Blog | Monday, August 31, 2015

Drug-company funded research in the New England Journal of Medicine feels like a conflict of interest


I thought I'd read the New England Journal of Medicine (NEJM) and learn something deeply meaningful. I usually love the NEJM (Wikipedia says it is “among the most prestigious peer-reviewed medical journals and the oldest continuously published one”) because I feel like it has such a strong history of academic excellence that whatever they print will have value. This is probably not true.

In 2009, Marcia Angell MD, a senior lecturer at Harvard University and the former Editor in Chief of the NEJM wrote an article entitled “Drug Companies and Doctors, a Tale of Corruption” in the New York Review about the way drug companies skew research to encourage increasing and inappropriate use of medications. It was based on what she had seen published in the NEJM and others. This might have been a hint that there was something amiss in the contents of my favorite professional publication.

In 2012, the Washington Post published an article about a diabetes drug, Avandia (rosiglitazone), which has proved to increase the risk of heart attacks and heart failure. The NEJM decided to publish articles which reported results of studies funded by GlaxoSmithKline, the company which produced the drug. These articles concealed information that showed that the drug was harmful. Editorial decisions were made which, at least in hindsight, were bad. The Washington Post article discussed the many ways in which a drug company which funds research for a medication can manipulate the presentation of the data and get that version published in a prestigious journal which doctors like me tend to believe.

The NEJM has several sections, but the Original Articles is the one I like best. This is the section where new research is reported. There is also the Perspective section, which has gotten more prominent in recent years, and consists of articles by people who are in the thick of something, maybe mass casualty situations, maybe health policy, big picture articles. There are also editorials, usually about the original articles, and there are letters and image challenges and case presentations and educational updates about specific topics.

Recently, the NEJM's Original Articles were primarily about new drugs, and were mostly funded by the drug companies that will or do make money off of those drugs. Oh yeah, and 1 about a new diagnostic test, funded by the company that will make money off of that diagnostic test. There was 1 article not funded by industry which looked at the causes of pneumonia in patients who were admitted to the hospital with it, reporting that the majority were caused by viruses.

The first article was funded by Pfizer and reported a new chemotherapy drug for breast cancer that, combined with another chemotherapy drug which costs over $10,000 per month, results in longer survival. The new drug's is not yet marketed and so a price has not yet been decided.

The second was funded by a Boston company, Vertex, for their new product that can reduce the lung problems that go along with cystic fibrosis, a genetic disease that causes pneumonia and problems with breathing. If the cost of other drugs for cystic fibrosis is a guide, its cost will be sky-high.

The third article is funded by Merck Sharp and Dohme, and studies their drug sitagliptan (Januvia), one of the many drugs that reduce blood sugar in patients with type 2 (generally adult onset) diabetes. The study was primarily to see if their drug caused heart problems, because people thought that it might. They studied more than 14,000 patients for about 2 years and found that their drug did not cause heart problems at least over the course of those two years. It also didn't work very well to reduce blood sugar, but not much was made of this in the conclusions. The drug, which helps reduce blood sugars by just a smidgen, costs $3,000 a year or thereabouts, far more than generic medications which work better.

The fourth article evaluated a test that could be done to more accurately determine if a person has lung cancer at the time of a bronchoscopy. Since the test can simply be ordered at the time of the bronchoscopy it will probably be ordered nearly all of the time this test is done, and, I'm just guessing, may just about double the cost of the procedure. The first noted funding source for this study was Allegro Diagnostics, which will be marketing the product.

Then came the pneumonia article (yay, information I can sink my teeth into.) If viruses cause most cases of severe pneumonia, there may actually be some argument for not putting everyone we see with pneumonia on antibiotics.

The final article which was funded by GlaxoSmithKline looked at the ability of an antibody to clear amyloid from the liver in a very rare condition called systemic amyloidosis, which mainly causes death and disability through deposits of a protein in various tissues, of which the liver is one. If this is released it will be very very, very expensive and will probably serve only to palliate a very rare disease.

Not to put down miracle drugs, because they are pretty cool, but perhaps the Original Articles section should be renamed Articles Funded by Drug Companies Supporting the use of Very Expensive Medications.

Drugs and Doctors

Doctors are increasingly prescribing more and more expensive drugs for just about any complaint. Even the Onion has noticed (read this brief article and chuckle.) This is in no small part because we believe that drugs are the answer, because the research tells us so. The research that tells us so is funded by the companies that make the medications, because they have the money to fund expensive studies. There is much less money in research on cool stuff like what causes severe pneumonia. According to the Washington Post article, the NEJM had published 60 articles about new drugs that were funded by drug companies in the year prior to the report in 2012. Since it publishes 54 times a year, that's just a touch over 1 article per issue. This week's issue had 4 such articles plus the one about the lung cancer test. It seems like they may be escalating.

But why does the NEJM publish this stuff? I think this may be a big part of it: we all love magic potions; it's in our basic makeup as people. Even societies nearly untouched by pharmaceutical companies delight in miracle cures. Doctors and chemists love to dabble in potion making and testing, hoping for that amazing discovery that abolishes misery and old age. They have even been successful. Look at penicillin and many others. But when big money backs these endeavors to the exclusion of other good science, we tend to focus on them, and our professional publications will reflect that in what they publish. Unfortunately the economic forces at work favor creating potions that sell, and not necessarily ones which work. Even though I think I understand the rationale, it's pretty disappointing that one of the “oldest and most prestigious peer reviewed journals” is filling its pages with research that is funded by the companies that financially benefit from positive results and therefore is likely to be skewed and misleading.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.