Politics & Policy

Show Me The Risk!

A drug's a gamble? Put the decision in the hands of doctors and patients.

According to The Archives of Internal Medicine, pharmaceutical companies market a drug that kills some 7,000 Americans annually. These people don’t die instantly, but instead expire after slowly suffering gastrointestinal bleeding. Oddly enough, TV-news producers are ho-hum about this deadly medicine. The Food and Drug Administration has yet to prohibit it. Personal-injury attorneys aim their crosshairs elsewhere. No one seems much concerned about a lethal substance called aspirin.

That’s right. Aspirin–a drug so trusted that moms give the St. Joseph’s strain to their children–kills more than 580 Americans each month. And nobody cares.

Americans judge aspirin’s risks (widespread deaths) against its benefits (pain relief, improved cardiovascular health). Our verdict: We love it!

Compare this to the often much-lower death tolls associated with newer, more exotic drugs, like Lotronex, Propulsid, Tysabri, and Vioxx. Rather than aspirin-driven complacency, these drugs fuel voluntary product withdrawals, government mandates, screaming headlines, and massive jury awards.

Americans should think differently about drugs, their risks, and their rewards.

First, the 100-percent-perfect drug is as illusory as the perfect, crash-proof car or the perfect, flood-proof house. Patients and doctors must weigh unfortunate imperfections (even potentially fatal ones) against whatever physical and/or mental satisfaction drugs offer.

Second, while some Americans stand and cheer–usually in front of TV cameras–when a drug disappears from pharmacies, others are horrified to see medicines that have eased or eliminated their discomfort suddenly vanish from their lives. Let’s call this man-made disease “stranded-patient syndrome.”

GlaxoSmithKline introduced Lotronex for Irritable Bowel Syndrome in early 2000. After reported complications, including four deaths, plus heightened FDA scrutiny, GSK withdrew Lotronex, although the vast majority of IBS patients enjoyed it.

“I don’t want Big Brother in my medicine cabinet,” Edna Wakeham told the Chicago Daily Herald in May 2001. “I know the risks, and I would take it again, warts and all.”

Those risks were, frankly, infinitesimal. Looking at deaths alone in this exercise, among the 300,000 IBS patients who took Lotronex, four passed away. Rough division reveals that this drug was 99.9867 percent non-lethal. Contrast that to aspirin’s 7,000 deaths among 20 million people who use it daily to prevent strokes and heart attacks. This ratio shows lower non-lethality at 99.965 percent. According to the January 16, 2005, Health Sentinel, common surgical procedures are even riskier. Cardiac catheterization is only 99.8-percent non-lethal, while hip surgery is an even worse gamble at 99.7101-percent non-lethality. Yet these operations are routine.

No one proposes padlocking hospitals, either, despite the massive toll of nosocomial infections, or those acquired inside medical centers. According to Hudson Institute Senior Fellow Jeremiah Norris, such infections contribute to 88,000 deaths annually at a cost of $4.5 billion. Across some 20 million hospital patients each year, this yields an even more frightening 99.56 percent non-lethality rate.

Not unlike the Lotronex case, just three months after the FDA approved Tysabri, Biogen-Idec and Elan Pharmaceuticals withdrew their Multiple Sclerosis drug last February 28. Among Tysabri’s 8,000 users, three developed a rare neurological ailment called PML. Although two died, Tysabri still was 99.975-percent non-lethal; general anesthesia is less safe at 99.9729 percent non-lethal. Nonetheless, America’s 400,000 MS patients have lost this once-effective treatment. Of six FDA-approved MS drugs, five remain.

Janssen Pharmaceutical’s Propulsid treated heartburn and acid-reflux disease until its removal in 2000. This followed an FDA report of 80 deaths since Propulsid’s 1993 launch. Against 30 million prescriptions, this suggests 99.9997-percent non-lethality–breathtakingly near 100 percent.

“People who need Propulsid have to cut through more red tape than a drug company filing a patent for a new pill,” Senator Charles Schumer (D., New York) complained in November 2000. “These patients have no other options left and have painful disorders that demand treatment right away. They don’t have the luxury of waiting to get their hands on this medicine.”

In October 1998, Wyeth-Lederle launched RotaShield, a vaccine to prevent rotavirus diarrhea, an ailment responsible for 50,000 to 60,000 hospital admissions and between 20 and 40 deaths in America alone. However, Wyeth withdrew the drug from the U.S. market in October 1999 after the FDA associated it with sometimes-fatal bowel obstructions in one child among every 40,000 vaccinated. Wyeth soon pulled RotaShield from clinics and hospitals worldwide.

Rotavirus kills 1,622 children in the third world daily, according to the National Institute of Health. Despite RotaShield’s non-complication rate of 99.9975 percent, the bodies of children who suffered death by diarrhea kept piling up at a rate of 592,000 annually. In India, the retrovirus death rate stood at one child per 200, a non-lethality rate of 99.5 percent, according to the May 2000 issue of Immunization Focus. Meanwhile, experts fretted about the far-lower risk of vaccine-related intestinal blockage rather than the clear-and-present danger of rotavirus itself.

After foreign pediatricians and public-health administrators determined that RotaShield’s benefits outweighed its costs, they persuaded the NIH to approve the drug once again in May 2004 to fight this disease in overseas nations that lack such things as soap and water, flush toilets, and readily available doctors. As one industry executive grimly observes: “Almost 3 million children under the age of 5 years died between the time RotaShield was removed from the market and the grant of a new license.”

What about Vioxx, the drug that launched 5,000 lawsuits? This shelved pain reliever has sandbagged Merck in litigation, soaked it in bad ink, and strapped cinderblocks to its stock price. Critics claim that 27,785 Vioxx users have died in cardiovascular episodes since its 1999 debut.

“Any estimates of harm from Vioxx are speculation,” a Merck spokesperson responds. “There are many risks for heart attack and stroke, including high blood pressure, smoking, high cholesterol, and genetics just to name a few. Thus, determination of whether Vioxx was responsible for any patient’s heart attack or stroke can only be made on a case-by-case basis.”

Still, across 9.28 million prescriptions, “big, bad Vioxx” is 99.7 percent non-lethal, even accepting these disputed fatalities. Those who long for Vioxx like those odds.

“When I was diagnosed with rheumatoid arthritis in 1998, my life changed dramatically,” Dimitra Poulos told an FDA panel on February 17. “Socially, I could no longer sit in a movie theater or take a walk. Car trips to visit out-of-town family members were out of the question.” She continued: “But that was before Vioxx. I have taken Vioxx for over five years with absolutely no side effects. Vioxx gave me my life back…I have 40 Vioxx left. I have 40 days before my life and my abilities will be severely altered. I will assume all responsibility and sign any waiver. Please give me that option.”

“Pain matters,” explained Atlanta rheumatologist W. Hayes Wilson. “It may not kill you, but you may wish that you were dead.” He added: “We should try to figure out what is unique about the 1 to 2 percent of patients with very serious side effects rather than deprive the 98 to 99 percent of patients with significant relief from their arthritis pain who have not experienced a serious side effect.”

Let’s ditch the government decrees and corporate recalls. Drug makers should market whatever they wish, provided they frequently disclose the numbers of deaths and serious side effects associated with their products along with the numbers of people taking them. Patients and doctors should compare risks and rewards and consider individual circumstances instead of categorical edicts. Forbidding and mothballing drugs may protect those jeopardized by certain compounds, but doing so often amplifies the agony of others for whom the disease remains worse than the cure.

Deroy Murdock is a New York-based columnist with the Scripps Howard News Service and a senior fellow with the Atlas Economic Research Foundation in Arlington, Va.

Deroy Murdock is a Manhattan-based Fox News contributor and a contributing editor of National Review Online, and a senior fellow with the London Center for Policy Research.

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