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Saturday, July 18, 2015

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

Today I thought I'd read the New England Journal of Medicine (NEJM) and learn something deeply meaningful. I usually love the New England Journal (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.

The New England Journal
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 New England Journal 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 New England Journal 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 New England Journal 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.

Articles this week: not great
This week'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 one about a new diagnostic test, funded by the company that will make money off of that diagnostic test. There was one 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 $3000 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 New England Journal 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.

Tuesday, July 7, 2015

Ultrasound in Tanzania--the gift that keeps giving

Another great trip! I have gotten to go with University of California at Irvine medical students to Tanzania for three years as their supervising MD. They do all of the work, pretty much, preparing lesson plans to teach clinical officer students basic ultrasound as well as designing study protocols, getting institutional review board approvals, and carrying ultrasound machines on fatigued shoulders through multiple airports. I get to teach them a bit about clinical medicine, field questions that they couldn't possibly answer and flaunt the MD on my nametag.

Ten students, just done with a pretty grueling first year, came to Mwanza, Tanzania this year and worked like dogs for a month teaching and doing research. Each year the project is a little bit different, with different research protocols along with improved and adjusted curricula. Their primary project is to teach a large group of students (this year about 100) who are in school to become clinical officers, roughly the equivalent of nurse practitioners. These students will go on to practice medicine in a country which has only 1 doctor per 125,000 people, the worst ratio in the world (Germany has one doctor for every 263 people, per the Economist 2015 World in Figures.) UC Irvine teaches their medical students, starting in the beginning of the first year, how to do ultrasound at the bedside, which cements their knowledge of living anatomy and gradually expands during their 4 years to competence in recognizing all kinds of diseases which have ultrasound findings. This group of students is comfortable teaching basic ultrasound to their African counterparts, who are amazingly knowledgeable in anatomy and physiology. The African students get 3 weeks of lectures and daily hands-on sessions, learning how to get good ultrasound views of the heart, lungs, abdomen and even the womb in pregnancy. Having a cadaver to dissect is apparently a luxury not available to these students, so ultrasound is their first opportunity to actually see inside a human body. Unfortunately 3 weeks is not nearly enough training to become competent in performing and interpreting ultrasounds, but these students will never be afraid to take the steps necessary to learn more, and they will never forget how the heart looks when it beats and how the liver, spleen and kidneys nestle close to each other at the peritoneal reflections.

There are ultrasound machines in Tanzania, and few people who know how to use them. There are not enough ultrasound machines in Tanzania, at least not ones that work, but as the technology gets cheaper, the older machines will be even cheaper, and if there are people who understand how powerful the technology is, they will buy them. The teaching project will not create radiologists, but it will make general practitioners push medical practice in the direction of including more bedside ultrasound. In my experience, this will save lives and reduce suffering.

Beside improving their understanding of anatomy, after 3 weeks most of the clinical officer students who were in the ultrasound class had skills which could have profound clinical impact. If provided with a functional ultrasound machine, they could determine the age of a fetus, the position of the placenta and the head, and determine the fetal heartbeat, an important indicator of fetal health. This information could result in appropriate referral for caesarian section, potentially saving the lives of both the infant and the mother. They could identify a pneumothorax (collapsed lung) in a patient with a traumatic chest injury, which would be easily treatable if found in time and maybe fatal if missed. They could identify bleeding into the abdomen or chest in patients who presented after motor vehicle crashes, which are terrifyingly common. They will be able to look at an ultrasound picture and see more than a bunch of blurry gray, black and white shapes.

This project is cool in so many ways. I love that students teach students. The process is very gratifying and makes the material even more exciting. The UC Irvine med students are now completely awesome at basic ultrasound, and they were only just good when we started. The teaching goes both ways--the African students have an accelerated curriculum so they teach the UC Irvine students things they don't know, as well as asking questions that make all of us think harder. I have done overseas projects which directly help people in need, which is wonderful in its way, but this project potentially has legs. Teaching medical practitioners to be better at their jobs is really powerful and has the ability to affect the lives of many patients. In teaching what they have just learned themselves, while they are still excited about it, the US medical students show the Tanzanian ones how to be teachers of each other and to love learning, which could end up being as important as what they actually teach. In Tanzania, medical students work incredibly hard for the opportunity to continue to work incredibly hard in overcrowded hospitals and clinics with inadequate resources. It feels like this project may make them just a little more effective and a little bit happier in the process.