April 4th, 2009 by Dr. Val Jones in Book Reviews
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Triumph of the Heart, as its name does not suggest, is about science. The book’s author, Jie Jack Li, is a medicinal chemist who meticulously reviews the history relevant to the discovery of lipid-lowering drugs. He spares no details, even recounting the amusing quarrels and quirks of the scientists engaged in the “apocryphal showdowns” leading to the manufacture of cholesterol in a laboratory.
The personalities of the various scientists and Nobel laureates described in the book are highly entertaining. From beating one another with umbrellas, to insisting on wearing blue clothing only, to egos so large and unappealing as to empty an entire academic center of all its promising young recruits, one has the distinct impression that brilliance does not go hand-in-hand with grace.
That being said, each of these scientists did seem to share a common approach to research: carefully testing hypotheses, repeating peer study results to confirm them, and patiently exploring complex biochemical pathways over periods of decades. The physicians, physicists, and chemists showed an incredible ability to doggedly pursue answers to specific questions – understanding that the results might influence human health. But even more importantly, they were each willing to invest their careers in analysis that may never lead to anything more than a dead end. In fact, the book is full of examples of great ideas, developed over decades, that did not lead to a marketable drug. In some cases the research was halted due to lack of efficacy, in others political forces or personal whims influenced the course.
What strikes me about the scientists described in Triumph of the Heart, is how rare it is nowadays for people to have the sort of patience required for laboratory work. In an age where kids suffer from iPhone and video game addictions, young adults expect a relaxed work environment with high salaries and no accountability, and adults are flummoxed by stores that are not open 24 hours… who has time for the hard work of science? Even The Onion, my favorite spoof newspaper, mocks modern attention spans calling science “hard.”
Triumph of the Heart is about much more than the discovery and development of statins. It traces the historical development of the first antibiotics, pain medicines, diuretics, and steroids, the rise, fall and merger of drug companies, patent wars, the unethical conduct of some researchers, and the financial pressures that shaped the industry, both in the U.S. and abroad. Other than Mr. Li’s inability to resist his chemist’s urge to delve into advanced concepts in organic chemistry (around mid-book) as a physician I found Triumph of the Heart to be quite interesting, and well researched.
The most important take away, however, is that science is about hard work, attention to detail, innovative thinking, advanced analytic skills, serendipity, and the patience of Job. Triumph of the Heart reminds us all what good science is about, and how life-saving discoveries are made.
April 1st, 2009 by DrRich in Better Health Network
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Recently, DrRich offered for your consideration a brilliant proposal that would assure at least some continued advances in pharmaceutical therapy, while at the same time providing for drug price controls.
DrRich was gratified to find that the majority of comments and e-mails he received regarding this proposal were quite complimentary. Sure, there were the obligatory cavils that the drug companies deserve what they’re getting (the essential evil nature of drug companies was, of course, a point that DrRich cheerfully conceded from the outset), and that certain interest groups (breast cancer, AIDS, etc.) even with government price controls would continue funding research aimed at treating certain specific illnesses (a prospect which ignores that translating the kind of basic research done by, say, the NIH into actual useful products requires specific companies to risk hundreds of millions of dollars in product development; see here), but on average the response to DrRich’s proposal was most favorable.
That proposal can be summarized as follows. Each American would formally elect to participate or not in a voluntary plan of price controls. Those who elected to participate would be entitled to receive any legal prescription drug at low prices set by a sympathetic government board, as long as the drug had been on the market for some fixed amount of time. (DrRich arbitrarily suggested five years, but that number could just as easily be set at 10 years, or any other value.) Those who choose not to participate in the price control plan would have to pay whatever the drug companies wished to charge them for all their prescription drugs – but they would be eligible to receive new prescription drugs immediately upon FDA approval (that is, the five- or 10-year waiting period would not apply to them). Finally, individuals would be able to change their status (from participant to non-participant, and vice-versa) only every two years.
Just as is the case with the drug price controls currently under consideration by the Obama administration, DrRich’s plan would achieve low drug prices for anyone who elected to participate. But DrRich’s plan offers, in addition and in distinction, a mechanism by which pharmaceutical progress could continue, albeit at a slower pace than we see today. That is, it provides a population of individuals willing to pay full price for new drugs, thanks to whom the drug companies will be induced to continue spending on drug development.
As a result, even those who choose to participate in DrRich’s price control plan would be able to count on a pipeline of new drugs, which would become available to them at very low prices after the mandated five- or 10-year delay. This is a very useful feature that would not be available under Mr. Obama’s price controls. Indeed, participants in DrRich’s plan would be placing themselves in a situation reminiscent of that experienced by Canadians today. (Canadians, of course, can rely on a steady stream of new, cheap drugs which come to them, with some delay, thanks to a population of individuals south of their border who are paying full freight for those same drugs.)
All we need now is to launch a grassroots movement to convince our legislators that this proposal offers all the benefits of the drug price controls now under consideration by the Obama administration, without its major drawback (i.e., a complete stifling of pharmaceutical progress). Then, having done that, we will simply need to set up the federal bureaucracy to establish and administer the participation status of every American, and a government board that will set the official prices of all prescription drugs. With the kind of streamlining in federal processes and procedures promised by the Obama administration, we should be able to implement DrRich’s plan in a matter of just a few years.
The Punch Line
There is, of course, a punch line.
Now that you have had ample time to digest the favorable implications of DrRich’s proposal, and can plainly see the wisdom behind it, you will be delighted to know that you don’t actually have to wait for federal legislation and the establishment of a vast new price-control bureaucracy in order to participate. You can participate today, right now, with nobody’s acquiescence but your own.
Here’s how. Simply declare to yourself that DrRich’s system is already in place, and that you are a participant, and that the only drugs available to you are the ones that have already been on the market five or 10 years or longer. (You can choose your own personal waiting period.) When you see your doctor, insist – demand – that he/she prescribe only older drugs. The price of most of these drugs will be set not by a government panel, but by WalMart (which for many common generic drugs has set a co-pay of $4). By declaring yourself as boycotting the brand new drugs that are being sold (unfairly, of course) at the highest premium, your personal drug costs will be remarkably reduced – just as if federal price controls were really in place.
Furthermore, since currently there really aren’t federally-mandated price controls, drug companies are not yet constrained from investing in new drugs. As long as this situation continues, there will be a steady stream of new drugs exiting that magic five- or 10-year boycott period you have set for yourself, and thus becoming available to you under your personal, voluntary price control plan.
And best of all, if you were suddenly to develop a medical condition that clearly calls for one of the brand new drugs, one that wouldn’t be available to you, either temporarily under DrRich’s Voluntary Price Control System, or ever under a government-mandated price control system (because under the government plan the drug never would have been developed in the first place), you won’t need to wait five or 10 years (or forever) to get that drug. Since you are really only “pretending” there are drug price controls, the moment you decide that a system of price controls is no longer accruing to your own personal benefit, you can simply ask your doctor to write you a prescription.
So: those clamoring for government price controls on drugs can have them today – this very afternoon. They can experience every aspect of price controls (both low prices and the unavailability of new drugs) in a way that places them in no worse a position (indeed, in a far better position) than if government price controls were actually in place, and without reducing the options for everyone else.
Indeed, considering the above, the only way it would make sense to continue demanding mandatory price controls would be if something other than reducing drug prices were the chief motivating aim.
DrRich leaves it as an exercise for his regular readers to determine what that motivating aim could possibly be.
**This blog post was originally published at Dr. Rich’s Covert Rationing Blog.**
March 25th, 2009 by Dr. Val Jones in Expert Interviews, Health Policy
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Today I participated in a conference call with Billy Tauzin, CEO of PhRMA (the Pharmaceutical Research and Manufacturers of America). The goal of the call was to let bloggers know about PhRMA’s position on healthcare reform. I counted at least 12 bloggers on the call, and I was the only physician. It pains me to see how few physicians participate in reform discussions and I’d like to get more of us involved.
The salient points, as I understood them, were:
1. PhRMA would like all Americans to have health insurance. They believe that Medicare Part D is a model health insurance program. They do not support a single payer system because it would likely attempt to cut costs by rationing care and denying options to patients. They don’t believe that insurance coverage mandates are a good idea unless the insurance is subsidized to the point of being affordable for all. They favor the current public (Medicare and Medicaid for the elderly, poor, or disabled) private blend of insurance, with roughly 50% of the population in each category.
2. PhRMA would like to support “precision medicine” where treatments are tailored more effectively to the individual. Mr. Tauzin suggested that some FDA-approved drugs are only effective for 30% of the patients in a given disease class. He’d like to see more research devoted to figuring out why that is, and supports comparative clinical effectiveness research insofar as it furthers this agenda.
3. PhRMA wants to preserve the unique features of the American healthcare system – to maintain our leadership in biomedical research and new drug development, and to protect the sacred shared decision-making between physicians and patients (to shield it from government intervention).
4. PhRMA wants to support IT infrastructure that would track patient medication compliance and let physicians know when/if they fill their prescriptions.
Now, the business case for all four of these positions is clear – the pharmaceutical industry benefits from having everyone able to afford medications (i.e. universal coverage), personalized medicine would reward the development of new and innovative drugs and establish a consumer base for many different treatments, protecting the doctor-patient relationship allows for off-label use of medications and a broader array of similar drugs, and IT infrastructure would help to increase drug purchase and compliance with treatment regimens, thus increasing overall sales.
However, the truth is that PhRMA’s positions on healthcare reform – beneficial as they are to themselves – also happen to be beneficial to patients. Increasing the number of insured improves access to medical care, personalized medicine could create more effective treatments with fewer failure rates and side effects, shared-decision making empowers patients to make the right decisions for their circumstances (with their physician’s guidance), and IT solutions that facilitate medication adherence, tracking, and reminder systems could improve patient health outcomes and keep them out of the hospital.
So, in a way pharmaceutical companies, advocacy groups, and physicians are fairly well aligned on many aspects of healthcare reform. Now if certain members of Big Pharma would please give up on those “me-too” drugs, stop creating more expensive medicines by simply combining two perfectly good ones into a new pill, stop hiding negative research studies, and refrain from aggressive direct-to-consumer marketing tactics, we might all really be on the same page.
***
Interesting factoids from call:
- Medicines only account for 10% of total healthcare costs (unchanged from the 1960s), but they “feel” like a larger cost driver because health insurance doesn’t cover their cost as completely as they do hospital fees.
- There are about 750 new cancer drugs in the research pipeline.
- Half of all prescriptions remain unfilled.
- Physicians provide 30 billion dollars a year in free care.
- The United States conducts 70% of the world’s research in biomedicines.
Please check out Billy Tauzin’s amazing story of triumph over cancer.