FDA caved to political pressure in OKing medical device

This kind of story, involving abuse of power and weak-willed bureaucrats, really drives me crazy. The congressmen in question had no business interfering with FDA decisions and ought to be punished by opponents and voters for doing so. Likewise, the FDA had no business caving into political pressure on a medical issue, although it’s reassuring to see that the agency has now publicly admitted its mistake and how it happened.

From the New York Times:

WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

39 comments Add your comment

FinnMcCool

September 25th, 2009
2:04 pm

We readily admit Democrats aren’t perfect. Expose and punish the bad ones.

Midori

September 25th, 2009
2:07 pm

exactly Finn.

unfortuately, the morans just don’t get it.

Midori

September 25th, 2009
2:08 pm

criminy!!

“unfortunately”….

TW

September 25th, 2009
2:09 pm

Yes, expose and punish. Country before party :)

Midori

September 25th, 2009
2:10 pm

this is why the right doesn’t believe in criticizing their own party or its members: http://img.photobucket.com/albums/v228/displacedtexan/blogstartdatefeb052005/foxnews.jpg

Mrs. Godzilla

September 25th, 2009
2:11 pm

Dumpster Democrats.

Expose them and vote them out.

TnGelding

September 25th, 2009
2:16 pm

Would this fall under waste, fraud and abuse? The Justice Dept. should investigate. Where have our ethics gone?

I think I’ve figured out why our health care is so expensive: everyone is sick or disbled. That includes mental illness, of course.

Mrs. Godzilla

September 25th, 2009
2:18 pm

off topic – breaking

judges dismisses MA GOP suit to prevent senate appt.

Biden swears in Kirk at 3pm

Horrible Horace

September 25th, 2009
2:18 pm

Obama probably telephoned them and asked them to use their influence for an under the table cash kick-back.

This type behavior reeks of Obama and his underhanded ways.

Taxpayer

September 25th, 2009
2:20 pm

I’d vote out every one of them if they were trying to exert pressure on the FDA to go against sound scientific evidence. Of course, I don’t live there. I live in Georgia so I have to vote against the likes of Saxby Chambliss, for example, for similar reasons.

Midori

September 25th, 2009
2:21 pm

thanks for the news, Mrs G.

:)

StinkFoot

September 25th, 2009
2:22 pm

“off topic – breaking

judges dismisses MA GOP suit to prevent senate appt.

Biden swears in Kirk at 3pm”

But of course…forget about the laws when OboboCare is at stake. Its anything goes for Obobo and Loser Teddy.

Just disgusting.

Link Report this comment

Taxpayer

September 25th, 2009
2:23 pm

Horrible Horace

September 25th, 2009
2:18 pm
Obama probably telephoned them and asked them to use their influence for an under the table cash kick-back.

This type behavior reeks of Obama and his underhanded ways.

If you have evidence and you are not turning it over to the authorities, you do realize that you are complicit in the crimes that you purport to have occurred. Do the right thing.

joe matarotz

September 25th, 2009
2:26 pm

New Jersey – what else would you expect?

In the meantime, don’t look now but the pu-pu may be about to hit the platter with Iran.

Mrs. Godzilla

September 25th, 2009
2:26 pm

Stinkfoot

I know you don’t want to hear this but it was all done legally and with the consent of the citizenry.

I know it’s tough, but you can handle the truth.

USinUK

September 25th, 2009
2:30 pm

and in other news:

“The Group of 20 largest economies will permanently replace the G-8 as the main forum for international economic cooperation in a move expected to give greater clout to developing nations, a senior White House official said Thursday night. ”

well done on including the BRIC economies, guys … ’bout time!

http://www.washingtonpost.com/wp-dyn/content/article/2009/09/24/AR2009092404910.html?hpid=topnews

I Report/ Vast White Wing Conspirator (-: You Whine )-:

September 25th, 2009
2:30 pm

We’ll get them in 2010, don’t worry.

StinkFoot

September 25th, 2009
2:34 pm

Enter your comments here

stands for decibels

September 25th, 2009
2:40 pm

I’m going to have to dig a bit deeper than the linked news story to pass ultimate judgment on the four NJ Congrefscritters involved, but beyond a simple “like Jay said” I’ll add that at some point we Americans are going to have to come to grips with the incredibly corrupt manner in which we allow campaigns to be funded.

Unless you’re in a truly safe district, you’re looking at fundraising as your full time gig, and legislating, well… it’s nice to have some clue about what you’re voting on, but it’s not really a prerequisite, now is it?

david wayne osedach

September 25th, 2009
2:40 pm

This kind of Congressional malarky goes on all the time. For many things with no redeemable value. Look at Senator Dodd!

StinkFoot

September 25th, 2009
2:44 pm

I just wonder how many palms were greased by Biden in his bid for the Number 2 spot? Biden may be more crooked than Obama…well then again probably not as Joe is pretty much a dullard.

AmVet

September 25th, 2009
2:48 pm

“All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money.”

The only difference between Democrats and Republicans is the velocities with which their knees hit the floor when the corporations knock on their door. ~Ralph Nader

Fascism should more appropriately be called Corporatism because it is a merger of state and corporate power. ~Benito Mussolini

And the Republicrats or is it Democans keep on stealing from we the people on behalf of their money masters on Wall Street and K Street.

This failed duoploy has to be eliminated.

And these white collar criminals must be imprisoned…

Say What??

September 25th, 2009
2:51 pm

It Bush’s fault. There, I beat you to it.

stands for decibels

September 25th, 2009
2:59 pm

Quick look at this Josh Sharfstein character, a.k.a. The Guy Who Made Public The Stink about this deal, if you’re interested.

I wasn’t aware that there is talk of “split[ting] the FDA into two parts, with [FDA Commissioner] Hamburg focusing on food safety, and Sharfstein running drug approvals.”

Say What??

September 25th, 2009
2:59 pm

Modori said “this is why the right doesn’t believe in criticizing their own party or its members: Hahahahahahaha.

Care to discuss the virtues of Charlie “tax fraud” Rangel or Barney “humping my male page” Frank and those of similar ilk.

jconservative

September 25th, 2009
3:01 pm

“…but all said they had acted appropriately and were not influenced by the money.”

What were they influenced by? Had to be something.

Say What??

September 25th, 2009
3:01 pm

It’s Cheney’s fault. There, I beat you to it.

stands for decibels

September 25th, 2009
3:05 pm

New Jersey – what else would you expect?

Inasmuch as Pharma and medical equipment are a pretty important pieces of NJ’s economy, and it’s not real surprising that these guys would be sympathetic to the urgings of a constituent business, sure. It’s not unexpected.

Is it really quid-pro-quo Corruption-with-a-Cap-“C”?, though? Any more so than business as usual in DC? Dunno, but if that’s the case, at $26,000 in contributions spread between four legislators, these guys are pretty cheap dates.

Say What??

September 25th, 2009
3:06 pm

Off topic, this just in:

Obama: Iran ‘breaking rules’

Wow! Who would have thought? Glad to have such a perceptive leader.

jconservative

September 25th, 2009
3:07 pm

“The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.”

It’s not just the Democrats folks, its the Republicans in charge of the FDA at the time.

Like most scandals in DC this is bi-partisan.

Say What??

September 25th, 2009
3:08 pm

jconservative, amen. Corruption knows no party lines.

Midori

September 25th, 2009
3:11 pm

Say What,

no, I don’t care to “discuss” anything with you.

you need to embrace and recognize the limits of your abilities.

I Report/ Vast White Wing Conspirator (-: You Whine )-:

September 25th, 2009
3:17 pm

Did AmWet really just quote Benito Mussolini?

Fascists of a feather…..

Say What??

September 25th, 2009
4:40 pm

Midori, you go girl! Point fingers at Republicans for corruption while Democrats participate in other illegal and sordid scandals.

Say What??

September 25th, 2009
4:43 pm

By the way, Midori, my “abilities” are presently not limited by the federal govt. You, on the other hand, are probably just waiting to receive your check the first Thursday of next month. Hopefully, our sovereign nation will continue the path of capitalism rather than have socialist representatives limit our abilities by devising schemes to take “care” of people from the cradle to the grave.

Cherokee

September 25th, 2009
6:41 pm

I wonder why conservatives always have to resort to insults about libs being on the dole. Weird, and tactless.

Cherokee

September 25th, 2009
6:42 pm

Especially when it’s pretty well proven that the weatlthiest and best educated Americans voted for Obama in the last election.

N.J.

September 26th, 2009
4:24 pm

Well regarding Obama care, latest polls show that 52 percent of the public trust Obama to get it right, while only 27 percent trust the Republicans in Congress to get it right.

The same poll shows that 2 out of 3 want a public option:

By a margin of 52 percent to 27 percent, Americans believe President Obama has better ideas about overhauling health care than Republicans do, according to a national poll conducted by The New York Times and CBS News. And nearly two-thirds of the country supports creation of a government-run insurance plan, or public option.

http://prescriptions.blogs.nytimes.com/2009/09/25/times-poll-americans-strongly-favor-public-option/

Even better the latest New England Journal of Medicine poll of doctors shows that:

Now, physicians have joined the ranks of the general population in supporting the public option. The New England Journal of Medicine reported just last week results of a poll showing that 62.9 percent of physicians in this country favored reform that includes a public option along with private insurance…

Finally, only 27.3 percent of physicians favored reform that included only private insurance options (i.e., the Baucus proposal).

http://www.reflector.com/opinion/baucus-bill-not-what-the-people-ordered-853017.html

Even of greater interest is who the public holds accountable for the high cost of medical care.

61 percent blame the private for profit health insurance industry.

27 percent blame the federal government and government regulations

As to tort reform, the most recent study of the last 13 years of malpractice cases has found that the number of cases has remained stable. The dollar amount of awards has dropped significantly. And the cost of malpractice insurance and health insurance has gone up. The report concluded that it is it is impossible for tort reform to have any effect on the cost of health care.

N.J.

September 26th, 2009
4:25 pm

What most polls have determined is that the public has noticed one thing about Republicans. They have been yelling and screaming about health reform but have not offered a single idea, other than leave it like it is. This is something the public massively opposes.