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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?

4 Responses to “How prescription drug harms can go unnoticed”

  1. Jane Morrisson said

    My mother was put on Plavix after a stroke. She was on it for several years. It seemed like once she was on it, no one wanted to stop it. Finally, after reading about it (especially that it was not recommended for patients with a history of ulcers, which she had) I just stopped giving it to her. Nonetheless, not long after, she suffered a perforated peptic ulcer at age 85 and died from complications thereof.

  2. apdjn said

    From http://www.straightdope.com/columns/read/2741/when-doctors-go-on-strike-does-the-death-rate-go-down


    One example often cited is that of a monthlong strike by Los Angeles County physicians in 1976, during which the mortality rate for patients was seen to drop by 18 percent. But a 1979 study in the American Journal of Public Health showed that the overall area death rate remained unchanged, as enough personnel remained on duty to handle the real emergencies. Any seeming benefit to patients’ health likely resulted from about 11,000 fewer operations (presumably elective) being performed that month than was typical, meaning that an estimated 50 to 150 patients who could have been expected to die didn’t.
    A four-month Israeli doctors’ strike in 1983 was found to have some definable effects on public health – the percentage of cesarean sections increased somewhat, and one study suggested hypertension patients might have received worse treatment – but no observed impact on mortality. Nonetheless, the popular wisdom saw the work stoppage as a disaster: a detailed study of public perceptions afterward found that nearly one in four urgent-care patients (or their relatives) felt the strike had resulted in major health problems.
    A 1984 doctors’ strike in Varkaus, Finland, mainly meant fewer visits for colds and stomachaches; no significant harmful effects to the public were seen, researchers found, and the uptick in visits after the doctors returned to work suggested that patients were glad to have them back.
    Another key example used to support the proposition that fewer doctors means fewer deaths comes from a June 2000 article in the British Medical Journal written during another Israeli strike; the author reported that in the three months after doctors walked out death rates fell significantly in affected cities. However, her data was by no means the result of a scientific study but consisted mostly of anecdotal reports from funeral home directors, who claimed they’d seen “the same thing in 1983.” What is known is that, as in the LA strike, many thousands of elective surgeries were postponed but emergency rooms and chronic care departments remained open.
    In 2003 a SARS outbreak closed four hospitals in Toronto, and all non-emergency services were suspended. Among other things, this led to the canceling of a quarter to a half of joint-replacement surgeries, 40 percent of cardiac surgeries, and as much as 93 percent of some outpatient procedures. The result? The greater Toronto area did see a slight dip in mortality rate relative to the prior two years, but so did the rest of Ontario, and the decrease wasn’t statistically significant anyway.

    So despite media suggestions to the contrary, doctors’ going on strike doesn’t seem to have much effect on the death rate one way or the other, and any reduction seen is probably the result of postponed or canceled nonemergency surgeries. And that figures: any surgery is risky, and some common procedures (like coronary bypass or aneurysm repair) have a death rate you just can’t ignore. But leaving the tummy tucks out of it, most elective surgeries boast a pretty serious payoff, either in quality-of-life improvement right now or in medical trouble avoided down the line. If 600 people die each year as a result of hip-replacement surgery, does that mean the 200,000-plus patients that pulled through were fools to go under the knife? You’re welcome to calculate the odds however you like, and in certain cases it may well make sense to question the value of surgery. As a general proposition, though, if my health is on the line, I’m glad to hear that the doctor is in.

    • David Raisman said

      we need to change our whole system of health care starting with a new uderstanding of what health care is, starting with the parents doing all the right things and the government keeping poisons out of our air, water supply, lan d, oceans and food supply. true health is not just not being sick. true health means really feeling good without drugs.

  3. David Raisman said

    As you know, death by medical care is called Iatrogenic Disease and according to the article ”Are Most Diseases Caused By The Medical SYSTEM?” by Walter Last, iatrogenic disease may really be the no 1 cause of death in America and around the world. indeed, whenever doctors go on strike, the death rate goes down.

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