The FDA’s incentive to let you die
Posted by Marc Hodak on July 18, 2007 under Invisible trade-offs | 
5 Comments to Read
Health policy advocates have long contended that the FDA’s power to review medical treatments has lead to far more patient deaths than lives saved. The theory, supported by a growing body of evidence, is underpinned by a simple set of incentives. If an approved drug leads to someone’s illness or death, it may get all over the news, and we know how the FDA’s antsy, congressional patrons would react to that. If an unapproved drug might have prevented hundreds or thousands of deaths, there would be no media or congressional reaction, because no one would likely know about it. So, the FDA has an institutional bias against drug approval below the very highest margins of safety, a decidedly non-economic standard, one that costs countless lives.
The exception that proves the rule: AIDS drugs. Here, the FDA’s cumbersome, time-consuming, costly review process was highlighted by a politicized, media-savvy group that acutely felt the lack of progress in the development of treatments.
Last year, the FDA’s authority was successfully challenged in court by the Abigail Alliance. This group was founded on behalf of 20-year old Abigail Burroughs (pictured above) who was denied access to a drug in 2001 that had passed Phase I trials. The drug that was later approved by the FDA, after she died. Imagine an FDA bureaucrat patiently trying to explain to you why a particular drug might have only an 9.3 percent chance of working on your dying child, and thus preventing your doctors or the drug manufacturer from selling it or giving it to you until more tests are done on its efficacy.
So, for the non-politicized masses with rarer diseases or no press agents, how far will the FDA go to protect its authority to tell dying patients what potentially life-saving drugs they may or may not take? After the court’s Abigail Alliance decision last year, the FDA filed a brief challenging the standing of Abigail Alliance members who have all died since their original briefs were filed in 2003. That’s right. The FDA, which arguably hastened their deaths, is arguing that their death undermines their standing to challenge the FDA.
That might be a statement about the size of their agency’s balls, or about the agency’s desperate grasp at a remedy for a judgment that threatens their regulatory body.
JD said,
So, Abigail was in the “control” group. If those given the drug tended to live, and she wasn’t given the drug and died, then the drug was probably effective.
Wasn’t that kind of how we used to test women to see if they were witches?
Hoople said,
This tack reminds me of the Menendez brothers asking the judge for clemency because they’re orphans.
Kenneth A. Regas said,
The problem here is that a lawsuit is being used where a political movement would be more appropriate. Let me explain.
The FDA’s authority comes from Congress. Its officers are bound by their employer-employee relationship to act in accordance with the law and to defend these lawful actions in court. Its attorneys are ethically bound to win the government’s case by any strategy short of outright deceit. If a case is moot for any reason, the attorney who didn’t point this out would be guilty of malpractice. In other words, everyone here his behaving correctly.
Families like Abigail’s have a bone to pick, all right. It’s with the Congress which gives the FDA its direction.
Now let’s look at why Congress gave the directions it did, much to Abigail’s misfortune.
A great many laws are on the books in response to abuses in the market place. Medicine is only one of many areas. For example, try to get a home loan funded on the day you sign the papers. You can’t. The lender is obliged by law to give you 72 hours to rescind the deal, to protect you against high-pressure sales tactics. These laws create exceptions to the principle of caveat emptor, intended to protect the least savvy members of society from the most. In short, they reduce the cost of being unintelligent in a world of smart strangers.
The cost of these laws, of course, is that every individual who doesn’t benefit from this protection instead suffers for reason of it. Most suffer via inconvenience – waiting for that bank loan. Others like Abigail pay with their lives.
Consider what would happen if all medicines became over-the-counter, as they are in many countries. It would be a boon to many who needed, could benefit from, and had the wits to detect the benefit from, drugs not eligible for FDA approval. Other self-medicators would unnecessarily appear in emergency rooms and morgues. The price of freedom is that the strong thrive and the weak suffer. In our society strong and weak are largely matters of intellect.
This is the problem Congress has to wrestle with. I agree that a better-nuanced approach to drug approval would be a good idea. I don’t agree that its absence is due to malfeasance on the part of FDA officials or anyone else. Legislation involves hard choices – and people die.
Ken
JD said,
Sorry, Ken. I’m having trouble reconciling your rationale that these laws intended to protect the weak (less savvy, whatever) necessarily must result in innocent kids dying.
These patients are not asking for cancer meds to be placed over the counter. They’re just asking, presumably with the advice of their doctors, and I’d guess more than 72 hours to think about it, to have access to drugs that can save their lives. I wouldn’t excuse ham-fisted legislation for this result.
M. Hodak said,
I wouldn’t excuse the FDA lawyers, either.
Notwithstanding their obligation to vigorously defend the agency’s authority, this argument will be quickly tossed aside by the judge under the “recurring and repeated” standard set up by the Supreme Court, then everyone else will be left to wonder how black must be the hearts of the agency hacks trying this flimsy argument to prevent substantive arguments on the issue from even being heard.