Posted on 01/11/2008 2:25:56 AM PST by Zakeet
Today the Supreme Court will consider a petition to hear a case raising profound issues regarding the right of individuals to make their own health-care decisions. The case is Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach.
The suit claims that FDA violates the due process rights of terminally-ill patients, who have exhausted all approved options and are unable to enter a clinical trial, by prohibiting access to promising investigational drugs.
Consider the plight of such patients. They search for clinical trials of new drugs that might extend their lives. Nearly all are ineligible. Of the few who do qualify, many learn the trial is fully enrolled and closed, or too far away. Others face a 50-50 chance of getting a placebo (a sugar pill) under blinded conditions (meaning neither they nor their doctors know what they are getting). Many are allowed to die without being told about or offered the active drug.
The FDA commonly insists on statistically comparing the timing and severity of the deaths of untreated (placebo) patients with those of patients who receive the potentially effective drug. This renders the FDA's vaunted "science" for drugs intended to treat terminal illnesses little more than a crude measurement of the height and accrual rate of two piles of bodies. There are better, less ethically challenged trial methods available to test drugs, but the FDA has consistently refused to accept them.
(Excerpt) Read more at online.wsj.com ...
No matter one's judicial philosophy, it is inconceivable that the framers of the U.S. Constitution intended unelected, tenured career bureaucrats to hold absolute power over American lives without prospect of challenge in the courts. The framers understood that the pursuit of life is an inalienable right that should not be abridged without due process of law.
IMHO, the entire editorial on FDA abuse is worth a read.
With the new off-label use of Enbrel for reversing the symptoms of Alzheimer’s, there should be massive pressure to allow infomed consent for experimental drugs.
Clinical trials are still the best way to go for final conclusions on new drugs, but desparate patients should be allowed to make decisions on their own behalf about risks they are willing to take.
Every experiment must have a control group.
I despise Government agencies as much as anyone on here, but Science has rules, and when things are approved without proper study, then the FDA gets crucified for that, too, and then there are Thalidomide headlines and Oxycontin lawsuits.
When rules of research are flouted, we end up with absurdities like Global Warming. No one wants something like that influencing their healthcare.
It sounds Marxist but this is a situation where the FDA must select the greater good for the greater number, and they are in a bad spot.
Yes, they do suck, but I have some sympathy for them.
This sounds like a trial-lawyer bonanza waiting to happen.
“I despise Government agencies as much as anyone on here, but Science has rules, and when things are approved without proper study, then the FDA gets crucified for that, too, and then there are Thalidomide headlines and Oxycontin lawsuits.”
This isn’t about studies its about the people. The studies certainly need to be controlled so that medicines work properly. However if someone is gonna die why not allow them to get the experimental drug. They don’t need to be part of the study. If I were in this position I would head to Mexico and buy the drug there.
Was not discovered until after the adverse effects had appeared in other countries, so the FDA instead touted their diligence in withholding the drug from the US market.
Believe me, the FDA does much more harm than good.
“Believe me, the FDA does much more harm than good.”
They are a government agency, what else could be expected.
I intended that by opting out of the placebo, they would be guaranteed to get the experimental drug, instead of wondering and taking the chance. I hope there would always be enough people who would fear the experimental drug so that there would still be a pool of people willing to be "Controls". The problem is that by self-selecting which group a patient belongs to, any placebo effects would not be part of the results. It's lousy Science, but more humane, and better than having no controls at all.
We were always quietly hinted that too many persistant requests, pressures, and inquiries during the approval process caused applications to somehow move to the bottom of the pile..
No one ever exactly said if checks were involved. You can't fire them, after all.
btt
traditional1 is right about the possibility of crazy lawsuites. Allowing patients all out access to non-approved drugs is too much of a liability for the FDA and drug companies.
“However if someone is gonna die why not allow them to get the experimental drug.”
I work in clinical research and patients can get experimental drug without being in the study. Its called Compassionate Use. Yes it takes work on the part of the doctor to go through a few necessary hoops, but many patients can get expirimental drugs this way.
“I intended that by opting out of the placebo, they would be guaranteed to get the experimental drug, instead of wondering and taking the chance.”
More than the drug’s effectiveness is being studied during the research phase. Side effects and other health issues the drug could cause are also studied. Blind studies (not even the sponsor knows which patients are on the drug until after the study ends) are necessary to determine if the drug causes more harm than good. If you have reached the point of opting to be a research subject you are not going to choose to take a sugar pill which you know will nothing to help you. Patient’s have a 50/50 chance of getting the study drug. If you’ve exhausted all other possibilities, those odds aren’t bad and its worth the risk.
bump
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