The announcement that Dr. Robert Califf has been nominated to become the next head of the FDA offers no encouragement that the failures and corruption of the FDA will be addressed in the foreseeable future. As Sabrina Tavernise writes in the New York Times, “…he has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.” As previously noted the FDA is a failed public agency with unanswered criticisms of regulatory approval of worthless and harmful drugs, flawed criteria for drug approval, lack of investigation of unpublished results of drug research products, and absence of oversight of the conclusions, methods, and conflicts-of-interest in published research studies. The agency’s uncritical use of R & D figures supplied by the industry makes the agency an unwitting apologist for outlandish U.S. drug prices. Hopefully Dr. Califf will be able to transcend his relationship with the pharmaceutical industry and use his knowledge and clinical sympathies to create a more honest, transparent, and effective agency.
MedPage Today recently published a four part series describing the results of a remarkable investigation in conjunction with the Milwaukee Journal Sentinel. It is the story of very expensive cancer drugs that have been released on the market with no evidence of efficacy or proof of safety. This is explained as being the result of desperate cancer patients and organizations advocating quick FDA approval of any drug that might hold hope. 54 such drugs were examined. The average charge for these medications is $10,000/month but as high as $40,000/month. That $40,000 drug has been shown to extend life by 4 months. 40 of the drugs were approved without showing any evidence that they prolonged life or improve the quality of life. Looking at 26 of those approved between 2004 and 2011 only three were found to increase survival. This was by 10 months and 8 weeks and the third improved the 3 year survival rate from 61% to 70%. Not very impressive.
What is the approval process? Instead of requiring proof of efficacy as measured by improved quality and quantity of life the FDA approves cancer drugs based on surrogate markers, supposedly showing that the drug is able to cause shrinkage or slowing of progression of a cancer. The FDA then gives the drug company many years to come up with better studies of safety and efficacy. The companies stall on this but they continue to collect exorbitant charges. Side effects, including drug caused deaths, are ignored. As Richard Deyo says “Maybe you live a month longer with a new drug but you are having horrible symptoms or horrible quality of life in the meantime”
What are the forces that create this perversion of research and approval? Yes, societal pressure is one of them. But we must not forget that cancer drugs are a $28 billion industry (in 2013). This is a strong motivation for an industry that has a history of distorting and profiteering from tainted research and marketing. Add to that the fact that half of the FDA drug evaluation budget is paid for by the very pharmaceutical companies it is supposed to monitor. Ironically, the FDA is now judging its own performance by using surrogate criteria, i.e., the number and speed of drug approvals. It certainly shouldn’t take $800 million to rubber stamp a bunch of applications. They should be able to do that before lunch. Maybe, just maybe, we need to replace the FDA with a true watchdog agency that has strong scientific integrity and maximum immunity from conflicts of interest, and political micromanagement. Also read http://wp.me/p4MwV3-3a
The rent-seeking Trans-Pacific Partnership is the work of big corporations. It would raise the costs of pharmaceuticals (even higher) and lengthen the patents. It extends the range of patents and it turns jurisdiction over to an international tribunal, circumventing national laws. Please read Dr.Flower’s “Backgrounder on the Trans-Pacific Partnership and health care“.
Peter Bach has stirred the pot with his recent article, “Cancer: Unpronounceable Drugs, Incomprehensible Prices”. Apologists for the drug industry like to argue that new anti-cancer drug, Zykadia (generic=ceritinib) is far superior to the current $11,000/month drug, Xalcori (crizotinib) and is therefore worth $13,000/month. At present the main argument for this superiority refers back to The New England Journal of Medicine article whose lead author has been an advisor and consultant to the company that makes the drug. If further evidence verifies the superiority it doesn’t argue that our medical system can afford the ever-growing list of multi-thousand dollar drugs. See the Hepatitis C treatment, Sovaldi, at $30,000/month for a total of $84,000 a treatment.
Bach rightly concludes that, “Regardless of the estimate, the pricing of new drugs for cancer and now other common diseases has come unglued from the rationale the industry has long espoused. Instead, pricing is explained by a phenomenon of increasing boldness by the industry against a backdrop of regulators and insurers who have no legal authority to dictate or even propose alternative pricing models.”. At present the model is that the companies charge what they do “because they can”. That won’t work. This free market cliché is unsustainable. The best (?only) solution lies in a medical payment system that gives universal coverage and the power of negotiated pricing with the drug companies. At another time we’ll discuss the lack of transparency of that industry when discussing the true cost of new drug research.
This last January two cancer specialists published an article explaining “Why Oncologists Should Support Single-Payer National Health Insurance”. In his Huffington Post Blog, Dr. John Geyman discusses this problem and points out that not only is the ACA is powerless to control drug prices but it is also unable to control the cost-shifting that is exposing all of us to unsupportable medical costs. Every person concerned with the future of health care and the economy in the United States should read these critiques. The future is now.
As we recognize the need for single payer medicine we must keep in mind the alter-description “Improved Medicare For All”. In this context it is important not to lose sight of the goal of improving Medicare. Even though Medicare is successful and highly regarded by seniors there are things that can and should be done to achieve true universal health care. Prescription drugs can have prohibitive prices for the Medicare as well as the general population. Sanders and Veght make a good case for four important changes:
- Restore Medicare prescription drug rebates
- Allow Medicare to negotiate drug prices
- Secure better discounts to close the doughnut hole faster
- Promote cost-effective drug prescribing
For an excellent article Click here to read the report.