Medtronic Under Fire with Questions of Financial Conflict

July 7th, 2011. By Hunter West

A blockbuster investigation by some print media outlets has spurred a US Senate Finance committee to start beating the bushes once again around the medical devices industry.

There are many questions:

How safe are the products that wind up in your body?

What do the manufacturers know about potential safety issues, but aren’t telling?

Why is it okay for a doctor or surgeon to be paid by a medical device manufacturer? And can you really trust what a doctor [who is paid by the device maker] says about that device?

Do you feel like a guinea pig?

It was revealed yesterday through a series of articles published by the Milwaukee Journal Sentinel and MedPage Today that there is some controversy surrounding Medtronic Infuse, a popular bioagent known as bone morphogenetic protein-2, designed to foster bone growth required for spinal fusions.

Infuse was approved by the US Food and Drug Administration (FDA) in 2002 and doctors love it. It’s easy to work with. And you don’t have to harvest a patient’s own bone from elsewhere, in order to accomplish the surgery. You have to love something that allows a surgery to proceed faster, and more easily.

But here’s the rub—and the reason for the Senate Committee investigation. It seems that a cadre of surgeons around the country were paid by the device manufacturer, Medtronic. Those same surgeons with financial ties to Medtronic were involved both in the clinical trials for Infuse, and the authorship of white papers on the product that allegedly failed to mention some of the more serious side effects.

Those side effects include sterility in men, and potential neurological disorders. In both cases, doctors having authored learned articles for medical journals with no financial ties to Medtronic duly included the potential for male sterility. They also mentioned the potential neurological complications from the growth of ectopic bone.

In a week’s time, more research papers are expected to be published by independent researchers who are expected to reveal even more potential complications with regard to Medtronic Infuse.

Doctors with financial ties to Medtronic noted that while the potential growth of ectopic bone in the spinal canal was obviously not desirable, it did not appear to have an ill effect on patients. Three, of the four authors of that particular paper were reported to have received $4 million from Medtronic in the last year. The reason for those payments is not known.

One surgeon and his consulting company are reported to have been paid $27 million by Medtronic since 2002—the year that Infuse was approved.

Critics of such papers by experts with financial ties to the manufacturer—and critics of such payments in general—have sounded the alarm, noting that reports authored by experts with a financial conflict are little more than a marketing article. Research by those accepting payments will always be skewed to the positive.

If you remember the name Medtronic, it’s because the name is associated with the compromised Sprint Fidelis heart leads that were found to be prone to failure—and recalled by Medtronic—a few years ago. The lead—as has Infuse—was lauded by doctors as being thinner than standard leads, and easier to use.

But the thinner lead was also prone to failure, developing hairline fractures that would compromise the operation of the lead. The latter is designed to serve as the vital connection from a pacemaker or defibrillator, to the heart. It’s failure has resulted in some patients getting shocks when they shouldn’t, others not getting life-saving impulses when they should.

Some patients have died. Others have been forced to live with a ticking time bomb in their chests. It’s a lot easier to install a lead to the heart muscle, than it is to remove it. Attempting to detach a lead from heart muscle can damage the heart, and some patients have not survived the removal attempt.

Oh, and by the way, you’re not allowed to sue medical device manufacturers for devices that are suspected of being defective. Apparently, the Supreme Court in 2008 agreed with a Congressional decision dating back to the 1970s that the buck stops with the FDA, and the agency’s recommendation to approve a device should not be challenged in the courts.

Feel better now?

That puts the medical device industry at the same level as XYZ manufacturing making widgets—a widget that will be made for the lowest cost possible, and certainly not nearly as well-made as widgets that came off the line 30 years ago.

I bought a hammer, once, that broke apart with the first good strike at a large spike. It was not made of steel. It was made of metal fibers glued together in some kind of glue or epoxy, then polished on the outside to make it look like steel.

I bought a new dehumidifier that failed to work right out of the box. The motor wouldn’t even turn on. I sent it back. Meanwhile the old dehumidifier that was built in 1958 is still going strong.

What do hammers and dehumidifiers have to do with bone protein and heart leads?

Here it is. It’s all about profit. There’s a market to be exploited and money to be made. If something breaks down…well, the FDA approved it. ‘Nuff said.

I hope the Senate Finance committee investigation uncovers an arsenal of smoking guns. And then I hope that the government has the balls to do something with it.

To that end, payments by drug and medical device manufacturers to doctors and surgeons, for any reason, should be stopped. And if they can’t be stopped, then the two parties have to sign an agreement that states any compensation—no matter how lucrative—is for their time, and not for their approval. Doctors and surgeons should be independent of thought. If they are not, they have to answer to their professional and ethical associations and risk losing their license to practice.

Restaurant and theatre reviewers, and automotive journalists say so when they don’t like something. Even if it’s a free meal, free tickets or free flight and accommodation paid by the manufacturer to a new model launch in some far-flung country, if the journalist thinks the car is a dud, he says so.

Doctors and surgeons should provide us with nothing less, whether the manufacturer pays them, or not. Outlaw the payments of any kind. It just makes subterfuge all that much easier.

And reform the FDA. Take away the political influence. Take away the industry funding. If the FDA is going to serve as the true gatekeeper of public health in this country, it has to be financed by the taxpayers. Period.

Nix the loophole that says a new product substantially close to an existing product, can escape rigorous testing. That would have saved thousands of Fidelis Sprint heart lead patients physical and emotional pain. It might have even spared them from an unnecessary death.

And if you get it wrong and people start getting sick or start dying, pull it. Hold the manufacturers accountable.

For that matter, if the buck stops with the FDA—and the Supreme Court says it does—then let’s hold the FDA accountable through the courts.

As long as you have a regulator with weak recall powers, and an industry that escapes the judge’s gavel or the jury’s scrutiny, what incentive is there for manufacturers to get it right?

Patients are people. The market is comprised of living, breathing human beings—with families, and children.

There is a lot still wrong with health care in this country. It starts with the FDA, and ends with a Supreme Court that attaches more value to the FDA than it presently deserves.

We all deserve better.

God bless the United States of America.

Tags: Infuse, Medtronic

This was posted on Thursday, July 7th, 2011 at 12:57 pm and is filed under Defective Products, Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.