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FDA Cites Pressure from Congressman and Inappropriate Approval
Since this blog more often criticizes Republicans than Democrats, there is something admittedly gratifying about a story in which Democratic Congressman are described as corrupt as anyone else.
Equally interesting is that this conclusion was reached by the FDA itself, in a probe spearheaded by Joshua Sharfstein.
It is "ironic," I suppose, that people like Frank Pallone, who have been active against device preemption, would also be active in approving devices outside appropriate FDA review procedures.
So reports the NYT:
http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=1&emc=tnt&tntemail0=y
Thursday, September 24, 2009
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Justice, my greatest fear is that no politician (Rep or Dem) is beyond placing their personal political or monetary advance above those that they serve. I think almost everyone has a price as we have seen time and time again.
ReplyDeleteA FDA void of political and industry influence is the only solution. These two entities are thoroughly untrustworthy when it comes to making decisions that require uncompromised ethics. The question is what organizational structure is required to boot them out of the regulatory machinery?
Politicians rail against each other when they see their opposing party-members take bribe money, but ask them if they would like to change the system to make such things impossible and they become quickly quite.
New Jersey is home to many phramaceutical companies so it should not suprise you that in a State where there are more elected Democrats that these politicians would be corrupted by a key constituency.
ReplyDeleteThe same holds true for New York where the Financial Services sector rules. Who do you think Senator Schumer is thinking about when talk of financial reform comes around.
David
ReplyDeleteThe only way to decrease, not sure we could ever completely remove corruption, would be to develop an ad hoc panel as a secondary review board for new drugs and devices. This panel would be made up of key opinion leaders. The information they would review would be blinded, meaning absolutely no descriptors at all of the company or drug/device. Their only role would be to review the raw data and the outcomes. The FDA would not manage the panel, nor interact with them directly. There would be a third party who would communicate between the parties. This secondary review process would not be able to override the FDA per se, but at least they would be able to corroborate the results. Much like a jury, the panel would have to agree that they would have no direct communications with the industry in this area preceding and during the review. Importantly the members of the secondary review panel should change regularly. So, yeah, in a sense the new drug or device is put on trial - does it do, according to the raw data, what it is and was designed to do?
Any politician (republican or democrat) in these types of situations have to leave office. They have destroyed the trust of their constituents, how then can they be affective?
So, what is going to be done about it? How does this information compensate human beings who have been injured? How can there be retribution when we have a law that protects medical device makers?
ReplyDeleteTonight, "ABC World News with Charles Gibson," will talk about lobbyists and politicians.
Lots to think about....
ReplyDeleteI am less sure that the FDA is beyond repair. This was FDA's own report. There have been times in the FDA's own history when there were people in charge who could and would have have prevented this kind of garbage.
Likewise, another layer of oversight does not seem to me more likely not to be influenced by the "octopus." The octopus has many ways, many friends, many strategies. Full insulation seems to me impossible.
So I would tighten incentives and disincentives on the other side. More definitive, and lucrative, whistleblower support and haven. Criminal and civil penalties against those involved inside the FDA. Public shaming of the relevant pols, as this episode has triggered, and demands for full disclosure up to, and including, election day. That means release of all relevant documents, communications, memos of meetings, staff involved, etc..
No, I'm not surprised it was New Jersey, where much of the octopus lives.
All this said, it is always shocking and saddening when "friends" go bad.
ReplyDeleteThanks to Alicia Mundy's work, we know that Tom Lantos--champion of human rights and the only Holocaust survivor to serve in the Senate--was directly involved in lobbying for approval of fen-phen, apparently in fairly direct exchange for campaign contributions to himself and a son-in-law.
Ted Kennedy, the Lion just passed, worked hard toward maximum extension of biotech patent protection. Mass. is Biotech. Central.
So, I guess what this says then is that we are all willing to put our mothers on the "ice flow" if it means more moolah in our pockets so that we can buy things.
ReplyDeleteThere seems to be more respect for inanimate things then for our fellow human being.
Impeachment of the corrupted politicians is our best weapon. Once people are convicted of these wrong doings then their capital and assets must be seized just as with illegal drug dealers. Looks like it will keep us all rather busy....
Who would have thought that ethics training would be in such high demand. Yet this is exactly what it is going to take to clean this up, everywhere we look lately, people have been used as a means to an end.
When will it be "enough"?
TELEGRAM TO:
ReplyDeleteAMERICAN PUBLIC
NJ CONGRESSMEN, MENENDEZ, LAUTENBERG, PALLONE, ROTHMAN AGGRESSIVELY SOUGHT FDA APPROVAL OF UNSAFE KNEE DEVICE **STOP** DEVICE MAKER REGEN PAID THEM BIG BUCKS **STOP** LAWMAKERS CLAIM THEY ACTED PROPERLY **STOP** AND WERE NOT INFLUENCED BY MONEY **[OH STOP]** DR. SHARFSTEIN ADVISED PATIENTS NOT TO PANIC **STOP** AMERICANS ARE NOT WORRIED **STOP** WE ARE TERRIFIED **STOP** TELL THE CONGRESSMEN TO RESIGN” **STOP** CORRUPTION MUST END **STOP** **STOP** **STOP**
Our usual discussion, Former. People like Tom Lantos spent much of their lives being guest speakers at ethics classes. Indeed, one of his better known moments was when he called some of his fellow Senators "moral cretins" for not agreesing with his position on Darfur.
ReplyDeleteSo I guess I still don't see moral education, in any form I know it, to be much help. The issue/problem is deeper than what education touches. I think it is a combination of "the system," its incentives and disintenives, the various ways bureaucratic organizations can neuter moral sensibility one genuinely has (being a team player, task segregration, the ease of denial--inward and outward, etc.), and the various forms of narcissitic character (especially among pols and other "successful" people) that allow almost anyone to do anything.
Lantos was, indeed, an exemplar in certain of his commitments. And he was a self-absorbed scuz in others. And everything else in between. Like a good many of us.
This brief excerpt from the Wiki article on Lantos:
ReplyDelete"Darfur
On April 28, 2006, Lantos and four other Democratic U.S. Representatives (Sheila Jackson Lee, Jim McGovern, Jim Moran, and John Olver), along with six other activists, took part in a civil disobedience action in front of the Sudanese embassy in Washington, D.C. They were protesting the role of the Sudanese government in carrying out genocide in the Darfur conflict and were arrested for disorderly conduct.[25]"
Neither his commitment to direct protest (civil disobedience) the genocide in Darfur, not his being a Holocaust survivor in which he actively saved many others in collaboration with Raul Wallenberg, prevented his also being an accessory to the injury and death of thousands, mostly women, in connection withhis interventions to help get fen-phen approved (knowing how serious were concerns about its safety).
If that doesn't tell us something about the limits of moral education, including the kind that is lived, I'm not sure what does.
Life is complex.
Looks like Sen. Menendez is still hanging out with his pals, as he was one of three Dems to join the Republicans on the Senate Finance Committee in voting against negotiating with pharma for higher discounts for Medicare drug prices.
ReplyDeleteThis is reported as "big victory" for President Obama.
Who, then, are the big losers?
So reports the NYT:
http://www.nytimes.com/2009/09/25/health/policy/25health.html?_r=1&ref=health
Hey Justice,
ReplyDeleteYou are right, life is complex. How do we as a society, make justice and fairness in all our dealings a priority? How do we get everyone to see their fellow human beings as mirror images of themselves, and therefore when you harm and endanger them you are doing this to yourself.
Maybe there should just be disclaimers on everything. i.e. on the rx sheet before you fill the prescription: " Caveat Emptor - your doctor has prescribed this medication to you because you may or may not have a certain condition. As a consumer it is your legal right and indeed your duty to fully investigate your doctor and this drug. Please refer to the following website where you can look up your doctor and see how much CME funding/honorariums he/she has received, along with any outstanding law suits against this drug company, review the FDA raw data on this drug, find out which politicians lobbied for the approval and connect with other fellow human beings who have had experience with this drug for treatment of this illness. You will also be able to look up the basic biology of your disease and be guided through a decision making process to help you explore the rationale for filling this prescription. Please give very careful consideration to all the information you collect and discuss it with your family and loved ones, consult a life coach. Be thorough; harm inflicted with this drug can be life threatening and in the very least lead to other diseases.
Remember you are just a consumer, it doesn't really matter to anyone involved in your health care whether you actually get better or not, but they do want you to consume. So ask yourself, can you live better without this drug/treatment? Good choice, bad choice - YOUR choice!
If you still fill the prescription anyway and something goes wrong, who do you get to sue?
Glad you got to the last sentence--I was concerned that consulting with a lawyer was not on the label.
ReplyDeleteBut seriously...I think the pathway is mainly institutional rather than moral-educational or mainly "arming" consumers to defend themselves in a system that so easily rewards (a few) for negligence, indifference, and greed.
How to survive in the meantime? Probably some of what you say, even ironically. I _do_ look up my own prescriber's relationships with companies, as well as whatever reliable info I can find about the product itself.
Regarding the congressmen, like robbers, they should be dealt with criminally. The problem is lawmakers make the laws, and find loopholes in their laws that allow them to get away with this crap, i.e. PAC.
ReplyDeleteI bet a “man on the street” interview would reveal that most people have no idea what a lobbyist is or what they do. But ask them how they feel about lawmakers taking money and you’ll get an all American answer.
Americans depend on our government to protect them, but our government has let us down.
Donovan, good to see you!
ReplyDeleteOne problem is that people have become so cynical about pols in general, that those who are consistently principled (and there are a few) are lost in the herd.
Thanks Eeleck.
ReplyDeleteAgree I with you re: politicians. They are in desperate need of a good shepherd. Here’s something I came across on Yahoo:
“A politician taking bribes is considered by far the greater sin (chosen by 37 percent of the respondents) when stacked against extramarital affairs (just 2 percent).” - CBS News poll, Aug. 2009 http://news.yahoo.com/s/ap/20090928/ap_on_re_us/us_tv60_minutes_vanity_fair_poll_2
Well, I'm not sure this is quite taking bribes, at least directly. Perhaps it's a polite form, like cigarette smoking is a polite form os suicide.
ReplyDelete