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: 


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

      • Yes, because all vaccinations are bad, right? Hepatitis and TBE vaccinations are so horrible and wrong, right?

        Utterly laughable, really. Yes, we need to keep our eyes open. Yes, a psychiatrist hitting 2 year olds with such medication is a case for the shrink himself, but generally dismissing everything is just stupid.

        • not all meds are wrong at all times, this being said, not all vaccines are good or even necessary what so ever.
          to critique the corruption and drug pushing which is so pervasive in our country, is a dialogue we need. To draw the line at vaccines is inane. the hep b vaccine has reduced hepatitis b in high risk populations but is absolutely unnecessary for newborns and has proven to be dangerous, it is only done because pharma has dictated so. This practice has resulted in some of the worst outcomes we have ever seen in the pediatric populations, so much that most countries stopped the practice years ago. Just like pointing out corruption in prescribing and recommending drugs when not needed, the same situation exists in the vaccine world, vaccine research science is every bit as corrupted by greed and politics as drug research science. The dialogue must be open to all aspects of medicine as it has all been corrupted.

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  3. This is why we should all be awake and alert, not be driven by opinions of others, but make up our own minds. Listen to the input, weigh and rationalize what is acceptable, and form our own opinion and beliefs. First step out of the Herd of “Sheeple”..,

    I bust up laughing, when I see the headlines in the Press about “Salt is bad for you, and will kill you”, and six months later, ” Clinical Trials have shown Salt to be good for you.”. It’s all a conspiracy for Power and Money, and who can influence the most People. Here is a sober report of what this looks like in a Documentary about Cancer research.: http://www.youtube.com/watch?v=S81PXHwjMAQ

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  9. This is no surprise to me, as I have been aware of such activities for many years. I am not a medical professional, just a person interested in scientific truth, and I first became aware of many inconsistencies around the subject of diet and health, specifically, how it can be possible that saturated fat and cholesterol can cause heart disease, seeing as these are both ancient nutrients that we have been consuming for thousands of years, yet they are being blamed for modern disease. It was obvious from this that there must be some serious corruption in the health industry, which make sense when you consider how much money depends on people believing this. There is a very good lecture by Prof Beatrice Golomb on this subject –

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    • You’re right, this isn’t news. As you can see, I wrote this article on November 9, 2009 – a year before that Atlantic piece came out. But this post keeps getting picked up/linked to/Tweeted/shared – which is likely why you’re just discovering it now.

  13. When Doctors accept funding from Pharma, in ANY form, their names should be published. Patients need, and deserve to be aware, of just who it is they’re placing their trust in…and why.

    • I agree, Joanne. But it goes farther than that. Merely disclosing financial conflicts of interest is not enough. We would never tolerate umpires taking money from sports team owners – just the perception of potential influence would be unthinkable. Why do we accept doctors being on the take from Big Pharma?

      • That’s true.. but I think it would need to be dealt with, from two angles:
        1) Pharma is a business, with a set of business ethics. Obviously, these ethics need to be reviewed, and until they are, Pharma is not going to change the way they do business.
        2) Doctors, on the other hand, are in a position of trust, and they should be expected to adhere to a higher standard. They are not just dealing with business, they are dealing the people’s lives. Patients should have the right to know which ones tend to forget that.

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  16. What did we think would happen when we “shrank” government? Part of government was independent scientific and medical research. Who would now publish the studies? Who is NOT on someone’s payroll?

    We have 2 big powers, business and government. Unfortunately, these 2 no longer counterbalance each other for the public good, rather they have become a racket of revolving doors, consulting contracts and lobbyists.

    Next time you complain about your taxes, I hope you will have a look at your medical bills. Every other country in the industrialized world provides health care for its citizens with a single-payer system, at a fraction of the cost in the US. The only reason the US has “private” medical industry is because the single-payer systems are NOT-for-profit. Add up all the earnings of Big Pharma, the insurance companies, Big Ag/chemical companies, and you have THE reason for our healthcare spending burden. Plus, government employees are typically based in the USA! It would be a net job-creator and good for the citizenry and the economy.

    Oh, and don’t forget all those private companies that handle the needlessly complex reinsurance rules that are different in each state. Yep, 50 different sets of rules, for what should be a public good: healthcare. Over 15% of our total GDP goes to healthcare spending! Medical bills are the #1 cause of bankruptcy. And cancer patients who survive are twice as likely as anyone to file for bankruptcy.

    Having lived abroad, I’ve experienced democratic capitalism. The US is carrying out a convincing charade, but it’s just for show. Tyranny of the elite class. Soon, they will have no need for “human capital” as they call it. Perhaps this is all part of the agenda. We have lost sight of caring for people with all the focus on profits.

    Keep people a little sick, and repeating purchases endlessly on what they told they need to survive. Quite a racket.

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  18. Why is Biederman still employed? He should have been deprived of license to practice. The medical profession
    is too involved with pharmaceutical profiteering; health is not primary concern.

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  20. This is my big beef with the Cholesterol Lipid Hypothesis. Every doctor I’ve ever seen as an adult has tried to push, either subtly or obviously, statins on me for my supposed high cholesterol readings.

    I’ve told them that I know about Ancel Keys’ cherrypicking of populations in certain countries, and how he omitted others to support his so-called hypothesis that cholesterol is the cause of heart attacks and the docs look at me as if I have lobsters crawling out of my ears.

    I tell them I’ve read quite a bit about the serious side effects of taking statins, along with supporting articles, and that I don’t want to take them at all. The way most doctors react to my questioning the purpose of their giving me statins has ranged from dismissive to sarcastic, as though I am questioning their Holy Grail, which in a sense, I suppose I am.

    But it’s very hard for me not to conclude that they are likely getting some kind of payoff from somewhere and the more they can push, the better for their little gravy train.

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  22. There are several issues here. First of all, as the post identifies, the actions of the pharmaceutical companies and the researchers are blatantly unethical and potentially fraudulent. Then, the editors of these journals have a duty to verify the credentials of authors and to choose reviewers who will challenge the methods and conclusions in a paper. If a study is under powered, or the stated conclusions do not match the actual results, the reviewers and editors must demand changes or refuse to publish.

    It is also important to note that just because a paper is flawed or the authors biased or bought, it does not necessarily mean that the conclusions are wrong. They are certainly untrustworthy and this is why we need registration of all trials, the replication of studies, and the publication of negative results in top tier journals. In the long run, front line treatments by physicians will be verified or contradicted. Unfortunately people can be harmed in the meantime.

    There is plenty of blame to go around in the current problems in modern medicine, and many improvements to be made, but we must be careful not to dismiss all progress because of flaws in the process.

      • Perhaps my choice of words was incorrect. A poorly constructed study can still result in a ‘correct’ answer. For example, if I feed 6 dogs a certain diet and they all get a cancer, and the 1 dog that ate different food didn’t get that cancer, I have created a very ‘untrustworthy’ study. However, it may ultimately turn out that this particular diet did cause the cancer. Replication is critical.

        • I understand your point. The point of this article, however, is these are not just “poorly constructed studies” Dr. Angell is talking about, but the pervasive influence of Big Pharma that brings to research deliberately systemic issues like selective outcome reporting, tainted data, flawed journal papers, data mining, file drawer effect, publication bias, kickbacks to “key opinion leaders” like Biederman, medical ghostwriting, ‘marketing-based’ medicine, etc. etc.

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