Friday, January 6, 2017
The 21st Century Cures Act--allowing drug companies to speed up development of drugs that may not work
The bill was hailed as supporting the development of new drugs and devices to cure dread diseases by reducing unnecessary regulation by the Food and Drug Administration. I found the text. It is amazingly difficult to read. The legal terminology is nearly impenetrable and the actual content is pretty hard to discern. It is also full of barely related measures, some of them excellent and some of them likely to have nasty consequences. I am particularly wary of the provision that encourages use of digital medical imaging by paying less and less for tests done with older x-ray machines, the one that allows pharmaceutical companies to pay for doctors' continuing medical education and the one that excludes approved generics from calculations of average manufacturers' price for drugs. I am perplexed by the creation of a 14 person working group specifically to address Lyme disease and other tick-borne diseases.
An excellent commentary by Aaron Kesselheim MD, a primary care physician with a law degree and special expertise in the ethics of pharmaceutical research and sales, discussed the many problems with this legislation. He is particularly concerned that the shift toward haste in approving new drugs will lead to new and expensive drugs that will enter the marketplace without convincing proof that they actually work. The FDA, at its inception, was instrumental in reducing the number of quack medicines on the market and inspiring trust in newly invented products. The bill will encourage the use of data which may be less accurate than what is presently required.
We do need more and better drugs to treat the conditions that make us miserable and shorten our lives. The US has been at the forefront of the world as an inventor of innovative products that save lives, though often at astronomical prices. The US was responsible for developing anti-viral medication that has allowed us to actually cure hepatitis C, a disease that often leads to endstage liver disease. The drug manufacturers charge $40,000 for a course of these medications, and many of those who have the disease are either uninsured or underinsured. We have come up with cancer chemotherapies that are less toxic and make metastatic cancer, which was once a death sentence, into a treatable disease, but they are oh so expensive. We have also made some terrible drugs. We have produced drugs for high blood pressure that don't reduce the risks associated with it, drugs for pain that have been pushed to the extent that huge numbers of Americans have become addicted, medication for bladder urgency that makes the mouth dry, but barely changes a person's urgency or incontinence. We have produced injectable medication for cholesterol which does reduce serum levels, but is not yet known to save lives or improve health. This can cost over $10,000 per year. I don't think we want to allow pharmaceutical companies to enforce their own ethical standards.
The bill was also roundly praised for a provision that was supposed to fight the opiate epidemic. Again, I find the text of the bill to be difficult to understand, but it appears to be pretty anemic. From what I can glean, it allows insurance companies to cut off payment for drugs of addiction to patients who are felt to be at high risk of prescription drug abuse. In addition these people must receive information on drug and mental health treatment programs which are federally funded. It does not have to actually provide this treatment. Dr. Kesselheim says there is money for grants to the states to reduce opioid abuse and to reorganize mental health care delivery, but I found nothing like that in the text of the bill.
The bill does provide better funding for the FDA, which is good, because with sequesters and budget cuts, the financial support for funding research through this agency actually went down 22% from 2004 through 2015, according to Dr. Kesselheim. The costs of this program will be paid for by selling off some of the US petroleum reserves and from cuts in the prevention and public health fund of the Affordable Care act. That doesn't sound like a good choice.
Overall, it is not clear that the Cures act actually cures anything. It will increase funding to the FDA and may streamline approval for innovations, but we will be less sure that those innovations are really useful. Congress may have passed legislation that gives drug and device manufacturers a pass to make products that are painfully expensive and may not work.