Whose Life Is It Anyway?
This is from a Gregory Conko (Competitive Enterprise Institute) op-ed. in The Wall Street Journal.
Why do terminally ill patients have to wait so long to get access to the only treatments that hold any promise of saving their lives? And why is it not their right to decide?
Last year alone, the FDA rejected five new cancer drugs, including a breakthrough treatment for prostate cancer called Provenge. A panel of cancer experts that advises the FDA on new drug approvals unanimously agreed that Provenge was safe, and voted 13-4 that it was effective enough. But the FDA demanded still more testing that may delay approval for three years.
A better question is why does the public sit passively and allow a government bureaucracy like the FDA to limit access to potentially life-saving interventions? Understandably, there is a desire to have drugs that are safe and effective. But risk aversion varies from person to person – as does the degree to which some people are in desperate need of a novel therapy. One possible solution would be some type of preliminary approval of select new drugs, allowing use by patients in life or death situations after they are fully informed of unknown risks.
Indeed, many drug experts advise patients to avoid all newly approved drugs until they’ve been on the market long enough for longer-term side-affects to show up. This may be good advice, but patients in need should have more say in the matter than does an unelected bureaucracy that is trying to cover itself against any perceived risk.
The preliminray approval mechanism postulated above was proposed to FDA in a Citizen’s Petition filed by the Abigail Alliance for Better Access to Development Drugs in June 2003. The FDA has yet to respond, even though they are required by their own regulations to respond to Citizen’s Petitions within 6 months. The Abigail Alliance sued the FDA in federal court in June 2003, claiming that denial of access to the only therapies with the potential to extend or save the lives of terminal patients violated those patient’s due process rights. We advanced the suit to a win in on appeal, but lost on a second appeal of the case filed by the FDA. we appealed the case to the Supreme Court, but the SC decided not to hear the case, leaving the final appeals court decision in place and rejecting a terminal patient’s right to reasonably and responsibly pursue life under the care of a qualified physician. Legislation called the Access Act has been introduced in both houses of Congress (S. 3046 and H.R. 6270) with bipartisan support. A very similar bill was introduced in the 109th Congress, but was blocked by the Senate HELP and House Energy and Commerce Committees in favor of legislation aimed at responding to the current wave of hysteria over drug safety. The current version of the Access Act has broad and building support, but its passage is by no means certain. Call your Senators and Congress person and urge them to support the Access Act. Your life could depend on it.
Steven Walker
Co-Founder, Abigail Alliance
Does Obama support the anti cancer drug provenge or not?
This is the same FDA that approves for human consumption high fructose corn syrup and other chemicals. It’s disgusting that the government refuses to let these things pass, yet the corn syrup is a known cause of cancer, diabetes, and heart disease. Lately, I’ve taken up the paleo diet and I’ve lost so much weight on it. A diet the FDA says should kill me.
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