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PHARMA: Pain Therapeutics causes yet more headaches

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Those of you hanging out here for a while know that I’m a long term holder of Pain Therapeutics stock. The pitch is that it has three drugs in phase III trials, one for pain, one for IBS and one a non-alterable version of Oxycontin. the stock went public at 14, it usually trades between 6 and 9, and I bought a boatload at between 2 & 4 in the dark days of late 2002/early 2003.

Now I’ve been hanging on for the last of two phase III trials of its star drug Oxytrex, which is supposed to be a non-addictive version of Oxycodone (the active ingredient in Oxycontin which is a multi-billion $$ drug). The first Phase III trial looked good, but was a little inconclusive, and the stock that was hovering in the 5-6 range didn’t move much. Still given the company’s market cap is only in the low hundred millions and any one of these drugs alone if successful is worth several billions, it’s always looked a good bet to me.

Then last week Pain Therapeutics cut a great deal in which it essentially passed off a share of the profits and all of the costs for its third line drug Remoxy (yes the CEO’s name is "Remi"–no ego huh!), which is a non-alterable version of Oxycontin (and therefore can’t be abused as Oxycontin or "Hillbilly Heroin" is frequently), to King Pharma for up to $400m, including $150m in cash.  The stock went up about $2.50 and I was looking forward to a conclusive phase III for Oxytrex leading to an FDA approval.

So today the Phase III results are out and they are maddening.  The drug appears to work, but too many people dropped out of the trial, and so the results are not statistically significant. My guess is that the FDA will make them go around again.  The stock is now back down to more or less where it was before the King deal (so I suppose it could have been a good deal worse). But still no clear end in sight.

I’ve been hanging on for about 3 years.  And of course in the meantime I didn’t buy any Google stock because it didn’t have much upside….

Any suggestions from my readers as to what I should do now?

POLICY: CHCF report on Safety Net Clinics

Given that the community clinics are apparently our brave leader’s only thoughts about how to provide care for the poor in America, it’s pretty timely that a new California Health Care Foundation study is out giving a primer on safety net clinics in California (PDF). And of course the population they serve is often underserved, uninsured, doesn’t speak English, and is growing. Here’s the conclusion.

SAFETY-NET CLINICS HAVE BECOME INDISPENSABLE components of the health care system for vulnerable and underserved populations. However, these clinics rely on a patchwork of funding sources to provide comprehensive primary care and preventive services in the communities they serve. In the current operational climate these clinics face major challenges to longterm sustainability and expansion to meet the needs of growing numbers of uninsured

Note: I have worked recently for CHCF, and while as a Foundation it cannot take political stances or voice exact opinions, I can only applaud its efforts in shining a bright light into the murkier parts of our nation’s health care "policy"

PHARMA/POLICY/POLITICS: Medicare Part D–A mess that will need fixing when the grown-ups get back into power

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Last week the most convoluted program in the history of Medicare began. I’ve heard comments from friends, neighbors and people in the press saying that they can’t make heads or tails of the new drug benefit. The Washington Post piled in on Saturday with yet more about how confused seniors are.

Whether you like it or loathe it, there are some interesting parts of the Medicare Modernization Act, including the HSA provision and the disease management provisions. But the main event–drug coverage–is neither rational nor ideologically consistent. It’s a dog’s breakfast put together to ensure that the PBMs and some private health plans have something extra to sell, and so that the pharmaceutical companies don’t have to deal directly with the government on pricing.

Now seniors are going to have to deal with a donut hole, out-of-pocket costs, in-network and out-of-network pharmacies, and deciding whether their employer-sponsored coverage is going to stay around. No wonder they’re confused.

And despite all this, the cost to taxpayers is going to be double what Congress was told it would be. Drug coverage for everyone (especially seniors) is needed. But the only prediction I can make is that a more fiscally and socially responsible government–should we get one–will be forced to re-sort this mess in the very near future.

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TECH: The evolution of wireless in hospitals

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Now that cell phones and Wi-fi have proven to be safe and essential for health care facilities, there’s a race on to get signals into those buildings. This is proving to have some interesting possibilities, but is also bringing some technical challenges to hospital technology managers. Frequently buildings are too dense to allow good cell phone signal, while increased demand for Wi-fi and VOIP is putting pressure on the ad-hoc Wi-fi networks being built up in many hospitals. One solution gaining traction is to locate PCS, cellular and paging, and Wi-fi services centrally and create a series of ceiling-based transmitters to amplify and distribute the various signals. One company in the forefront of this is InnerWireless, which has announced several installation wins in recent weeks. I recently spoke with Jim McCoy, chief technology officer of InnerWireless, and Tuomo Rutanen of Ekahau to find out a little more about what’s going on inside the wireless world for hospitals.

Wireless and Wi-fi are different. InnerWireless’ technology deploys Wi-fi, as well as PCS, cellular, 2 way radio, 2 way paging and other signals. Conventional practice for Wi-fi is to deploy those points throughout a floor or department. Innerwireless co locates those Wi-fi access points at one place per floor, combine their outputs and then injects them onto their distributed antenna, therefore giving every user the strength of multiple antenna to access. This enhances Wi-fi data and more importantly VOIP performance. There tend to be around 6 distributed antenna per typical 20,000 sq ft floor, each one up in a ceiling panel where it’s installed once and forgotten about. All other services (cellular, PCS, etc) are piped to the same access point from aggregated through a main console room. And of course once the central points are in for cellular, it’s probably more cost-effective to layer Wi-fi into that system than to do it with ad-hoc networks.

In addition InnerWireless, Ekahau, and others are developing the ability to track patients, products and equipment in a cost-effective real time manner using the Wi-fi network–an always-on alternative to RFID which works sort of like an “indoors GPS”. They are both deploying tracking tags on people and equipment, and the size and price of those tags is falling rapidly. Ekahau’s approach takes advantage of the existing Wi-fi network, whereas InnerWireless uses its installed antennas and adds several more battery-operated sensors (probably 20 more per floor) to extend the accuracy of its trackers. Innerwireless is running their tracking over a different system within their infrastructure and are using the 802.15.4 standard for the tags.

These are two innovative companies attacking a key problem for health care facilities. Given the problems hospitals have locating their staff, patients and other movable parts, expect this technology to spread rapidly.

 

FDA examining Oseltamivir risks by John Pluenneke

If you read FierceHealthcare, you had advance warning of this one on  Monday. The Wall Street Journal reported yesterday afternoon that the  Food and Drug Administration is probing as many as 12 deaths it  believes may be linked to oseltamivir (i.e. Tamiflu) in Japan.  According to the paper, all of the victims were children.

Quoting from the source:

The FDA said there were 32 reports of "neuropsychiatric" adverse events, 31 of which happened in Japan, and included abnormal behavior, hallucinations, convulsions and encephalitis. The agency said it received a report of two patients, ages 12 and 13, jumping out of their windows after receiving two doses of Tamiflu.

The antiviral, which is jointly distributed by Roche and Gilead Life Sciences, is considered the best available treatment for the H5N1 virus, although not everybody agrees it will work. Given the recent hype about the drug, this is a development worth watching closely. Apparently the FDA has known about these allegations for some time – as in for many months. Expect a lot of talk in the media about this story and its implications once it sinks in.

Also expect the story to take center stage in the fight in Washington over the liability protections vaccine makers and drug companies say they want …Update: On Friday, an FDA advisory panel said it could find no evidence linking Tamiflu with the deaths in Japan.  Meanwhile, in response to public pressure, Japan’s independent Pharmaceuticals and Medical Devices agency  said it will begin publishing detailed data on all reports of adverse events it recieves related to prescription drugs and medical devices starting in January 2006.

PHARMA/POLICY/INTERNATIONAL: Not all the wingnuts are in the US

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Australia had some great news yesterday as the national team qualified for the soccer world cup, even though it’s only the 4th most popular team sport with the word "football" in the title in the country. But there was also some more bad news. The way that the national broadcaster ABC presented it as Australia’s rural doctors disappointed by Abbott’s abortion pill decision.

Abbott is not the drug company, it’s Tony Abbott the health minister. Because I randomly know his sister and parents, I can tell you that what’s not in the article is that Abbott is a devout Catholic who nearly became a priest. Meanwhile he’s been kicked around in the Australian press for kow-towing to the pharmacist lobby on pricing, and also for not forcing promised cuts in generic prices. He was also at the center of some more complex wrangling over drugs in the free trade pact that many on the left in Australia are very suspicious about, but where I felt they walked a tight-rope fairly well in getting the free-trade deal done.

But the reason given for the ban on RU-486 is that rural doctors wouldn’t be able to treat women using it. Well as evidenced from the statements by rural doctors managed just fine to treat women who spontaneously abort, that’s pure bunk.  Which leads us to the conclusion that yet again religion and ideology have trumped science at the highest levels of national decisions about drugs.

POLICY: Yet more Dartmouth proof about doing too much

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We’re almost at the point that you know exactly what any study from the Dartmouth group is going to find before it’s published. Following the assessment last year that showed that the nations “Top 100” hospitals show a wide variety of difference in procedures in their ICUs, for no apparent difference in outcomes, the same result comes up again.  This time (with Stanford’s Lauren Baker playing a starring cameo) Wennberg, Fisher et al looked at Medicare spending on patients in the last two years of life in hospitals in California and once again geography is destiny. (Health Affairs article here)

The study found that reimbursements ranged from $19,745 per Medicare patient at Redwood Memorial Hospital in Humboldt County’s Fortuna to $88,661 at Garfield Medical Center in Monterey Park in the San Gabriel Valley

Sacramento was cheaper than the Bay Area which was in turn cheaper than Los Angeles.  And of course the outcomes were similar in all places and had little relation to the costs. Interestingly, hospital chain is also a predictor. Sutter, which isn’t exactly known by California’s health plans as being a low cost operator, did way less than Tenet. (although I don’t know if Redding Medical Center skewed the data by itself!)

Medicare spending was also higher in some large hospital systems. Sutter Health, which operates 27 hospitals in Northern California, spent $30,814 on average per Medicare patient in the last two years of life, compared with $46,323 at Tenet Healthcare Corp.

Given that these are the most expensive patients (the 10% that cost 50% of all dollars), and moreover “it’s my money dammit”, you’d think that our so-called conservative leaders would be seizing on this to try to do something about the practice variation problem. But it just seems to be accepted as some type of unintelligent design.

 

BLOGS: FierceHealthcare, free and daily

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Just in case you’re here from the WSJ for the first time, I also write a newsletter digest called FierceHealthcare which goes out daily and summarizes all you need to know about health care news.  It’s news (albeit with context) rather than opinion and perspective, so it serves a different purpose to THCB.

The WSJ was slightly wrong as it’s published (i.e. owned) not by me but by a company called FierceMarkets who also put out several other excellent newsletters. 

And it’s free. Sign up here

PHYSICIANS: One doc’s look at his own care patterns

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File this in the cleaning up my queue category, but there’s a pretty good article in last weeks NEJM about how a doctor judges himself.  I’d submit that apart from baseball players, and call center customer service rep, most of us don’t get the regular metricized feedback that would help us improve.

This doc, Richard Baron, surveyed a small sample of his practice and discovered (and I’m sure that he’s not alone) that although he and his staff were doing OK in servicing patients, and keeping them clinically in good shape, he was not doing so well communicating to them about how to manage their disease. So he needs to import a good dose of information therapy.

But this is a start. The only company I’ve ever worked where there was serious consultation via survey with staff and customers was a survey firm.  And to be fair, whatever the results of the survey, they didn’t seem to really change the organization’s behavior too much. Perhaps I should be surveying my clients and my readers….but I think many more doctors should be surveying their patients.

 

BLOGS/POLICY: Health Reform competition still on

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Just another reminder….

Please don’t forget to enter your solutions for the health reform compeition that Eric Novack and I are running, into this post. Only 250 words to save the American health care system? You can do that, go on!

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