Anecdotes Are Not Science: Law Firm
A Nelson Hardiman blog post says that the 21st Century Cures Act would weaken FDA oversight of new drugs and new uses for existing drugs. The post says that the bill would allow “evidence from clinical experience” to substitute for evidence gathered from clinical trials. “Essentially, doctors’ anecdotes would be adequate justification to approve new uses for existing drugs,” it says…. “Anecdotal evidence is not the same as true scientific evidence generated from randomized, well-designed clinical trials. And when government relaxes the criteria for what qualifies as sufficient evidence, it creates a situation for drug companies to take advantage of suffering patients desperate for a cure.”
The lawyers cite the example of laetrile, that was marketed to cancer patients in the 1960s and 1970s. “There was no evidence of its efficacy,” the report says, “yet patients spent thousands of dollars on the therapy, at times foregoing more proven forms of cancer treatment like chemotherapy and radiation.”
The post quotes media and medical sources to support its contention. Los Angeles Times columnist Michael Hiltzik is quoted as saying that two alarming provisions in the bill are:
- loosening standards for approving new antibiotics so that they would not have to be tested in humans; and
- reversal of the requirement that clinical trial patients give “informed consent” when a trial poses no more than minimal risk, because it is unclear who would determine a trial’s riskiness.
Hiltzik also says that the notion that FDA stifles innovation and is a bottleneck in drug research and development is false. He cites a study by Harvard researchers Aaron Kesselheim and Jerry Avorn who found that “more than two-thirds of new drugs are approved on a basis of studies lasting six months or less, a potential problem for medications designed to be taken for a lifetime.” The post also quotes Forbes writer Matthew Herper that rather than serving as a bottleneck for drug development, “FDA is basically providing a rubber stamp.”
Nelson Hardiman concludes that “when FDA is allowed to flex its regulatory muscle and demand sufficient clinical evidence before approving a medication, it can save lives. The 21st Century Cures Act, while noble in intention, encourages shortcuts to drug approval. Time and time again, it has been shown that shortcuts such as these lead to the release of ineffective or unsafe drugs onto the market.”