Good news, bad news?
Sen. Charles Grassley is now the senior Republican member and likely chair of the Judiciary Committee. Sen. Orrin Hatch will probably replace him as the chair of the Finance Committee. Some may see this as good news for big pharma, because in the latter capacity Sen. Grassley was a pain in the butt to drug companies. As chair of the finance committee, Sen. Grassley uncovered many abuses in the marketing strategies of pharma companies, most notably the manner in which clinical trial results and off-label uses for drugs were reported in the literature. Not only has this limited informational outputs for the industry, but reporting obligations to regulatory agencies have increased, placing additional demands on drug companies. Curiously, in much of his writing on this subject, Sen. Grassley misused the term “ghostwriter’ as a blanket term covering any person who contributes to an article that is not listed in the author line, causing undue duress to those medical writers whose livelihood depends on such assignments. Of course, a ghostwriter’s contribution to a work is not recognized anywhere in that work, whereas medical writers are typically acknowledged in a manuscript. Nevertheless, how Sen. Grassley became involved with this matter is interesting. In his position as chair of the powerful finance committee, he became aware of the tremendous profits that companies were making by promoting off-label uses for their drugs. In one example, the Pfizer subsidiary Warner-Lambert increased sales of gabapentin, approved for adjunctive treatment of partial complex seizures, 8-fold using an aggressive campaign that suggested applications in migraines, psychiatric disorders, and other conditions. Later, the results of a finance committee inquiry that were released in a Committee staff report in April, 2007, revealed that the pharmaceutical industry spent more than a billion dollars a year to fund continuing medical education programs. Subsequently, another Grassley-led investigation concluded that Wyeth used articles ghostwritten by the agency DesignWrite to: Mitigate the perceived risks of breast cancer associated with hormonal therapy, defend the unsupported cardiovascular “benefits” of hormonal therapy, and promote off-label, unproven uses of hormonal therapy, such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles. Consequently, corporate integrity agreements (CIA) have been issued to drug companies. These typically include large fines of a billion dollars or so, and place restrictions on the way companies can do business, including sales, medical education, and publications. These are available online, just search for the name of your favorite misbehaving drug company and “CIA”. Incidentally, these are issued by the Justice Department, so we probably have not heard the last of Sen. Grassley.
PS: Although gabapentin was later approved for the treatment of postherpetic neuralgia, in 2004 Warner-Lambert settled litigation and admitted guilt in connection to charges that during the 1990s it violated federal regulations by promoting the drug for off-label uses.