Stents Fail to Stop Strokes in Study

I would say "oh well," except strokes are a serious and can be extremely debilitating so it's a tragic study.  Again, I think we'll find prevention, though not glamorous nor exciting has got to be mission. I wrote about stents here, and medical device controversy here, here and here. You may want to read the article in its entirety if these topics interest you.  The stents cost $21,000 to insert, and Medicare would only pay if the patients were part of a study.  $21,000 could probably pay for a private nurse to go to the patient's house every day for 5 years to make sure they took their meds, ate their green leafies, and took their walk.  I know I'm being churlish...

Study Is Ended as a Stent Fails to Stop Strokes
By GINA KOLATA

A promising but expensive device to prop open blocked arteries in the brain in the hope of preventing disabling or fatal strokes failed in a rigorous study, researchers reported on Wednesday. Those who got the device actually had so many more strokes than those assigned to control risk factors, like blood pressure, cholesterol and diabetes, that the study was abruptly terminated.

The Food and Drug Administration approved the device six years ago on the basis of a humanitarian exemption, which did not require solid evidence that it would prevent strokes. Thousands of patients got the devices since then, according to the study’s lead researcher. The finding that the devices actually more than doubled the rate of stroke or death raised serious questions about whether the F.D.A.’s procedures for approving such a medical device ended up putting patients at risk.

The study comes just a month after an expert panel at the Institute of Medicine, a major scientific group, recommended that the F.D.A. replace its more usual regulatory system for devices because it failed to establish the safety and efficacy of less risky devices, like artificial hips, before licensing.

While neurologists were deeply disappointed by the study’s outcome, they also said it was better to find out that the treatment was, on balance, harmful before it became standard medical practice.

Larry Kessler, an expert on medical devices and a former director in the F.D.A.’s Center for Devices and Radiological Health, said that the humanitarian exemption made sense sometimes, but that the new study showed its dangers.

If the study’s findings hold up, Dr. Kessler said the approval of the brain stents “should be something the F.D.A. is very concerned about.” The agency, he added, has the authority to withdraw its approval...

The study’s results, published online Wednesday in The New England Journal of Medicine, were sobering. Thirty three patients, or 14.7 percent, who got the stent had a stroke in the first month, and five died. Among those who had medical therapy, 13 patients, 5.8 percent, had strokes in the first month. One died, but not from a stroke.

The medical therapy group actually did better than expected, perhaps because they were prompted and hounded to get their risk factors under control and also, Dr. Chimowitz said, because they took two drugs to prevent clots, aspirin and clopidogrel, for 90 days.

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Rethinking the Scientific Method from the New Yorker

The Truth Wears Off

This article from the most recent New Yorker looks at something called "the decline" effect. It is a phenomenon where an established result in science, or "fact" becomes less demonstrable over time. They give examples of antipsychotic medications,certain cognition effects and stents (ahem.) They mention several possible reasons for this effect. Wishful thinking on the part of researchers, for example. They cite acupuncture studies from 1990 to 2000 where all of the results from Asia were positive, when only 50% from the U.S. and Europe were positive. (This was obvious to anyone paying attention to the acupuncture literature at this time. I still ignore most of the studies out of Asia, China in particular.) Another possible explanation was just random chance that lead to the initial results that could not be reproduced.
The problem is, of course, that studies are very expensive! It's easy enough to call for more studies, but much more difficult to actually procure the money to pay for adequate studies. It was fortunate for the acupuncture community that the Insurance Companies in Germany were willing to pay for large enough studies to establish acupuncture efficacy for knee, hip and back pain. They did not discuss the corruption of studies by the drug companies as referenced in a previous post.

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ABSTRACT: ANNALS OF SCIENCE about the decline effect. On September 18, 2007, a few dozen neuroscientists, psychiatrists, and drug-company executives gathered in a hotel conference room in Brussels to hear some startling news. It had to do with a class of drugs known as atypical or second-generation antipsychotics, which came on the market in the early nineties. The therapeutic power of the drugs appeared to be steadily falling. A recent study showed an effect that was less than half of that documented in the first trials, in the early nineties. Before the effectiveness of a drug can be confirmed, it must be tested again and again. The test of replicability, as it’s known, is the foundation of modern research. It’s a safeguard
for the creep of subjectivity. But now all sorts of well-established, multiply confirmed findings have started to look increasingly uncertain. It’s as if our facts are losing their truth. This phenomenon doesn’t yet have an official name, but it’s occurring across a wide range of fields, from psychology to ecology. When Jonathan Schooler was a graduate student at the University of Washington, he discovered a surprising phenomenon having to do with language and memory that he called verbal overshadowing. While Schooler was publishing his results in journals, he noticed that it was proving difficult to replicate his earlier findings. Mentions psychologist Joseph Banks Rhine, who conducted several experiments dealing with E.S.P. In 2004, Schooler embarked on an imitation of Rhine’s research in an attempt to test the decline effect. The most likely explanation for the decline is an obvious one: regression to the mean. Yet the effect’s ubiquity seems to violate the laws of statistics. Describes Anders Møller’s discovery of the theory of fluctuating asymmetry in sexual selection. Mentions Leigh Simmons and Theodore Sterling. Biologist Michael Jennions argues that the decline effect is largely a product of publication bias. Biologist Richard Palmer suspects that an equally significant issue is the selective reporting of results—that is, the subtle omissions and unconscious misperceptions, as researchers struggle to make sense of their results. Mentions John Ioannidis. In the late nineteen-nineties, neuroscientist John Crabbe investigated the impact of unknown chance events on the test of replicability. The disturbing implication of his study is that a lot of extraordinary scientific data is nothing but noise. This suggests that the decline effect is actually a decline of illusion. Many scientific theories continue to be considered true even after failing numerous experimental tests. The decline effect is troubling because it reminds us how difficult it is to prove anything.

Read more http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer?printable=true#ixzz17XfGb9b7

Big Money in Stents

Doctor Faces Suits Over Cardiac Stents By GARDINER HARRIS

This is an article about a busy cardiologist in Baltimore, who had inserted more than 30 cardiac stents in a single day, and is now facing charges that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures in patients who did not need them.

The case has turned into a legal quagmire for Dr. Midei and St. Joseph, which have been sued by hundreds of patients who claim they received unnecessary implants. Some doctors say the case has revealed a level of inappropriate care that is more common than most patients know.

“What was going on in Baltimore is going on right now in every city in America,” said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents. “We’re spending a fortune as a country on procedures that people don’t need.”


and

"A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them."


and

"Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents."


and

"But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure."


and

Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

This is what happens when money can be made by procedures. You get more of them. And hope that no harm is done by them. Yeah right, what could possibly go wrong?
For those really interested, you can read more of the article below.

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A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them. Dr. Christopher J. White, president-elect of the Society for Cardiovascular Angiography and Interventions, said that inappropriate stenting was a problem, but a rare one. The federal Medicare program spent $3.5 billion last year on stent procedures.

Prosecutors, malpractice lawyers and state medical boards are only now waking up to the issue. The Texas Medical Board last month accused a widely known cardiologist in Austin of inserting unnecessary stents. In September, federal prosecutors accused a cardiologist in Salisbury, Md., of performing unnecessary stent surgeries, and last year a Louisiana doctor was sentenced to 10 years in prison for inserting unneeded stents.

J. Stephen Simms, a Baltimore lawyer who successfully pursued a federal whistle-blower lawsuit involving kickbacks for coronary procedures, said such cases were “the flavor of the month right now” with federal prosecutors.

Jay Miller, another Baltimore lawyer, said he was devoting his entire practice to unnecessary stent cases. “And I don’t think this is limited to just a few Maryland hospitals,” Mr. Miller said.

But far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure.

“Hospital patients expect their care to be based on medical need, not profits,” said Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee. “Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use.”

Dr. Midei’s fall was as rapid as it was dramatic. In a June deposition for a lawsuit against him, he said: “I didn’t know what hit me. I was bewildered by what had happened.”

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. When Dr. Midei agreed, the merger with Union collapsed, MidAtlantic sued, and the practice’s former chief executive vowed in a deposition to “spend the rest of my life trying to destroy him personally and professionally.”

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size.

That sort of increase in volume was an obvious red flag, said Dr. William E. Boden, clinical chief of the division of cardiovascular medicine at the University of Buffalo and an author of the 2007 stent study. “For him to have this brisk increase over those years is really unusual,” Dr. Boden said.

In stable patients, stents should be used only if X-rays show that most of the artery is blocked, and the patient has symptoms like frequent chest pain. Stent procedures can, in rare cases, cause bleeding, stroke or a heart attack. Once a stent is placed, it can result in a life-threatening clot that emerges weeks to months later. Stent patients must spend a year or more taking blood-thinning medications, which have their own risks.

In April 2009, a patient of Dr. Midei’s who was also a St. Joseph employee complained that he had received an unneeded stent and that many other patients had as well. The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. “It’s the right thing to do because he helped us so many times over the years,” an Abbott executive wrote in a January e-mail cited in the Senate report.

The company sent Dr. Midei to Japan, but news of the controversy made his duties impossible, and he flew home. After one particularly critical story in The Baltimore Sun, David C. Pacitti, an Abbott executive, wrote in an e-mail, “Someone needs to take this writer out and kick his ass!”

Edward Chaid, 68, a semiretired general contractor from Timonium, Md., is among those who have sued. Five years ago, Mr. Chaid decided to get his first physical examination in decades. Just to be safe, his doctor sent him for a cardiac stress test at MidAtlantic, which revealed a small “squiggle” of concern, Mr. Chaid said. He was sent to Dr. Midei to get his arteries X-rayed, and he emerged from the procedure with two stents.

“Dr. Midei said: ‘You sure are lucky. You had 90 percent blockage.’ And the nurse said, ‘Oh yeah, you were blocked in your widow-maker.’ And I said: ‘Thank God. I guess I’m really lucky you got it when you did,’ ” Mr. Chaid said in an interview.

Five years later, another doctor concluded that Mr. Chaid’s blockage had been minimal. “I was really shocked,” Mr. Chaid said. “I’m from a generation where doctors are thought very highly of.”

But Mr. Snyder, Dr. Midei’s lawyer, said that his client’s care had been entirely appropriate, that doctors often interpret X-rays differently and that St. Joseph was using him as a scapegoat. A Web site created by friends of Dr. Midei lists dozens of testimonials like this one: “Plain and simple, Dr. Midei saved my life.”