When was the last time you heard “ethical” and “drug industry” in the same sentence? These days, you are more likely to see “unethical” linked closely with the drug industry that during the time of its birth during the Civil War in the U.S. used “ethical” to distinguish its products from quack medicines. Here’s a piece of drug industry history from “The Evolution of Pharmaceuticals in the United States,” which I found by Google search:
“Frederick Stearns was [an] important industry pioneer. He started a manufacturing facility in Detroit in 1855 and it was an important supplier of medicines during the Civil War. Stearns also became a reactionary against the medical quackery that was rampant at that time, so he put his products into popular-sized packages bearing full directions for their use plus a plain statement of the names and quantities of the ingredients in the package. He thus pioneered the phrase ‘ethical specialty’ for his products, and that was the origin of the phrase ‘ethical pharmaceuticals’ that survives to the present day. (Frederick Stearns and Company was acquired by Sterling Drug in 1944.)”
I am not sure when this bit of history was written, but as I said, in the “present day” we no longer hear the phrase “ethical pharmaceuticals.” We all know why. The industry has been found guilty of unethical and even unlawful practices that include hiding clinical trial data (see “GSK’s Coverup of Avandia’s Heart Risk Data: Is This How the Entire Industry Views Its Responsibility to Patients?“) and illegally marketing drugs. In recent years, the industry has paid huge fines and instituted corporate integrity agreements to settle DOJ cases (see, for example, “Transparency Vs. Translucency in Reporting Physician Payments“). The industry’s low esteem among the general public is a direct result of this bad behavior and not, as some industry defenders claim, due to skewed media reports and anti-industry books like “Bad Pharma” (see here).
So it was with great interest that I read about a new effort to improve the drug industry’s reputation: the establishment by a bioethicist of an accreditation rating system (read all about it on Pharmalot: “Good Housekeeping Seal For Pharma?“). “Jennifer Miller, a fellow at the Edmund J Safra Center for Ethics at Harvard University and president of Bioethics International, a non-profit that advises educational programs on ethical issues on medicine and healthcare, is trying to develop the industry equivalent of a Good Housekeeping Seal of Approval,” reports Pharmalot.
“The standards [for the rating system] have been compiled and developed by a council that I put together,” said Miller. “It includes input from two former FDA commissioners – Mark McClellan and Andrew von Eschnebach, and some executives in the pharmaceutical industry, patient advocates, physicians.”
Her choice of former FDA commissioners leads me to believe Miller’s system is “fixed” so that no pharma company would get a bad grade. As one Pharmalot commenter pointed out “The credibility of this plan will depend on who the judges are. The fact that the ‘committee’ already includes an FDA Commissioner who himself resigned because of ethical trouble makes one wonder.”
Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in “Farewell Kiss”), is now employed as chairman of conservative think tank Manhattan Institute’s Project FDA initiative. If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won’t kill humans outright (see here)! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug’s efficacy will be proven (or not) in the marketplace. That would not be how the general public would want an “ethical” drug industry to operate.
Meanwhile, Mark McClellan was allegedly involved in the decision to bar Barr’s Plan B OTC conversion. McClellan resigned after a very short term. According to a story in the NY Times, the FDA deleted or threw out all of McClellan’s e-mail and written correspondence on the subject (see “Plan B FDAgate“).
Is it any wonder that no pharma company will touch Miller’s proposed plan with a 10-foot pole and become a “pilot” case?