about the goals of PSM India, please watch Bejon Misra’s speech in it’s entirety below.</p> <p>Youtube:&nbsp;<a href="https://youtu.be/fm7XXlHu_Nc?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK"> https://youtu.be/fm7XXlHu_Nc?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK</a></p> <p>Mr. Misra's slide presentation:&nbsp;<a href="http://www.slideshare.net/SafeMedicines/12-55-bejon-mistra">http://www.slideshare.net/SafeMedicines/12-55-bejon-mistra</a></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 News Partnership News SafeMedicines Editor Mon, 24 Aug 2015 07:10:00 -0700 http://www.safemedicines.org/2015/08/pharmacychecker-executive-indicted-in-canadadrugs-fake-cancer-drug-scam-8-24-15.html http://www.safemedicines.org/2015/08/pharmacychecker-executive-indicted-in-canadadrugs-fake-cancer-drug-scam-8-24-15.html Ram Kamath, who was listed as PharmacyChecker.com’s Director of Pharmacy Policy and International Verifications as of March 16, 2015, is one of eight people indicted by the US Justice Department for allegedly participating in a conspiracy to distribute $78 million worth of non FDA approved and counterfeit cancer medications into U.S. doctors’ offices. <div style="float: left;"><a class="asset-img-link" href="http://www.safemedicines.org/2015/PharmacyChecker.pdf"><img alt="PharmacyChecker.com Director named in CanadaDrugs.com indictment" class="asset asset-image at-xid-6a00e5550359d1883401b8d14c7266970c img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b8d14c7266970c-500wi" style="padding-right: 10px;" title="Pharmacy checker" /></a> <br /> <div style="text-align: center;"><span style="font-size: 8pt;">March 16, 2015 screenshot of the PharmacyChecker &quot;About&quot; page. <br />Click on image for full pdf. Screenshot courtesy of webarchive.org.</span></div> </div> <p><strong>Ram Kamath, who was listed as PharmacyChecker.com’s Director of Pharmacy Policy and International Verifications as of March 16, 2015, is one of eight people indicted by the US Justice Department for allegedly participating in a conspiracy to distribute $78 million worth of non FDA approved and counterfeit cancer medications into U.S. doctors’ offices. </strong></p> <p>On August 11 the U.S. Department of Justice unsealed a November 2014 grand jury indictment (<a href="http://www.safemedicines.org/2015/CanadaDrugs%20Indictment.pdf" target="_blank">pdf download link</a>) filed against eight individuals and six companies all associated with the Canadian online pharmacy giant, CanadaDrugs.com, according to <a href="http://www.pharmpro.com/news/2015/08/14-execs-charged-selling-78m-counterfeit-mislabled-drugs?et_cid=4750857&amp;et_rid=866449022&amp;type=headline" target="_blank">Pharmaceutical Processing</a>. Among those charged with conspiracy, money laundering and smuggling is a man named Ram Kamath, who until recently was listed as a PharmacyChecker.com executive. Kamath is charged with conspiracy to smuggle goods in the US.</p> <p>Mr Kamath is alleged to have assisted CanadaDrugs in hiding fake Avastin from the FDA. <a href="http://www.courthousenews.com/2015/08/18/pharmacy-exec-charged-in-fake-drug-scheme.htm" target="_blank">Courthouse News Service </a>reports: “As to Kamath&#39;s role in the scheme, federal prosecutors claim that when the Food and Drug Administration began investigating CanadaDrugs.com&#39;s distribution of counterfeit versions of the cancer drug Avastin in 2012 Kamath agreed to store the counterfeit drug in his garage while CanadaDrugs shipped its inventory back to the United Kingdom.”</p> <p>Kamath has been publically affiliated with <a href="http://www.safemedicines.org/2015/PharmacyChecker.2009%20about%20page%20web%20archive.pdf" target="_blank">PharmacyChecker.com since September 2009</a>, when he was added to the Key Management of the organization as an International Pharmacy Advisor. &#0160;<a href="http://www.safemedicines.org/2015/PharmacyChecker%20About%207%2022%202010.pdf" target="_blank">By July 2010</a>, he had been promoted to Director of Pharmacy Policy and International Verifications of the organization. &#0160;He is still listed as their Director of Pharmacy Policy and International Verifications on the company&#39;s social media channels, though the current status of his employment may be in dispute, according to <a href="https://blog.legitscript.com/2015/08/pharmacycheckers-tod-cooperman-panics-claims-key-manager-is-only-consultant-threatens-libel/" target="_blank">Legitscript&#39;s John Horton</a>.</p> <p>According to the <a href="http://archive.hhs.gov/importtaskforce/session3/presentations/Illinois.pdf" target="_blank">HHS archives</a>, in 2003 Kamath played a significant role in the ultimately failed attempt to set up a drug importation system in Illinois that bypassed the FDA. Called I-SaveRX, it was a health initiative offered to the public by former Illinois governor Rod Blagojevich. <a href="http://www.fda.gov/Drugs/DrugSafety/ucm179839.htm" target="_blank">In November of that year</a>, William K. Hubbard, the FDA’s Associate Commissioner for Policy &amp; Planning informed Kamath and his partner Scott McKibbon that although the FDA appreciated the need for Illinois residents to reduce their healthcare costs, “Against these relatively modest savings are important health risks that are either misunderstood or ignored in your report. These risks indicate that there are far better ways to get savings in medical costs for Illinois residents than by turning to a questionable importation scheme.”</p> <p>When the <a href="http://www.safemedicines.org/2015/Illinois%20Auditor%20General.pdf" target="_blank">Illinois auditor General examined the I-SaveRX program in 2006</a>, it found that failed to implement many of the required inspections of online pharmacies. &#0160;The program was found to have violated both Federal law governing the safety of pharmaceuticals as well as Illinois state pharmacy law.</p> <p><a href="http://www.wsj.com/articles/first-defendant-in-fake-cancer-drug-case-to-be-arraigned-1439939947" target="_blank">The Wall Street Journal</a> reports that Kamath is due in court in Missoula, Montana to face the indictment on August 25. If convicted, Kamath faces up to 5 years in prison, $250,000 in fines and 3 years supervised release, according to his indictment.</p> <p>The indictment is the result of 3 years of investigations into counterfeit drugs, including counterfeit cancer medications that have infiltrated doctors’ clinics and hospitals in the United States. In February 2012, the <a href="http://www.fda.gov/drugs/drugsafety/ucm291960.htm" target="_blank">FDA</a> informed doctors and the public that counterfeit Avastin had been discovered in U.S. doctors’ offices. Ultimately, the FDA sent warning letters to <a href="http://www.safemedicines.org/2013/01/fda-warnings-in28-states-six-prosecutions-511.html" target="_blank">over 100 doctors in 28 states.</a> To learn more about fake cancer medication in this country, please read <a href="http://safemeds.typepad.com/BlackMarketCancer_singlepage2.pdf" target="_blank">Black Market Cancer Drug Cases 2007-2013</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Law enforcement actions against counterfeit drugs News Partnership News SafeMedicines Editor Fri, 21 Aug 2015 14:13:38 -0700 http://www.safemedicines.org/2015/08/psm-psa-have-you-received-a-blast-fax-offering-cheap-medication-8-17-15.html http://www.safemedicines.org/2015/08/psm-psa-have-you-received-a-blast-fax-offering-cheap-medication-8-17-15.html Blast-faxes sent to doctors’ offices are the subject of the latest public service announcement from the Partnership for Safe Medicines In Have You Gotten a Blast Fax Offering Cheap Medication? PSM board member Dr. Marv Shepherd warns physicians to be... <p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/mOTss8NV3h4?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" width="560"></iframe></p> <p>Blast-faxes sent to doctors’ offices are the subject of the latest public service announcement from the Partnership for Safe Medicines In <a href="https://youtu.be/mOTss8NV3h4?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" target="_blank">Have You Gotten a Blast Fax Offering Cheap Medication?</a> PSM board member Dr. Marv Shepherd warns physicians to be wary of too-good-to-be-true medications prices in blast-fax offerings. To learn more about protecting your practice and your patients, read PSM’s <a href="http://www.safemedicines.org/protecting-patients-from-counterfeit-medications-guides-for-doctors.html" target="_blank">L.E.A.D.E.R.S. Guide for Physicians</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Marv D. Shepherd, PhD News Partnership News SafeMedicines Editor Mon, 17 Aug 2015 06:37:00 -0700 http://www.safemedicines.org/2015/08/us-attorney-unseals-indictment-in-usa-v-canadadrugscom-ltd-partnership8112015.html http://www.safemedicines.org/2015/08/us-attorney-unseals-indictment-in-usa-v-canadadrugscom-ltd-partnership8112015.html Learn More about Counterfeit Cancer Drug Distributors in the United States by clicking the image. Prosecutors move forward on closing the book on the counterfeit cancer drug ring that has infiltrated US cancer clinics by indicting a Canadian online pharmacy... <div style="float: left;"><a href="http://www.safemedicines.org/fakecancerdrugcomics.html"> <img alt="" border="0" height="300" src="http://www.safemedicines.org/slider/3.jpg" style="padding-right: 10px;" width="450" /> </a> <p style="text-align: center;"><em><small>Learn More about Counterfeit Cancer Drug Distributors <br />in the United States by clicking the image.</small></em></p> </div> <p><strong>Prosecutors move forward on closing the book on the counterfeit cancer drug ring that has infiltrated US cancer clinics by indicting a Canadian online pharmacy company.</strong></p> <p>On August 7, 2015, US Attorneys for the District of Montana requested the unsealing of the indictment in the case &quot;USA v. CanadaDrugs.com Ltd. Partnership.&quot; &#0160;The unsealed indictment, originally returned by the grand jury in November 2014, lists 14 defendants including, Canada Drugs. Com Ltd., Parternship, Thorkelson Consulting, Ltd., 4208081 Canada, Ltd., Rockley Ventures, Ltd., Global Drug Supply, Ltd., River East Supplies, Ltd., Kristjan Thorkelson, Thomas Haughton, Ronald Sigurdson, Troy Nakamura, Darren Chalus, Narinder Kaulder, James Trueman and Ram Kamath, reports The Associated Press.</p> <p>Prosecutors allege that CanadaDrugs.com sold $78 million worth of unapproved, mislabeled and counterfeit cancer drugs to doctors across the United States over three years. &#0160;In April 2015,&#0160;<a href="http://www.safemedicines.org/2015/04/canadian-department-of-justice-takes-part-in-canada-drugs-raid-4-21-14.html" target="_blank">the Canadian Department of Justice</a>, along with the Royal Canadian Mounted Police (RCMP), raided Canada Drugs.com headquarters in Manitoba. The company&#39;s wholesale prescription drug license was temporarily suspended in January 2014.</p> <p>Allegedly, CanadaDrugs.com and its subsidiaries sold non-FDA approved and counterfeit versions of cancer drugs and other medications until 2012, when the FDA began its investigations. Investigators found counterfeit and non-FDA approved cancer medications in US doctors&#39; offices that had allegedly been purchased from CanadaDrugs.com and its subsidiary companies.</p> <p>On February 14, 2012, the FDA made their discoveries public:</p> <p><em> The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. <strong>The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.</strong></em></p> <p>The medication allegedly distributed by CanadaDrugs.com contained, &quot;contain cornstarch and acetone but no active ingredients,&quot; reports <a href="http://www.cbc.ca/news/canada/manitoba/federal-justice-department-part-of-canadadrugs-com-raid-1.3011421" target="_blank">CBC/Radio Canada</a>.</p> <p>Learn more about the distribution of counterfeit cancer medications in the United States in our materials. &#0160;</p> <p><a href="http://www.safemedicines.org/infographics/RoguesGallery2.pdf" target="_blank" title="Rogues Gallery - Counterfeit Cancer Drug Peddlers">Rogues Gallery - Counterfeit Cancer Drug Peddlers</a></p> <p><a href="http://www.safemedicines.org/infographics/RoguesGallery_All_5.pdf" target="_blank" title="Rogues Gallery - Counterfeit Drug Distributors">Rogues Gallery - Counterfeit Drug Distributors</a></p> <h3>Get The Latest News on the CanadaDrugs Indictments:</h3> <p><a href="http://www.safemedicines.org/2015/CanadaDrugs%20Indictment.pdf" target="_blank">CanadaDrugs Indictment</a></p> <p><a href="http://www.safemedicines.org/2015/09/canadadrugs-indictment-narinder-kaulder-and-the-path-taken-by-fake-avastin-9-9-15.html" target="_blank"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Narinder Kaulder And The Path Taken By Fake Avastin</span></a></p> <p><a href="http://www.safemedicines.org/2015/08/pharmacychecker-executive-indicted-in-canadadrugs-fake-cancer-drug-scam-8-24-15.html" target="_blank"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">PharmacyChecker Executive Indicted In CanadaDrugs Fake Cancer Drug Scam</span></a></p> <p><a href="http://www.safemedicines.org/2015/10/drug-smuggling-charge-against-ram-kamath-dropped-5-22-15.html" target="_blank"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Drug Smuggling Charge Against Ram Kamath Dropped</span></a></p> <p>&#0160;</p> <p>&#0160;</p> Counterfeit Drugs News Partnership News SafeMedicines Editor Tue, 11 Aug 2015 14:45:02 -0700 http://www.safemedicines.org/2015/08/black-market-cosmetic-injectables-threaten-americans-8-10-15.html http://www.safemedicines.org/2015/08/black-market-cosmetic-injectables-threaten-americans-8-10-15.html The United States has been experiencing an uptick in the number of patients being treated with fake and misbranded injectable cosmetic treatments. Learn more about these cases, which are one of the most common ways Americans are exposed to dangerous... <a class="asset-img-link" style="float: left;" href="http://www.safemedicines.org/BlackMarketBotox_singlepg_PRESS_pcis.pdf"><img class="asset asset-image at-xid-6a00e5550359d1883401bb08564669970d img-responsive" alt="BlackMarketBotox_singlepg_PRESS_pcis-1" title="BlackMarketBotox_singlepg_PRESS_pcis-1" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08564669970d-320wi" style="margin: 0px 5px 5px 0px;" /></a><p><strong>The United States has been experiencing an uptick in the number of patients being treated with fake and misbranded injectable cosmetic treatments. Learn more about these cases, which are one of the most common ways Americans are exposed to dangerous counterfeit medications. </strong></p> <p>In June 2014, Elva Navarro, a spa owner in McAllen, Texas, <a href="http://www.justice.gov/usao-sdtx/pr/spa-owner-pleads-guilty-trial-set-begin" target="_blank">pleaded guilty</a> to violating the U.S. Food, Drug, and Cosmetics Act. Navarro had been injecting clients with adulterated liquid silicone that she falsely claimed was safe and FDA-approved, even though she knew her treatments had caused complications for her customers. According to the south Texas paper the Valley Morning Star, one of Navarro client's <a href="http://www.valleymorningstar.com/news/local_news/article_ce0779ba-5714-11e3-8a17-001a4bcf6878.html" target="_blank">underwent multiple surgeries and spent 17 days in intensive care</a> after receiving the injections. Another, a 28 year old mother of 3, died.</p> <p>Navarro's case is one of many that involve Americans being treated with fake and misbranded injectable cosmetic treatments. More than 46 doctors, cosmeticians and drug distributors have been investigated for the purchase or sale of non-FDA approved cosmetic drugs—a variety of substances being passed off as Botox, collagen or other injected cosmetic treatments—since 2005. The scale of the problem is larger than those prosecutions; in 2012 the FDA notified 350 medical practices in 43 states that they may have purchased counterfeit Botox from a <a href="http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm#Text" target="_blank">foreign supplier owned and operated by Canada Drugs</a>.</p> <p>Learn more about these cases, which are one of the most common ways Americans are exposed to dangerous counterfeit medications, by downloading <a href="http://www.safemedicines.org/BlackMarketBotox_singlepg_PRESS_pcis.pdf" target="_blank">Black Market Cosmetic Injectables in the U.S., 2005 – 2013</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 10 Aug 2015 06:31:00 -0700 http://www.safemedicines.org/2015/08/ausa-jaime-pe%C3%B1a-shares-a-tale-of-hospital-drug-diversion-at-interchange-2014-8-3-15.html http://www.safemedicines.org/2015/08/ausa-jaime-pe%C3%B1a-shares-a-tale-of-hospital-drug-diversion-at-interchange-2014-8-3-15.html While participating in an Interchange 2014 panel discussion on criminal prosecutions for drug counterfeiting and drug diversion, Jaime Peña, Assistant U.S. Attorney/Senior Litigation Chief, Criminal Division, Colorado District, U.S. Department of Justice, tells a disturbing story of hospital-based drug diversion.... <a class="asset-img-link" style="float: left;" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb0856452a970d-pi"><img class="asset asset-image at-xid-6a00e5550359d1883401bb0856452a970d img-responsive" alt="Panel 2 Jamie Pena 2" title="Panel 2 Jamie Pena 2" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb0856452a970d-500wi" style="margin: 0px 5px 5px 0px;" /></a><p><strong> While participating in an Interchange 2014 panel discussion on criminal prosecutions for drug counterfeiting and drug diversion, Jaime Peña, Assistant U.S. Attorney/Senior Litigation Chief, Criminal Division, Colorado District, U.S. Department of Justice, tells a disturbing story of hospital-based drug diversion. </strong></p> <p>Panel 2 at Interchange 2014, was titled “Patient Safety and Criminal Prosecutions in the U.S.” Three federal prosecutors shared insights from their recent counterfeit and misbranded drug prosecutions. AUSA Jaime Peña described several incidents at Colorado hospitals where hospital employees diverted opiates for their personal use, exposing unwitting patients to infections and bloodborne pathogens.</p> <p>AUSA Peña described how the case of Ashton Dagle first came under investigation. “We had essentially received a cold call from law enforcement in Colorado regarding the potential diversion or theft of fentanyl (a very strong opiate used as anesthesia during surgery.)…Because it involved fentanyl and it was a hospital setting, we had concerns about what happened to the fentanyl and how it was administered.”</p> <p>He continued, “ During the course of the investigation we found that Ashton Dagle (who was actually a fairly young man, he was under 30 years old), had been diverting fentanyl by accessing the Pyxis machine [an automated medication management system] at the hospital where he worked. He was accessing the Pyxis machine and obtaining the vials of fentanyl…about 15 times a day. And for anyone who knows anything about opiates, for us it would be a lethal dosage.”</p> <p>“It was very difficult to believe that an individual could steal 15 bottles a day and not be distributing it. So initially, we thought this was a distribution case.”</p> <p>AUSA Peña also described how Dagle was able to get away with the theft as long as he did. “He would access it, inject it into himself, re-inject saline solution, and then what was interesting about what he did, he was very smart, he took the vials, and the vials come with a spinning cap to prevent tampering, he would take surgical glue and glue the spinning cap back on so that if somebody then accessed the Pyxis machine and accessed some of those vial, they wouldn’t really readily identify that as a vial that had been tampered with.”</p> <p>AUSA Peña also pointed out the serious patient concerns saying “all those surgeries during that period of time, during those 30 days were exposed to the counterfeit or contraband fentanyl.”</p> <p>To watch AUSA Peña’s presentation in its entirety, <a href="http://youtu.be/XGZs-CdLVGo?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" target="_blank"><strong>click here</strong></a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> Interchange 2014 News Partnership News SafeMedicines Editor Mon, 03 Aug 2015 06:57:00 -0700 http://www.safemedicines.org/2015/07/psm-psa-dont-destroy-your-medical-practice-with-fake-drugs-7-27-15.html http://www.safemedicines.org/2015/07/psm-psa-dont-destroy-your-medical-practice-with-fake-drugs-7-27-15.html The latest in public service announcements from Partnership for Safe Medicines tells the story of what happens to doctors who make the mistake of purchasing substandard medication. PSM board member Jim Dahl advises physicians Don’t Destroy Your Medical Practice with Fake Drugs. <p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/LI5wVQf2m7E" width="560"></iframe></p> <p>The latest in public service announcements from Partnership for Safe Medicines tells the story of what happens to doctors who make the mistake of purchasing substandard medication. PSM board member Jim Dahl advises physicians D<a href="https://youtu.be/LI5wVQf2m7E?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" target="_blank">on’t Destroy Your Medical Practice with Fake Drugs</a>. Instead of drawing the attention of authorities, physicians can use PSM’s <a href="http://www.safemedicines.org/protecting-patients-from-counterfeit-medications-guides-for-doctors.html" target="_blank">L.E.A.D.E.R.S. Guide for Physicians</a> to protect their patients and their livelihood.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 27 Jul 2015 07:11:00 -0700 http://www.safemedicines.org/2015/07/ausa-lindsay-kelly-tells-the-story-of-gallant-pharma-prosecution-at-interchange-2014-7-20-15.html http://www.safemedicines.org/2015/07/ausa-lindsay-kelly-tells-the-story-of-gallant-pharma-prosecution-at-interchange-2014-7-20-15.html The second panel of the day at Interchange 2014, titled “Patient Safety and Criminal Prosecutions in the U.S.” featured federal prosecutors who provided insights into their recent counterfeit and misbranded drug prosecutions. AUSA Lindsay Kelly told the Interchange 2014 audience how Gallant Pharma operated. “Their competitors were the other illegal companies. They [Gallant Pharma] were trying to distinguish themselves in that market by saying ‘we actually have offices here, we can give you everything overnight delivery,’ and they had a sales force that actually set out recruiting doctors as patients, just like the legitimate pharmaceutical companies.” <p><a class="asset-img-link" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c79f1a7d970b-pi" style="float: left;"><img alt="Lindsay Kelly Interchange 14" border="0" class="asset asset-image at-xid-6a00e5550359d1883401b7c79f1a7d970b img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c79f1a7d970b-800wi" style="margin: 0px 5px 5px 0px;" title="Lindsay Kelly Interchange 14" /></a></p> <p><strong>During a panel discussion on criminal prosecutions and patient safety, Lindsay Kelly, Assistant United States Attorney in the Cybercrime Unit at the U.S. Attorney&#39;s Office for the Eastern District of Virginia, described for the attendees her prosecution of Gallant Pharma International. Gallant Pharma was an unlicensed wholesale pharmaceutical distributor, which until charges were filed, was operating a nationwide distribution ring from an apartment in Virginia. </strong></p> <p>The second panel of the day at Interchange 2014, titled “Patient Safety and Criminal Prosecutions in the U.S.” featured federal prosecutors who provided insights into their recent counterfeit and misbranded drug prosecutions. AUSA Lindsay Kelly told the Interchange 2014 audience how Gallant Pharma operated. “Their competitors were the other illegal companies. They [Gallant Pharma] were trying to distinguish themselves in that market by saying ‘we actually have offices here, we can give you everything overnight delivery,’ and they had a sales force that actually set out recruiting doctors as patients, just like the legitimate pharmaceutical companies.”</p> <p>AUSA Kelly also pointed out that Gallant Pharma’s stateside location made prosecution “more appealing” due to ease of access to all their records. She noted that the “apartment where they ran this out of was in Crystal City, right across from the IPR Center.”</p> <p><a href="http://www.safemedicines.org/2013/08/clandestine-pharmaceutical-distributor-in-virginia-that-posed-as-canadian-company-shuttered-11-indic.html%20 " target="_blank"><strong>The Story of Gallant Pharma International</strong></a></p> <p>AUSA Kelly explained that a “strategic decision” was made to delay charges until further investigations were made because; as she said “We wanted to take a bigger approach. We wanted to figure out who are all these sales reps, who are all these doctors, how much money are we talking about, and most importantly, how are they getting all this stuff [pharmaceuticals] into the country. Because we really wanted to make an impact and shut down the supply.”</p> <p>According to a May 2014 press release from the DEA, the co-owner of Gallant Pharma was sentenced to 3 years in prison. The DEA notes that Gallant Pharma “distributed more than 17,000 units of non-FDA approved cancer and cosmetic drugs to doctors across the United States.”</p> <p>To watch AUSA Kelly’s presentation in its entirety, <a href="%20http://youtu.be/XGZs-CdLVGo?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" target="_blank">click here</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 20 Jul 2015 07:07:00 -0700 http://www.safemedicines.org/2015/07/psm-psa-super-cheap-canadian-pharmacy-6-29-15.html http://www.safemedicines.org/2015/07/psm-psa-super-cheap-canadian-pharmacy-6-29-15.html In another public service announcement from Partnership for Safe Medicines warns of the dangers lurking for sale at fake online pharmacy websites. In Super Cheap Canadian Pharmacy, PSM board member Tom Kubic of the Pharmaceutical Security Institute cautions against buying medication from “a Canadian online pharmacy with cheaper prices,” <p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/8oa1POFJ5Tc" width="560"></iframe></p> <p>In another public service announcement from Partnership for Safe Medicines warns of the dangers lurking for sale at fake online pharmacy websites. In <a href="https://youtu.be/8oa1POFJ5Tc?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" target="_blank"><strong>Super Cheap Canadian Pharmacy</strong></a>, PSM board member Tom Kubic of the Pharmaceutical Security Institute cautions against buying medication from “a Canadian online pharmacy with cheaper prices,” and warns that they do not tell you that their drugs “do not actually come from Canada.” Learn the truth about Canadian online pharmacies by reading <a href="http://www.safemedicines.org/2013/03/questions-and-answers-on-medicine-importation.html#1" target="_blank">Questions and Answers on Medicine Importation</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 13 Jul 2015 07:19:00 -0700 http://www.safemedicines.org/2015/07/the-partnership-for-safe-medicines-wins-communications-award-for-consumer-safety-resources.html http://www.safemedicines.org/2015/07/the-partnership-for-safe-medicines-wins-communications-award-for-consumer-safety-resources.html The Partnership for Safe Medicines is pleased to announce that the organization has been honored with an Excellence Award for outstanding work in the area of nonprofit communications. The Academy of Interactive and Visual Arts gave The Partnership for Safe... <div style="float: left;"><a class="asset-img-link" href="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08501652970d-pi" style="display: inline; padding: 10px;"><img alt="Communications award" class="asset asset-image at-xid-6a00e5550359d1883401bb08501652970d img-responsive" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401bb08501652970d-320wi" title="Communications award" /></a></div> <p><strong>The Partnership for Safe Medicines is pleased to announce that the organization has been honored with an Excellence Award for outstanding work in the area of nonprofit communications.&#0160;</strong></p> <p>The <a href="http://aiva.org/" target="_blank">Academy of Interactive and Visual Arts</a> gave The Partnership for Safe Medicines the 2015 <a href="https://www.communicatorawards.com/awards/" target="_self">Communicator Award of Excellence</a> in the category of nonprofit magazine publication. The Award of Excellence is the Communicator Awards&#39; highest honor, &quot;given to those entrants whose ability to communicate positions them as the best in the field.&quot;&#0160;</p> <p>The award is for the series of comic books depict the true-life misdeeds of counterfeit drug criminals in the United States and the impact their crimes have had on American patients. The stories detail the criminals who attempt to break the secure, closed drug supply chain of the US. The first issue details the crimes, arrests and convictions of a whole black market supply chain devoted to ripping off American cancer patients including doctors who purchase medication from suspect sources to increase profits, mass pill counterfeiters and the grey market suppliers who connect the greedy medical professionals with pill counterfeiters. The second issue focuses on two large scale counterfeit drug entrepreneurs who used international connections to bring fake medications, including more counterfeit cancer drugs containing no active ingredients, into the lives of American patients. The Partnership for Safe Medicines is honored to be recognized for outstanding communications. &#0160;The series is available to <a href="http://www.safemedicines.org/fakecancerdrugcomics.html">download for free here</a>.</p> <p>Additionally, the Partnership for Safe Medicines was awarded three Distinction Awards for patient safety education materials. The <a href="http://www.safemedicines.org/2012/06/the-top-9-mens-health-risks-counterfeiters-exploit.html" target="_self">Top 9 Men&#39;s Health Risks</a> infographic won Awards of Distinctions for a promotions poster and infographic content marketing. &#0160;Additionally, the infographic <a href="http://www.safemedicines.org/infographics/PSM_Fake-Pharmacy_3.pdf" target="_blank">Learn How to Decode a Fake Online Pharmacy</a>&#0160;was given an Award of Distinction for infographic content marketing.</p> <p>All these materials are available for free on The Partnership for Safe Medicines&#39; website, <a href="www.safemedicines.org" target="_blank">www.safemedicines.org</a>.</p> <p>&#0160;</p> Counterfeit Drugs News Partnership News SafeMedicines Editor Thu, 09 Jul 2015 13:36:20 -0700 http://www.safemedicines.org/2015/07/canada-experiences-rash-of-deaths-due-to-counterfeit-medication-7-8-15.html http://www.safemedicines.org/2015/07/canada-experiences-rash-of-deaths-due-to-counterfeit-medication-7-8-15.html Fake Oxycontin pills actually made with fentanyl responsible for more than 50 deaths in Alberta since the beginning of the year. OpSecSecurity is reporting that Canada is experiencing a dramatic increase in deaths due to the sale and ingestion of... <p><strong>Fake Oxycontin pills actually made with fentanyl responsible for more than 50 deaths in Alberta since the beginning of the year.</strong></p> <p><a href="http://blog.opsecsecurity.com/fake-oxycontin-leads-to-a-number-of-overdoses-in-canada" target="_blank">OpSecSecurity</a> is reporting that Canada is experiencing a dramatic increase in deaths due to the sale and ingestion of counterfeit versions of the painkiller oxycontin. According to OpSecSecurity, there have been three recent deaths in Saskatchewan due to the counterfeit pills.</p> <p>According to the <a href="http://www.cbc.ca/radio/thecurrent/the-current-for-may-26-2015-1.3087566/50-fentanyl-deaths-in-alberta-calls-for-more-treatment-centres-1.3087576" target="_blank">CBC</a>, there have been more than 50 deaths so far this year in Alberta as a direct result of counterfeit oxycontin. The drugs are marketed as imported oxycontin, but are in actual fact the much more potent painkiller fentanyl. The CBC spoke to an Alberta police officer, who told them &quot;What we have here is a drug bust, and if you look at the 2,041 pills, you might as well look at those as bullets -- 2,000 bullets -- because each of those pills, very well, could kill somebody.”</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Wed, 08 Jul 2015 07:29:00 -0700 http://www.safemedicines.org/2015/07/operation-pangea-viii-takes-action-against-more-than-1000-purveyors-of-fake-drugs-medical-devices-7-7-15.html http://www.safemedicines.org/2015/07/operation-pangea-viii-takes-action-against-more-than-1000-purveyors-of-fake-drugs-medical-devices-7-7-15.html During The 8th annual International Internet Week of Action (IIWA) led by Interpol, the FDA along with law enforcement from across the globe acted to eliminate the sale of counterfeit medications and medical devices on the Internet. As part of... <p><strong>During The 8th annual International Internet Week of Action (IIWA) led by Interpol, the FDA along with law enforcement from across the globe acted to eliminate the sale of counterfeit medications and medical devices on the Internet. </strong></p> <p>As part of Operation Pangea, the FDA sent close to 400 warning letters to websites offering “unapproved or misbranded prescription medicines to U.S. patients and to nine firms distributing unapproved or uncleared medical devices online,” reports the <a href="http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm451755.htm" target="_blank">FDA in a press release</a>.</p> <p>According to the FDA, the illegal websites targeted were selling what they claimed were FDA-approved generic versions of asthma medications, HIV treatments, breast cancer medications, obesity treatments, antidepressants, hormone replacement therapies, sleep aids and other drugs to treat erectile dysfunction, high cholesterol and seizures.</p> <p>The goal of Pangea VIII, according to the FDA is “to identify the makers and distributors of illegal prescription drug products and medical devices and to remove these products from the supply chain.”</p> <p>This year’s IIWA is a collaboration between the FDA, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, Heads of Medicines Agencies Working Group of Enforcement Officers, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Tue, 07 Jul 2015 07:26:00 -0700 http://www.safemedicines.org/2015/06/black-market-discount-hivaids-medications-threaten-patients-health-6-22-15.html http://www.safemedicines.org/2015/06/black-market-discount-hivaids-medications-threaten-patients-health-6-22-15.html Since 2006, at least 86 individuals have been charged with the distribution of black market HIV/AIDS medications to American pharmacies, secondary wholesale distributors and patients. In the face of this threat, patients need the tools to identify questionable medicine and to seek better prices safely. <p>Modern medicines mean that HIV/AIDS patients can live full lives if they have access to reliable, continuous treatment. That treatment, however, can be expensive. Patients seeking better prices on life saving medicines may be taken advantage of by criminals selling black market drugs at 'discount' prices. Since 2006, at least 86 individuals have been charged with the distribution of black market HIV/AIDS medications to American pharmacies, secondary wholesale distributors and patients. These cases, which you can read more about in PSM's <a href="http://www.safemedicines.org/BlackMarketHIV_singlepage_CANN.pdf" target="_blank">Black Market HIV/AIDS Drugs in the News, 2006 – 2013</a>, are just the tip of the iceberg.</p> <p>Counterfeiters are canny marketers with convincing websites, but they sell medicines that may be expired, contaminated, diluted or damaged during shipping. They substitute cheap ingredients, offer medicines in unfamiliar doses and omit instructions and safety warnings.Their medicine may contain harmful chemicals or no active ingredients at all. Patients who unwittingly buy these drugs risk taking substandard medicines that can lead to higher viral loads, poor health and drug resistance. Because counterfeiters often purchase half used injectable medicines from addicts, these unlucky patients may even be exposed to bloodborne diseases like hepatitis C.</p> <p>In the face of this threat, patients need the tools to identify questionable medicine and to seek better prices safely.</p> <p>To save money safely, patients should:</p> <ul> <li>Consult their doctors about whether adopting generics would be appropriate</li> </ul> <ul> <li>Comparison shop online for the lowest prices for safe, licensed online pharmacies at <a href="http://www.pharmahelper.com/" target="_blank">Pharmahelper.com</a> or among online pharmacies which have earned the National Board of Pharmacy's <a href="http://www.nabp.net/programs/accreditation/vipps/find-a-vipps-online-pharmacy" target="_blank">VIPPS accreditation</a></li> </ul> <ul> <li>Compare prices at neighborhood pharmacies on websites such as <a href="http://werx.org/" target="_blank">WeRx.org</a>, <a href="http://www.lowestmed.com/" target="_blank">LowestMed.com</a> and <a href="http://www.goodrx.com/" target="_blank">GoodRX.com</a></li> </ul> <ul> <li>Seek out discount cards like the <a href="http://www.needymeds.org/drugcard/" target="_blank">NeedyMeds Drug Discount Card</a>, which offer substantially lower prices for un- or underinsured patients</li> </ul> <ul> <li>Search prescription assistance program resources at <a href="http://www.needymeds.org/" target="_blank">NeedyMeds</a> and the <a href="https://www.pparx.org/" target="_blank">Partnership for Prescription Assistance</a></li> </ul> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 29 Jun 2015 07:53:00 -0700 http://www.safemedicines.org/2015/06/are-the-men-in-your-life-safe-from-counterfeit-drugs-6-19-15.html http://www.safemedicines.org/2015/06/are-the-men-in-your-life-safe-from-counterfeit-drugs-6-19-15.html As we honor fathers all over the United States this Father’s Day, take a few minutes to understand the unique dangers men face from counterfeit medications. A quick glance at the National Crime Prevention Association page on counterfeit drugs will... <div style="float: left;"><a class="asset-img-link" href="http://www.safemedicines.org/2012/06/the-top-9-mens-health-risks-counterfeiters-exploit.html%20" style="display: inline;"><img alt="Joeheader 500" border="0" class="asset asset-image at-xid-6a00e5550359d1883401761517bcac970c" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401761517bcac970c-800wi" style="padding-right: 10px;" title="Joeheader 500" /></a></div> <p>&#0160;</p> <p><strong>As we honor fathers all over the United States this Father’s Day, take a few minutes to understand the unique dangers men face from counterfeit medications. </strong></p> <p>A quick glance at the <a href="http://www.ncpc.org/topics/intellectual-property-theft/counterfeit-drugs-1" target="_blank">National Crime Prevention Association page on counterfeit drugs </a>will tell you that medications for high cholesterol, hypertension, antibiotics, ED, cancer, and HIV/AIDS are the most commonly found to be counterfeited. These medications, along with treatments for hair loss, depression, obesity, &amp; diabetes are also the medications men are most likely to be taking on a regular basis.</p> <p>Please share <a href="http://www.safemedicines.org/2012/06/the-top-9-mens-health-risks-counterfeiters-exploit.html" target="_blank">The Top 9 Men&#39;s Health Risks Counterfeiters Exploit</a> with the men in your life. Don’t let too-good-to-be-true pricing on needed medications endanger the health and happiness of the husbands, dads, brothers, and friends you care about.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Fri, 19 Jun 2015 08:28:00 -0700 http://www.safemedicines.org/2015/06/psm-psa-doctors-protect-your-practice-from-fake-drugs-6-16-15.html http://www.safemedicines.org/2015/06/psm-psa-doctors-protect-your-practice-from-fake-drugs-6-16-15.html The Partnership for Safe Medicines has created a series of public service announcements to educate both patients and medical professionals about the dangers posed by fake medications. In Doctors! Protect Your Practice from Fake Drugs, PSM board member Tom Kubic of the Pharmaceutical Security Institute points out that “the physician is the last word on everything in the office, including medication purchases.” <p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/a_NaPYTYGgM" width="560"></iframe></p> <p>&#0160;</p> <p>The Partnership for Safe Medicines has created a series of public service announcements to educate both patients and medical professionals about the dangers posed by fake medications. In <a href="https://youtu.be/a_NaPYTYGgM?list=PLAUAYqnB046-qZ7_rFmxsjmkH8f2rW17d" target="_blank"><strong>Doctors! Protect Your Practice from Fake Drugs</strong></a>, PSM board member Tom Kubic of the Pharmaceutical Security Institute points out that “the physician is the last word on everything in the office, including medication purchases.” Counterfeit medication cannot make it into a doctor’s office if the physician in charge is vigilant about the source and quality of the medications purchased. Learn how to protect your practice from counterfeit medication by using the <a href="http://www.safemedicines.org/protecting-patients-from-counterfeit-medications-guides-for-doctors.html" target="_blank">L.E.A.D.E.R.S. Guide for Physicians</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News Thomas T. Kubic SafeMedicines Editor Mon, 15 Jun 2015 14:16:13 -0700 http://www.safemedicines.org/2015/06/black-market-medicine-is-a-serious-problem-in-g8-member-countries-6-15-15.html http://www.safemedicines.org/2015/06/black-market-medicine-is-a-serious-problem-in-g8-member-countries-6-15-15.html In 2013, the G8 recognized the counterfeit medicine trade as a significant problem in their countries. Read PSM's infographic to learn about their reporting on the issue. <p>In May 2013, the leaders of G8 countries (Canada, France, Germany, Italy, Japan, Russia, the UK and the United States of America) met at Camp David to discuss major global challenges, including rogue internet pharmacies and counterfeit medical products. They <a href="https://www.whitehouse.gov/the-press-office/2012/05/19/camp-david-declaration" target="_blank">committed</a> "to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products," and released a report(<a href="http://www.g8.utoronto.ca/evaluations/2012compliance/15-12-final-health.pdf" target="_blank">download pdf here</a>) in June 2013 to summarizing counterfeit incidents each country reported.</p> <p>The results of that report highlight just how unsafe it is to import medicines from non-FDA approved sources. Learn more by reading PSM's infographic, or check out all the details in the <a href="http://www.g8.utoronto.ca/evaluations/2012compliance/15-12-final-health.pdf" target="_blank">G8's report</a> (download).</p> <p><a class="asset-img-link" style="display: inline;" href="http://www.safemedicines.org/onepagerlandingpages/PSM_G8_FakeMedicines_9.pdf"><img class="asset asset-image at-xid-6a00e5550359d1883401b7c78d3473970b img-responsive" title="PSM_G8_FakeMedicines_9" src="http://safemeds.typepad.com/.a/6a00e5550359d1883401b7c78d3473970b-500wi" alt="PSM_G8_FakeMedicines_9" /></a></p> <p>&nbsp;</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 15 Jun 2015 08:01:00 -0700 http://www.safemedicines.org/2015/06/the-national-crime-prevention-council-wants-consumers-to-buy-medicines-safely-6-8-15.html http://www.safemedicines.org/2015/06/the-national-crime-prevention-council-wants-consumers-to-buy-medicines-safely-6-8-15.html The National Crime Prevention Council has released a guide about how to find a safe online pharmacy and protect yourself from products that may be contaminated, counterfeit or not approved by the FDA. <p>The National Crime Prevention Council has released a guide about how to find a safe online pharmacy and protect yourself from products that may be contaminated, counterfeit or non-FDA approved. The brochure reviews safety precautions and provides information about how to report suspicious drugs. Their tips for patients include:</p> <ul> <li>being familiar with the color, size, shape, taste and side effects of their medication so that they can detect counterfeits more easily</li> </ul> <ul> <li>making certain that their pharmacy is domestic and that it is licensed and in good standing by contacting the National Association of Boards of Pharmacy (www.nabp.net, 847-698-6227)</li> </ul> <ul> <li>never purchasing drugs without a prescription, examining drug packaging for tampering</li> </ul> <ul> <li>using common sense about unrealistic claims a website may make about medicines it is selling</li> </ul> <p>Learn more by <a href="https://docs.google.com/document/d/1-MPK0FYQWgXK4Gl5XhEpmd73WVIkV8x5PQbvttUo2e4/edit" target="_blank">downloading NCPP's brochure</a>.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 08 Jun 2015 07:12:00 -0700 http://www.safemedicines.org/2015/06/linda-marks-offers-her-views-on-criminal-prosecutions-and-patient-safety-at-interchange-2014-5-25-15.html http://www.safemedicines.org/2015/06/linda-marks-offers-her-views-on-criminal-prosecutions-and-patient-safety-at-interchange-2014-5-25-15.html Linda Marks, Senior Litigation Counsel for the Consumer Protection Branch of the Department of Justice, moderated Interchange 2014’s panel on criminal prosecutions and the patient safety issues that result from misbranded medication. In her opening remarks, she described the work the Department of Justice has done to combat counterfeit and misbranded drugs. <p>Linda Marks, Senior Litigation Counsel for the Consumer Protection Branch of the Department of Justice, moderated Interchange 2014’s panel on criminal prosecutions and the patient safety issues that result from misbranded medication. In her opening remarks, she described the work the Department of Justice has done to combat counterfeit and misbranded drugs.</p> <p>As an introduction to Panel 2: Criminal Prosecutions: Patient Safety Ms. Marks provided updates from last year’s counterfeit and misbranded drug cases. She first described the case of counterfeit cancer medication, in this instance Altuzan (called Avastin in the U.S.), that made its way into U.S. doctors’ offices. Referring to it as the “From Turkey to Missouri case,” Ms. Marks shared how the case first began.</p> <p>“This case based in Missouri started, and here is where we give kudos to the sales reps from pharma companies, because a pharma rep found that a physician in the Saint Louis area in Missouri, Doctor Abid Nisar, had stopped buying their injectable drugs. He was curious and found out from one of the office staff that the practice had started buying the drugs from an overseas [non-FDA approved] source.”</p> <p>The information the pharma sales rep shared with the Department of Justice led to the eventual prosecutions of <a href="http://www.safemedicines.org/infographics/RoguesGallery_All_5.pdf" target="_blank">James Newcomb</a>, <a href="http://www.safemedicines.org/2012/02/saint-louis-area-oncologist-pleads-guilty-to-purchasing-and-distributing-fake-cancer-drugs.html" target="_blank">Dr. Nisar</a>, <a href="http://www.safemedicines.org/2013/07/british-owner-of-fake-cancer-drug-distributor-sentenced-in-federal-court-1.html" target="_blank">Richard Taylor</a>, and ultimately <a href="http://www.safemedicines.org/2014/08/owner-of-turkish-drug-wholesaler-pleads-guilty-to-smuggling-fake-cancer-drugs-8-19-14.html" target="_blank">Ozay Pharmaceuticals</a>, as the convoluted chain of distribution was unraveled by investigators.</p> <p>Ms. Marks also shared examples of the “blast faxes” that the black market cancer drug suppliers used to advertise their wares to doctors’ offices. To watch Linda Marks’ Interchange 2014 presentation on counterfeit, misbranded, and illegally diverted medication criminal prosecutions that have occurred, <a href="http://youtu.be/XGZs-CdLVGo?list=PLAUAYqnB046-5IKPuybWmf_X9Eu16E2VK" target="_blank">click here</a>, or see below. To take a look through Ms. Mark’s slide presentation, <a href="http://www.slideshare.net/SafeMedicines/10-40-marks-16-9-revised" target="_blank">click here.</a></p> <p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/XGZs-CdLVGo" width="560"></iframe></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 01 Jun 2015 11:41:00 -0700 http://www.safemedicines.org/2015/05/doctors-do-you-know-where-the-medication-you-prescribed-came-from-fda-wants-you-to-know-your-source-5-18-15.html http://www.safemedicines.org/2015/05/doctors-do-you-know-where-the-medication-you-prescribed-came-from-fda-wants-you-to-know-your-source-5-18-15.html Doctors, medical office managers, and others responsible for medication purchasing need to know about the FDA’s “Know Your Source” campaign. With the help of a few simple pieces of advice from the agency responsible for guaranteeing medication safety, you can make sure that the prescription drugs in your office are FDA-approved. By sticking with state-licensed wholesale medication distributors you can safeguard the health of your patients and protect your practice from liability as well. <p><strong>Doctors, medical office managers, and others responsible for medication purchasing need to know about the FDA’s “Know Your Source” campaign. With the help of a few simple pieces of advice from the agency responsible for guaranteeing medication safety, you can make sure that the prescription drugs in your office are FDA-approved. By sticking with state-licensed wholesale medication distributors you can safeguard the health of your patients and protect your practice from liability as well.</strong></p> <p>In September 2014, The Food and Drug Administration (FDA) asked all medical professionals to verify the authenticity of medication they purchase to treat patients. Called, <a href="http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm" target="_blank">“Know Your Source: Protecting Patients from Unsafe Drugs”</a> , the campaign is designed to appeal to doctors, medical office managers, and other medical professionals responsible for wholesale purchases. It’s goal is to educate about the dangers of purchasing medication from medication wholesalers who do not play by the rules.</p> <p>The four flyers are intended for the non-clients sections doctors’ offices. Each one demonstrates the various things to watch out for when purchasing medication wholesale.</p> <p><a href="http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396536.pdf" target="_blank"><strong>Beware of Offers</strong></a> confronts the aggressive marketing practiced by rogue medication wholesalers. If the prices are too good to be true, then it probably is not real medication.</p> <p><a href="http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396537.pdf" target="_blank"><strong>Caution!</strong></a> shows how to spot fake medication. Errors on labels, labels not in English, imperfect or puzzling packaging can all be visual indicators that the medication is counterfeit.</p> <p><a href="http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396540.pdf" target="_blank"><strong>Ensure You Receive</strong></a> asks medical professionals to make sure that they only make medication purchases from wholesalers licensed to sell in their state.</p> <p><a href="http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396544.pdf" target="_blank"><strong>Pay Close Attention</strong></a> asks medical professionals be on the lookout for patient feedback such as lack of therapeutic effect or new side effects from familiar medications.</p> <p>By following the simple rules offered by the FDA, doctors can safeguard both their patients’ health and the security of their medical practice.</p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 25 May 2015 12:27:00 -0700 http://www.safemedicines.org/2015/05/interchange-2014-highlights-fda-ocis-philip-walsky-speaks-about-the-global-scope-of-counterfeit-medi-5-13-15.html http://www.safemedicines.org/2015/05/interchange-2014-highlights-fda-ocis-philip-walsky-speaks-about-the-global-scope-of-counterfeit-medi-5-13-15.html At the 2014 Interchange, PSM was pleased to have Philip Walsky, the Acting Director of the FDA's Office of Criminal Investigations (OCI) speak about OCI's efforts to respond to the challenge of fraudulent drug schemes. <p>At the 2014 Interchange, PSM was pleased to have Philip Walsky, the Acting Director of the FDA's Office of Criminal Investigations (OCI) speak about OCI's efforts to respond to the challenge of fraudulent drug schemes. Walsky characterized recent pharmaceutical crime as more complicated than in the past, with "more actors in many different parts of the world." He described OCI's coordination with INTERPOL and the Permanent Forum on International Pharmaceutical Crime (PFIPC), but also discussed their expanded international presence in the rest of the world. In June 2014, OCI sent an agent on permanent assignment to Europol and the office is contemplating placing staff in enforcement agencies in Asia and South America. The office has also sent agents on short assignments to Singapore, India and Chile, where they offered education about counterfeit drug crime and drug regulation.</p> <p>Walsky also spoke about OCI's relationship with Health Canada and the Royal Canadian Mounted Police and about organized crime's exploitation of counterfeit medicines trade, "not just in the U.S., but worldwide." Organized crime finds fake medicines attractive, he said, because the trade is "high profit and low risk. The fact of the matter is...ounce for ounce, Avastin is 3 times more expensive than an ounce of gold."</p> <p>Learn more about the FDA's global efforts to protect Americans from counterfeit medicine by listening to Walsky's comments below, or listen to the whole panel, <a href="https://www.youtube.com/watch?v=j6USIGOJxG0&amp;feature=youtu.be" target="_blank">Drug Counterfeiters Target Americans</a>.</p> <p>&nbsp;</p> <p><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/j6USIGOJxG0?start=1640" width="560"></iframe></p> <p>&nbsp;</p> <p>AND</p> <p><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/j6USIGOJxG0?start=2840" width="560"></iframe></p> <p>&nbsp;</p> <p>AND</p> <p><iframe allowfullscreen="" frameborder="0" height="315" src="//www.youtube.com/embed/j6USIGOJxG0?start=3113" width="560"></iframe></p> <p><a href="http://www.safemedicines.org/editorial-masthead.html">By S. Imber </a></p> News Partnership News SafeMedicines Editor Mon, 18 May 2015 12:23:00 -0700