DC Medical Malpractice & Patient Safety Blog

Common sense says that putting stents into blocked arteries in the brain should help prevent strokes, just like propping open heart arteries cuts heart attacks.

But Medicare asked for a scientific study before it started paying for widespread use of the brain stents. So doctors tested stents versus medical therapy in high-risk patients. After one month, a dramatic answer: in one group, 6 in 100 patients got a stroke, but in the other group, 15 in 100 had strokes.

Problem is that the stent group was the one that had more than double the strokes of the medical treatment group.

The result was so big that doctors pulled the plug on the study, as they could no longer ethically put patients into the stent group.

This is yet another example of how therapies that seem like they should work, based on our knowledge of the body and medicine, turn out not to work. We have a lot left to learn.

In the case of brain arteries, bypass surgery to put in a new artery to go around blockages, also similar to what's done in the heart, also has failed to prove out in scientific studies.

You can read the new stent study in the New England Journal of Medicine.

A drug prescribed for smoking cessation is linked to an increased risk of heart problems, according to a study published July 4 in CMAJ (Canadian Medical Association Journal). Varenicline, known by the brand name Chantix, was associated with a 72% increased risk of a serious cardiovascular "event."

That sounds huge, but the scientific number-crunching shakes out a bit differently. Although attention must be paid, many critical minds are not ready to dump the drug. Fifty-two (1.06%) of the participants who took Chantix had serious cardiovascular events compared with 27 (0.82%) of those who took a placebo.

One bottom line for smokers who may want to rationalize continuing to puff: It's always better to stop smoking. No excuses.

When varenicline was launched in 2006, the FDA noted that it could raise the risk of cardiac problems, and the federal agency recently updated the label for Chantix to reflect that risk among smokers with heart disease. And we wrote about the drug a couple of years ago. But the new study's authors said, "These increased risks ... are seen in smokers with or without heart disease."

The irony, of course, is that one major risk of smoking is heart disease.

The Chantix-using subjects of this trial were able to abstain from smoking at a significantly higher rate, an achievement that should potentially confer a cardiovascular benefit. Many members of the medical community believe the drug should remained a valuable treatment option, given the devastating effects of smoking. Apart from heart issues, nicotine and the other ingredients of cigarette smoke, of course, compromise lung function and can lead to lung cancer, and also increase the risk of stroke and diabetes.

The results were based on a review of 14 studies of approximately 8,200 smokers or users of smokeless tobacco. Most had no history of heart disease. They were followed for as long as a year, a comparatively short term that gives many researchers pause. It's possible, for example, that the risk diminishes over time.

Dr. Taylor Hays from the Mayo Clinic opined, "Although these results suggest a measure of caution should be taken in prescribing varenicline for tobacco dependence treatment ... [T]he risk for cardiovascular events is low and is far outweighed by the benefits of diminishing the truly 'heartbreaking' effects of cigarette smoking."

If you're taking Chantix, don't stop without consulting your doctor. If you're unable to stop smoking via other methods, discuss the cost-benefit question of treatment with Chantix.

Here's a new research finding that is encouraging but discouraging at the same time for patient safety.

After 16 Michigan hospitals began to share patient safety information, surgical complication rates dropped by nearly 10 percent, according to a recent study.

That's encouraging, of course. The disquieting piece is why it would take a major research study to reach such an intuitively obvious result, and why sharing of data doesn't already happen on a wide and routine scale.

The University of Michigan study followed a program called the Michigan Surgical Quality Collaborative, which involved 300,000 patients who had general or vascular surgery between 2005 and 2007.

The greatest reductions were seen in blood infections, septic shock, prolonged ventilator use and cardiac arrest. Death rates remained the same.

According to the study’s author, Darrell A. Campbell Jr., MD, a professor of surgery and chief medical officer of the University of Michigan Health System, “the collaboration of hospitals in terms of identifying and disseminating information about best practices is actually a much more effective way of improving quality than just relying on each hospital alone to come up with what they think is a way to improve quality. In other words, sharing ideas is important and it's effective." He added that this type of program could help achieve the health care reform goals of improving quality and reducing costs.

“Surgical complications are very expensive,” Campbell says. “Once something bad happens following surgery, it takes a lot of resources for the patient to recover.”

A preventable surgical complication can add weeks to a hospital stay and thousands in added costs. Contracting pneumonia from prolonged ventilator use following a surgical procedure, for example, can add $50,000 to a hospital bill.

Given the high cost of surgical complications, authors estimate that it would take only a 1.8 percent reduction in complications a year for three years to offset the cost of supporting the pay for participation program.

“If this system was adopted nationally, not just in Michigan, I think you would find a greatly accelerated pace of surgical quality improvement,” Campbell says.

Inspired by the Michigan group, surgeons in Tennessee and upper New York have launched collaboratives. Similar ones are in the works in Pennsylvania, Virginia and Illinois.

Source: University of Michigan press release.

You can view an abstract of the study in Archives of Surgery here.

A diet drug which safety advocates called to be withdrawn from public use eight years ago has finally bit the dust. Under pressure from the Food and Drug Administration, the drug’s manufacturer, Abbott Laboratories, voluntarily pulled the drug from the market due to longstanding concerns that it increased the risk of heart attacks and strokes.

“There was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” said John Jenkins, MD, director of the office of new drugs at the FDA. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke.”

The move was described as “commendable but dangerously too late,” by Sidney Wolfe, MD, a member of the FDA’s Drug Safety and Risk Management Committee and director of the Health Research Group of Public Citizen, a consumer and health advocacy group.

The pressure from the FDA came after results of a clinical trial involving more than 10,000 patients showed that people who took Meridia had a 16% increase in relative risk of heart attacks. The trial also showed that individuals taking Meridia only lost approximately 2.5% more weight than those on placebo and that the weight loss didn't last very long.

Abbott maintained these results weren’t relevant because most of the individuals in the trial had cardiovascular disease and should not have taken the drug in the first place. The company continues to maintaion that for the right patients, the drug is safe.

European regulators took the drug off the market in January 2010. An FDA advisory committee was split on whether to remove the drug, but the ultimately decided to recommend doing so because “there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks,” Jenkins said, adding that he did not believe Meridia users would have any residual increased risk once they stopped taking the drug.

Source: The New York Times

You can view an abstract of the clinical trial that led to the FDA recommendation here.

When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that's what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital.

Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once a New York Times reporting team found that the doses of radiation given to patients at the Huntsville Hospital were 13 times the normal dose for this type of scan, called a CT brain perfusion scan. The scan is used to test patients for stroke.

Even a properly done CT brain perfusion scan delivers about 200 times more radiation to a patient's head than a skull X-ray.

According to the Times, the hospital claims it used higher doses to get sharper images.

A quotable quote from the article, the latest in a series about medical radiation overdoses:

“It is absolutely shocking and mind-boggling that this facility would say the doses are acceptable,” said Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans.

Stroke experts have widened the window for when the clot-busting drug tPA can be given intravenously. The previous U.S. guideline was to give the drug only if treatment could be started within three hours of the onset of symptoms. Many patients did not get the drug because they didn't get to the hospital in time or it took too long to do tests to make sure the drug could be helpful. (Everyone with stroke symptoms has to have a CT scan to make sure the stroke is not caused by bleeding in the brain, because if tPA is given on top of bleeding, it could worsen the hemorrhage or even kill the patient.)

The new guideline widens the effective time window to four and one-half hours after symptoms start. It comes from the American Heart Association/American Stroke Association and is based on European studies.

Stroke experts stress that just because there is more time now to administer this drug does not mean patients or doctors should think they can go slow. The faster treatment is begun, the more likely it is to help break up the clot and restore normal blood flow in the brain. Anyone with stroke symptoms needs to be rushed to a hospital with special expertise in stroke treatment.