Quote Of The Week: Skinning An FDA Commish
20 CommentsBy Ed Silverman // April 23rd, 2008 // 10:04 am
The chairman of the House Energy and Commerce Committee made his stinging remarks yesterday at a hearing held to review FDA oversight. As The RPM Report notes, Dingell (to the left) lost his patience with FDA commish Andy von Eschenbach, who once again refused to say how much money the agency needs to do its job, particularly inspect facilities. And so Dingell offered this:
“I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can’t maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don’t have resources.”
Before Andy could say much, Dingell continued: “You are carrying water for an administration that has not given you the resources that you need. This committee wants you to have the resources that you need to do the job you have to do to protect the American people.” He then brought up the deaths and adverse events related to Baxter’s contaminated heparin. And started shouting. “You presided over this because you do not have the resources to do the job that you need to do. How much money do you need to do the job that you are supposed to do?”
Von Eshenbach (to the left) remained calm, but didn’t do much for his cause: “Mr. Chairman, I would like to have the resources that would enable us to do a systemic overhaul of the entire process, not a figure that’s related to a cost per inspection times the number of facilities.”
Dingell repeated again and again, slamming his hand against the desk, the question of exactly how much money FDA needed for the overseas inspections, RPM writes. “You have one fine scandal going on, you have others going on with regards to fish and fish products and you simply are absolutely incapable of addressing your responsibility.”
Hat tip to The RPM Report
harpy
Heckuva job, Andy!
James
He fell off the cabbage wagon? No wonder he wants tighter FDA regulation.
Was that wagon importing cabbage? I’m sure there were HACCP violations if he fell off. And why was he allowed on the wagon to being with?
Lots of questions–might need to get the DOT involved as well.
Justice in Michigan
As a constituent of Rep. Dingell, I am heartened by his taking it to AVE. But I am disheartened by his refusal (so far) to take up the issue of FDA preemption.
If the agency is as he exclaims, then why is he apparently willing to allow the other side of our institutions of consumer protection to go down the tubes? (Neither of which is close to what it should be, but both of which are far better than either one alone.)
Heparin will look like a very small picnic compared to the disasters inevitable under a preemption regime.
So, in the end, I am not impressed. Not at all.
Justice in Michigan
Re: James’s comment, I must say I have never seen a cabbage wagon. I assume it is a device for carrying around heads. Perhaps the heads of former FDA commissioners. You probably have to think French Revolution/Reign of Terror to get the whole image.
“Carrying water,” on the other hand, I like. It has the right balance between imagery from football, battlefields, and prostate hypertrophy - a real guy thing.
If I were falling off a cabbage wagon, I would want to move on to football asap.
LILLI
Dingell and all elected officials should know about all our government agencies, they receive reports from the Government Accountability Office. Every government agency reported by the GAO advises congress that the government agencies are not responsible and cannot account or make qualified reports. In fact, all government agencies are unablre to report a legitimate account of funds. But more important is that congress must protect the people against corruption in the medical profession. Thousands of medication cause fatal death and are not reported because it involves the greed of power and money. Doctors do not report medication adverse errors.
Melody
Justice in Michigan–
I was sure the cabbage wagon is a distant cousin of my turnip truck.
James
LILLI, what makes you think they would pay attention to the reports they receive? Please don’t tell me you believe they actually read those things?
Their staff of LAs, LCs, LDs and interns read them, then select a few bits that they know will play to the respective legislator’s interests and desires to grandstand. They congresspeople rarely even understand the reports–they know just enough for their talking points.
Living in the DC area, I have more than a few friends who work for these people. These are the same people who want investigations into whether the New England Patriots cheated, but can’t get their act together when it comes to wars, budgets, transportation or food safety.
As Justice pointed out, they’re missing the boat on this issue, and in my view, almost every other. Don’t look to Congress to safeguard your drugs–you’ll be left wanting 10 times out of 10.
But I think Justice’s reference to prostate hypertrophy is most apt–when Congress is involved, a prostate exam is the best metaphor.
LILLI
jAMES
So our govenrment is Corrupt. What is the awnswer? Allow the corruoption to continue?
Jaynesday
The really sad thing is that this issue of lack of inspection of overseas facilities is just the tip of the iceburg for the FDA… or the only part that was picked up on by the public in liew of the China recall issues. I think it’s been posted before but read the long list of self proclaimed FDA deficiencies that are on the FDA’s own site.
YOU MUST SEE THIS IF YOU HAVEN’T ALREADY!!
Go to the FDA site:
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
Under Briefing Information look at the first item:
2007-4329b_02_01_FDA Report on Science and Technology (pdf)
You will see what I mean. Honestly it is scary to know that this level of incompetency exists in the FDA.
I say that Von Eshenbach was calm because he was thanking his lucky stars that Mr. Dingell *only* wanted to discuss the cost for improving inspections. AVE must have been chuckling to himself. He may be hesitating to give a number because he knows that addressing this small FDA issue will come nowhere close to fixing the FDA.
I also agree with Justice and others that Mr. Dingell must only be looking for favorable press. He knows that the hot button is bad overseas products. Fixing the FDA? Dealing with the hide and seek policy called Preemption?.. we’ll deal with that when the voters find out about it.
Justice in Michigan
Jaynesday - I _hope_ we’ll deal with preemption when the voters find out, but - as relayed - it will take a lot of work. We’ve been doing that work in Michigan for thirteen years. We haven’t won yet.
Also agree that Heparin and related is the tip of the iceberg. We’ve talked before here about FDA funding. It is not because FDA hasn’t asked. Janet Woodcock (yes, I know not everyone’s idea of a hero ) virtually begged for $10 mil a few years ago from Congress for post-approval drug safety. She got squat.
So if Dingell wants to invoke his forty years on Energy and Commerce, great. But he should have gotten off the cabbage wagon some time ago.
James
No, LILLI, I don’t want the corruption to continue. This is why, if you were to go through my comments here, I have argued consistently against the growth of gov’t. Why, when they fail us time and again, do we throw even more money at them, hoping against hope that this time, it will be different?
I argue for personal responsibility. Learn what you are putting in your body before you do so. Don’t trust the FDA to make our drugs safer.
If a drug company misrepresents their drug, we should be able to pierce the corporate veil, and hold individuals responsible. No preemption. No limit on damages that can be awarded in a tort action.
If we do these two things–put drug companies and execs at peril if they don’t tell the truth, and expect people to not just trust doctors, the FDA, and drug companies to protect them, we could have a much, much smaller FDA. And you keep more of your tax dollars.
Yay!
Kerry
I wrote an op ed sometime ago (two months ago) and sent it to a dozen major newspapers. Nobody would run it. One of the things I set forth therein was the frustration of Congress (DIngell) in the fact that von E previously refused to tell Congress what amount of funding they needed to properly accomplish their mandates. Von E would not tell him.
Now for a second time Von E has refused to answer the question again.
The first time the esteemed Peter Barton Hutt spoke on behalf of the need for more funding for the FDA. Mr. Hutt indicated they needed a lot more funding. Believe it or not, I agree that the FDA needs more funding.
The problem seems to be that the current FDA comisioner is an absolute moron. I am convinced the guy is a complete idiot.
AS LONG AS THIS IDIOT IS AT THE HELM NO AMOUNT OF MONEY WILL MAKE THE FDA FUNCTION PROPERLY.
Mr. Dingell needs to start calling for his resignation. If he does perhaps CareToLive will not hold the planned demonstration outside his Dearborn office on May 30th.
Help the patients. Resign Andrew von Eschenbach. Resign now!!!!
Money is just part of the problem. For FOIA requests the requester pays the cost yet the FDA still cannot timely comply with federal law. The FDA is poorly managed and arguably not controllable by this “leader” who is nothing more than an incompetent figurehead.
It has been nine months and the FDA is unable to comply with federal regulation and properly respond to the CareToLive citizen petition, even thought 83 men a day are dieing to hear.
RESIGN ANDY!!
LILLI
James
Whom have you argued with?
It is our elected and appointed officals that must be stopped from being infuenced by the greed and the poweer of the medical profession, healthcare industries, hosptials and the pharmaceuticals. Too many lives are being lost because of these conditions and the medical profession does not tell the truth.They must be discipined. New Jersey has a Patient Safety Act sponsered by Sen. Joseph Vitale, it is only in name only and does nothing for the patients, but protects the medical profession. If we write and call our representatives things will happen, yes there is corruptiion in our government.
Justice in Michigan
Kerry - Are you also in JD’s district? It looks like it may be a more interesting election for him this year than usual. Not because of his oponent (whoever that is), but because of his constituents.
I won’t post the numbers again, but the FDA budget is miniscule compared with other regulatory agencies. And it has been that way for a long time, through both Dem and Rep administrations. Beyond the impact of lobbyists, etc., one can only conclude there is some kind of national death wish.
Behind AVE, there remain the rest of senior management who have also been there a very, very long time. So it will take a good deal of house cleaning.
Justice in Michigan
Our Supreme Commander will probably include reference to it, but the brand new NEJM contains a commentary by Alistair Wood on “Kicking the FDA.” It is immediately germane to the discussion here. Here is a sample passage:
“It is easier to attack the FDA than to assume one’s own share of responsibility. The press, for its part, frequently reports legislators’ criticisms of the agency without providing any analysis of their voting records on FDA appropriations. But the bigger scandal is Congress’s grossly inadequate funding of the agency, which demands swift and decisive action. No longer should our legislators be able to publicly excoriate FDA employees while ignoring their own complicity.”
Amen.
James
OK, LILLI, feel free to call and write your reps until your heart is content. Then a lowly member of their staff send you back a lovely form letter signed with their AutoPen, and the reps will continue to do what those who make the big campaign contributions tell them to.
They’ll make the occasional fist-pounding speech, sprinkle in some down-home rhetoric for the rubes back home, and then send out a glossy flier trumpeting “I’m working hard for YOU!” Then look at the bottom, in small print, and note that the brochure was paid for with your tax dollars.
If Congress really wanted to change things, they would implement the solutions I noted above. Think that will happen? Hell no.
I’m moving on, LILLI–if you want the last word, you are welcome to it.
Lisa Van S
James,
You sure know your politics,.. and I cant agree more with your summary of those loveley politicians.
Melody
Lilli, James–
Contacting congresscritters may do little good. But, if the contact is written, individuals have proof (if it can ever be used) to show that the CC cannot claim “I didn’t know.”
Like Lilli, I keep writing . . . and feel “lucky” if I get an automated response (usually, I get no acknowledgement). But first, I’ve ‘vented’ my frustrations (a healthy thing, no?) and I’ve added to the papertrail that precludes claims of ignorance.
Letter writing and voting seem to be our only course of action (short of revolt) . . . and we all recognize that vote-counting is suspect.
Justice in Michigan
If anyone sees this …
As is clear, my view of influencing reps is also not sanguine. But if _enough_ people write, and write consistently, and show up at rallies, and ask the right questions when the press is there, and so on, and so on….Things _can_ happen.
It takes organization, perseverance, and numbers.
Tony F
How much money does it take for the FDA to ACT upon written, DETAILED complaints forwarded to them of possible wrong doing?
Hello, Dr. Andy!!!!
As I’ve written time and again, including to the FDA’s Office of Investigations and to the HHS’s Office of Investigations, and I contend an investigation of Dr. Howard Isadore Scher of Sloan Kettering in NYC needs to be done for these reasons:
In order to sit in judgment of Provenge, a new immunotherapy treatment for TERMINAL prostate cancer victims, Scher certified to the FDA via his application that he had, but 3 Conflict of Interests. Internet research has shown he has possibly as many as 17–itemized below.
Provenge is applying for approval to treat TERMINAL cancer where the ONLY approved alternative treatment is Taxetore, a highly toxic chemotheraphy which is said to KILL between 1 and 2% of the patients it’s administered to.
Provenge, in stark contrast, has mild chills/fever or flu like symtpoms in “some” patients for 1 or 2 days only. It is an immunotherapy which seeks to rev up one’s own body’s immune system to fight the cancer. Provenge requires a blood extraction every two weeks over a 4 week period–3 times–with the treated blood products re-infused a couple days following extraction after being treated.
Scher has been alleged to have as many as 17 (SEVENTEEN) Conflict of Interests as found on the internet last year after he wrote his letter urging FDA non-approval–which, also coincidentally–found his CONFIDENTIAL FDA letter along with 2 others leaked outside the FDA–again with NO investigation being done as to who leaked these letters.
Scher’s alleged 17 Conflicts of Interest are:
. These 17 (SEVENTEEN) have been found on the internet for Scher.
NOTE particularly items 1 & 17
1. NOVACEA: grants & research support; STUDY CHAIR of DN-101 ;
…. and DIRECT COMPETITOR to Provenge
2. GPB BIOTECH: financial conflict of interest per Scher in MedPage
3. PHARMION: financial conflict of interest per Scher in MedPage
4. SANOFI-AVENTIS: grants & research support
5. BRISTOL MYERSSQUIBB: consultant, grants & research
6. MILLENNIUM PHARMCEUTICALS: grant of research support
7. COUGAR BIOTECHNOLOGY: principal investigator; advisory board;
8. INNOVIVE PHARMACEUTICALS: principal investigator
9. INFINITY PHARMACEUTICALS: principal investigator
10. BIOGEN-IDEC: jointly held stock with spouse
11. PFIZER: jointly held stock with spouse
12. GENTA: scientific advisory board (as of Mar 6, 07; since removed but cached)
13. CONFOMA THERAPEUTICS: scientific advisory board
14. DEPARTMENT of DEFENSE: Principal Investigator PC Clinical Trials-P1 and P2
15. AMBRILIABIOPHARMA INC: Principal Investigator PCK3145, Phase I/II
16. MEDIVATION, INC: principal investigator MDV3100
17. PROQUEST INVESTMENTS, Board of Directors, Advisor. Novacea Investor
So, what’s holding up the FDA and the HHS from investigating allegations of federal law violation by Scher???
Specific allegations have been made; no known investigation has been done.
Why not, Dr. Andy?
Not enough money??? Not enough manpower?
That’s baloney simply because we’re talking about TERMINAL prostate cancer patients… not some treatment for a hang nail.
Resign, Dr. Andy, and let someone be in charge who’ll take action to restore the FDA’s tarnished image and get to the bottom of any illegal activities–such as leaking CONFIDENTIAL FDA letters to outside publications and investigating SPECIFIC allegations of wrong doing.