Wednesday, March 22, 2006

America's injustice to Sam Waksal

This op-ed by John Lewis and me goes out to newspapers today:

Remember ImClone? This was the company founded by physician Sam Waksal, an immunologist who worked for years to develop a treatment for cancer. His company had one product: the drug "Erbitrux" which promised to extend the lives of thousands of desperately ill people. While Erbitrux has lived up to its pledge, the government has nevertheless destroyed the life of its creator.

First a recap. In 2001, Waksal was told by a government insider that the FDA was going to reject approval for his drug. The FDA's ruling would prohibit him, along with every doctor and every patient in America, from using Erbitrux-even in a last ditch effort to save a dying life.

The fallout from the FDA's decision would be ruinous, for Waksal, his family, his shareholders and for desperate patients, yet securities law required Waksal say nothing of the "inside knowledge" that the government had leaked to him. In the face of the impending castration of his company by regulatory fiat, Waksal was simply expected to sit silently and do nothing. Unsurprisingly, Waksal was unable to squelch himself.

So in June of 2003, Waksal was convicted of "insider trading" and sentenced to prison for seven years for the crime of telling his family to sell their stock. During his sentencing, U.S. District Judge William H. Pauley told Waksal that the harm he caused was "truly incalculable." Since his conviction, Waksal has been forced to pay millions in restitution to his alleged victims.

Yet despite all the attention paid to his case, it is not Waksal, but FDA regulators who have blood on their hands. The FDA was the source of the leak that prompted Waksal to tell his family to sell. The FDA decision to forbid the use of Erbitrux destroyed hundreds of millions of dollars in shareholder wealth and led to Martha Stewart being sent to prison for the ridiculous crime of asserting her own innocence to federal investigators. All the while, the cancer patients who would have benefited from Erbitrux needlessly suffered and died--as many as one hundred people a day according to one estimate.

In the face of thousands of lives needlessly shortened, it still took the FDA over three years to reverse its original decision and permit doctors to use Erbitrux as a treatment for colon cancer, and only this month has the FDA expanded its permission for doctors to use the drug to treat cancer of the head and neck. All the while, the FDA has repeated the regulator's mantra that it has acted only in the "public interest."

But is the FDA's claim true? It is worth comparing the goals of Waksal-a scientist, businessman and creator--to the goals of a government regulator. 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. Success would mean that his cutting-edge drug prolonged the lives of dying patients and profits for Waksal and his investors.

In contrast, the government regulator's goal is not command nature, but to command men--men like Waksal. Why? Because we have vested regulators with the absolute power to substitute their judgment for our own in the name of protecting us from our choices. It matters not to the regulator whether a million people could have been saved during the wait for a new drug to meet their approval--any appraisal other than the regulator's simply does not factor.

In a system that respected freedom in medicine, a doctor and his patient would choose for themselves if the benefits of new medicines outweighed their risks. Yet under the current system of government controls, it is the regulator alone who decides who lives or dies. If one wants to see the naked exercise of power and the horrific price paid by innocent victims, it can be found in the saga of Erbitrux and its creator. It is not Sam Waskal, but government regulators who have caused "truly incalculable" damage to people's lives.

So at root, government regulation--the real cancer metastasizing in the brains of America-remains unexcised. Sam Waksal is confined to prison with over four more years to serve for the crimes of creation and of self-protection. All the while, Waksal's regulators sit comfortable in their government offices, secure in the knowledge that they will never be held to account for any of the lives they destroyed as a result of their deeds.

There is no drug to fight diseases such as the FDA--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. To avenge the injustice done to Dr. Waksal and the thousands of faceless victims of the Erbitrux fiasco, Americans must take back the power of the regulators and leave people free to live by their own minds.
This case is one of those monstrosities that makes one want to punch the wall. For years there has been grumbling that the FDA is "risk adverse" and that its posture is to blame for untold deaths, while at the same time, the drugs that it does approve are later recalled. So who are these people to make massive life and death decisions for anyone, let alone a nation of 300 million people? Why do we allow it? It mystifies me.

And it makes me think that another article that deserves to be written would be on the legacy of Upton Sinclair's The Jungle--the novel that led to the passage of the Pure Food and Drug Act. The theme of Sinclair's ponderous tome is that life is a hospice and man in incompetent to cross the street (a character literally drowns in a street puddle) let alone make a decision about his life. According to Sinclair, only the group is omniscient, by virtue of the fact that it is a group.

When I read The Jungle about year ago, I was stunned just how ridiculous its portrayal was, yet I can’t count how many times--going all back to grade school--that I have seen this text referenced as the foundation of our modern era. Spare me. The ImClone debacle is the fruit of our era. If we value our lives, it would behoove us to fight against those who think they have the right to control us.

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