Fast-Tracking Medical Devices: Innovation, or Opportunism?

Oakland, CAWhen it comes to medical devices and medical drugs, it can be argued that the US Food and Drug Administration (FDA) is no real friend to the everyday Joe (the Plumber, or otherwise). That's because the FDA routinely allows so-called improvements to drug and medical devices through the pipeline and into the consumer marketplace, without completely vetting the process.

The foregoing was revealed in a damning expose published in the New York Times on Sunday, but is a subject that is not new and has long been talked about from Congress, all the way down to the kitchen table.

In this latest example of just what consumers are assuming as safe and reliable, a new system for treating breast cancer in women was approved by the FDA in 2002. Unlike traditional radiation, which typically happens after a diagnosis for breast cancer and / or the removal of cancerous growth or a cancerous tumor, the MammoSite system is based on the insertion of radioactive 'seeds' in the tumor site. The latter completes a treatment in five days that would normally take upwards of six weeks—the normal turnaround for the conventional process of irradiation of the entire breast.

Since MammoSite was approved six years ago, radioactive seeds have been implanted into the breasts of 45,000 women.

However, it is unclear how many of those women, if any, are aware that six years on the MammoSite system is still considered experimental.

That's right, experimental. Yes, the FDA did require a label warning that MammoSite had not shown to be a substitute for conventional radiation. But there is no requirement for a doctor to share that information with a patient.

That's what happened to Karen Medlock, whose story was recounted in the New York Times on October 26th. Following the removal of a cancerous mass from her breast last November, Medlock was referred to a cancer center in Oakland, California that specialized in the new, MammoSite system. Medlock embraced the idea at first as making perfect sense, until she sought a second opinion.

It was then she learned that the MammoSite system is experimental. It was tested on only 25 women and fast-tracked to the consumer market (with the warning label) with only minimal testing.

Medlock opted, in the end, for a more conventional treatment option.

The FDA maintains that exhaustive testing is not required for devices, or procedures that are simply an improvement on an existing treatment. The agency says that more rigorous testing would stifle innovation.

But critics wonder just who is benefiting here, and who is it that assumes the most risk? The ability to have a new device involved in existing treatment protocol speeds profitability on the part of the medical device manufacturer. It is even a boon to doctors, who are often compensated additional dollars by Medicare for taking the time, and incurring the expense of adopting a new procedure.

So the risk is really incurred by the patient, who more often than not isn't told that the new procedure is still experimental.

Playing the devil's advocate, it should be noted that for some patients, for whom conventional treatment is ineffective and their cancer looms as a death sentence, the availability of experimental procedures could be a godsend. What have they got to lose?

However, for the remainder of the population, shouldn't it be a strict requirement that medical devices, or medical drugs which are still experimental, should be vetted with the patient?

Chantix, the anti-smoking drug, was never labeled as experimental when it was approved with much fanfare just a few years ago. However, perhaps it should have been—especially given the fact that pre-approval clinical trial participants were apparently handpicked for their physical and emotional health—attributes that are not assigned to the typical smoker. And there has been so much fallout over Chantix in the last year, with reports of suicides and other weird goings-on with the head, that people are beginning to wonder. After all, Chantix works by directly targeting the brain—and when you mess with the brain, anything can happen.

Presently, the FDA has put Chantix under review yet again after reports of elevated incidents involving traffic accidents and seizures.

And even medical drugs are subject, on average, to much more pre-marketing scrutiny than a medical device will ever get. According to the New York Times story, a medical device fast-tracked to market is never fully vetted to determine if it is truly effective. Rather, all a manufacturer has to prove to the regulator is that the device will do what the regulator says it will do, and whether or not it poses any undue and known safety risks.

The public, as a result, will erroneously conclude that if the FDA clears a device, then that device must be safe—when in actual fact, it may not be.

Fans of the MammoSite system maintain that the new technology is safe and effective, and critics are simply resisting change.

The medical device industry is a $75 billion dollar juggernaut in the US. And that's in one year…