Sunday, July 31, 2005

College (Governance) Follies

One issue that at least some of us here on Health Care Renewal think may be important in the revitalization of academic medicine (see post below) is the revitalization of the governance of academic medical organizations.
In the US, at least, medical schools own or operate most academic medical centers and teaching hospitals. Medical schools, in turn, are usually part of larger universities.
Heather MacDonald, writing in the latest City Journal, has quite a bit to say about the governance of American universities, which should be relevant to the governance of academic medicine.
In particular, she indicts the trustees, who ought to have ultimate authority over how the universities are run, and ought to be insuring that they are run in accord with their missions:
College trustees seem even more determined than alumni to see and hear no evil. Nothing produces more discomfort and denial in your average trustee than being told about the excesses at his college. Federal appellate judge Jose Cabranes has served as a trustee at Yale and Colgate, and is currently on the Columbia board. Have you ever heard your fellow trustees express an interest in the curriculum? I asked him. “Not only never, but such questions make them anxiety-ridden. If the question comes up, most trustees stare vacantly into space.”
A Brown trustee explains: “The culture wars are vicious; most trustees don’t want to be involved. They don’t care about the curriculum. All they want to know is if SATs are up.”
To test this claim, I asked a New York University trustee what she thought about Andrew Ross, a royally paid American studies professor. [Ross is the editor of Social Text, the journal that published Alan Sokal's hoax article about post-modern science.] But though Sokal’s hoax won wide press coverage, including a front-page New York Times story, the NYU trustee had never heard of Andrew Ross. She quickly changed the subject to NYU’s rising place in U.S. News and World Report’s annual college rankings.
[MacDonald inteviewed John Moores, Sr., a "renegade regent" at the University of California, San Diego.] “The regents are furniture,” he says. “They do absolutely nothing. If they were a board of directors of a corporation, they would fire people on the spot for not revealing material information. But the regents don’t want to know about admissions standards. They accept [them] with a sort of biblical inerrancy [as] the revealed truth....
A trustee at one of the most notoriously liberal private universities in the country sounds anguished discussing his service. “Being a trustee is hard to do if you want to live an examined life,” he says. “It’s a very problematic equation. Maybe I should just walk away. It would be completely rational, because so much is so bad.”
Such unruffled acquiescence in whatever folly one’s university has cooked up is not surprising. A board is a creature of the college president, nominated by people close to him or by alumni associations whose members are also chosen for their loyalty. Trustees are usually so grateful for the honor and prestige of the position that they shy away from rigorous oversight. As one big donor observed, the “anxiety for status among what should be self-confident businessmen is remarkable. Once on college boards, they grovel.”
This is all anecdotal, to be sure. But if it is at all representative of how universities are run, the implications for how academic medicine is run are dire. If university trustees are cronies of the administration, and/or unwilling to exercise any oversight over central academic matters such as curriculum and admissions, what sort of oversight should we expect over issues peculiar to academic medicine. And is it then any surprise that American medical schools offer so little instruction on evidence-based medicine, on one hand, and on the business ethics of medicine (for want of a better term), on the other?

Thursday, July 28, 2005

Five Future Scenarios for Academic Medicine

Simultaneously published this month in PLOS Medicine in a longer version, and the British Medical Journal in a shorter version is an article by the International Campaign to Revitalise Academic Medicine (ICRAM) presenting five possible scenarios for the future of academic medicine. In the longer version are a list of "current instabilities in academic medicine," which includes some items that many will find familiar, and "drivers of change in academic medicine," most of which are pretty telegraphic.
The five scenarios are fairly extreme, and seem to be products of some fairly severe disagreement among the widely geographically dispersed members of ICRAM (see the BMJ version, "The members of the group often couldn't agree. They disagreed, ofr example, over the importance of business, particularly pharmaceutical companies, in academic medicine. Would business interests destroy or enhance academic medicine?") The scenarios include:
  • "Academic Inc" - academic medicine becomes entirely a private, predominantly for-profit enterprise
  • "Reformation" - academic medical centers disappear, and all "academic" activities take place in the community
  • "In the Public Eye" - academic medicine as celebrity culture
  • "Global Academic Partnership" - academic medicine focusses almost completely on the plight of global health
  • "Fully Engaged" - academic medicine became fully engaged with stakeholders
The ideas are interesting, and the future may hold some elements of some of them. It wasn't clear whether some of the scenarios were meant as dsytopias or utopias. Surely, this article ought to generate some discussion, but my concern is that this worthwhile movement has not yet clearly defined the problems in academic medicine that it seeks to address.
The lists of "current instabilities" and "drivers of change" contain many poorly defined items. For example, the latter includes "'big hungry buyers' demanding more from health care," "managerialism," and "expanding gap between what could be done and can be afforded in health care." All these touch on issues explored in Health Care Renewal, but don't seem to quite get at the core of the problems. It may be that the problems afflicting academic medicine in countries throughout the world are so varied that it really is hard to define a set of universal issues. On the other hand, international gatherings often end of speaking "international-speak," in which crucial distinctions are blurred in order to avoid offending one party or the other.
Maybe the group will be able to get beyond "international-speak," and engage more directly with the nitty gritty issues that are afflicting academic medicine in individual countries, even if that means coming up with solutions customized to each countries' needs. Let's wish them luck.

Wednesday, July 27, 2005

Health Care Renewal Blogger in the New England Journal of Medicine

In the New England Journal this week is a skeptical commentary on echinacea by our intrepid Health Care Renewal blogger, Wallace Sampson. [Sampson W. Studying herbal remedies. N Engl J Med 2005; 353:337-339.]

New York City Public Health Proposes Gathering Data on All Diabetic Patients Without Their Consent

From the Associated Press, how the New York City Department of Health proposes to collect data on individual diabetic patients' control (assessed by hemoglobin A1C). "The plan would require medical labs to report to the city the results of a certain type of test that indicates how well individual patients are controlling their diabetes." "By pinpointing problem patients, then intervening in their care, [City Health Commissioner Thomas] Frieden said the city can improve thousands of lives." "The city's program wouldn't initially get patients' consent to collect data, but allow them to opt out later." "Doctors could receive letters, telling them whether their patients have been getting adequate care."
Frieden justified the program thus, "There will be some people who will say, 'what business of the government is to know that my diabetes is not in control?'" "The answer, he said, is that diabetes costs an estimated $5 billion a year to treat in New York and was the fourth leading cause of death in the city in 2003, killing 1,891 people." Frieden concluded, "I don't think we can afford not to do anything."
Dr. Paul Simon of Los Angeles' public health agreed, "Some people are uncomfortable with public-health departments expanding their scope beyond infectious disease, but I would say we have to do it. Chronic disease accounts for the major portion of life lost to illness, these days."
Hold the phone, here. Because diabetes is a severe and costly chronic disease, a local government feels it has the justification to collect individual patient data, without the patients' consent, and then intervene directly in their care? We are on a real slippery slope here, since this justification could be used to intervene on nearly any aspect of medical care, or of private behavior for that matter.
In the past, public health has involved some uncomfortable trade-offs between protecting the population from disease and individual rights. However, most of those diseases were infectious or toxic, and the measures involved protecting people from exposure. But using chronic disease as a justification for the government assuming this degree of control of medicine and of individual's behavior would involve breath-taking trade-offs.
Health Care Renewal quiz time: what nation in the 1930s was known for the unprecedented vigor of its anti-smoking campaign? Hint, an article in the British Medical Journal in 1996 featured a poster with this testimonial, x "drinks no alcohol and does not smoke.... His performance at work is incredible." [For the answer, go here.]
For the tip, thanks to MedPundit.

More Troubles at Provident Hospital

The Chicago Sun-Times reported more troubles at Provident Hospital, a part of the Cook County health care system. In one story, it reported how the hospital has been cited by the Illinois Department of Health for some severe patient safety problems, leading the Department to declare the hospital in "immediate jeopardy." It has until September to correct these deficiencies, or lose its Medicaid funding.
But even more interesting is the choice of Cook County Board President as the new chief operating officer of the hospital. The Sun-Times reported that John Fairman:
  • was accused of conspiring to defraud the Houston public health system in the 1980s, and had liens filed against him by the Internal Revenue Service (IRS);
  • was accused of excess spending personal spending using public money from the Denver public health system in the 1990s, and was fired from his job there; and
  • was under criminal investigation in the District of Columbia for how he ran the Public Benefit Corp, which folded after Fairman was fired as its head.
Fairman's brother is Cook County's public safety director.
Provident Hospital got attention from Health Care Renewal late last year, after allegations were made that its security contract with Digby Security Services was politically motivated.
Another troubled health care organization with questionable leadership for our collection....

Quality Improvement Organizations: Organized to Address Their Mission?

The Washington Post continued its series on Medicare with a story on Quality Improvement Organizations (QIOs). The story points out some legitimate policy questions about these organizations, particularly related to how their roles have changed as they evolved from "peer review organizations."
  • QIOs are apparently still tasked with collecting and addressing patient complaints. However, their current role is mainly to work collaboratively with physicians and hospitals on quality improvement projects. They have been accused of being slow and unresponsive in the face of such complaints, and the number of complaints seems inconsistent state to state. Although they have the power to sanction doctors and hospitals, they rarely do so. The boards of QIOs are made up almost entirely of physicians, but rarely include more than one consumer advocate per state.
  • Given that QIOs are tasked to do quality improvement projects, old rules that mandate a high level of secrecy about their work no longer clearly make sense. "These rules even prohibit them from publicly naming the hospitals they work with unless the facilities agree." Why "few do" is unclear. Specific QIOs said "the names and outcomes of their projects are private under their contract with Medicare."
But more in the Health Care Renewal bailiwick, the article revealed that QIOs now provide their leaders very generous remuneration. Forty-one of the state-wide QIOs provided their CEOs with more than $200,000 in total compensation, while eleven provided more than $300,000. The highest compensation, $519,084 pluse use of a BMW, went to Martin Margolies, CEO of PRONJ of New Jersey. Many of their boards are paid, even though in the larger not-for-profit world, board members are rarely paid. At best, such generous compensation may distract leaders from their primary mission.
Although the issues here don't seem as severe as many discussed on Health Care Renewal, many QIOs no longer seem organized to optimally address their mission.

Tuesday, July 26, 2005

Reasoning By (Mis)Analogy: Should Hospitals be Compared to Microchip Factories?

Rant alert: I have become increasingly distressed by changes in health care prompted by poor analogies between it and various businesses. One of my pet peeves has been hospital quality improvement schemes based on what purportedly works to improve quality on production lines.
Hospitals couldn't resemble mass production in a factory less. Yes, of course, most products used in hospitals are mass-produced in a factory, and physicians and other health care professionals depend on products manufactured with great uniformity and predictability. Each patient presenting to a hospital, however, has a unique set of problems and issues. Attempts to manage these issues are based on our currently far from complete understanding of human biology, and how psychosocial factors impinge on it. Patients present at any time, with varying degrees of severity, at various stages in their life. The goal is to provide the best approach to each patient customized to that patient's situation and problems. Doing so is likely to require using drugs, devices, and equipment that will perform predictably and reliably. But the choice of what tests to do, what treatments to employ, how to discuss and inform the patient of what is going on, etc are unique to each patient.
In contrast, the goal of production lines is to produce identical products, designed by humans, based on good understanding of physics, chemistry etc., and the principles of engineering. So how would practices designed to improve the design and manufacture of goods and equipment on a production line likely apply to how hospitals take care of unique patients?
In this week's JAMA there appears a good example of the genre of applying industrial production techniques to health care, an article by Andrew S. Grove PhD, the "former chairman of the board of Intel Corporation." [Grove AS. Efficiency in the health care industries: a view from the outside. JAMA 2005; 294: 490.]
Grove starts off with this comparison: "the health science/health care industry and the microchip industry are similar in some important ways: both are populated by extremely dedicated and well-trained individuals, both are based on science, and both are striving to put to use the result of this science." These criteria are extremely broad. One could use them to compare health care with the airline industry, major league baseball, or the Communist Party in the Soviety Union under Vladimir Lenin. All these organizations could have claimed to be populated by well-trained, dedicated people, who based their work to some extent on scientific principles.
Then blithely dismissing that "one industry deals with the well-defined world of silicon, the other with living human beings," Grove goes on to tell us how to do health care better.
Particularly galling, I think, is his criticism of the slow pace of the "war on cancer" compared to the increase in the number of transistors included on microchips.
Maybe he really got to the point nearer the end, when he pushed for more and quicker implementation of the electronic medical record. "When it comes to operational efficiency, nothing illustrates the chasm between the 2 industries better than a comparison of the rate of implementation of electronic medical records with the rate of growth of e-commerce." This comparison is hard to fathom. EMRs, to be useful, need to digitally categorize data that is very hard to organize. No one yet knows how to store, for example, the contents of the medical history in anything other than a text file. Yet an electronic medical record that consists mostly of text and image files may be no easier to manipulate than a paper chart. E-commerce, on the other hand, must simply keep track of stereotyped transactions. (Readers of Health Care Renewal have seen why the EMR may not be as much of a panacea as its promoters proclaim.) But selling more EMR systems may increase the demand for Intel's chips.
I have no objection to inter-disciplinary work. And health care can obviously benefit from insights from other fields. But why are we in health care constantly berated by people based on bearing such bad analogies as those proposed by Grove?

Allegations of Conflicts of Interest at JCAHO

The Washington Post has been running a series on Medicare. One particularly significant article was on how Medicare has farmed out most evaluation of health care quality to the Joint Commission on the Accreditation of Health Care Organizations (JCAHO), pursuant to language in the original 1965 legislation that set up Medicare. Also, many states have closed down their inspections of health care facilities, and rely on JCAHO accreditation. For example, "Maryland regulators used to conduct their own hospital inspections until a wave of deregulation swept the state in the 1980s and state legislators agreed to accept joint commission accreditation for licensing purposes. According to Carol Benner, director of the state Office of Health Care Quality, Maryland 'had no authority' over the joint commission: 'We couldn't tell them what to look for in their surveys, and they didn't consult us.'"
Yet the article stated, "the joint commission's practices raise questions about potential conflicts of interest and the rigor of its hospital surveys." The article charged:
  • There have been "glaring examples" of JCAHO missing important quality problems, notably at Redding Medical Center (California), Maryland General Hospital, Norwalk Hospital (Connecticut), and Palm Beach Gardens Medical Center (Florida).
  • "The board of directors of the joint commission is dominated by representatives of the American Hospital Association and the American Medical Association." [The listing of the current Board of Commissioners is here. The listing does not appear to have many people with overt associations with the AHA and AMA. The web-site describes the Board as having "diverse experience in health care, business and public policy. The board consists of 29 individuals, including physicians, administrators, nurses, employers, a labor representative, health plan leaders, quality experts, ethicists, a former health insurance executive, a consumer advocate and educators."]
  • "About 99 percent of the hospitals reviewed by the joint commission win accreditation...." "Some critics point to the approval rate as evidence that the joint commission is captive to hospitals."
  • JCAHO sells hospitals "We Are Accredited" products, e.g. "banners, coffee mugs and enamel pins."
  • JCAHO has a "subsidiary, Joint Commission Resources, [which] was established in the 1990s to consult with hospitals on how to gain accrediation and improve their performance." "Directly or indirectly, most of JCR's nearly $33 million in revenue comes from helping hospitals win the joint commission's seal of approval." JCR CEO Karen H. Timmons "said that there is a firewall between the subsidiary and the joint commission...." However, there are substantial money flows between the groups. "In the past three years, JCR has paid its parent about $10.5 million in management fees and $867,000 in royalties. And according to its 2003 tax return, JCR owes the joint commission nearly $8.4 million."
In my humble opinion, if the main function of JCAHO is for hospitals and other health care facilities as a group to improve their own health care quality, that would be admirable, and the practices above would not constitute problems, for the most part. However, if the federal and state governments have out-sourced quality control to JCAHO, the questions about conflict of interest raised by the Post become very serious.

"Buffeted Biovail"

I noticed this one on my trip to Canada last week.... From the Globe and Mail, a story about the ongoing travails of Biovail, a large Canadian drug-maker best known as the manufacturer of Wellbutrin. The article described how the company's largest shareholder, Eugene Melnyk, is promoting a buy-out to take the company private, prompted in part after the company "became a pariah when regulatory probes, governance issues and operating profits drove the stock price down." But, "Mr. Melnyk has attracted controversy at Bioval because of his compensation and governance practices." "In 2001, he earned $122-million, making him the most handsomely paid CEO in the country, and in one three-year stretch he pocketed $226-million by cashing in stock options." In addition, "the U.S. Securities and Exchange Commission announced recently that it was expanding its 18-month investigation into the company's accounting practices.... The Ontario Securities Commission is probing four instances of probable insider trading involving Biovail, along with whether a company press release about a trucking accident in the fall of 2003 contained 'misleading statements.'" The press release apparently arose after the company issued a profit warning due to an accident in which a single tractor-trailer truck whose load included Wellbutrin XL got in an accident outside Chicago. The company valued its cargo between $10 and $20 million.
This is just a reminder that management and leadership issues are hardly limited to US health care organizations.

Saturday, July 23, 2005

The New England Journal of Medicine on Guidant

In this week's New England Journal of Medicine, the indefatigable Robert Steinbrook has provided a nice summary of the Guidant case to date, complemented by some notable original reporting. (The link is here, but getting the full article requires a subscription. The full citation is: Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 2005; 353:221-224.)
Steinbrook summarized the events in the case, including how in 2002 Guidant discovered a fault in its implantable cardiac defibrillators (ICDs) that could cause them to short-circuit and fail; how Guidant re-designed the devices in 2003, but continued to ship devices prone to the fault; and only notified physicians and the public of the problem in 2005. (We have posted frequently on the Guidant case, most recently here.)
The problems with Guidant's ICDs first became evident to physicians after a young man with an ICD implanted for hypertrophic cardiomyopathy (pathologic excessive growth of the heart muscle) died in 2005 of a rapid heart rhythm that his ICD failed to stop. Steinbrook reported how his physicians at the Minneapolis Heart Institute investigated, searching the Manufacturer and User Facility Device Experience (MAUDE) data-based held by the US Food and Drug Administration (FDA). They found other reports of short-circuit induced failures of Guidant ICDs. Steinbrook quoted Dr. Barry Maron, director of the Hypertrophic Cardiomyopathy Center:
"We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, 'What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, 'Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, 'I think this is the biggest mistake you will ever make.' They said they didn't agree."
This appears to be a chillingly direct example of external threats to physicians' core values arising when the leaders of a large health care organization put the organization's short-term financial interests ahead of their ethical obligation to provide the information needed by doctors and patients to make good clinical decisions.
Steinbrook concluded, "For more than three years, Guidant kept quiet about the serious malfunctions of some of its ICDs and continued to sell defective devices after it made manufacturing changes to fix the defects. The company will have to regain the trust of patients and physicians."
The New England Journal and Robert Steinbrook deserve commendation for treating this story as one of broad significance. This article stands in sharp contrast to the kid-glove treatment given the Guidant's Chief Executive Officer Robert W. Dollens during his interview by a senior editor of Health Affairs (see our post here). The interviewer never acknowledged either that Guidant had manufactured ICDs that were prone to fail, that they had knowingly shipped such ICDs from stock after beginning re-designed models that corrected the fault, or that Guidant had concealed these facts from physicians and the public for three years. The Health Affairs interview seemed to be an example of the "anechoic effect," how stories about threats to physicians' core values arising from concentration and abuse of power produce no echoes outside of the local news media. The New England Journal and Dr. Robert Steinbrook have dealt the anechoic effect a mighty blow.
[In other news about Guidant's troubles, also note that the New York Times has just reported that Senator Charles E. Grassley, Chair of the Senate Finance Committee, may have his committee review the recent Guidant recalls; and the Times also reported that Guidant's recommendations for correcting problems with some of its ICDs by reprogramming them might not prevent the devices from failing, and that Guidant has yet to come up with an alternative solution, other than removing and replacing these devices.]

Friday, July 22, 2005

EMR's are coming...perhaps not so fast

I agree with Egan that EMR's have the potential to be abused. The disquieting metaphor of clinicians becoming "glorified data entry personnel for third parties (to a greater extent than we already are)" is a distinct possibility unless clinicians take charge of the tools of their own profession.

On the other hand, to throw a monkeywrench into the beliefs of the optimists, there's this:

J. Am Med Inform Assoc. 2005 May 19; [Epub ahead of print]

The Impact of Electronic Health Records on Time Efficiency of Physicians and Nurses: A Systematic Review.
Poissant L, Pereira J, Tamblyn R, Kawasumi Y.
Clinical and Health Informatics, McGill University, Montreal, Canada.

A systematic review of the literature was performed to examine the impact of electronic health records (EHR) on documentation time of physicians and nurses and to identify factors that may explain efficiency differences across studies. In total, 23 papers met our inclusion criteria; five were RCTs, six were posttest-control studies and twelve were one group pretest-posttest designs.

... Studies that conducted their evaluation process relatively soon after implementation of the EHR tended to demonstrate a reduction in documentation time in comparison to the increases observed with those that had a longer time period between implementation and the evaluation process.

This review highlighted that a goal of decreased documentation time in an EHR project is not likely to be realized. It also identified how the selection of bedside or central station desktop EHRs may influence documentation time for the two main user groups, physicians and nurses.

PMID: 15905487

Ten year timeline to national EMR's in the U.S.? I recall that same timeline being championed - when I attended the AMIA conference (then known as SCAMC) for the first time in 1991.

-- SS

Thursday, July 21, 2005

EMRs are coming, EMRs are coming

Here is my response to an article by Ken Karpay in the periodical, Physicians Practice (July/August): The article's thrust is fairly obvious from the title: that electronic medical records are on the way, in a big way, whether physicians resist or not, but with potentially great benefits to us, blah, blah, blah...


EHRs are coming – Like it or Not

Dear Ken,

I recently read your ‘Politics and Your Practice’ column for July/August of Physicians Practice. I too believe we have reached a ‘tipping point’ in the migration toward EMR in medical practice; politics surely has proved to be the critical force in the impending turning point. In general, I agree with the main thrust of your article. As a physician and medical informatician in Rochester, New York who has both developed and used EMR technology in an Internal Medicine practice I can attest to both the pitfalls and benefits in this space.

I would expound on one point you made in the article: “…you will have something you’ve never had before: hard data about your practice.” Control of one’s data is the critical point here. Many central entities around the nation (Regional Health Information Organizations, or RHIOs, for example) are forming in an effort to entice/push (depending on your perspective) physicians toward EMR adoption. These efforts often entail centralizing data (e.g. lab data) in a community; in some areas of the nation the efforts are quit evolved—e.g. offering an ASP (application service provider) model to deliver EMR technology from a central source. The central stores of data in these initiatives will have the potential to NOT be in the control of individual practitioners. This potentially could serve as yet another means to micro-manage physicians’ practices. And if you think current “report cards” often produced by IPAs today are detailed just wait until the highly granular data from an EMR makes it to a centralized data repository. Third parties will have unprecedented access to very detailed information regarding practice operations.

I implore physicians and other providers to educate themselves about health information technologies. We all must ensure that we have first access to the data we collect; that we retain a high degree of control over these data. The risk is that we become glorified data entry personnel for third parties (to a greater extent than we already are) and hence, actually diminish our already slipping grip on practicing medicine. I am a big advocate of information technology. However, if physicians approach EMR adoption passively (or passively aggressively) they risk getting run over by this horse that is clearly out of the barn.

Egan F. Allen, MD

Internist and Health Information Technology consultant

Pittsford, New York

Wednesday, July 20, 2005

Suddenly Sick

At this site, the blog's readers will find a fascinating series by some truly intrepid Seattle Times reporters, on a topic near and dear. Namely, big business manipulating doctors. But there's a subtle twist here which, to whatever extent it holds water, gives a real frisson. How does marketing impact the way we actually make diagnoses? Download this, while it's free (as a PDF, about 6 MB), and decide for yourself.

Neutralizing doctors

In my avocation ham radio, the term "neutralize" refers to applying capacitive or inductive feedback in an amplifier, often a high-power radio transmitting amplifier. The purpose of the neutralization is to prevent unwanted, out-of-control waverings and oscillations that can cause interference with the business of radio operation, or damage the critical and potentially saleable assets of the ham radio operator, i.e., the amplifier itself.

In pharmaceutical marketing to clinicians, however, "neutralization" means providing education, according to the press report below.

Next time your drug rep appears in your office, ask them if you are being neutralized, and if being neutralized carries CME credit.

Merck executive testifies in nation's first Vioxx trial

By KRISTEN HAYS / Associated Press

Merck & Co.'s marketing team targeted doctors viewed as unfriendly toward Vioxx to bring them into the fold, neutralize or discredit them, the plaintiff's lawyer in the nation's first Vioxx-related lawsuit to go to trial alleged Tuesday.

Houston litigator Mark Lanier questioned Nancy Santanello, head of Merck's epidemiology department, about an internal list of 36 doctors identified as "physicians to neutralize" in an e-mail circulated two months after the popular painkiller went on the market in 1999.

"Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics. You will notice that some have already been 'neutralized,'" the e-mail said. It also said a previous e-mail had a subset of the 36 physicians "we would like to get involved in Merck clinical research" and that the e-mail's recipient should "be aware of our most challenging (and also most vocal) national and regional physicians."

Santanello said the term "neutralize" was a marketing strategy to educate doctors about Vioxx.

On another note, some press releases such as this one review issues in FDA warning letters that had been received. For example:

... among those [warning letters] was a letter Merck received in September 2001 — two years after Vioxx was introduced to the market with much fanfare — about Vioxx marketing in the aftermath of a 2000 study dubbed VIGOR. The study found some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen, sold under the brand name Aleve.

"The [FDA] letter said Merck was engaged in a promotional campaign for Vioxx "that minimizes the potentially serious cardiovascular findings" observed in the 2000 study, and "misrepresents the safety profile for Vioxx."

The letter also said that Merck's campaign discounted the fact that patients on Vioxx "were observed to have a four to five fold increase in myocardial infarctions (MIs)," or heart attacks, compared to patients taking naproxen.

The FDA also challenged Merck's attribution of the disparity to naproxen's cardioprotective qualities, not a defect in Vioxx.

"That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence and there is another reasonable explanation, that Vioxx may have pro-thrombotic properties," or the ability to cause blood clots, the letter said. "

Company representatives have repeatedly opined that non-clinical trial data such as from retrospective review is invalid, since it is not based on the gold standard of randomized clinical trials. For example:

... an FDA analysis of a Kaiser Permanente database reportedly showing that 27,785 heart attacks and sudden cardiac deaths might have occurred, and might have been avoided if Celebrex were used instead of VIOXX, was reported by the Wall Street Journal. This conclusion is controversial, however. In an interview in the Boston Globe, Merck CEO Raymond Gilmartin refutes the study's findings because it was based on a review of medical records, not a clinical trial. "You can't take a study like this and take a patient population and extrapolate those kinds of numbers," he said. "It's just not valid to do that."

Yet, the explanation proposed for cardiovascular observations about VIOXX compared to Naproxen - that Naproxen protects the heart - "has not been demonstrated by substantial evidence" and is hypothetical, according to the FDA.

Contradiction alert. It seems it's not quite valid to make hypothetical, unsubstantiated assumptions about pharmacology and drug effects. To do so seems a significantly greater leap of faith compared to making inferences from retrospective review of actual medical data -- such as non-clinical trial data from HMO claims or from an EMR. But what do I know. I'm just a physician-Medical Informatics specialist (who pushed hard to improve provision of scientific information to Merck's research lab scientists), who then got "neutralized" by the non-medical former computer executive who presided over biomedical information provision to the labs. This occurred as part of the non-VIOXX related 4,400 layoffs in Nov. 2003.

-- SS

Monday, July 18, 2005

Now It's Guidant's Pacemakers that Spring Leaks

From the New York Times, another story about faulty products from Guidant. The company just announced that the "hermetic sealing component" in a variety of its older pacemaker models "may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case," leading to failure. 28,000 pacemakers still implanted out of 78,000 manufactured in the Pulsar, Pulsar Max, Discovery, Meridian, Virtus Plus II, Intellis II and Contak model lines are affected.
Guidant's CEO Robert W. Dollens stated "the health and safety of our patients is paramount. Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients."
Guidant has previously reported several problems with its implantable cardiac defibrillators (see our posts here and here.) In addition, as detailed in the links in the latter post, Guidant withheld information about some of these problems from physicians and the public, and continued to sell older versions of the devices from inventory that included a known design flaw even after it had started manufacturing improved versions that were not flawed. Guidant's CEO and other executives have been sued for securities fraud for concealing these problems while the company was in merger negoations (see this post).
Guidant seems to represent the many troubled organizations which collectively are an important cause of health care dysfunction, but one rarely discussed outside of Health Care Renewal. (We had noted how a recent long interview with Guidant's CEO Dollens in Health Affairs barely touched on any of these issues.)

Where Does the Money Go? - From New York State Medicaid, Nearly Everywhere

The New York Times just published the results of a massive investigative reporting effort documenting amazing levels of Medicaid mis-spending in the state, amounting to billions of dollars.
New York's state Medicaid program, started in 1966 under Governor Nelson Rockefeller, has become the most expensive in the US, spending $44.5 billion annually. Yet the Times reported that it is "so lightly policed that it is easily exploited." The retired chief state investigator of Medicaid fraud estimated that 10% of that amount goes to fraud, and another 20-30% to abusive, if not frankly illegal spending.
Examples the Times noted spanned a large spectrum. They did include a Russian-trained physician who prescribed $11.5 million worth of the drug Serostim in one year, much of which may have been diverted to the black market for body-builders. However, some of the less usual suspects included:
  • A dentist who once billed for 991 procedures in a single day, and who, with an associate, billed Medicaid for more than $5 million a year. After the Times told the Medicaid Fraud Control Unit about this case, the two dentists were indicted for grand larceny.
  • Ambulette services that often billed for more than 100 rides a year for a single individual, or billed for rides for fully mobile patients. Very few of these services have even been audited by Medicaid.
  • Multiple public school systems which can bill Medicaid for services such as speech therapy for their students. Medicaid paid $1.2 billion to public schools for speech therapy over eight years. The Times reported how school officials literally rubber-stamped documents stating that thousands of students needed such therapy, without evaluating more than a fraction of them. 86% of claims from New York City schools were unsupported by any explanation of the need for services. However, the US Justice Department suspended its inquiry into this matter after complaints from politicians like Senator Charles Schumer (Democrat - New York).
  • Executives and owners of nursing homes. Nursing homes in NY get more than two-thirds of their revenue from Medicaid. 70 nursing home executives made more than $500,000 in 2002, and 25 made more than $1 million. New York nursing homes have at times been known for their poor care, according to the Times, and have lower than average staffing levels.
This story is a telling illustration of how health care dollars can be siphoned off in multiple directions. Health care practitioners, unfortunately, must share a good chunk of the responsibility, but a variety of other people and organizations clearly account for a major part of the problem. What is most striking is how this particular government "single payer" system seemed so oblivious to where its money was going.

Celebrities More Often Pitching "Disease Awareness"

The Associated Press reported on the increasing frequency of "disease awareness" advertising featuring celebrities. Examples included Cheryl Ladd talking about menopausal symptoms (for Wyeth, makers of Prempro and Premarin), and Lance Armstrong talking about cancer (for Bristol-Myers-Squibb, makers of various chemotherapeutic agents). Important older examples include Dorothy Hamill and Bruce Jenner talking about arthritis (for Merck, maker of Vioxx, now off the market) and, of course, Bob Dole talking about erectile dysfunction (for Pfizer, maker of Viagra). The article suggests that pharmaceutical companies will be increasingly turning to disease awareness campaigns, since such advertisements do not necessarily mention specific drugs, and hence do not have to discuss adverse effects.
The article noted that celebrities may make from $200,000 to $1 million for such advertisements, and that their work is facilitated by several agencies that specialize in connecting them to health care companies.
I was surprised that Thomas Abrams, head of the US Food and Drug Administration (FDA) division of marketing, advertising, and communication, endorsed such advertisements, "we think disease awareness commercials are very beneficial. There's a number of diseases in the United States ... which can have devastating effects of they go untreated." Based on the examples above, it appears his definition of "devastating effects" may be a bit broad.
Again, it appears that some pharmaceutical companies are eager to entice patients with emotional appeals made by popular public figures skilled in communicating, but hardly expert in medicine. There won't be any extra support, however, for physicians who will have to balance their patients' new "disease awareness" with the risks and costs of the drug manufacturers' latest products.

Sunday, July 17, 2005

Connecticut Medicaid HMOs Keep Their Physician Payments Secret

The Hartford Courant reported how Connecticut Medicaid HMOs have tried to keep what they pay doctors secret. The story started when a group of clinics in New Haven found their patients were having trouble getting appointments with cardiologists and gastroenterologists. They wondered if low rates of reimbursement of these services by the patients Medicaid HMOs were deterring doctors from seeing them. But when the clinic doctors asked the state's Department of Social Services (DSS), which administers the state Medicaid progam, what its HMO contractors paid for sub-specialty services, the Department refused. The clinics' attempt to force the state to reveal these rates using the state Freedom of Information Act is pending. The state attorney general said, "as a matter of policy, I disagree with the DSS position." The article noted that "lawyers for the HMOS - Community Health Network of Connecticut, Health Net of Connecticut, FirstChoice Health Plans of Connecticut and WellCare of Connecticut, decline to comment for this story, but referred a reporter to legal papers filed with the Freedom of Information Commission. In the papers, the HMOs claim that disclosing the amount they pay doctors would reveal commercial secrets."
There they go again. The biggest secrets in health care these days, it seems, are what some organizations charge or pay for specific services. (See our post here about how hospitals keep their "list prices" secret.)
This secrecy seems to contradict claims made by some of the HMOs, for example, that "our members are very important to us, (by Community Health Networks of Connecticut), or to "be responsible for the commitments we make and the results we deliver," by (WellCare, in its statement of values.)
Prices paid for physicians services hardly seem like trade secrets like Coca-Cola's secret syrup formula. So inquiring minds want to know what it is about these prices that the HMOs so strongly want to keep secret.

Rhode Island Blue Cross Settles Class-Action Lawsuit

Our own Rhode Island Blue Cross just settled a class-action lawsuit, according to the Providence Journal. The plaintiffs had claimed that Blue Cross collected inflated inflated co-payments for drugs by charging patients a percentage of the list price, while the company actually was only charged a discounted price. The example given in the article was someone "might, for example, get $100 in perscriptions ... and end up paying $20, based on a 20-percent copayment, while Blue Cross would secure discounts and pay just $40 for that medication." Although Blue Cross did not admit wrongdoing, the settlement would prevent it from basing co-payments on inflated list prices in the future.
Blue Cross was not exactly forthcoming in this matter. The plaintiff's lawyer described its defense of this lawsuit up to the time it was settled as "trench warfare."
This is, of course, yet another example of a insurance company/ managed care organization "bilking subscribers," to use the article's words. More importantly, it also appears to be an example of how mismanaged health care organizations end up hurting the patients they are supposed to serve. At the time Blue Cross was inflating patients' copayments, it was lead by a CEO who turned out to have an equally inflated salary, received an interest free loan from Blue Cross to help finance a lavish new house, and be getting free treatments from a local acupuncturist who hoped to get the company to start paying for his services (see our post here). In addition, Blue Cross is currently being investigated after a state legislative leader revealed they he accepted money from the company to promote its legislative agenda (see our post here).

Thursday, July 14, 2005

NIH Report Revealed "Ethical Problems Are More Systemic and Severe Than Previously Known"

The Los Angeles Times reported that an internal review conducted by the National Institutes of Health showed that 44 of 81 scientists investigated violated the then current NIH policies on conflicts of interest. NIH Director Elias Zerhouni wrote to senior members of the House Energy and Commerce Committee that "we discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of the NIH as an affiliation."
Rep. Joe Barton (R-Texas) said that the "ethical problems [at the NIH] are more systemic and severe than previously known."
The 44 people found in this effort may be but a fraction of NIH employees and officials who had conflicts of interest. The LA Times referred to "industry consulting deals that involved hundreds of agency scientists." However, the NIH would not provide Congress with documentation of the extent of this problem. The 81 identified for the current review were derived from responses from 20 companies to letters sent by the Congressional committee inquiring about NIH employees who had consulted for them. Many other companies were not contacted.
Also keep in mind that the policies the individuals mentioned above violated had already been substantially relaxed in the 1990's from the previously stringent rules. Furthermore, individuals previously identified by LA Times investigative reporters as having major conflicts of interests included not just rank-and-file scientists, but leaders of NIH laboratories and divisions. (See the LA Times summary article from December, 2004 here, and this Health Care Renewal post, which recounts how Director Zerhouni concluded that the NIH had a systemic problem, and refers to many previous posts on the subject.)
One can only hope that Director Zerhouni stands firm against those who are still protesting his new, more rigorous conflict of interest rules (See relevant posts here, here, and here). Too much damage already has been done to this once proud institution.

A "Tune-Up" from Nesiritide?

Here is another story about a pharmaceutical company appearing to go well beyond the evidence in its promotion of a new, expensive drug.
This week's New England Journal of Medicine features a Perspectives article on the marketing of nesiritide, sold as Natrecor by the Scios division of Johnson & Johnson. (Topol EJ. Nesritide - not verified. N Engl J Med 2005; 352: 113). Also, an article about the marketing of the drug appeared in the Boston Globe.
The main points made by Topol were:
  • Two randomized controlled trials of nesiritide showed that it lead to short-term improvement in the pulmonary capillary wedge pressure (PCWP) of patients with acute decompensation of congestive heart failure (CHF). PCWP assesses the degree of lung congestion. One trial also showed some short-term symptom improvement.
  • Both trials showed increases in 30-day mortality of patients treated with nesiritide, although these increases did not achieve statistical significance, i.e., could have been due to chance alone. However, the trials were to small to prove that nesritide did not lead to a higher risk of death.
  • Patients who received nesiritide also had a higher rate of kidney problems, but again, this could have been due to chance.
  • No trial demonstrated any long-term improvement in any clinically important outcome due to nesiritide.
  • There have been no controlled trials of nesiritide used for prolonged periods of time, or in out-patient settings.
  • Nonetheless, previous news reports, and the new Boston Globe article showed that Scios has been encouraging physicians to open "infusion centers" to administer nesiritide to outpatients over weeks or months, as a "tune-up." Each dose of nesiritide in this setting costs about $500. The company set up a telephone hotline to help physicians get reimbursement for this service, and published a "Natrecor Reimbursement and Billing Guide," that shows how physicians can collect professional fees for outpatient nesiritide administration. The Globe quoted Dr. Steve Nissen from the Cleveland Clinic, "my moral compass went off when I saw this. It felt like the company was promoting the use of a drug to profit physicians, rather than to benefit patients." However, Mark Wolfe, a Johnson & Johnson spokesman, said "Scios does not promote Natrecor for regular, scheduled outpatient infusions."
Topol concluded, "in my view, nesiritide has not yet met the minimal criteria for safety and efficacy." So, "we need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety."

Wednesday, July 13, 2005

Medicare Overpaid for Chiropractic

The Washington Post reported that the Inspector General of the US Department of Health and Human Services concluded that Medicare overpaid chiropractors about $285 million in 2001, about two-thirds of the total paid that year for chiropractic services. Most of the excess payments went for "maintenance treatments," periodic manipulation of the spine in absence of specific symptoms, which Medicare currently considers ineffective. The American Chiropractic Association claimed, however, that the issue was really "a universal problem in physician documentation."
This apparently will not discourage the Center for Medicare and Medicaid Services (CMS) from starting a pilot program to increase coverage of chiropractic care. According to the Mark McClellan, CMS administrator, the program is meant "to evaluate whether expanding coverage of chiropractic services reduces overall Medicare expenditures for neuromusculoskeletal conditions." The article did not mention whether it was also meant to improve patients' health outcomes.
Of course, I haven't heard about any CMS pilot programs to pay more for physicians' services for primary care, yet, as we have documented, their reimbursement has failed to keep up with rising overhead expenses.
Again, this is a reminder that most cost-cutting efforts by federal payers and managed care organizations seem to have been directed to across-the-board cuts of reimbursement for general primary care and acute care services, while the prices of some "complementary and alternative medicine" (like chiropractic), on one hand, and some "high technology," like BilDil and Thalidomid, go unchallenged.

WellPoint Settles RICO Law Suit

As reported in the Los Angeles Times (and elsewhere), WellPoint has recently agreed to settle its role in a class-action lawsuit brought by California physicians under the RICO (Racketeer Influenced and Corrupt Organizations) standard. WellPoint will pay about $198 million, including $135 million in damages to physicians, $5 million to set up a foundation to improve medical practices, and up to $58 million in attorney's fees. WellPoint, lead by Chief Executive Officer Larry C. Glasscock (2005 total compensation according to Forbes, $24, 970,000), is the largest health care insurer in the US.
The suit charged that WellPoint systematically denied and under-payed physicians' claims. According to the Times, "it includes a ban on WellPoint's alleged use of computer programs to systematically deny and underpay purportedly legitimate claims." (Ah, the uses of health care information technology....) Glasscock commented, "we see this agreement as a very important step in further collaborating with physicians."
The class-action suit originally targeted ten insurance companies/ managed care organizations. Those that have already settled included Aetna, Health Net Inc., Prudential Financial Inc., and Cigna Corp. Those that have not settled so far include UnitedHealthGroup and Pacificare, which just merged. (See post here.)
Juxtaposed with our previous two posts, it appears that some managed care companies vigorously tried to control costs by across the board cuts of payments to physicians, while they seemed to ignore the high prices charged for supposedly "high tech" drugs and devices. But why?

Oh, The Prices We Pay: Thalidomide for Cancer

The New York Times recently reported on the high prices paid for drugs to treat cancer, notably the newer "targeted therapies." Some examples included:
  • $54,000 per year for Avastatin, made by Genentech,
  • $31,000 per year for Terceva, made by Genentech, and
  • $25,000 for Thalidomid, made by Celgene.
The article shows how the prices of these drugs drastically ratcheted upwards in the 1990's, starting with Taxol, made by Bristol-Myers-Squibb, at $4,000 per year, starting in 1992, through Herceptin, made by Genentech, at $20,000 per year, in 1998, to Erbitux, at $100,000 per year, made by Bristol and ImClone Systems.
The article stated that these prices are unrelated to manufacturing costs, and simply based on what the market will bear. A biotechnology analyst, Geoffrey Porges, said, "it's sort of one of those things where everyone looks over their shoulder at everyone else, says, 'he started it, it wasn't me,' and it builds."
Of course, this raises the question of why those organizations whose goal is to control health care costs, particularly federal payers represented by the Commission for Medicare and Medicaid Services (CMS), and managed care organizations haven't been able to address this price inflation.
A notable example is Thalidomid, whose price is listed above. Thalidomid is thalidomide, a drug whose adverse effects in the 1960's lead to major reform of the US drug approval process. (For a background article on the history of thalidomide go here: Rouhi M. Thalidomide. Chemical and Engineering News, June 20, 2005. ) "Chemie Grünenthal introduced thalidomide--under the brand name Contergan--to the German market on Oct. 1, 1957, as a sedative to treat insomnia as well as to reduce nausea associated with pregnancy." Richardson-Merrell had applied to introduce thalidomide, under the trade name Kevadon, to the US in 1960, but the application was held up by a diligent officer of the US Food and Drug Administration, because of inadequate documentation of drug safety. The drug never made it to the US market, because by 1961, there were widespread reports in Europe of babies born with severe deformities to mothers who had taken thalidomide. (For more background on the history of thalidomide, see the materials from the NIH here, and from the March of Dimes here.) Later, discoveries that thalidomide had anti-inflammatory properties lead to studies of its use in several severe diseases, including multiple myeloma.
Now, what can the possible rationale for charging $25,000 per year for the nearly 50 year old drug thalidomide for multiple myeloma, other than it is considered a new "targeted therapy?" The drug is a relatively simple molecule first sold, again firs sold almost 50 years ago. Its manufacture does not involve high technology. Celgene raised the price of thalidomide from $6.00 to $29.00 per 50 mg capsule from 1998 to 2004. The price of a 100 mg capsule in Brazil is $0.07.
So thalidomide becomes another poster child, not only for the production of serious birth defects that lead to reform of the drug approval process 40 years ago, but also for how those organizations who claim to control health care costs are willing to pay amazingly high prices for "high tech" health care interventions, even if they are just re-named low-tech interventions from the last century.

Tuesday, July 12, 2005

BilDil: Discrepancies and Contradictions

The BilDil saga has now gotten complex enough to merit comment on Health Care Renewal.
For some commentary on the background, see the Perspectives article in the recent New England Journal of Medicine (Bloche MG. Race-based therapeutics. N Engl J Med 2004; 351: 20). The first major study to show the benefits of what was then called vasodilator therapy was the VHeFT study, published in 1986. (Cohn JN et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure. N Engl J Med 1986; 314: 1547). This study showed that the combination of the isosorbide dinitrate, a long-acting nitrate used to treat the symptoms of coronary artery disease, and hydralazine, a vasodilator used to treat hypertension, prolonged average survival in a group of patients with congestive heart failure. A later study, however, showed that an angiotensin converting enzyme (ACE) inhibitor drug, was superior in prolonging survival in a population of patients that included about 27% black patients. (Cohn JN et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of congestive heart failure. N Engl J Med 1991; 325: 303). The combination of hydralazine - isosorbide dinitrate then fell out of favor except for patients who could not tolerate ACE inhibitors.
As Bloche discussed, based on a theory that hydralazine - isosorbide dinitrate might work better in African-Amercian patients, a "biotechnology" firm called NitroMed obtained intellectual property rights to a fixed combination of these two by now quite old (and easily available generically) drugs in 1996. In 1999, the company obtained additional intellectual property rights to this fixed combination as a treatment for heart failure for African-Americans. Last year, a trial funded by the company, which recruited only patients who self-identified as "black," showed that the fixed combination of the two old drugs was superior to placebo in prolonging survival for patients already taking the current conventional therapy for heart failure (that now usually includes an ACE inhibitor or an angiotensin receptor blocker [ARB]). (Taylor AL et al. Combindation of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049).
Most recently, the New York Times reported that NitroMed has set the price of BilDil, the fixed combination of 37.5 mg of hydralazine and 20 mg of isosorbide dinitrate, at $1.80 per pill. Most patients would take one or two pills three times a day, for a daily cost of $5.40 to $10.80. In contrast, similar treatment with generic hydralazine and generic isosorbide dinitrate would cost approximately $1.50 to $3.00 a day.
Finally, Newsday noted that the official label for BilDil does not carry as major a warning about the risks of developing systemic lupus erthymatosus as does the label for generic hydralazine. Development of lupus has been a well-known possible adverse effect of hydralazine since before I went to medical school. The label for generic hydralazine suggests testing patients on the drug for lupus every six months, but the label for BilDil makes no such suggestion.
So here are the discrepancies and contradictions that this all brings up:
  • NitroMed patented a new "drug" BilDil, but it was simply a combination of two old drugs that were long off patent. NitroMed touts its "nitric oxide technology" on its web-site, but again, at the moment this only seems to consist of a fixed combination of two drugs from 30+ years ago.
  • NitroMed got the US Food and Drug Administration (FDA) to approve a trial limited to only a single racial/ethnic group, but the US National Institutes of Health (NIH) has for years required clinical trials to include a broad selection of under-represented minorities (i.e., groups other than African-Americans), and prohibited exclusion of such groups unless there is a clear reason to do so. (See the policy here.) If NitroMed had included patients who were diverse in terms of race/ ethnicity, it might have been possible to see if hydralazine - isosorbide dinitrate actually works differently in patients with differing race/ ethnicities. But allowing only "black" patients in the trial prevented drawing any conclusions about whether the drug would work better, similarly, or not as well in, for example, Asian-Americans, Latinos, American Indians, and whites. Bloche suggestion that "market and regulatory incentives shape research agendas" seems relevant here.
  • NitroMed is marketing its brand-name fixed combination drug for $1.80/pill, but a cheaper generic equivalent (requiring, admittedly, the patient to take twice as many pills, but no more often a day) costs less than $0.50. The New York Times article noted that "NitroMed has aggressively solicited the support of black physicians and politicians in promoting BilDil."
  • The FDA suggests patients taking generic hydralazine should be tested periodically for lupus, but does not suggest those taking BilDil (which contains hydralazine) should be so tested.
In summary, this seems to be a story of how "market and regulatory incentives," and perhaps also some political incentives, may shape research and clinical care in confusing and contradictory ways, maybe not always in ways that primarily benefit patients of all races.

Saturday, July 09, 2005

There He Goes Again: UnitedHealth's CEO on the Pacificare Merger and the State of Health Care

UnitedHealth Group has acquired Pacificare in a $8.1 billion dollar deal, as reported here by the Los Angeles Time. United is already the second largest health care insurer/ managed care organization in the US. Even Alain Enthoven, a charter member of the Jackson Hole group, and long-time advocate of managed competition, was not enthused. "I don't see this as beneficial to California consumers or employers," he said. "I regard this as a loss and doubt there are any economies of scale to be achieved here."
United Chief Executive Officer William W. McGuire MD, on the other hand, called the merger "compelling, straightforward and powerful" and said it will advance "a national presence that can help address a highly fragmented healthcare system."
Later, the Times reported McGuire justified the merger by saying, "There is not enough money … to pay for the healthcare system as it operates today. It is indiscriminate, it is non-scientifically based, it is founded on anecdote as much as it is science. We have to change course."
I actually agree with him here. But the Times also noted that the deal will result in Phanstiel profiting to the tune of about $190 million from transactions involving stock options, restricted stock shares, and other equities. And we earlier posted that McGuire's total compensation was reported to be over $124 million (here). So claims that this merger was motivated by a desire to cut the total costs of health care ring a little hollow. Maybe there would be a little more money to pay for actually providing health care if the CEO's of managed care organizations (and other big health care organizations) were not making such immense amounts.
I agree with McGuire that much of health care is "indiscriminate," "non-scientifically based," and "founded on anecdote." But what has United, the second largest health insurer in the country, done to remedy these problems. How much does United spend on scientific research? Or on teaching physicians evidence-based medicine?
We may often criticize the pharmaceutical industry, but at least they actually pay billions for research, some of which is of good quality, and some of which leads to products that actually improve health.

Friday, July 08, 2005

"Pharma Goes to the Laundry"

And nobody is left feeling clean....
Thanks for Sue Pelletier's blog Capsules for discovering an article written in 2004 entitled "Pharma Goes to the Laundry." (Full citation: Elliott C. Pharma goes to the laundry: public relations and the business of medical education. Hastings Center Rep 2004; 34: 18-23.) The article suggested that pharmaceutical companies "launder" their marketing message through medical education and/or communication companies to produce medical education or scholarly articles that appear to be independent and unbiased, and that these practices are much more frequent than even I previously thought.
In particular, Elliott, in turn, pointed out a 2003 article by David Healy (Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psych 2003; 183: 22-27) which took advantage of documents released during litigation from a medical communications company (Current Medical Directions) used by Pfizer to market sertaline (Zoloft). Healy and Cattell compared Current Medical Directions' log of the "scholarly" articles it wrote and PubMed searches. The results suggested that the majority of articles on sertaline from 1998-2000 were ghost-written by Current Medical Directions. If this data is generalizable, then the majority of apparently independent, scholarly articles in the medical literature related to the use of pharmaceuticals may have been ghost-written. Yikes!
Elliott also summarized how Wyeth allegedly marketed Fen-Phen via a "medical education" campaign designed to convince physicians that obesity was causing a "public health crisis," a few strategically placed articles ghost-written by Excerpta Medica, and an additional $100 million campaign to minimize the adverse effects of the drug (all derived from the book Dispensing with the Truth, by Alicia Mundy).
Finally, Elliott suggested that bioethicists have not helped, because "we forfeited any credibility we may have had when we started taking pharma money ourselves." As examples, he juxtaposed Healy's data about how Pfizer supported ghost-written articles about sertaline with the company's support for the Pfizer Hall for Medical Humanities at New York University Medical School, the Pfizer Lectureship in Medical Humanities at Royal Free and University College Medical School (in the UK), and the Center for Bioethics at the University of Pennsylvania. (And he noted that Hasting Center Reports are funded by Merck.)
More yikes! Read it, and read Sue Pelletier's post here.

Finally, An Ethical Framework for the Relationship Between Medical Schools and Teaching Hospitals

The excellent team of Frank A. Chervenak and Laurence B. McCullough have produced another pioneering article (unfortunately, available by subscription only. The full citation is Chervenak FA, McCullough LB. Responsibly managing the medical school - teaching hospital power relationship. Acad Med 2005; 80: 690.) They had previously written the first article to propose an ethical framework for the leaders of academic medical centers (see our post here.) The fact that this 2004 article was the first to ever discuss the need for such a framework was, of course, disturbing.
The new article is the first ever to propose an ethical framework for the relationship between medical schools and their teaching hospitals. From the introduction,
  • "Finances are an increasingly contentious aspect of the relationship between medical schools and their teaching hospitals. Joint budget negotiations can be shaped by incomplete information and sometimes even misinformation, failure to consider enhancements to other services, strategic procrastination and strategic ambiguity in the process and substance of the negotiations, unfunded mandates for matters vital to the hospital, such as quality, and attempts by each party to shift costs toward and reimbursements away from the other party. Both parties are under mounting and relentless fiscal pressure, creating an environment in which each party increasingly tends to focus on protecting its organizational self-interest, especially its bottom line. As a result, both parties are at risk of acting solely on self-interest, thus losing sight of and failing to be guided by their co-fiduciary responsibility for excelllence in patient care, education, and research. This could result in ethically unacceptable organizational cultures and practices that could adversely affect the parties' ability to fulfill that responsbility."
Sound familiar to those in medical education? Their solution first is transparency:
  • "Transparency means that both parties must be forthcoming about revenues, including collateral revenues, and actual and assigned costs."
  • "Sharing this information routinely will allow a factually based, informed allocation of revenues and costs as they relate to the mission of excellence in clinical care, education, and research."
  • "The justification of transparency in business ethics ultimately involves an appeal to rational self-interest in avoiding (mutual) exploitation in market exchanges."
Furthermore, the reason for transparency is not just based on business ethics:
  • "An explicit appeal to the medical ethical concept of co-fiduciary responsibility provides a crucial, additional basis for such responsible management, because fulfilling co-fiduciary responsibility makes transparency obligatory, not just a matter of rational self-interest."
The article is worth reading in its entirety. I only hope that a few leaders of medical schools and teaching hospitals will take it to heart.

Thursday, July 07, 2005

"Investigations Swirl Over Medical School's Finances"

Two recent New York Times articles outline a growing scandal at the University of Medicine and Dentistry of New Jersey, "the nation's largest health-care university." They refer to a story that has been reported thoroughly by the local New Jersey press, although most relevant articles are no longer available on the web.
The first article, entitled "Investigations Swirl over Medical School's Finances," documented the state-supported university's many questionable practices, including:
  • No-Bid Contracts, Often Resulting in No Documented Work - "It is not just that university officials handed out contracts to politically connected people without any competitive bidding. What is more astonishing is how pervasive the practice was, with more than $700 million in no-bid contracts awarded over five years, and that it appears that some of the contractors did no perceptible work in exchange for their payments." For example, a recent report still available from the Newark Star-Ledger noted that the school gave a $75,000 no-bid contract to Ronald White, a former top fund-raiser for former NJ Governor James E. McGeevey, but could provide no evidence he did any work for it: also, the school paid over $1 million over ten years to Chip Stapleton, a Republican consultant, to advise the university, but again the university cannot document that he did any work, either.
  • Hiring Lobbyists to Influence the State Government, and Making Political Contributions - "It is not just that the university hired influential lobbyists and consultants, ostensibly to promote its interests in Trenton - itself a rare step for a public university - but that it hired so many of them. The school, which receives more than $300 million a year from the state, went a step further in strengthening its political ties, giving campaign contributions to many elected officials, a nearly unheard-of practice whose legality has been questioned by some legislators." For example, the Star-Ledger noted that the school gave a $10,000 campaign contribution to a "breast cancer group" linked to Newark Councilwoman Gayle Chaneyfield-Jenkins.
  • Allowing Political Bosses to Make Decisions - "It is not just that university posts were handed to people with powerful political connections and potential conflicts of interest - though the extent of that practice was impressive. University officials and politicians alike say that political bosses actually dictated to the university who received what jobs, and who was shoved aside." For example, "Stephen N. Adubato Sr., a Newark power broker and president of the North Ward Educational and Cultural Center, has publicly taken credit for the ouster of Harvey Holzberg as university chairman. Stanley S. Bergen Jr., a former president of the university, and several other people tied to the institution and to state government, say that Mr. Adubato engineered the appointment of Mr. Petillo as chairman and then president - something that Mr. Adubato now vigorously denies. Last November, Mr. Petillo awarded a $95,000 no-bid contract to an organization run by Mr. Adubato."
This article also illustrates some pheonomena that are beginning to be familiar on Health Care Renewal:
  • Health Care Organizations Seem to Operate with Little Oversight or Accountability - "But lawmakers, watchdog groups and political scientists say the causes boil down to two basic factors: a relative lack of scrutiny at the university, and the unique political structure and culture of New Jersey."
  • The Anechoic Effect - "If people within government are not watching the doings of state agencies closely enough, the same may be true of those outside government." Furthermore, "But the newspapers in New York City and Philadelphia that are read by so many people in New Jersey have focused on the issue only occasionally, and the out-of-state television stations that dominate the state's airwaves have paid even less attention. And there may lie a reason the university long escaped scrutiny for practices that, in some cases, date back at least a decade."
If that weren't enough, another report by the NY Times noted that UMDNJ is now under investigation by the Inspector General for double-billing Medicaid, even though school officials were warned of the practice in 2001 by a law-firm that had been reviewing the university's billing practices, and in 2002 by the university's Chief Financial Officer (CFO) James Lawer, and by Adam Henick, a vice-president who was since dismissed by the university because he had "lost the confidence" of the top executives.
I should note that my first faculty position was at UMDNJ, at Cooper Hospital/ University Medical Center. I described how top executives swindled Cooper Hospital, a major teaching hospital in the UMDNJ system, of over $20 million in the 1990's (after I left - see the post here). I concluded my article in the RI state chapters ACP newsletter thus, "The case of Cooper’s corrupt executives can be viewed as the forerunner to the even more massive bankruptcy of AHERF. One can only speculate that learning the lessons of the Cooper
case could have mitigated the AHERF disaster. However, as noted in my last article, the lessons from AHERF are also not widely known. Yet, as George Santayana wrote, 'Those who cannot learn from history are doomed to repeat it.' " Replace AHERF with UMDNJ, and it works just as well.

Wednesday, July 06, 2005

Memorial Hermann Uses Rockets for Marketing

The Houston Chronicle reported how Memorial Hermann Healthcare System has reached a confidential agreement with the Houston Rockets, Comets, and Aeros to get more well-to-do patients. The article quoted the system's Chief Executive, Dan Wolterman, "we want to work with these fine organizations to increase our exposure to paying customers." A local "health care expert" noted, "people who go to Rockets games are rich. Those are corporate and season ticket-holders. They are older, they are well-heeled...."
The system will be the "official health care partner" of the teams, and will provide medical care to their athletes. How much the system will pay the team is confidential, although some local experts predicted it was worth more than $1 million.
The system's mission statement is: "Memorial Hermann Healthcare System is a not-for-profit, community-owned, health care system with spiritual values, dedicated to providing high quality health services in order to improve the health of the people in Southeast Texas."
But it looks like the system will go to some marketing lengths to get those "people in Southeast Texas" who are at least "paying customers," if not from "well-heeled" to "rich."

Boston University Back-Tracked on Conflict of Interest Guidelines

The Boston Globe reported how Boston University has back-tracked on its conflict of interest policy for its board of trustees. In April, 2004, the board approved new and more stringent guidelines, which barred financial relationships between trustees' companies and the university unless such a relationship "has been found to be of exceptional necessity to the university."
However, apparently the new guidelines were never implemented, and in December, the board enacted new relaxed guidelines that would allow such a relationship if it "has been found to be of clear benefit to the university." The new code of ethics resulting was only distributed to university staff last week.
In 2004, the chair of the board, Alan Leventhal, heralded the "very high standard" set by the "exceptional necessity" requirement. But the Globe reported that this week, Stephen Burgay, Vice President for Marketing and Communications, said that the board's audit committee found that the "exceptional necessity" requirement would be "unworkable."
The example given was that Boston University did $6 million in business with Lehman Brothers, while its Vice Chairman, Howard L. Clark Jr, was on the board.
Some trustees whose firms did business with the University have left, e.g., Gerald S. J. Cassidy, whose lobbying firm, Cassidy & Associates, got $1 million from Boston University last year.
However, Frederick H. Chicos, President and CEO of Chickering Group, which has been bought out by Aetna, is still on the board. Chickering is the only company allowed to provide health insurance to students. It received only $36,000 from the University last year. How much it got from University students for premiums is unknown. Also remaining on the board are executives for Barnes & Noble, and John Hancock Financial services, both of which did more than $1 million worth of business with the University.
One Boston University Professor commented that University officials' claimes that "they were trying to improve the public image and make people think they were cleaning up the place" were a "misrepresentation."
My comments are that allowing board members with such conflicts of interests makes it unclear whether they will put their companies' or the universities' interests first, and whether the university will put their companies' interests or its mission first.

Monday, July 04, 2005

Report Vindicates NIH Whistle-Blower, But Doesn't Prevent Him From Being Fired

The Associated Press reported on an internal National Institute of Health (NIH) study of charges made by whistle-blower Dr. Jonathan Fishbein about how the NIH Division of AIDS (DAIDS) ran a study in Uganda of the anti-retroviral drug nevarapine. The internal study reportedly stated, "it is clear DAIDS is a troubled organization," and that Fishbein's complaints were "clearly a sketch of a deeper issue." Furthermore, "to have the senior management ... behave in this manner, spend incredible amounts of time feuding, and writing numerous long e-mails while seemingly unaware of the need need for appropriate behavior, decorum, and enforcement of good management practices and the rules of supervision and concerns about appearance of reprisal clearly indicates a serious problem."
Meanwhile, the Associated Press also reported that the NIH has made good on previous threats to terminate Fishbein, whose last day of work was apparently Friday, July 1. This drew fire from congress, specifically the senior members of the Senate Finance Committee. Senators Charles Grassley (R-Iowa) and Max Baucus (D-Montana) wrote to the NIH, "retaliation against an employee for reporting misconduct or voicing concerns is unacceptable, illegal, and violates the Whistelblower Protection Act."Previously, an internal report to the Director of the NIH, Elias Zerhouni, also concluded that trying to fire Fishbein gave "the appearance of reprisal."
We had posted on this issue awhile back, here, here here, and here.
This is just a reminder that in government, just as in commercial and not-for-profit health care organizations, there are too many heavy-handed bosses who respond to criticism by trying to shut up the critic, even when the criticism is about quality problems in research or provision of health care.

HealthSouth Box Score So Far

Richard Scrushy, former CEO of HealthSouth, was recently acquited. However, a recent Associated Press report reminds us that many top HealthSouth executives have plead guilty so far. Fifteen have plead guilty, including the company's first Chief Financial Officer (CFO), Aaron Beam, who plead guilty to bank fraud, Will Hicks, a former Vice President, Mike Martin, another former CFO, and Richard Botts, another former Vice President. Two other former HealthSouth executives, former President Jim Bennett, and former division controlled Hannibal "Sonny" Crumpler, are awaiting trial.
The company itself agreed to pay $100 million to settle civil fraud charges made by the Security and Exchange Commission (SEC), and to pay $325 million to settle charges made about it Medicare billing practices by the Department of Justice.
HealthSouth remains a prime example of a large health care organization run by managers many of whom turned out to be crooks.

Sunday, July 03, 2005

Don't Ask, Don't Tell: Health Affairs Interviews Guidant CEO Ron Dollens

Health Affairs, which bills itself as " the leading journal of health policy thought and research," just published a lengthy (18 page in the PDF version) interview of Guidant CEO Ronald W. Dollens by Founding Editor John K. Iglehart. The interview was notable for the interviewer's extreme deference to the interviewee, and more for what the interviewer didn't raise that what he did.

The Case of Guidant's ICDs

An accompanying editor's note stated, "On May 24, 2005, one month after the interview that follows was conducted (25 April), the New York Times reported that an implantable cardiac defibrillator (ICD) sold by the Guidant Corporation had failed to operate properly while a twenty-one year old college student who had the device implanted in his chest was suffering a cardiac arrest. The student later died. Following the Times report, John Iglehart posed an additional question...." Furthermore, the note stated that Guidant had issued a press release on June 17, 2005, that Guidant was "volunatarily advising physicians about important safety information regarding certain devices [three ICD models]"; and that the Associated Press quoted a US Food and Drug Administration spokesman as saying "This is a voluntary recall." It also noted that Guidant confirmed reports of 45 failures of ICDs out of 63,000 implanted worldwide. Finally, the note quoted Dollens, "Patient safety is paramount and our highest priority."
The question that Iglehard asked Dollens about this issue was:
  • "A recent New York Times story, which focused specifically on ICDs, raised broad questions relating to the inherent risk associated with invasive procedures and the understanding of various groups of risk. Could you share with us your thoughts on the specific issues addressed in the Times article?"
Dollens replied,
  • "The article focused on the communications issues surrounding the continuous evaluation of patient risk when using novel, life-sustaining medical technology. We encourage public debate and discussion about the pros and cons of broader dissemination of infomation about product safety. Guidant looks forward to participating in that discussion."
This interview and the accompanying editor's note, however, left out some important information. In particular, the New York Times article of May 24 reported not only on the failure of the defibrillator that was associated with the death of the young patient, but also that Guidant had known for three years of a flaw in the design of that particular defibrillator, the Ventak Prizm 2, that could cause the unit to short-circuit and fail, and that the company had made changes in its manufacturing process three years earlier to correct this flaw. We posted about this New York Times article on Health Care Renewal, and concluded, " there seems to be no good excuse to hide data about this device's flaws from the public and from doctors."
Furthermore, there was other news about Guidant that appeared after the May 24 but before the June 17, 2005 press release. On June 2, the New York Times reported that Guidant continued to sell ICDs from stock manufactured before the flaw was corrected after it had started manufacturing an upgraded version that corrected the flaw. (See our post here.)
A day after the Guidant press release, the New York Times published another article disclosing flaws in additional models of Guidant ICDs, that Guidant had also failed to previously disclose these flaws to doctors as soon as it knew of them, and also that Guidant continued to ship the old version of these models of ICDs from stock after it started manufacturing new models which corrected the flaw. (See our post here.)
Thus, the prominent, lengthy interview in Health Affairs of Guidant CEO Dollen, done by the most senior Health Affairs editor, avoided mentioning most of the serious criticisms made of how Guidant handled the problem of faulty ICDs. Iglehart characterized the problem only in the most general terms, and allowed Dollen to provide an answer that was equally vague. Although the editor's note suggested that Health Affairs editorial personnel were aware of news about Guidant made public from May 24 to June 17, 2005, it failed to mention that the news after May 24 had raised additional issues about Guidant ICDs.

The Case of the Ancure Endograft System

Iglehart asked Dollens to opine about such diverse matters as "the era of evidence-based medicine," how Guidant provides health care coverage to its employees, and how "the American way of delivering and financing health care is flawed." Yet he never mentioned another serious problem in Guidant's past that eerily presaged the ICD problem.
In 2003, Guidant agreed to plead guilty to multiple felony counts for hiding, as the New York Times put it, "serious health problems, including 12 deaths, caused by one of its products." Guidant agreed to pay over $90 million in civil and criminal penalties, the largest fine ever paid by a device-maker for concealing problems with one of its products.
In summary, the facts reported by the Times in 2003 were as follows. In 1999, Guidant began marketing a new type of aortic graft that was inserted via a catheter, the Ancure Endograft System. Soon after the device was marketed, physicians who inserted it began complaining that the device would be become lodged prior to achieving correct positioning, requiring abdominal surgery to repair the problem. Guidant sales represented began instructing doctors to break the device into pieces and then extract them, even though this method had never been clinically tested, and despite the sales representatives' lack of qualifications to give such clinical advice. Guidant eventually reported 172 reports of problems with the device to the FDA, but later prosecutors charged that Guidant had concealed more than 2000 of the the reports it had received. The FDA heard of the scope of the problem in 2000 after seven anonymous whistle-blowers sent it a letter. Guidant pulled the aortic graft system off the market in 2001, and then revealed it had received thousands of reports of problems with the device. (See summaries of other news articles here, but most original articles are no longer on the web.)
Yet the Iglehart interview never mentioned the case of the Ancure Endograft System, which was undoubtably important, and seemed relevant not only to the more recent case involving ICDs, but indicative of the extent that Guidant really regards safety as "paramount."

In Summary

A prominent editor of a prominent health policy journal devoted considerable effort to and published considerable pages of an interview with the CEO of a large device manufacturing firm, yet avoided asking skeptical or probing questions about a current problem that raises substantive concerns about the quality of the company's products, and even bigger concerns about how the company has dealt with quality problems. The interviewer avoided asking any questions about a similar case from a few years ago.
This is only one article, but it seems to indicate how deferentially the health services and policy literature may treat leaders of large health care organizations. This literature is a major source of information about the health care system and health care policy for physicians, researchers, and policy-makers. While it may show deference to leaders of large organizations, however, this literature often includes pointed criticisms of physicians.
Here is another example of the "anechoic effect," the curious lack of echoes resulting from cases that show the down-sides of concentration and abuse of power.
But to fix these problems, we will at least have to start talking about them.
To help us do that, journals about health services and health policy should begin to show skepticism of the powers that be befiting these journals' scholarly aspirations.