Menaflex: I am a scandal.
The report [PDF] makes for interesting, if dense, reading. It's the result of an internal FDA investigation 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. Essentially, it reveals that in this case, poor adherence to internal procedures, a lack of adequate staff, and lobbying from ReGen itself combined to overwhelm the scientific objections to approving Menaflex for use. It is the perfect storm of horrible for what should be a science-based institution.
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.
TIP:
Enter the amount, and click "Tip" to submit!
Redstocking Grandma
cmnaylor
Kathy Riordan
aging hippie chick
Poet of Logan Square
Just Cathy
Salon.com
Comments
Stacey, I feel for New Jerseyites on this one, I do. ReGen is based there, so when the company takes a hit -- and it sure looks like it will -- so will the workers.
R
My MIL just got a new hip. I sure hope it isn't a sub par piece of equipment that will require additional tinkering.
(reaching for the wineglass). Nice reporting SS.
But the FDA and their practices are in fact, my lifeblood, and I'm not sure you hit the mark here. I read the report you provided (thank you, been too busy to keep up with all the news; the children’s Tylenol recall is quite interesting ) and I'm not clear that your correlation between companies spending money to buy congressional interference on a clearance classification decision constitutes a legitimate "cost" factor. Clearly ReGen spent untold millons in attorney's fees to fight the FDA's NSE decision and apparently to buy their Congressmen's interference, and all drug and device companies pay lobbyists exorbitant amounts to fight for their concerns. This is wasteful for certain, but unlikely to ever change in this industry, or any other, given that our Congress lacks the fortitude to stop it.
The problems with the clearance system have been well recognized for years. Having been through the classification system first-hand, as well as witnessing the 510k abuses personally, I hope like hell this report is the beginning of long-needed changes in the medical device clearance system.
However, the bottom line in this case is that one or more high-level FDA authorities overruled the scientific recommendations. This is no different from the Plan B debacle when GW Bush was directing the Commissioner and his Directors to ignore all scientific opinion and rule against the OTC status for the drug. The real problem in both cases is that career politicians are allowed to make decisions that overrule the credible scientific evidence presented through the normal review system. They do this for political reasons, and it needs to be stopped. FDA must become a scientific organization if they are to meet their mission of protecting the public against unsafe and ineffective drugs and devices.
Also, the Regn device was not rejected several times because it was unsafe; the primary issue was that is was ineffective. The NYT got that wrong, "safety and efficacy" are the stock terms in trade, but a careful reading of the report shows it was ineffectiveness that got it shot down by the scientists.
Finally, I am not sure what this means "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."
I can tell you that field enforcement of safe and effective manufacturing processes for cleared devices has been intensely targeted by FDA in recent years. But the clearance process itself is very, very weak.
PS and you heard it here first - the generic drug scandal will come around again. The American public, and even most doctors, have been taught to believe that generics are equivalent to the name brands. Very untrue. But that's another post (that I will probably never write in case my real name was ever connected to good ol' kellylark)