April 2011

Paul Krugman has a recent column, "Patients Are Not Consumers." He concludes the column by saying:

The idea that all this can be reduced to money — that doctors are just “providers” selling services to health care “consumers” — is, well, sickening. And the prevalence of this kind of language is a sign that something has gone very wrong not just with this discussion, but with our society’s values.

I like Krugman’s having the good common sense to realize that medical care is NOT all or only about money – and that we are in trouble if we think it is. The reduction of EVERYTHING to money is a key driver, I think, in making corruption invisible to people. As Krugman observes:

Now politicians and supposed reformers talk about the act of receiving care as if it were no different from a commercial transaction, like buying a car — and their only complaint is that it isn’t commercial enough. What has gone wrong with us?

James Kwak at the Baseline Scenario details research which shows that the more people think about money, the less admirably they act. As well, taking economics classes may have a negative effect on behavior:

Robert Frank, Thomas Gilovich, and Dennis Regan wrote two papers on this back in the 1990s that most of the professional economists out there already know. In one of their experiments, they asked undergraduates at the beginning and end of the semester several questions such as whether or not they would return $100 lost by a stranger at the end of the semester. They found that the proportion of students who gave more dishonest answers at the end of the semester than at the beginning was highest for students who took introductory micro from the mainstream economist, lower for students who took introductory micro from the developmental economist, and lowest for students who took introductory astronomy.

If there’s an effect here, I don’t think the mechanism is that economics makes you a bad person. Instead, it changes your expectations about what the rest of the world is like. If you are an altruistic person and someone teaches you that (a) most people are self-interested and (b) the world would be better if everyone behaved in a self-interested way, that is likely to make you behave in a less altruistic way.

I was really struck by Krugman’s words that: “and their only complaint is that [medicine] isn’t commercial enough.” Somehow, more commercialization has become the always-prescribed panacea to everything. The same universal nostrum is also prescribed for education. Recently in Texas, there has been a lot of emphasis in education in whether professors and research are on balance money-making or money-losing for their universities.

Commercialization is not only no panacea – it is often not a remedy at all, like other quack prescriptions. Fortunately, many good people within organizations that pay lip service to money as the only value do NOT act that way and do subvert their corrupt leadership. But we also need to challenge the frameworks that people use when they talk – very unrealistically – as though human beings were, above all, “consumers.”

In reality, life is NOT all about money – and we get in trouble when we act or think as though it is.

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RUCing About - Conflicts of Interest Affecting the Members of the RBRVS Update Committee

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Will a Pharmaceutical CEO Finally Be Held Accountable for Misbehavior on His Watch?

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Henry Ford Health System Decides Meaningful Use Not That Meaningful

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Abbott Laboratories Settles, Again

In 2007, we discussed a scheme that Abbott Laboratories seemed to be using to boost the price of Kaletra, a combination of two protease inhibitors it markets to treat HIV and AIDS. Kaletra is a combination of rinoavir (Norvir, sold by Abbott as a single drug), and leponavir. Kaletra was apparently losing sales to the combination of Norvir with Reyataz (atazanavir), made by Bristol-Myers-Squibb. So Abbott increased the price of Norvir by 400%.

As reported so far only by Bloomberg, Abbott just settled a class-action lawsuit alleging that its price hike for Norvir was anti-competitive.

Abbott Laboratories agreed to pay $52 million to resolve claims by direct drug buyers that it tried to harm competition when it quadrupled the price of its HIV medicine Norvir in 2003.

The settlement, which is subject to court approval, would resolve a class-action lawsuit filed on behalf of Abbott customers that purchased Norvir, a boosting agent for other HIV drugs, and a second medicine Kaletra, which includes Norvir, according to an April 8 filing in federal court in Oakland, California. Abbott denied wrongdoing, according to the accord.

Abbott increased the wholesale price of a Norvir capsule containing 100 milligrams to $8.57 from $1.71, the Abbott Park, Illinois-based company said in court documents. GlaxoSmithKline Plc and drug retailers and distributors sued, claiming other drugmakers that used Norvir in their medicines couldn’t compete on price with Kaletra, and the price increase penalized drug customers that wanted to buy medicines that competed with Kaletra.

Note that, as we discussed here, this is the third significant settlement by Abbott in the last six months. In December, 2010, the company settled claims that it defrauded Medicare and Medicaid for $421 million, and claims that a subsidiary paid kickbacks to doctors to sell its products for $41 million. For other discussion of Abbott's recent misbehavior, look here.

So while we were discussing other issues, the parade of legal settlements continued. It is beginning to seem like every major pharmaceutical/ device/ and biotechnology company has settled or pleaded guilty to multiple allegations of significantly bad behavior in the last few years. This suggests how bad the leadership of most of these companies has become.

Nonetheless, in the current case, like nearly all others, the penalties were paid by the companies themselves, not the people who authorized, directed or implemented the bad behavior. We and others have commented repeatedly that the resulting relative impunity of leaders of health care organizations will hardly deter future bad behavior. (Note that this impunity seems similar to that employed by leaders of finance after the global financial collapse/ Great Recession.) Not only do the leaders not pay penalties, but they continue to become hugely rich at the expense of their companies. For example, Abbott CEO Miles D White enjoyed total compensation of $25,564,283 in 2010, down only slightly from the 26,213,996 he received in 2009, according to the 2011 Abbott proxy statement (available here). Threats by government officials to start to employ the "Responsible Corporate Officer Doctrine," (available since 1943) to hold individuals accountable for health care organizations' misdeeds so far appear to be empty (see this post).

So to repeat Cassandra-like, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

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Khadafy's Academic Mercenaries' Health Care Connections

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Henry Kissinger, Iceland's Promoter, Khadafy's Apologists, and the Rise of the Academic Mercenary

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FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs

Well, not exactly, but they have decided regulation of another medical device is a political hot potato, and demurred on enforcing regulation:

Health IT.

Health IT are medical devices.

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated this explicitly on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems).

That leaves no doubt that these are medical devices. However, he also stated:

To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

In other words, this medical device receives special accommodation over all others,such as heart stents, defibrillators, spine and knee implants, etc., all of which have been in the news in recent years for major defects and malfunctions, up to and including causing patient deaths. The extent would have likely been far, far worse had these gadgets been unregulated.

One should ask: why the special accommodation for health IT medical devices? What are the underlying politics, and who is behind them? Especially when FDA is aware of potential risks that may only be the "tip of the iceberg?"

The selective reluctance to enforce the FD&C Act persists to this day. See for example this link regarding his statements just a few days ago here in Philadelphia: Will FDA Regulate EHR's? :

Speaking at the first annual PharmEHR Summit in Philadelphia on April 7, Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health at the FDA, said his agency could change its traditional hands-off approach to EHRs, but he acknowledged that the potential of FDA regulation raises serious clinical issues [the only clinical issues I can think of are in holding vendors accountable for patient injury - ed.] and is a “political hot potato.” “As of right now we’re not regulating EHRs, and it may turn out that we won’t,” he said.

A "political hot potato" as the reason for an FDA hands-off policy? Remarkable.

Tossing away political hot potatoes and ... patients.

Likely translation: FDA regulation of health IT will never happen.

One implication is that health IT quality, safety, efficacy, privacy, security, and other issues about these systems will remain subject to HHS and industry caprice.

While we're at it, let's deregulate knee implants too...

-- SS

Addendum April 19, 2011:

Roy Poses observes that:

Here is a great example of regulatory capture. The health care IT industry has amassed such political clout that it now has impunity to regulation. Once again, combined economic and political power trumps patients' and the public's health and safety. We will not be able to really reform health care until we can provide for honest, independent health care regulation to uphold patients' and the public's health.

-- SS

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"The 'Third Rail' that No One Wishes to Analyze" - Conflicts of Interest Affecting Health Care Foundations

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Johnson and Johnson Runs Afoul of Foreign Corrupt Practices Act

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Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company PatientKeeper entitled "Toward Meaningful Usability: Five Keys to Creating Physician-Centric CPOE" (PDF), an organization whose motto is "Enabling Physicians to Focus on Patients ... Not Technology", I again note a common phenomenon.

Certain verboten terms are absent.

What might those terms be? More on that in a moment...

They speak of "the failure of CPOE":

The failure of CPOE to date can be attributed to many factors that ultimately lead to a lack of physician adoption. CPOE systems have historically been designed to support the workflow of the departments responsible for fulfilling the orders rather than the physician workflow around entering orders. As a result, entering orders electronically can take significantly longer than written or verbal orders and often requires the physician to change the way they currently practice medicine.

That's a problem, considering the following observation (paraphrased from a "why-pharma-fails" post at this link):

"The machine was made for Clinicians, not Clinicians for the Machine."

But still, words are missing from the White Paper. Again, more on that in a moment.

... Hospitals often purchase CPOE on the premise that standardization of care through evidence-based order sets is the optimal way to improve patient care delivery and reduce healthcare costs. In fact, most standardized care is not
supported by evidence so spending months or even years to achieve order set consensus only serves to delay implementation and use while increasing the overall cost of the order entry system.

Well, yes, but where are those missing words?

Most CPOE systems expose physicians to all clinical alerts regardless of severity.
The preponderance of these alerts disrupts the ordering process, leads to alert fatigue, and results in frustration on the part of the physician. Finally, the number of available workstations, including those on the hospital floors and in patient rooms, is limited, and physicians may have to wait in queue to enter their orders. This may lead to an increase in verbal orders from the physician to the nurse, pharmacist, etc. as well as frustration with a process that requires more physician time than simple pen and paper.

There must be a lot of frustrated doctors out there. Still, the shibboleth terms are missing.

Cited are the usual KOL's:

1 D. W. Bates, J. M. Teich, J. Lee et al., “The Impact of Computerized Physician Order Entry on Medication Error Prevention,” Journal of the American Medical Informatics Association 6 (July/August 1999): 13–21.
2 D. W. Bates and A. A. Gawande, “Improving Safety with Information Technology,” New England Journal of Medicine 348 (June 19, 2003): 2526–34.
3 Jason Hess, KLAS Enterprises (Orem, Utah), “Are We There Yet? Getting to Meaningful CPOE Use”, July 13, 2010

Still no mention of the missing critical terms.

The next generation of CPOE solutions must ultimately save physicians time, rather than simply being time-neutral. Otherwise, they will suffer the fate of most previous attempts to implement this required functionality – at the cost of improved patient care, better outcomes, and lost ARRA stimulus dollars.

In other words, the worst-case scenario is wasted promotional dollars and maintenance of the clinical status quo.

Still, key terms are missing.

What are those terms?

Here they are, the unaccounted-for outcomes of CPOE and its toxicity in its present form:

Safety (as in, "reduction of")
Risk (as in, "of injury, increased")
Danger (as of, "putting patients in")
Error (as in, "the outcome of toxic HIT")
Harm (as in, "injury and death")

This was no mere White Paper. A more appropriate term might be a "Snow White" paper:

CPOE, An Enchanted Technology. Find the Prince!

Health IT, including dysfunctional and toxic CPOE, causes frustration among doctors. CPOE failure is merely "physician nonacceptance."

But the frustration among injured or dead patients and their families seems never to be mentioned or considered in this industry.

I pointed out that similar terms were missing from the PCAST (President’s Council of Advisors on Science and Technology) report on health IT at my Feb. 2011 post "Brief Comments on the PCAST Report on Health IT."

Shhhh!

-- SS

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