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Taking on big pharmaceutical companies

There is something insidious about what is going on in the pharmaceutical industry. If these products were stopped in their tracks, or if these products were curtailed with warnings and not sold over the counter, the difference in sales would be substantial. What we have found is a profound disconnect between the marketing department and the medical research department. The medical research department, for example, may be aware of ongoing studies suggesting an association or a probable causation relationship between a drug and a disease, but the marketing department does not know. At the same time that the marketing department is out giving doctors incentives to prescribe, or just simply hand the drug over to their patient population, the marketing department is completely unaware of some untoward, perhaps life threatening, disease that may harm consumers. This internal conflict is a phenomena that besets the entire pharmaceutical industry, and unfortunately, the FDA. The FDA is overworked and yet dependent on only the information that they are given by the pharmaceutical department. There are not enough personnel in the FDA to be able to police this industry sufficiently. And increased vigilance would be needed in order to avoid nightmares like what has happened with any number of drugs. The one that I am most intimately involved with at the moment is Children’s Motrin. Drug companies under the law have an obligation not only to report to the FDA what they know, as far as adverse events or illnesses that occurred in consumers taking the drug, they also have an obligation under the law to do a reasonable search of the medical literature and to report to the FDA cases or studies in which their drug has been implicated in serious illness or death, including diseases like Stevens-Johnson syndrome. What we have found in our cases are, time and time again, the drug company either does not do a reasonable search for the medical literature or has those articles in its files and chooses not to forward them to the FDA. There is also the issue if the company gave the proper and complete package of information to the FDA, and whether or not this product was suitable for over-the-counter use. And that involves billions of dollars in profits. You will find as we take the depositions of these pharmaceutical employees that many of them have stock options tied to the success of the products, and that is a classic conflict of interest.

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