At the Lown Institute annual conference, Vinay Prasad, MD, Assistant Professor of Medicine at the Oregon Health and Sciences University, explained how to improve access to medicines–how to ensure that new prescription drugs that come to market are safe and effective and are priced fairly. In short, he says we must fix the incentives in the current system. Here are some of the key problems he highlighted:
- Drug companies can get FDA drug approvals based on a single trial.
- The drug trial does not usually need to be on people needing the treatment but can often be on surrogate endpoints, mice or young healthy people, with no evidence that the drug actually works on the people it is intended for.
- Drug companies do not need to show comparative benefits of a drug, only that it works a slight bit better than nothing.
- Drugmakers can earn a huge windfall from a new cancer drug, as much as $7 billion a year.
Prasad explains that based on the way pharmaceutical companies are permitted to structure trials, they should be able to find a clinical benefit 5 percent of the time, no matter what they are testing, including spices! Of course, the finding of clinical benefits in these cases are false positives. But, they still would be enough for FDA approval. It might cost the pharmaceutical company $20 million a trial, but with 20 trials, at a total cost of $440 million, the company would see a benefit to whatever it was testing. Since the typical revenue for a cancer treatment is close to $7 billion, a $440 million investment is not unreasonable.
What is to be done? Prasad believes that people will do whatever they are incentivized to do. The likelihood of success in persuading them to do what they are not incentivized to do is extremely low. So, we need to change their incentives. To change incentives with drugs, we need to focus on five key elements in the drug development and distribution pipeline: the basic science, the clinical trials, the drug approval process, news coverage, and, the prices and marketing.
Prasad recommends that the FDA change its drug approval process to better ensure drugs are safe and effective before they are marketed. The FDA should not rely as much on surrogate endpoints–mice or indicators that are not directly related to patient testing–to establish efficacy but rather on how the drug affects prospective patients. The FDA should expect more trials. And, it should take a much more active role in overseeing drugs after they go to market than it currently does.
We also should do away with pharmaceutical company direct-to-consumer advertising. These ads are often misleading. Prasad points out that he saw one ad for a new prescription drug claiming its benefits were “clinically meaningful” when in fine print the pharmaceutical company noted that the benefits were not statistically significant.
In addition, pharmaceutical companies should not be allowed to design the trials or influence how they are conducted, as they generally do now. The trials should be conducted by independent non-conflicted entities. And, finally, a public drug development and distribution chain should compete against the private drug companies to drive competition and lower drug prices.
This all requires a dramatic change to our health care system. When will we have the political conditions that will allow these changes?
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