Salmon - A Former FDA Reviewer

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

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.

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)

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

“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

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.