corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 4701

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Heavey S.
Sick patients need access to drugs sooner: US court
Reuters 2006 May 2
http://go.reuters.com/newsArticle.jhtml?type=healthNews&storyID=12041977


Notes:

Ralph Faggotter’s Comments:

Perhaps the guiding principle here, in this most difficult of decisions, should be “First do no harm”.

On the other hand, if the patient has a terminal illness, and only a few months to live if no active treatment is undertaken, perhaps there is a case to be made for trialing an experimental drug, where the patient provides fully informed consent.


Full text:

Sick patients need access to drugs sooner: US court
Tue May 2, 2006 02:34 PM ET

By Susan Heavey

WASHINGTON (Reuters) – The U.S. Food and Drug Administration’s policy to withhold early-stage experimental drugs from terminally ill patient infringes their right to choose, a U.S. appeals court said on Tuesday, sending the case back to a lower court.

The FDA requires developing drugs to undergo a wide battery of tests, ranging from preclinical testing in the laboratory to large, advanced trials with people. Drug companies say the process can take up to 10 years.

But the U.S. Court of Appeals for the District of Columbia sided with two advocacy groups that filed the suit seeking patient access to new cancer drugs after initial tests show they are safe but before they receive FDA approval.

Judge Judith Rogers, writing for the majority, said terminally ill patients should be allowed to decide whether to accept the risks of taking a medication that might help them live longer.

“The key is the patient’s right to make the decision about her life free from government interference,” she wrote.

The ruling overturns a 2004 dismissal by the U.S. District Court for the District of Columbia, which will now have to review the case unless the FDA appeals.

In the lawsuit, filed in 2003, the Washington Legal Foundation and the Abigail Alliance argue patients have the constitutional right to available treatments.

“If death is certain and you have no options, it’s the individual’s option to decide,” Abigail Alliance President Frank Burroughs told Reuters.

While some patients can take experimental drugs as part of a clinical trial or other programs, he added the lawsuit was critical because many patients are excluded.

The court agreed, saying patients are simply looking for the same access that others have.

In a dissenting opinion, Judge Thomas Griffith sided with the FDA regulatory process, saying government has the duty to ensure that drugs are safe and effective before they are sold.

“Although terminally ill patients desperately need curative treatments, their death can certainly be hastened by the use of a toxic drug,” he wrote.

The FDA has moved to review drugs for cancer and other serious conditions faster than other medicines.

FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb said the agency was “sympathetic” to terminally ill patients and was improving its efforts to make such therapies available.

The Washington Legal Foundation said it was hopeful it could work with the agency to develop a new policy.

© Reuters 2006. All Rights Reserved.

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909