The new gum was marketed as Alert Energy Caffeine Gum and it contains about 40 milligrams of caffeine, reports Reuters, about the same amount as a half cup of coffee.  Chewing the pack would be the equivalent of four cups of coffee, according to the FDA website.

The announcement from Wrigley comes less than a week after the FDA announced it would take a “fresh look” at the issue of caffeinated products, the gum just the latest in an array of products largely aimed at a young consumer.

Alert gum has a slightly bitter taste and is not marketed at children, but at adults age 25 and older. Other similar products include Stride Spark Gum with vitamins B6 and B12 and Trident Vitality Gum with ingredients such as Vitamin C, green tea and ginseng.

FDA is increasingly concerned with how to regulate the growing field of caffeinated products especially in light of the adverse events reported such as heart attacks suffered by some young users of energy drinks. In November, the agency received reports of 18 deaths and 150 injuries linked to caffeinated products.

Historically this is not entirely a new problem. In the 1950s, the FDA approved the use of caffeine in cola drinks. Since then there have been a plethora of caffeine-fuelled products. Leading the pack are energy drinks with names like Monster and Jolt.  Monster Beverage Corp skirts FDA regulations by calling its product a dietary supplement. The FDA does not regulate dietary supplements and allows the industry to self-regulate.

The central concern is the effect of too much caffeine on developing youngsters, particularly the neurologic and cardiovascular effects.   Fox News reports that major medical associations fear children may not be able to process caffeine as well as adults.

The American Academy of Pediatrics does not recommend caffeine or caffeine-containing products for children.

Make no doubt about it. Caffeine profiteers see children and adolescents as a potential market. Food manufacturers have jumped into the trend such as Arma Energy Snx which contains caffeine. Recently Jelly Belly “Extreme Sport Beans” have been launched with 50 milligrams of caffeine, according to Fox News, in every 100-calorie pack.

An FDA spokesman, Michael Taylor, noted that “some in the food industry are on a dubious and potentially dangerous path,” reports the Los Angeles Times.

The FDA is finally poised to establish some guidelines and boundaries which could include a designation as a food additive. The amount of caffeine added to consumer products could then be restricted.

The federal Centers for Disease Control and Prevention (CDC) reports that the number of deaths attributed to prescription painkillers now exceeds those attributed to illegal street drugs such as heroin and cocaine.

PBS recently talked to the family of Oklahoma Sooners Linebacker, Austin Box, who died in 2011 from a combination of five pain medications and an anti-anxiety drug that stopped his heart at the age of 22. No one had any idea that this young man was addicted to prescription painkillers.

The CDC reports the number of deaths attributed to prescription drugs had quadrupled in the U.S rising from 4,030 fatalities in 1999 to 16,651 in 2010. OxyContin, Vicodin, Opana and methadone are believed to be responsible for about 125,000 U.S. lives over the last decade and the CDC reports that is just part of the picture.

For every fatality there are 32 emergency room visits, 10 drug treatment admissions and 130 other users who are addicted.

The CDC reports on the Top 10 things you should know about Prescription Drug Abuse:

1. More Americans are killed by drug overdoses than car crashes – about 105 deaths every day.
2. There were enough painkillers prescribed in 2010 to medicate all U.S. adults every four hours for one month.
3. Prescription drugs deaths increased four times from 1999 to 2010.
4. Non-medical use of painkillers for a “high” is sought by one in 20 Americans.
5. It is suggested you hide or lock up prescription painkillers or dispose of them properly.
6. Community and state policies are being employed to prevent painkiller drug overdoses.
7. The Patient Review and Restriction Program and Prescription Drug Monitoring Programs can coordinate care for patients.
8. State laws can address doctor shopping and pill mills.
9. Substance abuse programs can intervene and help save lives by reducing overdoses among addicts. 
10. Prescribers should turn to painkillers as a last resort, prescribe only what is necessary and monitor patients for substance abuse.

The problem isn’t just with teenagers but of adult Americans as well. The CDC estimates about 12 million adults and teens used prescription painkillers to get a “high” while emergency room visits have doubled to nearly a half million.

Even if you are not a statistic, the CDC estimates the painkiller epidemic is costing all Americans more than $72.5 billion annually in related healthcare costs.

Not that anyone is intentionally increasing the complication rate, but the Boston Consulting Group reports that patients on Medicare or private insurance who experience complications after surgery may provide higher profits for that hospital.

Published in the Journal of the American Medical Association (JAMA), researchers from Harvard Medical School found when a patient experiences a blood clot, stroke, septic shock or cardiac arrest the hospital’s profit margin jumps 330 percent higher when compared to a patient with no complications.

That translates to $56,000 for a privately insured patient compared to $17,000 when the outcome is complication-free. For a Medicare patient hospitals will receive $3,600 for a patient with complications versus $1,800 for a complication-free surgery.

When a hospital has fixed costs for patients covered by Medicaid or the patient covers their own care, the hospital will make less money if it has to cover the costs of a complication.

One co-author believes the incentive process is backward.  Instead of rewarding a hospital with fewer complications, those with the most problems actually make more money on patients who have to stay in the hospital longer and receive additional care.

The Boston Consulting Group analyzed data from more than 34,000 surgeries performed at the 12-hospital system of Texas Health Resources. Among those 5.3 percent of patients or 1,820 experience some type of types of complications.

While it’s always been known there is no incentive system for quality hospitals it was never understood before just how badly things had swung in the opposite direction. An investment in reducing risk may not help underwrite hospital costs but it goes a long way in improving patient confidence and outcomes and underscores the need to focus on payment reform in conjunction with healthcare reform.

No one knows how many patients have died due to the malfunctioning devices, but the New York Times reports in one case a nurse was trying to help a patient in cardiac arrest when the defibrillator read “memory full” and it shut down. The patient died. In another instance the software showed an “equipment disabled” message. That patient also died.

The FDA reports that there have been 45,000 failures of defibrillator hardware and software since 2005, and manufacturers have had to recall AEDs 88 times. In order to improve that dismal record, the proposed order will require manufacturers to make available designs of the AEDs. The agency would also be given tighter controls on buying defibrillator components overseas.  Dr. William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas.
The FDA could have downgraded AEDs to a lower or moderate risk device (Class I or II), but an expert panel convened in October 2011 recommended AEDs remain Class III (highest-risk medical device) and required pre-market approval (PMA),  higher degree of scrutiny than the current notification process.

One application for PMA approval would cost about $248,000 according to Dr. Maisel, but that would cover all models of AEDs made by the company. Dr. Maisel says the safety data has already been conducted by the companies so most will not have to do any additional clinical studies.   The revamp of FDA safety oversight should be completed by 2014.

AEDs are known as “pre-amendment devices” which means that they were already in the marketplace before 1976 when the FDA began regulating medical devices.  At that time there were 170 devices called Class III that were approved through the 510(k) notification process that were never required to submit PMAs.  The FDA’s website says 19 medical devices are still waiting to be reclassified, including the high-risk metal hip joints with uncemented acetabular components as well as cemented acetabular components.

How do we know they are safe and effective?

The simple answer, which would surprise most patients and physicians, is that we do not know if the medical devices are safe and effective. A study published in the Archives of Internal Medicine in 2011 found nearly three-quarters of medical devices that caused injury or death from 2005 to 2009 had entered the market through the 510(k) process.   Any changes in the 510(k) process, however, would also need to address the false notion that the PMA process leads to safer medical devices.  That is not necessarily the case, with the Birmingham metal-on-metal hip implant marketed by Smith & Nephew being a prime example of a PMA-approved medical devices that has injured untold thousands of patients who have had to undergo revision surgeries and suffered other bone and tissue damage and disability as a result of cobalt and chromium poisoning and premature failure of the devices.

In Palm Beach County there are over 750 homeless families and over 1600 homeless children at any given time.

I know a guy who gives me a ration of criticism for giving money to people along the road. His response is they are all drug addicts, criminals or just plain lazy. He says the solution to homelessness is to make everyone get a job and “learn how to support themselves”.

I can tell you from experience and from learning about it that being poor or being homeless has a lot less do with laziness and a great deal more to do with a few missteps and a lot of bad luck. In our present economy, those of us in the middle class may be simply the loss of a job away from homelessness.

Have you ever begged for money? Panhandled along the busy streets? Begged for food? It is a sad and difficult skill to learn. First, you have to overcome the fear and shame you find yourself in a position of having to do it. You have to harden yourself against the people who look at you with disdain and judgment written all over their faces. You have to prepare yourself for the taunts, insults and, sometimes, the food thrown at you.

One of my bosses here at the law firm, Jack Scarola, has spent the better part of his adult life working with a worthy organization called “The Lord’s Place”. Jack is a past chairman and a regular at what The Lord’s Place calls the “Sleep Out”. If it is like nearly every year, Jack’s beautiful wife Anita will be with him as will many of his friends and family. They will all gather at the Meyer Amphitheater at 6:00 PM and sleep outside all night long.

The Lord’s Place is not a place for a hand out as much as a leg up. It is an organization that will help individuals and families find a place to sleep, a place to eat and will help them get back into the job market. My wife is a principal and many of her students would not have been at school today but for The Lord’s Place helping their family. Sadly, I know about families right now living in their cars, but still trying to get their kids to school and themselves to a job.

Jack Scarola and all the volunteers will not just be sleeping out under the stars in the torrential downpour or through the onslaught of mosquitoes; they are also raising funds to help the Lord’s Place help the homeless by giving them just a little leg up.

So, if you believe as I do; that in a country like America no one and certainly no children should have to be homeless or hungry reach into your pocket and support this worthy organization. It is only a click away right here!

So this latest warning from healthcare giant Johnson & Johnson is especially troublesome.

Its popular OneTouch Verio IQ blood glucose meters have been found to be faulty when the blood sugar is especially high. Instead of providing a warning, they turn off.

J&J is recalling almost 1.9 million units following the death of a patient in Europe.

About 900,000 units were sold to U.S. consumers. The problem was detected when a high blood sugar of 1,024 milligrams per deciliter caused the device to trip off.

The company says the likelihood of reaching that level of blood glucose is remote but the failure to deliver an accurate reading could delay treatment that can result in serious complications including death or a diabetic coma.

Just for comparison, a diabetic wants to keep his blood sugars in the range of 160 milligrams per deciliter or below. Any higher and the sugar travelling through the body can damage the heart, eyes, blood vessels and other organs. Amputations, blindness, kidney failure and heart attack can result when blood sugar goes unchecked.

These meters were sold in the U.S. and in other countries. J&J’s LifeScan unit says it will replace them for free. Those recalled include the OneTouch VerioIQ, OneTouch VerioPro, and the OneTouch VerioPro+.

The VerioIQ meter can be used until replacement meters come in.

The problem was detected by internal company testing soon after the patient died following an inaccurate reading which may or may not have been linked to the medical device.

Over the last couple of years, J&J has issued about a dozen recalls for faulty medications, contact lenses and hip implants. You’ll recall the children’s Tylenol and Motrin recalls, the DePuy ASR metal-on-metal hip recall, a bone putty to stop bleeding and the complete overhaul of a nonprescription medicine factory that was taken over by the FDA after an inspection found contaminated products and dirty conditions.

Bloomberg reports 2012 sales of LifeScan diabetes care products at $2.6 billion.

Visit the company’s website www.onetouch.com or contact customer service at (800) 717-0276 to return the meter.

None of us likes to think we’re getting older but the Centers for Disease Control and Prevention (CDC)  finds that among Americans age 65 and older, one in three will experience a fall every year with results than can range from minor to fatal. Even a minor fall can lead to head trauma that is not initially recognized.

According to the CDC there were 2.3 million Americans who experienced falls in 2010 and were treated in emergency rooms. Among those more than 662,000 were hospitalized with injuries that included hip fractures, lacerations and head trauma.  Hitting your head can easily cause anything from traumatic brain injury (TBI) to a concussion and can be experienced by people of all ages, but falls are the most common cause according to the CDC.

Falls are the cause of hip fractures about 95% of the time says the federal agency.

Falls are preventable if some precautions are taken.

• Americans of all ages commonly trip from pets, loose rugs or objects on the floors or furniture that is in the way. The CDC recommends your walking space be adequate and the floors have a lot of traction.
• A grip bar in the bathroom is recommended especially around the tub, shower and next to the toilet.
• Keep areas well lit.
• Have eyes examined and update glasses prescriptions as needed.
• The CDC suggests regular exercise will increase leg strength making a fall less likely and recovery easier.
• Any dizzy spells should be taken seriously. A consult with a physician can help determine if a medical condition is causing dizziness or a medication may be the cause.

The CDC campaign called, “Heads Up to Brain Injury” was created to recognize March as Brain Injury Awareness Month.

TBI causes at least 1.7 million injuries every year and can be described as a head injury that alters the normal functioning of the brain. Even a mild bump can cause TBI. The majority of TBI are concussions.

The CDC reports there are about 3.5 million Americans with TBI which has proven fatal to 53,000.

Wearing a seat belt, avoiding drunk and distracted driving and wearing a helmet are some suggested ways to protect your head from blows.

Now a Georgia compounding pharmacy, Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, has voluntarily recalled all lots of sterile syringes loaded with the cancer drug Avastin. The recall was undertaken after an FDA inspection revealed sterility concerns.

At least five people have serious eye infections associated with the Avastin drug that was repackaged from vials into syringes by CSCP. The condition is called endophthalmitis, which the FDA reports occurs inside the eyeball and can lead to permanent blindness. The link to the syringes was brought to the federal agency’s attention by the Centers for Disease Control and Prevention (CDC).

The FDA is playing catch-up after 48 people died from a contaminated epidural steroid injection. Over 700 patients continue to be treated for fungal infections and hundreds of lawsuits have been filed against NECC, which has filed for bankruptcy.

Historically, compounding pharmacy regulation has fallen outside of FDA radar and states have not been picking up the slack. There is a move to increase the FDA’s authority over compounders and the surprise plant visits are part of the plan.

Meanwhile the voluntary recalls continue with three announced during one week in March.

Med Prep Consulting of Tinton Falls, New Jersey voluntarily recalled 83 types of antibiotics and drugs used during surgery because of a possible mold contamination, which was visible to the eye. Regional hospitals in New Jersey, Connecticut, Delaware and Pennsylvania received the infusion bags, glass vials and plastic syringes linked to the mold.

An inspection at Pallimed Compounding Pharmacy of Massachusetts led to the recall of all sterile products made at the plant in an “abundance of caution” even though there had been no injuries reported. The FDA inspectors indicated there were “deficiencies” but the recall does not include the facility’s non-sterile products.

The state took the next step and issued a “limited Cease and Desist Order” to prevent the sale of 16 sterile compounded products. Last December, the Boston Globe reports the company had been ordered to stop compounding Viagra because of “improper components.”

Originally, compounding pharmacies were developed to mix small batches of custom ordered drugs. Depending on the individual state’s regulations, they were not intended to become full-blown mini-pharmaceutical manufacturing facilities, but that is the role many have undertaken.

State laws vary and the FDA is seeking additional authority over the growing industry, however, as we’ve seen so many times, the agency does not have enough funding to oversee about one-quarter of the consumer products used by Americans.

One proposal has the compounding companies pay a user fee to cover the cost of FDA inspections.

Bottom line – inspect the products coming from a compounding facility. In the case of the mold, a nurse, not FDA regulators, noticed the contamination problem which led to the recall.

The passengers remained helpless at sea about 150 miles off the coast of Mexico for five days. It’s still uncertain why the ship remained disabled for so long.

CNN reports a class action lawsuit has already been filed by passengers who say that Carnival knew or should have known “that the vessel Triumph was likely to experience mechanical and/or engine issues because of prior similar issues.”

The ship’s condition presented a risk of injury, illness and disease, but reportedly there was only one man taken off the ship who had to be treated for dehydration at a Houston hospital. Considering the fact that feces overflowed from toilets onto the ship, there was little or spoiled food to eat and with no air conditioning, passengers had to sleep in public areas, it’s amazing more people were not sickened.

Even though others are likely to join this class action you should know it is very difficult to sue any cruise line. That’s because the small print on the back of your ticket contains your legal obligations and rights with the corporation and Carnival has covered itself for any eventuality including bad weather or mechanical problems.

The mechanical condition of the Triumph before it launched from Galveston, Texas for the four-day cruise to Mexico will be explored. A fire reportedly broke out damaging the propulsion system and generators and knocking out power. The fire started from a leak ignited from a fuel-oil line from one engine.

One of the lawsuits filed in Miami claims the Triumph had mechanical troubles recently so it will be important to determine whether Carnival was negligent in allowing the ship to return to sea so quickly.

Passengers are generally restricted to filing in the Miami jurisdiction under the rules as set out on the back of the ticket. Consumers are reminded to read the fine print which is essentially an iron-clad contract between you and the cruise line.

Usually a judge must decide whether the contract can be waived and a class action can be filed. Otherwise you might have to depend on the cruise line and its willingness to win some public relations good will.

The product is sold by Toys R Us which has issued a recall for 9,000 units of the walkers, used to help babies take their first steps. The walker has a wooden push handle at the top of the walker and the base has four wheels.  A small bolt and spacer attached to the front wheel can potentially detach and cause the child to fall and/or choke on the parts.

Consumers are encouraged to take the walkers back to the store for a full refund.

The Imaginarium Activity Walker was sold exclusively at Toys R Us stores from August 2011 through January of this year at a cost of about $30. The walker was made in China and imported by Toys R. Us Inc of Wayne, New Jersey.

Health Canada has issued a similar Consumer Product Recall.

The U.S. Consumer Product Safety Commission (CPSC) and its CPSC Safer Products site will continue to take consumer calls and complaints regarding this recalled product.

Federal law prohibits anyone from selling or re-selling a defective product on the retail or second-hand market where many children’s products end up.

The CPSC protects the public from thousands of consumer products that pose an unreasonable risk of injury or death. The cost to the nation for defective consumer products? More than $900 billion annually.

That may include baby products and children’s bedding with carcinogenic flame retardant chemicals, which were removed from the market in California beginning in January; defective baby furniture and cribs which can trap and suffocate infants; and defective child products containing lead, among many other products that have been recalled over the years.

The agency has been criticized for working too closely with manufacturers. In August 1995, the CPSC initiated a fast-track recall program to get defective products off of store shelves.

In a concession to manufacturers, the CPSC eliminated the preliminary determination to establish whether or not a product is defective in its design, its manufacturing or in its instructions for use. In return, manufacturers agreed to comply with a recall and to notify distributors, wholesaler and retailers within 20 days. This saves years of litigation and gets defective products off the store shelves quicker.

Under law, manufacturers must report any risks of serious injury or death to the CPSC and the agency receives about 300 a year. A failure to report a defective product can result in a civil penalty of up to $1.5 million.

In this case, the loss of the product itself will cost Toys R Us around $270,000; plus the overhead and costs involved in announcing and running the recall process. Why can’t we reach a program in which manufacturers actually test their products before placing them on the market; to, for example, determine whether the wheels will fall off before they go on the shelves for sale to unwary consumers.

The company can be reached at (800) 869-7787 from 9 a.m. to 11 p.m. ET Monday through Saturday and 11 a.m. to 7 p.m. Sunday.