You are currently browsing the daily archive for September 21st, 2009.
Ghostbusters Patch by JD Hancock, on Flickr
There’s a brand new drug
Here to save the day,
Who you gonna call?
Ghostwriters!
If want thumbs-up
From the FDA,
Who you gonna call
Ghostwriters!
Company develops new drug. Company sends drug out for independent safety and efficacy testing. Researchers who complete the testing write up safety and efficacy information. If proven safe and effective, researcher sends article to appropriate medical journal for publication. FDA uses researcher’s report to rule on acceptance of drug.
What, that’s not how it works?
In a recent article from the NYT, the process was sketched out a little more clearly for those of us who are clueless (like me.) Now, I’m the wife of a publishing professional and am well acquainted with the practice of ghostwriting. It’s not evil, it’s not done for illicit purposes or to deceive, at least not in the world of novels. When someone wants a letter of recommendation from an employer upon leaving a job, it is customary in many industries to write your own for the employer to sign. That’s just how it’s done.
But ghostwriting in medical research is a far more insidious practice. Medical ghostwriting involves authors working at drug companies (read: employed by or paid by) crafting the documentation. Words are chosen to describe the testing in the most positive light to maximize sales. The funding is never revealed, and the resulting sales pitch is not unlike the drug ads you see on television. The major difference is that these sales pitches are being used as “evidence” in the decision making process by the FDA and the prescribing process by your doctor.
Once the pitch is written, prominent doctors and universities are approached to become the author of record on the article before its publication in major medical journals. “Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug,” Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, said this month. “This happens all the time.” He declined and the drug pushers company looked elsewhere for an “author.”
There are entire companies that exist for the purpose of ghostwriting medical research. Internal documents at one such company indicates that the maker of a hormone replacement therapy drug asked the emphasis of the report to de-emphasize the danger of breast cancer to those who take that particular drug. This skewed “research” was quoted for eight years in various medical journals.
These journals are how practicing physicians stay current on research and advances in their field. Running ghostwritten sales pitches there is, in my opinion, about equivalent to Domino Sugar rewriting elementary history textbooks with a more “sugar-industry friendly” version of slavery, complete with advertisements and recipes.
It is no wonder there is a trust gap. So much money changes hands between researchers, the drug companies, medical journals, the FDA and NIH that the process can’t possibly be without corruption. My best ammunition while the powers-that-be duke it out is avoidance. I’ve cleaned up my diet, my environment, my lifestyle. I’ve gotten off all lifestyle medications that I possibly can, especially those that cause cascading failures in other body systems. Of course, I did this only with a doctor’s supervision, but I also asked questions. Do research. Don’t accept the line from the advertisement, “It’s FDA approved, so I know it’s safe” at face value.
As we move closer to a system of national health care, it will become increasingly important to have sound information and trusted sources. Your own knowledge could become as important as your doctor’s. It’s time to start taking those first steps toward health independence now.
