FDA: NJ Politicians Pressured Them Into Approving Unsafe Medical Device - After They Received Large Donations
I wish I could say I was surprised, but pharmaceutical companies and medical device manufacturing is very big business in New Jersey and when those companies say jump, elected officials say "How high?" Wouldn't it be nice if they put as much thought into the health and safety of their constituents?
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.
“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.
just another example of capitalism gone wild. never mind the facts. money/profit rules. this is just more buyer beware strategy.
Are there no prosecutions for these criminal actions.,.
That's right Attorney General Mukasey said that all crimes are not crimes to be prosecuted.
So Holder will follow the same path as Obama has taken and not prosecute the republcans or corporate criminals either...
None
Okay, I've had it. I'm through with that type of corruption, and I'm going to end it now.
So, if you're a senator or congressman, and you actually care about the USA and democracy and the US Constitution, then follow this simple plan. Let the lobbyists woo you. Promise them the world. Promise them you'll be their bitch. Take the money.
Then vote your conscience. Sometimes this will involve going back on those promises. Fuck 'em. Apologize if you like. Tell them you forgot. Or they were outbid. Ask for more money, and keep voting your conscience and the will of your constituents (the human ones, not the corporate ones.)
Eventually, those jackasses will get the point that lobby money is wasted. Don't worry about your gravy train... This will take a few years.
For those politicians who don't play this game, the ones that companyies aren't screaming about... We won't vote for you again. If some big corporation is paying for dirty ink on you, however, we'll always vote you back in.
There. I fixed it.
http://www.nndb.com/people/870/000047729/
Be sure and read down to "Best Quote"
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
Good quote. Too bad it isn't a part of the oath of office.
.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
...and he tried it.
jerk reaction.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
Capitalism gone wild....not so much. Capitalism can work if people we more ethical.
That's a big if. Human nature is such that greed and envy are going to override ethical precepts for a sufficient proportion of the population that capitalism can only work with oversight and regulation.
Our founding fathers knew that within the government you need co-equal branches and a system of checks and balances to prevent tyranny (although the system is breaking down now in some very serious ways). The same is no less true for the economic system--maybe even moreso. Instead of hoping folks will be more ethical, we need to accept the need for a balance of power provided by oversight and regulation. The Republican siren of the perfection of the free market is nothing but a pipe dream.
who proved they knew where their bread was buttered when they
winked at their ethical precepts and bowed to slavery, left the slave trade in place until 1808, and counted some people as three fifths human.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
your response concerning the decisions made by the framers of the Constitution is too facile. Read James Madison's "Notes of Debates in the Federal Convention of 1787," and you'll see that the compromise about slaves was reached after much argumentation, including arguments against slavery that we would make today.
Clearly the issue of slavery and how it was dealt with in the Constitution has been one of the worst aspects of American history, leading to the Civil War and many of the issues of race and racism that we still deal with today. But to think the framers were unaware of the issues and blithely declared slaves to be 3/5's of a person is not correct.
It also does not reduce their wisdom in assessing human nature and thereby seeing the need for competing co-equal branches.
you get it. the idealism of capitalism is fine. the reality is another story. without rules/regulations capitalism has no boundries for profit. people/corporations will cheat and seek the unfair advantage. from steriods in sports to ghost writing scientific research papers for PHarma research.
The wave of the future is socialism. It is the only way to deal with worldwide overpopulation.
once the Cons get ahold of this story, they're not going to let go.
government run health care!
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
These 4 Dems are hardly the whole party. Although there are more like them there are also progressive Dems out there too.
This has nothing to do with "government-run" anything. It has to do with shitty politicians taking bribes from one of many shitty pharma companies.
would be coming from the CONS was going to sound like.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
they shouldn't let it go and neither should we. Wrong is wrong no matter the stripe.
go to prison for this? They should! Then NJ can get some actual progressives to give health care to citizens instead of handouts to corporations.
Maybe kinda small-time for him nowadays, but this was the type of issue he excelled in tackling.
"Parachutes are allowed in checked or carry-on baggage, but may not be worn in flight."
---Southwest Airlines
DemocRats looking out for the little guy.
The pols did what their supposed to do for their rich contributors, likely without a care whether the company had a dangerous product or not. Do you wonder if the harmed patients had complained to these politicians they would have gotten the time of day?
The FDA bowing to pressure was more despicable since they are the ultimate watchdog.
The FDA are the guilty ones here. They shouldn't make any decisions that their own scientists won't back up.
This buck stops at the FDA.
These pols are like little children begging Mom and Dad for something that Mom and Dad knows is not in their best interest...
Then Mom and Dad GIVE IN, let the begging, whining children have their way and things don't turn out so well with the idea (camping during a thunder and lightning storm anyone?).
Oops. Johnny and Susie got killed by a lightning strike!
Mommy and Daddy should have gone with their first instincts after they saw the weather advisory.
"Sorry Johnny and Susie. NO CAMPING THIS WEEKEND DUE TO BAD WEATHER!!!"
"SORRY POLITICIANS! WE WILL NOT APPROVE A PRODUCT THAT OUR SCIENTISTS DEEM IS NOT SAFE/EFFECTIVE FOR THE PUBLIC".
Personally, I'd like all the parties involved in this one to go down in flames. And obviously these types of practices should be banned.
"The US has an army of 90,000 soldiers in Afghanistan and is spending $100bn a year, but has still been unable to defeat 20,000-25,000 Taliban who receive no pay at all." - Patrick Cockburn
Almost all scientific research is controlled by corporations. They are the ones who are funding it. My friend had to go to Europe to finish her masters because she wanted to be able to do some actual science. Sad thing is that our government scientists were gutting during the last administration and the ones that had any independent thought were fired. Science in the US is all politics all the way through. Beware of any research coming from the US and find out who is funding the study. It gets really sad.
This is much more common than you know. However, until this Bush-RAVAGED country puts bushco on trial, nothing, and I mean nothing, really seems quite as bad as the fact that they are all allowed to run free like feral cats.
NEVER FORGET BUSHCO DESTROYED OUR COUNTRY.
http://www.time.com/time/magazine/article/0,9...
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
His vision of Fascism coming to life. A system where the common folk are considered inferior, because they are poor, or have principles and morality. Where the rich get richer through bribes, graft, and corruption, and the Corporations run the Government, for the benefit of themselves.
A system built for, and by, the Mafia. It's just that they figured out how to infiltrate Wall Street, and now REALLY run things.
There is no Left wing in this country. Both the Dems , and the Repubs, are corporate fascists, of the Business, by Business, for Business.
Those who do not remember history, are doomed to repeat it.
People remember the past TO repeat it.
What we need is to learn from past mistakes. (even then we will repeat some)
"I know that there are people who do not love their fellow
man, and I hate people like that! " ~ Tom Lehrer (1928 - )
sequels.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
is funny!
Yo, Ricky, yoo ded et!
Campaign finance and lobby reform is screaming at us all.
We have to get the big $$$$ out of politics. How many times has it be proved money = corruption. It doesn't matter party, ideology, geographical locale - enough is enough.
"I know that there are people who do not love their fellow
man, and I hate people like that! " ~ Tom Lehrer (1928 - )
Yes, but where do you get money to fight for reform?
Reform lobbyists?
(jk)
"I know that there are people who do not love their fellow
man, and I hate people like that! " ~ Tom Lehrer (1928 - )
the reform lobbyists.
No wonder we are the most corrupt state in the nation!!
I can't wait to get out of here. It's such a joke now that my friends want to run me for town council just to see if I can win.
dead?
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
The position only pays $3000 a year, so they probably do wish me dead!!!!
of said town. They handle garbage contracts I presume?
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
youuuuuuuuu betcha!
not to mention various stimulus contracts.
that comes to mind is Crestor. I remember watching C-SPAN a couple years ago and there was someone from the FDA (ex-FDA) saying that Crestor and other drugs had been rushed thru the process and that he himself wouldn't take those drugs. People sure will do the right thing if they are just given the chance.....
The NY Times article doesn't make clear what kind of pressure these four congresscreatures exerted on the FDA. Did they bribe someone there or what?
you question whether a reporter who is spoon fed a story connecting an
inquiring politician to his campaign finance disclosure list to a bureaucratic decision has to offer proof or even clarity?
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
Placed a favorite horses head in their beds . . .
(wait a minute - maybe that was a moive)
"I know that there are people who do not love their fellow
man, and I hate people like that! " ~ Tom Lehrer (1928 - )
it had sequels.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
No tolerance for crooks, no matter what letter they put in front of their names.
based is that there is nothing to indicate what, exactly, the nature of the "pressure" was that made it unprecedented. As the Time magazine article I linked to earlier indicated, the FDA Commissioner, a Bush appointee, was noted to favor prompt regulatory approval. His role is not given much play here.
"I mean Romney is the most conservative on illegal immigration and I don't think Ronald Reagan could get elected in California today."
Ann "Clipped" Coulter
You'd never ask what party a murderer is because it has nothing to do with the crime.
Makes no difference what party - crime is criminal.
Put a "C" for convict after their names.
"I know that there are people who do not love their fellow
man, and I hate people like that! " ~ Tom Lehrer (1928 - )
I am shocked, shocked I tell you!
statusquObama, change you can only pretend in
Those poor, poor
corrupt bastardFDA administrators werebribedforced into doing something against their better judgement by thosecorrupt bastard polscorrupt bastard pols who were givenbribescampaign donations by thosecorrupt business typesconstituents.Tsk Tsk!
Next case…
Federal Reserve offloads $500 billion to foreign accounts and bankster buddies…
Nobody home but us unemployed would-be wage slaves…
Brother can you spare a dime…
statusquObama, change you can only pretend in
We need to redefine how politicians get money for their next campaigns.
It is well known that job one with most politicians is to get re-elected. It is therefore very tempting to take advantage of the current system of laws allowing questionable campaign "donations" from corporations (commonly knowbn as "bribes" in more than a few cases.) This appears to be one of those cases. Given the politicians involved here, note that even democrats are not above craven greed.
Public financing of elections is becoming more and more of a need, and current law allowing the consideration of "corporations" as being equivalent to "persons" must be changed.
We are quickly becoming equivalent in many respects to those countries we used to consider as "banana republics".
Public Campaign Financing is necessary if we want to see the kind of change the majority of citizens in this country want to see. If we had public campaign financing, we would already have universal health care coverage for everyone.
Do not give another dime to the Democratic Senate Campaign Committee (DSCC) or the Democratic Congressional Campaign Committee (DCCC) AND tell them you will not until they pass public campaign finance reform legislation. I would say this should go to the Republican donors as well, but anyone paying attention knows the Republican party is for corporate feudalism. They are a lost cause.
Why not focus on passing such legislation at the state level. This is probably easier to achieve as several states have already passed similar legislation, and we are starting to see the results as their legislatures are becoming more diverse and representative of the people they represent.
It's particularly sad that this doesn't even surprise me. Less so that it happened with Bush's FDA thanks to the generous help of Democratic congresscriminals. Though there's a shred of hope in the fact that at least the FDA is fessing up to this now.
It's also nice to note that when Democratic congresspeople do something horribly wrong Crooks and Liars shouts about it just the same, with a nice bolded paragraph. No accidentally changing the "D" to an "R" as soon as they do something wrong like some major news networks in reverse.
the two basic paths to approval for a medical device are the Pre-Market Application (PMA), analogous to the New Drug Application (NDA) for drugs, and the pre-market notification process. The pre-market notification, or 510(k), process is used to gain Food and Drug Administration (FDA) clearance to market a medical device that has been determined to be “substantially equivalent” to another, previously cleared predicate device. FDA guidances make clear that “devices which do not have the same intended use cannot be substantially equivalent.”[1]
In determining substantial equivalence for a new device, the FDA’s guidances state that the agency’s “scientific expertise enables it to exercise considerable discretion in construing intended uses.”[1] Different indications are permitted, as long as the modifications do not present questions of safety and effectiveness different from those posed by the use of the predicate device.[1]
Important to note: According to the FDA, the agency “has not previously cleared a surgical mesh device for this specific indication.”[2] The Menaflex device is “to replace or repair damaged soft-tissue in a weight-bearing, articulating joint.
In order to ascertain whether the Menaflex device could “withstand the functional demands placed upon it over a multi-year period of time prior to complete resorption,”[3] the FDA asked the company to compare the tensile and suture pull-out strength of CS to that of a human meniscus. The company instead compared its product to a dog meniscus; as it happens, the suture pull-out strength of CS is notably weaker than dog meniscus
I provided some but you read entire testimony here:
http://www.citizen.org/publications/release.c...
Crimes like this should require the death penalty for the politicians, the lobbyists and the heads of the corporations involved.
...and the Mafia (Cosa Nostra) is 100% Pure Unrestrained Capitalism.
May the Capitalist United States soon perish.
but unfortunately, all these politicians were Dems.
have the DOJ appoint a special Prosecutor, now Maximum sentence with FINES and JAIL time NO plea bargaining. Immunity for the FDA regulators that Blow the Whistle and a strong warning to those Indicted anything that even looks like a accident and they get bail revoked and it is HARD JAIL time NO Prison negotiation, now at the same time go after the PUKES in the PHARMA Industry and Medical device Industry a failure of the Government to even attempt and go ahead with this means they are OWNED by these companies.
The company paid the four corrupt politicians to pressure the
"Spine-Less" FDA managers to approve a faulty designed device.
Who suffers: The American people. The corrupt politicians, the corrupt Company personel and the Corrupt FDA Managers get off scott free and the american people having the faulty appliance installed wind up in the HOSPITAL NEEDING SURGERY!
Ain't this a wonderful country!!
and the FDA managers wa
Quid quo pro bribery. Influence peddling. Denial of honest service. Don't care if the belong to the wholly wned Democratic Subsidiary of the Corporatist Party or the wholly owned Republican Subsidiary of the Corporatist Party. No matter who sold us down the river, we still got sold.
God, but I hate a crook. Nothing lower than a betrayer of trusts.
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