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INDUSTRY: HealthcareRenewal skewers Health Affairs

John Iglehart’s rather soft questioning of Guidant’s CEO in Health Affairs comes under most excellent and accurate fire from Roy Poses over at Health Care Renewal.

A prominent editor of a prominent health policy journal devoted considerable effort to and published considerable pages of an interview with the CEO of a large device manufacturing firm, yet avoided asking skeptical or probing questions about a current problem that raises substantive concerns about the quality of the company’s products, and even bigger concerns about how the company has dealt with quality problems. The interviewer avoided asking any questions about a similar case from a few years ago. This is only one article, but it seems to indicate how deferentially the health services and policy literature may treat leaders of large health care organizations. 

Health Affairs has a delicate balance to tread. It publishes inter sting interviews with CEOs that a more than just puff pieces–and one doesn’t often see those these days.  However, in order to keep corporate CEOs coming to talk to them they can’t attack them directly. But, you would think that in the light of what’s gone on at Guidant recently, there’d be a bit more of an attempt to hold various feet to the fire, and I hope we’ll see more of it in the future.

POLICY: Thank God there’s no rationing here!

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Back with more a little later (Typepad’s been a bit problematic today) but to start, just a quick note to those who say that there’s rationing in Canada and the UK and that we’re so lucky it doesn’t happen here. You need to amend your statements to "it doesn’t happen here — to nice people like us". But if you’re poor, good luck on getting the rest of us to help out.

For those of you too lazy to clickthru, the story is about Mississippi limiting Medicaid recipients to 5 prescriptions each. Something similar was tried back in the early 1990s with anti-psychotic drugs in New Hampshire, and I seem to remember that the result was that whatever was saved on the drug side was wiped out by the consequent increase in nursing home admissions.  So if this is the future (again) of rationing for the poor — and Medicaid covers 25% of the population in Mississippi — it’s not too clever a way of going about it.

(BTW This isn’t an argument in favor of Medicaid’s continued existence in its present form–it needs serious reform and in fact abolition. I’m just crying bullshit on those who say there’s no explicit rationing in the US–again).

POLICY: This weekend we celebrate Freedom!

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This weekend we celebrate our nation’s birthday and its proud heritage of freedom and justice. It seems that the most important freedom left in America is the freedom to push the limits of laws, especially those designed to protect the interests of investors and taxpayers. In addition in the last couple of decades and, especially the last five years, corporations and other powerful interest groups have re-written countless laws and influenced several government agencies to ignore or change their application of regulations.

Now the health care industry provides the best example of the ultimate freedom. A corporation can break the law, defraud taxpayers and investors, and still stay in business. And best of all if you run such a corporation you can now use the ultimate excuse that has failed schoolboys the world over — "It wasn’t me sir!". And you can get away with it. Not a strategy I’d recommend, but it seems to work if your name is Scrushy. Perhaps Thomas Jefferson needs to revisit those lines about "all men being created equal".

Happy Independence Day.  See you here next Tuesday

QUALITY/POLICY: P4P get official in Businessweek, no less

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So in a remarkable bit of futurism, only 8 years after Greg Schmid invented the concept at IFTF (well, we end up calling it performance-based reimbursement, but it’s the same thing as P4P), Businessweek has noticed and Pay for Performance has gone mainstream.

I’m still looking for someone to find an earlier citation of an equivalent term or concept–I still can’t believe that we allowed a non-healthcare economist to invent the term!  And with reference to the Gianfranco post from yesterday…. Greg came into work every day for 5 years and always said to me "How come they named the football team you support after the President’s daughter?"

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.

POLICY/INTERNATIONAL: The Weekly Standard on moron support

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In an article called Socialized Medicine on Life Support, there is just yet more rubbish from a libertarian doctor form a libertarian "think-tank" writing in a conservative weekly. For chrisssakes, Canada doesn’t even have "Socialized Medicine" — defined as the physicians providing the care working for the state.  That would be Cuba, Sweden or even the UK.  Canada has single payer….In American terms Medicare is single payer, the VA is socialized medicine…

It’s not even worth refuting the rubbish they write, but just once it would be nice if the sources they quote actually had done some, say, real research.

And as for the hackneyed old arguments; "Canadians flooding the US looking for care". Rubbish. "Opinion polls show Canadians think their health care is in crisis" — not compared to the US (read down to "System Satisfaction"), and "long waits for care everywhere but the US" — again just BS.

But the point is that these guys don’t need to deal with the truth or even fake real research.  Spreading FUD about anything that’s not the US status quo is all that’s needed.

INDUSTRY: Scrushy verdict is in–He walks

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So after about 15 years of deliberation, the biggest fraud in the history of health care is coming to its zenith. The news is that the jury has reached a verdict in Scrushy trial. Now we’ll see if all that showing up at black churches and sponsoring Christian boy bands was worth it….

My guess is that in the Michael Jackson tradition he walks, but in my book the crook who blames his underlings and then claims that God forgives him is the lowest kind.

Check back soon for the verdict….

And of course he walks. Not guilty on all charges. Every CFO and person who works there said that he was fully in charge of orchestrating the whole fraud, but up to 200 local preachers appeared on Scrushy’s evangelistic radio show on Alabama cable and said he was innocent. So who would you trust.  A bunch of admitted crooks or emissaries from God?

The amusing thing is that he’ll now try to get control back of HealthSouth. Listening to Jim Cramer on CNBC has been quite amusing…Cramer is not too impressed with the wisdom of the Alabama jury.

Now he’s live on TV giving all the thanks for God, thanking all the pastors and ministers, and everyone who helped get him off.  On CNBC the squawkbox wag said "How about a foursome at the Alabama golf club–Scrushy, OJ, Robert Blake and Jacko?".  His other good line was "Lucky the charge wasn’t ‘Poor interviewing of CFOs" as 5 out of 5 managed to put one over on him…"

POLICY/QUALITY: The Nursing Shortage — It’s real

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Over at Code: the WebSocket Alwin has a really great article about the nursing shortage called A hard rain is gonna fall. I think he’s right and that after we’ve emptied every third world nation of their meagre nursing supply, we’ll realize that we have do something about it here. And in my view that means training fewer doctors and more nurses instead.

PHARMA/POLICY/POLITICS: The FDA remains in tatters

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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.

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