Policy and Medicine

State Policy: Minnesota Clarifies Restrictions on Payments to Physicians

2010-02-08T09:57:52-05:00

In response to recent joint hearings held by the Minnesota Commerce and Labor, and the Business, Industry and Jobs committees, “the Minnesota pharmacy board maintained that it's legal to pay doctors to answer bona fide marketing surveys.”

Their support of such legal work comes after debating legislation that the pharmacy board maintains “may keep the state a marketing research “dead zone.” In fact, the Minnesota Board of Pharmacy, which collects physician gift data under a 1993 state law, asserted that it does not consider payments to physicians illegal, as long as the payment compensates the doctor “in connection with a genuine research project.” The Board also noted that although they consider such payments legal, “pharmaceutical companies must still file an annual report with the board concerning such payments.”

To clarify their stance, the Board posted an “FAQ on their website last month, which reflected their long-standing position that “those sorts of payments were allowed.” According to Cody Wiberg, the pharmacy board's executive director, people “were misinterpreting the FAQ because of the way it was written.”

Mr. Wiberg further explained that “legitimate surveys involve those which manufacturers hire a marketing-research company to carry out … in the physician never knows which company is the sponsor, and payments come through vendor, not manufacturer.”

Howard Fienberg, director of government affairs for the Marketing Research Association (MRA) applauded the board’s actions as a good “first step,” especially since “the board had not meant to dissuade industry from conducting legitimate marketing research.”

Part of the problem came from the 1993 Minnesota statute banning physician gifts over $50. The language was confusing because the original FAQ was talking about “marketing surveys—direct payments to practitioners for filling out a survey," not marketing research.

In addition to MRA, the Pharmaceutical Marketing Research Group (PMRG) and the Council of American Survey Research Organizations prompted the board to make the distinction clear.

Minnesota Legislation

This recent development from the board could be a temporary solution if recent legislation introduced in Minnesota is passed. The joint committee hearing in the Minnesota House and Senate last week, debated “three bills related to various aspects of pharmaceutical marketing.” Mr. Fienberg asserted that these bills will make Minnesota a “marketing-research “dead zone” to medical-device research.” In addition, Fienberg noted that states who have enacted similar laws about drug and device-company payments in connection with marketing research “have seen firms have stopp doing research in those states. In Massachusetts however, “MRA won an explicit exclusion for marketing research in regulations last year.”

During the hearing, Mr. Fienberg testified in front of the joint committee and defended the use of physician incentives in pharmaceutical and medical device manufacturing.
He asserted that MRA would “like to see a blanket exclusion of bona fide marketing research from both reporting requirements and a ban.”

Ultimately, with pharmaceutical and medical device companies abandoning research in states with such rules, can patients and physicians really afford to be losing such accessible experience and funding? Without the support of medical device and industry, how are academic medical centers going to train and update physicians across each state with little funding for travel, lodging, and time away from practice? Mr. Fienberg’s testimony is an important voice in showing how crucial it is that industry remains in states to support the efforts of medical research and innovation to help create newer and better treatments for patients.

FDA Official Cleared of Conflict Allegations in Heparin Contamination Case

2010-02-08T09:38:08-05:00

Last week Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA was cleared of a conflict of interest allegation. The charge came from her engagement of a firm developing a low molecular weight heparin generic, to find the source of the 2008 heparin contamination.

In 2008, Dr. Woodcock, and scientists at Momenta Pharmaceuticals were among a team of researchers that identified a contaminant in Chinese-imported heparin marketed by Deerfield, Illinois-base Baxter International that was sickening and, in some cases, killing patients. According to The Baltimore Sun, the findings were reported in a pair of science journals in April 2008.

In competition with Momenta to develop the drug was Amphastar Pharmaceuticals, Inc., located in Rancho Cucamonga. Both the version of heparin under development by Amphastar and Momenta is chemically similar but distinct from the form of the Baxter drug, according to the Sun.

Problems arose in April 2009, when Amphastar raised conflict allegations against Dr. Woodcock’s work with the drug. “Amphastar alleged that Woodcock's research work with Momenta essentially forged a bond with the company and created the appearance of a conflict.” Amphastar also alleged in its complaint that “earlier contacts in 2007 between Woodcock and Momenta-connected scientists discussing issues that would later figure in requirements imposed on both companies' applications.”

Eventually, Dr. Woodcock “voluntarily removed herself from considering the application, as well as a competing one filed by Amphastar Pharmaceuticals.”

Last week however, FDA legal counsel Ralph Tyler announced that “the research collaboration between Janet Woodcock, and scientists at Momenta Pharmaceuticals during the 2008 heparin crisis did not constitute a conflict, even though the drugmaker had an application pending before the agency.”

Mr. Tyler asserted that there was “no conflict” and that “as an act of good grace Woodcock stepped aside from any involvement in both applications last August.” In addition to this announcement, Mr. Tyler also acknowledged that the investigation by the Department of Health and Human Services Inspection General was dropped.

An attorney for Amphastar, Jason Shandell, was not happy with the announcement. He questioned the timing of Woodcock’s withdrawal from the study, and how the FDA contacted reporters before notifying his company. He asserted that that agency had handled the matter contrary to the “face of transparency” advocated by the Obama Administration.

In defending the stance of the FDA, principal deputy commissioner Josha Sharfstein told the Sun that “the agency needed to be able preserve its ability to respond to public health emergencies and also assure safety of new products.” Mr. Sharfstein further added that just because officials are involved in “both activities, does not mean they are automatically conflicted.

Ultimately, this case demonstrates an extremely important consideration: there is a difference between conflict and confluence.

In this case, it is clearly in the nation’s best interest that FDA officials have access to the most knowledgeable scientists to solve public health issues, and that means access to company scientists and technologies.

Continuing Medical Education: Bringing Evidence Based Medicine to Patients

2010-02-05T09:59:02-05:00

A recent article in the Journal of the American Medical Association (JAMA), titled “Continuing Medical Education: Let the Guessing Begin,” examines a potential change in medical and continuing medical education (CME). The author Robert H. Brook, MD, ScD writes that “the purpose of this Commentary is to suggest exploration of a culture shift in medicine to reinforce the notion of knowing the right answer every time.”

He poses the question: “What if the testing process in medical school or CME were changed so that the medical student or physician were faced with a problem and had to decide what to do?” In response to this question, he noted that medical students and physicians would use this type of experience to “how to look up information, read articles, determine if the articles were relevant, and how to apply the literature and evidence-based medicine to individual patients.”

The importance of such experience is necessary because sometimes, “a physician needs to know immediately what to do.” As a result, he acknowledges that a list of medical emergencies and related patient scenarios have already been “developed, as well as a system for reminding all physicians, regardless of specialty, what to do in these situations.” For example, when a patient comes in to complain about “certain types of chest pain, headaches, and other symptoms” physicians are able to refer to these scenarios “100% of the time without looking it up.”

Using this example, the author suggests that such experience and related patient scenarios should be expanded to the rest of medical practice, and to do so, Robert H. Brook, M.D., asserts that “evidence-based medicine must be translated into practice.”

His editorial goes on to talk about his experience with the Medical Knowledge Self-Assessment Program curriculum for internists, and how it lacked “any quantitative decision tools.” Seemingly, although “private firms are beginning to collect decision tools and make them available to physicians … medical decision making has been largely ignored.”

Dr. Brook goes on to discuss his apparent frustration with the fact that “few physicians enter on a patient’s record the probability that the patient will have a cardiac event in the next 10 years.” Additionally, he wanted to understand why there are no formal assessments of probabilities and utilities in making difficult clinical decisions?” In his ideal clinical practice, a patient should enter a physician’s office and the doctor should record “a prior probability that the patient has condition x, y, or z; then, based on the history and physical, produce a posterior probability that serves as the basis for ordering tests.” While such an idea certainly could benefit numerous patients, more research and evidence is needed to back up the effectiveness of such a proposal—but it’s still worth a try. The only problem today is, Congress doesn’t want doctors to order ‘unnecessary tests’ and predict the probability of such conditions because it raises the cost of government run programs such as Medicare and Medicaid.

Consequently, Dr. Brook goes on to further his claim by noting that electronic health records and health information technology are making it easier for doctors to order tests, and over the next 5 to 10 years “a multitude of new tests will come to market to measure specific aspects of a patient’s genetic, proteinic, or physiological nature,” which will ultimately make people healthier. The question remains though: what price is society willing to pay for the kind of decision making and practice so that physicians can “make the right diagnosis, and monitor therapy.”

Ultimately, he asserts that because “physicians are using the same information sciences that were used 30 years ago … it is time for a change, otherwise, innovative medical researchers who develop a new array of tests and measurements” will make it even less likely that physicians will have the right answer.

In order for physicians to start using evidence-based decisions, funding and research is going to be needed to examine the importance of tests, medical devices and new treatments. While the recently released budget does not seem to have money specifically for such decision based research, industry will most likely have the responsibility of bringing evidence-based medicine to patients.

Ghost Writing: Crisis or Fact of Life

2010-02-05T09:41:07-05:00

This past week we have received several journal editorials around the “evils of ghost writing”.

On the writers defense it does not take much intellectual work to make something framed and titled “ghost” sound sinister. We all grew up with visions of Ghosts waking us up at night from our dreams only to run into or parent’s rooms screaming. This was re-enforced by attending endless horror movies which in from 1960 - 1980’s were released at a pace of once a week.

In one recent article in the Mens Sana Monographs titled “Of Sophists and Spin-Doctors: Industry-Sponsored Ghostwriting and the Crisis of Academic Medicine,” makes the claim that “Ghostwriting for medical journals has become a major, but largely invisible, factor contributing to the problem of credibility in academic medicine.”

The author, Leemon McHenry, uses a one sided approach to only “explain the harm done to academic medicine and to patients,” instead of considering the benefits. Most likely, McHenry has chosen to criticize ghostwriting practices because he has been a research consultant to the law firm of Baum, Hedlund, Aristei & Goldman, Los Angeles, California, since 2003. The firm specializes in “Drug Product Injuries” and has a list on its website. The article reads more like a trial lawyer’s newsletter on how to prosecute companies who use ghostwriters.

McHenry also acknowledged funding support from the Prescription Project and the Pew Charitable Trusts.

Ghostwriting

His article starts off by asserting that “pharmaceutical companies commonly employ ghostwriters to write or draft manuscripts that subsequently appear in peer-reviewed medical journals under the name of one or more academic researchers.” He goes on to claim that such ghostwriters create articles that “obscure the contributions of industry,” which as a result, “undermines scientific integrity and jeopardizes public health.”

It remains hard to see how providing valuable input on research, development, and clinical data at various stages, to expedite the timely publication of data “jeopardizes public health.” We find giant leaps of logic common in these types of commentaries.

McHenry goes on to discuss how early in the process of drug development, a pharmaceutical company will develop a “publication strategy” to identify target journals and "key messages" tied to the promotion of the drug. Such a practice is no different than any other business venture: if no one is going to buy or use a product, then why make it? In fact, television shows for decades have been screened by audiences to determine whether people will watch. Yet no one complains about the violence, inappropriate behavior, or the constant branding of products seen on television.

The author claims that the publication strategy is a problem because “manuscripts are developed with a focus on marketing goals and with little or no consultation from the eventual authors.” McHenry goes on to claim that such manuscripts that appear in “medical journal articles, letters to the editor and abstracts for professional conferences are designed to give the sales force tools to drive prescriptions."

Such a claim however, forgets that these prescriptions are the very same medicine and treatments that have reduced the death rate of cancer for decades, helped millions with heart disease, and made HIV a livable condition. Perhaps it is easier for the author to talk about prescriptions, since the company that pays him, often sues the doctors and drug company’s who make the medicine being prescribed.

Further evidence of McHenry’s bias towards plaintiff’s attorneys is the fact that although he believes ghostwritten articles are objective, “they conceal pervasive conflicts of interest.” In contrast, numerous articles we have published discuss at lengths the practices of journals, academic medical centers, and drug companies who all have strict guidelines for transparency and disclosure.

The article tries to account for the prevalence of ghostwriting by associating it with “legislation which allows drug and medical device manufacturers to claim that their business practices are protected from revealing secrets to competitors.” While the "Trade Secrets Act" certainly helps protect companies who take significant risks and make tremendous investments, any secrets McHenry is talking about are no different from the information and data protected by a patent, trademark or copyright.

Although the article goes on to claim that “financial relationships compromise the credibility of the medical literature,” evidence of such bias is problematic. While the disclosure of financial interests has had a few recent mix-ups, the use of ghostwriting to help develop content produced by pharmaceutical companies does not compromise the integrity of the data or research. Does a law clerk who helps write an opinion or a staffer who helps write a bill compromise the integrity of our democracy? All are working for the common goal of helping more people.

In the end, ghostwritten papers do not undermine the integrity of science or the trust placed on individual clinicians and researchers because these professionals are aware of the contributions and work they receive.

Since McHenry acknowledges that “it is less than clear how many journal editors are seriously concerned about the ghostwritten papers they publish,” his position should call for more discussion, instead of criticism.

CME Support: Collect Data Before Making Changes

2010-02-04T08:11:38-05:00

In the recent edition of the American Medical Associations CPPD Report, Todd Dorman, MD, Associate dean and director of the Office of Continuing Medical Education for Johns Hopkins University School of Medicine, wrote an article titled “CME: Ailing from a case of systemic inflammatory response syndrome.” Dr. Dorman also was a member of the committee for the Institute of Medicine (IOM) who released its recommendations in the report Conflict of Interest in Medical Research, Education and Practice, last April.

Dr. Dorman starts off by evaluating continuing medical education (CME) providers, planners and faculty today the way a doctor evaluates their patient. He noted that CME was enjoying a “usual state of good health until media, government and regulatory agencies began to question the veracity of CME programs and the transparency of their process.” Specifically, Dr. Dorman noted that the source of this questioning began with the recent investigations conducted by the Senate Finance Committee into relationships between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies.

The problem with these investigations is that all CME funding and programs are coming into question, when the investigations are focused “on individual physicians who have had discrepancies in disclosing payments.” So, because of a few, all patients and physicians are beginning to suffer.

The rest of Dr. Dorman’s article focuses on the IOM report he worked on because it “addressed a diverse set of circumstances and utilized the same principles to recommend improvements that would still protect and allow the great good that comes from interaction between the health care and industry sectors.” He also emphasized the IOM recommendation “that a COI committee exists within an organization’s management infrastructure.” Moreover, Dr. Dorman asserted that a standard approach for disclosure for every journal, CME provider, institution and national organization should be established.

His article also focused on the need of “training for all physicians by academic centers and teaching hospitals,” to educate doctors about the rules and regulations surrounding relationships and conflict management in cases relating to the CME world. Part of his belief for such training comes from the results of the Cochrane Collaboration and an AHRQ monograph on the effectiveness of CME, which both “found that educational meetings are effective.”

Ultimately, Dr. Dorman recommended that “the health care industry should work to reduce the stress and confusion surrounding the CME environment and COI by embracing the concepts within the IOM report.” In fact, it is crucial that industry work with CME because it is so “poorly funded by sources other than commercial entities. As a result, Dr. Dorman acknowledged that while such work is being done, “the community outside of health care should allow time to collect data” on how such changes affect CME because without such information “broad-based sweeping regulation is simply inappropriate at a time of such change.”

Obama Budget for Fiscal Year 2011: Health Care Provisions

2010-02-03T11:24:01-05:00

This week, the Obama administration released a proposed budget for Fiscal Year 2011, with and overall total spending of $3.834 trillion. The budget also allocates $50.6 billion in advance appropriations for the Veteran’s Administration (VA) medical care program so that care for the Nation’s veterans is not hindered by budget delays.

Below is a summary of the proposed budget for the Department of Health and Human Services (HHS) and some of its major agencies. In addition, Health and Human Services (HHS) Secretary, Kathleen Sebelius, gave a speech announcing some of the departments goals for the upcoming fiscal year in response to the President’s proposed budget.

The Budget includes $561 million in discretionary resources, an increase of $250 million, to strengthen Medicare and Medicaid program integrity activities, with a particular emphasis on fighting health care fraud in the field, increasing Medicaid audits, and strengthening program oversight while reducing costs.

Such an investment against fraud and abuse claims to help save $9.9 billion over ten years. According to HHS, the additional funding will better equip the Federal government to minimize inappropriate payments, pinpoint potential weaknesses in program integrity oversight, target emerging fraud schemes by provider and type of service, and establish safeguards to correct programmatic vulnerabilities.

Additionally, the HHS budget will install a set of new program integrity proposals that will give HHS the necessary tools to fight fraud by enhancing provider enrollment scrutiny, increasing claims oversight, improving Medicare’s data analysis capabilities, and reducing over-utilization of Medicaid prescription drugs. These proposals will claim to save approximately $14.7 billion over 10 years.

Other healthcare related budget expenditures include:

$3.6 billion, an increase of $186 million, to CMS to meet current administrative workload demands from recent legislative requirements and continuous beneficiary growth. The money also helps revamp information technology (IT) systems and optimize staffing levels so that CMS can meet the future challenges of the Medicare and Medicaid programs and can be an active purchaser of high quality and efficient care.
$110 million of CMS’ increase is for a new, comprehensive Health Care Data Improvement Initiative to transform CMS’s data environment from one focused primarily on claims processing to one also focused on state-of-the art data analysis and information sharing.
$1 billion in funding is budgeted to strengthen and support the country’s health care workforce by increasing the capacity of nursing schools, helping more low-income and minority students become doctors, and ensuring that America’s seniors can get care when they need it. This funding will expand loan repayment programs for physicians, nurses, and dentists who agree to practice in medically underserved areas.
An increase of $290 million for further expansions of health center services, including the creation of 25 new access points in communities without access to a health center, and will facilitate the integration of behavioral health into the existing health centers’ primary care system.
$78 million, an increase of $17 million, for the Office of the National Coordinator for Health Information Technology (ONC) to advance the President’s health IT initiative by accelerating health IT adoption and electronic health records (EHRs) utilization as essential tools to modernizing the health care system.
An additional $261 million, including program support costs, in the Agency for Healthcare Research and Quality (AHRQ) to support new research projects including comparative effectiveness research.
$20 million for a CDC initiative to reduce the rates of morbidity and disability due to chronic disease in up to ten of the largest U.S. cities.
$162 million for Health Statistics, an increase of $23 million, to improve CDC’s ability to collect data on the health of the Nation for use by policy-makers and Federal, State, and local leaders. This increase will ensure data availability on key national health indicators by supporting electronic birth and death records in States and enhancing national surveys.
$222 million, an increase of $16 million, for Autism Spectrum Disorders (ASD).
The Food and Drug Administration (FDA) will receive $3,237,218,000. Of this $3 billion, $1.4 billion, is for medical product safety. This increase will enable FDA to invest in tools that will enhance the safety of increasingly complex drugs, medical devices, and biological products. Also, $61,860,000 of funds for HHS are derived from medical device user fees.
$102.5 million in increased funding for a new Caregiver Initiative at Administration of Aging (AoA).
$32.2 billion for NIH, an increase of $1 billion, to support innovative projects from basic to clinical research. In FY 2011, NIH estimates it will support a total of 37,001 research project grants, including 9,052 new and competing awards. With regards to clinical research, HHS announced that “new partnerships between academia and industry are working to revitalize the drug development pipeline.”
$25 million for advancing regulatory science at FDA, $15 million of which is for nanotechnology related research. The additional resources will also enable FDA to update review standards and provide regulatory pathways for new technologies, such as biosimilars.

Ultimately, while significant amounts of money are budgeted for HHS and its related agencies to improve health care, the focus on clinical research and innovation for breakthroughs in treatment, drugs, and devices is inadequate.

For instance, on average, it costs approximately $1 billion for one drug to reach the market, and only $32.2 billion for NIH—an increase of $1 billion from last year—is being provided from the budget. Without the support of industry and other organizations to work in collaboration with academic medical centers and the government, advances will be limited. Certainly, it would be in the best interest of patients, doctors and Congress to begin discussing the shortfalls of such a budget for the kind of research and funding that is needed to help care for an increasingly sick and older population, especially if any sort of health care reform is passed.

Physician Payment Sunshine: Cephalon Reports 2009 Payments to Physician Consultants and Speakers

2010-02-03T09:48:33-05:00

As part of their September 2008 corporate integrity agreement, Cephalon posted payments to physician consultants and speakers for 2009.

The report is broken out by ranges paid to their consultants and speakers for services from $500 to $149,900 for the year. According to their website Cephalon has a cap on the total compensation for speakers and consultants.

In addition to the payments they have included a Question and Answer section that outlines the reasoning behind the disclosures and the format that they are presented.

Cephalon joins GSK, Eli Lilly and Merck as pharmaceutical companies reporting payments to physicians

It is important to note in reading these transparency reports that because of legal reasons there is very little context to the payments.

In the end the physicians working with Cephalon educated thousands of physicians around the country on important treatments.

Physician Payments: Doc Fix – 5 Years On the Table

2010-02-03T08:19:17-05:00

According to the Wall Street Journal, although Medicare payments to doctors were supposed to fall by 21% at the start of this year, Congress passed a last-minute, two-month patch to block the cuts. WSJ also noted that another possibility for fixing Medicare payments is a five-year patch, which the President included in his budget could be on the way.

Typically, Congress passes legislation each year to provide a one year patch of Medicare pay cuts to doctors. Groups such as the AMA and the AARP “want Congress to permanently repeal the payment formula that keeps calling for the cuts,” and to come up with a new long-term solution. In the past, proposed legislation to permanently block the “cuts have failed in the Senate, in large part because senators couldn’t figure out how to pay for it.”

Many have noted however, that to repeal the payment formula, the “nation will spend hundreds of billions more on Medicare over the next decade.” With an aging population, and a significant increase in Medicare enrollees, the prospect of spending billions more is pretty much inevitable. Such a consequence should not come out of the cost of doctor’s pockets who are already facing high expenses for insurance, administrative resources, and other costs to stay afloat.

One factor that will contribute to the final decision on how to deal with the payment formula is that “the Senate recently passed a pay-as-you-go law that would require balancing all new spending with tax increases or spending cuts.” Contrary to the name itself, “the Hill noted yesterday, that the legislation included a loophole of sorts: Congress can allocate an additional $82 billion for physician payments without having to find new sources of revenue or savings.”

According to the article, that kind of money cannot eliminate the payment system, “but it could be enough to block scheduled pay cuts for five years.”

It should be important for all politicians and legislators to find a bipartisan way to approach a new form of payment system for physicians who see Medicare patients. With the potential of health care reform adding millions of new people to the health care system, a dwindling number of doctors retiring and entering into primary care, the last thing the health care system needs it to neglect physician pay. While there are many ideas being proposed to offset costs for Medicare such as rooting out fraud and abuse, comparative effectiveness, and the use of generics, the cost of physician service cannot be sacrificed or else the quality of care is soon to follow.

UK Vaccine Scare Linked to Attorney’s Payments to Physicians

2010-02-02T10:13:57-05:00

A recent blog entry in Psychology Today, acknowledged that Andrew Wakefield, along with two of his collaborators, were “found by Britain's General Medical Council (GMC) to have engaged in misconduct in relation to sparking a controversy over the autism-MMR myth.” He could potentially lose his license to practice medicine.

Yesterday the Journal Lancet retracted the 1998 study linking a routine childhood vaccine to autism and bowel disease after a U.K. investigation found flaws in the research.

One of the charges against Wakefield was that “he provided a research proposal to a lawyer seeking to sue vaccine manufacturers for causing autism.” In this case, it was not a pharmaceutical company who paid a doctor to promote a drug off-label or to ‘ghostwrite’ a manuscript, rather, it was the litigators trying to deepen their pockets—a goal that most plaintiff’s attorneys pride themselves in. In Comparison, drug and medical device companies exist for the sole purpose of improving patient treatment and health, with the goal of advancing science and technological innovation.

A case like this should raise more questions about the doctor’s attorney’s use to testify as experts, and whether their attorneys are “ghostwriting” their reports and testimony in a favorable light to their case. One group of experts cannot be victimized—those that work with industry—while another group—those that work with litigators—go unchecked.

Wakefield’s research “suggested that measles was a cause of autism because he and his colleagues purportedly detected components of the measles virus in the gastrointestinal tracts and blood of children with autism that were not present in typically developing children.” In contrast to his research, “D'Souza and colleagues (2006) “found that although his technique produced many positive reactions in both children with ASDs and typical children, these reactions were further analyzed and found to be false positives for all subjects.”

According to the blog post, Wakefield was “found by Brian Deer to have been paid a great deal by this group seeking to pursue litigation against vaccine manufacturers in the United Kingdom.” This “conflict of interest” resulted “ten of Wakefield's co-authors requesting that their names be withdrawn from the original publication in the journal Lancet used as support for this hypothesis.”

The damage done by Wakefield is significant because it has destroyed the “public's confidence in vaccination,” and it has given people another reason to distrust the work of doctors on valuable clinical research. The fact that such fear can come from the financial incentives offered by attorneys is disturbing. While it is certainly true that everyone deserves their day in court, falsifying information to get on the stand will never bring about justice.

New York Times: Follow The Science Not the Money

2010-02-02T07:41:27-05:00

Although recent media and government attention to conflicts of interest have centered on the medical world of physicians and the drug industry, a new development regarding COIs has come to the attention of one New York Times reporter in an article titled Corporate Backing for Research? Get Over It.

The story of conflict focuses on Nobel Laureates Al Gore and Dr. Rajendra K. Pachauri, who won the prize in 2007 on efforts “to protect the planet from the ravages of greedy fossil fuel industries.” Their work however, came under scrutiny “journalists started looking at the money going to companies and nonprofit groups associated with Mr. Gore, and Dr. Pauchauri, the chairman of the United Nations Intergovernmental Panel on Climate Change (IPCC).

Dr. Pauchauri is now contending with accusations of conflict of interest due to his initial warnings of a “very high” likelihood that global warming would cause the Himalayan glaciers to disappear by 2035. In response to such an idea, “the Indian government subsequently published a paper concluding there was no solid evidence of Himalayan glaciers shrinking because of global warming.”

Putting these findings aside, Dr. Pachauri dismissed such research as “voodoo science” beneath the I.P.C.C.’s standards. His dismissal however, was deeply flawed because it relied on a claim by Syed Hasnain, a glaciologist who now works in an Indian research group led by Dr. Pachauri. Essentially, “the I.P.C.C.’s projection was based not on the latest peer-reviewed evidence, but on speculative comments.”

Not only did Dr. Pachauri apologize for this mistake, he also had to acknowledge his “worldwide portfolio of business interests, which included relationships with carbon-trading companies and his research group, the Energy and Resources Institute.”

In his own defense, Dr. Pachauri responded that “he had not profited personally and that he had directed all revenues to his nonprofit institute.” Such an assertion highlighted the common and unfortunate reality of conflict-of-interest accusations that too often “follow the money” even though it leads to nothing but “cheap ad hominem attacks.” As we usually comment about why media feel that doctors being paid for legal work with industry constitute a conflict, NYT posed the question: “why are journalists and ethics boards so quick to assume that money, particularly corporate money, is the first factor to look at when evaluating someone’s work?”

As the article accurately describes, journalists are “lazy,” and would rather try and tie money and corporate connections than “analyze all the other factors that can bias researchers’ work: their background and ideology, their yearnings for publicity and prestige and power, the politics of their profession, the agendas of the public agencies and foundations and grant committees that finance so much scientific work.” Such difficulty in the field of journalism is not monitored by any well followed or nationally recognized code or standards.

Application to Medicine

Some critics of work with industry such as The Journal of the American Medical Association made it a requirement that any published had at least one author with no ties to the industry who would formally vouch for the data. When the author in question works with a totally different company or on a different kind of drug or study, or multiple companies, why should this matter?

The weaknesses of this approach were quickly addressed in BMJ (formerly The British Medical Journal), “which analyzed dozens of large-scale clinical trials in previous decades and reported that industry-sponsored ones met significantly higher standards than the nonindustry ones.”

Another unintended, yet harmful consequence is that these so called ‘conflicts’ are scaring away “the best medical researchers and causing them to shun drug company money altogether — not because they think it leads to bad research, but because they are tired of that fact being highlighted every time they are identified in a news story, as if that were the most important thing to know about their work.”

In fact, NYT even asserted that “too often, corporate conflict-of-interest accusations have been used as smear tactics to silence scientists who ended up being correct. (Go to nytimes.com/tierneylab for examples.)”

Ultimately, as the author suggests, journalists should simply list a link to a page where scientists can list all their public and private donors, “and let readers decide which ones are potentially corrupting.” Moreover, conflicts that should be reported should be relevant, not a financial life story.

We agree with Dr. Pachauri: “follow the science, not the money,” because that’s what will help physicians treat patients and make people healthier.