Statins good for you? Think again. FDA issues warning

Long overdue. People have been complaining about the statins for years, finally the FDA takes action. Good for them. I discussed the irrational boosterism about statins here, their link to diabetes here.
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Maybe one more for the "Follow the Money", and "First Do No Harm" files.

February 28, 2012
Safety Alerts Cite Cholesterol Drugs’ Side Effects
By GARDINER HARRIS

Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.

It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin...

Dr. Sidney M. Wolfe, director of Public Citizen’s health research group, is among those who contend statins are overused. He said the new alerts about risks provided more reasons that otherwise healthy people with cholesterol levels less than 240 “should not be taking these drugs.”..


Reports about memory loss, forgetfulness and confusion span all statin drugs and all age groups of patients, the F.D.A. said. Dozens of well-controlled trials of statins have offered few hints that the drugs cause any kind of cognitive impairment, Dr. Egan said. Still, the F.D.A. has received many reports over the years that some patients felt unfocused or “fuzzy” in their thinking after taking the medicines.

Officials in the F.D.A. debated whether such reports were truly worrisome, Dr. Egan said. But in recent years, the F.D.A. — criticized for waiting too long to issue some safety alerts — has become more willing to be public about possible drug risks, even when the evidence is uncertain...

That statins can cause muscle pain, particularly at high doses, has long been known, but in its new alert the F.D.A. reminded doctors that some other medications increase the likelihood that statins linger in the body longer than normal and increase the risk of muscle pain.

Coronary Stents: No advantage found

To file in the "First, Do No Harm" file. Or the "Follow the Money" file. You decide. I've discussed some of the hesitations about coronary stents here, and here.
We learned that the FDA "endangered countless patients' lives when it stopped enforcing 30-year-old requirements that medical device makers meet federal lab standards before testing their products on humans." We also learned that the procedures could cost $30,000 to $50,000 per procedure, so no one wanted to stop that gravy train. There was a study published in 2007 in NEJM showing that many patients given stents would fare just as well without them. So this is nothing new. There are a number of forces at work here. Following the money is big, but also the tyranny of doing a procedure that makes sense, even though the data doesn't support it. I talked about "believing in treatments that don't work" here.
Talked about better mental models for treatment here.
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No Extra Benefits Are Seen in Stents for Coronary Artery Disease
The common practice of inserting a stent to repair a narrowed artery has no benefit over standard medical care in treating stable coronary artery disease, according to a new review of randomized controlled trials published on Monday...


Some of these devices, called drug-eluting stents, are coated with medicine that helps to keep the artery open. The cost of the procedure varies from about $30,000 to $50,000, and more than one million are performed every year in the United States.

The procedure has certain risks. According to Dr. David L. Brown, an author of the analysis, the risk for death is about one in a thousand, and complications can include stroke, heart attack, bleeding, kidney damage and serious allergic reactions. But those events are rare, and the review did not detect any increased risk in P.C.I. compared with medical treatment...

The researchers reviewed eight randomized trials comparing P.C.I. with standard medical care. Combining data from all the studies, the researchers found that prescribing beta blockers, ACE inhibitors, statins and daily aspirin — now standard for treatment of stable coronary artery disease — was just as effective as stent implantation for prevention of chest pain, heart attack, the need for a future P.C.I. and death.

More than half of patients with stable coronary artery disease are now implanted with stents without even trying drug treatment, Dr. Brown said. The reason, he believes, is financial.

“In many hospitals, the cardiac service line generates 40 percent of the total hospital revenue, so there’s incredible pressure to do more procedures,” he said.

“When you put in a stent, everyone is happy — the hospital is making more money, the doctor is making more money — everybody is happier except the health care system as a whole, which is paying more money for no better results.”


Angina is often the symptom that convinces doctors and patients that medical therapy is not enough and that a stent is required. But in this analysis, 29 percent of people who had P.C.I. still had angina, compared with 33 percent of those on medicine, an insignificant difference.

These results support the current concept of coronary artery disease, the authors wrote — that it is a systemic inflammatory disease of the arteries that cannot be successfully treated by surgical intervention at a particular site on one artery.

According to Dr. Brown, a professor of medicine at Stony Brook University, many doctors cannot accept this. Instead, he said, “interventional cardiologists use the analogy of a pipe blocked in a house — it’s a terrible analogy, but patients accept it. It’s simplistic and erroneous.”

Johnson and Johnson Pays out in Texas Law Suit

This to be tossed into the "Corruption" file, or the "Follow the Money" file. I guess they're sort of one in the same, except the "Corruption" file contains those who have been caught.

January 19, 2012
J. & J. to Pay $158 Million to End Suit Filed by Texas
By REUTERS

Johnson & Johnson said on Thursday that it would pay $158 million to settle a Texas lawsuit accusing the drug maker of improperly marketing its Risperdal antipsychotic drug to state residents on the Medicaid health program for the poor, including children.

The lawsuit accuses the company of pushing Risperdal as “appropriate and safe to treat a broad range of symptoms in populations and disease states for which it had no F.D.A.-approved indication, including in the child and adolescent population...”

“Johnson & Johnson’s scheme to profit from the Medicaid program by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars,” Texas’s attorney general, Greg Abbott, said in a statement...
The company is in various stages of litigation with several other states.

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Tragic. High Cost of Failing Artificial Hips

To be filed under "Follow the Money." This has got to be horrendous for patients since you know that the insurance company's costs will be reimbursed first since they can hire more lawyers. And to have to be dealing with these kinds of financial issues and law suits when you're not feeling well. Horrible. Some excerpts follow. I've been following this story for the 6 months and it follows the typical trajectory of the companies ignoring complaints, blaming the physicians and then finally having to cop to the problem. Not good. Not good at all. Recent blog post on topic here.
The High Cost of Failing Artificial Hips
By BARRY MEIER

The most widespread medical implant failure in decades — involving thousands of all-metal artificial hips that need to be replaced prematurely — has entered the money phase.

Medical and legal experts estimate the hip failures may cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company...

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs...
Still, some patients are weathering some of the financial impacts on their own. While Charmin McCune, a teacher in Wylie, Tex., is recuperating well from a recent replacement operation, she said that she and her husband, also a teacher, have had more than $12,000 in expenses that have not been covered by insurance.

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New Joint Implants no Better Than Older Ones

Filed under "Follow the Money"
December 22, 2011
New Models of Implants Not Better, Study Finds
By BARRY MEIER

A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs.

The study, which draws on data from Australia’s orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.
The Australian study showed that not a single new artificial hip or knee introduced over a recent five-year period was any more durable than older ones. In fact, 30 percent of them fared worse...


“Not only has the introduction of this technology been potentially detrimental to patient care, but the current approach may be an important driver of increased health care costs,” the review concluded...

That review, by researchers in Austria (mistake, should be Australia), found that surgeons involved in the original published reports are often involved in its development and may have a financial stake in them. In addition, such reviews tend to be short term...
This month, bipartisan legislation was introduced in the Senate that could force manufacturers to track the performance of implants like artificial hips after they have been approved for sale. Proponents of the bill acknowledge that the measure faces an uphill fight.
Both device producers and their allies in Congress have maintained that any additional F.D.A. regulations would slow the development and marketing of innovative products that benefit patients. For his part, Dr. Graves, the Australian official, said he believed that such arguments were misleading.

Where have we heard that before?? That regulation will somehow damage innovation, or hurt business and job creation? Just about every time any sort of regulation is proposed, that's when.
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An Ounce of Prevention: Parallel Stories in the Newspaper

This article was a plea from a computer scientist at UCB for more computer experts to get involved in the "war on cancer." And, indeed, in such a multifactorial, huge medical health issue, the more help the better. In the last week there was also this article outlining an online website to raise funds for cancer research: a highly laudable effort, also.

In the same bout of newspaper reading, there is this article exploring the increasing dust in the American west and its effect on snow melt (it increases it.) Some of the reasons posited for the increase in dust (which has lead to high asthma rates) is global warming and off road vehicle use.
And this article looking at the risky but lucrative practice of deep sea drilling off the coast of Brazil. ""We see big slicks of oil, fish that have changed colors," he said."
And this article examining the ground water pollution resulting from the controversial practice of hydraulic fracturing, or fracking. ""Fracking poses serious threats to safe drinking water... Last year, Wyoming became one of the first states to require oil and gas companies to publicly disclose the chemicals used in fracking. Colorado regulators are considering doing the same."

And this article describing the dangerous lack of regulation, ie "self regulation" in the natural gas pipelines in Pennsylvania.

The point being, that there is a cavalier, reckless attitude toward the potential health risks in all of these practices mentioned above from carbon emissions, to off road vehicles, deep oil drilling, fracking, and natural gas production. And then scrambling on the other end to try to combat cancer, asthma and other health risks that are increasing by the day. It is glaringly obvious that it is all about incentives, and that is where the conversation needs to go.

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Update:
And then there is this story about the nuclear regulatory commission members, all pro-industry fighting tooth an nail to relax regulations. It never ends.