Tuesday, October 27, 2009

Risks vs. Benefits

Risks vs. Benefits
The public consciousness of risk vs. benefit was raised considerably with the media’s discussion of the benefits of taking a Cox II inhibitor (Celebrex and Vioxx) vs. the potential risks (Cox II inhibitors are linked to the risk of gastrointestinal bleeding as well to an increased risk of heart attack).

That consciousness raising continued in the days between October 13 and October 18, when the following were mentioned in the media:

60 percent of those with Alzheimer’s disease are prescribed antipsychotic medication. In the United Kingdom alone, the annual cost of these drugs is 80 million pounds. But in 2006, a 42-center U.S. trial found no significant differences between the placebo and the antipsychotic medications after 12 weeks.

French scientists analyzed 19,000 patients with inflammatory bowel disease. The patients who took immune-inhibiting drugs (thiopurines such as Imuran) were more than five times as likely to develop lymphoma than those who had never received the drugs.

Gardasil vaccine is suspected as the cause of ALS/Lou Gehrig’s disease in two young women. According to the 8/18/09 issue of the Toronto Globe and Mail, 23 million doses of the HPV vaccine have been administered to young women in the United States, resulting in 32 deaths, 12,424 reported adverse reactions and 772 reported severe reactions (blood clots, pancreatic failure, motor neuron disease and anaphylaxis).

An analysis by the National Trauma Databank has highlighted that the rate of warfarin/blood thinner use has increased significantly: from 7.3 percent in 2002 to nearly 13 percent in 2006. Warfarin use was associated with a 30 percent increase in risk of death among trauma patients and a 20 percent increased risk in those aged 65 and older. And according to the Canadian Medical Journal, the rate of heparin-induced lesions is four times what was officially reported.

An analysis of 1998-2005 Medicare data has shown that patients with new lower-back pain were more likely to have surgery if they were treated in an area that had a higher-than-average concentration of MRI machines — even though, according to previous research, increased back surgery has not produced improved outcomes for patients. The Wall Street Journal had earlier reported that Pittsburgh has more MRI scanners than all of Canada.

Research published in the October 2009 Chest reviewed the current guidelines for using an inhaled steroid along with a long-acting beta agonist for COPD. Researchers found the benefit of the two-drug approach was limited and accompanied by substantial risks of pneumonia and other infections.

The FDA has announced plans to work with the National Eye Institute and the Department of Defense to review LASIK eye surgery. Of the approximately 6 million Americans who have undergone the surgery, which permanently reshapes the cornea, 5 percent are dissatisfied with the results. The long-term safety of the surgery is unknown. There have been reports of permanent damages to the eyes following surgery, including double vision, dry eye and halos around objects at night. Letters citing inadequate reporting of adverse events were sent to 17 LASIK eye surgery centers.

It is staggering to think these seven examples are drawn from only one week of media coverage. When we consider the number of prescription drugs used daily in American medicine, as well as the number of surgical and scanning procedures, it becomes clear we have little appreciation for the risks of prescription drugs and medical procedures. To address America’s healthcare costs in a meaningful fashion, the risks as well as the benefits of a therapy must be considered.

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