October 20, 2003
Liberty or Death? FDA life-saving drug access regulations
Access to beneficial drugs is not a sexy issue, but it is important and emotional. Ought altering FDA regulations to improve the access in life-or-death cases be a partisan issue? How you feel on a pending lawsuit may tell.
But first imagine: your daughter is in the last stages of cancer. Then your doctor reports there is a new drug in development showing real signs of extending her life. You try to get it for her, but standing in the way are FDA regulations forbidding access to unapproved new drugs. By the time the drug will get through the approval phase, it will be too late. Something like that faced Frank Burroughs.
It ultimately proved too late for Frank’s daughter, but an organization he founded which bears her name, The Abigail Alliance , is suing the FDA to alter its regulations to allow earlier access for patients in dire necessity to developmental drugs which show promise. (The technical name for the earlier proposed access is Tier 1. There are already ad hoc voluntary expanded access programs that pharmaceutical companies may be allowed to offer for free, but the idea being presented in the challenge to the FDA is for a general right of patients to purchase a promising developmental drug without a waiting period or a requirement that the company donate the drug. )
This is important and sensible enough that it should be embraced by all parties. Greens, progressives, and Democrats should embrace it for compassion’s sake; Republicans, conservatives, and libertarians ought to embrace it for placing rational limits on government regulation. A source familiar with the issues and politics has noted to me that what political resistance there is has come from a few on the “progressive” side who find objectionable the idea that purchasing experimental drugs to save lives will “favor the rich.”
It’s a strange egalitarianism that prefers equality in death to opportunity for life. This issue should not be partisan -- the Abigail Alliance isn’t -- but is it true that some people are so full of “compassion” that they have forgotten the meaning of cruelty? If that is the case, could it become partisan?
Posted by at October 20, 2003 09:10 AMInteresting topic Matthew. Does it have to be an ‘equality in death vs. opportunity for life’ issue? Cannot a bill providing fast track delivery of experimental meds to last resort patients be both egalitarian and opportunity for life?
It seems to me, a couple of things could make this work fo all perspectives. First, if the patient (or family if the patient is not congnizant), and the doctor/hospital request the drug, why can’t the maker provide the drug for the amount of available insurance coverage or gratis in the absence of insurance? In return, the pharmaceutical company is granted safe harbor by virute of the signed request by patient/doctor, in the event of deleterious consequences of the drug’s administration.
Under this scenario, the pharmaceutical company gains additional human trial of their experimental drug, legal protection from suit should the drug fail or produce ill effects, and any last resort patient will have access.
Posted by: DRRemer at October 20, 2003 10:05 AMNearly all insurance companies (maybe all, but I have to allow that there is one out there) will not pay for the cost of experimental drugs. With cost a big issue rather than liability, it’s difficult for doctors to include patients in studies without procedural parameters that ensure costs are carried through.
I certainly think that the patient can waive drug company/doctor/hospital liability easily enough, but I don’t see the cost issue being cleared very easility.
In addition, there’s no question that the FDA, in order to approve a drug, would only make it more difficult to approve a drug in a timely manner if studies were “open.”
Sorry, I actually think that the process needs to be streamlined myself, and just see that I have not offered any solutions or ideas.
Posted by: Frederick T. Courtright at October 21, 2003 02:00 PMWhile I agree with the tragic nature of this, it pales in comparisson to the millions of americans and billions worldwide who cannot get non-experimental drugs because they are uninsured or underinsured. This issue, while sad, is yet another GOP diversion and is only slightly more noble than Fox’s gaudy use of the Laci Petersen case. It points us away from the elephant (no pun intended) in the room.
Posted by: Glenn Brown at October 21, 2003 04:40 PMIn the end, someone has to pay for it. One reason health care costs so much here is that we indirectly subsidize every socialized system through protectionism, overregulation, guild-style licensing, and a closed immigration system in health care (while little control is exercised in other immigration areas, too much limita health care supply) all of which keeps the supply low and allows socialized systems to keep their labor and their price controls..
Forcing taxpayers or insurance companies to pay is an option…but it should not be a prerequisite to access to life saving therapy.
Posted by: matthew hogan at October 26, 2003 07:41 AMMany drugs for cancer treatments are toxic. They just kill you slower than the disease. If you are talking about bureacratic gridlock getting in the way, I can sympathize, from experience. But if you’re talking about tests on the drugs, I don’t think it’s a gamble worth taking. Thing is, there is a degree of uncertainty as to how drugs work. The medical community does not completely know the mechanisms by which they work.
That’s what side-effects and bad drug reactions are all about. The complex biochemistry of the human body is dependent on a number of things that can differ from one group, one individual to another. They are looking for drugs that give the fewest surprises, in terms of their effectiveness, vs. nasty unexpected effects.
Wouldn’t it be tragic if insufficient testing lead to your daughter dying faster than she otherwise would have? Is her life and remaining health worth gambling with? And what if she’s the lucky one in the genetic lottery, and a majority of other people have debilitating reactions to the drug? What then?
Millions have perished throughout history for want of antibiotics. thousands of AIDS patients died early and badly, for want of the new drugs. Many will die for want of the Vaccine, if it ever comes out. Many will die for a lack of the treatments and drugs that could have saved them, if only they were known at the time. But that is better than people dying of the treatments and the drugs unnecessarily.
Posted by: Steve Daugherty at October 27, 2003 10:23 PM
