Monday, June 02, 2008

Cancer Kills, But So Does The FDA's Bureaucracy: Cancer's Cruel Economics

BUSINESSWEEK -- Billions of dollars are spent developing cancer drugs, but precious few get approved. Is the FDA part of the problem?

The U.S. government has doled out more than $75 billion for oncology research since President Nixon declared his War on Cancer in 1971. Outlays by the pharmaceutical industry have been far greater. Yet the death rate from cancer has dropped only about 7% in the past three decades, with most of the progress in the last few years. The disease continues to strike 1 in 3 Americans, and it kills 1 in 4. That averages out to 1,500 deaths every day, at an annual cost to the nation of $210 billion and climbing. Cancer is expected to become the nation's biggest killer within a decade, surpassing heart disease.

There are many plausible reasons for so much disappointment, not least the complexity of the disease. But more and more researchers, companies, and patients lay part of the blame on the FDA. They complain that the agency is using outmoded and overly rigorous methods for evaluating a new generation of cancer treatments, rather than doing everything possible to get better drugs to sick patients.

Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data. Only 8% of experimental cancer drugs end up receiving FDA approval, compared with 20% of medicines for all other diseases.

Those difficulties haven't kept the pharmaceutical industry from trying. There are currently some 750 cancer drugs in human trials, far more medications than in other disease categories. Successfully ushering any one of these drugs through the necessary development stages will take up to 15 years and typically cost more than $1 billion—about $200 million more than is spent winning approval for a noncancer drug. The clinical trial sinkhole most threatens small biotechs that develop the bulk of new cancer drugs, and it is these firms that complain the loudest about the FDA.


At 6/02/2008 9:59 AM, Anonymous KJ said...

Well, this is kind of hard to believe because the FDA has a track record of leaving harmful drugs out for too long before yanking or limiting their use.

At 6/02/2008 12:41 PM, Blogger OBloodyHell said...

I predict China and/or India will become the home grounds for Big Pharma development. One of them will see the opening and pass rational testing rules which will allow the kind of testing needed, and Pharma will gravitate to those places.

That means the first patents and such will go to those nations, as well, mind you, which is where the bucks will end up landing.

> FDA has a track record of leaving harmful drugs out for too long before yanking or limiting their use.

Yeah, right.

1) Reel off a list of such cases, so we can trash it by showing how it doesn't work like you think it does.

2) You're still looking at the wrong end of things, even if the above were true. That the FDA might be slow to pull does not have anything whatsoever to say about their speed to release.

At 6/02/2008 3:42 PM, Blogger randian said...

The FDA is the way it is because of the standard reaction to bureaucratic incentives. It shows the insanity of overly worrying about the safety of treatments for otherwise lethal medical conditions. It makes no difference to the patient if they die from cancer or its treatment.

Consider a drug for pancreatic cancer. Pancreatic cancer is on the order of 90% fatal 18 months after diagnosis. This drug cures pancreatic cancer, but its side effects, which are usually temporary, nevertheless end up killing 45% of the people who take it to treat pancreatic cancer. I would argue this is a miracle drug that will save hundreds of lives every year. It would never pass the FDA's safety criteria.


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