Conflicts of interests at Institute of Medicine (IOM) may have coaxed the US Food and Drug Administration (FDA) to approve a new narcotic painkiller, Zohydro
When FDA Commissioner Margaret Hamburg was criticized for the agency’s approval of Zohydro, she countered saying that “100 million Americans” suffer from severe chronic pain warranting use of the drug
However, this figure, which equates to 40 percent of American adults, is highly exaggerated and misleading, according to pain experts
IOM’s new President, Victor Dzau, is on the board of directors of four companies, including PepsiCo, thereby extending the IOM’s conflicts of interest to both drugs and the junk food industry
I’ve written quite a bit about growing conflicts of interest over the past few years—conflicts that, in the end, affect your health by impacting the practice of medicine. Yet despite growing awareness of this problem, matters keep getting worse.
Now it’s becoming apparent that the Institute of Medicine (IOM), one of our premier government bodies of science and medicine, has been turned into yet another agency promulgating corporate greed-driven science…
In a recent article,1 Dr. Sanjay Gupta discusses conflicts of interests that may have coaxed the US Food and Drug Administration (FDA) to approve a new narcotic painkiller, Zohydro ER (Zogenix).
The drug, which is the first drug containing pure hydrocodone (synthetic heroin), was approved at the same time that the FDA was also recommending tighter controls on narcotic painkillers, in light of alarming addiction rates and deaths linked to accidental overdoses.
All other hydrocodone-containing painkillers on the market are mixed with other non-addictive ingredients. Zohydro ER was approved for patients who need around-the-clock pain relief, and contains an opioid dose that is five to 10 times greater than anything else on the market.
As noted by Dr. Gupta, when FDA Commissioner Margaret Hamburg was criticized for the agency’s approval of Zohydro, she countered saying that “100 million Americans” suffer from severe chronic pain warranting use of the drug. This figure amounts to about 40 percent of the US adult population!
Misleading Statistics Used to Push Stronger Narcotics Onto the Market?
Prescription painkillers have been identified as one of the primary causes of lethal overdoses, not to mention widespread drug addiction. If 40 percent of American adults are in chronic pain and in need of a potent narcotic that will place them at very high risk of addiction or lethal overdose, surely something must be seriously wrong!
The question is, what is the root of the problem? What’s causing all this chronic pain? Or, is the problem rooted in the statistic itself? As it turns out, it appears to be the latter…
“The 100 million figure has become a staple in the ongoing debate over the use of narcotic painkillers,” Dr. Gupta writes.2 “It is cited in news stories, by medical organizations and by drug companies seeking approval for new opioid therapies…
But that number is exaggerated and misleading, according to pain specialists familiar with how it was derived. The number originated with the Institute of Medicine report,3 ‘Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education, and Research.’
A Journal Sentinel/MedPage Today investigation found that nine of the 19 experts on the IOM panel that produced that report had connections to companies that manufacture narcotic painkillers at the time or in the three years prior to their work on the report.”
The IOM did not disclose any of these financial conflicts of interest when the report was published. One must wonder why, as the IOM itself has claimed that disclosing conflicts of interest is “essential.”
Drug Companies Are NOT Concerned by Rising Addiction and Death Rates
With nearly half of the IOM’s pain panel having financial conflicts of interest, it is not surprising that the report warns against restricting the use of opioid drugs. As Dr. Gupta notes:
“Past Journal Sentinel/MedPage Today investigations4 found that the boom in narcotic painkillers has been fueled in part by an aggressive push from drug companies that funded nonprofit groups which advocated for greater use of opioids.
Indeed, six of the IOM panel members have been officers or board members of advocacy groups that were named in a 2012 U.S. Senate Committee on Finance investigation into the links.
A seventh panel member co-founded another organization that is the subject of a separate investigation5 launched in February by two US senators.”
In the latter case, pharmaceutical companies, including the maker of Zohydro, paid up to $35,000 to attend private meetings with FDA and National Institutes of Health (NIH) staff, in which discussions revolved around the development of new pain treatments. This prompted two US Senators to launch an investigation into what appears to be a classic “pay to play” scheme. According to a previous MedPageToday report:6
“[T]he meetings also involved discussions of ‘enriched enrollment’ for pain trials, which enables drug companies to weed out nonresponders or patients who have adverse reactions to the drug from enrollment in clinical trials — which critics say stacks the deck in favor of the drug…
Zohydro clinical trials used the enriched enrollment methodology. During its FDA advisory committee hearing, several experts expressed concerns about what would happen once the drug moved from trials into the real world because of that methodology.”
The Problem with the 100 Million Chronic Pain Figure…
So, are 100 million Americans really plagued by chronic debilitating pain? Is there really a vast need for a product such as Zohydro, in light of our current drug abuse epidemic? This is highly unlikely. According to Allan Basbaum, PhD and Michael Von Korff, ScD, the 100 million figure constitutes anyone who has reported chronic pain lasting three to six months, including those with manageable pain, and those recovering from surgery.
“Their comments came at a meeting of pain experts held at the National Institutes of Health,” Dr. Gupta writes.7 “In a video of the meeting, Allan Basbaum, PhD, who reviewed the Institute of Medicine pain report, said he was stunned when he saw the 100 million figure. ‘If we are concerned about the message we are sending, we shouldn’t exaggerate the message because the eyeballs start to roll,’ said Basbaum, a pain expert and professor of anatomy at the University of California, San Francisco.
‘The message will be more powerful if people can believe it.’ A moment later, pain expert Michael Von Korff, ScD, said the 100 million figure was derived from a research paper that he co-authored. ‘Nobody asked me about it before they used it,’ said Von Korff, senior investigator with Group Health Research Institute in Seattle… While the 100 million represents about 40 percent of the adult population… Von Korff said only about 20 percent to 25 percent are substantially impaired by chronic pain and a smaller number — about 10 percent to 15 percent — have substantial work disability because of chronic pain.”
Conflicts of Interest Abound
The conflicts of interest now running, and ruining, the IOM are many. For starters, the chairman of the IOM’s pain panel that created the “Relieving Pain in America” report, Phillip Pizzo, MD, was formerly the dean of Stanford Medical School. Less than a year before the pain panel convened, Stanford received a $3 million medical education grant from Pfizer.
According to Stanford, there were no conditions attached to the grant. However, Pfizer does create a number of painkillers. Other drug companies selling pain relievers have also contributed funds to the school. Although the panel members claim that these conflicts in no way affected their evaluations or recommendations, numerous studies have shown that financial conflicts of interest does exert undue influence. And even a modest amount of psychological insight will tell you that this is the case. One typically does not bite the hand that feeds…
Another pain panel member, Dennis Turk, PhD, is the co-founder of a group called IMMPACT. This is one of the two groups that received up to $35,000 per drug company attendee at private FDA/NIH meetings to discuss pain treatment. He’s also served as a consultant and received research grants from drug companies that make various painkillers.
“Daniel Carlat, MD, a psychiatrist and director of the Pew Charitable Trusts’ Prescription Project, which seeks to increase transparency in healthcare, said doctors and the public need to know if financial incentives influence the institute’s recommendations,” Dr. Gupta writes.8 ‘It’s hard to rationalize why they would not simply disclose all the potential conflicts on that panel,’ Carlat said.”
IOM President Has Fiduciary Responsibility to PepsiCo and Its Shareholders…
Speaking in more general terms, the IOM appears to have been taken over by corporate interests in general. For example, the IOM’s new President, Victor Dzau,9, 10 is on the board of directors of no less than four companies: Genzyme, Medtronic, Alnylam Pharmaceuticals, and PepsiCo, thereby extending the IOM’s conflicts of interest far and wide between both drugs and the primary purveyors of chronic disease, the junk food industry. As noted by Forbes Magazine:
“As a prominent and influential health care leader, how could Dzau treat a tax on soda, or a ban on vending machines in schools, or any of a multitude of other health policy issues relating to the obesity and diabetes epidemic? In addition, might Dzau’s involvement with PepsiCo (and the other companies) produce a chilling effect on the free speech and activities of Duke faculty and affiliated doctors?”
Dzau is also the chancellor for health affairs at Duke University and the CEO of the Duke University Health System. He also serves on the Scientific Advisory Board of three companies: CV Therapeutics, Atherogenics Inc., and United Therapeutics. Interestingly enough, Duke University never disclosed this myriad of conflicts of interest either, even though being on the board of directors of a company means he has a fiduciary duty to each of these companies, and its stockholders.
In a 2010 Lancet paper,11 Dzau says his vision for global “health science” is driven by a “public-private financial partnership” between academic institutions and governments. Unfortunately, large US universities – who have long maintained close ties with Big Pharma – are now increasingly creating very lucrative “public-private partnerships” with government, which creates a major conflict of interest. How can a person with such extensive corporate board memberships realistically uphold the IOM promise of providing unbiased health information?
Dr. Paul Offit Was Elected to the IOM in 2011
Dr. Paul Offit, who became an IOM member in 2011, also has similarly concerning conflicts of interest. Dr. Offit reportedly received a $350,000 grant from Merck to develop a rotavirus vaccine, and has served on the scientific advisory board for Merck. He received another estimated $6 million when Children’s Hospital of Philadelphia (CHOP) sold the patent for the RotaTeq vaccine he developed. He was also on the CDC advisory board that approved the addition of a rotavirus vaccine to the US National Immunization Program (NIP) in 1998—a decision that paid off handsomely.
The original rotavirus vaccine added to the NIP, which was made by a competitor, was pulled from the market due to adverse effects. The RotaTeq vaccine replaced it, and Dr. Offit continues to receive royalty payments from the sale of RotaTeq to this day. (According to Wired Magazine,12 Merck’s revenue from RotaTeq was $665 million in 2008 alone, of which Offit and his RotaTeq co-creators are said to receive a percentage.)
In 2005, Merck, CHOP, and the University of Pennsylvania School of Medicine announced the creation of the Maurice R. Hilleman Chair in Vaccinology. The chair, paid for by Merck, went to Dr. Offit, who still holds it to this day. In addition to his faculty salary at CHOP, he gets another $90,000 a year from this Merck-endowed chair. Offit has been severely criticized for his blatant conflicts of interest in the past and is also notorious for his claim that infants can tolerate 10,000 vaccines at once. Last year, he was also a primary figurehead behind a flurry of media reports that told readers to beware, if not outright be afraid, of taking supplements.
Take Control of Your Health, and Beware of Who You Trust
The revolving doors between academia, government, and industry have effectively led to a situation where it’s now extremely difficult, if not impossible, to trust conventional health advice from the federal government. This includes recommendations supported by non-profits like IOM, which is supposed to be independent. Clearly, when the president of a scientific organization has fiduciary responsibility to four for-profit corporations, it is hardly in a position to produce truly independent recommendations anymore.
It’s unfortunate, but when it comes to your health, you simply cannot accept claims at face value… You’ve got to dig below the surface and use all the resources available to you, including your own common sense and reason, true independent experts’ advice, and other’s experiences, to determine what medical treatment or advice will be best for you in any given situation. Ultimately, you must come to the realization that 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 or vaccine manufacturer’s payroll.
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