Monday, August 22, 2011

A Medical-Industrial Complex? (Part I)

“This conjunction of an immense [medical] establishment and a large [drug and medical device] industry is new in the American experience. The total influence -- economic, political, even spiritual -- is felt in every city, every State house, every office of the Federal government. We recognize the imperative need for this development. Yet we must not fail to comprehend its grave implications. . .

"In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the [medical] industrial complex. The potential for the disastrous rise of misplaced power exists and will persist . .

". . . in holding scientific research and discovery in respect, as we should, we must also be alert to the equal and opposite danger that public policy could itself become the captive of a scientifictechnological elite.

"It is the task of statesmanship to mold, to balance, and to integrate these and other forces, new and old, within the principles of our democratic system -- ever aiming toward the supreme goals of our free society.”

The above quote is my adaption of President Dwight Eisenhower’s famous farewell address to the country, warning about the influence of a military-industrial complex. I took the liberty of replacing the word “military” with “medical”—to raise the question of whether close ties between the medical profession and the manufacturers of drugs and medical devices have also resulted in “unwarranted influence” over public policy.

Eisenhower was concerned about the implications of military spending on the economy; today, rising costs of health care pose the gravest threat to the economic health of the country. We know that without changes, Medicare and Medicaid spending will consume so much of national resources there will be little left for other needs. It will be impossible to reduce the deficit and debt without getting health care spending under control.

We can’t get health care spending under control without getting control of medical technology costs. A 2009 ACP position paper, Controlling Health Care Costs While Promoting The Best Possible Health Outcomes, observed that “Technological progress has been seen as accounting for as much as 75% of the increase in U.S. health care expenditures over time.” To address the costs of health care technology, ACP proposed that:

“A coordinated, independent, and evidence-based assessment process should be created to analyze the costs and clinical benefits of new medical technology before it enters the market, including comparisons with existing technologies. Such information should be incorporated into approval, coverage, payment, and plan benefit decisions. The assessment process should balance the need to inform decisions on coverage and resource planning and allocation with the need to ensure that such research does not limit the development and diffusion of new technology of value to patients and clinicians or stifle innovation by making it too difficult for new technologies to gain approval.”

But the flap over a new IOM report on regulation of implantable medical devices shows that even a modest effort to assess the benefits of technology before and after it gets to market will run right into intense opposition by manufacturers and some physicians. The IOM recommended that the FDA no longer automatically grant approval to implantable medical devices, in the absence of clinical trials, based only on a showing that they have “substantial equivalence” to an existing device.

According to a supportive editorial by Drs. Gregory Curfman and Rita Redberg in the NEJM, the IOM found that it is “impossible for such clearance to assure safety and effectiveness, because it assesses neither, instead establishing only ‘substantial equivalence’ to an existing device. The report therefore recommended that [such] clearance be eliminated. In addition, it recommended monitoring medical devices throughout their life cycle, especially during the postmarketing period.”

Yet what Drs. Curfman and Redberg call an “insightful, judicious, sensible, and long overdue” report was subject to a “highly unusual . . . preemptive strike” by industry opponents, reports the New York Times. “That attack began even before the study panel finished its review, and has intensified in recent weeks.” According to the Times, a preemptive legal challenge to the IOM report was filed in court by a pro-industry legal foundation, with the implied support of at least some orthopedic surgeons. An orthopedics trade publication, Orthopedics This Week, labeled the IOM report as a “stink bomb,” citing a statement by AdvaMed, the medical device trade association, that it was undeserving of “serious consideration.

The IOM’s report was focused on harm to patients of the current approval process, not the cost of medical technology You can imagine then the even greater furor that would result if it called for assessing “the the costs and clinical benefits of new medical technology before it enters the market, including comparisons with existing technologies” (as proposed by ACP)!

I am sure that there are two sides to this story, and I encourage critics of the IOM report, and particularly orthopedic surgeons, to post comments to this blog. And by no means do I want to suggest the concern about physician-industry influence over public policy is limited to one specialty or one trade group. I plan to examine the issue of drug industry sponsorship of clinical trials in the same light in a future post.

The larger question is whether the close ties between drug and device manufacturers, and physicians who benefit from the products made by them, have created a medical-industrial complex with “unwarranted influence” over “every city, every State house, every office of the Federal government.”—today’s health care version of Eisenhower’s prescient warning about the military-industrial complex.

Today’s questions: Do you think there is a medical-industrial complex that has unwarranted influence over public policy? And what is your take on the specific controversy over the IOM report on medical device regulation?


Steve Lucas said...

There is no question pharma and the device companies have an outsized influence on medicine in this country. All we have to do is look at the statistic that we spend twice on medical care as other industrial countries to realize someone is driving this cost.

As a patient it is disappointing to go into a doctor’s office and hear word for word the latest drug advertisement repeated by the doctor as if it is some sort of Holy Grail of health. It really does not take a math background to realize that the slightest shift in standards creates massive new potential customers for any drug or device in our deviation driven medical environment.

If general medicine wishes to see what the drug/device companies have planned they need look no farther than psychiatry.

The IOM report was only the opening salvo on attempting to gain cost control over medical procedures. I have been recently reminded of a scam from the late 60’s early 70’s called Dare To Be Great. The premise is that if I say something with enough confidence it then becomes your task to prove me wrong. Of course I frame the question and then also control the follow on questions. A win win for me and a loose loose for you.

The drug/device companies have learned this lesson well.

Steve Lucas

Robert J. Sobel, M.D. said...


The analogy is of course a propos and has been written about for years. While scientific-technological elite is an interesting term, there is no doubt this is the gist of independent physicians' concerns on many issues (guidelines gone amuck, overhyping of the new, the rebound third party coercion on financial lines alone). That a percentage (and in this case, I'll stick with Steve that the influence is undue) are either involved with or overly influenced by the new commodities is undeniable. This has been my point for a while. We need to protect independence of clinical decisions, where old and new can be judged without the multiple entanglements that extreme price differentials engender.

I remember the ACP 2009 position paper. It was comprehensive. In my mind, if we fix the pharmaceutical issue, we will be able to handle technologies as well. I will have to review further the IOM report before I comment further on devices, but you are welcome to promote my Regulated Royalties concept.

Eisenhower was prescient. The search for balance comes back to respecting independence and the primacy of empowered patients seeking out valued services. We need a regulatory structure to protect us from cost extremes. Otherwise, the medical-industrial complex can indeed trample us. That is why the added consolidation of much of the latest reforms is so troublesome.

ryanjo said...


You are going to the wrong doctor's office if he/she is quoting from the Pharma ads verbatim. Most of us don't see reps any more. If they still see reps, ask why?

Steve Lucas said...


Thank you for your comment. This is only part of the reasons I do not currently have a personal physician.

What is common in my part of the state is for large hospitals to own private medical practices supplying them with EMR’s. What we find as patients is that in a fee for service environment test are used as a means of maximizing income for the hospital and practice.

In a recent legal suit between a small non-profit hospital and the larger non-profit hospital, that owns a for profit insurance company, one nonaffiliated practice was paid $25,000 per doctor for exclusive referrals.

My personal belief is that the pharma ethos of maximize profits has infected much of medicine. The new practice model is a well insured patient with no real health issue that can be coerced into 90 day visits, using pharma based date, showing a slight deviation from some questionable norm.

Those who suffer under this system are often the elderly, and others, with serious medical conditions that require large amounts of time, and the doctors who valiantly try to serve this population.

Dr. Sobel’s point is well taken. Today Spain announced that in the future doctors will write the chemical name of a drug along with the delivery system and dosage on a prescription. The pharmacist will then fill the prescription with the lowest cost drug available.

My wife and I have been blessed with very good health and the ability to interact with doctors of various specialties. When turning 50 we were drummed with the need for a doctor. Now we find these same doctors patting us on the shoulder and telling us that if we have a problem, any problem, just give them a call and they will get us in touch with the best person available.

As far as asking about drug reps, I rarely get that far. My question, after being told of the need for a large number of drugs prior to any testing is: What is the NNT for a person with my profile? Doctors have walked out of the room and I am told not to come back.

We often forget that all of us on this blog are smart, and want to change a system that we see problems with that is causing undue pain and suffering at inflated prices. The bulk of the patients and doctors, while not happy, are willing to accept a dysfunctional system.

Steve Lucas

Jay Larson MD said...

Food for thought. Who is more responsible for health care costs...people with MDs or people with MBAs?

Harrison said...

"most of us don't see reps anymore"??
It is wrong to think that doctors are not influenced by Pharma advertising and reps.
Perhaps there are fewer doctors who now allow reps into their offices for meetings or lunches. I would still bet that many, if not more than 50% still do.
And there is a lot of access to ads and reps outside of the office.
ACP meetings are very much influenced by reps. We carry bags that advertise companies and drugs.
Doctors at our annual meeting flock to play the silly games that the reps offer.
They line up to have their cholesterol tested.
They sign up for the 10 minute talks that are clearly labeled as advertisement at least as much as educational.
They sign up for golf simulators.
They do scavenger hunts for information so that they can be eligible for drawings.

We are really easily bribed.
God forbid we actually buy our own pens.

I'm pretty sure that most if not all physicians practicing in the US have significant annual contact with Pharma reps, and we are clearly influenced by them.
We may not quote their ads, but we rely on their information.
We trust their efficacy studies.
We completely rely on their own reporting of their drugs side effects.
And we rarely think outside the box as to whether our patients really need their drugs.

Are any of us brave enough to tell a woman to stop bisphosphonates after 5 years?
Why not?
There no evidence that they are reducing hip fractures any more after that?
Are we looking for reasons to continue the drugs, or are we just too lazy to look beyond the industry generated guidelines.

Pharma is not the only reason that our costs are out of control.
But they influence us and we write the orders and we are part of the problem with them.


Stew said...

I think this "complex" only applies greatly in the United States as pharma companies have greatly manipulated the standard of living in most states and cities. Their constant lobbying efforts make it more and more difficult for the average joe to have the purchasing power towards their products. feedback

Unknown said...

I think there are indeed possibilities that such a medical complex does exist which influences how the public policy is drawn up. There are both positive and negative pointers that derive from this issue and we as patients (or end consumers) are the ones who will eventually be greatly affected by the impact. Research is very critical for existing and new medical and health issues, thus if we have unwarranted influences that affect the platform that supports the research sector, then we are definitely in for a loss.