Democrat Congresswoman Rosa DeLauro is making a big stink that her amendment to have the FDA forcibly yank drugs off the market before companies are forced to conduct large randomized studies to establish a safety problem was lifted out of an appropriations bill. Rosa is hypocritical. Here’s Rosa — a cancer survivor — on the vaccine to prevent cervical cancer: Ã¢Women across the country should be encouraged, as I am today, with mounting scientific evidence of the benefits of the HPV vaccine,Ã¢ said DeLauro. Ã¢It is clear that the science exists to fight a cancer that thousands of women fall victim to each year and there is now significant scientific and medical evidence proving the benefits of the HPV vaccine. With countless public health officials and medical providers agreeing on this medical breakthrough, I am hopeful the FDA will approve this vaccine for use.Ã¢
DeLauro, a member of that subcommittee and a cancer survivor, is also the ranking member of the House Appropriations Agriculture Subcommittee with oversight responsibilities of the FDA and its budget. In November, she and over 100 Members of Congress wrote the CDC Advisory Committee on Immunization Practices urging them to make a decision for use based on the advice of medical providers, researchers and public health officials.
As with all products, vaccines will yield safety problems in real world settings and may lead to serious illnesses and some deaths….Yet under Del Lauro’s proposal a vaccine that could wipe out 40percent of the viruses that cause cervical cancer could be yanked forcibly if companies don’t conduct safety studies that get at the source of the the problem….such studies could — because the statistical power and confidence level needed — be ten times the size of the study required to prove the product was effective. And with products As FDA official Scott Gottlieb noted in his blog (fdainsider.com),”The biggest reason why companies are unable to complete post-market studies after drugs are approved through the accelerated pathway, is that all of these drugs treat life-threatening disorders (they have to in order to qualify for accelerated approval) and dying patients are unwilling to roll the dice on a placebo controlled trial Ã¢ taking a chance they may get little more than a sugar pill Ã¢ when the drugs are readily available on the market.” Indeed, there are questions if it is ethical to deliberately deny a potentially effective treatment to a patient for study purposes. But Del Lauro would make it a crime not to run such trials.
In fact, there are dozens of studies being conducted independent of the FDA. For instance, Bristol Myers Squibb is working on a drug that is tailored to people whose cancer is Gleevec resistant. There are dozens of studies of genetic tests in development that if used before a drug is taken will help patients avoid well know toxicitieis.
But Del Lauro would suffocate medical progress in order to make a few headlines. She would fine the inventors of innovative medicines for life-threatening illnesses millions of dollars and would deny millions of patients accelerated access to medicines. Her amendment was a death sentence for people like her who live with cancer everyday. Is there anything people won’t do for political gain?