Over the last few years, the Laura and John Arnold Foundation has tried to influence the national conversation over rising prescription drug costs by funding pilot projects and academic research.
Despite increasing scrutiny of their motives, the couple generally lets their work do the talking. But last Friday, John Arnold made a rare appearance before a select group of mostly drug company employees, as well as a few academics and patient advocates.
The occasion was to discuss ways to improve clinical trial transparency, one of many issues that plague the pharmaceutical industry. The session was hosted by Jennifer Miller, a Yale University professor who runs Bioethics International, a nonprofit that receives backing from the foundation.
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ed and Mary,
I am of the opinion that some new regulations are absolutely fabulous. One excellent one has to do with compelling the FDA to consider patient-based outcomes for expedited drug approval for alternate indications! Any comments from either or both of you?
So Ed,
What is your view on compelling all non-US based drug companies to charge their drugs in the US at the same level as in their own countries?
Hi John,
Not sure how that would work. How does one force them to do so? Refuse to pay the requested price? So does Medicaid then not make a drug available? There are requirements, although not clear if the Trump proposal addresses that satisfactorily.
Overall, it’s not such an easy thing.
Cheers
ed at pharmalot
Increasing regulations each year are making the cost of developing drugs to rise exponentially, so prices do too. As long as regulatory costs climb, drug prices will continue to rise—or companies will be forced out of business. These regulations, which are the driving force behind drug prices, aren’t making drugs safer either; the withdrawal rate has been about 3.3% for decades. Any reforms that don’t address the underlying problem of rising regulatory costs will result in further loss of innovation.
Hi Mary
Thanks for stopping by. Not sure, though, I follow the train of thought. In general, I can understand the idea of peeling away regs that increase costs – but which ones and at what price?
There are reasons, after all, the FDA promulgates safety and effectiveness standards, along with good manufacturing practices. Perhaps a thorough review might turn up some regs we could live without.
But the real cost of developing drugs is the work that goes into R&D and, of course, that math itself is debated.
Anyway, I appreciate the sentiment but not sure how easing regulation makes for safer and better drugs – at lower prices.
Regards,
ed at pharmalot
Ed, since you mentioned a review of regulations, I’ve recently published one on the 1962 Amendments (see “Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It” at Amazon). Before the Amendments, the withdrawal rate of approved drugs from the market was about 2.5%; since Amendment passage, it’s been about 3.3%. Vioxx, the biggest drug disaster in US history, was approved under the Amendments. Thus, it is tough to argue that the Amendments have increased safety. The reason: most drugs that are eventually withdrawn from the market are approved because our science isn’t good enough to predict some side effects in advance.
Studies on effectiveness before and after the Amendments show that they might have saved consumers—at most—about 10% on ineffective drugs. However, since the Amendments have increased drug prices 20-40 fold, that’s a poor monetary trade-off. This estimate does not depend on Tufts’ R&D calculations, BTW.
If the Amendments haven’t given us safer and more effective drugs, but have increased pharmacy prices 20-40 fold, getting rid of them should help slash our pharmacy bills without compromising innovation, safety, or effectiveness. Because I was in pharmaceutical research in the decades following the implementation of the 1962 Amendments and their continuing expansion, I wanted to measure their impact and was shocked at what I found.
The Amendments have side effects that are just as deadly as bad drugs. They’ve probably cost each of us 5-10 years of our lives as they’ve increased the time it takes to get drugs from the lab bench to the market, slashed innovation, and shifted our medical paradigm from inexpensive prevention to costly treatment. This loss of life is an even more compelling reason to reconsider these regulations. Bad law is just as deadly as bad drugs.