No Experimental Meds For The Terminally Ill
6 CommentsBy Ed Silverman // August 8th, 2007 // 8:16 am
That’s what a federal appeals court has ruled. Even if a terminally ill patient may likely be dead before a medicine is approved, they don’t have a constitutional right to be treated with experimental drugs, MSNBC reports.
The ruling by the U.S. Court of Appeals for the District of Columbia Circuit overturned last year’s decision by a smaller panel of the same court, which held that terminally ill patients may not be denied access to potentially lifesaving drugs, the network reports. But the full court disagreed, saying in its 8-2 ruling that it wouldn’t create a constitutional right for patients to assume “any level of risk†without regard to medical testing.
“Terminally ill patients desperately need curative treatments,†Judge Thomas B. Griffith wrote for the majority. But “their deaths can certainly be hastened by the use of a potentially toxic drug with no proven therapeutic benefit.†You can see the full opinion here. Before you continue reading the rest of the story, please take our poll…
Does the court ruling make sense?
- No (67%, 75 Votes)
- Yes (33%, 37 Votes)
Total Voters: 112
Loading ...Please continue reading…..
FDA approval generally requires extensive testing that can involve years of trials and thousands of patients. But 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.
FDA spokeswoman Susan Cruzan said the agency was pleased with the decision, which she said considered the public’s safety and the need for access to experimental drugs. Conversely, Abigail Alliance founder Frank Burroughs pledged an appeal to the Supreme Court. Burroughs’ daughter, Abigail, was denied access to experimental cancer drugs and died in 2001. The drug she was seeking was approved years later.
“What the opinion by Judge Griffith is saying is, ’We don’t want to risk one life or a few lives, even at the expense of the lives of hundreds or thousands of people,â€â€™ Burroughs said. “The logic of that escapes me.â€
In a sharply worded dissent, Judge Judith Rogers called the ruling “startling.†She wrote that courts have established the right “to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one’s own body even if it results in one’s own death or the death of a fetus. But the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.”
The case cut across party lines, with conservative and liberal judges taking both sides of the dispute. The court noted that there are government programs that provide access to experimental drugs in certain situations. It said the matter is not closed and said Congress might be a better venue than the courts to address the issue. Burroughs said he expects such legislation to be introduced this session. Both the Senate and House have considered such legislation but it languished in committee.
Mother Jones, RN
That’s just crazy. Enough said…
Laurie
If a person is willing to take the risk, KNOWING the risk I don’t see why they shouldn’t be able to do it. People in clinical trials are at risk everyday, yet we allow that to happen. To deny a terminally ill person any possibility of a longer life is wrong. So many of the “orphan” drugs will never make it to the market due to the lack of blockbuster status, that at least some may benefit from this practice.
MyPharmalotID
Certainly there must be some circumstances (that can be defined) under which such drugs could be made available. Erbitux serves as a prime example. The FDA initially turned down approval, only to approve the drug some 2 years later on data that were within a decimal point of the previous results! How many people died during those two years who could have benefitted from that drug, which already had been through Phase 3 trials? Clearly, it’s time that the FDA was forced to take a new, more aggressive approach to the use of experimental drugs for cancer and other life-threatening diseases and to give patients more of a say in use of these drugs for their own treatment.
Dr. Sal Giorgianni
Unfortunately, the court’s ruling- as distasteful as it is – I believe is within the context of a strict interpertation of law and regulation. They say Justice is blind and - as in this case - I guess sometimes compassionless too.
There is no more a RIGHT to any investigational drug as there is to driving a car without a license. Of course, FDA can grant that privledged access - as they do under the IND process or even the personal importation rules. This all begs a larger question and is one of the great debates that has only been touched on in the margins and this is; is there a Constitutional Right to health care as a part of every American’s right to “lifeâ€, and thus by extension to all things that might protect life? Who knows that may be tested some day soon.
Those who believe that the societal needs of patients are not in concert with law or regulation or at least FDAs view of it in mid-2007 (as I do in this case) should take heart. There are remedies. I believe it is within the broad powers of FDA itself, through Congressional legislative action or regulatory agency oversight, to provide a remedy. FDA’s standards of proof of efficacy and safety are theirs to make. One of the issues that have been very difficult to move FDA on is flexibility of approval standards to apply certain types of reasonable standards to one condition vs. another. FDA has, under certain Commissioners and Administrations, moved a bit on creating approval standards that vary with the context of the product, the circumstance or the needs of the society that they serve. (I think that sometimes they forget that they serve the needs of society not the needs of the scientific community per se) but that is very rare. For example, the so-called Parallel Track approval process as it was fairly liberally applied to treatments for AIDS or the Compassionate Use provisions could all be pulled out, dusted off, reconfigured and applied – if regulators and sponsors cared to do that. Sometimes though it requires concerted effort by affected groups to make that happen.
The courts rightfully allow FDA in this case to do their job – so in that sense the ruling makes sense. What does not make sense, at least to this humble pharmacist, is FDAs inflexibility when reasonable, scientifically and legally viable options exist to try and save or extend life.
jason
to quote:
Laurie
If a person is willing to take the risk, KNOWING the risk I don’t see why they shouldn’t be able to do it.
Isn’t that the basis of medicine every day, and we seem to find lawsuits - A LOT. Listen to the radio or watch TV.
Now put out meds that we have no idea if it is worth the risk and you don’t see a recipe for disaster if something goes bad?
I think the public makes it hard enough for physicians and pharma, we don’t need 1 more way to get sued and look bad. Thanks anyway
Muriel Freeman
legendless waxer fingerlet hereditary chromosantonin punctuist heliographer inconcinnity
Portland Wheelblazers
http://www.hyperion-records.co.uk/artist_page.asp?name=bostridge