Friday, September 13, 2019

New but necessarily improved

One of the major arguments that Big Pharma and its apologists make against any attempt to lower the sky-high prices Americans pay for medication is that doing so would stifle innovation. While it is true that many new drugs introduced in recent years have helped extend life, it is also true that many have been of marginal benefit at best. One example is the recent flurry of “check-point inhibitors” that have been tested against a variety of cancers. There are now six checkpoint inhibitors on the market and more on the way. The Cancer Research Institute estimated recently that some 2,250 clinical trials are underway testing this class of drugs. Unfortunately, many of these trials duplicate each other, and three recent studies looked at the use of these drugs against multiple myeloma. All three showed no benefit. Did we really need to put so many patients through these trials? Could not the investigators have waited for preliminary results from one before starting another trial?
Many cancer drugs are approved by the FDA based on “statistically significant” improvement in life span even if the extension is measured in weeks and comes at the price of nasty side effects. Still others are approved based on so-called “surrogate end-points:” tumor shrinkage or lab test improvement, even if they have not shown any improvement in lifespan. We really need pharmaceutical companies to be looking for drugs that give meaningful extension of life without horrid side effects rather than developing yet another “me-too” drug that will probably be able to obtain FDA approval and then be marketed at high price.
Another way drugs can get FDA approval without offering much benefit is by showing “non-inferiority” compared to a treatment already approved. Do patients really want to be offered a drug that “is probably not much worse” than another? A recent study published in JAMA Network Open at the end of August 2019 looked at 74 such trials of cancer drugs. While 61% could justify their use by offering convenience (such as oral rather than IV use) along with similar survival, 39% offered no obvious reason to choose the new drug over an old one - but did come at higher cost. The majority of trials showing non-inferiority without any justification for caring if the new drug was probably as good were industry-sponsored.
To regain our trust, the pharmaceutical companies need to show they are concentrating on developing truly innovative drugs that make a difference in patients’ lives and not just pushing out high-priced drugs that do little to improve quality or quantity of life but do add to our already staggering financial burden.

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