Free Pens and Poor Research

The Truth About the Drug Companies by Marcia Angell is not a new book. Even the epilogue is roughly a year old and now I can finally afford the paperback print. I’m just getting around to reading it and this week I was able to witness Angell’s phrama critiques in person.

Side note: for those of you who don’t know Marcia Angell is a brilliant woman and physician and a former editor of the New England Journal of Medicine. She became one of the most hated women in the world in the mid to late nineties when she illustrated breast implants did not cause breast cancer and that the class action law-suits against physicians and the companies producing the implants were not legitimate.

In Angell’s epilogue she discusses the controversy of the COX-2 inhibitors (Vioxx, Celebrex and Bextra). Studies have repeatedly shown that COX-2 drugs are not much more gastrointestinal (GI) protective than normal non-steroidal anti-inflammatory drugs (NSAIDs) and moreover they actually increase the risk of myocardial infarctions (MI) or heart attacks.

Side note: COX is an enzyme called cyclo-oxygenase. There are two isozymes (similar enzymes chemically, but with different functions). COX-1 has “housekeeping” properties in the GI tract. Essentially it helps protect against too much acid production and subsequently GI ulcers. COX-2 is entirely involved in inflammatory reactions. NSAIDs block both COX-1 and COX-2 enzymes, which increases the chances of ulcers. Hence, COX-2 inhibitors were created to theoretically decrease GI side effects by only blocking the COX isozyme involved in inflammation. This theory has been verified to be incorrect.

The ineffectiveness of COX-2 inhibitors was best shown with the Merck drug Vioxx. However, because Merck funded the original studies of this the adverse reaction results were omitted. A few years later, the research was reviewed and Vioxx was not more protective against adverse GI effects, such as a bleeding stomach ulcer versus traditional NSAIDs and more importantly it increased the risk of heart attacks in patients taking this medication.

The FDA advisory panel dragged their feet and then eventually pulled the drug from the market. After that the other COX-2 drugs, Celebrex and Bextra (both Pfizer products) were reviewed. These drugs carry the same cardiovascular risks but to a less extent and were allowed to continue on the market by the FDA panel. The final vote of the panel was 5-4 and six of the nine members had some sort of affiliation with Pfizer.

Fortunately I had never really had any interactions with drug reps, because when they find out I’m a medical student they ignore me.

This past Wednesday I thought I would have an early day because there were only two colonoscopies in the AM and then the day was over. Wrong. Consults and an Infectious Disease (ID) conference kept me at Henry Ford Wyandotte Hospital for the whole day and then some. (Sorry Ozkar I got home so late.)

Side note: for those of you who don’t know who Ozkar is, he’s my four-month-old kitten. He rules.

Outside of the conference rooms there were drug reps with nice pens promoting their products. Many medical students and physicians have began a group called, “Say No to Free Pens” and boycott drug reps and their handouts. The drug reps are creepy salespersons most of the time and often lie about their products. But they also give free samples to practitioners and these physicians can use them to help individuals who do not have insurance or their coverage is poor and the medication is too expensive. So these companies are not all bad and I have no problem taking their free pens.

The conference discussed antibiotic resistance and new antibiotic medications. There is an increasing concern in the ID community and in medicine in general about resistance to antibiotics. One serious bacterium has become resistant to most medications: Methicillin-resistant Staphylococcus Aureus or MRSA (pronounced mur-sa). MRSA infections were once thought to be only nosocomial (hospital) infections, but now is being found more and more in the community setting. MRSA is resistant to almost all medications and the last line of defense is an antibiotic called vancomycin. However, there have now been six cases in the world in which MRSA is now resistant to vancomycin. Four of these cases have been in Michigan.

A recent study was done to see if a new drug produced by Pfizer, linezolid (Zyvox), was more effective at treating MRSA infections than the traditional vancomycin treatment. The study was funded by Pfizer and found that linezolid was just as effective and perhaps more effective than vancomycin in treating MRSA.

The drug reps were quick to point this out and even a leading ID physician at Henry Ford Hospital in Detroit commented on the importance of this study. However, it was a family physician in the crowd who pointed out the major flaw in this study.

The study did not use the proper dosing regimen of vancomycin and therefore the drug would be less effective in general. Oops. The drug reps did not mention that nor did the study. Luckily, linezolid has a low side-effect profile and serious adverse reactions such as a MI have not been seen.

This is another example similar to the COX-2 studies of a pharmaceutical company influencing the research and promoting results that are not entirely accurate. It’s frustrating as an aspiring physician and insulting to think that these companies believe extravagant advertising can substitute for poor scientific research.

I still took several of these reps pens, but every time I go to write with it I’ll now that it is not the miracle drug Pfizer has tried to say it is.