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A Brilliant Plan For Preserving Pharmaceutical Progress

Almost a decade ago, during the antediluvian period of the internet, on a now-defunct and little-read precursor to this blog (before actual “blogs” were even invented), DrRich wrote a piece entitled, “Phillip Morrissing The Drug Companies.”  In that piece he predicted that, since the American media and the American legal profession had just finished savaging the tobacco companies, they would turn their great engine of destruction (highly-tuned engines of destruction being a terrible thing to waste) on a new target, one that some might consider less worthy of destruction than the evil tobacco companies but a ripe target nonetheless, namely, the pharmaceutical industry.

Many of DrRich’s readers laughed at him, but a few wisely sold all their drug stocks. (These latter would be very happy campers today had they not re-invested their profits first in Pets.com, then in REITs. If one is going to follow DrRich’s investment advice, one ought not jump too far ahead.)

Today the editors of the Wall Street Journal, for all practical purposes, have placed the official seal of validation on DrRich’s long-ago prediction (though, unaccountably, they fail to mention DrRich by name).   The WSJ notes that the big drug companies, in the few weeks since the Obama budget was sent up, have engaged in an incredible acceleration of mergers – though not in the manner of “creative destruction” that usually typifies such deals, but rather, in the manner of trying to construct a hardened shelter in which to survive the coming nuclear winter. The government price controls and the rationing of drugs which the drug company executives seem to have found in that proposed budget (apparently lobbyists take their jobs seriously enough to actually read legislation before it is voted upon, even if our congresspersons do not) appear to have convinced said executives that the game is about up.

Now, nobody needs to remind DrRich that drug companies are evil. DrRich has watched along with all his readers as the drug companies have fired off a never-ending parade of “me too” drugs mainly aimed at keeping the joints, bowels, bladders and genitalia of aging baby boomers nicely lubed up, then running a steady stream (so to speak) of television commercials regarding same, that render it far too embarrassing to watch prime time television any more with preadolescents. DrRich has watched the drug companies systematically fail to publish research that makes their products look less than spectacular; routinely over-hype research that suggests a modicum of effectiveness; callously corrupt doctors with plastic, logo’d ink pens, and legislators with huge campaign contributions and rides on private jets equipped with plenty of booze and bimbos (causing the indignant legislators to propose rules against logo’d ink pens); and most annoying of all, gouge American citizens with astronomical prices for their new drugs while selling those same drugs to Canadians and other undeserving foreigners at greatly discounted prices.

Still, most objective observers will reluctantly admit that, unlike the tobacco companies, every now and then a drug company will do some good. Here and there they manage to come up with a real breakthrough product that cures a disease, prolongs survival, restores functionality, or relieves suffering. That is, the pharmaceutical industry (in spite of all their evil behavior, which DrRich hastens to remind his readers he has formally acknowledged, as recently as in the prior paragraph) has done a lot of good over the years. Ask a parent whose child has survived acute leukemia, or the person who has survived a life-threatening infection, or the woman whose heart attack or stroke was aborted with clot-busting drugs, or – yes, this too –  the aging Lothario who once again can enjoy fine and durable erections upon demand. For such individuals, even if today they would join us in cheering on the demise of the pharmaceutical industry, recent advances in drug treatment have undeniably improved their lives.

But the real question we must address before allowing the pharmaceutical industry to roll itself into a ball and hide in the shadows for the duration, is not, “What have you done for me lately?” (since their inventions will live on even if they do not), but rather, “What can you do for me tomorrow?”  Some of us in the boomer class, for instance, would like to think that current research in the areas of Alzheimer’s, Parkinson disease, kidney disease, heart attack, stroke, arthritis, osteoporosis and cancer will allow us to remain healthy and functional for a few extra years. And judging from the massive amounts of money American citizens of all ages donate to medical research of all types, it is apparently not held among the whole of the populace that medical progress has already gone far enough. Many of us would not be entirely pleased to stand pat right here. Many of us would like to see more improvements.

And here is where we run into a dilemma.

Everyone agrees that the cost of new prescription drugs has been kept obscenely high in the name of maximizing profits, and that the rising cost of drugs has been one of the prime drivers of healthcare inflation. Accordingly the plans that apparently have been included in the Obama budget proposal to check those prices – techniques such as federal price controls, drug re-importation and the like,  (but again, who’s actually read the thing?) – will greatly restrict if not eliminate the huge profits made by the evil men (and, one must say it, women) who run these drug companies.

The problem, of course, is that if the potential for reaping large (obscene, if you insist) profits from new drugs is significantly curtailed, the hugely expensive process necessary for drug companies to bring new drugs to market will be proportionally curtailed. So if we place price controls on drugs, then we’d better be happy with the drugs we have today, because those are likely the only drugs we’ll have tomorrow.

There are some who would be quite satisfied with this outcome, and who would readily sacrifice pharmaceutical progress to keep prices low. And judging from the recent election results, these may even constitute a majority of Americans. Still, others of us appreciate the fact that every few years some truly earth-shattering drug will hit the market, and would think it a shame if progress on such drugs – even if they are but a few scattered islands in a sea of boutique pharmaceuticals – were to come to a halt, and even if for a good reason.

So here’s the question: Can we have our cake and eat it too? Can we bring down the price of the drugs we buy, while at the same time allowing at least some pharmaceutical advances to continue?

DrRich is delighted to reply, “Yes, we can!”

And he hereby humbly offers a plan to achieve this very end. It is a system of voluntary price controls. Of course, DrRich is talking here about us doing the volunteering – we the consumers – and not the drug companies.

DrRich’s Voluntary Price Control System works like this:

1) Each American will make a formal declaration of whether or not he/she wants to participate in a system of voluntary price controls on drugs.

2) Those who opt to participate will receive immediate, substantial discount pricing on all available prescription drugs, such pricing to be fixed by a sympathetic government agency whose makeup includes a wide diversity of representation, except, of course, that drug company representatives and their physician shills will be specifically excluded.

3) “Available prescription drugs” under this price control system will be any drug whatsoever appearing in the U. S. Pharmacopoeia – that is, any legal prescription drug – as long as that drug has been on the market for at least five years.

4) Individuals who choose not to participate in the price control system will pay whatever price the drug companies feel like charging them for all their prescription drugs, but they will be allowed to receive any drug, as soon as it is approved for marketing, with no five-year waiting period for new drugs.

5) Individuals may switch their status (between participant and non-participant) only during one 30-day window every 2 years, determined by their month of birth.

Why DrRich’s Voluntary Price Control System is brilliant:

For drug companies it is the prospect of making large profits from new drugs, and only that prospect, that drives drug development. So as long as we want new drugs to be invented we’ve got to allow for the profit incentive to continue, as odious as we may believe that to be. The chief advantage of DrRich’s system is that it maintains at least some of the profit motive – to whatever extent citizens opt to be non-participants in the Voluntary Price Control System.

Given the growing hue and cry for price controls on drugs, one can confidently predict that only rich people will opt for this non-participant status. Therefore, a side benefit of this plan is that the rich – those who, after all, can afford it, and who, by virtue of the very fact that they are rich, owe much to the rest of us – will fund virtually all progress in drug therapy. Again, this is a burden they ought to feel obligated to bear, being rich and therefore, well, obligated.

In contrast, under the universal, mandatory price control system of the kind that many politicians seem to favor (and which may be voted into existence in a matter of days) drugs available to our citizens would be essentially “frozen in time,” and henceforth there would be little or nothing new under the sun.

Of course, under DrRich’s Voluntary Price Control System, access to new drugs would be similarly restricted for participants. Yet this voluntary system would be far better to even those who choose to participate than would be a universal price control system – because under DrRich’s plan at least some drug progress would continue. And as new prescription drugs matured in the marketplace, and once their hidden dangers and side effects – during the 5-year “shakedown period” –  manifested themselves on the physiology of the wealthy (nya-ha-ha), these drugs would (eventually) become available even to plan participants, and at a substantial discount to boot.

The bottom line: a five-year lag in gaining access to new drugs is vastly better than never having any new drugs at all, especially when the burden of paying for all that drug development, and the risk of becoming early adopters of new, relatively unproven, relatively risky pharmaceuticals, falls entirely on the rich.

So, while at first blush you may not like DrRich’s system – it being two-tiered and all – on further objective and logical reflection DrRich is confident you will see that it is far better for everyone than the universal system of price controls which now appears imminent.

DrRich suggests you contact your legislators immediately to recommend to them this brilliant new plan, before it is too late. In making your case, you might remind your dedicated congresspersons that a robust pharmaceutical industry is inherently good for America (what with all the campaign contributions, airplane rides, booze, bimbos, etc. it provides to grease the wheels of American democracy).

**This post was originally published at Dr. Rich Fogoros’ Covert Rationing Blog**

Announcing The Science-Based Medicine Conference

My colleagues and I will be holding a Science-Based Medicine conference on Thursday, July 9th. This is an all-day conference covering topics of science and medicine. The conference is designed for both a professional and general audience.

The conference will be at the Southpoint Casino and Hotel in Las Vegas, Nevada. It is also part of The Amazing Meeting 7 (TAM7) which is run by the James Randi Educational Foundation (JREF). You can register for the conference either separately or packaged with TAM7.  You can register for both here.

Physicians can earn 6 hours of category 1 CME credits for attending the conference.

Below is the list of speakers and the titles of their talks, and below that is the bio for each speaker.

Topics:
Introduction to Science-Based Medicine (Steven Novella, MD)
Case studies in cancer quackery: Testimonials, anecdotes, and pseudoscience (David H. Gorski, MD. PhD)
A Scientific Critique of Chiropractic (Harriet Hall, MD)
Why Evidence-Based Medicine is not yet Science-Based Medicine (Kimball Atwood, MD)
Lyme: From the IDSA to the ILAD to the ABA (Mark Crislip, MD)
Online Health & Social Media: The Good, The Bad, and The Ugly (Val Jones, MD)
Conclusion (Steven Novella, MD)

Speakers:

Steven Novella, MD
Dr. Novella is an academic clinical neurologist at Yale University School of Medicine. He is the president and co-founder of the New England Skeptical Society. He is also the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe. He authors NeuroLogicaBlog and contributes to several other science blogs: The Rogues Gallery, SkepticBlog, and Science-Based Medicine, of which he is also the founding editor.

David H. Gorski, MD, PhD
Dr. Gorski is an Associate Professor of Surgery Division of Surgical Oncology, Wayne State University School of Medicine, Detroit, MI. He is also the Program Leader, Breast Cancer Biology Program, Barbara Ann Karmanos Cancer Institute. His cancer research has been funded by the NIH, ASCO, and the Breast Cancer Research Foundation. He is a long-time science blogger who regularly tackles issues related to science and medicine. He is the associated editor of Science-Based Medicine.

Harriet Hall, MD
Dr. Hall is a retired family physician. She spent 20 years in the Air Force as a flight surgeon and family physician and retired as a full colonel. Also known as “The SkepDoc” from her column in Skeptic magazine, she has written extensively about alternative medicine. She is an editor of The Scientific Review of Alternative Medicine and the Science-Based Medicine blog, is an advisor to Quackwatch, and is a contributing editor to both Skeptic and Skeptical Inquirer magazines. Her website is www.skepdoc.info.

Kimball Atwood, MD
Dr. Atwood is a practicing anesthesiologist who is also board-certified in internal medicine. He has been interested in pseudoscience for years. He was a member of the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners, and subsequently wrote its Minority Report opposing licensure for naturopaths. He is an associate editor of the Scientific Review of Alternative Medicine and co-editor of Naturowatch. He is particularly concerned with implausible claims being promoted, tacitly or otherwise, by medical schools and government. He is also dubious about the ethics of human trials of such claims.

Mark Crislip, MD
Dr. Crislip has been a practicing Infectious Disease specialist in Portland, Oregon since 1990. He is Chief of Infectious Diseases for Legacy Health System.
He is responsible for the Quackcast, a skeptical review of Supplements, Complementary and Alternative Medicine, The Persilflagers Annotated Compendium of Infectious Disease Facts, Dogma and Opinion a guide to Infectious Diseases, the Persifalgers Puscast, a podcast review of Infectious Diseases, and Rubor, Dolor, Calor, Tumor, an infectious disease blog.

Val Jones, MD
Dr. Jones is the CEO of Better Health, LLC, a medical blogging network, and VP of Strategic Partnerships at MedPage Today, an online health news source for healthcare professionals. She has been the Senior Medical Director for Revolution Health, and the founding editor of Clinical Nutrition & Obesity, a peer-reviewed e-section of the online Medscape medical journal. Dr. Jones volunteers once a week as a rehabilitation medicine physician at Walter Reed Army Medical Center.

What’s Wrong With Canada’s Healthcare System?

This post is a continuation of my discussion of foreign healthcare systems, and what the US can learn from them… I’ve summarized one particularly provocative and outspoken Canadian’s opinion below:

Is Canada’s healthcare system a political monopoly?

Dr. Brian Crowley is the Founder and President of the Atlantic Institute for Market Studies in Halifax, Nova Scotia. He describes the Canadian healthcare system this way:

Canadian Medicare operates in an unregulated, tax-financed, pay-as-you-go model. Our provincial governments are our monopoly provider. They not only pay for necessary care, but they also govern, administer, and evaluate the services that they themselves provide. They define what we call “medically necessary services” and pay for 99% of all physician services. They also forbid the use of private insurance for medically necessary services. They set the budgets for nominally private healthcare institutions. They appoint the majority of their board members and have explicit power to override management decisions.

Under these circumstances, no hospital or hospital administrator can be expected to take any responsibility or initiative because decisions will always be second-guessed by those in political power.

Before the advent of competition in our telephone industry, dissatisfied customers faced the massive indifference of a bureaucracy that took their business for granted, despite some theoretically powerful regulatory agencies. Administrators of the Canadian healthcare system likewise suffer no direct consequences for poor customer service. They aren’t even answerable to a regulatory agency. Accountability is a vague political concept which cannot be enforced in any meaningful way. Like all monopolists, Canada’s healthcare authorities abuse their positions of power.

Dr. Crowley argued that the provincial governments have no desire to measure how many people are waiting for health services, how long they’ve been waiting, or how many people leave Canada to get treatment south of the border. (He claims that the US is Canada’s secret safety valve.) Apparently the province of Ontario contracted with New York State for cancer care for their patients when wait times became politically untenable.

A couple of years ago, the Supreme Court of Canada ruled that the healthcare system violates Quebec’s charter of rights because it collects taxes, promises healthcare in return, forbids competing suppliers and then often doesn’t deliver the care. The justices summarized the situation this way: “A place in a queue is not healthcare.”

Canada-wide average wait times for surgery is 17.8 weeks, though in Saskatchewan, wait times for hip replacements are as long as a year and a half. That’s after a physician has ordered the surgery. Getting to see a physician in the first place is very difficult. Statistics Canada reports that 1/5 of Canadians do not have a family doctor.

In Canada, family physicians are the gatekeepers of the health care system. Patients cannot obtain access to specialist services without having a general practitioner referral. The doctor shortage is so severe now that doctors have begun resorting to lotteries to kick people off their patient rosters, (see Tom Blackwell, MD Uses Lottery to Cull Patient ListNational Post, August 06, 2008); and Canada is about to face a wave of retirements in the system that will greatly exacerbate the shortage.

As for the comparability of wait times in the US and Canada, Dr. Crowley suggests reviewing a letter from a US physician published in the Wall Street Journal a few years ago (Susan Weathers, MD, published April 30th, 2004). Dr. Weathers works in a county hospital and in reference to her  uninsured patients she writes,

[The Canadian health care system] resembles the county hospital where I work. Our patients pay little or nothing. They wait three months for an elective MRI scan and a couple of months to get into a subspecialty clinic. Our cancer patients fare better than the Canadians, getting radiotherapy within one to three weeks. The difference is that our patients are said to have no insurance (a term used interchangeably with “no health care”), whereas Canadians have “universal coverage.”

Dr. Crowley suggested that the Canadian healthcare system has become an unresponsive monopoly though it wasn’t supposed to be that way. It was designed to usher in a “grand era of choice.” It was supposed to be a healthcare system in which people would be able to get all the healthcare they needed without having to “worry about the cost.” Dr. Crowley concluded that “some of the ideas bandied about in Washington will lead to the worst features of the Canadian system without that having been anybody’s intention.”

The Friday Funny: Avoiding Exercise

rockingcardioThis caption is brought to you by our friends at the Canyon Ranch Institute. In the near future, Better Health will begin having corporate caption contests, where companies can challenge one another to create the funniest caption for a specific cartoon. If you’d like to challenge a company (or hospital, or organization) to a caption contest, contact me at Better Health.  val dot jones at getbetterhealth dot com.

Blood Pressure Medicine Cures Facial Deformity

There is an article (see reference below) in the June 12, 2008 issue of the New England Journal of Medicine (h/t Medpage Today) that shows some amazing regression of hemagiomas using propranolol.

Hemangiomas of infancy are the most common tumor of infancy. They typically appear within a few weeks after birth and peak within three months. Hemagiomas are more common in girls than boys, more common in white than other races, and more common in preemies. Most of these lesions are innocuous and regress without treatment. Up to 75% shrink to insignificance by the time the child reaches school age. However, 5-10% of the lesions that will ulcerate during the rapid growth phase in the first 6 months of life. Ulceration is the most common reason for referral to specialists, and may be associated with pain, bleeding, infection, disfigurement, and scarring.

This one series of photos shows the results:

Panel A shows the patient at 9 weeks of age, before treatment with propranolol, after 4 weeks of receiving systemic corticosteroids (at a dose of 3 mg per kilogram of body weight per day for 2 weeks and at a dose of 5 mg per kilogram per day for 2 weeks).

Panel B shows the patient at 10 weeks of age, 7 days after the initiation of propranolol treatment at a dose of 2 mg per kilogram per day while prednisolone treatment was tapered to 3 mg per kilogram per day. Spontaneous opening of the eye was possible because of a reduction in the size of the subcutaneous component of the hemangioma.

Panel C shows the patient at 6 months of age, while he was still receiving 2 mg of propranolol per kilogram per day. Systemic corticosteroids had been discontinued at 2 months of age. No subcutaneous component of the hemangioma was noted, and the cutaneous component had considerably faded. The child had no visual impairment.

Panel D shows the child at 9 months of age. The hemangioma had continued to improve, and the propranolol treatment was discontinued.

Christine Léauté-Labrèze, M.D., of Bordeaux Children’s Hospital, and colleagues used the drug to treat two infants with heart disease (one with cardiomyopathy, the another with increased cardiac output) who just happened to also have hemangiomas. Unexpectedly, the lesions began to fade. They then used propranolol on nine other children with hemangiomas with similar success.

Johns Hopkins researchers have developed a protocol for the beta-blocker as a first-line treatment for the skin disorder. Propranolol could replace or supplement steroids such as prednisone which are often used currently. The children receive 1 mg/kg of propranolol on the first day, divided over three doses, and 2 mg/kg — also divided in thirds — after that.

Prednisone use carries the side effects of growth retardation, elevated blood sugars, and reduced resistance to infection.

Propranolol has side effects that include hypotension and hypoglycemia, but these are short-lived.

So far, Dr. Cohen and Katherine Puttgen, M.D., also at Johns Hopkins, say they have treated 20 patients with propranolol. Working with cardiologists, they decided to hospitalize the infants for the first two days of treatment to monitor for possible side effects such as hypotension or hypoglycemia. (They have seen none so far.)

Dr. Léauté-Labrèze, and colleagues reported that they are applying for a patent for the use of beta-­blockers in infantile capillary hemangiomas.

REFERENCES

Propranolol for severe hemangiomas of infancy; New Engl J Med 2008; 358: 2649-2651; Léauté-Labrèze, C et al

Ulcerated Hemangiomas of Infancy: Risk Factors and Management Strategies; eLiterature Review (John Hopkins Medicine) , Oct 2007, Vol 1, No 4; Bernard A. Cohen, MD, Susan Matra Rabizadeh, MD, MBA, Mark Lebwohl, MD, and Elizabeth Sloand, PhD, CRNP

Related Blog Posts

Vascular Birthmarks (July 15, 2007)

Early Surgical Intervention for Proliferating Hemagiomas of the Scalp — An Article Review (Sept 1, 2008)

**This post was originally published at the Suture For A Living blog**

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