Politicians and regulators should be asking themselves whether a system of massive cash awards to people who may or may not have been adversely affected by Vioxx is a logical, fair or efficient way to run a drug regulatory system. They should also be asking whether juries that scorn medical evidence are the right judges of what information should or should not have been on a prescription label.You might have expected something like this from a right-wing think tank like the American Enterprise Institute (see, for example, "Saving Public Merck"), but from the Washington Post?! You should read the comments from some intelligent people about whether and how Merck should be saved by Congress (ibid).
The first principle of reforming this system should be that a company that follows the FDA's rather extensive guidelines should be protected from punitive, if not compensatory, damages. At the very least, it is time for Congress to start considering whether a model such as the one set up for children's vaccines -- in which a fund is set up to cover the costs incurred by children harmed by vaccines -- should be constructed for all drugs.
See "The Vioxx Hex" (Washintong Post, 9/16/2005).
The editorial suggested that the jury "scorned medical evidence." This is the hoax perpetrated by this editorial! More likely the jury did not understand the science. Here's the case I make in this month's issue of Pharma Marketing News:
My oldest son recently started as a freshman at Penn State and I miss him a lot. The first email message I sent him was intended to encourage him to stick with engineering and science. "When you consider your major and your future," I wrote, "keep in mind that the sciences and engineering will put you among the technical elite in this country. That means big rewards! Also, given your ability to get along with people, your mom and I have no doubt that you will do well in business and in life. So, good luck and keep up the good work."The WP editorial also said that the Vioxx label "did warn of coronary side effects." Ha! Whenever someone mentions "drug label" I take out my pistol! See, for example, "Labeling / TV DTC Revisited."
The "technical elite" class of people I referred to in my email is a dwindling national asset. While the SAT math scores of U.S. high school seniors increased somewhat this past year (my son scored a 780!), the U.S. is still, I believe, just one notch ahead of Latvia. Added to that are our leaders who suggest that there is an alternative theory to evolution that should be taught in our science classrooms!
Is it any wonder, therefore, that jurors who voted against Merck in the first Vioxx liability case said much of the science sailed right over their heads?
Or could it be that the Merck witnesses did not know how to explain the science? (See Merck science "like wah, wah, wah").
There is no doubt that the industry needs to do a much better job communicating drug benefits and risks to consumers. How will they do this if the population at large is scientifically illiterate?
Also, how can the drug industry focus on this problem if its leaders are not grounded in science?
Take, for example, the current CEO of Merck, Richard T. Clark. He is an operations guy, who promises to bring efficiency, not scientific glory back to Merck. As described in the Wall Street Journal at the time he was named CEO, Clark is "an insider without a background in medicine at a time when observers agree that the company desperately needs to focus on developing new drugs. Moreover, Merck made its selection even after its glory faded under a previous nondoctor, Ray Gilmartin."
At the recent Pharmaceutical Marketing Congress I met Roy Vagelos, M.D., former Chairman and CEO of Merck, who gave a keynote presentation entitled "Medicine, Science, and Merck: The Changing Pharmaceutical Industry."
Vagelos told the story of how Merck science and leadership was responsible for some of the greatest drugs ever developed. As Dr. Vagelos went through his presentation, I felt that I was in the presence of a dying or already dead breed of pharmaceutical executive -- an executive with a passion for and a deep understanding of science. He also did a great job explaining the science and making it sound exciting!
It's difficult to imagine Merck employees feeling excited about their company today, especially with years and years of Vioxx-related litigation to look forward to ("We are in this for the long haul," Merck general counsel Kenneth Frazier said).
I mentioned this to Dr. Vagelos as he signed a copy of his book, "Medicine, Science, and Merck." He nodded his head and looked sad as he wrote the inscription: "Good luck - keep up the good work."
I could go on, but it's the weekend. See you next week!