Terminally-Ill Drug Access Appeal Rejected

WASHINGTON -(Dow Jones)- A campaign to make it easier for terminally-ill patients to gain access to experimental drugs failed to convince the U.S. Supreme Court to hear its challenge of U.S. Food and Drug Administration policies on Monday.

Known as the Abigail Alliance, the group sued in 2003 to force the FDA to alter regulations limiting the use of drugs that are still under federal review but are being tested in clinical trials for effectiveness and safety.

The group was founded by the father of Abigail Burroughs, who died of cancer at age 21, and helps and advocates for terminally ill patients who can't get into limited clinical drug trials.

The lawsuit argues that patients have a constitutional right to drugs still being tested for approval. It seeks both the easing of restrictions on drugs undergoing clinical trials and a change to regulations barring companies from profiting on the sale of experimental drugs.

"All that petitioners seek is a right for terminally ill patients with no remaining treatment options to fight for their own lives," attorneys for Abigail Alliance said in the appeal.

The federal government, in a court brief for the FDA, defended the FDA regulations, saying the existing regulations are balanced and protect patients from potentially dangerous drugs. "Successful clinical trials are the exception, not the rule," U.S. Solicitor General Paul Clement said, adding only 5% of cancer drugs that undergo clinical trials are ultimately approved.

Clement said the Washington-based U.S. Circuit Court of Appeals had correctly ruled there isn't a constitutional right to access of unapproved drugs. "For nearly 70 years patients have required advance approval by the FDA before they can lawfully obtain drugs to treat their illness, even if they are terminally ill and lack alternative treatment," Clement said.

After the lawsuit was filed, a federal trial judge dismissed the case. The D.C. Circuit initially revived the lawsuit but later looked at the case again and ruled the Abigail Alliance couldn't bring constitutional claims for experimental drug access.

I want to read the opinion. While the lead claims Abigail is was a "Supreme Court" opinion, there is nothing about what the court had to say about Plantiff's argument.

The FDA is a monster-sized bureaucracy with too much power delegated to it by Congress, and too little Congressional oversight.

As a chronic pain patient, narcotic-free because a German pharmacutical company that invested in the miracle of Suboxone-B - and not sympathetic the the marijuana arguments, - I know the reason 60 million suffers can't be effective politically is the social isolation that accompanies misery. The Internet is changing that, too. Not enough, yet, but it will happen eventually.

These regulatory fights are not about safety. They are about power.

If there were, there would have been no need to amend the Constiution in order to prohibit alcohol.

Precisely. Just as the "clear and present danger" clause became, through Court decisions, "a compelling state interest," which then became "Continuity of Government.." the Government Schools teach kids how to use a condom, but not how to think, or gain even a remedial education about what made the Volsted Act "constitutional."

This simple logic was common knowledge less than a hundred years ago among those who took an oath to uphold and defend the Constitution. Now, you have to wonder why such an oath has any meaning. Clearly, it does not in many cases.

The win-win situation is for the drug companies to make agreements with the government of Mexico to test their drugs on sick Americans just across the border from the US. That way, they can compile lots of data about their drugs, and terminally ill people can get experimental drugs.

While the FDA might stomp its feet and refuse to accept the results of the Mexican tests, conducted by Americans on Americans, it would save the drug companies millions of dollars in development costs in the long run. That is, they would only take drugs through the rigorous US approval if they already *knew* that they worked on the people who needed them.

Them drug companies is big and bad ... John Edwards says so!

This isn’t about pharmaceutical companies. It’s about the FDA.

Sometimes the FDA does a good job but too often they don’t.

The FDA makes it very difficult and very expensive for a Pharma to bring a new drug to patients. That can be seen as a good thing as it supposedly prevents bad drugs with dangerous side effects or no positive effect from coming to market but even FDA approval doesn’t mean a drug is safe. There have been a lot of FDA approved drugs that were later pulled from the market and remember how the FDA was supposed to protect us from those tainted Chinese foods and drugs including pet foods and they (the FDA) completely fell down on that one.

Once a drug has been FDA approved for “clinical trials” it’s already gone though a myriad of tests and trials and studies, including multiple animal tests for safety. I know this having worked in the Finance Dept of a Pharma and I had to process and pay the invoices for all the outside independent labs and study facilities; millions and millions of dollars are spent and many years pass before a drug is even considered safe for clinical trials on humans. And drug companies have a very real interest in not harming patients due not only to the ethical concerns but also to the cost of litigation if something does go wrong (the John Edward’s of this world to thank) but most of the scientists and researchers I knew during the time I worked for this Pharma were very committed to really helping people, they were very ethical and very caring folks, who in the case of the Pharma we worked for, was developing a drug to slow the growth of a particularly malignant form of brain cancer - Glioblastoma multiforme. The people receiving this drug had already been handed a death sentence and although this drug did not promise a cure, it was proven to extend life which was very important to those receiving the treatment. Even a year or a few more moths of a quality life for these patients spent with their families, their children, meant the whole world to them.

The FDA is a huge bureaucracy and a very impersonal and political machine and I’ve seen that at work.

If I was diagnosed as “terminal” and had exhausted all conventional and “approved” treatments and having nothing else to loose, was willing to undergo an experimental treatment with conformed consent, I’d do it. I would figure that I had nothing to loose and everything to gain and if the treatment wasn’t successful and I died anyway, at least my death might mean something in that what was learned might help save another life.

That decision should be left to me and my doctors and the reaserchers and not to some nameless government bureaucrat.

If you were diagnosed as “terminal” and had exhausted all conventional and “approved” treatments and having nothing else to loose, move to a different country that permits all treatments. Don’t get involved in the p[ower battle here.

Why should I or any other American citizen have to move to another country in order to get medical care?

I’m not talking abortion or fetal stem cell therapy and I’m not talking about the government paying for an experimental treatment. But what if my doctors and the drug company are willing to let me receive a drug that is not yet FDA approved? How is it the Government’s business to interfere?

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