Category Archives: Ethics

PhARMA Bought Buyer

This on representative Buyer–a representative for $200,000 that’s the cost of some drugs for a just year or two.

  • “Rep. Buyer is a member of the House Energy Subcommittee on Health, which regulates drugs, and matters in which PhRMA has a stake frequently appear before the committee. Buyer himself in 2007 led an effort to kill a ban on advertisements for new drugs and other restrictions.”

Medicynical Note: I wonder what Buyer’s position is on negotiating prices with drug companies, health reform, direct to consumer ads, etc.


What’s different about healthcare

That’s a deceptive title because when talking about a “free market” for products, there are many things “different” about the health care product.

I touched on a few in yesterday’s entry.

Today I’d like to explore the notion of effectiveness. In my specialty medical oncology, the only way we gauge effectiveness is through large studies of patients with the problem and comparing the outcomes (length of survival, rate of recurrence, etc). In any given patient it’s often difficult, if not impossible, to ascertain whether the treatment has actually worked or not.

For example, consider the patient with breast cancer who has had surgery with the tumor completely removed. If nothing else is done we will know in time whether the surgery cured the patient or not.

But, we often treat these patients with some type hormonal blocker (tamoxifen or another) with or without chemotherapy (called adjuvant therapy in doc talk). This can get quite expensive and is associated with frequent severe side effects.

If treated in this way and the tumor doesn’t recur, in any individual case we cannot know whether the surgery removed it all or the ensuing hormone blocking and/or chemo had some effect. Furthermore, if the tumor does recur later we are unable to determine whether the treatments delayed the recurrence.

The same is true for all other cancer types. In an individual case we simply cannot know whether the therapy given was worth the pain, cost and side-effects, unless large comparison studies of treatments and their outcomes are done.

You can of course say well, if it doesn’t return who cares. But given that tumors often recur and that there are extreme side-effects and greatly decreased quality of life from treatment and yes extreme costs, it’s important to understand whether a therapy works and just how effective it is.

Now to the difference between health care and other products. We spend literally thousands of dollars on treatments for cancer. Single drugs can cost as much as $100,000/year–that’s more than the great majority of people earn in year. In most instances, in cases of advanced disease, the improvement in survival from these agents (take Senator Kennedy’s case for example) is limited, measured in days to a few months. We, our health care non-system spend literally hundreds of billions of dollars for treatment of just these cases.

Can you name another product in this cost range, bought in the free market, that may not work? or may work for only a few days or months? or if it does work costs hundreds of thousands of dollars?

Well, that’s the situation in health care. Our costs are untenable; Our outcomes difficult to measure; and the purveyors of these products don’t want to do comparison studies to figure out what works and how it actually does work.

We do need reform!


It’s the Money

Fascinating article in The New Yorker (June 1, 2009) on the variations in health care costs. Atul Gawande visits one of the the most expensive Health Care Markets, McAllen Texas, and looks at the reasons.

No surprises here, but nice documentation and explanation of the issues.

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Miami’s Health Care Costs: What Happened to Supply and Demand?

Medicine’s costs confound economists. Classical economic theory (I’m not an economist, correct me if I’m misinterpreting) would have you believe that as supply increases demand is met and prices stabilize. In health care as supply increases, demand increases and prices increase. Health care is simply not a reasoned rational system.

Consider Miami: (Time, May 20,2009)

“the 2008 average private-provider costs for a Miami family of four – $20,282 – as the highest among the 14 major U.S. cities it studied, adding that more than 40% of that amount came out of Miamians’ own pockets.”

“Miami’s inordinate health-care outlay – 20% more than the national average – “is not a pretty picture,””

“That’s especially true since Miami-Dade County also has one of the country’s lowest median incomes ($43,495).”

“”South Florida has an “excess capacity of health-care providers and institutions,” Quick notes. And to make sure they all get a piece of the action, they’ve created a wasteful and ill-coordinated system of health-care redundancies, from unnecessary MRIs to inpatient treatment that too often could have been cheaper outpatient treatment. Miami-Dade, for example, has one of the nation’s highest hospital readmission rates – and more MRI machines than Canada.” (Medicynical emphasis)

Medicynical Note: For-profit medicine is simply for profit. In Miami, efficiency and even the patient’s welfare comes second. Can we learn from Miami?

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Conflicts of Interest:Medtronics and Infuse

Conflicts of interest continue to bedevil medical information.

I just received my Amgen sponsored American Society of Clinical Oncology education booklet and at the meetings later this month there will be all manner of company sponsored events. Many of the speakers will have noted their paid employee/consultant status for sponsoring companies.

This from the NY Times suggests that our system of research support and clinicians on the payroll of drug companies has problems.

“A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits”

“reported that a bone-growth product sold by Medtronic Inc.had much higher success in healing the shattered legs of wounded soldiersat Walter Reed than other doctors there had experienced,”

A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, (Medicynical emphasis) said he believed that Dr. Kuklo’s data was “strong””

“The results reported by Dr. Kuklo in his Infuse study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors,”

Medicynical note: What’s a medicynic to do? View company sponsored studies with suspicion? Disregard all company sponored drug studies? Look for studies not tainted by conflicts of interest? Hope that in the future comparison studies of efficacy (opposed by drug companies) clarify the benefits and risk of various treatments?

Come to think of it, why in the world would companies dedicated to knowledge and the improvement of medical outcomes oppose studies of efficacy?

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Drug Company Gifts: Conflicts of Interest

Gifts from drug companies to doctors continue despite reports to the contrary. Companies claim that such gifts are ethical and necessary. The NY Times notes:

“Drug companies spend billions (medicynical emphasis) of dollars wooing doctors – more than they spend on research or consumer advertising. Much of this money is spent on giving doctors free drug samples, free food, free medical refresher courses and payments for marketing lectures. The institute’s report recommends that nearly all of these efforts end.”

Imagine the cost savings to consumers if drug companies spent less on marketing. These companies claim it takes $800,000,000 to bring a new drug to market. How much of this inflated figure is gifts to doctors aimed an influencing their treatment decisions? If we presume the NY Times is correct and more is spent on gifts and advertising then research then the real cost of new drugs is significantly less than companies claim. Guess who ultimately pays for all this?

With drug prices increasing faster than any other part of health care expenditures is it too much to ask, as the IOM (Institute of Medicine) does, that companies and docs forgo this unethical practice?

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Big PHarma and Families USA–A Unholy Alliance

Politico reports Families USA and PHarma working together on reforming Medicaid.

Medicynical note: Medicaid reform is probably a good idea but should not take the place of a more fundamental review of health care policy, with particular emphasis on cost containment.

PHarma has one and only one goal. To promote and protect the profits of pharmaceutical companies. That’s their responsibility as the lobbying arm of the industry. It’s as close to a fiduciary responsibility as there is. They oppose a public insurance plan, oppose comparison studies of efficacy, oppose negotiation of prices for Medicare part D, oppose patent reform and by inference oppose cost containment if it effects company profits

PHarma doesn’t want reform they want surrender to their goals and objectives.

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Lilly Gross Profit of 84%– Show No Mercy

Lilly announced an earnings increase of 23% over last year’s results.

“Lilly, which reiterated its 2009 earnings target, is among a slew of pharmaceutical firms that have raised some prices aggressively.” in recent months even as government and private insurers struggle to rein in health care costs.”

“Gross margin rose to 83.8% from 76.9% (Medicynical emphasis) as the stronger dollar eased international sales costs. Total sales costs slumped 27%.”

Investopedia defines gross margin as “A financial metric used to assess a firm’s financial health by revealing the proportion of money left over from revenues after accounting for the cost of goods sold.Gross Profit = Revenue − Cost of Goods Sold.”

Medicynical Note: Big profits, seemingly defying the pull of gravity (the current financial crisis). It would seem to me that 86% margin is excessive. But then what is excess profits in a capitalistic society? The larger question is can we afford this level of profits in health care? How to limit? Should we limit?

New advances that we cannot afford have the same impact as trees falling in the woods.

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Arguing Against Comparison Studies– Anti-intellectualism or Greed?

It’s hard to believe that one can argue against learning what works. But that’s exactly the position of drug and device makers in this article in the Wall Street Journal. It’s hard to believe that this is an issue.

At a minimum such studies will guide physicians in explaining benefits of, risks from and alternatives to various treatments. Comparisons will also help with analyzing the cost-effectiveness of various interventions. Whether insurers will use such data to decide what they will and will not cover is an open question.

My question is when new drugs are prohibitively expensive and have minimal effect on disease course, should insurers pay for their use? Should doctors recommend their use? Should there be limits on “choice” in health care when someone else is paying?

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Medical abuse?–Torture and strip searches

While not as egregious, the school nurse supervised strip search of a 13 year old school girl has parallels in the torture of suspected terrorists.

The CIA medical staff:

“monitored prisoners undergoing water boarding, apparently to make sure they did not drown. Medical workers were also present when guards confined prisoners in small boxes, shackled their arms to the ceiling, kept them in frigid cells and slammed them repeatedly into walls, the report said.”

“Facilitating such practices, which the Red Cross described as torture, was a violation of medical ethics even if the medical workers’ intentions had been to prevent death or permanent injury, the report said. But it found that the medical professionals’ role was primarily to support the interrogators, not to protect the prisoners, and that the professionals had “condoned and participated in ill treatment.”

The Arizona school’s behavior is similar to the CIA’s in intent and misuse of medical staff. It raises questions both for what is allowable in the context of a school situation and how the medical profession can be used to facilitate such actions. First strip searching a 13 year old without the permission and/or presence of a parent is untenable. Using medical staff undermines the original functions of that staff in the school setting.

“Vice Principal Wilson removed her from class and brought her to his office. She gave permission for a search of her backpack, which turned up nothing.”

So far so good, appropriate use of the principal’s authority.

“Then Wilson told her to go to the nurse’s office with two female staffers. They told her to remove her socks and shoes, her stretch pants and pink T-shirt. They told her to move her bra from side to side, which exposed her breasts, and pull out the waistband of her underwear.”

In my view this is inappropriate use of the school’s authority and the medical staff. It eerily parallels the use of CIA staff to “to support the interrogators, not to protect the prisoners, and that the professionals had “condoned and participated in ill treatment.”

It’s amazing and a bit revealing that such a case would get to the Supreme Court without a resounding rejection of the use of a strip search. Any reasonable person, and that might even include a judge, should be offended by the school official’s behavior (and the CIA’s).

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