Thursday, May 26, 2011

FDA: Feed the Dim Administrators

Sometimes I wonder if the FDA sucks as much as I think the FDA sucks.

And, it turns that it DOES.

An article, "Medical Devices: Lost in Regulation," by retired medical device researcher Paul Citron in the Spring 2011 Issues in Science and Technology [downloadable here] argues:

Although the United States is still home to numerous medical device companies, these companies no longer bring cutting-edge innovations to U.S. patients first. And U.S. clinical researchers now often find themselves merely validating thea pioneering work that is increasingly being done in Europe and elsewhere in the world. Worse still, seriously ill patients in the United States are now among the last in the world to receive medical innovations that have secured regulatory approval and clinical acceptance elsewhere in the developed world.

Citron cites several cases in which European patients benefited from early access to new medical devices: Deep brain stimulation to treat Parkinson's disease by 44 months; a ventricular support device to improve circulation by 29 months; a pacemaker device to manage irregular contractions in failing hearts by 30 months. Why is this happening? Citron maintains:

What's behind this erosion of leadership and late access to innovations? Simply stated, an overreaching, overly burdensome, and sometimes irrelevant Food and Drug Administration regulatory process for the most sophisticated new medical devices.

(Nod to Angry Alex)


eightnine2718281828mu5 said...

Maybe things move more slowly in the US because the FDA is aware of studies like this.

Neurology. 2006 Jun 27;66(12):1830-6.
Neuropsychological effects of bilateral STN stimulation in Parkinson disease: a controlled study.
Smeding HM, Speelman JD, Koning-Haanstra M, Schuurman PR, Nijssen P, van Laar T, Schmand B.

Department of Neurology, Academic Medical Center, Amsterdam, the Netherlands.


To evaluate the cognitive and behavioral effects of bilateral subthalamic nucleus (STN) stimulation in patients with Parkinson disease (PD).

The authors included 103 patients; 99 patients were evaluated 6 months after surgery. A control group of 39 patients with PD was formed and 36 patients were evaluated 6 months later. At baseline and at follow-up we administered neuropsychological tests of language, memory, visuospatial function, mental speed, and executive functions. A depression rating scale, a quality of life scale, self and proxy ratings of memory and dysexecutive symptoms, and a neuropsychiatric interview were also administered.


Six months after surgery, the STN group showed a larger decline than the control group on measures of verbal fluency, color naming, selective attention, and verbal memory. Moreover, the STN group showed a decrease in positive affect, and an increase in emotional lability and cognitive complaints. On the other hand, the STN group showed an increase in quality of life and a slight decrease in depressive symptoms. Nine percent of the STN patients had psychiatric complications (vs 3% of controls).


Bilateral subthalamic nucleus stimulation has an adverse effect on executive functions with implications for daily life of the patients and their relatives.

BadTux said...

U.S. companies have always released their products overseas before they released them here. The issue isn't the FDA (which has always been more cautious than most agencies -- see Thalidomide), but, rather, lawsuits. France, for example, allows new treatments to be marked "experimental", which largely exempts them from lawsuits because people must explicitly give up their right to sue if they wish to partake of an experimental treatment. Meanwhile, U.S. insurance companies refuse to pay for "experimental" treatments at all (in France they're covered by their Medicare, which, remember, covers everyone in France, not just the prunes like here in America).

So you want to know why "experimental" treatments happen first in France? A) Follow the money (because the French will pay for them!) and B) Follow the money (because the French won't sue them if the treatments don't work!). The FDA situation is an annoyance, but even if the FDA rubber-stamped everything like Thalidomide that crossed their doorstep, it still would get sold in France first for the simple reason that French Medicare will pay for "experimental" treatments and Aetna / Blue Cross / Chiseler Permanente / etc. won't.

Anonymous said...

Sorry BadTux. I'm with you on B), but not A). Pharmaceutical/Device companies would/will gladly pay for patients to take their experimental products. Who will pay is not an issue.

BadTux said...

You're defining "experimental" the way normal people do, not the way insurance people do. Aetna (or any large U.S. insurer, due to the race to the bottom caused by the fact that employers, not individuals, buy insurance, and employers go for the cheapest insurance, not the best) says any treatment that's less than ten years old is "experimental" and won't pay for it unless you go through a painful and slow appeals process where they hope you'll either die or get cured using an older treatment before they're required to pay for it.

So clearly for any new treatment that the large insurers claim is "experimental", it will get introduced first in France (where it is law that Medicare must pay for it), rather than in the United States (where there is no law to force Aetna to pay for it). This isn't a matter of true experimental drugs (i.e., drugs that have not yet been approved in *any* country), this is a matter of how insurance companies define the term "experimental" -- which is *not* the same way you and I define the term.

BTW, if it sounds as if I'm slagging U.S. insurers, I'm not. If we banned private insurance in the U.S. tomorrow and went to Medicare For All, we would save a whole 10% on U.S. healthcare spending. That's it. The main cause of the spiral of healthcare costs in the U.S. is provider and drug costs, not the insurance industry, which has adopted wonky things like their silly definition of "experimental" as desperate attempts to contain costs, not because they're inherently out to kill people (though as corporations their first duty is to their shareholders, not to patients, something to bear in mind).

Anonymous said...

How diligent the FDA is, when approving new devices can be seen with the Lorad Mammography system.
The document for concerning the clinical trials and physical data reports on a device using 12 CCD sub-images (page 5 at the PMA approval P010025 from 3/12/02 at

Later (PMA Approval P010025/S001 from 10/2/02) the FDA gave the "Approval for an amorphous selenium digital receptor, a change in the name of the product to Selenia™ and the addition of a soft copy display for interpretation of screening and diagnostic mammograms." without indication of any further clinical test.
The changed device has different physical properties and technical specifications (the difference is larger than the one changing from one digital camera brand to another). So the FDA used data of one device to approve another device.

Thats what I call diligence ;-)

Ben A said...

Med devices and drugs are different. In particular, in the EU there's a process for getting a devices cleared for the EU market (CE Marking) which is usually much easier than FDA approval. Although CE Marking doesn't necessarily make state payers reimburse a product, so that market clearance and patient access in this case can come apart. EMEA drug approval may be a bit easier than FDA, but there's no comparable fast track process.

(I'm a VC who works primarily in biotech, for the record)