Stupak To Obama: Just Say No To Woodcock
39 CommentsBy Ed Silverman // December 5th, 2008 // 7:02 am
Bart Stupak, a Michigan Democrat who holds a key post on the House committee that oversees the FDA, wrote President-elect Barack Obama to urge him to to avoid naming any current FDA officials to lead the agency, even temporarily. And he made a point of singling out FDA deputy commish Janet Woodcock, according to The Wall Street Journal.
Congressional aides tell the paper that Democratic officials have discussed naming Woodcock, a longtime FDA official, as interim head after FDA commish Andy von Eschenbach leaves next month. And pharma lobbyists have also floated Woodcock as either interim or permanent FDA chief (here is Stupak’s letter).
But in a letter this week to Obama, Stupak wrote, “I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA. Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for.” He called for a “complete change in the FDA’s leadership,” according to the Journal.
The FDA has been harshly criticized by both Democrats and Republicans, and Woodcock, who heads the drug safety division, has been involved in several controversies, the paper notes. These include contamination of the Heparin blood thinner from China; the withdrawal of the Vioxx painkiller and delays in approving the Plan B contraceptive for over-the-counter sale amid political pressure.
Stupak called for Woodstock’s resignation this year during the heparin scare, and the ranking Republican on the committee, Joe Barton of Texas, sought an investigation of the FDA. He also cited Woodcock for failing to disclose some meetings with pharma representatives as required by federal law, the Journal writes, which her office called it an administrative error.
Woodcock’s supporters include other Republicans in the Senate and House and some Democrats, as well as members of the medical community. Jeffrey Drazen, editor of the New England Journal of Medicine, tells the Journal that “it’s clear that she’s made some mistakes,” noting the long delay in the removal of Vioxx from the market. But he called her a “smart, capable leader” who is able to learn from her errors. “Someone’s going to have to run the agency while they decide on a commissioner.”
For her part, Woodcock says she set up a system for reporting adverse events with drugs and said of her critics: “What have they done for safety? Look what I have done.”
Richard Adams
“Look what I’ve done.” Indeed. What she has done is establish a consistent pattern of kowtowing to big Pharma. Her favorite initiatives are and have been thinly veiled moves to deregulate. It has been apparent for years that Dr. Woodcock believes that her mission is to transform FDA’s relationship with big pharma into a partnership.
On the other hand, she has imposed a hiring freeze on the Office of Generic Drugs at the same time the rest of the Agency is frantically engaged in hiring some 1600 new full time employees! When questioned about this matter, she (cynically) replied that OGD couldn’t hire beyond its ceiling!
Woodcock regards the Congressional overseers with disdain, if not contempt, referring to them in internal meetings as “those geniuses on the hill.” This lack of regard for Congress has been made obvious by her lack of preparedness for testimony, frequently answering questions with “I’ll have to get back to you on that.” She does not ‘get back’ nor does she request the company of career FDA’ers who could answer the questions, most likely because she would not like their answers.
Of course pharma supports her nomination for commissioner. That fact alone should disqualify her.
Lisa Van S
Ed,
Ms Woodcock,.. a woman who couldnt find her way out of a paper bag, says in the last paragraph, she set up a system for reporting adverse events with dugs. Do you have any idea as to what system she is refering to?
Anon.
Richard,
Good comment about Woodcock and the hiring ceiling with OGD.
I was at a talk where one of the other FDA Sr. managers Russ Abbott, who’s in charge of the money at FDA, said that Janet had always told him to ignore ceilings for hiring for the new drug reviewers or anything else she was pushing.
harry
Fire her. In any other job she would be long gone. accountability to us the public who pay her and her cronies to protect us from defective drugs. The FDA has absolutely failed in this regard. If there is not a change in the FDA, Obama’s administration will be seen as weak; are up against one of the most powerful lobby groups in town. If this administration can’t stand up to the FDA/drugers, what about the other tough stances required to steer the US in a different direction.
Salmon
“For her part, Woodcock says she set up a system for reporting adverse events with drugs and said of her critics: “What have they done for safety? Look what I have done.””
Yes, but consider possible motives.
On Feb 8, 2008 Medscape released an article on detecting and reporting suspected AEs which was paid for by PhRMA entitled “Turning Adverse Drug Events into Better Patient Care”. There are also articles in NEJM and it’s well known that new drugs come from understanding biology of the outliers who have serious reactions. Just look at the orphan drug for Hereditary Angioedema which also happens to be a problem with many new biologics.
Last Aug 17 Woodcock was on NPR pushing genetic testing of CYP2D6 in pregnant women claiming extensive metabolizers (EMs) might not have a response. Hate to tell you Janet but you got it backward. It’s poor metabolizers who might not have a response. Tut don’t worry around the same time you were involved with the cardiac toxicity of OTC cough and cold meds in children and guess what EMs likely form more toxic metabolites. But then most psych drugs are metabolized by CYP2D6 and Pfizer has pointed out publicly at the AAPS 2006 meeting that demethylated oxidated metabolites that are substrates for MAO (and in my opinion probably COMT) Like Zyprexa’s N-Desmethyl 7-OH metabolite are likely 5HT2B agonists and cause a phen-fen like cardiac valvulopathy. (Plus isn’t it interesting that the previous week that Pfizer dropped a son of Zyprexa compound saying it wasn’t good for their portfolio yet Schering bought the company mainly for that drug and to replace Vytorin sales.)
But then the FDAAA act of 2007 requires if additional postmarketing safety testing shows any safety issue FDA can require drug-device (think genetic tests) labeling and thus comarketing.
Yes I know you’ve pushed safety monitoring Janet the question is what are your motives.
Salmon
Lisa Van S
Ed,
Is it because Im a female, or my question isnt worth answering. Maybe I should chnge my name to Tom or Pete,.. what do you think?
Salmon
Lisa,
In addition to the FDAAA 2007 providing for collection of AE information on 100 million Americans. Larry Lesko head of the office of clinical pharmacology and one of the favorites of Drugwonks for pushing pharmacogenomics had a protegee of his Felix Frueh (ex-head of the pharmacogenomics group) leave FDA to become VP at a large HMO which is providing pharmacogenomic info to the FDA. In addition this past week FDA announced that they were entering into an agreement with WebMD (same outfit as Medscape which pushes meds and indications using professional continuing education paid for by PhRMA and specific companies) that they were setting up a Web based system to report AEs to FDA. Plus this last week Lesko also announced that FDA would be using genetic info collected from those companies that will analyze your DNA to see where you came. Basically to find genetic mutations in specific genes of interest that they can then replicate and look at the effects in animals in order to discover new drugs.
Yes as FDA says regarding lethal toxicities ‘it’s not the drug it’s the person’.
And remember Von Eschenbach also says the promise of personalized medicine will begin to pay off by 2010.
What a wonderful brave new world we live in.
Lisa I’ve spoken about cardiac toxicities with psych drugs and structure activity relationships. When the right article comes around I’ll write some comments about structure activity relationships ‘activating’ features of psych drugs and mitochondrial effects.
Salmon
Seeks the Truth
It is very likely that Woodcock was involved in a “Byzantine-era-like” plot to ensure that Dendrion’s Provenge, a revolutionary vaccine therapy for late stage, TERMINAL Prostate Ca, would not be approved after an FDA empaneled group of EXPERTS ruled that Provenge was SAFE and SUBSTANTIALLY EFFECTIVE
A huge THREAT to Big Pharma’s chemo-cartel, approval of PV would have certainly hurt Woodcock’s biggest patrons.
Almost two years later, >45,000 men with PCa have DIED, many of whom most certainly would have had some increased survival from the vaccine therapy.
Go to CareToLive.com to learn all the lurid details.
But take some Phenergan beforehand, lest you get sick to your stomach reading about the FDA’s effort to block PV approval.
Blue Dog Dem
If you take the phenergan just make sure it’s not via IV push.
scott
Who are her supporters on the hill? She has to go, she hasn’t done her job for years, and many have died because she had information on adverse side affects on antidepressants in kids and decided to sit on the information.
Lets see if the new president is really about change or not.
Jim
Well, Dr. Woodcook, your adverse event brag was too late for my family. I’m with Rep. Stupak, who also lost a son to Pharma. Fire the lot of them - all the top echelon, because they have completely forgotten that they are to be working for the American citizen, not a greedy and very strong lobby.
I remember the day I went to a hearing that Rep Waxman was having on Heparin. I happened to sit next to a very well turned-out fellow and asked him why he was attending. Pharma exec., he said. When I told him why I was there, he moved his seat within ten seconds.
Get rid of them all. Rep. Stupak is correct. And if the Obama team does not, change will be a lie.
Jeffrey Clark, CEO of Beaker.com,
From a post earlier today on Beaker:
It’s tough to tell whether Obama (or really Tom Daschle as the new Secretary of HHS) will prefer an FDA insider with baggage to overcome or an outsider with credibility to earn. It’s virtually impossible to imagine a selection that would avoid both.
harry
FDA insiders can take their bags and go. A future selection may have no experience within the FDA but may have earnedcredibility in another capacity. Daschle could be a bit dodgy but he will have to implement Obama’s policies-isn’t that the way it works. we will find out soon enough.
Justice in Michigan
In my view, Woodcock has probably been less toxic than other FDA senior managers in recent years - Lumpkin, Galson, et. al.
There are moments when she rose to the occasion, fighting for more funding for the ODS and speaking frankly about the “sweat-shop conditions” (her phrase) which reviewers lived in.
Nevertheless, if Woodcock is appointed to this role, even temporarily, we can probably flush “change you can believe in” down the toilet.
FDA Reviewer - Are you out there? I’d be interested to hear your take.
Pharma Res. III
Incredibly I agree with Congressman Stupak and many of the comments here. Sadly while Woodcock would still be a great improvement over “Andy”, she does not represent significant change for an agency desparate for it. There are great people at the FDA and they deserve genuine leadership. We have seen scandal and incompetence piled on top of each other. The FDA is a regulatory agency that basically just stopped regulating. Bush advanced de-regulation through executive discretion rathar than through the legislative process. However, the concern is that Obama simply has too much on his plate to tackle the FDA crisis. And it’s not just the wars and the financial crisis, it’s virtually every agency in Washington. FEMA is a mess. After Gonzales the Department of Justice is a mega mess. Sec is a mess. Treasurey: mess. EPA? what’s the EPA and what do they do? does anyone know anymore? Immigration and the INS — do we have a policy?
So while I personally want to see substantial change at the FDA I am just not sure it gets on the list of top 5 crises to deal with right now. He may have to turn to an insider to get up through a year or so while he fixes bigger bleeds.
pharmavet
I don’t think that bringing back Kessler would be a bad idea.
Anon
No Salmon….
Granted, you know a lot about PK, but alas, you are confused, Woodcock is correct.
Unless you are talking about a PRO-DRUG, EMs will basically break down the active form of a drug faster than usual, and therefore, have sub-therapeutic drug levels and responses. On the other hand, if you are a poor metabolizer, you have trouble breaking down or getting rid of the drug. Again, this is assuming you are not administering a drug in its prodrug form, which is usually not the case
harry
The FDA should be one of the new administration’s top priorities. the problems are the same in all of the agencies, poor vision, too private sector friendly, lack of transparency and no freedom of information. Any change in the current FDA would be a welcome one.
Congress is in the midst of a unprecedented flurry of activity handing out our tax dollars to anyone that asks, with the exception of the agencies who really need it. Wallstreet got billions, and who knows where the dollars went and why…scare tactics and the lobby groups. It is a farce and reflective of the priorities of the people in charge. Unfortunately, patients, children who have died as a result of blatant failures in the system are not enough or not as important as the mighty dollar to attract the attention of those who are in a position to act, with the exception of a few Grassley, comes to mind. he should pick the next commish!
Salmon
Anon,
Thank you for pointing it out. I should have mentioned that Janet was talking about a Pro-drug. She was talking about codeine which is an inactive pro-drug and only relieves pain due to formation of the active metabolites (morphine and codeine-6-glucuronide). So if anyone doesn’t know whether they respond to codeine or not I would tell ask for oxycodone instead when they go to the dentist. Because by the time you figure it out that the codeine isn’t working and you can get the dentist to write another Rx (if you can) you probably won’t need it anymore and you’ll have suffered needlessly.
I did make a mistake however, it wasn’t LAST August 17th, it was August 17, 2007 on NPR in the afternoon.
Salmon
PhD, FDA Reviewer
Justice,
Sorry to take so long. I agree if Woodcock were made acting Commish even temporaily then flush change at FDA down the toilet.
I disagree with you about Galson being more toxic and Janet rising to the occassion.
Janet is really the brains behind everything. Galson is just a Yes man and Janet likes Yes men. Prior to Galson becoming head of CDER in the late 1990’s and up through 2001 when we had like 10 drugs pulled from the market including phen-fen the hepatotox with troglitazone (Rezulin - Glaxo), Plan B, and IBD with Lotronex (Glaxo). Janet was heading everything up.
Towards the end there were articles by Alistair Wood suggesting we should look into why all these things caused problems (almost all had toxic metabolites), and an exchange with Richard Horton from the Lancet about the discussions between upper management and Glaxo and exclusion of reviewers who raised safety issues on Lotronex, and Janet was leading the response. I think that when they saw the suicidality with antidepressant and the Vioxx issues developing prior to them blowing up in 2004 Janet moved upstairs and let Galson take point. (The way things work is you let a subordinate take the heat and then don’t do anything to them afterward, that keeps you clean. Plus when Von Eschenbach came in they needed an insider as his right hand woman who was really running things. She’s also been heading the critical path initiative and if you look her Yes man Larry Lesko, Bob Powell (ex-Glaxo VP), and Don Stanski (VP at Novartis) wrote a paper about some on this stuff in 2000, but Bob and Don didn’t come to work at FDA until end of 2003 where they then spearheaded a lot of the critical path and worked on the FDAAA 2007 (Don came in from Novartis to the FDA and was working on it). Plus a lot of this need for more resources etc. is all needed for the critical path initiative to help pharma develop new drugs and do pharmacogenomics and I’m sure Big Pharma was very happy to hear her say these things. Also remember Janet was in charge of the computer systems at FDA while associate commish and we’ve recently had the stuff from Congress that suggests that changes in the adminstrative computer system has been used to retaliate against people.
No I see things that make me believe that Janet is keeping her hands clean and if she even gets to be acting commish for even a few days she will have the opportunity to fire some whistleblowers who they’ve set up and it will look like it was done by someone without an axe to grind. In addition she will make some decisions about drugs that should be pulled from the market and I’m pretty sure what she’ll decide. Plus by the time a permanent commish takes the position she will have had time to finish up a lot of things that will be too late to undo.
For an acting commish we need someone who’s an insider at a fairly high level who knows the players, and who to trust and who not to trust, has management experience, and the staff will have confidence that this person is honest.
Plus this person needs to have relationships with the new drug division, the pharmaceutical sciences and the field inspectors, know something about biologics, and even nutrition and devices, and is not a whistleblower.
The only person I can think of who fits the bill is Sol Sobel, M.D.. He’s the only one of the 4 old guard medical division directors who is still around. Sol is probably is in his 80’s and used to be the head of the Endocrine Division and he was stuck between upper management and the staff over the statins and troglitazone. Consequently, Janet got rid of him
for fighting for the staff and he’s basically been stuck in an office sitting for the last 8 years, but he goes to meetings and has gotten to know the chemistry and clin pharm people very well. Plus he’s an M.D. who was a division director for decades and as a diabetologist/endocrinologist he knows biologics, something about devices (insulin pumps and glucose meters), and nutrition and he’s a really nice guy who the staff respects and can talk to. I don’t know if he’s up to the political infighting a permanent commissioner will need to do, but he would definitely be someone who wouldn’t let things deteriorate in the interim and he would likely be a good advisor to the new commissioner. (I hope I haven’t spoiled his chances).
There may be others who might be a good choice and the person who probably would know is the VP of the Union Chapter at FDA.
Opinions are my own and I’m fairly certain they don’t represent the opinions of the FDA.
Justice in Michigan
Thanks, FD-R (has a ring to it). “Toxic” was an unfortunate word choice, but I get your drift. Your description of Sol Sobel reminds me of Leo Littwak, except Leo left after exile.
When my students watch the Frontline documentary, “Dangerous Rx,” they spontaneously laugh each time they hear SG trying to shmooze his way out of something. It ain’t subtle. That fits your description of how things work.
As I recall, JW does not appear in the program except as a background participant at one of the meetings filmed - not a speaking part.
Justice in Michigan
p.s. I have often wondered how Jane Henney fit, or didn’t, into all this. Of course, she presided during the period you mention. My sense has been that she more or less stood back and let the “veterans” do whatever.
PhD, FDA Reviewer
I’ve wondered about Henney too.
Interesting that you teach about Galson. Some of his testimony from before he came to FDA about the lack of toxicity of radioactive exposure is simply amazing.
Another thing about Woodcock, it appears she may be trying to cover up exactly what Salmon is writing about the antipsychotics 5HT2B and cardiac toxicities, because on September 29th she personally sponsored a seminar on this regarding psych drugs with Bryan Roth from the University of North Carolina. It basically dismissed the whole thing. Plus FDA management was even passing around materials to the entire psych group dismissing it.
harry
I think the FDA needs to be opened up. An outsider can only accomplish this. think of obama. insiders have too many connections with the industry and vetern FDAers and won’t make the changes necessary. it’s human nature. The fda has to regulate, like uncle sam regulates my income. if i cheat on my taxes i go to jail. very simple. It is very clear with uncle sam what his role is in my life!
So, no more parties, dinners, stupid conferences, where ego’s are on display not research and engaging industry, just do your job, the one the US public pays you to do.
Justice in Michigan
re: Henney, she served when Clinton/Gore were trying to actualize their concept of “reinventing government” - which translated into what was to be a less confrontative relationship between regulators and industries. There are obviously some things to be said for the notion, but also a fair amount of naivete, given market realities and what was becoming more and more normative on the industry side.
For Henney personally, my sense is that she was caught between carrying out this charge and the realities of cases like Rezulin and fen-phen in which confrontation was required, if it ever was. My sense also is that she mostly punted to Lumpkin et. al..
I only teach about Galson through that video and as a “moral type” within the agency and bureaucracties more generally; just as Graham is a type, Temple is a type, etc..
Justice in Michigan
Here is a link to a self-congratulatory speech that then HEW Secretary Shalala gave in 1998 - just before the roof fell in.
http://www.hhs.gov/news/speeches/FDAinnov.html
Salmon
Justice, Lisa, Condor, et al.
In addition to Woodcock’s apparent coverup regarding 5HT2B and cardiac toxicity of drugs, It appears from her October 18 2007 statement on hearing loss with drugs for erectile dysfunction (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01730.html) which are used to treat PAH (what side benefits would there be to the recent push for female arousal syndrome) and with her safety comments last spring regarding tendons rupturing with fluoroquinolone antibiotics that she’s apparently in the know about mechanisms and appears to be covering up for companies regarding mechanisms of a lot of different serious drug toxicities, i.e. many more than I’ve indicated here.
I’m not ready to reveal the specifics mechanisms and what to look for, or the techinques companies would likely use to coverup each one. Yet! But if something isn’t done by the early part of this next administration I may have to reveal a lot more about what I know and it doesn’t take any inside info. There’s enough public information in the literature, drug labeling, etc.. That’s how I figured it out. You just have to spend the time to connect the dots and have a good enough scientific and medical background to be able to do it.
Salmon
Anon.
Sounds like Salmon is going to make a lot of lawyers very rich if Woodcock is selected.
Jaynesday
Anon, just wondering about your feeling on the preemption issue. The reason I ask is that your comment is very similar some of the recent arguments made by the pro-preemption camp. In a nut shell they reason that if preemption doesn’t become policy, product liability litigation spearheaded by trial lawyers will sink the industry.
Just curious.
Anon.
If you’ve done nothing wrong then you have nothing to fear.
Lawsuits did not kill off Wyeth or Merck.
Plus who’s going to pay for all the kids (1%, 500,000, and growing on antipsychotics) who are permanently maimed and need care and $1000 CAT scans (GE and the cardiologists will make a ton) every couple of months for the rest of their lives. Oh yah Medicaid!
What is a shame is that the executives are unlikely to be held criminally liable. Instead it’s the employees and the stockholders who will pay while the executives and those working with them will laugh all the way to the bank.
Jaynesday
Thanks Anon, (Ed please see also) I agree - BUT a resent mini-rash of articles supporting preemption clearly want to present an unaware public with a blatantly distorted representation of the issue. For example an article in the Atlanta Journal Constitution and one in the Washington Examiner both want us to believe the following type of fabrication. - from the ajc -
“Without preemption, the billion-dollar FDA drug-approval process would become almost meaningless. State legislatures and local juries would be free to second-guess FDA evaluations on everything from the costs and benefits associated with a drug to the text on an approved product’s label. Medical firms would find themselves on the defensive at every turn.”
“Would be” being the operative term -
These people are trying to make it sound like we have lived with preemption for many years and now the courts are going to try an force a change on the helpless FDA and pharma industry.
Other twists are presented in the articles. I won’t comment on the details here because it would be too long.
I would appreciate it Ed if you ran their article. More discussion on this would be helpful.
The full article can be seen here - http://www.ajc.com/services/content/printedition/2008/12/08/bateed.html
Anon.
I think that with some of the information coming out here and in the NY Times and elsewhere that some companies (Lilly, JNJ) are getting scared.
Henry
Jaynesday,
Remember the Robert Goldberg, Peter Pitts’ associate, used to work at the Washington Examiner and CMPI has freedom to publish there anytime they want.
Not that it’s as influential as the Washington Post but it does get Pharma’s position into the DC news media.
Henry
Salmon
Let’s not forget the other companies that are in the Predictive Safety Consortiuum and the Critical Path Institute.
Roche (diagnostic tests and yesterday’s Boston Globe)
Schering Plough (asenapine - son of olanzapine and diagnostic tests)
Glaxo (diagnostic tests with Roche and owns Smith Kline Beecham Clinical Labs and Diagnostic Tests)
Merck
FDA (Janet Woodcock’s critical path baby with Larry Lesko, Shirely Murphy, and Bob Powell)
University of Arizona Critical Path Institute (Ray Woosley previously of Georgetown with so many people previously or currently at FDA and involved the Critical Path Program)
Pfizer
Pharsight (Bob Powell’s old Stomping Grounds)
Jaynesday
Henry, Good point - In my humble opinion they are using the “lesser” outlets to test their arguments for the big push or at least to begin to foster the support of the unaware public. I’ve learned recently that some very large law firms, public relations firms and phamaceuticals make it their business to monitor web sites and blogs. I can only assume their purposes but I suppose my guess would be pretty close to the truth.
Henry
Yes I’ve been aware of the monitoring for quite some time. It’s obvious if you follow the news and certain blog sites.
Let’s hope that people like Ed, Gardiner Harris at the NY Times and others who are interested in the FDA (e.g. Waxman’s office and certain lawyer associations) are also monitoring certain web sites and blogs.
Then maybe they’ll be ready knowing some of these hidden agendas that have been laid out here and where to look.
Salmon
The author of the AJC article is from the American Enterprise Institute which first proposed the idea of preemption in the 1970’s.
Salmon
FDAer
Boy lot of stuff coming out here on cardiac problems, psych drugs, biederman etc..
It’s interesting but at FDA Bob Powell created a QT evaluation group. They have to do the evaluation of the QT studies for every drug (if it’s positive) but not if it’s negative. We all went Huh? Why are they only interested in only reanalyzing the positive studies? Do they want to make them negative?
Even though they’re supposed to be a consult group and provide consults before the reviews are done so the primary reviewer can incorporate them, instead what they do is hold up their review until the reviewer has finalized theirs and then they change things to dismiss the reviewer’s concerns or make it so the QT is the big issue when other cardiac problems are the concern (sure is a good way to distract from a real problem). Some have actually gone into reviewer’s offices and threatened them including at least 1 medical officer I know. I think this whole QT thing is a cover for the serotonin toxicity being discussed. A lot of the antipsychotics effect potassium channels and that’s claimed to be assoc with QT and with Torsades d’ Pointe (but that’s rare). Instead you can say QT is positive and no worse than X in the label but this is a single dose study and metabolites may not have built up and long term tox may not have shown up yet. So what they have is these computer people overruling the cardiologists and cardiologists have even said they’ve been told just to look at the company’s summary and don’t read the independent cardiologist’s report.
Bob Powell’s group has also been doing a lot of modeling on neuro and psych drugs but only when the statisticians and the regular reviewers say there’s a problem and they come in and save the approval. Powell also had one of his ex-employees from Pfizer joint the diabetes group (avandia) and then she was promoted after a couple of months, whereas a couple of really senior and really good clin pharm reviewers were forced out altogether.
There’s also Medical Officers in the Psych group who came from Harvard and I think worked with Biederman. One of whom worked at Pfizer in between and who was rapidly promoted 2 levels with only 1 NDA review under their belt. This ex-Harvard Pfizer Psychiatrist has also been harassing and intimidating other reviewers and a medical reviewer left the psych group because of this person. Another psychiatrist has been forced out of the group for turning down a drug. Then there’s Tom Laughren’s new Assoc. Director. He was made assoc director after working with Shirley Murphy in Peds and helping approve a drug on orders from the White House over everyone’s objections. I can go on about similar things in the cardiology group. Plus the organizational charts were updated and placed on the website at the end of July but the organizational structure was changed immediately after that for cardiology. Makes you wonder what they don’t want people to know. Unfortunately I can’t speak about specific drugs or name names but things are really, really corrupt. I heard that Laughren yelled at the reviewer who was forced out saying ‘our job is to approve drugs’.
Then there’s the head of OTS. She’s an MD, PhD (6 year combined program) with only a 1 year pediatrics residency and no other training. She worked under Shirley Murphy for like 2 years before being promoted and then another 2 years as assoc director of OTS (over stats and pharmacogenomics and bob Powell’s group and clin pharm). Then she was made head of OTS but Bob Powell seems to be really pulling the strings. She claims she’s writing articles on pediatric study designs (good way to become FDA’s “expert” but pediatric neurologists, psychiatrists, and clinical pharmacologists with years and years of experience disagree with her.
Yep this is what Woodcock has put in place.
Opinions are my own and do not represent the opinions of the FDA.
Salmon
Looks like Janet Woodcock reads Pharmalot too.
Salmon - A Former FDA Reviewer