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POLICY: Firing smokers? Who’s next?

One of my favorite non-health care policy organizations, the Drug Policy Alliance, has a flash animation out about an insurance company that fired four smokers for possibly smoking in their free time. The company allegedly believes that it’s OK to fire smokers because their health care costs are likely to be higher than other peoples.  The Drug Policy Alliance folks’ sub-text is of course that what you do in the privacy of your own home away from the workplace is your business and not anyone else’s including your employer, so long as you do a good job in your workplace, and by that they mainly mean pot-smoking.  There was also a great study a while back that showed historically that companies that drug-test their employees do worse in terms of standard business measures like productivity and stock performance than those which don’t.  And of course no one is yet alcohol-testing employees, unless it concerns taking alcohol immediately before flying a plane or something similar which impairs the ability to do a good job.

But the key points in this "firing smokers" issue were drawn home to me while watching a Harris Interactive webinar yesterday. (The webinar will likely be up here sometime soon but doesn’t seem to be up yet.) They’ve done a lot of work about the obesity problem, and as their colleague Bill Rosenberg said it’s getting clearer that there’s little point in a company trying to do anything to reduce the obesity in its workforce  — there’s no ROI there.  So the next best option to reduce health care costs is of course to get rid of those who cost the most.  Once we’ve got rid of the smokers, drinkers, druggies and perverts, then who’s next?  The obvious answer is that it’s the fat and the sick, who of course tend to be lower paid than average, which in turn means that their health care costs are a higher proportion of their overall compensation.

I also had a recent meeting with Brian Klepper and Patricia Salber of the Center for Practical Health Reform.  They believe that employers are dropping out of offering benefits rather more rapidly than the overall figures suggest, and Brian points to a study showing that only 45% of jobs come with health insurance (as opposed to 62% of people getting their health insurance via someone’s insurance), and that the percentage of jobs offering insurance is going down by up to 5% a year. And of course the amount of coverage being offered in the brave new high-deductible world is at least somewhat (and maybe greatly) less than people were used to a few years ago. They believe that this is leading to a crisis of funding for the whole system, and have some interesting ideas about what to do.

But in the absence of reform (which will last at least another 4 years) there’s a very nasty scenario in all of this.  Employers may actively start looking at their workforce with an idea of who to keep in and who to kick out, based purely on their health status.  After all insurers have done this for years, to great effect on their bottom lines.  Now that many big employers really see health care as their biggest challenge, and small employers get the picture too, what’s to stop them really looking at the pre-cursors for health care costs and getting rid of people who smoke, look fat, or like a drink, or are getting old?  Nothing really, especially as a class-action lawyer won’t take on a small company because they haven’t enough money to be worth taking down. Particularly for a small employer, they don’t have to state anything in their policies about it, or even look into medical records, as those things are pretty self-evident.

And of course the costs of this end up on the individual and the taxpayer.

POLICY/POLITICS: Fast Times at NIH by John Pluenneke

An internal review at the National Institutes of Health has
cleared many of the NIH researchers the agency had earlier accused of violating
conflict of interest rules, the Washington Post reports.
NIH director Elias Zerhouni asked for sweeping restrictions on outside
consulting after reports of widespread rule breaking. The Post notes:

"The finding that most of the allegations are false has
many scientists complaining that Zerhouri did not get a better measure of the
the problem before succumbing to pressure from congress and the government
ethics office to prohibit virtually every kind of outside collaboration and to
demand across the board divestitures."

The Los Angeles Times played a major role in bringing the consulting crisis to
a head with a series of front page stories
in December focused on prominent scientists at the NIH including cholesterol
researcher Dr. Bryan Brewer, a member of the team which developed the nation’s
new cholesterol guidelines two years ago and Dr. Harvey Klein, a leading expert
on blood transfusions.

Interestingly, the adversarial relationship between the paper and the NIH dates
back to at least to the late nineties, as this 2003 piece by Slate’s Jack Schafer
documents.

The Post has an editorial
today
which agrees that changes were necessary  but argues the
proposed restrictions on consulting and stock ownership are far too
harsh.  As the paper notes, the findings of the internal review appear to
support the position that Zerhouni may
have seriously over reacted.  Of course, it remains to be seen if anybody
will be convinced by  an internal review.

POLICY: More on the realities of the crisis of uninsurance, by Anonymous

There’s been quite a fuss about the recent study showing that bankruptcy is frequently caused by high health care bills, or at least by the inability of those who are sick to return to work and pay off those bills. THCB contributor Anonymous wrote about her tough experience accessing care last November.  Now the bills are due and she finds herself on just that slippery slope. Here’s Anonymous story:

I was seen at the Alta Bates ER twice within a week for the same problem. Both times I received a form for the charity program. No one explained anything to me about two separate billing systems or that the charity program wouldn’t apply to the physician part of the bill. I initially needed help providing the proof required by the charity program. Alta Bates ignored my first letter in this regard, and I went through phone tree, transfer, and wait time hell to get to the right department to help me with the problem. When I eventually ended up with a financial counsellor, who was very helpful. She told me she could use  my prior year bank statements, and the charity care program then covered me 100%. I thought everything was wrapped up at that point.
A couple months later, I started receiving threat letters and calls from a collections agency. I called the financial counsellor and asked why I was being billed after I had been covered by the charity care program. She told me that there was a separate physician’s bill not covered by the charity care program. She also told me I had another outstanding bill from 2001(!) The 2001 bill is from a time when I was covered by insurance: I didn’t find out about that until it went into collections, either. But at that point I called my insurer, Blue Cross, and they took care of it. I haven’t heard about it since. Now Alta Bates expects me to remember my insurance information from 2001 to fix it when they were the ones who made the mistake of only applying my insurance information to one of my bills. I’m just boggled by that. Anyway, the counselor told me she couldn’t help me further at that point, and she gave me no guidance on how to proceed.
I went through phone tree, transfer, and wait time hell again, and I ended up at Berkeley Medical Group. I explained to them that I had qualified for the charity care program, no one had explained the two-bill concept or provided me with any alternate charity forms in the ER, and that I had been unaware that I had an outstanding bill until it had gone into collections. I was given the address of somebody in Washington State to write if I want to dispute the bad debt from 2001.The Berkeley Medical Group representative told me that they have no charity program and the fine print of the third bill warns it would go into collections. She did not seem to get what was wrong with the fact no one in the ER explains the fact there are two separate billing systems or explains steps indigent patients should take beyond giving them the forms for the charity care program. I asked her how I should proceed. She told me I had to deal with the collections agency now, and there was nothing she could do for me. I pointed out that the only thing adding a bad debt to the credit record of a person with no income would do would be to make it even harder for them to recover financially and be insured and/or able to pay such bills in the future. She told me that all I could do was call the collections agency.So, here’s where things stand now. I’m not going to call the collections agency. I went through this with the same agency in 2001 to deal with Alta Bates’ billing mistake, and I know this particular agency, American Capital, has a bad business reputation. I will only be setting myself up for threats and harassment if I call them. One amusing aspect is that the collections agency has been leaving messages on my answering machine: they don’t say who they are, but they give the collections case number and expect me to call them long distance! Anyway, I’m not going to deal with them.
I’m considering filing for bankruptcy. Whether I do that depends on whether I can take care of my student loans at the same time. My student loans might be exempt from a bankruptcy claim because they can always be deferred, but if I can get the loans taken care of that means that bankruptcy for hospital bills has larger ramifications for the U.S. financial system as a whole. I’m sure anyone who has to file bankruptcy for a hospital bill will take care of their other bills while they are at it. The question for me at this point is whether it does more damage to my credit rating to file for bankruptcy or simply ignore the collections agency notices. Which will fall off my credit record faster?  I’m also amazed that Alta Bates has been continuing a practice that’s bound to confuse anyone who comes to their ER. Because of the 2001 billing problem, I know that problems like this have been going on at least that long. Surely I’m not the only person who has brought up that patients aren’t being given all the information in the ER. I’m wondering if there isn’t a Patient’s Bill of Rights violation in there somewhere. Even if there isn’t, Alta Bates and Berkeley Medical  Group end up paying extra administrative costs to hunt down people who were simply confused by their billing system.

This type of foul up is very common.  A friend of mine who was well insured was sent to collections by a local medical center for a bill he’d already paid and was dismayed to find it reported as an unpaid debt recently on his credit report when he wanted to get a mortgage. And I personally just finished getting an unnamed insurance company to pay my final provider bill because they had miscalculated my deductible for surgery I had back last April. The move to more HSAs and forcing more people into dealing with a system that can produce bills from 5-10 seperate providers from one procedure is not exactly going to simplify matters. Horror stories like that of Anonymous’ are going to multiply.

BLOGS AND BLOGGING: Grand Rounds is up

A particularly feisty Grand Rounds is up today hosted by the not-quite-mad libertarians over at Catallarchy. A great job by Trent McBride. One day I’ll be brave enough to host one of these things myself!

BLOGS AND BLOGGING: THCB technologically reborn

So after suffering through Blogger’s growing pains, seeing it acquired by Google and waiting patiently for it to catch up with the rest of the market in blogging software, I’ve given up.  It’s disappointing that, even with all the money of Google behind them, the Blogger gang seemed to be having increasing problems keeping their site up–there were two days last week when I couldn’t post at all.  I also use the service to record headlines for my FierceHealthcare newsletter, and several times they weren’t accessible when I came to write the letter near deadline,which was a little stressful.  Furthermore, getting even basic features like category posts up on the service continues to elude Blogger, and the work-around that I used for topic listing cost lots of time and money.

So today THCB moves over to SixApart’s Typepad service. So far I and my webmaster John have been pretty impressed by the uptime and the customer service.  And although Blogger is free and the version of Typepad I’m using is $15 a month, it was becoming a case that in the evolution of my service, free wasn’t cheap enough! Typepad isn’t perfect yet, but at least they are working on it!

We were planning to wait until next month to move, but last week’s problems at Blogger were so severe that we advanced it over this weekend (and I want to thank John for putting in hours over the holiday weekend to get this done). So this current site isn’t quite done, and you’ll see some improvements soon I hope. Please let me know if you have any comments or suggestions.

The other thing that is a first for THCB is that comments will now be on. Let’s see how that goes!

Finally if you get TCHB via RSS, please add the new RSS address to your reader: it’s http://matthewholt.typepad.com/the_health_care_blog/index.rdf If you use a different aggregator service see the box in the right hand column to select the relevant link.

TECHNOLOGY: Informatics position at Highmark

Those of us who spend too much time whining about why this or that health plan can’t get their IT and customer service together now have a chance to do something about it. Highmark, one of the nation’s biggest and richest Blues plans is looking for a VP of Healthcare Informatics, and via one of their vendors asked me to publicize their search.

Here are some minimal details –the catch of course is that you have to move to Pittsburgh (cue abusive letters about snobby Californians…). You can email me if you want the full description and I can send you on — (and no I’m not getting a cut!).

By the way the first job for the new VP of Informatics should be to fix the careers part of the Highmark web site which is totally fouled up when viewed in Firefox and not a whole lot more helpful (but at least is functional) when viewed with Explorer.

PHARMA: Celebrex can remain on the market

Celebrex_2And to add to yesterday’s post (which Blogger prevented from getting up there till most of you had gone home, so it’s really today’s post) the FDA panel this morning ruled that Celebrex can stay on the market, although they concluded that it did have risks. They are due to rule on Bextra and Vioxx later in the day.

UPDATE: The FDA also said that Bextra and Vioxx can stay too, even though Vioxx has already gone.

PHARMA: The FDA, the new safety board and the Cox-2 debacle–an opportunity seemingly being lost

None of this is quite as timely as it would have been 24 hours ago, but it’s worth giving my take on the new developments at FDA, and with the Cox-2s.

Logo3cThe news is that a new board within the FDA will oversee drug safety, and publicize more about its inner workings reviewing drug safety on the Internet. That’s all very well, although it’s not the announcement of an entirely new Federal agency to review post approval marketing and safety that some people might want. And of course it’s a role that will be subject to the FDA overall. The FDA will be led by an insider, Lester Crawford, who has been there all the while that the sky has been falling. THCB contributor Blunter is not alone in describing his appointment as a cop-out.

But it does appear that the FDA ostrich is lifting its head out of the sand. In today’s testimony on the Cox-2s, internal whistleblower David Graham revealed that he was given permission by Crawford to discuss unpublished studies and to give his full opinion. That marks a big change since his last testimony and it suggests that the FDA higher-ups realize that politically they can’t get away with their stonewalling.

It’s also good news that there are now promises to release more information earlier in the process. Part of the issue with the Cox-2s, particularly with Celebrex, is that the FDA (eventually) found out information about trials that it didn’t release to the public. The most pressing example of this is discussed by John Abramson in the excellent Overdosed America. Pfizer had basically hidden results of a 12 month Celebrex study from the FDA and only initially put forward the 6 month interim data. But while FDA got the new results eventually, it required a Freedom of Information Act request so that the public could discover what the FDA knew.

Now that the Cox-2 cat is out of the bag, there’s more and more bad news:

"A new study has linked pain killers Vioxx, Celebrex and Bextra to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs."

It’s not just the FDA and big pharma that comes out of this looking bad. The NEJM which published the original results doesn’t seem to be falling all over itself to eat crow. Abramson called them yesterday a "mouthpiece for the industry". The short comment from Jeff Drazen in the NEJM basically in a most understated way suggests that if just possibly Merck and Pfizer had conducted studies to investigate problems with the Cox-2s rather than new trials to get other indications, we might just have figured out the severity of those problems a little sooner. But nowhere is there a real admission from the NEJM that it either misrepresented the VIGOR results in its peer review process, or allowed itself to get conned by big pharma. In terms of further FDA reform, the slightly more aggressive piece also in NEJM by Psaty and Furberg notes that:

For an approved drug, the FDA currently engages in protracted negotiations with manufacturers rather than mandating manufacturers (1) to change a product label, (2) to conduct patient or physician education, (3) to limit advertising to patients or physicians, (4) to modify approved indications, (5) to restrict use to selected patients, (6) to complete post-marketing studies agreed on at the time of approval, (7) to conduct additional post-marketing studies or trials, and (8) to suspend marketing or immediately withdraw a drug. The FDA has recently claimed to lack adequate authority in these areas. We believe that to protect the health of the public, Congress needs to provide the FDA with the necessary authority and also to create an independent Center for Drug Safety with new authority and funding. Civil penalties should be commensurate with the scale of drug sales. Provisional approval and regular repeated review would provide opportunities to reevaluate risk and benefit. In addition, ongoing congressional oversight of the FDA would afford an important forum for the public discussion of drug safety.

But of course we’re probably not going that far anytime soon with the news out yesterday that the drug safety office will be staying within the FDA, which makes it unlikely to be quite as "independent" as all that.

And we’re never going to get to the rational debate about making more drugs available to more patients with everyone concerned having a real understanding of the potential risks and benefits involved. Which is a big pity because that’s what a grown up responsible FDA and medical system should be doing. I’m not convinced that Vioxx should, in a perfect world, be taken off the market. All drugs have some side effects and while Vioxx and Celebrex clearly shouldn’t be given out like candy, there may be patients where they work well with few side-effects and where they are a big improvement over NSAIDs. Theoretically the clinical trial data should be able to identify those patients, and patients on those products could be monitored for cardio-vascular risk, and taken off them if bad things start to happen.

But because the FDA didn’t do its job in the first place, and because the NEJM looked the other way, and because big pharma’s marketing machine ran roughshod over the minimal checks and balances in the system, we’re now in a mess which will likely see more good drugs not getting to market and the development of an overly-conservative approach to patient safety.

Perhaps integrating the use of drugs fully into the medical care delivery process might be a good place to start, rather than having the use of a prescription as a way for a doctor to get a patient out of their office. But that would require a whole new mind-set.

PHARMA/POLICY: The outsider the FDA needs is the consummate insider, with comment from Blunter

Two days before the latest hearings on Vioxx and Celebrex, with a stand-up Republican Senator all but accusing the FDA management of fraud, Bush names the new head of the FDA. And who gets the gig? None other than the guy who’s been temporarily running it onto the rocks. Crawford, the acting head of the F.D.A. is the new leader. THCB contributor and ex-FDAer Blunter last month suggested that a real outsider was needed to rescue the agency. While he wasn’t expecting Syd Wolfe to get the job (and the NY Times has a big profile on Wolfe today too), you can assume that the appointment of Crawford was not what Blunter was looking for. He writes:

Aaarrggh! The President?s nominee to head the Food and Drug Administration is none other than the current acting head: Lester Crawford. This is a real life Phoenix rising out of the ashes of death, and ashes that he created. With controversy swirling around the FDA and its treatment of and failure to protect whistleblowers, and warnings on Vioxx and other COX-2 inhibitors, and then the Adderall situation, and the surreptitious change in the antidepressant labeling, the odds of such a miserable record were against him retaining his present job, let alone getting a promotion.

Any FDA Commissioner nominee must face a Senate confirmation process. As some of my exile friends from Cuba would say: "We ought to hire a balcony for this one." Look on the FDA Web site and see Crawford’s resume — devoid/scrubbed of any association with regulated industry interests. Those who know Crawford say he was once associated with American Cyanamid and several industry groups and associations. Last time his resume was floated for possible confirmation as FDA Commissioner, the ranking minority member on the committee that handles this nomination, Senator Kennedy (D-MA) telegraphed a "dug in" opposition position, and the nomination did not see the light of day.

What a political donnybrook the President has created for himself. Here will be the person who is presiding over one continuing debacle over drug warnings and safety incidents being put into the spotlight in a public confirmation process. Expect real fireworks here that are likely to doom the nomination and wash over onto the Presidency.

Furthermore, the need for the head of the FDA to be paying attention to business is critical right now, and the need to get a Commissioner in place as quickly as possible is also critical. But in the current controversial context surrounding many FDA decisions, who would think that the situation will get any better with the current FDA head off promoting his nomination on Capitol Hill and elsewhere.

No good can filter through to the FDA or the Bush Administration as a result of this faux pas.

Two things to note here. Without revealing his identity I can tell you that Blunter has strong Republican leanings, and thus you should take his views very seriously. Second he thinks that Crawford won’t make it through the nominating process. I’m not sure I agree. It may surprise you all to know that I am not a Republican, but even with some Republican support for some things that the FDA and the Administration opposes (e.g. reimportation) I’m not sure that the Senate has the guts to turn down any Bush nominee–after all they just confirmed torture-memo man Gonzales for AG.

But this will be an opportunity to drag more FDA laundry out in public — and after all the recent posturing by Leavitt, the appointment is made well before the IOM "reform" (whitewashing?) report that is supposed to fix the FDA’s problems. How this makes the FDA better is beyond me.

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