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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

• 5

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

• 23

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.

TECH: Conversation with Girish Kumar, eClinicalWorks

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I wrote a brief editorial in THCB and also on FierceHealthcare last week, suggesting that the problem with IT in the US wasn’t so much a lack of interoperability as it was a lack of use of IT in the clinical workspace by physicians in small practices. My editorial was in part inspired by a comment emailed onto me from Girish Kumar, who’s President of eClinicalWorks–an EMR vendor aiming at that market. Given that I’m doing some work on the use of ePrescribing by doctors in that market anyway, I thought I’d imitate MrHISTalk and do a CEO interview to go down a layer or two about how that small practice segment of the market is playing out. So here’s my take on my discussion with Girish.

 

 

eClincial Works is based in Westborough Mass , and it’s a private company with no debt and no investors and no plans to go public — working in a similar philosophy to Meditech just down the road. Currently it has around 150 employees with some $20-25m in software revenues on an annualized basis. They are doubling in size each year with 1500+ customers representing 3300 providers (meaning nurse practitioners and doctors). Their business is focused on the small end of the market, which they define as practices with 1-15 physicians, although they have started going into mid (15- 50) and large (50 +) practices. And a couple of even bigger practices have signed on recently, although that’s not been their prime market.

What about the market in general?

Girish believes that EMR adoption in health care is a long term process — and that realistically we are still 5-7 years away from peak adoption rates and some time after that from total penetration. He was (he says somewhat mis)-quoted last week as suggesting that government help was needed to get that market to take off. He does think that the conversation emanating from Washington is creating a catalyst which is helping physicians move towards automating their practices. But this is a numbers problem. While there are only a few thousand hospitals and big practices, there are over 150,000 small practices. Their EMR adoption is low in percentage terms but quite a few have EMRs which makes a large total number. Girish says that as eClinicalWorks continues to see more and more business every quarter, that tells him that the market is moving forward rather than backwards or sideways. But, and this is the key issue, the numbers of doctors needing to make that move are so large that unless the government puts in place bigger incentives the market won’t go from 30% adoption to 80% without a catalyst any time soon.

Is there a distinct set of players for different practice size?

For practices with 50 + doctors there are a now a more or less dominant set of EMR vendors, such as NextGen, Epic, Allscripts & GE Centricity (Logician). When you go to the below 50 doctor market, it’s coming down to 6-8 companies too, but not the same as the larger ones. For example, Epic doesn’t sell into that market. There are many smaller vendors who used to be able to be much cheaper than the better known companies, but the challenge for those companies is that original price point of $15-20,000 per physician is now falling. So the difference between the small vendor and bigger, better-known players has come down. For example eClincalworks’ EMR is $7500 a seat (you need to add $2500 more for the practice management module).

This is being accompanied by some level of market confidence in the vendors. Girish claims that others are telling him that eClinicalWorks is becoming a brand name for EMR. In addition the vast majority of doctors who buy their EMR product are also picking up the practice management application, and are starting to replace the Medical Managers of the world. As in many other parts of the health care IT arena, the value of the pre-integrated product can exceed the reason for keeping a legacy practice management system, and he expects to see that trend continue. Incidentally, some of his competitors, don’t share that view–Allscripts for instance doesn’t have a practice management module and integrates with those legacy systems. But clearly if physician organizations can recognize a distinct set of vendors who will be around for a while, then it will help the market.

So what should the government do?

In Girish’s view government is recommending the standards for building the highway, (interoperability and RHIOs). There’s no question that you need that for nodes (or in his analogy, cars) to be able to able to connect with each other. But we need to focus on the nodes, and we have to build the on-ramp and off-ramp to the highway. The government needs to incentivize both the infrastructure creation and incentivize the plug-in at the doctor’s office. He’s not critiquing building the highway but we must realize that we need the cars too.

What should that look like at the node level?

The government should come up with a subsidy either via Medicare or a pay for performance package directly related to IT adoption. Then the government should mandate that vendors implement interoperability standards at no additional cost — customers shouldn’t be burdened with the extra costs of interoperability. We need to build an incentive to vendors to do that and that incentive for vendors should be a growing market. In other words, create a market so that the vendors make more money but force them to make interoperability part of the products features. In one example Girish cited a vendor who wanted $60K to integrate inpatient and outpatient information together for single practice. That’s not acceptable to him and the path to interoperability ought to be built into vendors’ standard product roadmaps.

Having said that, there is only a small demand from doctors for seeing the inpatient chart in the outpatient environment, although that varies by specialty. For example, no dermatologist cares, but an ObGyn or cardiology practice might care. The big deal in terms of interoperability is access to lab results. However, overall adoption will be easier if physicians know that the products they buy are interoperable and that they are both able to get information from other systems and able to walk with their data if they don’t like the system they have.

So why should the government subsidize the EMR?

Putting aside the fact that the government subsidizes lots of parts of the health care system already, I pushed him a little on the idea of subsidies. After all if adopting technology gives the physician efficiency (and several vendors show that in their studies) and it’s saving them money, why should there be an incentive from the taxpayer? Girish felt that the improvement in care EMRs would create would save Medicare and the government money in terms or reduced hospital admission, better drug compliance, etc — so in his view it would be an investment. But he was happy enough with a proposal that any subsidy should be budget neutral overall for physicians, but that Medicare or the government would essentially be paying them to adopt the EMR while they were paying them less for other activities in their practice.

While I agree and I think that the P4P movement is pushing this way, I can imagine the AMA might not agree quite so readily! Still, I’m with Girish in believing that the adoption of EMR tools in small practices is the most crucial aspect of IT in health care, and it’s good to hear that there is some activity in that arena. And that at least one vendor is talking a good game about how that market can be grown at benefit to all of us.

HEALTH PLANS: The Gadfly seems to have caused Kaiser real trouble

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So the Gadfly has really had an effect, and in some ways so has THCB. But I’m not sure it’s a good one. Yesterday for the breach of patient confidentiality that was fairly exhaustively documented on THCB and elsewhere, the California Department of Managed Healthcare (DMHC) fined Kaiser $200,000.

Just to remind you, some contractor left some database schemas of Kaiser’s Health Connect project on an open web site some time between 2002 and 2004. Somewhere in those charts, which I looked at (not knowing what was in them) were patient records for 150 real live patients (although I never saw one and the Gadfly said that she only ever saw three and never knew they were real). The Gadfly linked to the site from her website, and after she wrote to me, I put it in a story here last August. Within a few days, that website had been taken down, and I assumed that that was that.

But apparently not. The Gadfly, who was involved in a nasty if unrelated dispute about her firing, had mirrored and copied the site to prove (at least to her satisfaction) that Kaiser was doing something wrong. Kaiser apparently is being fined for not reporting its breach of confidentiality. "DMHC officials were concerned that Kaiser allowed the site to languish on the Web in an accessible format and did not act to remove it until its existence was brought to the attention of federal civil rights authorities in January 2005. In addition, Kaiser authorities chose not to inform state regulators until after the site had been reported to the media in March. However, Kaiser has since informed all of the approximately 150 members who may have been affected." So playing out the time-line, Kaiser knew (we can assume) in August 2004, started going after the Gadfly in March 2005 when the story broke in the SJ Mercury News, but apparently had been told by the Civil Rights Commission in January that there its data had been (or still was) online, but didn’t inform the DMHC until March.

However, given that they had taken down the offending site the previous August, really Kaiser is being punished for not informing DMHC when it knew, rather than keeping it quiet and pretending (or at least insinuating pretty heavily) that it was the Gadfly who’d allowed public access to the site. But then again the Gadfly was allowing access to the data from August 2004 until March 2005, although it was a mirror of the site that had been up for over two years.

In some ways there is some karmic justice to all this. Kaiser didn’t treat the Gadfly at all well as an employee. She went after them rather too aggressively, even if she didn’t know that she was showing real patient data. Kaiser in turn responded in a more than proportionally aggressive response, and never tried to work it out with the Gadly to see if some reasonable accomodation to her problems could be reached. And they failed to do the CYA necessary to stop themselves getting in trouble with DMHC. But if $200,000 is a fair fine, then it’s more than $1200 per person, and probably more than a few thousand dollars per actual viewing by anyone on the web. So to my mind that’s a more than proportional punishment.  And I’m not sure that it’s not just DMHC grandstanding–I mean I know it was against the law, and Kaiser was slow, but I can’t see that that much harm was done to any of those patients.

Now Kaiser is a very wealthy organization and had a very good year last year ($481m profit in Q1 2005 alone), so $200,000 is not exactly that much to it. But on the other hand, it’s real money that could be used to provide health care to many needy people, and I suspect that had just a little been spent on better health insurance for the Gadfly, all of this could have been avoided. Of course the DMHC can now try to go after the Gadfly, but it appears that HIPAA privacy requirements do not apply to individuals.

So the lesson for health care organizations is mind your data and mind your employees, and treat both with common sense.

POLICY/INTERNATIONAL: More rubbish being talked about single payer and Canada by major newspaper columnist

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I had hoped that when the Boston Globe gave Jeff Jacoby a chance to rant about Canada and single payer, and THCB was able to call bullshit, that I wouldn’t have to repeat myself quite so soon. But to no avail. The Chicago Tribune gives a columnist called Steve Chapman, who incredibly enough worked for the liberal  New Republic (although aside of that has a long list of writing for libertarian and conservative newspapers), a chance to spread way more disinformation.

It’s good to know that a serious newspaper can allow a leading columnist to write about Canadian health care using numbers about the length of Canadian waiting lists from hopelessly biased organizations like Fraser and Cato, but ignore the official statistics which indicate that Fraser is wrong on waiting lists by a factor of 4. And for that matter the average waiting lists quoted by Fraser of around 4 months for elective surgery aren’t that bad–yet somehow Chapman starts talking about two year waiting list because one orthopedic surgeon said so.

Chapman then goes on to cherry-pick different outcomes on cancer to show that American care is better. Of course he doesn’t bother looking at overall care in different countries. This article in Health Affairs did just that (and is one in a series). The result, as again commented on in THCB, is that overall there is no real advantage to being in America. We do worse on somethings and better on others, but the suggestion by the Canada bashers that we get what we pay for is well off-base. And we clearly pay a lot more than anyone else and the share of those costs borne directly by poorer Americans is much, much greater than that borne by poor Canadians (or poorer people in other nations).

And if you look at the Health Affairs study a little more carefully you come to the authors’ conclusions.  Remember this is a real academic peer reviewed study, not some rubbish that Fraser Institute made up to suit its political agenda.  Here are the conclusions:

Across multiple dimensions of care, the United States stands out for its relatively poor performance. With the exception of preventive measures, the U.S. primary care system ranked either last or significantly lower than the leaders on almost all dimensions of patient-centered care: access, coordination, and physician-patient experiences. These findings stand in stark contrast to U.S. spending rates that outstrip those of the rest of the world. The performance in other countries indicates that it is possible to do better.

There’s plenty wrong with Canadian health care–something I looked at in depth in my "Oh Canada" piece. I’m also pretty sure that it’s not a good model for America, whereas Germany, Holland, France or Japan might well be.  But I really wish that if right-wing know-nothing columnists are going to write about this subject, that they’d either learn something about it themselves, or try to abstain from feeding at the research trough of totally biased organizations like Cato and Fraser. I suspect though that I’ll be wishing in vain for a while, but shouldn’t the Chicago Tribune hold itself to a higher standard?

INTERNATIONAL: The Future of Europe, Seen from a Sickbed

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Timothy Garton Ash is a veteran British journalist, sort of from the Blairite "Third Way" school. He has lectured Bush on foreign policy and has been an influential writer about the collapse of communism in Eastern Europe. So his thoughts about how the health service in the UK is a microcosm of the future of Europe, which is called The Future of Europe, Seen from a Sickbed, is a great read.

It’s also very relevant in the US, where an aging white population is going to have proportionately more Hispanic youngsters looking after it in the coming decades.

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