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PHARMA/POLICY: The NY Times misses the point on medicinal marijuana

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The New York Times has a very dumb article about medical marijuana called Medicinal Marijuana on Trial, which suggests that medical marijuana hasn’t been properly proved by clinical trials.

Well leaving aside that plenty of drugs have been approved by the FDA which have had less than full trials, there are three points not made in the article.

1st: Medical marijuana has been broadly favored by an Institute of Medicine report, and the Federal government has been sending it out for years to a very few patients.

2nd: There have been no major trials in the US, and precious few elsewhere, precisely because the DEA has stopped it for purely political reasons. So this article, which shows modest benefits from the few studies that have been done, but irrelevantly claims that this is outweighed by the impact on teenagers who smoke vast quantities of marijuana for no medical purpose. So we deny sick people medicine because of the actions of other people.  Well in that case, we shouldn’t allow Percocet for people coming out of surgery, because some people are heroin addicts.  Illogical rubbish and the NY Times should know better.

3rd: Most importantly, like Ginko, vitamins, fish oil and God knows how many other "cures", sick people take medical marijuana because they think it makes them feel better and healthier.  Making people feel better is the point of medical care. Rightly or wrongly people should be allowed to have what they believe to be medicine.  And despite some 75% of the country being in favor of allowing medical marijuana, it’s purely political grandstanding by extremist (and predominantly family values Christian) groups–being used as a front for the vast amount of money that the taxpayer has to pour into law enforcement–that has opposed sick people getting what they believe to be medicine.  Shameful.

HEALTH PLANS/POLICY: Another terrible patient story

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Paul Martin has a terrible story to tell of how his health plan let him down badly, and how the health care system is stopping him getting what seems necessary care. I of course only have his word for all this, but at THCB we from time to time try to remember that health care is about real patients with real problems.  And Paul certainly fits that description:

Here is a summary of some of the things I’ve experienced in dealing with our health care system over the past 12 years. After a major health insurer (“MHI”) bought out my school district’s insurance in 1998, they permanently terminated the one benefit which, at the time, appeared to be allowing me to make slow headway against MPS — the rare disease with which, it would later turn out, I had been misdiagnosed.
Every mediator, doctor, and lawyer who looked at my policy’s language agreed that the provision cited by MHI to justify its termination did not do so. The doctor trying to prescribe the treatment was one of the world’s leading authorities on MPS. My local specialist, a participating provider with MHI, wrote two forceful letters on my behalf, terming MHI’s decision against me "arbitrary."
MHI nevertheless terminated the benefit.

When, as a last resort, I started calling law firms, the first three I called couldn’t help because they were already being retained by MHI. Hundreds of letters and calls later, it became clear that no lawyer was going to take my case. Lawyers know the legal deck is stacked against them when it comes to defending patients against insurance corporations. Examples: boilerplate policy language that explicitly allows medical directors to overrule the treatment decisions of patients’ doctors. The deep pockets of insurance corporations that allow them not only to retain outside law firms, but their own legal staffs.

Two outcomes of MHI’s decision: 1) I became an "HMO refugee" – forced out of my job and out of my home state. Most of the school districts in my region were insured with MHI. How could I remain employed in a situation where I was covered for everything except the one treatment that all my doctors were recommending?  2) Watching my condition deteriorate, I took half my life’s savings and spent them on an experimental therapy with a good reputation that was less expensive than what my doctors wanted. The three weeks of therapy caused irreparable harm.

About a year ago, after experiencing increasing difficulty keeping outpatient appointments, I was permanently hurt on 2 out of 3 of my last doctor visits. My neuromuscular condition had become too fragile to allow safe transport by any means. Ever since, my family and I have been trying to arrange for physicians to come to my home. During this time, what began as a slightly impaired ability to take walks turned into the complete loss of that ability, then the loss of the ability to drive. By now I am only able to move about the house with a shuffling gait, and must spend increasing amounts of time in bed to alleviate pain.

As one example of the obstacles to home care that we have faced here in Delaware County PA (a suburb of Philadelphia): Delaware County Visiting Physicians does not accept Blue Cross/Blue Shield, only Medicare. I was granted Medicare as part of my social security benefit. However, social security does not allow the benefit to become active for two years.
Although my primary symptoms are soft tissue wasting and pain, I cannot receive pain medication. Federal law prohibits even immediate family members who are carrying the patient’s identification from obtaining pain scripts for the kind of serious (morphine-based) pain medication doctors were prescribing for me when I could still function as an outpatient. The patient either goes to the pain specialist’s office – at a minimum, every 30 days – or does without. (I worked as a school counselor for 23 years and have zero history of substance abuse, addiction to any drug, or even recreational drug use.)
The condition underlying my tissue wasting, severe osteoporosis, peripheral neuropathy, and a few enigmatic skin lesions "consistent with Sarcoidosis," remains unidentified.

Over the course of 12 years, I have proceeded from one specialist to another, usually at my own initiative. I have learned that a patient with an unusual and complex condition, arriving with the 50-page abridged version of his medical record, seldom receives more than the usual 10 minutes. There has never been a coordinated effort among specialists to reach a diagnosis or treatment recommendations. The minimal communication that has occurred among them has almost always been at my initiative.
In brief, a corporate dominated system of health care has no financial incentive to spend the extra time and resources to care adequately for patients falling outside the "best practices" box designed to meet the needs of the many. That’s where the money is.

PHARMA/PHYSICIANS: How to deal with the prostate conundrum

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Dame Edna was always making a running gag about her husband Norm’s enlarged prostate. But what should one do about it? Contributor Dr Krankheit (who as you might suspect is just playing one on television) has a solution:

The results of a recently completed project allow me to offer some tips in the interest of informed medical consumerism. It appears there is a major split among urologists in methods of treating benign prostatic hypertrophy
depending upon the specialist’s age.  Younger uros still possess the fantasy
image of themselves as surgeons and this disproportionately inclines them to
procedural/surgical fixes. In the case of BPH this means TURPs (transurethral
resectioning procedures) and TUNAs (transurethral needle ablations).  As with
older, neutered cats, older uros lose interest in these insertion procedures
because the callbacks from patients and evening/weekend rounds start to become a
drag.  Older uros instead prefer pharmaceutical remedies for BPH such as the
5-alpha reductase inhibitors (Proscar or Avodart).  So as an informed medical
consumer, if you find yourself getting up more than once a night to go to the
bathroom, you can choose to remedy the condition with someone putting a laser up
your wang and burning off part of your prostate or, alternatively, by taking
pills that may cause you to develop breasts (gynecomastia).  Select a
young buck urologist for the stick-and-burn option and one into his 50’s for the
D-cup treatment.

PHARMA: Pain Therapeutics update

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Wacky trading indeed in Pain Therapeutics stock Thursday.  As faithful THCB readers know I’ve been in this stock for some time. They have two parallel phase 3s on the first of their potentially huge drugs– Oxytrex, a replacement for Oxycontin.  In the phase 2 Oxytrex  did better on pain control than generic oxycontin (oxycodone).  In the phase 3 it did only as well (or slightly better depending on how you interpret it) BUT it showed lower side effects. The stock would obviously have been much better today if it had done better on pain (the primary end point) and on the news the stock sold off from $6 down to about $5.20.  But over the course of the day people started looking at the side-effects — particularly proxies for addiction — and the stock came back to where it started.

Ptie_1

Of course oxycodone is already pretty good at dealing with pain, as any hillbilly heroin addict knows, so the FDA’s decision is probably as dependent on the side-effects as it is on the pain reduction effects of Oxytrex. In that way it’s an improved me-too. But many successful US drugs are improved me-toos (anyone for Lipitor?) and reducing the addictive properties of opiates would be  a substantial improvement in the real world of DEA crack-downs on doctors.

It’s the addiction story that has been the key all along, as the drug binds a molecule to the opiate that has shown it to be less addictive in rats. That’s hard to test in humans, but they got a finding which suggests that it’s working in this trial. If it does OK (i.e. no negative surprises) in the next phase III then I think they’ll get FDA approval at the end of the year.  I’m surprised that the stock hasn’t gone up alot more on this news — but even if it’s a moderately successful drug which gets 25% of the market for OxyContin (now $1.5bn), that’s revenues of 3-400m a year for a company with a market cap of less than 300m with 100m in cash.  That should translate to a market cap of $1-1.5bn or a stock price of 30-50.  So the market is confused, but I think the downside is low from here — and Pain Therapeutics has TWO more drugs in phase 3!

I still think this stock eventually will be a barn burner, but it  definitely would have been better for us poor shareholders had it shown better performance on the pain metric v oxycodone. Of course Oxycontin will come off patent soon and the revenue size of the market will fall, but Oxytrex looks like the logical replacement to me. I still think anyone who got some at 5.20 this morning will be very happy.  I have a bunch lower than that but I’ve been here since 1999 and I ain’t leaving yet!

HEALTH PLANS: KP Gadlfy update and my commentary

The Gadlfy gets some good press in a Bay Area blog called SFist which notes her side of the story and not Kaisers. The story is called David Versus Goliath — And Goliath’s Bigger Brothers, Backed By The Persian Army –to give you an idea of where it’s coming from. They also credit THCB for fair and balanced coverage, and frankly I think I’m the only one calling for reason and moderation in this whole thing.

But what’s been the damage to a great non-profit health care institution?  Perhaps nothing, but now rightly or wrongly they’ve been castigated as a bad employer, they’ve had their proprietary data on the Health Connect program up for all their competitors and potentially hackers to see, and worse they’ve had to admit in court to a patient privacy violation that they waited at least 5 months and maybe much longer to reveal to the  patients concerned. And this says nothing about trying to rather brazenly blame the whole thing on the Gadfly — not that she’s blameless, but she couldn’t have done this without their sloppiness.

Kaiser should be getting great kudos for its roles in promoting IT in health care and running disease management programs. But instead what happens if you do a Google news search about KP? You get basically a page of stories about this incident?  And it could all have been avoided with a decent handling by middle management and HR of the exit of the Gadfly, which included a small settlement and a no-sue confidentiality agreement. Dumb, dumb, dumb.

BLOGS: Alter-lanche

Wow, my hit counter is going crazy.  If you’re coming over from Eric Alterman’s blog, welcome & please take a look around.  This blog combines health care business and health care policy, and tries to tell the truth about the present, while highlighting big issues for the future. And in health care, the present is very, very messy. If you want more on health care policy, please fell free to peruse the policy and policy/politics categories on the left column — there’s plenty there for all types, but I am very cynical about the practical prospects for "market reform", particularly if it leaves out a large segment of the population.

INDUSTRY/TECHNOLOGY: How GE Medical helped boost offshoring to India, with UPDATE

This is a great article from the WSJ (but reprinted in another paper so you can see it) about how outsourcing to India was  in part driven by the medical products group of GE. I am not in general an opponent of outsourcing per se. There is obviously pain and dislocation for workers in richer nations as their jobs get sent to poorer one, and in the US  both government and corporations (as if there’s any difference any more) do a shoddy job in retraining and softening the blow to workers here. But moving up the value curve is part of Schumpeter’s creative destruction.  And of course India needs the money more than we do. How we distribute the money (and the work remaining here) is a political decision.

Meanwhile I recall that my colleague David Hansen wrote an article in the 1995 Institute for the Future 10 Year Forecast suggesting that significant chunks of the then growing high-tech economy in the US would find that their jobs could be moved off-shore due to the very technology that they were creating.

Recently I’ve been investigating working with some research companies in India.  Many major research companies are already outsourcing large parts of their research activities to India (after all Google works there too!).  And although the rates are cheaper than in the US, they’re not that much cheaper.  So methinks this trend overall will level off.
On a related topic, at the excellent HIS Talk blog, read what one CEO of a transcription company has to say about the future of medical transcription being done overseas.  He thinks that trend is ending too.The transcription part is only a piece of long and fascinating interview. Kudos to the HIS Talk blog for getting this type of informed opinion out there.

UPDATE: David Hansen has sent me copies of the two articles he wrote for the 1995 IFTF Ten Year Forecast.  One is about India called India Strides Into The Information Age
Dragging One Foot In Its Past and the other is a wildcard called InfoSerfing that suggests that US white collar workers might find their incomes dropping dramatically due to the exporting of their jobs to similarly skilled people in other countries (just as happened to factory workers). Both pretty prescient articles given that we’re ten years on now.

PHARMA: Some funnies from the Pharma Marketing list-serv

Over on the pharma-mkting list serv there’s been some fun with those slighly misspelt words that make more sense than the original — apparently this started in the Washington Post’s Mensa Invitational.  Well the pharma marketing folks got into it and I saved them all meaning to compile  them on a rainy day.  John Mack has published these already over on his Pharma Marketing Blog but as we don’t share too many readers I thought some of you might like to see them. (I’ve also had them cluttering up my in-tray for a while and I’m up late uncluttering it! (Author is listed after definition).

Adhorence – deep hatred of advertising (John Mack)

Relationslip Marketing:  Establishing an initial connection with a consumer and then never doing anything meaningful with it.

Derail Aid:  A tool to confuse physicians (both David Reim)

DTC advertising: Direct to courthouse (James Gardner)

Salety Study: Which proves that the drug is worth selling, whether safe or not.

Generich Companies: Which make plenty of $ with somebody else’s innovations.

Phate III: Which concludes that the drug can be sold, the fate of a certain % of the target population being left to a higher power. (all Sanjay Virmani)

Charmaceutical:  An SSRI taken by someone who thinks they have a genuine diagnosis, but in reality are simply unpleasant.

Byotech:  A small, specialty pharmaceutical company whose stock rises paradoxically whenever they announce failed clinical trials.

Contrasindication:  A DTC ad deliberately designed to generate controversy, so as to get aired on cable news 10 times for every paid slot. (all Paul McNiven)

DTP-Direct to Plaintiff:  The art and science of creating plaintiffs with puffery enticing them to try dangereous drugs they would be better off without. (Terry Nugent)

Antibositics: Therapies undertaken to antagonise bosses’ criticism. (Kamran Shamsi)

Adverstising: The fine art of promoting adverse reactions through the use of realistic images of afflicted patients to target audiences consisting of physicians and consumers in a repulsive, yet memorable fashion. (Mario Nacinovich)

CEA: A term used to describe a ranking officer whose public utterances remind one of a pejorative or disdainful reference to a bodily part normally used to express intense disagreement with another’s expressed opinion. (Harry Sweeney)

Complieance — what patients tell their doctors about whether they are taking their pills (Me)

Pharmochondria: a morbid condition characterised by depressed spirits
and fancies of ill health induced by pharmaceutical "awareness"
campigns and advertising (Michael Lascelles)

and my favorite

Pharmasuitickle:- An overall pleasant tingling a personal trial attorney gets when contacted by a former Vioxx patient. (Jim Weidert)

And finally from Bob Iles (?), these are not misspellings but "daffynitions" from his Dictionary of Pharmaceutical Research.

Conclusions — What you designed your study to prove.

Informed consent — A document lawyers, doctors and administrators took weeks to write and revise but which a 100-IQ patient is expected to read, understand and sign within minutes before getting the drug, needle, knife and/or shaft.

Insight — The innate ability I have to see the clinical importance of my data. Called bias in those who disagree with me.

Null hypothesis — Conclusion you do not want to prove but which you strive mightily to reach. Makes as much sense as anything else in statistics.   

Strategy — The name you give after the fact to any series of random events that ended in your favor.

Statistics — [From Sanskrit "sadistics," meaning confounding verbiage] A means of getting people to argue about numbers instead of whether the test drug worked.

HEALTH PLANS: Kaiser/Gadfly update

So the court case was held this morning, and the court issued an injunction telling the Gadfly to take down the pages with the patient information (and I assume the system diagrams too).  That’s pretty much what I expected, althought the Gadfly is a little upset about what she perceives to be biased treatment from the court in her Corporate Ethics blog. 

The real question is whether the Department of Managed Health Care looks into this further, as it said it would — it claimed that it would have a hearing in the notice it issued to the Gadfly if she asked for one. I don’t know as yet whether the Gadfly is requesting such a hearing, but as she’s done all the work already for the KP hearing I suspect that she will. In the same press release the DMCH said that "DMHC authorities are also examining Ms.Cooper’s claims that Kaiser Permanente’s computer systems previously allowed public access to the same patient information." If I was KP I’d be hoping that this would all go away, as the threat of that latter investigation is probably most damaging to them–if of course it actually happens. I just hope that I don’t get supoenaed because I’d have to plead the Fifth (that’s an inside joke for you Ali G fans).

POLICY: Yet another shoddy article on single payer

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The major outlets of the SCLM (so called liberal media) tend to give lots of column inches to conservatives like William Safire, Debra Saunders, and now Tucker Carlson on NPR and you don’t see the reciprocal placing of Michael Moore on Fox News or the Wall Street Journal. This week’s wingnut is Jeff Jacoby writing in the Boston Globe about how single payer would suck.  There may be a valid conversation about the merits of single payer, but this ain’t it. If the only people Jacoby can quote in his favor are the CDHP flacks at the NCPA and the appallingly biased Fraser Institute, he really needs to get a real education in this subject before he starts wasting column inches in a great newspaper.

Did he bother talking with anyone who knows something just across the Charles from Boston, like Bob Blendon or Marc Roberts at Harvard, both of whom are able to give an unbiased overview of the issues.  Did he even get America’s leading single payer advocate Steffi Woolhandler to tell her side of the story? It was all a cab ride away.  Even Bill O’Reilly’s had her on.

And he brought out a laundry list of where health care systems abroad are in trouble, and are resorting to rationing. No shit.  I can find him a much much longer list of bad things going on here, but why bother when the Wall Street Journal ran a whole series on rationing in the US in 2003.  Wasn’t Jacoby reading his fellow travelers’ stuff?  He never bothers to mention that the universal health care nations pay far less for their health care and get better population outcomes. Did he even know that?

This is a complex and difficult argument, but any rational analysis (like my rather good one about Canada!) shows that our system has at least as many problems as those abroad, and considerably more than those countries with a sensible public/private mix like France and Germany.

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