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Conflict of Interest on Drug Approval

Story at-a-glance -

  • Physicians and scientists with financial ties to the drug industry should not be permitted to participate in broad policy and public health recommendations, yet this routinely happens
  • A recent study reviewed how financial interests affected the voting behavior of nearly 1,400 FDA advisory committee members who took part in drug approval decisions between 1997 and 2011
  • Members with financial ties to the company sponsoring the drug under review voted in favour of approval 63 percent of the time; members without financial ties had a 52 percent chance of favouring approval
  • Committee members who served on a sponsoring firm’s advisory board had a whopping 84 percent chance of voting in favour of the drug’s approval
 

Conflicts of Interest Rampant Among FDA Advisors, Study Shows

September 24, 2014 | 179,571 views

By Dr. Mercola

It should be obvious that patients need unbiased advice when it comes to making decisions that can impact their health.

With that in mind, it stands to reason that physicians and scientists with financial ties to the drug industry should not be permitted to participate in broad policy and public health recommendations. But this is exactly what happens, and it happens more or less routinely.

In fact, conflict of interest is rampant in the field of medicine, even when it comes to recommendations from supposedly independent authorities like the federal government, which makes it very difficult to trust conventional health advice.

This issue was recently highlighted in a study published in the Milbank Quarterly,1 a multidisciplinary journal of population health and health policy.

The author, Genevieve Pham-Kanter, reviewed how financial interests affected the voting behavior of nearly 1,400 Food and Drug Administration (FDA) advisory committee members who took part in the decision process for Center for Drug and Evaluation Research between 1997 and 2011.

FDA advisory committees are created to help the agency make approval decisions on drugs, and the presence of external experts is supposed to ensure that decisions are unbiased and grounded in sound science. Alas, Pham-Kanter's findings show this system can result in significant bias when conflicts of interest are ignored, as they typically are.

Conflicts of Interest Rampant Among FDA Advisors

In all, the 1,400 FDA advisory committee members cast nearly 15,740 votes between 1997 and 2011. After carefully examining the financial relationships between these committee members and drug makers, Pham-Kanter's study2 showed that:

  • On average, 13 percent of the members in any given committee had financial interest in the company whose drug was up for a review by that committee.
  • About one-third of financial interests involved consulting for a drug maker; 25 percent involved ownership interest; 14 percent involved serving on an industry advisory board or steering committee.
  • Committee members with financial ties to the company sponsoring the drug under review voted in favour of approval 63 percent of the time, while members who did not have financial ties had a 52 percent chance of favouring approval.
  • Committee members who served on a sponsoring firm's advisory board had a whopping 84 percent chance of voting in favour of the drug's approval.
  • Committee members with financial ties to several competing drug firms did not, on average, show pro-industry bias in their voting behaviour.

Quid Pro Quo May Be at Work in Your Doctor's Office

As noted by the New York Times,3 the same kinds of conflicts of interest occur between prescribing doctors and drug firms.

The irony is that most doctors perceive themselves as being immune to influence, even though statistics clearly show that when a drug company provides a doctor with a gift of some kind, the doctor's prescribing behavior is typically affected:

"Physicians sometimes travel to nice resorts for education. A study published some time ago in the journal Chest4 followed doctors who went to two all-expenses-paid symposia on new drugs.

Eighty-five percent of the physicians interviewed stated that accepting such invitations would not influence their use of the drugs. Nevertheless, their prescriptions for those drugs nearly tripled after the meetings, far above increases in the use of those drugs nationally.

Other studies5 have shown that physicians who meet with and accept gifts from drug companies are significantly more likely to ask that their drugs be added to hospital formularies...

A study6 of radiation oncologists found that only five percent thought that they might be affected by gifts. But a third of them thought that other radiation oncologists would be affected."

Yes, Transparency IS a Deterrent...

To combat the undue influence drug companies have on doctors' prescription behavior by way of gifts, the Physician Payments Sunshine Act7 was passed and went into effect last year.

This payment transparency program requires drug companies to report payments, including non-cash payments, made to doctors, which are posted in a public database. Payments that must be reported include:

  • Meals
  • Travel
  • Speaking honorariums
  • Research grants
  • Company shares or ownership

In August, ProPublica8 used this database to reveal that nearly half of the doctors who billed Medicare for the expensive drug HP Acthar Gel9 were speakers, researchers, or consultants for the drug company in question. This included all of the top four prescribers.

This drug, despite there being questions about its effectiveness, has an average price tag of more than $41,700 per prescription, making it one of the most expensive drugs on the market. (It's authorized as a treatment for a total of 19 different diseases, including multiple sclerosis.) As noted in the featured article:10

"The doctors mentioned by name in that article probably did not appreciate their loss of anonymity. Many others have begun to limit their acceptance of gifts, knowing that they will be made public."

'Doctored'—a Look at the Business of Medicine from the Inside

Dr. Jauhar, author of the book, Doctored: The Disillusionment of an American Physician, was recently described as "a compelling writer and an astute critic of the wasteful, mercenary, cronyistic and often corrupt practice of medicine today."11

"He is brutally honest, not just about his own shortcomings, but about those of colleagues, bosses and institutions. There is the cardiologist who pressures him to perform expensive, unneeded diagnostic tests; the hospital, which wants him to see patients for ever-shorter sessions; the pharmaceutical company that pays him on the side to give 'lectures' but will let him use only its slides and data," the New York Times book reviewer notes.

Indeed, such complaints have been well documented before. Too much cancer screening, too many heart tests, too many cesarean sections—mounting evidence suggests that Americans are basically being overtreated to death... A number of polls also show that doctors are truly struggling—mentally, emotionally, and physically. Like Dr. Jauhar, a vast majority report being disillusioned and dissatisfied with their work. In one 2008 survey,12 a mere six percent of 12,000 US doctors rated their work morale as positive...

There are many reasons for this, including the fact that doctors' hands are tied by insurance companies when it comes to treatment decisions. But I think that the root of the problem goes back to the fact that doctors enter the field wanting to truly help people get well, but find that the system works against disease resolution at every turn.

Most all fail to appreciate the massive collusion between multinational corporations, peer reviewed journals, professional advisory committees, and federal regulatory agencies that decimate any hope of objective honest recommendations. Medicine has become a for-profit business, and this automatically promotes waste and less-than-optimal treatment options.

Doctors Over-Prescribe Antibiotics While Study Finds Honey May Work Better

A major part of medical waste is using profitable treatment options rather than what's most effective. Case in point: recent research13 shows that many hospitals prescribe too many antibiotics, while other research finds that honey may actually outperform antibiotics for a number of serious infections—including antibiotic-resistant ones. According to Capital OTC,14 data from 500 American hospitals suggest that 78 percent of cases in which multiple antibiotics were prescribed to treat an infection between 2008 and 2011 may have been prescribed unnecessarily, costing the health care system a whopping $163 million:

"Director of the Premier Safety Institute, Premier, Inc Leslie Schultz, who is also the lead author of the study said, 'Sometimes in an effort to 'do whatever it takes' to fight a serious infection, clinicians use multiple antibiotics to treat the same infection. This practice can contribute to antimicrobial resistance, put patient safety at risk and increase costs. We hope these findings help to enhance the antimicrobial stewardship initiatives that the majority of US hospitals already have in place today.'"

Meanwhile, Swedish scientists have concluded that honey contains a wide variety of active ingredients that make it a potent ally against infections.15 Honey was actually a conventional therapy in fighting infection up until the early 20th century, at which time its use slowly vanished with the advent of penicillin. Today, in light of the rapidly rising threat of antibiotic-resistant pathogens, alternative tools are sorely needed, and medical scientists are now taking a second look at this ancient remedy. According to the authors:

"Natural products such as honey have been applied against human's infections for millennia without sufficient scientific evidence. A unique lactic acid bacterial (LAB) microbiota was discovered by us, which is in symbiosis with honeybees and present in large amounts in fresh honey across the world... [W]e tested the LAB against severe wound pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and vancomycin-resistant Enterococcus (VRE) among others.

We demonstrate a strong antimicrobial activity from each symbiont and a synergistic effect, which counteracted all the tested pathogens. The mechanisms of action are partly shown by elucidating the production of active compounds such as proteins, fatty acids, anaesthetics, organic acids, volatiles and hydrogen peroxide. We show that the symbionts produce a myriad of active compounds that remain in variable amounts in mature honey."

Manuka Honey Can Be Used for Therapeutic Wound Care

As long as you use the right kind of honey, science does back up its use for wound treatment, which is especially relevant today as antibiotic-resistant bacterial infections are on the rise. Hospitals have become particularly notorious for spreading lethal infections. According to the US Centers for Disease Control and Prevention (CDC), hospital-acquired infections now affect one in 25 patients. GreenMedInfo.com16 lists a number of clinical studies showing Manuka honey's effectiveness against a wide variety of diseases and conditions, including:

Leg Ulcer Dental Caries Dental Plaque
MRSA Periodontal Infection and Gingivitis Ulcerative Colitis and Inflammatory Bowel Disease
Helicobacter Pylori Infection Wound Healing Bacterial Infections

The US FDA authorized the first honey-based medical product in 2007. Derma Sciences uses Manuka honey for their Medihoney wound and burn dressings, which can be found online from medical supply stores. Amazon.com also sells them. These products can also be found in Great Britain, Australia, New Zealand, and Canada.

What Can You Do to Take Control of Your Health?

Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the United States your chance of achieving optimal health through the conventional medical system is getting progressively worse. As just one example, while the US spends more than twice the amount on health care as other developed nations, we rank 49th in life expectancy worldwide—far lower than most other developed nations...The time is ripe for you to take control of your health, and my site is chock full of free comprehensive recommendations that can serve as an excellent, truly independent starting point.

When it comes to your health, you simply cannot accept claims at their face value… Quite often—definitely too frequently for comfort—treatment recommendations are biased in favor of a specific drug simply because people making the decisions stand to profit from it. Whatever your health problem might be, I strongly recommend digging below the surface using all the resources available to you; including your own commonsense and reason, true independent experts' advice and others' experiences to determine what medical treatment or advice will be best for you.  

Ultimately, you are responsible for your and your family's health -- not me, not your physician, and certainly not any researchers or government health agencies on a drug manufacturer's payroll. I cannot stress enough how important it is to become an active participant in your own care, and make sure you are making decisions that correspond with your own best judgment, knowledge, and experiences. Most of us live in free enough countries where we still have the ability to take back control of our health, but we need to grab the initiative.

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