By Special Request -- Salmon's Up, In The Comment-Box. . . .

Go now, and follow this PharmaGossip story-link. Then, see the comment box, below -- for Salmon's take.

. . . .Sen. Bernie Sanders (I-Vt.), a champion of importing drugs from Canada and reducing the cost of pharmaceuticals, professes continued suspicion of the industry, including its deals with the White House.

“The drug companies form the most powerful lobby in Washington,” he said. “They never lose.”

Great line from Sen. Sanders. The drug companies. . . They never lose. . . .

Off the grid for a bit, am I. . . .

Here is Salmon's take on it all:

. . . .With the death of Senator Edward Kennedy this past week the press has been reminding us of his decades long quest for health care reform. We have also been reminded that it was Senator Kennedy's endorsement of then Senator Obama's bid for the presidency 10 days before Super Tuesday that really broke open the nomination for him.

Thus it's not unreasonable to assume that President Obama's push for Health Care Reform as his initial major piece of legislation that could set the tone for his dealings with Congress for years is a payback of sorts to Senator Kennedy.

At the time of Kennedy's endorsement I was struck by the statement given by Senator Obama being grateful not only for the support but for the access it provided him to Senator Kennedy's funding sources.

If you look back several years ago you see Sen. Kennedy takes in huge amounts of money from the pharmaceutical industry. Now Sen. Kennedy was head of the Senate Health Education Labor and Pensions committee (HELP) so receiving lots of donations from an industry he regulates is not suprising. However the amounts from the pharmaceutical industry out of wack with other health care sectors. In fact the amounts are much more than he could possibly need himself for reelection and thus I assume it can be spread around to other candidates he likes.

Besides Health Care Reform which Pharma has indicated they will make out on because of increased usage in spite of giving up $80 billion over 10 years, (or less per company than many are paying in fines), the last major piece of Health Care legislation that has come out of Sen. Kennedy's office is the Food Drug and Amendments Act of 2007.

This piece of legislation was supposed to clean up FDA. However if you look at it closely it really does nothing of the sort.

Now it's fairly well established that there were major problems at FDA under the Bush administration and especially under FDA Commissioner Andrew Von Eschenbach, (Bush’s personal physician). According to several different sources there was actually an FDA staffer from the commissioner’s office assigned to Senator Kennedy’s office to help write legislation. Now this isn’t so unusual in Washington but considering the documented corruption at the FDA it’s kind of interesting that a Bush appointee would have an employee assigned to the Democratic Senator’s office to help write legislation ostensibly to clean up the FDA.

The initial draft of this legislation came out around labor day of 2006 and was called the Enzi-Kennedy Bill and which after the November elections became the Kennedy-Enzi Bill. Just prior to the initial draft being published, VPs from certain pharmaceutical companies came to Washington to work on this bill with FDA officials, including those involved in the critical path initiative and the Reagan-Udall Institute. If you recall Rep. Rosa DeLaura sent a letter to Commissioner Von Eschenbach in Nov 2007 criticizing the lack of controls over the Reagan Udall Institute and how it could be a Trojan Horse for Pharma setting FDA standards especially since ex-industry VPs (Shirley Murphy and Bob Powell) were in the FDA Office of Translational Sciences which was setting up the R-U institute and who would be intimately involved with the R-U insitute. Shirley Murphy was VP of I think Pediatric Neurosciences (originally hired with a marketing in the title (I would need to check) at Glaxo and Powell also came from Glaxo via Pharmacia then Pfizer then Pharsight. (This is a story in and of itself.)

At the time Pharma was lobbying for shorter PDUFA time lines (i.e., eight months) for NDAs. This of course was an impossible timeline as the decision to file an application is not made until 60 days, plus there needs to be several weeks of time for each of the 5 levels of FDA signoff, not to mention the lead time and followup for advisory committee meetings. On top of this was a new requirement in this legislation that labeling negotiations had to begin 60 days before the PDUFA due date if the NDA was approvable. This of course could facilitate insider trading. However the final law replaced this provision with one that any MOUs between FDA and the industry (likely PhRMA) now had the force of law. (To see these MOUs you have to physically go to the FDA reading room and request them.)

When the bill finally became law was shortly before the supreme court case on FDA preemption but it was at the same time that the FDA was pushing preemption and it was a major agenda item for Pharma. Looking at the language of the FDAAA of 2007 it basically anticipates another Vioxx and sets up a series of requirements for once it’s detected to have a series of advisory committee meetings to look at class effects (common tactic to misdirect from the most toxic of a class of compounds and delay doing anything), then it requires the drugs to remain on the market for those who might need it (even if it’s only 1% or less of the population it was being sold to) and that it be available in the least restrictive manner possible (i.e. no registries like for clozapine). It also goes into that if it’s a pediatric toxicity but there is a drug – device (like a genetic test for drug metabolism to a toxic metabolite) that the FDA can force labeling changes but the way the law is written it’s clear that this is intended primarily for generics. So it appears that by the time this occurs the drug will be off patent and sales will have already decreased. This of course may have the effect of driving patients to newer drugs or therapeutic classes for the same disease. So it appears to anticipate another Vioxx like debacle but in children with detection after drugs in the class have already gone generic. Of course you need to ask what possible class of drugs could have such widespread use in children among other questions.

Another interesting observation is that Senator Kennedy’s son Ted Jr. (the one who had a leg amputated due to osteosarcoma) runs a consulting business to the pharmaceutical industry investors called the Marwood Group. In fact they deal with some of the same type of inside information on health care legislation as lobbying firms and recently have been advertising for a healthy care legislation analyst and have been involved in law suites about this type of information.

Another interesting is coincidence is that Janet Woodcock the head of the FDA Center for Drug Evaluation and Research and ex-Associate Commissioner had a meeting with Ted Kennedy Jr. in NYC on June 30th, 2008 the same day as the PDUFA due date as asenapine (see the briefing documents background package) and the same day as Fred Hassan’s rant on the front page of the WSJ complaining about what does it take to get drugs approved.



This is also only two weeks after the Senate Finance Committee warned about health care expenses breaking the bank on Medicare and Medicaid and the Federal Budget if it wasn’t contained with a graph by Condor (see above), but with the very big caveat at that the graph assumes spending would level off, and thus an assumption of no major new illness such as a phen-fen effect that might effect a significant portion of the US population. . . .

-- Salmon

August 31, 2009 10:15 am