How Industry Money Keeps Unsafe Products in Wide Use — and the Public in the Dark
June 01, 2016
|
102,904
views
By Dr. Mercola
The recent federal lawsuit filed against former Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg again highlights industry influence at the highest government levels.
Hamburg, her husband, Peter Brown, and Johnson & Johnson are charged with conspiracy, racketeering and colluding to conceal the dangers of the antibiotic Levaquin, made by Johnson & Johnson.1
The suit was filed by Larry Klayman, a former federal prosecutor, who claims the parties concealed the drug's dangers for financial gain. Peter Brown is an executive in the hedge fund Renaissance Technologies, which held hundreds of millions of dollars of Johnson & Johnson stock. The suit charges that:2
Only after Hamburg left the FDA did the agency put clearer warnings on Levaquin's label says the complaint.
This is not the first time there have been questions about the relationship between the FDA's drug decisions and Hamburg's financial interests. In 2013, Hamburg verbally supported approval of the extreme opioid Zohydro despite its rejection by an FDA advisory board.
It is very rare that the FDA does not accept and follow an advisory board's decision. Subsequently, 28 state attorneys general, reeling under their states' opioid epidemics, urged the FDA to reverse the Zohydro decision.
Hamburg defended the Zohydro approval by saying that "100 million Americans" suffer from severe chronic pain, a fact that most public health experts not linked to drug companies dispute.
Yet Renaissance Technologies, the hedge fund, also held significant stock in Alkermes, the maker of Zohydro, at the time, giving the appearance of a financial conflict of interest.4
While Hamburg sold her stock, she retained her stock options, which in a few weeks gained from being "under water" (no value) to having market value.
Under Hamburg's leadership, the FDA refused to acknowledge the health dangers of mercury fillings in direct opposition to positions taken by the Department of State, the Environmental Protection Agency (EPA) and the White House Council on Environmental Quality, and a worldwide treaty addressing mercury dangers.
Under Hamburg's leadership, the FDA rolled out pathetic, "voluntary" measures to control the use of antibiotics on farms, despite their clear link to antibiotic resistant bacteria and thousands of deaths a year.
In a Frontline News documentary, Hamburg contended that a voluntary approach is the most effective way to stop the excess use of antibiotics.
She was wrong. Voluntary measures have resulted in more antibiotics used by livestock operators who routinely use the drugs because they make livestock gain weight with less feed.
According to the FDA's 2014 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals5 domestic sales and distribution of cephalosporins for food-producing animals increased by 57 percent between 2009 through 2014.
Lincosamide antibiotics like clindamycin increased by 150 percent and aminoglycoside antibiotics like gentamicin by 36 percent. (Aminoglycosides can have such serious side effects in humans, they are considered a last resort drug. It is shocking they are even considered for use in livestock.6)
But in 2011, Hamburg said the FDA was having trouble finding experts not taking money from industry, even though lists of conflict-free medical professionals were and are readily available from health watchdog groups.8
Finally, before leaving the FDA, Hamburg named Duke University's Dr. Robert Califf as FDA Deputy Commissioner for Medical Products and Tobacco,9,10 despite his thicket of financial links to the drug industry. He later succeeded Dr. Hamburg and became the new FDA Commissioner.
According to author disclosures listed in the Journal of the American College of Cardiology,11 between 2010 and 2013, Califf received grants that partially supported his salary from no less than 13 drug companies, including Johnson & Johnson, Bayer, and Roche.
He also did consulting work for an even longer list of drug companies and drug research organizations. The naming of Califf as FDA Commissioner despite at least 40 industry financial links including board positions12 is the end of any pretense of a firewall between industry and the FDA.
Yet, when Hamburg was asked if she was surprised by Democratic opposition to Califf's nomination she said, "I was a little surprised by that because he's in fact never actually worked in industry, but his programs have been supported by industry dollars.
The world is changing and most academic research centers get money from companies to do clinical trials."
Hamburg is right that clinical trials, contract research organizations, and institutional review boards are increasingly for-profit and run by industry. That's precisely why we need a conflict-free FDA to regulate the lucrative but often dangerous drugs that arise from such arrangements.
Califf, for example, is known for defending the safety13 of Vioxx and leading trials for the blood thinner Xarelto, linked to 379 subsequent deaths.14
Duke University, where Califf directed clinical research until he moved to the FDA, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers, and a 60 Minutes special.15
Former CDC director Dr. Julie Gerberding had a similar history of industry collusion. The CDC is charged with overseeing vaccines and drug companies and after her tenure there, she took a job as president of Merck's vaccine unit.
In a recent article for the magazine Undark, Paul Raeburn, former science editor at BusinessWeek and the Associated Press notes the increasingly popular "partnerships" between industry and news outlets. A recent conference at the National Press Club in Washington D.C. for example:16
While some participants at the conference told Raeburn the presence of respected journalists they knew would not be swayed by industry dollars reassured them the industry would not "taint" the conference, others expressed reservations. For example, GMO Answers is a slick organization created by the PR firm Ketchum for the Council for Biotechnology Information to "sell" the nation on the safety of GMOs. Is Scientific American now a Monsanto bedfellow?
New and exciting research is also suppressed through an academic and publications system that favors the status quo, says William A. Wilson in the magazine First Things.17
For example, Dr. Richard Borison, former Psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud conducted on unsuspecting veterans but his "U.S. Seroquel® Study Group" research is unretracted and cited over 300 times21 in subsequent research, including in medical textbooks.22
It is not surprising that both the FDA and mainstream media have become industry captives failing to perform their sworn duties of protecting and informing the public because of their lucrative partnerships with industry. Unless there is a major system of reinvigoration, the spiral of compromised ethics will only continue.
The recent federal lawsuit filed against former Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg again highlights industry influence at the highest government levels.
Hamburg, her husband, Peter Brown, and Johnson & Johnson are charged with conspiracy, racketeering and colluding to conceal the dangers of the antibiotic Levaquin, made by Johnson & Johnson.1
The suit was filed by Larry Klayman, a former federal prosecutor, who claims the parties concealed the drug's dangers for financial gain. Peter Brown is an executive in the hedge fund Renaissance Technologies, which held hundreds of millions of dollars of Johnson & Johnson stock. The suit charges that:2
"While Defendant Hamburg was FDA Commissioner, her husband, Defendant Brown's annual income, not coincidentally, increased from a reported $10 million in 2008 to an estimated $125 million in 2011 and an estimated $90 million in 2012, due in whole or in part to Defendants' racketeering conspiracy to withhold information about the devastating, life threatening, and deadly effects of Levaquin."
Did Hamburg Conceal Drug Dangers for Financial Gain?
Many safety questions arose after Levaquin's 1996 approval, including the drug's role in tendon ruptures (like its fluoroquinoline cousin Cipro), possible cell damage, links to neurodegenerative diseases like Parkinson's, Alzheimer's, and Huntington's, and permanent peripheral nerve damage.3Only after Hamburg left the FDA did the agency put clearer warnings on Levaquin's label says the complaint.
This is not the first time there have been questions about the relationship between the FDA's drug decisions and Hamburg's financial interests. In 2013, Hamburg verbally supported approval of the extreme opioid Zohydro despite its rejection by an FDA advisory board.
It is very rare that the FDA does not accept and follow an advisory board's decision. Subsequently, 28 state attorneys general, reeling under their states' opioid epidemics, urged the FDA to reverse the Zohydro decision.
Hamburg defended the Zohydro approval by saying that "100 million Americans" suffer from severe chronic pain, a fact that most public health experts not linked to drug companies dispute.
Yet Renaissance Technologies, the hedge fund, also held significant stock in Alkermes, the maker of Zohydro, at the time, giving the appearance of a financial conflict of interest.4
Hamburg Has a Long History of Conflicts of Interest
Questions about financial conflicts of interest clouded Hamburg's entire tenure. To be appointed, she had to agree to sell her stock and stock options in Henry Schein Inc., the largest seller of dental amalgam (mercury fillings) and a flu vaccine seller, and to recuse herself from regulatory matters affecting Schein.While Hamburg sold her stock, she retained her stock options, which in a few weeks gained from being "under water" (no value) to having market value.
Under Hamburg's leadership, the FDA refused to acknowledge the health dangers of mercury fillings in direct opposition to positions taken by the Department of State, the Environmental Protection Agency (EPA) and the White House Council on Environmental Quality, and a worldwide treaty addressing mercury dangers.
Under Hamburg's leadership, the FDA rolled out pathetic, "voluntary" measures to control the use of antibiotics on farms, despite their clear link to antibiotic resistant bacteria and thousands of deaths a year.
In a Frontline News documentary, Hamburg contended that a voluntary approach is the most effective way to stop the excess use of antibiotics.
She was wrong. Voluntary measures have resulted in more antibiotics used by livestock operators who routinely use the drugs because they make livestock gain weight with less feed.
According to the FDA's 2014 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals5 domestic sales and distribution of cephalosporins for food-producing animals increased by 57 percent between 2009 through 2014.
Lincosamide antibiotics like clindamycin increased by 150 percent and aminoglycoside antibiotics like gentamicin by 36 percent. (Aminoglycosides can have such serious side effects in humans, they are considered a last resort drug. It is shocking they are even considered for use in livestock.6)
Other Questions About Hamburg's Tenure
Hamburg also moved to loosen the traditional conflict of interest rules that govern participants on advisory panels who are supposed to be independent.7 While waivers are sometimes issued, if an expert receives $50,000 or more from industry he or she is generally barred from the agency's 50 or so expert panels.But in 2011, Hamburg said the FDA was having trouble finding experts not taking money from industry, even though lists of conflict-free medical professionals were and are readily available from health watchdog groups.8
Finally, before leaving the FDA, Hamburg named Duke University's Dr. Robert Califf as FDA Deputy Commissioner for Medical Products and Tobacco,9,10 despite his thicket of financial links to the drug industry. He later succeeded Dr. Hamburg and became the new FDA Commissioner.
According to author disclosures listed in the Journal of the American College of Cardiology,11 between 2010 and 2013, Califf received grants that partially supported his salary from no less than 13 drug companies, including Johnson & Johnson, Bayer, and Roche.
He also did consulting work for an even longer list of drug companies and drug research organizations. The naming of Califf as FDA Commissioner despite at least 40 industry financial links including board positions12 is the end of any pretense of a firewall between industry and the FDA.
Yet, when Hamburg was asked if she was surprised by Democratic opposition to Califf's nomination she said, "I was a little surprised by that because he's in fact never actually worked in industry, but his programs have been supported by industry dollars.
The world is changing and most academic research centers get money from companies to do clinical trials."
Hamburg is right that clinical trials, contract research organizations, and institutional review boards are increasingly for-profit and run by industry. That's precisely why we need a conflict-free FDA to regulate the lucrative but often dangerous drugs that arise from such arrangements.
Califf, for example, is known for defending the safety13 of Vioxx and leading trials for the blood thinner Xarelto, linked to 379 subsequent deaths.14
Duke University, where Califf directed clinical research until he moved to the FDA, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers, and a 60 Minutes special.15
Former CDC director Dr. Julie Gerberding had a similar history of industry collusion. The CDC is charged with overseeing vaccines and drug companies and after her tenure there, she took a job as president of Merck's vaccine unit.
Industry Conflicts Are Also Invading Media
Most people trust mainstream news outlets more than the FDA to tell them the truth about the safety of drugs and foods — but should they?In a recent article for the magazine Undark, Paul Raeburn, former science editor at BusinessWeek and the Associated Press notes the increasingly popular "partnerships" between industry and news outlets. A recent conference at the National Press Club in Washington D.C. for example:16
"[T]itled 'Lost in Translation: Is Science Explained Fairly in the Media?' was the product of a partnership between Scientific American magazine and two commercial sponsors: Johnson & Johnson, and GMO Answers, a public information agency funded by members of The Council for Biotechnology Information, which includes the industry powerhouses BASF, Bayer, Dow AgroSciences, DuPont, Syngenta, and Monsanto.
'The conference was an example of what is now a widespread and growing practice in the publishing industry: the use of 'branded partnerships' to extended publishers' reach and boost their income. While these arrangements might generate revenue, they also raise important questions about journalistic credibility.
After all, how can news outlets like Scientific American, a respected — even revered — source of science news, maintain the appearance of impartiality while accepting checks from companies they cover? And should respected journalists lend their names and reputations to such conferences by participating on the panels?'"Scientific American has also helped "Celgene showcase its leadership in cancer innovation," writes Raeburn, and has reviewed Caterpillar's communications, including assisting "them in revamping their overall strategy." The magazine has also partnered with the Biotechnology Industry Association on various projects says Raeburn.
While some participants at the conference told Raeburn the presence of respected journalists they knew would not be swayed by industry dollars reassured them the industry would not "taint" the conference, others expressed reservations. For example, GMO Answers is a slick organization created by the PR firm Ketchum for the Council for Biotechnology Information to "sell" the nation on the safety of GMOs. Is Scientific American now a Monsanto bedfellow?
Industry Money Squeezes Out Valuable Products From Smaller Companies
Clearly, the FDA's big bucks, pay-to-play approval system buoys the agency's budget with the drug industry's seven-figure fees. Most people realize "pay-to-play" is how drugs like Zohydro and Xarelto get approved. But the corrupt system also prevents new and innovative products from getting to the market. Companies without deep pockets and crony links seldom if ever negotiate the FDA's approval system.New and exciting research is also suppressed through an academic and publications system that favors the status quo, says William A. Wilson in the magazine First Things.17
"In many fields, it's common for an established and respected researcher to serve as 'senior author' on a bright young star's first few publications, lending his prestige and credibility to the result, and signaling to reviewers that he stands behind it.
In the natural sciences and medicine, senior scientists are frequently the controllers of laboratory resources — which these days include not just scientific instruments, but dedicated staffs of grant proposal writers and regulatory compliance experts — without which a young scientist has no hope of accomplishing significant research.
Older scientists control access to scientific prestige by serving on the editorial boards of major journals and on university tenure-review committees. Finally, the government bodies that award the vast majority of scientific funding are either staffed or advised by distinguished practitioners in the field."
Fraudulent Research Threatens Entire Field of Science
The same system can also encourage misleading or even fraudulent research when so many paychecks and egos are affected, notes Wilson, and it may explain why so much published research proves non-reproducible.18"The 'bad' papers that failed to replicate were, on average, cited far more often than the papers that did! As the authors [a group of cancer researchers] put it, 'some non-reproducible preclinical papers had spawned an entire field, with hundreds of secondary publications that expanded on elements of the original observation, but did not actually seek to conform or falsify its fundamental basis.'
What they [the researchers] do not mention is that once an entire field has been created — with careers, funding, appointments, and prestige all premised upon an experimental result which was utterly false due either to fraud or to plain bad luck — pointing this fact out is not likely to be very popular. Peer review switches from merely useless to actively harmful."From Vioxx to Paxil, to hormone replacement therapy and flame retardants, many dangerous products have rested on faulty research.19 Worse, much research discovered to be fraudulent, including instances where researchers actually went to prison, has never been retracted and still stands to mislead future generations.20
For example, Dr. Richard Borison, former Psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud conducted on unsuspecting veterans but his "U.S. Seroquel® Study Group" research is unretracted and cited over 300 times21 in subsequent research, including in medical textbooks.22
It is not surprising that both the FDA and mainstream media have become industry captives failing to perform their sworn duties of protecting and informing the public because of their lucrative partnerships with industry. Unless there is a major system of reinvigoration, the spiral of compromised ethics will only continue.
Email
No comments:
Post a Comment