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Old 10-21-2008, 07:29 PM
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Default FDA's Labyrinth Of Rules For Drugs Hurts Patients

Suppose we live in a time when the FDA and National Institute on Drug Abuse give us free marijuana every month.

For eight people, that's a reality. Since marijuana relieves AIDS symptoms, the compassionate access program offered the drug until the early '90s, according to a 1999 New York Times article.

Compassionate drug use may seem like an oxymoron, but the program provides patients with medications that are still in the middle of clinical trials and haven't been passed by the FDA.

Several groups, such as the Abigail Alliance for Better Access to Developmental Drugs, have been pushing for compassionate access since the program is usually the patients' last resort.

No matter what your thoughts are on marijuana's medicinal purposes, the sad fact remains: It isn't the only drug that's out of most patients' reach.

Colon cancer carries the second highest mortality rate among the different types of cancer. Between 2001 and 2003, 80,000 people succumbed to colon cancer, according to a 2003 Wall Street Journal article.

Yet, Erbitux, a potential colon cancer drug, was rejected in 2001, according to the same article. Erbitux showed off its tumor-shrinking powers in 23 percent of the test subjects. The drug also deflected cancer for over four months. And to think its only side effect was a rash.

The article also suggests that Avastin, another colon cancer drug, hasn't been given the thumbs up because the FDA is fickle over things like medicine labels.

Moreover, the FDA's approval process is akin to a turtle, but in the race of life and death, slow and steady does not win.

According to the Wall Street Journal article, about 43,000 people were denied one of the two colon cancer drugs - and that figure applies to just the six months when the FDA was sorting out papers.

In addition, the FDA can't make up its mind on the requirements for approval, according to U.S. Rep. Diane Watson's 2008 news release.

In 2005, the FDA endorsed Gefitnib since the drug worked on 10 percent of lung cancer patients. While Erlotinib offers a similar one-two punch for kidney cancer patients, the drug didn't get the FDA's seal of approval because of new eligibility criteria. According to the news release, the road to FDA approval changes every year.

Apparently, 10 percent doesn't cut it anymore.

There are currently 14 cancer drugs in limbo, and 95 percent of possible cancer cures don't even bend that far, according to a 2008 St. Petersburg Times article.

Furthermore, the FDA appears to be indecisive about how it judges the results of clinical trials, according to a 2007 Wall Street Journal article. Rather than simply going over the data (which is what they've done in the past), the FDA applied "a nonstandard statistical approach" to determine the effectiveness of Genasense, a melanoma and chronic lymphocytic leukemia (CLL) drug.

When the drug's approval was put to a vote, the FDA dismissed the only CLL expert at the meeting, according to the same article. Surprisingly, Genasense hasn't moved to the front of the line since then.

In the St. Petersburg Times article, Greg Luter, a cancer patient, was quoted as saying, "You would assume the FDA's goal would be looking out for patients and making it easier for them to get drugs. … That's not the case."

The FDA claims it wouldn't fight companies that choose to give away investigational drugs, according to the 2003 Wall Street Journal article. Most companies, however, maintain that they can't afford to do that. Apparently, they've never heard of tax write-offs.

Another one of the FDA's defenses is that it isn't safe for people to receive developmental drugs, but the patients should be able to decide that for themselves. It's their lives that are at stake. If the drug doesn't work, they'd still face the same outcome they would have before - death. On the other hand, if the medicine does work, then the people's right to life would be upheld.

Besides, every drug that the Abigail Alliance wanted compassionate access to (but didn't receive) eventually secured FDA approval, according to a 2007 written testimony to the Energy and Commerce Committee. The Access Act would include "built-in safeguards" for eyeing the drugs that go through the experiment's three phases, according to the press release.

In fact, before the 1906 Pure Food and Drug Act, the government didn't dare mess with people's use of the latest medicines, according to an Abigail Alliance v. von Eschenbach court document. Technically, we have the separation of church and state, so why not a separation of health and state?

Other viable options include having "single-patient studies" or experiments in which only some people have to meet the requirements or have their results published, according to a 2008 New York Times article.

After all, compassionate access isn't false hope. It is hope.

http://www.420magazine.com/forums/in...-patients.html
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