NEJM editor: “No longer possible to believe much of clinical research published”

NEJM posterHarvard Medical School’s Dr. Marcia Angell is the author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It. But more to the point, she’s also the former Editor-in-Chief at the New England Journal of Medicine, arguably one of the most respected medical journals on earth. But after reading her article in the New York Review of Books called Drug Companies & Doctors: A Story of Corruption, one wonders if any medical journal on earth is worth anybody’s respect anymore.

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

Dr. Angell cites the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard’s Massachusetts General Hospital. She explains:

“Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose, and none of which were approved for children below ten years of age.”

Biederman’s own studies of the drugs he advocates to treat childhood bipolar disorder were, as The New York Times summarized the opinions of its expert sources, “so small and loosely designed that they were largely inconclusive.”

In June 2009, an American senate investigation revealed that drug companies, including those that make drugs he advocates for childhood bipolar disorder, had paid Biederman $1.6 million in “consulting” and “speaking” fees between 2000 and 2007.

“Two of Biederman’s colleagues received similar amounts. After the revelation, the president of the Massachusetts General Hospital and the chairman of its physician organization sent a letter to the hospital’s physicians expressing not shock over the enormity of the conflicts of interest, but sympathy for the beneficiaries: “We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them.”

Biederman’s failure to disclose his Big Pharma payments to his employers ar Harvard (as is required for all Harvard employees) has been under investigation* for the past two years by Harvard Medical School, in as journalist Alison Bass describes this: “what must be the longest investigation in that school’s history”).

Dr. Angell’s article contains bombshell after bombshell, all gleaned during her tenure as NEJM editor. For example, on the subject of doctors who are bought and paid for by Big Pharma, she writes:

“No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top 9 U.S.-based drug companies that it comes to tens of billions of dollars a year in North America alone.By such means, the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease.”

Revelations like this from medical profession insiders cast serious doubt on more than what’s printed on the pages of these medical journals.

Your physician reads these journals, treatment decisions are changed, care is affected, drugs are prescribed – all based on Big Pharma-funded medical ghostwriter-prepared journal articles from physicians who fraudulently claim to be the study authors. Then you walk out of your doctor’s office with a prescription for a drug that may or may not kill you, based on treatment protocols written by doctors like Biederman who are on the take from Big Pharma.

A very recent example of the sad reality over at the once-prestigious New England Journal of Medicine is their decision to publish a drug company-funded review article. This review attempts to discredit emerging research suggesting that many years of using Merck’s Fosamax or Procter & Gamble’s Actonel (both osteoporosis drugs in a class called bisphosphonates) could actually result in more leg bone fractures.

Not surprisingly, drug manufacturers of bisphosphonates are fighting back ferociously against this emerging (independent) research.  A Merck-funded review paper published in the NEJM on March 24, 2010 concludes:

“The occurrence of fracture of the subtrochantericor diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years.”

Sounds promising for Big Pharma. But if you look very, very closely, the article’s fine print confesses:

“The study was underpowered for definitive conclusions.”

You might justifiably ask yourself why a medical journal would stoop to publishing a meaningless scientific paper that the paper’s own authors admit lacks any conclusion. Even more troubling than a journal article that was itself bought and paid for by Merck, is the conflict of interest disclosure list at the bottom of this NEJM article.  It reads like a Who’s Who of Big Pharma.

Of the 12 study authors listed in the NEJM article, at least three are full-time employees of Merck or Novartis. Each one of the other nine admit owning equity interests in or receiving cash, travel expenses, or “consulting and lecture fees” from companies including Merck, Novartis, Amgen, Roche Nycomed, Procter & Gamble, AstraZeneca, GlaxoSmithKline, Medtronics, Nastech, Nestle, Fonterra Brands, OnoPharma, Osteologix, Pfizer, Eli Lilly, Sanofi-Aventis, Tethys, Unilever,Unipath, Inverness Medical, Ortho Clinical Diagnostics, OSIProsidion, or Takeda.

Why is the New England Journal of Medicine or any other credible medical journal accepting for publication articles submitted by paid employees of pharmaceutical companies?

As a cardiac patient, I’m gobsmacked by what appears to be this systemic corruption of not only medical journals who continue to publish what they clearly know is tainted research linked to drug marketing, but of the very doctors whom patients trust to look out for us.

Since my heart attack in 2008, I take a fistful of cardiac meds every day, and I have no clue which of them were prescribed for me based on flawed research or tainted medical journal articles funded by the very companies that make my drugs.

And worse, neither do my doctors.

Happily, there are other decent physicians out there who, like Dr. Angell, are just as outraged as she is. Her targets are not just guilty of unethical conflict of interest – they are criminals who should be charged with endangering our health while padding their wallets.

.

Read Dr. Angell’s article from the New York Review of Books, called Drug Companies & Doctors: A Story of Corruption.

* NEWS UPDATE:  “Massachusetts General Hospital Discloses Sanctions against Three Psychiatrists for Violating Ethics Guidelines”, July 1, 2011:   The Boston Business Journal said today that three psychiatrists have been sanctioned for failing to adequately report seven-figure payments they received from drug companies.

Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens disclosed the disciplinary actions against them in a note to colleagues. According to a copy of the note made public upon request by the hospital, the three doctors:

• must refrain from all industry-sponsored outside activities” for one year

• for two years after the ban ends, must obtain permission from Mass. General and Harvard Medical School before engaging in any industry-sponsored, paid outside activities and then must report back afterward

• must undergo certain training

• face delays before being considered for “promotion or advancement.”

The three doctors have been under the political microscope since June 2008 when Senator Charles Grassley, R-Iowa, began investigating conflicts of interest involving clinicians. Biederman and Wilens have since admitted to accepting $1.6 million from drug companies whose drugs they were promoting; Spencer took $1 million.

Senator Grassley said, according to an online version of the Congressional record:

“These three Harvard doctors are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

See also: 


160 thoughts on “NEJM editor: “No longer possible to believe much of clinical research published”

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  2. As a physician, I have found a partial solution. I monitor legal sites that deal with malpractice. They often have details about questionable drugs years before the knowledge becomes commonplace in medical journals. Doing this has saved me several times by leading me to discontinue using a drug that has later been recalled from the market.

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    • You’re right, Dr. Soco. Legal sites – however maligned as ambulance chasers – are the ones actually hearing what patients and their families are saying about dangerous drugs or debilitating side effects. We’ve had some pretty hellish experiences with recalls of deadly drugs – usually far too late. Thanks for this.

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  4. I have had my doubts about the safety and efficacy of many of the medications I have been prescribed by my physician. I regularly read articles from Pubmed, PLOS1, and many online journals and see a disturbing trend concerning medications consisting of bad research, retracted studies (that went against big pharma) and just blatant fraud. I talked to my physician about my concerns and his attitude was “If you are not going to trust my judgement why are you here?”.

    This article in a small way vindicates my concerns. I was once a pre-med student who did not get accepted at any medical school, but I continued taking medical courses for two more years in the hopes of a second shot that never came. I no longer believe anything out of big pharm. The line between allopathic medicine and quackery has become a blur. If I cannot trust the medications my physician prescribes, then why am I taking these medications?

    For example, I take the statin, Lipitor; however, after reading many articles about its safety and efficacy, I am questioning why I am taking such a dangerous drug, especially when the lab results show only a slight drop in my cholesterol numbers. My faith in modern medicine is vanishing and now on the cusp of obama care, I am starting to see that the American health care system has become just another big scam.

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    • Statins deplete your liver of an essential enzyme called Co-Q10. And as long as your good cholesterol is at a good level, then you don’t have to worry about your overall cholesterol levels. High cholesterol does not lead to heart attacks. Look up the cholesterol myth.

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  5. A whole class of Multiple Sclerosis drugs have been called into question for claims that are not founded and data that may have been skewed.

    Interferon’s in particular do not stop disease progression like previously thought. “Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.” http://jama.jamanetwork.com/article.aspx?articleid=1217239#!

    Rare disease drugs are a billion dollar market, so I can see the pressure that would be put on drug companies to produce with positive results regardless of ethics! http://www.forbes.com/sites/matthewherper/2010/11/19/rare-disease-drugs-a-1-trillion-market/

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  9. Before we throw the baby out with the bathwater, let’s remember that we have life-saving antimicrobials, chemotherapies, RA disease modifiers, and a host of other drugs for which our ancesters would have been eternally grateful – all brought to us by pharmaceutical companies. Would we prefer drug development be solely in the hands of government bureaucrats?

    It is obvious there is unethical behavior and corruption with which we urgently need to deal (look at the history and present day situation with hormonal contraception), but this is a complex situation which demands a change of behavior on the part of manufacturers, prescribers, and consumers. There is no single monster – everyone of us has some degree of culpability and, therefore, a part to play in the solution.

    I am grateful that Dr. Angell has been willing to speak up over the last eight years or more. As a prescriber I am reminded by Dr. Angell that I must never rely on research I have not thoroughly read, even though it is difficult to find two free seconds in a day. If I see inadequate or questionable research I must take the time to write the editorial board so they realize that subscribers are aware when standards are not up to par. Also, Dr. Soco’s example of following the malpractice trail is an excellent one which reminds us that there will always be information gained as new drugs are become more widely prescribed. Whereas there may be valid reasons to prescribe a new agent, we can be guilty of jumping on the bandwagon too early.

    Regarding prescriber compensation, I think compensation is not totally inappropriate considering the staff time and effort involved in research. Perhaps we can develop ways to “blind” the reimbursement so money does not pass directly from manufacturer to prescriber (example: a national “pool” of funds created congregately by all drug innovators from which clinicians, staff, or clinics can be reimbursed according to a predetermined universal fee schedule.)

    Last, as a consumer, I should also question, question, question. In addition, I should not expect to pop a pill for every little ache and ailment I experience. And, of course, I should work harder at maintaining a healthy immune system. In the end, consumer demand does fuel some of the greed.

    I apologize if this seems like I am pontificating, but, honestly, I think there is something that every single person can do. I just think we should not paint one or more group with a malevolent label and feel righteous for not being directly involved, or feel victimized and impotent.

    For my part, I need to be more willing to take the measures I have available to me to make a positive impact .

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    • Of which government bureaucrats are you speaking ? The ones who pass through the constantly revolving doors to and from Big Pharma? It is this unholy alliance which demands more government involvement; the FDA has been little more than a rubber stamp for Big Pharma for the better part of three decades. Government bureaucracy in the form of actual regulation and proper testing would be a welcome change.

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  10. This doesn’t surprise me at all. What about doctors performing non medically necessary genital alteration surgery on infant boys born with normal genitals? Unethical. But let’s keep touting those ridiculous Africa trials and suggesting that boys will benefit from having a normal functional part of their penis amputated lacking any medical necessity! The AAP should really be ashamed of themselves.

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    • The AAP is a trade body whose sole job is helping their members (mutilating doctors) make money. In that regard they are proud of the way they promote genital mutilation and they will jump into bed with anyone who assists them in this.

      The methodology of the African trials you mention is so poor they don’t even qualify as bad science. They are pure scientific and medical fraud.

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      • Dear god whatever next, why do they get away with it? IF it is so unethical, how could they? What is wrong with drug companies, that they have grown so powerful, and can fly in the face of the law. Where is their concern for ethical practice, for humanity. Do they have NONE AT ALL. Can we trust the vaccination program our Governments recommend? Can we trust anything Governments say or do? Are they also run by drug companies??

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  11. Things appear more subversive than we may think.
    After being discharged from the hospital after my melt-down, I was told I’d be on medication for the remainder of my life, as in the other video. So, I’ve taken matters into my own hands and am weaning myself off prescribed medications, but I’m uncertain of the longterm side-effects from the radioactive injection I was given while in hospital.
    Yet, another ‘trust’ betrayed by being in the right place at the wrong time. When picked up by the ambulance, instead of being taken to the closest hospital I was taken to one across town. Is there collusion regarding certain prospects for hospitals doing certain studies?
    Well, we the people may never know, except being statistics for the Medical Procession.

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  12. So in light of this what would someone do if they were prescribed drugs for psychiatric mental health issues, who do they believe, and what should they take. I would not take anything from a medical practitioner unless I have looked at the research first, but as most of that is so dodgy and tainted with BRIBES from the drug companies, I am at a loss. So I go without.

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  13. I have lived for the last 40 years with this philosophy:- if I get sick or ill in any way, take me to my herbalist/acupuncturist/homeopath/osteopath/healer/etc, but if a tall building falls on me, take me to the hospital. The longer I live and see more and more of my peers get sick, ill and die, the more certain I am that I have acted wisely……

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  15. I think the answer is simple. Don’t publish any articles that are sponsored by Pharm companies. They obviously have a motive for stretching the truth.

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  16. Wallenberg family are behind much of this in Europe ….
    The tax free “charity” foundations of the Wallenberg family give massive of money to medical research projects and reap the profits from their AstraZeneca holdings and 100 other Pharma and Med Material companies. How do the family members benefit? Via investment management companies such as EQT and SEB Bank!!!

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  17. These are the very people who totally rewrote the DSM IV and took out Pedophilia when they made the new DSM V. One wonders what the political motivation was behind that or past changes done to that manual. If they are willing to have positive review for tainted studies then conclusions in the past should be suspect as well.

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  21. This article could be said to be equally inadequate. It states the studies were too small or underpowered yet no data is provided. How small? 10 cases? 100 cases? 1,000 cases? Perhaps it’s the journalists failure to provide hard numbers and data. If NEJM dumbs their article down to a summary that is devoid of any numeral data a prescribing doctor has little opportunity to make an intelligent decision.

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    • Cate, the NEJM paper reviewed 284 records for hip or femur fractures in female subjects studied, a fact that you’d already know if you’d bothered to simply click on the link I provided here. Perhaps it’s sometimes the reader’s failure, and not the journalist’s?

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      • That just it … the reader, the prescribing physician, is not going to click on the link either; they rely on the journalist summary.

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        • Too true, Cate. So smart folks don’t rely on their doctor’s advice alone. About any medical intervention, which includes all pharmaceuticals.
          Great article, Carolyn. Sharing widely.

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  23. Now comes the deluge. Check out Deadly Medicines and Organized Crime, by Peter Gotzche, one of the founders of the Cochrane groups. The Cochrane groups carefully examine the methods, data, and conclusions from clinical trials and studies. Anatomy of an Epidemic, by Robert Whitaker, was gentle compared with Gotzche’s new book and with the video you can also find in which he has spoken to groups and they have recorded his talks.

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