“Is Drug Research on the ‘Up and Up’?”

Medical ethics of various pharmaceutical companies have come into question regarding their practices of providing financial incentives to scientists doing research involving their products.. We have heard of the “blue wall of silence” when referring to the police department’s turning a blind eye to departmental infractions but it was surprising to see a similar indifference to standard codes of ethics in the scientific industry. When watching televised advertisements of various drugs new to the market, the tremendous side effects that are possible with each dose come as no surprise. It makes one wonder if these side effects are a byproduct of researchers, scientists and the pharmaceutical companies pushing a drug through to market without the necessary testing required. More testing would cause a delay to the consumer market but in the long run, would eliminate some of the detrimental risks involved with each dose. Mechanisms put into place to sanction any unethical practices and dealings between scientists and pharmaceutical companies are either delving into the same pool of impropriety that they are supposed to monitor, are oblivious to the ill dealings, or are rendered powerless to act because the practices fall beyond the scope of their responsibilities.  I was both disappointed and astonished to read that the IRB’s main responsibility is to handle cases of missing paperwork. The exchanging of monies is not in the scope of their jurisdiction; incredible! What recourse could one take to rectify unethical practice between scientists and ‘Big Pharma” should it come to their attention? What can one do when realizing that financial compensation to a research scientist by one of these companies could pose a potential threat to consumers? These are complex questions being that those in place to monitor and sanction such actions are themselves a part of the problem, i.e. Robert Lindsay. Another instance of mishandling involving research scientists and pharmaceutical companies is “ghost writing” of scientific journal articles. Research scientists are putting their names and reputations to journal articles written and designed by writing firms hired by pharmaceutical companies. This appears to be a slippery slope because guidelines for such practices are so convoluted that it is almost impossible to govern the authorship criteria. There are cases where paid writers who authored first drafts of journal articles with prominent scientist’s names in the bylines were deemed acceptable because the paid writers were thanked in the acknowledgements for their “editorial assistance.” (www.healthnewsreview.org/2013/01/ghostwriting-part-3-psych-drug-paxil-and -conclusion/). One case is when Wyeth-Ayerst created “fen-phen” diet drug, Redux. Wyeth-Ayerst farmed out nine journal article requests to an outside firm called Excerpta Medica. Excerpta in turn hired doctors to review and sign their names to the articles on Redux (no research or experiments for the product were done by these doctors). The doctors then submitted the articles to journals with no mention of Wyeth being their benefactor although Excerpta claims to have told the doctors about Wyeth’s involvement. The doctors claim they signed and submitted the papers thinking Excerpta was an independent researcher. (www.cbsnews.com/2100-204_162-327012.html)

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Though it may be true that the doctors were not aware of direct pharmaceutical ties to the articles they signed and submitted, one cannot deny the breach in ethics involved with signing and submitting a research article when you have no actual research involvement in its making. Why would you trust the findings of an “independent researcher” who you had not heard of before reviewing their paper? Also there lies the fact that ignorance is a poor excuse for laying your reputation and name on the line for a product that later turns out to be faulty. We live in an electronic age, did no doctor think to Google the name Excerpta to find out just who they were dealing with? Many drugs; Redux, Paxil (www.healthnewsreview.org/2013/01/ghostwriting-part-3-psych-drug-paxil-and -conclusion/), NuvaRing (www.lawsuit-nuvaring.com/), etc., that were marketed to the consumer have later been found to have detrimental side effects that rival if not exceed the illness it was intended to treat.

It has been documented that Redux and Paxil are products whose journal articles were ghost written in the fashion stated previously. With the time, effort and the multitude of certifications and protocols in place to ensure the ethical treatment of both humans and animals as test subjects and as patients, why does such a basic convention as having extensive knowledge about the research performed on a product you are endorsing fall by the wayside? Could it be the lure of money, the prestige of having your name on a large amount of papers or just the indifference of the repercussions that could follow sloppy research practices? Whatever the answer may be, it leaves the consumer in the dark and in danger.