New York Times Addresses Concerns Raised About "Ghostwriting" of Drug Studies
For those of us lawyers who have been fighting Big Pharma over the last many years, the issue of drug companies "ghostwriting" studies about their drugs and then having doctors sign on to the studies to give them credence, has been one actively pursued. Last week, one of the most prestigious medical journals, Journal of the American Medical Association (JAMA) took this issue head on in addressing documents which have been uncovered during the litigation that has transpired regarding Vioxx and its manufacturer Merck. The article discussed how Merck drafted dozens of research studies regarding Vioxx and then paid prestigious doctors to put their name on the study to make it look like the study was done by "independent" doctors. Literally, with "ghostwriting", the drug companies hire marketing companies to help them write up the results of the study and to give the study the most positive spin. The drug companies then hire doctors who were not even involved in running the study and have never reviewed the detailed information regarding the results of the study, to sign off on the publication so it can be submitted to a medical journal and have some credibility.
As the New York Times reported, the JAMA article discussed one study by Merck on Vioxx which indicated Merck was still looking for a "big-name researcher" to sign on to the study. The draft of the study identified the lead author as "External author?" indicating Merck was still trying to find a doctor who would vouch for the study. The lead author of the report in JAMA, Dr. Joseph Ross indicated "It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician."
The real problem with these type of studies that are done and drafted by the drug company and a "spin doctor" they hire, is that it is an attempt to "pollute" or manipulate the information out in the public domain on these drugs. Once these positive studies are published, the drug companies will use them to promote their product to doctors, with the doctors having no idea the information has been manipulated in such a manner as to give the most positive spin on the information developed from the study. Additionally, if there is ultimately litigation involving the drug, the lawyers for the drug companies will use all these slanted studies to show the court that there is no problem with the drug.
This information came to light just at the right time. The FDA is in the process of considering a proposal which would allow drug companies to use articles printed in medical journals to promote the use of the drug for "off-label" use or for uses not approved by the FDA. As an example, with hormone therapy which was approved to give to woman who were experiencing symptoms of "the changes" such as hot flashes, etc..., it has been found the the pharmaceutical companies making these drugs were promoting these drugs to also help woman with their heart, which was not approved by the FDA. This article that has been published in JAMA now calls into question these articles the drug companies would use to promote these off label uses since they the studies are being "ghostwritten" by some for-profit company and the drug companies then search out doctors to sign off on the studies. Several groups have now objected to this FDA proposal including the New York State's health commissioner and the Blue Cross Blue Shield Association , a trade association made up of 39 major health insurance plans.
I don't have problems with off label uses of drugs and doctors always have the ability to prescribe drugs for uses that have not been approved by the FDA. But if drug companies are allowed to use studies which they have bought and paid for to promote off label use with the doctors who are prescribing the medications, doctors may not be provided with all the necessary information needed to determine whether the potential benefits outweigh the risks of taking the drug. Experience has shown that in studies published by "ghostwriters" on behalf of drug companies, the risks are always downplayed and deemphasized, if mentioned at all, opening the door to problems on an unsuspecting doctor and his patient.
