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Month: March 2005

PHARMA/QUALITY: Can Cancer Care Get Better? by Greg Pawelski

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AP Biotechnology Writer, Paul Elias,  wrote an article this week that described how while the cost of cancer drugs have skyrocketed, the benefits are less apparent. It’s been more than 30 years since we declared a war on cancer and although there have been some real triumphs, and some great advances, the overall picture is not good. Tomorrow one of my closest friends is going into the local oncology center for the removal of what we all hope are some benign breast lumps. This post is dedicated to her, and to all those with cancer or at risk for cancer. Part of the issue is surely environmental, and we have much more to learn about what causes cancer and whether the toxins that we put into the planet are coming back to attack us.  Part of the issue, though, is how we approach cancer care.  THCB contributor Greg Pawelski has written before about the need for more chemosensitivity testing, and now writes on how we can use what we know to more effectively care for patients.


We have produced an entire generation of investigators in clinical oncology who believe that the only valid form of clinical research is to perform well-designed, prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination. The problem is not with using the prospective, randomized trial as a research instrument. The problem comes from applying this time and resource-consuming instrument to address hypotheses of trivial importance (i.e. do most cancers prefer Pepsi or Coke?).

There are 60-80 different therapeutic drug regimens out there, any one or in combination can help cancer patients. The system is overloaded with drugs and underloaded with wisdom and expertise for using them. Government and academic clinical investigators have failed to support the individualization of chemotherapy through laboratory testing, in favor of attempts to identify "one size fits all treatments" through trial and error testing which has consumed tens of thousands of human lives. This entire effort has been a colossal failure and a colossal waste of human and financial resources.

One of the main problems in providing effective chemotherapy is the situation that every patient is unique. Tumors grow and spread in different ways and their response to treatment depends on these characteristics. The amount of chemotherapy that each patient can tolerate varies considerably from patient to patient. Therapeutic protocols currently in use are limited in their effectiveness because they are based on the results of clinical trials conducted on a general patient population, yet no two patients are alike. Chemosensitivity testing can help to improve the efficacy of cancer therapies on an individual patient basis.

Without the information provided by chemosensitivity testing, oncologists have the freedom to choose between multiple different drug regimens, all of which have approximately the same probability of working. Some of these regimens are highly profitable to oncologists. Other regimens are much less profitable. Pre-screen testing takes away a lot of this freedom to choose and narrows the selection to those drugs that have the highest probability to be successful but may have lower profitability for the oncologist. This cuts into the oncologist’s bottom line, though it benefits the patient.

The hallmark of the disease is heterogeneity, yet the powers that be insist on trying to homogenize it, rather than tailoring treatment to the individual nature of the disease. If we devoted 10% of the "one-size-fits-all" resources to developing and testing methods to individualize therapy, we’d have actually made some progress at lowering the costs of cancer drugs.

POLICY: Florida HIV mystery raises questions, by John Pluenneke

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A little
more than thirty days ago, a statistician at the Palm Beach Department of
Health accidentally sent out an internal email containing a list with the names
of more than 6,000 local residents with HIV and AIDS. Officials immediately shut down and scrubbed
the county network. Relieved supervisors
praised the rapid response of the county IT department, which
was able to eliminate all of the offending emails within 10 minutes. A lot of
people – including me – wondered how they could be so sure the problem had been
solved that easily. 

A month
later it looks as though somebody has gotten their hands on the list.  One by one,  mysterious letters have begun turning up at
the homes of people with HIV/AIDS across Florida. Not surprisingly, many of those people are
upset and quite understandably concerned that the  information could travel further.
The director of the Palm Beach County health department calls the
incident “medical terrorism” and says the letters remind her of the 2001 anthrax
attacks.  That may well be a little
strong.   

Like the
Kaiser Permanente story, the Palm Beach debacle has been
largely ignored by the media in the early going.  The issues the incident raises, however, are very
similar. How safe are patient  medical records, really?  What use are expensive network security
systems when human error can easily bypass their defenses?  If recent trends are any indication, these
cases are only the tip of the iceberg.  That
should be very worrying.

HIPAA was designed, at least in part, to prevent this kind of problem. The real
question at this point seems to be how effective is it really going to be at doing its job?  A little over a month from now, we’ll have a
very good idea.

County health officials in Palm Beach are arguing – in
the way officials often do – that last month’s email incident and this latest
problem are a complete coincidence.  That
boggles the imagination. Such coincidences just don’t happen. The
story itself
is made a little more interesting by the fact that the letters do not
appear to
be at all threatening. The problem is that they reveal information they
shouldn’t. Whoever is sending them appears to be motivated by a desire
to reach to the HIV/AIDS community and to simply have not thought
through his or her plan
very well.  This is one to follow.

INTERNATIONAL: The UK plans for a group practice future

Showing again that innovation isn’t dead in single-payer (and for that matter socialized) systems, the Brits are serious about creating the environment for pay for performance.  In an article called Super-surgery plan signals end for the family doctor, the Times reports that the British government is planning on coalescing its traditional onesy-twosey GP practices into bigger units.

While the article is full of fears about the end of Dr Finlay (the UK’s TV version of Marcus Welby), and also ridiculous claims that it’s being pushed because mass murdering GP Harold Shipman got away with his crimes because he had no partner looking over his shoulder, the real issue is that the Brits now believe that group practice in primary care will create better quality care.

They have already instituted a pay-for-performance model for primary care that rewards physician practices for hitting a number of process targets.  And over the last decade, they have spent the money and the necessary political capital to computerize practices.  Now they are going to force the GPs into the organizational form that has been shown in the states to create the environment for continuous care quality improvement, and of course have the shared resources to put in the systems that can monitor those processes.

Obviously there are lots of problems with the British system, and the connectivity both in terms of IT and in terms of communication between the primary care and the specialty care parts of the system is still an issue, and will be even when the huge IT project gets done — and that has its own problems.  But the fact remains that, despite all the knocks on the UK system, because it is government controlled it’s able to push the providers into a format that–according to the tenets of the best health services research–has been shown to produce the most effective medical care.

Of course, while there is a good game talked about that by Brailer and McClellan, they must be very envious of the relative power of their British equivalents.

PHARMA: Two quickies

The guy who was mentioned in a THCB post a while back about writing a tell-all book about being a slacker Viagra salesman has found that his new employer, Eli Lilly, didn’t approve, and fired him. I assume he’ll do well in his new role as a consultant on the next Michael Moore movie.

Meanwhile, John Mack apparently has his sights set on a bigger challenge than turning around Merck, (chortle, chortle).

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.

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