Government to Kill More People

I do go on about the FDA. But, freedom lovers, let me remind you that John Locke and Thomas Jefferson claimed life to be the first birthright: life, liberty, estate/pursuit of happiness.

A guest editorial in the WSJ today (right next to Greta's column on a missing college student), tells of five promising Cancer drugs that have been pulled because the manufacturer felt they could not get FDA approval -- even after successful trials. Dr. Richard Miller, president and CEO of Pharmacyclics, and adjunct professor of oncology at Stanford University Medical Center, is concerned that "the fight against tumors is regressing."

This is not the way the regulatory system is supposed to work for patients with life-threatening diseases such as AIDS, cancer and Alzheimer's. Thanks in large part to AIDS activism, Congress passed legislation that in 1992 resulted in new regulations that streamlined the approval process for drugs intended to treat life-threatening diseases. One such regulation, accelerated approval, gave desperately needy patients faster access to new drugs. It allows for conditional approval based on data "reasonably likely" to predict clinical benefit while more definitive trials are being conducted.

The idea worked: 26 new cancer drugs for 30 different clinical indications were approved between 1995 and 2005 under the accelerated approval regulation. Important drugs such as Camptosar, Eloxitan, Gleevec, Temodar and others were made available to patients more quickly than under the standard approval procedures. Thousands of patients benefited from faster access, and these drugs went on to find vital and expanded roles for the treatment of many types of cancer.

There appears to be no evidence that any harm was done by accelerating the approval process for these products. Indirectly, the streamlined review and approval process has also stimulated the pharmaceutical industry to invest in the development of new drugs for these diseases.

In recent years, the FDA has effectively regressed to a pre-AIDS mindset. The accelerated approval requirements have stiffened and the real benefits of the process for patients have been whittled away. Since 2005, only one drug has achieved accelerated approval and this year none have been able to break through the FDA's iron gate.

I feel a little lonely in this fight some days. It seems that only me and the WSJ Ed Page care (and the Ed Page was just sold). But I read an article in last month's Reason that is now available online..

Kerry Howley shares my concern and makes a point I had not contemplated. The current system for approvals cannot allow dying patients access to lifesaving drugs because it requires a continuing stream of desperate, dying patients who are desperate enough to sign up for a placebo trial for a terminal illness. I'm paraphrase sensationally, but read the whole thing. I'm paraphrasing accurately.

Since the 1960s, when randomized, double-blind clinical trials became a standard requirement for bringing new drugs to market, clinical researchers have confronted the chaos of disease with the trappings of a regimented, uncompromising order. Drug trials are rooted in centralized authority: trial slots are numbered, subjects handpicked, control groups maintained, patients monitored. Maintaining this level of precision requires not only the cooperation of willing test subjects, but the coercion of the general population. To preserve pristine testing conditions, the federal government curtails our freedom of exchange and our right to take risks. Ailing individuals and drug companies are prohibited from trading in unapproved drugs, and terminal patients forbidden to experiment outside a clinician's watch.

This approach to drug testing is rife with serious ethical problems, but the preconditions for meaningful change are mind-boggling. The current clinical trial regime is cemented in place by legal restrictions that prevent patients from waiving their rights to sue and a regulatory regime that resists even incremental change. Alternatives to the standard placebo-controlled, closed clinical trials exist, but guarantees that such trials will lead to a drug's approval do not. A system meant to facilitate innovation in drug development is itself resistant to change.

It is a serious and heartbreaking story. Government bureaucracy is stifling innovation, chasing capital out of the pharmaceutical and biotech sectors, and killing tens of thousands of Americans every year.

I can blame my buddy FDR. There is a great story in "The Forgotten Man" where the publisher of Good Housekeeping gives one of Roosevelt's cabinet an earful because the government is taking over the "Good Housekeeping Seal of Approval." Drug testing is a private function in Europe and should still be here.

Pharmaceuticals Posted by jk at August 1, 2007 11:21 AM