The Martha Stewart Debacle…the Real Scandal

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Watching the Martha Stewart circus on TV has been a disheartening experience, to say the least. It has been nauseating to watch the Jacobin glee that the press has expressed while marching this modern-day Marie Antoinette off to the gallows.

This distaste for the whole affair has been made even worse by the fact that most Americans have completely missed the real scandal.

Let us briefly review the particulars of this sorry tale.

ImClone Corporation is a young company which has been developing the drug Erbitux (Cetuximab) for several years. Erbitux is a relatively new chemotherapeutic agent which works according to a radically new paradigm. Old chemotherapy agents function by indiscriminately killing rapidly dividing cells…both tumor cells and healthy cells (hence the well known side-effects of most traditional chemotherapy drugs).

Erbitux, on the other hand, is a monoclonal antibody targeting a protein (EGFR) found in increased concentrations on the surface of many cancer cells. This means that the drug binds specifically to these cells and not to other cells which do not bear this protein…meaning that the drug’s action is much more specific for cancer cells. This increases its effectiveness and tends to minimize side effects.

The drug has been in clinical trials for some time, and has shown significant promise. It has been most thoroughly studied in patients with metastatic colon cancer. These patients generally have a grim prognosis with few options available. Erbitux shrinks the tumors in a significant percentage of cases and can extend the lives of these patients for months to years.

Physicians have been clamoring for the drug for some time and have enthusiastically awaited its release.

In October of 2001, ImClone completed its application to the FDA for approval. Since it was intended for advanced stage cancer patients, the FDA placed the drug on its "fast track" (which is moderately faster than its usual application process…as in "send us the paperwork in the Jurassic Era and we’ll get back to you by the early Bronze Age).

Due to some relatively modest problems with the application (mostly related to study design), it was rejected by the FDA. This rejection set into motion the chain of events that included the alleged insider trading by Martha Stewart (who was supposedly contacted about the application rejection before it was public knowledge).

ImClone reapplied in August of 2003, and received final approval from the FDA in February of 2004.

The drug is thus safe and effective, even by the FDA’s often Byzantine standards.

The media saw this story and immediately focused on the evils of capitalism, as represented by the alleged cronyism surrounding Martha Stewart’s stock sales. But there is a much more profound issue here that should be obvious to every advocate of a free society:

Namely, a drug that showed enormous promise for the treatment of advanced stage cancer patients was held up for almost 2 years by the FDA while they nitpicked at its application paperwork.

In a free society, treatment decisions are made via a discussion between a patient and his physicians. The physicians relate to the patient the diagnosis and treatment options available, including the risks and benefits. The patient then decides what avenues he wishes to pursue…and the patient bears the ultimate responsibility for those choices.

But alas, we do not live in a free society.

In America, the FDA sits astride the path between research and clinical usage like the Great Wall of China. New drugs can take years and cost millions of dollars to finally bring to market. Often, these same drugs are available in "Old Europe" for years before American patients have access to them.

In typical fashion, the media has focused on the persecuted "little guy" who lost money due to "greedy insider trading".

But what about the thousands of cancer patients who died between Oct of 2001 and Feb 2004 waiting for the FDA to approve Erbitux?

Who is responsible for their deaths?

Not Martha Stewart.

And who caused the collapse of ImClone’s stock, which bankrupted thousands of "moms and pops"?

Again, it wasn’t Martha Stewart…it was the FDA.

The accusations against Martha Stewart were largely bogus anyway. She was accused of "insider trading"…a "crime" which shouldn’t even be a crime in a free society (as eloquently noted in Tibor Machan’s recent column on this site). And besides, that charge didn’t even stick…so the feds had to resort to even more bogus crimes, like "lying to the government". Aside from the fact that she wasn’t even under oath when she committed this "crime", the frequency with which our government lies to us makes this accusation a farce.

The history of our government’s lies (and their devastating consequences) is too obvious to bother reciting. At least Martha’s "lies" didn’t result in body bags and billions of dollars in government debt.

So while the media cheers Martha’s walk to the guillotine, those of us who are believers in a truly free society should take a moment out to recall the memories of those cancer patients who passed away over the past several years, having been denied a treatment that may well have extended their lives. They are our neighbors, our friends, our fellow citizens, and our beloved family members. While Erbitux may have only given them a few more months of life…who can calculate the value of that time?

Not you, not me, and not even the wizards at the FDA.

And that, my fellow libertarians, is the true scandal behind the Martha Stewart affair.

Steven LaTulippe [send him mail] is a physician currently practicing in Ohio. He was an officer in the United States Air Force for 13 years.

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