US Supreme Court: No Review Of Experimental Meds
12 CommentsBy Ed Silverman // January 14th, 2008 // 10:40 am
The Supreme Court refused this morning to review a ruling that terminally ill patients have no constitutional right to be treated with experimental drugs — even if that means the patient will likely die before the medicine is approved, the Associated Press reports.
Last August, a federal appeals court sided with the FDA and decided the government may deny access to drugs that have not gone through extensive testing and received FDA approval, a process that can take years and, sometimes, angering cancer patients who are frustrated by FDA decisions, such as the controversy over the Provenge prostate cancer vaccine.
The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA in 2003, seeking access for terminally ill patients to drugs that have undergone preliminary safety testing in as few as 20 people but have yet to be approved. Abigail Alliance was created by Frank Burroughs, whose daughter, Abigail, was denied access to experimental cancer meds and died in 2001. The drug she was seeking was approved years later. The group was asking for “a right for terminally ill patients with no remaining treatment options to fight for their own lives.”
The FDA said the appeals court was correct and in line with other rulings “that have rejected constitutionally based demands for access to unapproved investigational drugs.” The full US Court of Appeals for the District of Columbia Circuit ruled against the group after a smaller panel of the same court held that terminally ill patients may not be denied access to potentially lifesaving drugs. The court said patients can access experimental drugs in certain situations and suggested Congress could change the law to broaden such access, the AP notes.
C. Payne
A cowardly and irresponsible decision….a final link of betrayal in the shackles of tyranny, even more grievous considering it eminates from our “highest” court.
The FDA has been empowered to continue the usurpation of what our Founding Fathers would no doubt have assumed a clear and self evident right to persue “life”.
The Tree of Liberty withers for lack of watering….
What a thoroughly emasculated society we have become.
The Supreme Court justices have smeared their robes with the blood of the innocent…previously reserved for tyrants at FDA. They will stand some day before the Creator of all things….the same mercy will be shown to them as they demonstrated by this decision.
Phil Vardena
I see a couple or ironies…
… one is that in the USA you can purchase a firearm without restrictions (so you can kill people), while you can’t purchase a cure to save yourself or your loved ones;
… the other is that it is easier to buy recreative drugs and tobacco - that harm your health - than buy experimental, therapeutic drugs.
The Supreme Court ruling is bureaucracy at work at its best!
Oh, yes, the USA want to export democracy. If this is the case, no thank you, please keep it for yourself.
Regards,
phil
Lawrence
Just further Proof that Al-Queda has WON the WAR! For they are in FULL control of the U.S. Goverment. Pick ANY Agency and see the Corruption for Yourself!
Nathan
Although I have a lot of sympathy people who want to try experimental treatments, it’s not at all clear that pharmaceutical companies would even provide the drug to those patients desiring it. The patient population wanting the drug would be extreamly small, and even with very high prices, the pharma companies are likely to loose money by providing the drugs. Think about all these issues:
1) Who is responsible and what would happen if the patient died due to a drug reaction?
2) What happens to the results? In other words, does “curing” a patient in this highly uncontroled environment constitute proof that the drug works? Most likely the patient will die — giving the impression that the drug does not work. Is that somehow incorporated into future FDA filings as a “risk”?
3) What formulation would the drug be provided in? What dose should be used? Translation of animal results into human results is plauged with problems.
4) What should the pharma company charge? Given that the market is only a few patients, the “real” cost is likely to easily be in hundreds of thousands of dollars for a treatment. What if the patients can’t afford it?
Given all these questions (and more that I can’t think of at the moment), I seriously doubt that pharma companies would be even willing to sell experimental drugs to patients.
David
Phil, and anyone else. Time to take a serious look at the concept of the “authoritarian” personality and it/their function/ing in human societies in general and the U.S. today.
John Dean apparently has written about this in his recent book “Conservatives Without Conscience.” I have not read his book but am familiar with some of the research on the subject, plus the book which originated the concept. With which I essentially agree.
I saw Dean on CSpan recently and everything he said ‘rang true’ hence my decision to bring this up. With morbid fascination, sadness and alarm I have watched this socio-cultural-political debacle forming for more than twenty years.
The Court decision is simply one more manifestation.
Bob Freeman
Nathan, one of the constraints on a company’s ability to provide drugs in clinical trials to patients outside the trial is the availability of supply. CThey only manufactuer enough drug doses for the trails and manufacturing is done from a pilot plant, not a full-blown manufacturing site.
There are regulatory provisions to allow drugs to be supplied to critically ill patients for which no alternative is available and the company is allowed to charge the patient on a cost-plus basis. ( A physician should apply for what’s known as a Treatment IND from the FDA)
Still, the manufacturing capabilities are extremely limited at this point.
phil_vardena (Pharm. D.)
David, and anyone else.
While I stand by my earlier post, I also want to make it clear that I admire the U.S people.
I travelled the USA a lot, talked to people, made friends.
The USA are a great country. Americans are nice and friendly people. It’s its ruling class that leaves much to be desired - and its obsession to rule the world.
I acknowledge this comment is way OT, and I’ll stop here.
Very kind regards,
phil
PS. phil is from Italy, another country with great people and a very bad ruling class. ;-)
Bob Freeman
Phil, my wife was born and raised in Italy. Great people who don’t like to be governed and go to great lenght to game the system.
James
I find it noteworthy that the FDA in 2006 published two proposed rules–one to allow expanded access to drugs in Phase I and even earlier studies, and one to allow drug companies to charge for this expanded access:
http://www.fda.gov/cber/rules/expandind.htm
Funny how we haven’t (at least I haven’t) heard anything new since then, even though these proposed rules were issued more than a year ago.
Of course, considering Part 11 still remains unrevised (despite FDA saying it would be done in 2005), aspects of PDUFA III remain unfulfilled, et al, I guess it’s no surprise.
Seems the FDA would do well to read the Peanut Butter Manifesto:
http://online.wsj.com/public/article/SB116379821933826657-0mbjXoHnQwDMFH_PVeb_jqe3Chk_20061125.html
Drug Law Blog
Supreme Court: No Review in Abigail Alliance…
Pharmalot notes that the Supreme Court has decided not to grant cert on the Abigail Alliance case, which had to do with terminally ill people’s right to access experimental drugs. Seems like a shame to me, because I think it…
softwareNerd
The government is way out of bounds when it bans drugs. It is one thing to ensure a patient’s informed consent, but quite another to actually ban a drug.
A patient’s life belongs to the patient, not to the government. The ultimate decision must be in the hands of the patient. It is terrible that the SCOTUS judges do not understand the basic concept of individual rights, and the right to one’s life.
As another blogger said, “Legalize Drug (medical drugs) now!”
Seditta
Its amazing how short our memory is. Pre FDA, many people suffer from dangerous drugs, even recently we experience what can happen when a drug have serious side effects–the Vioxx, celebrex, crestor, bextra, just to name a few on te list of dangerous drugs approved by FDA and later had to be recalled. Aren’t we a litigious society? All of a sudden when it pleases us, it is OK for the government to loosen the reigns on drug regulation? Think about. Who will be responsible for the manufacture and distribution and protection of these people? we live in a get rich quick society.