I am a scandal.
Today, the F.D.A. admitted that it bowed to pressure from congressmen in approving an unsafe “patch” for patients with a torn or damaged meniscus (a common knee injury). The patch, called Menaflex, routinely failed and required patients to seek further surgery, but was approved for use after both New Jersey senators and two of the state’s congressmen lobbied for its approval. All four had received sizable campaign donations from the maker of Menaflex, ReGen Biologics.
The report [PDF] makes for interesting, if dense, reading. It’s the result of an internal FDA investigtion spurred in part by coverage like the Wall Street Journal’s March piece, “Political Lobbying Drove FDA Process,” and also by congressional inquiries and loud internal dissent.
Business as usual in Washington? Maybe. Certainly, it’s a story that Senators Bob Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steve Rothman should be ashamed of. Nice work, Jersey.
But there’s a bigger story here, and it’s one that we haven’t seen much of during the health care debate. Check this out [NYT]:
The [FDA] report, sharply critical of the agency and the lawmakers, demonstrates the sharp departure from the past that the Obama administration intends to take in approving devices and publicizing its internal deliberations.
On Wednesday, the agency asked the Institute of Medicine to review the entire process by which the agency approves the vast majority of medical devices.
Both the request to the Institute of Medicine as well as the agency’s reassessment of its approval of ReGen’s knee device augurs poorly for the entire medical device industry, for whom the F.D.A. is a crucial gatekeeper. For decades, most medical devices have received only cursory reviews of their safety and efficacy from the agency.
One of the most abstract and difficult to grasp parts of the Obama health care plan has been the insistence that cost-cutting measures can account for a savings that will partially fund a national plan. The argument makes it sound very simple — we just stop wasting money. Phrasing it that way, though, makes it sound like something fake. If it were really that simple, why wouldn’t someone have done it before now?
The truth is it’s not that simple. There are thousands of people and millions of dollars heavily invested in making sure that wasteful practices continue in health care, because hospitals, doctors, insurance companies, medical research firms, and just about any other health-care related organization you can think of benefit from the government (and others) being willing to put up “whatever it costs.” People like those at ReGen, who were apparently quite comfortable spending money to get a sub-par and dangerous medical aide put on the market, and — if their corporate report of $X profit is correct — were also quite happy to profit from both it and from their campaign connections.
This is the other side of the “death panels” fear story. The government can intervene in medical decisions at the production end to the betterment of all. American pocketbooks and the knees that carry them will benefit from this decision.
SATURN SMITH 