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A Little Guidance on Guidant by Jib

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WALL STREET has basically blown off reports of a defect in a defibrillator made by Guidant.  The company’s stock has fallen only slightly since Tuesday, when the New York Times ran a front page story detailing problems with the Ventak Prizm 2 Model 1861. The story was prompted by the death of Joshua Oukrop, a 21-year old from Minnesota.  So far the death is the only one linked to the defibrillator. Twenty-five other incidents of non-lethal malfunctions have been reported.

Did the Times go a little too far in giving the story such prominent play under the circumstances?  Were editors at the paper possibly just a little bit overeager in their zeal to nail a major device manufacturer and embarrass the FDA?   A lot of doctors and other healthcare people I know are still angry about the way the Times and other media outlets handled the drug safety story. I’m not sure that I know the answer to this one,  but its certainly a question worth thinking about. 

A Mistrial in the Scrushy case?

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Scrushya_2Could the jury in the Scrushy case be on the verge of deadlock? It certainly sounds that way from this report in today’s Wall Street Journal:

"Jurors in the corporate-fraud
trial of HealthSouth Corp. founder Richard M. Scrushy told the judge
that they "cannot unanimously agree on a verdict" and asked for "an
explanation in layman’s terms."

The handwritten note, delivered to the judge about
halfway into the jury’s fourth day of deliberations, appears to be an
ominous sign for federal prosecutors while giving Mr. Scrushy another
reason for optimism about the outcome of the four-month trial here."

Now, it’s a little early to say anything conclusive about what a mistrial would mean, but that does not exactly sound like good news if you’re one of the people who think Scrushy was involved in the massive accounting fraud at HealthSouth. 

Policy: Another take on HSAs by Jib

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The Los Angeles Times has an excellent piece on Health Savings Accounts (HSAs) this week, which almost sounds as though whoever wrote it read some of the comments in the threads here! No surprises in the conclusions :  employers kind of like HSAs (go figure), employees are kind of confused (ditto) and some people are ending up paying a little bit more for their medical bills than they had reckoned on. BusinessWeek also has an article on the topic this week, which has a more positive take on HSAs, including some interesting wrinkles in place at one plan.  Hat tip Ezra Klein.

Policy: Stem Cell Wars Afternoon Update

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The House appears to be on its way to approving legislation which would relax federal rules on stem cell research.  The debate on both sides has been emotional, as was to be expected.  Ever popular House Majority Leader Tom DeLay is quoted by the Associated Press as saying stem cell research equates to the "dismemberment of living, distinct human beings."  In an effort to sway the undecided, President Bush spoke out against the legislation again this afternoon. "This bill would take us across a critical ethical line," Bush said "by creating new
incentives for the ongoing destruction of emerging human life."

In a carefully orchestrated demonstration of political spontaniety, the White House arranged to have a group of children adopted through fertility clinics appear with the president, all wearing t-shirts which say "former embryo."

UPDATE: As most people were predicting, the House passed the Castle-DeGette bill by a vote of 238-194, which is not a wide enough margin to withstand a presidential veto.  The alternative legislation favored by some Republican leaders, which encourages stem cell research using umbilical cord blood, passed 430-1. Rep. Ron Paul of Texas was the lone dissenter.

Pharma: At last we talk about the issues! By Jib

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For those of us who thought the government would never take health care seriously, there’s finally evidence that people in Washington are starting to get serious.  The latest thought-provoking issue is … Medicaid viagra for sex offenders! 

Apparently up to a hundred sex offenders in New York have been getting government sponsored Viagra through the state’s Medicaid program.  New York Governor George Pataki scored political points at a press conference this morning, blaming the problem on a Clinton-era loophole in the law.  The reference did not go unnoticed.

A story nobody even knew existed 36-hours ago now leads Google News with 617 stories, putting it ahead of Crestor (503), the bird flu (295) and the stem cell debate (137 stories).   

Policy: Stem Cell Wars, Episode III

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Last week’s news that Korean scientists have been able to develop an efficient technique for harvesting stem cells is creating quite a stir. Over the weekend, President Bush made it clear that he would veto any legislation which leads towards cloning, or as he put it "destroys life in order to preserve life" despite the arguments from researchers who say the experiments have nothing to do with cloning babies. That sets up a fight on Tuesday in Washington between supporters of therapeutic cloning and opponents who  say stem cell research is morally wrong.  There are two bills in Congress aimed at easing restrictions, both of which have "strong bipartisan support" in the estimation of the New York Times.   Many researchers are saying neither bill accomplishes particularly much.

The Castle-DeGette Bill would allow limited use of embryos left over from fertility treatments for scientific research. .S.681 The Cord Blood Stem Cell Act of 2005, would attempt to get around the moral issues involved in cloning by creating a national stockpile of cord blood stem cells and bone marrow for futher research.   

Indications are strong that Bush will use his veto to try to kill Castle-DeGette if it
passes. Supporters of Castle-DeGette are arguing that because the legislation authorizes research only on embryos that otherwise would "go to waste", no harm is being done. The Pro-Life camp meanwhile, is basically saying no way, it doesn’t matter.  We’re not interested.  This is not for us.  This is evil.

Interestingly, this seems to be one fight which is increasingly dominated by Republicans. The loudest voices on both sides, both for and against, are Republicans. Democrats are
supporting the measure, but rather quietly. That is probably a sign of the times. 

The thinking on the Democrats’ part is clearly that this is another round like the Schiavo battle. Polls show the majority of Americans support stem cell research.  Very few seem all that worked up about the story.  America will watch Tom DeLay and his team take the issue all the way, and will be disgusted. That may or may not be the way it happens. We’ll have to wait and see.  Meanwhile in Korea, the government shows no signs of slowing down. Over the weekend, health officials announced they will
seek funding for an international consortium which would bring foreign researchers in to work on further research. Initial reports are that one of those involved, will be Ian Wilmut, the man who created Dolly the sheep.  In another move, the Korean government unveiled plans over the weekend to create a "tax-free" international zone on the island of Cheju, where a medical center will be set up to attract foreign patients. 

One government official is quoted as saying the experiment gives South Korea a "two year head start." 

TECHNOLGY: Too much of a good thing?

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Walking the floor at the TEPR show this week brought home the wonders
of electronic medical records. The show had a multitude of
presentations on EMR use, but more than 35 years after the first EMRs
were developed we’re still early in the adoption cycle. Most
presentations were about fairly small-scale case studies. But despite
the exit of hundreds of firms from the EMR and practice management
market, and the slow emergence of several dominant players, there are
still plenty of new entrepreneurial companies with booths — and not
all small ones — out on the exhibit floor. Many of these companies
have new EMR technology that, while it may be more advanced, doesn’t
look that dissimilar to those on show a few years back.  What they lack
is a customer base. But as the legacy players in practice management
and small hospital IT systems have shown, in health care getting into
the market is relatively cheap and you don’t need that big a customer
base to anchor a business.

One of the major problems in physician
adoption of technology is the lack of familiarity with a few trusted
brands, and the insistence on doing everything differently than the
practice or hospital down the street. The sheer number of vendors
willing to support that demand for "doing it different", including
those based on software from physicians who claimed that "what was on
the market didn’t meet their needs", means that we’re a long way from
getting to the status of other industries where everyone is comfortable
with using a few widely known applications.  This might be a case where
we have just too much good old American ingenuity.

Having said that, I saw some interesting products and there are some interesting new developments that I’ll comment on later….

POLICS: Galloway vs. The US Senate

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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.

INTERNATIONAL/QUALITY: The Brits are in court over “how much is enough?”

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Well I was up late late last night working on some client stuff and am about to head back to that meat grinder, but for now consider this….

You may (unfortunately) remember the Terri Schiavo incident.  The Brits are playing this rather differently.  Here we’re keeping people alive who want to die (or at least we’re keeping some people who want to die alive). In the UK the issue of the NHS continuing to treat people who are going to die but who want all the stops pulled out anyway is ending up in court. Traditionally this process played out in the UK in a "stiff upper lip" way, mostly controlled by the medical profession.  Now the government is being explicit that it feels some medical care is a waste of resources. Pretty interesting stuff, because of course they are right, and the same thing is going in here but no one has the cojones to point it out.  But with the baby boomers about to hit Medicare and the Federal budget in the pocketbook, and way too much excessive care of the nearly dead going on in America’s ICUs,  the day when this discussion starts here will come.

THE INDUSTRY: Down to the wire for Scrushy

Well the jury is out at the Scrushy Trial. Don’t really want to spend a whole lot of thought about it, but I’m a little intrigued to see if the preaching at the black Churches and the sponsoring of the Christian boy bands can keep poor Richard out of the slammer. I doubt it, but then again I pride myself on being rational! I read somewhere that it’s easier for a camel to pass through the eye of a needle than for a Medicare fraudster to enter the Kingdom of Heaven.  But what would I know….

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