TCS Daily


'Murder on Patients'

By Michael Fumento - May 4, 2005 12:00 AM

The yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, the agency and pharmaceutical companies are both under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous suffering, as multiple sclerosis (MS) sufferers using a recently-pulled drug called Tysabri can attest.

Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. These are synthesized "super" versions of natural antibodies. Monoclonals have repeatedly shown an ability to slow or reverse diseases for which previously there had been nothing available but pain relievers. They also have a knack for combating a broad spectrum of diseases rather than just one.

Such appears to be the case with Tysabri, produced in partnership by Biogen Idec and Elan Pharmaceuticals and approved for MS in late November. (MS is an autoimmune disorder, one in which the body's immune system turns on itself). About 400,000 people in this country have MS, which attacks both the brain and spinal cord and causes a host of symptoms including blindness, paralysis, and sometimes death.

There are other MS drugs, but none seem nearly as effective as Tysabri or as well-tolerated. In fact, results released this month of two years of clinical trials showed a stunning a 42 percent reduction in the risk of disability progression and an even more amazing 67 percent drop in clinical relapses.

In late clinical trials Tysabri has apparently been extremely effective against another autoimmune illness called Crohn's disease, a severe bowel disorder. It was also in human testing for rheumatoid arthritis. So it came as a stunning blow to the approximately 8,000 patients using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.

The force behind that axe was a tiny virus that most of us probably carry but that the immune system keeps under lock and key. If unleashed, though, it causes an often fatal disease of the central nervous system called progressive multifocal leukoencephalopathy. (PML) Unfortunately two MS patients on Tysabri contracted the disease and one died. When the drug makers scoured their databases they found another PML death in a Crohn's trial patient. He also died.

It's possible that in suppressing the immune system's attack on the brain and spine, Tysabri may have let loose the virus. But tremendously complicating matters is that all three patients were also on other immunosuppressive drugs at the time, leaving the real possibility that Tysabri alone is harmless. There are no known cases of PML in patients using only Tysabri, according to the FDA.

What's bizarre to Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami, is that less-effective MS drugs known to kill people have been used for years. "We allow Novantrone," he says, "and yet take Tysabri off the market." Novantrone's side effects can include heart failure and leukemia.

Likewise all the drugs that slow the progression to rheumatoid arthritis carry FDA warning labels, and two have been implicated in several deaths. Yet sufferers practically worship the companies that make them.

"Tysabri is a great drug," says Horstmyer. "My patients took other MS drugs because they felt they had no choice, but they were glad to take Tysabri. They were delighted with the lack of side effects and its effectiveness." He adds, "Patients who got it are really ticked because they can't get it anymore."

In fact, New York Newsday headlined a recent story, "MS Patients Plead for a Recalled Medication" and the drug makers are being deluged with requests from desperate MS sufferers.

Horstmyer thinks the threat of lawsuits was primarily responsible for the drug being withdrawn, while the Competitive Enterprise Institute's Sam Kazman blames government pressure. "What we've apparently got is FDA reverting to its traditional operating mode of deadly over-caution," he says. "That plays well in both Congress and the press but it's murder on patients." Yet both agree that but for the COX-2 calamity there would have been no withdrawal and it's wrong for Vioxx's tentacles to be reaching out and grabbing other drugs.

"The Biogen and Elan people were trying to demonstrate the highest level of scrutiny" in pulling Tysabri until all patients could be evaluated says Horstmyer. But, "So many drugs have serious side effects, including all the MS ones," he adds. "And in the world of medicine, it would probably be accurate to say MS patients are among the most well-informed" in being able to balance the risks of their disease versus the rewards and risks of various drugs.

Says Horstmyer, "I really hope they can bring Tysabri back."

Michael Fumento (mfumento[at]pobox.com) is author of BioEvolution: How Biotechnology is Changing Our World, a fellow at Hudson Institute, and a nationally syndicated columnist with Scripps Howard News Service.

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1 Comment

Your article is very interesting and accurate. I read many news and articles on this topic and many of them told this story from another angle. They extracted the information about the death and published a false story, not to mention putting Tysabri in a bad light. The truth is that patients were always for the drug because of the amazing results they achieved. Well at least is back on the market now, and the long term statistics on progressive multifocal leukoencephalopathy pml symptoms and complication rate is still low.

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