Regarding Those Conflicts of Interest On The Government’s Guideline Panels

DrRich | November 3rd, 2011 - 1:33 pm

Podcast:

DrRich does not like to pick on the New York Times.

No, really. DrRich does not like to pick on the New York Times, because he receives two paychecks each month from the New York Times*. This fact (which has been disclosed on this blog since its inception in 2007) constitutes a clear conflict of interest, at least when it comes to writing blog posts which might criticize or satirize or mock articles that appear in that venerable publication, from which he receives a not insubstantial proportion of his livelihood.

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*DrRich holds two positions at About.com, which is a New York Times Company. He has manged About.com’s Heart Health Center for 11 years, and also serves on About.com’s Medical Review Board.
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Yet, regular readers will know that the New York Times has served as a regular source of material for DrRich here at the CRB, and little of what he has written in response to that material has been supportive of it. Indeed, the opposite is true.

DrRich considers it his duty to respond to the New York Times whenever it publishes an article that advances the covert rationing of American healthcare, which (through no fault of his), it does frequently. The New York Times serves as a chief voice of Progressive America, and the Progressive takeover of the healthcare system has become, since this blog was first begun, the chief driver of covert rationing. So, conflicts of interest to the contrary notwithstanding, DrRich submits to his readers that he has acted responsibly and honorably despite his unfortunate financial conflicts.

But still, he does not like to pick on the New York Times.

It is unfortunate for DrRich, then, that for the second time this week he is compelled to do so. And this time, as it happens, the subject matter has to do with conflicts of interest (a subject about which, as he has just disclosed once again, DrRich knows something).

Today, the Times writes that experts are beginning to worry that the GOD Panels (Government Operatives Deliberating) now working to devise the clinical guidelines under which American doctors will be strictly compelled, under penalty of the law, to decide which patients will get what, when and how, are tainted by members who have had ties to (gasp!) industry.

When the GOD Panels were first set up, not very long ago, it was still considered acceptable for some members to have industry ties as long as they fully disclosed those ties, and recused themselves from voting on matters specifically related to their industry work. Having at least some members with industry ties was deemed essentially unavoidable, because it was thought that deep subject-matter expertise would be desirable on these panels. Since most clinical research in America is paid for by industry, it is difficult to have deep expertise without having had at least some contact with industry.

But as the Times indicates, modern medical ethics has now advanced well past this kind of primitive thinking. Nobody with any industry ties has any business being on a panel with such overwhelming authority over the practice of American medicine.

David J. Rothman, president of the Institute on Medicine as a Profession, tells the Times, “Consciously or not, they may well be making decisions that fit their funders, their payers and not the patient’s best interests. If you want the public to really believe in the guidelines, why not have a committee that is conflict-free?”

And the ubiquitous Dr. Steven Nissen of the Cleveland Clinic (a person DrRich numbers among those individuals who, by their public words and deeds, he speculates may be auditioning for the really important GOD Panels) says, “Recusing, disclosing — the reason it doesn’t work is the process involves give-and-take. Even if you don’t make a formal vote, you can still have a huge influence over what happens in the process.”

And so, while the Times does not come out and say so, it seems as if a purge of the GOD panelists may be already afoot. If not an actual purge, then at least the “conflicted” panel members are being sent a clear message, well before they take any final action. And at the very least, Ms. Sebelius is being given the cover she needs to select the people she really wants for the truly important GOD Panels which are being constructed for Obamacare.

All of this is pretty clear, and DrRich has great confidence that his readers can figure it out for themselves.

What DrRich really hopes to accomplish here is to note for posterity the great paradigm shift that has occurred in just the last two or three years, regarding the appropriate relationship between physicians and industry.

Until very recently, the American public, doctors, industry, and medical ethicists thought about that relationship in a certain way, which DrRich will call Theory A:

Theory A:

-  Medical progress is Good, and benefits mankind.
-  Industry is responsible for a high proportion of medical progress.
-  Industry-driven progress requires the active participation of physicians.
-  Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable conflicts of interest, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

So traditionally, the debate about conflicts of interest have been about where to draw the necessary limits.

What today’s New York Times article points out is that Theory A is no longer operative. The new thinking begins with the proposition that no amount of conflict of interest is acceptable, and ALL physician-industry ties should be prohibited. One of the most prominent advocates of this new thinking is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of conflicts of interest is not to have them at all.” For these voices, Theory A simply does not apply. Rather, they subscribe to Theory B:

Theory B:

-    The greed of medical industry creates excessive costs, and produces far more harm to society than good.
-    Physician-industry alliances strengthen industry, and increase the harm.
-    Therefore, crippling these unholy alliances is critical to the interests of society.

Underlying Theory B, of course, is the largely unspoken and unacknowledged, but nonetheless fully-embraced, proposition that medical progress is not Good after all, but is the very thing that is driving up our healthcare costs, and so it must be stifled.

A corollary of Theory B is that not only is the Central Authority the only entity which is strong enough to cripple these unholy alliances between physicians and industry, but it is the duty of the Central Authority to do so.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude (in a manner compatible with Progressive if not classical logic) that therefore industry will always behave in ways that are counter to the interests of society.  While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce to the collective. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.

Proponents of Theory B rarely say what their real goal is. To come out and say that their goal is to cripple the companies responsible for producing medical progress would not be expedient. So most of them still give lip service to Theory A. One must discern their real motives from their behavior.

Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who ought to use industry’s products, or when and how. That kind of information can only be managed by unbiased sources.

This is the very thinking that produces the impetus for GOD Panels in the first place. Only experts who are free of industry ties and who answer only to our beneficent, unbiased, completely objective government can say which products of industry are good and bad, and can manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed by whatever means are necessary.

To any reader who believes that our government is or can ever be an unbiased and honest broker, or that government officials (or GOD panelists) can cancel their own human natures when they put on a government name tag, DrRich can only wish upon you the grace of God (the old fashioned one). You’ll be needing it. To the rest of us, it is obvious that the government is desperately biased when it comes to medical progress in general, and in particular when it comes to establishing “guidelines” for the use of expensive drugs and medical devices.

For Theory B to have become the operative paradigm in America, as the New York Times today suggests it has, will assure the Central Authority that it is free to seed its GOD Panels only with members whose bias runs in their direction.

But under Theory B there is no government bias. There is only industry bias. And when we purge the GOD Panels of all industry bias, by definition we will have created perfect objectivity.

And this is why DrRich feels so comfortable continuing to write this blog despite his obvious financial conflict of interest in favor of the Times. For a conflict of interest in the direction of the Progressive agenda is no conflict at all.

A Brilliant Plan For Pharmaceutical Progress – The Punch Line

DrRich | March 18th, 2011 - 10:40 am

Podcast:

In his prior post, 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 the drug price controls which we all very much want, and which many (mainly those of the Progressive persuasion, who assert that the essentially evil nature of drug companies justifies any action we care to take against them) insist we deserve.

For those readers who have seen fit to e-mail and Tweet DrRich to complain that his Brilliant Proposal is not nearly punitive enough toward the drug companies, DrRich reminds you that, while cheerfully acknowledging at the very outset that drug companies are indeed evil, his Proposal attempts to balance that unchallenged fact against the (apparently lamentable) truth that, every now and again, one of these companies will inadvertently stumble upon a product that actually benefits people in a very substantial way. His plan proposes a method by which the price controls we all deserve can be established, while still allowing for occasional spurts of pharmaceutical progress.

DrRich’s 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 more traditional drug price controls which many Americans are calling for, 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 much slower pace than we see today. That is, it allows for a population of Americans who are willing to pay full price for all their drugs in exchange for earlier access to new products. Thanks to these individuals, drug companies will be induced to continue spending something on drug research and 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 the more traditional price control plans being advocated by most Progressives, such as the price controls being enforced in Canada today.

(Canadians, of course, today rely on a steady stream of new, relatively cheap drugs which are made possible only thanks to their Southern neighbors’ “willingness” to pay full price. DrRich’s plan, fundamentally, mimics the relationship between the US and Canada regarding drug prices. Those who participate in DrRich’s plan are the “Canadians,” and those who do not participate are the “Americans.” So in truth, DrRich is not actually inventing anything novel.)

So: All we need is to launch a grassroots movement to convince our legislators that this proposal offers all the benefits of the drug price controls which many Americans are insisting upon, without its major drawback (i.e., a complete stifling of pharmaceutical progress). Then, having done that, we will simply need to set up the sundry federal bureaucracies which will establish and administer the participation status of every American, and a government board that will set the official prices of all prescription drugs, and a few new enforcement agencies here and there, and of course some sort of administrative judge that can hand out exemptions to unions and other indispensable entities which would really like to have some new drug they’re not legally supposed to have. But with the kind of streamlining in federal processes and procedures promised to us under Obamacare, we should be able to implement DrRich’s plan pretty quickly and efficiently.

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 federal bureaucracies 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 any federally-mandated price controls, drug companies are not yet constrained from investing in the development of new drugs. As long as this situation continues, there will be a reasonably 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 Brilliant Proposal, 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.

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.

A Brilliant Plan for Preserving Pharmaceutical Progress (Part 1)

DrRich | March 15th, 2011 - 1:16 pm

Podcast:

Evidence is building that our pharmaceutical industry is becoming diminished.

Recently, for instance. Pfizer announced a $2 billion cutback in R&D funding. One does not so massively trim R&D because of mere cyclical economic conditions; one only does this as part of a fundamental restructuring in business strategy.

Furthermore, the Wall Street Journal has noted that the big drug companies have entered a period of rapid acceleration in company mergers – but decidedly not in the manner of “creative destruction” that usually typifies such deals. Rather, it is being done in the manner of constructing a hardened shelter from which to hunker down for the coming nuclear winter, which they believe will be brought on by government-induced disincentives for innovation and growth.

Now, nobody needs to remind DrRich that drug companies are evil. DrRich has watched along with all of you as the pharmaceutical industry has fired off a never-ending parade of wasteful “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, which renders prime time TV far too embarrassing to watch with adolescents (especially if one is of a certain age).

Other evil behaviors abound. We can all see 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 likewise corrupt legislators with huge campaign contributions and rides on private jets equipped with plenty of booze and bimbos (causing the indignant legislators to propose laws 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.

But still, most objective observers must reluctantly admit that, every now and then, and most likely by mistake, a drug company will do something worthwhile. 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 its 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. Such individuals, even if today they would join us in cheering on the demise of the pharmaceutical industry, have undeniably had their lives improved by drug companies.

So the 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, we hear much talk of federal price controls, drug re-importation, more restrictive FDA policies, and other tools the Central Authority can employ to 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 costs down. 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 will include a wide diversity of representation, except, of course, that drug company representatives and their physician shills will be specifically banned.

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 obligated.

In contrast, under the universal, mandatory price control system of the kind that many Progressives seem to favor, the 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 for 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 (another great benefit of DrRich’s plan), these drugs would, eventually become available even to plan participants, and at a substantial discount to boot. And because only the rich will be harmed for the first few years, perhaps the FDA can relax its safety standards a bit, and pass a higher percentage of the effective drugs that are submitted for approval.

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 undeserving 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 many now want.

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.

Why the American NICE Will Not Be Like the British NICE

DrRich | June 22nd, 2010 - 8:26 am

Podcast:

The United Kingdom’s National Institute for Clinical Excellence (NICE) has now issued its final ruling on the new cancer drug, Nexavar, which has proven effective in treating liver cancer. NICE will not cover Nexavar “because its high cost could not be justified by its marginal benefit.”

In a well-designed randomized clinical trial, Nexavar significantly prolonged the survival of patients with liver cancer, by an average of 2.8 months. Prolonging survival by a little less than 3 months may not seem like much, except for two things. First, that’s only the average. Some liver cancer patients treated with Nexavar have survived a year or longer, a result which is at least a little remarkable. And second, Nexavar represents a true and long-awaited breakthrough in the effort to find an effective treatment for hepatocellular carcinoma. Until Nexavar came along no chemotherapy had ever been shown to significantly prolong the survival of patients with liver cancer. For the first time, thanks to Nexavar, these unfortunate patients have been offered a real glimmer of hope.

But alas, Nexavar is expensive. Very expensive. It was a difficult drug to develop and test and bring to market, and it is expensive to make. So to recoup its costs, and to make the sort of profit that justifies its risk, the Bayer company is charging about $5000 a month for Nexavar. This means that any insurance company or government that agrees to pay for this drug is going to be out some big bucks.

The UK’s NICE was not being evil when it declined to pay for Nexavar. NICE simply did the math, and determined that spending money for the marginal benefit provided by Nexavar would create too high an opportunity cost – that is, that money would be better spent elsewhere, on other patients, for greater gain.

This is what open healthcare rationing looks like. It’s ugly, all right. But because it is open and transparent, making clear to everyone the rationale for its coverage decisions, NICE gives the British electorate all the information it needs to decide whether to accept the process, or to change it. This is far better – far more equitable and far less destructive to a society – than rationing healthcare covertly. DrRich tips his hat to NICE.

But DrRich notes that this recent decision by NICE has caused some of his conservative friends to descend into major bouts of caterwauling. Horrified that NICE has condemned liver cancer patients to an avoidable premature death, they insist we all notice that Obamacare creates an Outcomes Research Institute that is modeled after the British NICE, and so, we could soon have the same kinds of coverage decisions here in the U.S. American citizens, they demand, must consider how well they will like it when some government “panel” refuses to cover life-saving medical therapies because they are too expensive.

DrRich agrees that Americans will not like it much at all, but believes his conservative colleagues are overlooking an important difference between the British NICE, and any American NICE that might accompany our new healthcare system.

The Brits are plagued with a constant deluge of new medical products that are extremely expensive, and that, like Nexavar, offer real but only marginal improvements over current, cheaper therapies. Each time NICE has to render a coverage decision on one of these new therapies, the process is painful for everyone involved. But, being Brits, when faced with a difficult but necessary task they suck it up and carry on.

It is important to note, however, that the British NICE is required to deal with a constant stream of new medical products only because there is a ready market for those products elsewhere, and that market is in the U.S.

For, in the U.S., we have always recognized that medical progress usually occurs in incremental steps, and that to encourage continued medical progress we have to accept (and pay for) these incremental steps. That is, medical progress is much like all other forms of progress. Americans famously went to the moon, for instance, but did not do so all at once. Hundreds of incremental steps were required, several of which were seemingly trivial and expensive, and others of which involved catastrophe and tragedy. But we all understood that this is how one gets to the moon.

So a product like Nexavar, which does not cure liver cancer but gets us one step closer, would traditionally be viewed in the U.S. as an important incremental step toward the ultimate goal. And indeed, in contrast to the British NICE, the FDA has approved the use of Nexavar for liver cancer. This approval, in turn, encourages medical industry to keep going.

But consider: If a new American NICE steps in, and begins refusing to cover treatments that provide only incremental improvements, then the companies that invest hundreds of millions of dollars to achieve those incremental steps will simply stop doing so. After our new American NICE refuses to cover Nexavar-like therapies two or three times, medical industry will get the message loud and clear, and as a simple matter of corporate survival will change its business model. And the rapid succession of new medical therapies we have enjoyed will stop, or at least slow markedly.*

This means, of course, that if our new American NICE can just find the intestinal fortitude to make a few tough calls like the one the Brits have just made, and stick with those tough calls despite the firestorm that may ensue, then the hard part of their job will end. Forever. Pretty soon, they simply won’t be faced with any more Nexavars.

The healthcare bureaucrats in Britain and elsewhere around the world, whose jobs are made very difficult by the continual medical progress which is stimulated by the traditional American healthcare system, are cheering on our new reforms. Most especially, they are praying that the American NICE will have enough backbone to do what needs to be done. If the Americans can just make a few of the tough calls the Brits and others have had to make routinely, the job of healthcare bureaucrats will become vastly easier all over the world.

In any case, the prospect raised by conservative alarmists – of a NICE-like panel that is forever condemning American patients to an early death through their refusal to cover effective new therapies – will be only a very temporary phenomenon. After a very short time, such coverage decisions will no longer be necessary, and Americans will no longer be subjected to the anguish these decisions will provoke.

*If individual Americans are permitted to purchase with their own money medical products that are not approved for coverage by the government, then at least some stimulus will persist for continued medical progress. But as DrRich has documented in detail, the plan is to disallow such individual prerogatives.

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Physician-Industry Relationships – What Is Appropriate?

DrRich | June 17th, 2010 - 5:53 am

Podcast:

The following is a close approximation of a talk DrRich gave to a gathering of some of the world’s most promising young cardiac electrophysiologists, in Nice, France, on June 15, 2010. He was asked to talk to these young physicians about physician-industry relationships. The organizers of this gathering apparently did not know, as anyone who reads this blog would know, that DrRich should never, ever be allowed an opportunity to influence promising young physicians.  But, what’s done is done.

* * * * * * * *
A worldwide controversy is now roiling over the appropriate relationship between physicians and industry. Superficially at least, this controversy has to do with the undisputed fact that a physician’s relationship with industry can unduly influence his or her behavior.

That is, this controversy is said to be related to the conflicts of interest (COI) that are always inherent, to some degree, in such relationships.

I believe there is a deeper, and far more disturbing, reason behind this controversy, and I will address it in a short while.  But let’s first talk about COI, because it is ostensibly the chief concern, and it is in fact a very important issue.

A COI is present when an individual has a sacred, fiduciary duty (i.e., a duty of trust) to Entity A, but then develops a secondary relationship with Entity B, which (by creating self-interest, competing loyalties, or even just an inability to be objective), threatens to interfere with the primary duty to Entity A.

Physicians, especially academic physicians, have (at various times) at least three primary fiduciary duties that must take priority. These are: a duty to patients when practicing medicine; a duty to students (i.e., actual students, colleagues, or the public) when teaching; and a duty to society (and truth itself) when conducting medical research.  It is clear that ties with specific companies and their products can easily create important COI that may interfere with each of these primary fiduciary duties, and it is equally clear that physicians have commonly allowed this interference to happen.

Far more often than we like to imagine, doctors have allowed bias to creep in when recommending a course of action for their patients, in imparting knowledge to trainees, colleagues or the public, or when designing, analyzing or reporting results of clinical trials. And typically, most doctors who exercise inappropriate bias have convinced themselves that they are really acting in the best interests of their patients, students or society at large. For it is quite difficult to be objective about one’s own COI.

And there is no question that industry has become adept at the gentle art of creating COI among physicians (subliminally whenever possible), and have carefully incorporated the creation of such conflicts into their business models.

Obvious abuses we have all seen include doctors “shilling” for companies or their products at national meetings; clinical guidelines committees seeded with biased members; unbelievable amounts of money (well above “fair market value) being paid to key doctors for consulting services; long advertisements disguised as CME events; and ghost-writing scientific papers, then recruiting prominent physicians to sign on as “authors” after the fact. There are many others.

Such ongoing abuses of our fiduciary duties ought to be deeply embarrassing to us in the medical profession.

And if it’s not embarrassing, it is at least becoming painful. In the US, physicians who are discovered doing some of these things are being called out publicly, being investigated by Congress if not the Justice Department, losing their prestigious academic positions, and having their reputations destroyed. It is hard to be sympathetic toward them.

Despite all the negative attention – both public and legal – that such COI have brought to our profession in recent years, many of us continue to have tin ears.  A recent example, which has caused a stir in the blogosphere if nowhere else, happens to relate to the EP community. (Thanks to Larry Huston of Cardiobrief who did the heavy lifting on this one. )

Recently, the ACC/HRS collaborated in the launch of a new website, called AFibProfessional.org, which is described as “a unique collaboration to address atrial fibrillation for the cardiology community.” The site has only one corporate sponsor – Sanofi, the maker of Multaq.

At the time of launch, all the content on this new website consisted merely of old, recycled material from older ACC and HRS websites, with a single exception. The single exception was a slide lecture by a prominent electrophysiologist, who we all know and love, on “Managing Atrial Fibrillation.”  This lecture makes a strong case for the off-label, off-guideline use of Multaq. The lecture was posted without any COI disclosure statements, though the lecturer, it turns out, has significant financial ties to Sanofi.  When the matter became a public issue, the lecture was pulled from the site, and the ACC promised to investigate. A few days later, the investigation apparently completed to the ACC’s satisfaction, the lecture was reposted, this time with a COI disclosure.

While one hesitates to suggest malfeasance here, it certainly looks bad.  For the ACC and HRS to co-sponsor a brand new website that , by all appearances, is chiefly a vehicle for advertising Multaq suggests, if nothing else, that we in the medical profession, and our professional organizations, still don’t get it. If we don’t police our own COI, it will be policed for us.

What remedy should be applied?  A reasonable approach would be to recognize that physician-industry ties will always bring at least some COI, and to manage the problem by strictly limiting inappropriate COI, and fully disclosing any that remain.

Accordingly, a number of groups – most prominently the Institute Of Medicine – have recently made formal, and tough, recommendations regarding physician-industry relationships. The final “rules” under which we will all have to live are still being negotiated.

But it is highly likely that they will include many if not all of the following:

-    Doctors should not accept any gifts, no matter how small, from industry. These include trivialities such as pens and notepads, and more substantial gifts such as meals and travel.
-    Doctors should not give presentations in which content is controlled or influenced by industry.
-    Doctors should not consult for industry without a written contract, nor should they receive more than “fair market value” for consulting activities.
-    Doctors should not accept drug samples from industry.
-    Doctors who have a financial interest in a product or company should not participate in clinical trials in any capacity that involve that product or company, including patient enrollment, data collection, analysis or reporting.
-    Doctors who have industry ties should not participate in the development of clinical guidelines.
-    Medical schools and professional organizations should not accept direct funding, or attributable funding, for CME.
-    Any interaction with industry will be fully disclosed, and made publicly available.

What this “full disclosure” will look like can be seen in the Physician Payment Sunshine Act, a law which is pending in the US. Under this act,  all “transfers of value” totaling $100 or more in a year to any physician will be reported by each company to the government annually, along with each physician’s identifying information. Such “TOV” includes food, trinkets, entertainment or gifts; travel; consulting fees or honoraria; funding for research or education; stocks or stock options; ownership or investment interest, and any other economic benefit.  This information will be posted on a public, searchable government website. Companies will be fined $10,000 for each incident of an unreported TOV.

You younger physicians will be spending your careers in a COI environment that is significantly different from that which we, your elders, have experienced. Activities that have been acceptable, and even encouraged, will now cause you to be publicly stigmatized, or worse. This matter is in great flux, and you need to pay close attention to it as the rules are changing. In the meantime, you need to choose your interactions with industry very carefully, and very circumspectly.

Everything I have just discussed assumes that the real issue regarding doctor-industry relationships is COI. Indeed, everything I have discussed assumes a particular way of looking at industry relationships, which I will call Theory A. Theory A, goes as follows:

Theory A:

-  Medical progress is Good, and benefits mankind.
-  Industry is responsible for a high proportion of medical progress.
-  Industry-driven progress requires the active participation of physicians.
-  Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable COI, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

On the surface, at least, that’s what the debate is about – where to draw the necessary limits.  But just below the surface, the debate is about something else entirely. Beneath the surface, Theory A is rejected outright.

Today we hear prominent voices telling us that merely managing COI does not go far enough. No amount of COI is acceptable, and ALL physician-industry ties should be prohibited.  Among these is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of COI is not to have them at all.” For these voices, Theory A simply does not apply. Rather, (I submit) they subscribe to Theory B:

Theory B:

-    The greed of medical industry creates excessive costs, and produces far more harm to society than good.
-    Physician-industry alliances strengthen industry, and increase the harm.
-    Therefore, crippling these unholy alliances is critical to the interests of society.

A corollary of Theory B is that it can only be the State’s job to cripple these alliances.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude that industry will always behave in ways that are counter to the interests of society.  While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.

Proponents of Theory B rarely say what their real goal is. Most of them give lip service to Theory A. One must discern their real motives from their behavior.

Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who gets to use industry’s products, or when and how.

That kind of information can only be managed by unbiased sources. Proponents of Theory B invariably refer to government-appointed panels of experts to determine which products of industry are good and bad, and to manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed.

Inherent in this viewpoint is the notion that the State is an honest broker, with no bias of its own, except to do what is best for the population. The State, in its disinterested beneficence, is the only civil entity which can pass judgment on which medical information is suitable for general consumption.

But even as a general proposition, no government is an unbiased and honest broker. Politics, according to Harold Lasswell, an early Progressive political scientist, is determining who gets what, when and how. Government officials do not cancel their own human nature when they put on a government name tag. As they go about the business of determining who gets what, when and how, they inevitably – and most often intentionally – create various favored constituencies, fiefdoms, and clienteles to suit their own goal. That goal is to consolidate and expand their own authority. In this way, in the exercise of its political mandate the government always creates co-dependencies, and determines winners and losers. So even in the general case, the government cannot be an honest broker.

But with regard to healthcare, government bias goes far beyond the general case. Healthcare spending is the chief problem governments face today. In the US, projected Medicare expenditures over the next 30 – 40 years will be $35-55 trillion. Numbers like this are deeply destabilizing, and simply cannot be abided, and promise nothing but chaos, revolution, and societal disintegration.

To the State, controlling healthcare spending is an existential problem, a matter of life and death, an issue that justifies any solution that has even a slight chance of working.

Why is the cost of healthcare rising so rapidly? Fundamentally, it is medical progress. Medical progress has greatly increased overall healthcare expenditures. Simply consider, for instance, the many fatal illnesses we have converted to chronic, and chronically expensive diseases – coronary artery disease, kidney disease, HIV/AIDS, various forms of cancer, and heart failure, to name a few.  Medical progress has made great strides in early detection and prevention, and preventive medicine always increases the cost of care.  And thanks at least partly to medical progress, life expectancies are on the rise, and people have many more years to consume healthcare.

Medical progress is very expensive, and the more we have of it the more it costs. The State can only look at medical progress and say, “Medical progress is killing us.”

But it is not politically feasible to come right out and say that stifling medical progress is necessary to the survival of the State. Rather, the State must assert that what it is stifling is greed.

Hillary Clinton gave us the State’s operative formulation in 1993: “There are just too many greedy doctors using too much expensive technology.”  So, to control costs, the State must control the doctors; and the State must control the technology, which is to say, industry.

I submit that an underlying theme within the debate over doctor-industry relationships is a desire to greatly slow or even stop the real threat to the State: medical progress, and the vast expenditures which medical progress produces.

The State has several means for stifling medical progress.  The State can institute increasingly oppressive regulations, which can have the effect of hamstringing industry, but more importantly, has the effect of converting industry to a client of the State, dependent on the State’s favors for its success. The State can demonize industry, trying to convince the public that drug companies and medical device companies are evil entities that would just as soon harm them as help them, and indeed, without the strong hand of the State would prefer to distribute pain and suffering as the more favored pathway to windfall profits. But more to the point of today’s discussion, the State can stifle the doctor-industry relationships that are so critical in steering medical progress in a clinically relevant direction.

So the  interests of industry must be represented as being fundamentally counter to the interests of society, and the doctors who have relationships with industry must be painted as their evil (or, at best, deluded) minions.

Yes, industry is biased, and industry will act on that bias whenever they can get away with it. Industry just can’t help itself. That’s just the way it is.

But the State is also biased. And the State will also act on that bias whenever they can get away with it. The State can’t help itself. That’s just the way it is.

Industry will try to exercise its influence over us by data-driven persuasion, and when that fails they will try to sweeten the persuasion, perhaps even with subtle or not-so-subtle bribes.

But the exercise of persuasion is even more dangerous when done by the State. While the State may also try to influence us with data-driven persuasion, it is very quick to resort instead to propaganda (i.e., the art of information-control by which the unwashed masses are told only what the specialized classes have determined is best for them), and when that fails, the State will resort to its ultimate form of persuasion – the enforcement of new and suppressive regulations at the point of a gun.

So, while industry is indeed biased, and needs to be kept at arms length, de-legitimizing industry altogether would be disastrous.  It would create an open field for extraordinarily powerful forces which are at least as biased, but in the opposite direction. If we value medical progress, we need the balance that industry provides – and that includes not only industry’s products, but its voice.

Medical progress driven by industry-physician collaboration is good for mankind. But that collaboration inevitably creates conflicts. We physicians need to control those conflicts, or the collaboration will be forcibly terminated altogether. Our professional history to date is bleak in this regard, and we only have one chance left to get it right, if that.

But in controlling our COI, we should not allow ourselves to be pushed too far. We should agree to reasonable limits on conflicts, and on full disclosure of any conflicts that remain. But we should draw the line when we are urged to forgo all relationships with industry altogether. We must recognize that industry and its selfish goals provide a necessary counterbalance to even more powerful forces whose goal is to stifle medical progress.

I don’t ask that you accept my synthesis of this problem at face value. I simply ask that you listen to what I am suggesting, and observe for yourself what is happening out in the wild. Then challenge yourself to come up with a better explanation for what you see happening out there. I sincerely hope you can, as I would much rather that my conclusions were not true. So if you do come up with a better explanation, I will greatly appreciate hearing about it.

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Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

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