If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again), but even those who would like to do away with the user fees might find this latest rehashing a bit over the top.
An article titled “Risky Drugs: Why the FDA Cannot Be Trusted” at the website for Harvard University is the latest to take up the issue of user fee-induced malfeasance at FDA. The article starts out by stating that another soon-to-be-published article “presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.” The italics are provided courtesy of author Donald Light, PhD, an ethicist at Harvard. Also among the claims in this article is that prescription drugs “are the fourth leading cause of death.” And it's all because of user fees.
These are quite some allegations, but are they true?
Light does not disclose where he gets his information about the fourth leading cause of death, which is quite convenient. CDC pegs stroke as the fourth-leading cause of death in 2010 (by the way, the term “drugs” does not appear anywhere on the CDC top 10 list).
This reminds us of the 1999 screed by the Institute of Medicine titled in part “To Err is Human.” IOM claimed that somewhere between 44,000 and 98,000 patients lose their lives to medical errors annually. I’ve enunciated the position for some time that if you have that fat a margin for error, you really aren’t sure of anything at all, are you?
That doesn’t account for other methodological issues of substantial heft in the IOM report, but as for Light’s allegation about the fourth-leading cause of death, my response is “are you sure you didn’t make that up?”
As for the efficacy question, Light omits entirely the fact that drugs that hit the market 30-plus years ago were administered to patients under pharmacological treatment for that disease for the first time. The newer drugs are used on many patients who are refractory to those other treatments and hence are likely to be resistant to treatment.
I’d add that if any such analysis includes generics, it stands to reason that improved efficacy is not the idea. Lower cost is.
But I dare Dr. Light to make such arguments to cancer patients. If he really thinks that the therapy for cancers in 1983 are the match for modern pharmacology, he should screw up the nerve and tell that to cancer patients to their faces. I promise he will not. He’d get slugged if he did, and rightly so.
One might extend this kind of conspiracy theory to FDA advisory panels, because these panels approve many of the truly new drugs and are populated by people who have conflicts of interest. However, the only analysis I’m aware of indicates that the outcome of advisory panels would be the same if the purportedly conflicted voting members hadn’t made it to the meeting.
In fact, the report states that the data suggest that advisory committee members and consultants “with financial ties to pharmaceutical companies tend to vote against the financial interest of those companies.”
Light’s lightweight rant is yet another example of academicians going off on things that they either utterly fail to understand – despite the enormous amounts of time spent in their ivory towers “studying this important issue” – or understand all too well and simply want to justify their tenure by making controversial remarks. I’ll add to the pile of pointless controversies by arguing that PhDs who spend their time adding yet more hot air to the debate might be a source of global warming.
Can you prove me wrong?
And when one considers the possibility that the taxpayer is on the hook for a good chunk of Light’s salary, I’d ask “who is really guilty of malfeasance here?”