Tag: Policy/Politics

PHARMA/POLICY: Quick Plan B update with UPDATE

For those of you still playing along at home, it now looks like the FDA is going to make a final decision on the status of Plan B by September 1. So that should get us to a confirmation of Crawford as FDA Commissioner soon thereafter, although if Plan B is over-ruled I doubt whether the Democrats holding up the confirmation will be best pleased.

Meanwhile one of my dinner companions last night (can you guess the gender?) scoffed at the need for Plan B anyway, saying that if you just take 3-4 normal contraceptive pills it works exactly the same way. I timidly pointed out that if a woman had contraceptive pills lying around the house she probably wouldn’t need Plan B in the first place.

UPDATE: Late Monday Crawford was confirmed as commissioner.

PHARMA/POLICY: Medicare Part D

This is a complete cop-out as I’m still hacking away on my Hillarycare piece, and haven’t even read this, but the article in Health Affairs called Riding The Rollercoaster: The Ups And Downs In Out-Of-Pocket Spending Under The Standard Medicare Drug Benefit looks pretty interesting and I think suggests that we have an ongoing spending problem emerging in Part D even before it hits!.

Does one of my contributors care to read it and review? (email me for a Health Affairs pw if you haven’t got one)

POLICY/POLITICS: The evolution of Hillary Clinton and the failure of reform in 1993 (TO BE CONTINUED)

I have been meaning for some time to write about what really happened in 1993-4.  But I’m finally going to get off my duff (or more accurately) sit on my diff and do it because of the close to ridiculous rubbish written in an article called The Evolution of Hillary Clinton in Wednesday’s New York Times. But as that’ll take me a little while, I’m reproducing the key part of the argument about health care here:

No other policy issue defined Mrs. Clinton in the 90’s as starkly as health care. Not only did her effort to establish universal health insurance end in embarrassing defeat for her husband’s administration, but it also emboldened Republicans and contributed to the notion that she was a big-government liberal. More then a decade later, it is clear that that experience has profoundly altered her approach now that she is a member of Congress.

She has deliberately avoided the major mistake she made as first lady, namely trying to sell an ambitious plan to a public with no appetite for radical change. Over the last four and a half years, she has stuck to a host of more modest initiatives, apparently mindful of the political perils of overreaching. She summed up her approach in the first floor speech she delivered in the Senate about four years ago, when she unveiled a series of relatively modest health care initiatives.

"I learned some valuable lessons about the legislative process, the importance of bipartisan cooperation and the wisdom of taking small steps to get a big job done," she said, referring to the 1994 defeat of her health care plan. She has not completely discarded her 90’s view that there is an urgent need to overhaul the way health care is delivered in the nation. In fact, she has not been shy about embracing proposals that might be seen as liberal in some quarters, like seeking to provide medical coverage to everyone living in poverty.

But on the whole, Mrs. Clinton, who has served in a Republican-controlled Congress for most of her tenure, has assembled an agenda with practical-minded initiatives that appear to be aimed at the political center.

Perhaps one of the most notable is one that drew support from unlikely quarters: Senator Bill Frist, the conservative majority leader from Tennessee, and Newt Gingrich, the former House speaker who had a major role in defeating her health care plan in 1994.

The bill these three embraced seeks to encourage greater online exchanges of medical information among patients, doctors, medical insurers and other health care experts. Mrs. Clinton has argued that such an approach would, among other things, reduce medical errors resulting from poorly kept paper records and reduce the number of costly malpractice suits.

She has denounced the "contagion" of sex and violence in children’s entertainment, apparently attempting to move the issue beyond the question of morality and values, where Republicans have long held a political advantage. Citing studies indicating that graphic images of violence lead to more aggressive behavior among children, she has cast the problem as a health issue that amounts to an epidemic and requires a vigorous response from public health officials.

Her longtime focus on children’s health has also continued through her Senate service, most notably in the passage of legislation she sponsored ensuring that prescription drugs approved for adults but prescribed for children be tested for children.

I’ll be back later to explain why Hillary Clinton doesn’t understand what went wrong in 1993-4 and why that may have some big time implications if she is the candidate in the game of "continue the dynasty" that we’ll be playing in 2008 or 2012.

Meanwhile, read the full article

To Be Continued

PHARMA/POLICY: Steeves responds to McGarvey

Ayelish McGarvey is back with a follow up to her piece in The Nation on Plan B, which was the subject of a previous piece here in THCB.  The new piece called Plan B for Plan B explains the weird double application for joint "behind the counter" and prescription status, and suggests that it cannot be signed off on by FDA lawyers. She continues her thesis that this is mostly Galson’s fault. Robert Steeves is not so sure. He writes

There is nothing in the Ayelish McGarvey piece that went unconsidered in my piece.  I think she is wrong on the Galson "acting alone" and apart from Crawford. A new guy just appointed in a ‘acting’  capacity just would  not step out on his own and create this national storm certain to reach the White House.  Give me a break.  This casts Galson as a "suicide bomber" ready to sacrifice self for the cause (a certifiable disqualification to lead CDER if there ever was one). 

For sure, most FDA lawyers would not "sign off" on the distribution scheme, but who says they must. They are not barriers to a decision(unless the decision-maker wants a place to hide) but advisors. This is illustrated by the line authority for the lawyers at FDA coming from the HHS General Counsel, not the Commissioner. Usually, a legal warning that "if you go there, you are on your own legally" is enough to scare any one into a "revise" this policy mode, but it need not be.  Somebody at FDA must have a reasonable rationale for legal support for the policy which neither Barr nor FDA has revealed. However, this overlooks the possibility that the Bushites do not intend Plan B OTC to be approved in any event under any theory. 

As we will see with the State Law workarounds for Plan B, the first "religious right" lawsuit is likely to overturn any state law giving Plan B OTC status under the Federal Supremacy Clause of the U.S. Constitution.  And the same legal challenge is sure to come to any "unconventional" Federal OTC approval scheme like the bifurcated OTC/Rx status pending.  FDA has raised the issue of the under 16 women as a safety problem, so it seems unlikely that it can now go back and "admit error" to permit a legally correct approval.

If State Plan B workarounds were doable, we’d have marijuana, laetrile, and lots of other substances legalized in many states. No one can establish that Plan B is not in "interstate commerce", no matter where it is distributed today. The States work under the police power(denied the Feds??) to protect their citizens. In the past, this has meant a State can more rigorously regulate a drug product, but cannot relax that status. Perhaps the argument will be that a State "must act to provide Plan B to better protect its women and citizens because the Fed’s have failed to do so and . . . . .(this is the tough part).

Barr CEO Bruce Downey says Barr may turn to the States to get Plan B on the market but he is a lawyer and should know all the above. Importantly, I have never heard or seen him expound on his "legal rationale" for this position.  Nor can I understand Barr’s strategy in raising this faux solution unless, like Galson, he has some secret ally that we have not yet heard  about.

As for Hager, thanks to Ayelish McGarvey’s earlier article, we now know he’s a hypocrite or worse.  But I think she fails to understand the basic principle involved in both cases — do not put much weight in what is being said, watch what they actually do.  And FDA has not, and will not, approve Plan B.  The Congress might have a case to legislate the approval if it is to be done at all.

In any event, the interests of science and women’s health are not at the forefront of this FDA decision.

PHARMA/POLICY: More on Plan B and its relationship to the overall chaos at the FDA

A little more about my FDA article from Monday….

Prospect/Nation journalist Ayelish McGarvey, who wrote the article about David Hager, and knows way more about Plan B than I’d ever want to, says that I (and by implication Robert Steeves who’s earlier article on Plan B I lifted for THCB) don’t actually understand what’s really going on with Plan B’s non-approval. She tells the real story in a long comment to my piece over at Ezra’s blog.

Essentially Barr’s first application to make Plan B available OTC was turned down. The delay in approval, over which the three Dem senators are holding up Crawford’s nomination is for a second application in which Barr Labs asked to put Plan B behind the counter for women over 16 years old and by prescription only for those under 16. FDA hasn’t approved drugs in that manner before, and its lawyers won’t sign off. To know more we need to wait till McGarvey’s article comes out (next week), but it’s clear that in her view, Steven Galson, the director of the Center for Drug Evaluation and the surprise signatory to the original non-approval (the one that turned over the 23-4 scientific vote in favor of approval) acted more or less independently from Crawford. It’s certain that he went against the staff scientists advice. This is what it says on the FDA page about Plan B:

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

And the differences between the political leadership of the bureaucracy and the staff are huge. Meanwhile there is a pretty good article which I missed at the time in the NEJM on what happened, and another blog, The CarpetBagger Report, picks up the story from what Jon Cohn wrote in TNR.

On the other hand, I really only wanted to make two points about the FDA.

First, there are fundamentalist loons with an agenda inside FDA (i.e. whoever it was inside FDA who asked Hager to provide a dissenting opinion), or at least those who want to air the fundamentalist loon’s opinions. I can never tell if its the fundamentalist loons using the cynical rightwingers or the other way around, but their views are clearly being heard and acted upon.

Secondly, forgetting Plan B — which in the grand scheme of things is just another story of how screwed up sex education and reproductive health in this country have become — the issue of whether FDA can be trusted on pharma safety overall is still a complete mess. That cannot change unless we get a total change in the current regime at FDA including Crawford, Galson and anyone else favoring either fundamentalist loons or the short term interests of big pharma over full disclosure about drug safety. I know that Ted Kennedy (and by Ayelish’s implication Sens Clinton and Murray too) have given up on trying to fix that, but someone needs to be reminding the American public about it!

And, for the nth time, full disclosure about drug safety may lead to people taking drugs that could be considered dangerous.  Some people might want to take a Cox-2 and trade off pain relief for a higher chance of heart disease.  But the key is that they need to be sure that the FDA is making all the information available — and that’s where it’s fallen down on the job and lost the public’s trust. And in the end it’s better for big pharma to be in a market where the public trusts what the government says about their products.

On another topic, talking of what pharma says about its products, the Washington Legal Foundation, which got DTC ads on TV in the first place, is causing a little more fuss in that arena.

PHARMA/POLICY/POLITICS: The FDA remains in tatters

It’s time to dip into the murky waters of the FDA once more. This is a classic tale of politics intruding into an agency that should have science as its prime motivator. Here’s the story summarized so far.

The FDA has barely had a full time official commissioner since the start of the Bush Administration. Mark McClellan was officially head for a brief while in 2003, but he barely had time to look embarrassed on 60 Minutes when asked why Canadian drugs weren’t safe enough for Americans before he nipped off to the rather more rarefied atmosphere of CMS — where he’s much better suited.

Meanwhile before, after (and basically during) McClellan’s time at FDA, the acting commissioner has been Lester Crawford. Some cynics have noticed that there are a few clouds over Crawford. He was involved in some pretty close to the wind activities when he was in charge of Food Safety (ironically this weekend, there’s more suspicion about the Administration covering up a second case of Mad Cow).  But more recently there’s been much fuss over both his personal affairs (i.e. was he or wasn’t he abusing his power to forward the career of a female colleague with whom he was having a close relationship) and, much more importantly, about his being behind the non-approval of Barr Labs’ Plan B emergency contraceptive.

Robert Steeves has written convincingly on Why Plan B went down.  Essentially Crawford overruled a scientific committee which voted overwhelmingly that Plan B (an emergency morning-after contraceptive) was safe and effective.  So it won’t go on the market. Of course, any time you hear anything to do with "safety" in reproductive health care in this country, your ears should prick up. There are allegations that information was withheld from the Senate Panel investigating this. Whether that’s true or not, David Hager the physician who apparently has Crawford’s ear and was a one of the few dissenters on the panel, appears to be a certifiable loon. Yup, he attributes all his research skills and influence to God and is not shy about telling the world about it.  However, his ex-wife is not shy about telling the rest of the world about Hager’s at the least inhumane and at most criminal treatment of her — including paying her (at first) and then forcing her into types of sex that many on the Christian right probably think of as against God’s law and should be banned (although they all probably indulge in private…OK that’s my last direct slam on the Fundamentalists in this piece).

At any rate, it’s good to know that the future of contraception in this country is in such stable and rational hands. And overall of course the whole thing is a payback from Crawford to the Christian right for supporting his appointment. 

As a result, three Democrats on the panel are going to hold up Senate confirmation of his nomination even though it got out of committee — even with Ted Kennedy supporting him. (Kennedy says that FDA needs a leader of some kind to remove uncertainty). The real joke is that one of those delaying his vote is an even more extreme member of the Christian right, Sen. Tom Coburn of Oklahoma (ironically like Hager another ObGYN obsessed with sex, although in his case it’s rampant schoolgirl lesbianism) who thinks that the FDA should be printing warning labels on condoms because they aren’t effective enough preventing disease (and of course Coburn probably thinks that people shouldn’t be having sex anyway).

This might all be fun and games in an inside baseball kind of way if the issues at hand weren’t so damn important. Since the Vioxx scandal there is no trust of anything the FDA says about drug safety, and it’s fairly clear that the FDA leadership at least has basically been in PhRMA’s pocket. We’re now even getting whiff of a bigger scandal about the contentious link between mercury and autism. I won’t even pretend to look at the science behind that, but it’s safe to say that the Robert Kennedy article that has reignited this fuss wouldn’t have had nearly so much press if the FDA commanded more respect, and if the allegations that it covered up studies on behalf of the pharma industry — as essentially it did in the cases of Vioxx and Celebrex — weren’t so believable.

The final piece of the puzzle rest with now famed FDA whistleblower David Graham. With maverick Republican Sen. Chuck Grassley in his corner, he is taking aim at the newly appointed FDA safety panel. Essentially, instead of creating an external review board with the power to pull drugs from the market, the FDA has created an internal panel to which insiders like Crawford control all the appointments. FDA needs to be seen to be scientific and neutral, but that’s not happening. For example, the advisory panel that voted to continue sales of Celebrex and narrowly voted to allow Vioxx to return to market was shown to be filled with scientists with drug company ties, and that when they were excluded the tallied votes would have been very different. This may be what big pharma thinks it wants, but it’s not what is good for the country or for that matter for the future of big pharma. We need an FDA that is beyond reproach or politics.

Instead we have a series of government agencies, with the FDA being a prime example, where whistleblowers are needed to maintain standards of honesty and dignity; something our Dear Leader said he was going to bring back to the White House (ha, ha). And the whistleblowers are being treated pretty badly, even if they do have the protection of an influential Senator.  (If you want more look at this article and editorial from PLoS about the treatment of whistleblowers)

Given that there are other Presidential appointments in deep trouble, and that a Supreme Court fight is about to start that will get nasty very quickly, one cynic has suggested to me that Crawford will be confirmed without a vote as a recess appointment. In any event, the politicization of every government agency has now produced a situation where the politicians, the bureaucrats and the industry are conspiring against the public. This is bad for business, bad for health care, and bad for America.

POLICS: Galloway vs. The US Senate

Off-topic for health care but great fun nonetheless. A snooty Minnesotan Republican Senator (who would never have been elected unless Paul Wellstone hadn’t very conveniently died in a plane crash just before the election in 2002) decided to take on a Glaswegian streetfighter who’d already beaten The Daily Telegraph, and the Christian Science Monitor.  Galloway was more than happy to hop on a plane to get his 15 minutes of fame in the US, and to call the Republicans on the disaster they have walked into and exacerbated in Iraq.  And there was little doubt who was going to win, and who did.

POLICY: The (Very) Odd Couple


This week Hillary Clinton met with Newt Gingrich and together they declared
unity and agreement on America’s health care future —  at least as far as the
role of information technology goes in it. 

The author of "The Great Right Wing Conspiracy" cosying up with the woman who dreamed up "HillaryCare?" 

That surprising sight led to an immediate media
freakout. What could it all mean?  Could some sort of earth-shattering political announcement be about to follow? 

The New York Times sheds some light on things:

"As it turns out, Mr. Gingrich and Mrs. Clinton have a lot more in
common now that they have left behind the politics of the 1990’s, when
she was a symbol of the liberal excesses of the Clinton White House and
he was a fiery spokesman for a resurgent conservative movement in

Both Clinton and Gingrich seem to agree that government should help fund the technological transformation of the healthcare industry.  Historically, the implications of this kind of bipartisanship are big indeed.  Well, sort of.  Providers and payers can expect more legislation impacting information
technology, but realistically probably not much more
money from the feds.   

care veterans may recall the last time significant legislation affecting health
care IT was passed: in 1996, when the Senate voted 100-0 in favor of the
Kennedy-Kassenbaum legislation. That law is better known today as HIPAA. Ten
years later payers and providers are still struggling with the implications.  So cast
a jaundiced eye when you hear that Washington is preparing to intervene. 

POLICY: Super Size This! By John Pluenneke

Supersizeposte200_1 As if the US fast food industry didn’t have enough worries with new labeling rules under discussion at the FDA and the campaign for healthy school foods being led in California by the Governator, there is more bad news on the way. Morgan Spurlock’s Super Size Me has been edited down and re-released so that it can be shown to middle school and high school audiences.  The film, which shows Spurlock’s physical deterioration over the course of a month as he consumes a steady diet of Big Macs, fries and sodas, has won praise from nutritionists for its depiction of the health problems junk food can lead to.  Perhaps objectionable segments, like the moment where Spurlock’s vegan chef girlfriend discusses the impact of his fast food diet on his penis with almost eery clinical detachment have been edited
out.   What sort of impact could the film have? According to a
report in Newsday, students in New York went on strike last week after watching the film, demanding healthier food. Could this mean a wave of radical civil disobedience might follow at school cafeterias and vending machines across the country? 

POLICY/POLITICS: Wanna be physician of the year? Pay Bush $1,500

AwardIn a hard hitting investigation ABC news is shocked, shocked(!) to find out that such an honorable profession as that of physicians is not above creating lots of phony awards so that everyone can win one.  The joke is that the hundreds of physicians who won the "Physician of the year" award found that the title came not from a fake medical college or diploma mill, but straight from the Republican National Committee. Well if they’re dumb enough not only to pay up but also to go to Washington DC for a couple of days to collect, why shouldn’t Tom Delay take their money — after all the half mill or so he needs to pay his wife has to come from somewhere? (Hat tip to Kevin MD & John P for this one)


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