Remember Sam Waksal

by | Mar 10, 2006 | POLITICS

Remember ImClone? This was the company founded by physician Sam Waksal, an immunologist who worked for years to develop a drug to treat colon and other cancers. His company had one product–Erbitrux–and it promised to extend the lives of thousands of terminally ill people. In 2001 Dr. Waksal learned–from a government insider–that the FDA was […]

Remember ImClone? This was the company founded by physician Sam Waksal, an immunologist who worked for years to develop a drug to treat colon and other cancers. His company had one product–Erbitrux–and it promised to extend the lives of thousands of terminally ill people.

In 2001 Dr. Waksal learned–from a government insider–that the FDA was about to reject Erbitrux. The result would be ruinous, for him, his family, his shareholders and desperate patients. For three days he walked around knowing that his company was about to be castrated by government fiat, but forbidden to tell anyone of the impending destruction. He was expected to wait silently, like an animal for the slaughter, denying his own mind and repressing his desire to act, without telling even his family.

In June of 2003 he was sent to jail for seven years. He has paid millions in “restitution” to “victims,” including the State of New York. The FDA decree destroyed hundreds of millions of dollars in shareholder wealth. Martha Stewart went to jail for asserting her own innocence. Cancer patients continued to die.

It is worth comparing the goals of Dr. Waksal–a creator–and an FDA bureaucrat. Dr. Waksal’s mission was to command nature, by bringing life to people suffering from the most intractable disease to ravage the human body. He relied upon the independent judgments of doctors and patients that his product would help them. He understood the risks involved, both in the use of the drug and in the enormous financial investments. Success would mean that his cutting-edge drug has prolonged the lives of dying patients. If one wants a vision of an entrepreneur who opens his work to the independent judgments of others, think of Sam Waksal.

For the FDA bureaucrat, success requires ruling those who command nature. The goal is to avoid bad publicity or lawsuits, and to follow the rules. It matters not whether a million people could have been saved, if a single allegation of a pimple can be prevented. Thousands died waiting for the drug–but the only safe route for the agency was to ban the drug. If one wants to see the naked exercise of power by those who care not a whit for the lives of others, this is it. The FDA is a tumor at the heart of medicine in America.

About a year after Dr. Waksal went to jail, the FDA approved the drug.

But Dr. Waksal’s achievement turns out to be even better than we thought, and the death toll from the FDA even higher. Last week the FDA approved Erbitrux for head and neck cancer. The drug is “the first significant advance for head and neck tumors since the 1950’s” (WSJ “Drug Reckoning,” 3/6/2006). An FDA reviewer was quoted as having “extremely compelling data” about the effectiveness of the drug on head and neck cancer as early as 2000, and that it was “hard to argue against providing it to patients” when it was rejected.

The Abigail Alliance for Better Access to Developmental Drugs, founded by the father of a woman who died of head and neck cancer while trying to obtain Erbitrux, was quoted in the editorial: “The news serves as yet another reminder that the biggest ‘ImClone scandal’ of 2001 had nothing to do with Martha Stewart, but instead resulted from the FDA’s failure to approve a drug that had been proven safe and effective for thousands of patients.”

Some readers may see a good ending here. People who survived long enough are no longer denied Dr. Waksal’s creation. ImClone may survive as a company, although they have yet to find a CEO as competent as Dr. Waksal. The FDA is now protecting a different group of people from other “unapproved” drugs. The Bush administration still claims the mantle of a “pro-business” party.

Yet the injustice remains unexcised. The Wall Street Journal piece does not mention Dr. Waksal. He is still IN JAIL, with over four more years to serve–for the crimes of creation, and of self-protection from malignant government parasites. There is no drug to fight such diseases–only better ideas can end the plague of a government that tells the terminally ill and their doctors what is good for them, and jails those who create the means they need to live.

One day, when the world rediscovers its moral compass, Dr. Sam Waksal will be among the greatest of the victims to be avenged.

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John David Lewis (website) is a Visiting Professor of Political Science, Duke University. He has been a Senior Research Scholar in History and Classics at the Social Philosophy and Policy Center, and an Anthem Fellow.

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