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.”

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

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    • Why is this shocking conclusion not being covered widely in mass media?

      Thanks for bringing it to our attention here. THis is truly disturbing.

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      • Because Big Pharma have more bucks than the media and even our governments. Look up ‘What Doctors Don’t Tell You’ and ‘The Campaign for Truth in Medicine’ for many more disturbing stories about the pharmaceutical industry.

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        • Your doctor will probably not listen. In the UK my mother was told if she refused to take the statins, then her doctor of 35 years would have to report it back to her insurance, which would result in them cancelling her insurance. No mater what data she provided, he looked upon her like a child that knew no better, he was protecting her, rather than actually reading the science data she was presenting.

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      • Why isn’t this in mass media? Here’s why.
        1. Watch TV, which is free because it’s paid for by commercials.
        2. Count the number of commercials that are directly or indirectly related to the drug industry.

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  2. I hope all physicians take note of this depressing commentary from an informed insider.

    I urge your readers to show this to their doctors. I plan to print this off and give a copy to my PCP. They all need to be aware of this shocking reality.

    THX for this.

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  4. “…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 others admit owning equity interests in or receiving cash, travel expenses, or ‘consulting and lecture fees’ from the drug companies…”

    How can any decent physician claim with a straight face that they actually see nothing illegal, immoral or unethical about taking cash from the same drug companies whose products they are pushing? This is marketing, not medicine. As for having three full-time employees of Big Pharma listed as study authors !!??!! – well, what the hell is going on with medical journal editors if that reality is okay with them?

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    • Bob, I’m one of those “decent physicians” who “claim with a straight face” that I actually see “nothing illegal, immoral or unethical” about the small honoraria I have accepted on occasion for my valuable time. Would you suggest that I take a day off from my very busy practice to travel out out of town to help educate a group of rural doctors for FREE? Rural professionals whose general practice may not give them adequate experience in treating conditions or symptoms that we urban physicians see more frequently tell me that they do appreciate my willingness to come to them to answer questions and provide my own examples of case studies and recommended clinical protocols.

      Those who lack this personal experience should get off their self-righteous high horses and try to show a bit of respect for our work as educators.

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      • Trusted doc, while your intentions are good, you are nothing more than a puppet.

        All of the horrible drugs out there with laundry lists of side effects that often include death, are all approved by the FDA as safe and effective. Many doctors I work with are very book smart, but when it comes down to common sense, they’re lacking severely.

        Do yourself a favor and find unbiased information about the drugs you’re peddling rather than accepting the clinical data you get from the companies who clearly have everything to gain by manipulating the data and convincing you and the rest of the doctors out there to deal their drugs for them.

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        • I agree.

          Here in BC, our lame duck provincial government has just announced an appallingly boneheaded agreement with the drug industry, while at the same time limiting the powers of THERAPEUTICS INITIATIVE, a well-respected independent drug research watchdog agency at UBC. As one critic said: “It is like putting biker gangs in charge of street crime!”

          Big Pharma is laughing all the way to the bank. And I’m sure that most drug rep-educated doctors will sit by idly and say nothing against Big Pharma’s encroaching influence on “marketing-based medicine”. Read this.

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          • I love it! There are few doctors out there that actually read from science journals and protect their patients correctly, like Dr. Rosedale, M.D – the first thing he does is take his patients OFF statins, OFF calcium, and within 3 weeks typically OFF BP drugs and insulin, OFF ANY DPP4 inhibitors, OFF SULPHONYLUREA’s. He has been doing this for 20 years with amazing results, he would be a millionaire many times over by now if he had accepted any one of the offers that had come his way to represent the lies with no firm science proof.

            Any doctor who takes the research only from the pharma studies is nothing more than a drug rep, not as pretty, but a drug rep and nothing less.

            Any doctor saying they are too busy for someone’s life, to aid in giving them cancer?? too busy to read the truth from real science journals and not drug company marketing magazines? That is just as criminal as manslaughter.

            It is time, time for change and to stop this madness.

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        • I would too. Or suggest that they could pool their personal funds or have a bake sale to hire you for educational purposes directly, rather than with any product sponsorships. That is just so unnecessary.

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          • Hi Lili – I can already imagine the snickering from doctors reading your suggestion that they host a bake sale to bring in an urban doc to lecture in rural areas. Ain’t gonna happen . . .

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      • You’re a doctor. The massive paychecks you receive for your main career compared to the pittance someone gets who’s an EMT or an LPN, you know, the people who see your patients more intimately than you do, aren’t enough for you?

        And you don’t know the difference between shilling for a drug company and providing continuing ed for rural doctors, and they entrusted you with an MD and a medical license?

        Post under your actual name next time. I want to know which doctor never to hire.

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        • Massive paychecks? Have you been to a doc lately and have you seen the crap the insurance companies are paying them. I think people need to start worrying about Obamacare,then we will have no docs to take care of patients after they all start dropping out of the insurance plans. Our goverment needs to come down hard on the insurance and drug companies. Drug reps aren’t permitted to bring a doc lunch let alone pay them for prescribing their meds. How do you compare what a EMT or and LPN gets to what a dr gets. Docs have to spend years studying,not to mention what it cost to finally get an MD degree. My plumber charges me more than my doc does.

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      • You bet I believe you should do this for free. In fact, I believe that all health care should be free. If you are taking money from Big Pharma then you are corrupt and I would not want you as my physician because I would not trust you.

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  5. It’s even worse in the veterinary medical field. Everyone is paid off by big pharma – the vets, animal charities … even the government licensing body makes decisions in favour of industry at the expense of the animals. Check out Canine Health Concern which has been trying to stop over vaccination for the last 18 years.

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  6. Exactly why I go to the physician I do – she does NOT allow any pharmaceutical companies near her office. She rarely prescribes a drug, and if she does it’s because it’s necessary. She doesn’t take insurance so she’s not influenced from that end either. It’s a little more expensive to go there because of this, but at least I know my family is being well taken care of.

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  7. Great article, but can you please change the name of it? In the article the doctor is quoted as saying “much” of the research, not “most” of it. (Without changing it, you risk making the same mistake bad research does—the drugs helped “most” patients, etc.)

    Thanks. The article otherwise is great.

    Like

    • Done. You’re the first person in over two years to notice this unintended error. Thanks for bringing it to my attention, Suzi.

      Like

  8. The tale wagging the dog… this is a morality issue more so than a research quality issue. And doctors who present to other doctors should be paid for their time, but not by a Big Pharma sponsor, but by the participants. It’s a bit “self-important” to expect be paid millions of dollars to present to others on behalf of patient care and a conflict of interest and a conflict of honor, proper ethics and uprightness. Again, another morality issue.

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    • pdbrit, it’s actually both a morality AND a research quality issue, what with known industry-funded research and journal publication practices out there like selective outcome reporting, data mining, file drawer effect, publication bias, etc etc etc.

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  12. Whenever a news story is published about a “research study”, the journalist should list the funding source for that study. With big pharma, the drug companies themselves are often the ones doing their own studies…and the FDA lets them! They have ZERO incentive to release the negative facts about their drugs/devices.

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  14. Quite alongside the conflicts of interest with spending and such are the studies whose researchers draw the wrong conclusions from the existing data. Or even when they get it right, the media’s known to misreport what was done and what was concluded. I see this all the time with research connected to diet and nutrition.

    For example, a good chunk of the reason so many of us believe saturated fats are unhealthy now is thanks to studies that lumped trans fats and saturated fats together. A good chunk of the reason we believe meat is unhealthy is based on studies that did not control for refined carbohydrate intake, so what looked like an all-beef patty causing a heart attack might have actually been put down to the soda, fries, and bun intake. Even T. Colin Campbell of the famous China Study misread his own data. There’s actually a much stronger connection between *wheat* and heart disease than there is between meat intake and same.

    The way we approach research in this country is flawed all the way through and it matters very little, in the grand scheme of things, who’s paying for it. The central problem here is almost no one approaches science like… well… a scientist.

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  17. This is exactly why there is so little understanding and acceptance among docs of a diagnosis like gluten sensitivity — there is no Big Pharma bucks to be made from telling your patients to stop eating wheat — which is also tied to Big Ag and Big Food.

    As we come to understand the vital importance of eating the right foods for our human species and how the practice of eating real foods reduces serious diseases like autoimmune conditions, psychiatric conditions, diabetes, obesity etc., this era of Big Pharma-dominated medicie which has us taking a pill for every ill will seem like the dark ages.

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  18. “Richard Smith, chief editor of the BMJ until July 2004, said that peer reviewing is “slow, expensive, prone to bias, easily misused, hardly effective in uncovering crass defects, and almost useless in the exposure of fraud”

    “Just recently it came out that hundreds of scientists from the US health department NIH received millions of dollars of financial contributions from the pharmaceutical industry. These financial conflicts of interests in the meantime have undercut the whole research industry and its reviewers – and with that also the credibility of professional magazines, whose articles appear through the glory of unbiased science through the reviewing process”.

    Maybe the term “conflicts of interest” should be called the true name – corruption?

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  19. ‘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’

    As far as a scientific manuscript goes, there is no reason for non publication based on that statement.

    As for small sample size, that is obviously an issue & large multi-centre research projects with large catchments are ideal but not always possible. As such, studies with small sample sizes have a use as they can contribute to meta analyses. The key is not to base conclusions on single studies. I have no problem with NEJM for publishing the work (especially as they make the authors declare conflicts of interest). The problem is the erroneous claims that pharmaceutical companies make based on inaccurate or exaggerated interpretations of the results.

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    • Dr. No – how about grounds for non-publication based on the fact that at least three of the study’s authors are full-time employees of the drug company producing the drug being studied?

      Like

  20. I’m a doctor and medicine teacher. I’ve finished a clinical research course last year. It was an opportunity to learn how to read and criticize a scientific paper. The only way to deal with the power of Big Pharma is to doctrinate the medical students throughout the world, teaching them the scientific principles to analyse published medical papers.

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  21. In the early 1950’s big pharma funded some research to discover why some people hemolyzed when given primaquine. Dr Beutler, the head of the study, published the results in 1956. He called the genetic disorder he discovered Glucose 6 Phosphate Dehydrogenase Deficiency. It affects an estimated 10% of the world population. Unfortunately, the condition was downplayed.

    You see, people with G6PDD hemolyze when they take many drugs, not just primaquine. And also, many foods cause hemolysis as well. Can you imagine the financial setback if 10% of the world population knew they could not take aspirin, sulfa drugs and many others? Let alone all the other drugs. How about all the extra research for approval of a drug? We’re talking a huge amount of money here. Now people die because babies are given a vitamin K shot at birth or some other drug. But what are a few deaths compared to the billions of dollars to be made. This has angered me for many years. And I have worked very hard to make the genetic disorder known, but we are just ignored. Very frustrating.

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