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.
Info on my practice here.

Drugs causing the problems they're supposed to prevent

From the NYTimes:

"In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.
One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone.
The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that..."

They then go on to quote experts who feel that the FDA doesn't do enough to track drugs after they've been turned loose on the (unsuspecting) public. Since drugs only undergo a relatively short testing period, it would, of course make sense to continue tracking drugs once on the market. Where that money will come from I have no idea in this political climate, especially since the FDA has shown to be infiltrated with people from the drug industry with a vested interest. (See blog post "When oversight means overlook")
Given the shortcomings, and lack of oversight in the FDA I think it makes utmost sense as a health care consumer to wait at least 7 years before taking any newly released drug. Let others be the guinea pigs and if possible, take the version of any medication that is tried and true if given a choice. It's often cheaper, too.
I like to think that attitudes are changing among physicians, and that they're less willing to prescribe newly minted drugs, but I'm not sure if there is any evidence for that. I understand the drug companies rushing drugs to market, after all there is a boat load of money to be made. But I'm not sure I understand the eagerness of physicians to enable them. It could be pressure from patients themselves, who knows. But they should remind themselves of their oath to "first do no harm" and consider counseling weight bearing exercise and dietary changes before bisphonphonates and Avandia.

(To read more about acupuncture and my practice, please click here.)

When "Oversight" means "Overlook"

In yet another depressing instance of profit motive undermining patient well-being we are presented with the story of a private company, "Coast Independent Review Board", charged with overseeing the safety of new drugs and medical devices (An Overseer of Trials in Medicine Draws Fire Published: March 26, 2009 NYtimes.) "Coast,"located firmly inland in Colorado Springs, was snared by undercover federal agents when it approved a make-believe surgical device rejected by two of Coast's competitors.
"Where was the due diligence of your company?" demanded Congressman Stupak at a Congressional hearing on Thursday March 26th. In retort, remaining as combative and self-righteous as any thug worth his salt, the CEO Drueber griped that he could not imagine why anyone would design a fake trial. (You mean besides catching frauds?) "I cannot believe that my government did this to me and my company. It is unconscionable.”
What is "unconscionable" is a company that is willing to sign off on potentially dangerous drugs or devices for a fee. There have been recent hearings on patient deaths from unsafe devices which were allowed because of fraudulent data submitted to the FDA. The charges against Coast are not trivial. In recent years, review of new medical devices and drugs has shifted from academic medical institutions to private review companies that are paid by the company that develops the new device. This setup can lead to corruption of the process as seems to have happened at Coast.
Following the money we find out from the article that "over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008."
It cuts down on outlays if you don't actually do the work of reviewing and increases profits if drug companies seek you out because you're known to overlook rather than oversee.
(For more information about my practice please click here.)