How prescription drug harms can go unnoticed
Posted by medconsumers on July 12, 2012
Twelve years ago, the American public first heard the shocking news that deaths due to medical care constitute the third leading cause of death in the U.S.—after deaths from heart disease and cancer. Sadly, the death of the research physician who introduced this statistic has recently been attributed to her medical care. Implicated is the commonly prescribed and widely advertised drug Plavix.
The circumstances surrounding the death of Barbara Starfield, MD, of the John Hopkins School of Hygiene and Public Health, were described online first at the Archives of Internal Medicine. The story is told by her husband, also a physician, who has raised critical issues about how common but serious harms of prescription drugs can go unreported. He calls on doctors and the general public to be vigilant about reporting adverse effects to FDA. His wife had published many papers about improving the quality of medical care.
Neil A. Holtzman,MD, got more information than usual because an autopsy was required for his wife. She died while swimming alone in a pool. Although the immediate cause of death was “pool drowning,” Dr. Holtzman wrote that he was stunned by the description of “cerebral hemorrhage” as the underlying condition. “The pathologist attributed the massive hemorrhage to cerebral amyloid angiopathy (CAA), listing “anticoagulation therapy” on the death certificate under “other significant conditions.” CAA is not so rare, says Dr. Holtzman who learned that it is present in about 8% of everyone over age 75, which includes his wife.
Plavix is the “anticoagulation therapy” mentioned in the autopsy report. Dr. Holtzman explained that his wife had been diagnosed with a heart condition called coronary insufficiency three years before her death. Initially, she was put on aspirin therapy, but six months later a stent was implanted to open the right main coronary artery. Plavix is the standard open-ended treatment thereafter.
Unfortunately re the “thereafter” part, only two aspirin vs. Plavix clinical trials had been conducted in people who had stents implanted. (Not incidentally, both trials were industry-sponsored.) Neither lasted more than one year; yet many cardiologists prescribe Plavix beyond one year after stent placement, as did his wife’s cardiologist.
(Forgive me for inserting myself into this story, but my husband and I discovered the same gap in research information after he had a drug-coated stent implanted during a “possible heart attack.” We too noticed the short duration of the two Plavix vs. aspirin trials. And we were disturbed by the higher rate of major bleeding shown for Plavix plus aspirin compared to aspirin alone in one study of unstented people post-heart attack. With his cardiologist’s approval, my husband stopped the Plavix 15 months after his stent was implanted and stayed on the 325 mg dose of aspirin. None of this bad news about Plavix was explained to us by the cardiologists, by the way, we found it on our own.)
Searching the medical literature for current Plavix data, Dr. Holtzman found two trials published after his wife’s death that showed a significant increase in major bleeds. All but one of the Plavix studies were published before his wife died, but their alarming results seemed to be ignored by most cardiologists, he wrote. “Neither the American Heart Association nor the FDA issued an alert on prolonged use of the drug.”
Dr. Holzman observed that the studies on Plavix following coronary stent placement reflect the focus of the cardiologists who are largely concerned with the short-term effects of a drug following stent implants. The patient, on the other hand, would want to know about bleeding risks throughout entire duration of drug treatment.
The autopsy showed a bruise on Dr. Starfield’s scalp but no skull fractures. Her husband suspects that a bump against the bend in the side of the pool could have precipitated the cerebral hemorrhage. He knew that she had informed the cardiologist that she bruised more easily while taking Plavix and bled longer following minor cuts. Had cardiologists known to look for cerebral amyloid angiopathy, the ”significant condition” listed on Dr. Starfield’s death certificate along with “anticoagulant therapy” perhaps a connection would have been made to the strokelike symptoms she experienced in her last weeks.
Ironically, Dr. Starfield’s death would not have been counted in the third leading cause of death statistic. When she identified the sources for this statistic back in 2000, she was careful to note that it is probably an undercount, given the fact that the studies looked only for iatrogenic deaths in hospitalized patients. It doesn’t take into account people who die of medical treatment outside of a hospital.
Maryann Napoli, Center for Medical Consumers©
Related info: Report adverse drug reactions to the FDA’s Medwatch Program (for consumers) and (for health professionals). Sign up for FDA drug alerts and recalls. Read Dr. Starfield’s 2000 commentary in the July 26, 2000 issue of JAMA (Is US Health Really the Best in the World?).
Related post: Angioplasty overuse and Bill Clinton 2010 post about overuse of stents.
Stents vs drugs from one of our favorite websites.
Read this 2012 article by ProPublica Why can’t medicine fix simple mistakes?
This entry was posted on July 12, 2012 at 3:47 pm and is filed under Aspirin, Conflict of Interest, Doctors, Drugs, Heart, heart disease. Tagged: 3rd leading cause U.S. deaths, American Heart Association, autopsy cerebral hemorrhage, Barbara Starfield, cardiologists and Plavix, cerebral hemorrhage Plavix, FDA and drug harms, Plavix, Plavix-related death, US health best in world. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.