Maggie Mahar, author of Money-Driven Medicine: The Real Reason Health Care Costs So Much, argues at TPMCafe that our “me”-oriented healthcare system makes it difficult to permit terminal patients to purchase potentially life-saving drugs that have not yet been approved by the FDA.
A recent study shows that fully 42% of the products that make it to the third, and final phase of FDA trials ultimately fail because they prove ineffective and/or unsafe.
How do so many lemons get so far? The study suggests that once a drug company has invested a certain amount of money “and reserachers have invested a certain amount of time and ego” it becomes difficult to admit failure. Moreover, as long as investors think a drugmaker has a new product in the pipeline, the stock will stay afloat.
Meanwhile, Wall Street hype about a “life-saving drug” tends to spill over into the media where it fans faith in the miracle drug, a phenomenon I’ve written about here in a story about a prostate cancer vaccine…
So physicians … have reason to fear that if patients could buy the drug, it could become difficult to mount the full-scale randomized trials needed to establish firm evidence of a drug’s efficacy and safety.
If drug-makers are allowed to sell experimental products at a profit, who will buy cancer drugs at $50,000 a pop? Wealthy patients. Others will have to wait for FDA approval.
Meanwhile, if an individual who uses the drug outside of carefully monitored trials dies, there is a real risk, as a drugmaker in this WSJ story points out, that the FDA will halt randomized trials until the company can investigate what happened. This means more delay for the less affluent.
In the end, the questions the debate raises remind me of the point Michael Moore made in “Sicko”: In other countries, people think about healthcare collectively, in terms of â€œwe.â€ In the U.S. we think of healthcare individually “in terms of me”. This is one reason why our heatlhcare system is broken.