Clinical Trials Performed by Commercial Firms, and the Commercial IRBs that Oversee Them

Bloomberg News published an investigative series (see links here and here to the version in the Seattle Times) about commercial firms that perform drug trials and the commercial institutional review boards (IRBs) that are supposed to supervise them.
The articles noted that most (75%) of US drug trials are now done by commercial firms, rather than by academic researchers. In 1991, 80% of trials were done in academia. Most of these trials have been approved by commercial, rather than academic IRBs.
This arrangement may have inherent conflicts of interest. For example, former New England Journal of Medicine Editor Marcia Angell charged, "the fundamental problem is a system in which investor-owned businesses have control over the evaluation of their own products. Oversight of clinical trials is too important to leave in the hands of drug companies and their agents."
The Bloomberg News articles suggest that there are major problems afflicting the conduct of these commercial trials. Visits by reporters to a 675-bed trial site in Miami owned by SFBC International revealed the shoddy condition of its physical plant (a bathroom with "chipped white tiles [which] reeks with urine; its floor is covered with muddy footprints and paper towels.")
The reporters suggested that trial subjects are frequently poor. They may ignore study rules to forego alcohol and narcotics. Most trial participants stated that "they barely read" informed consent documents. Reporters noted that "participants in the Miami clinical trials openly talk about how they violate SFBC rules intended to protect the integrity of the research findings."
Ken Goodman, the Director of the Bioetics Program at the University of Miami, visited the SFBC International Center, and declared

The setting is jarring. It's an eye-opener. Every one of these people should probably raise a red flag. It these human-subject recruitment mills are the norm around the country, then our system is in deep trouble.

The reporters reviewed FDA records that also suggest that commercial trial centers "have used poorly trained and unlicensed clinicians." They "sometimes have incomplete or illegible records. In California and Texas, clinicians have used themselves, staff or family members as drug-trial participants."
Dr. Joanne Rhoads, who directs the FDA Division of Scientific Investigations, noted, "unfortunately, I don't think it's been recognized how important it is that people who actually conduct the trial be trained. We oftentimes see people with no qualifications whatsoever, but they'll go to a one-day training course and they call themselves a certified study coordinator."
The reporters also suggested that oversight by commercial IRBs is weak. For example, Western IRB, which is responsible for overseeing 17,000 US trials, had approved trials whose investigators ended up convicted of "lying to the FDA and endangering trial participants." Leaders of commercial IRBs have been accused of conflicts of interest. For example, Bloomberg News noted that Southern IRB, which has approved SFBC International's trials, is owned by Alison Shamblen, wife of the SFBC International vice president of clinical operations, E. Cooper Shamblen.
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, commented,

This whole world gives me hives, this privatized review process. They've had conflicts of interest since the beginning.

We previously have posted about how commercial research sponsors may try to manipulate the design, conduct, and reporting of studies to increase the likelihood of results favorable to their interests. These concerns mainly applied to studies done in academic settings.
These disturbing articles suggest that we should be even more skeptical about trials conducted by commercial firms.

Health Net Stalls Surgery for Rare Disease

The San Francisco Chronicle has been covering a case of a young boy with metatropic dysplasia, a disease so rare, according to the Chronicle, that it appears there is only one surgeon in the US, Dr. William MacKenzie at the duPont Hospital for Children in Delaware, who has experience treating it.
(A quick PubMed search did corroborate the disease's rarity, revealing only 27 articles ever published on it. The most recent case report, from 2005, noted that only 67 cases have been reported world-wide.)
Yet, Health Net, the family's managed care organization, has resisted four appeals to authorize payment to Dr. MacKenzie.
Chronicle columnist, C. W. Nevius, wrote, "HMOSs never want to hear about rare diseases." He quoted a local health care advocate, "When you have to fly a patient out to the East Coast, it is a fundamental HMO no-no. It is the M.O. [modus operandi] of health care providers [presumably meaning HMOs] to deny access to expensive treatments. They give you the runaround and hope you go away."
The HMO in question, Health Net, which initially failed to respond to Nevius' requests for comments, apparently was not moved by a note from the patient's primary care physician that "it is imperative" that he see the East Coast specialist. The Chief of Pediatric Orthopedics of University of California- San Francisco, Dr. Mohammad Diab, admited he had no experience with the necessary surgery, but suggested it be done fast, "the door is closing, if not closed."
After the story appeared in the Chronicle, Health Net partially relented, according to Nevius' next column, authorizing a consultation with the specialist, but no further treatment. David Olson, the Senior Vice President for Corporate Communications, dismissed the notion that the patient is in imminent danger, calling it a "typical lawyer ploy. There is nothing in the record to indicate that something has to happen right now."
This sort of heavy-handed approach to cost-containment is what sparked the anti-managed care backlash in the 1990's. As is usual for managed care, the emphasis seems to be on restricting access to care, rather than on bargaining down the costs of egregiously high-priced goods and services.
Moreover, focusing on restricting treatments for patients with rare diseases will almost never be truly evidence-based, because rare diseases will not be subject to studies of sufficient statistical power to demonstrate that particular treatments will not work. But focusing on such restrictions will not even save much money in the aggregate, since rare diseases are, well, rare.
So the main result of this approach will be to reinforce managed care's reputation for heartlessness. In the case of Health Net, it seems particularly distinct from the preamble to the company's statement about business conduct and ethics, "Health Net, Inc. is dedicated to helping people be healthy, secure and comfortable. To succeed in our mission, we must maintain our customers' trust...."
Perhaps managed care would do better if it were lead by people who have some knowledge of the clinical context. In contrast, Mr. David Olson, the one Health Net official who has spoken publicly about this case, according to his his official biography seems to have no obvious direct health care experience. Mr. Olson is now responsible "for the company's investor relations function and internal and external communications, and also oversees government relations and charitable contributions." He previously served as "vice president, Investor and Public Relations, for Health Systems International, Inc. (HSI)," and " vice president, Corporate Communications for National Medical Enterprises, Inc. (NME), having joined NME in 1989 as director of Shareholder Communications." His only academic qualifications are "a BA in English from Washington and Lee University." Maybe he needs to talk to a doctor.

The US Gets Less Bang for its Buck: The Health Affairs Six-Country Survey

A survey in Health Affairs of the experiences of sick patients in six countries (Australia, Canada, Germany, New Zealand, the UK, and the US) raises some important issues, especially here in the US. (The article is currently only available on the web here. Its citation is: Schoen C et al. Taking the pulse of health care systems: experiences of patients with health problems in six countries. Health Affairs 2005.)
The first issue is how the US performance compared with that of the five other countries on a variety of measures.
The US was best or next to the best of all the countries at: diabetes process of care, hypertension process of care, waiting times to see specialists, and waiting times for elective surgery.
The US was worst or next to worst at: medical errors, providing patients with regular doctors, waiting for appointments with regular doctors, providing care after hours, access problems due to cost, and out of pocket expenses.
As reported by the Washington Post , Dr. Carolyn Clancy, Director of the US Agency for Healthcare Quality and Research (AHRQ), commented, "The findings here reinforce how difficult it is coordinating care .... That's the next frontier."
What Dr. Clancy seems to have been implying, in her understated way, was that these results show that the US had difficulty providing continuous, comprehensive, and coordinated care, the sort of care which is generally provided by primary care and generalist physicians.
Thus this pattern corresponds to the US priority on specialized, high-technology, invasive care, while primary care/ generalist care has been taken for granted. Furthermore, as US costs have continued to rise, most of the pressure to cut costs has been applied to primary/ generalist care. As a consequence, primary care and generalist physicians must put up with reimbursement that barely keeps up with inflation, while the costs of running a practice rise much faster; with growing mounds of paperwork and bureaucratic intrusions, while, like Rodney Dangerfield, they get no respect. (See our previous posts on the worsening plight of primary care, for example, here, and our wooden-headed system of reimbursement, here.)
An even more striking issue is the contrast between how much the US spends and the performance of its health care system compared to that other countries. The US spends far more on the health care than the other countries, surveyed, 14.6% of gross domestic product versus 10.9% for Germany, the next biggest spender. Yet, as noted above the US was more often at the bottom than the top of the survey ratings. Thus, the US gets the least bang for the buck of any of the six countries. So, as the Washington Post reported, the first author of the Health Affairs study said, "What's striking is that we clearly are a world leader in how much we spend on health care. We should be expecting to be the best. Clearly, we should be doing better."
No hypothesis to explain this contrast appeared in the Health Affairs article, or in the comments of the experts quoted by the Wahington Post.
At best, the Post quoted Lucian Leape, of the Harvard School of Public Health, opined, "This provides confirming evidence for what more and more health policy thinkers have been saying. The American health care system is quietly imploding, and it's about time we did something about it." Why the system is imploding, and what should be done about it were apparently left unsaid.
I submit that the missing link here are some perennial topics on Health Care Renewal: the domination of health care by large, increasingly bureaucratic organizations, lead too often by the ill-informed, the conflicted, and at times the frankly corrupt.
What else explains how we can spend more than other countries, yet get less access, impose higher costs on patients, and provide by most measures, poorer quality care?
This really is something for those health policy thinkers to think about.

Providence Health Systems Settles Case About Unfair Billing of Uninsured Patients

The Portland Business Journal reports that Providence Health Systems "is the first nonprofit hospital group in the country to settle charges alleging unfair billing for uninsured patients." "The settlement, pending approval by the courts, spells out a revised pricing system under which uninsured patients would receive discounts on par with the prices insurance companies negotiate with Providence for the insured population. These preferred provider discounts are about 31.6 in Portland [Oregon]."
The settlement was of one of the many lawsuits filed that "charge health systems with giving private insurance companies and federal payors Medicare and Medicaid substantial discounts off their full 'sticker' prices, while charging the uninsured the full amount for these services." Many of these health systems' mission statements include service to the poor. For example, Providence Health Systems' mission statement opens with:

Providence Health System continues the healing ministry of Jesus in the world of today, with special concern for those who are poor and vulnerable.

We have posted frequently about hospitals and health systems accused of violating their missions by charging the poor and uninsured more than insured patients (see most recent post on this subject here).
Again, this sort of practice by the leadership of large health care organizations seems emblematic of what is wrong with our health care system, yet gets little attention in health policy circles.

Eliot Spitzer Sues Guidant for Fraud

According to the Indianapolis Star, and Bloomberg News, New York Attorney General Eliot Spitzer has sued Guidant Corporation for alleged fraud in connection with its sales of implantable cardiac defibrillators (ICDs).
We have discussed Guidant several times. ( See recent posts here and here)
"Spitzer's claim: Guidant failed to tell doctors from 2002 to 2005 that its Ventak Prism defibrillators had a flaw that could cause them to short-circuit and stop working without warning. Spitzer said,

Concealment of negative facts that might influence a consumer to purchase another manufacturer's product is the essence of fraud. We wouldn't permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.

The Star noted, "Spitzer's suit, filed in New York State Supreme Court in Manhattan, adds credibility to the 10 or so privately filed cases against Guidant over its handling of the defibrillator flaw...."
To recapitulate:

• Guidant has admitted that it did not disclose information about defects in ICDs to doctors and patients.
• These ICDs are very expensive, costing about $25,000.
• Had the physicians and patients known prospectively that the ICDs were not as reliable as previously thought, they might have chosen not to implant them, and implanting such flawed defibrillators provided less benefit to the population of patients receiving them than they thought they would receive.
• Thus, by concealing the information, Guidant likely made more money and increased costs to the health care system, but decreased the benefits to patients.

And lots of experts in health care policy wonder why our costs are going up, our quality of care is no better than stagnant, and patients and physicians are disgruntled and demoralized?
Doesn't it seem that this sort of mismanagement and potential malfeasance by the leadership of large health care organizations has something to do with it?

The Muraglitazar Case: A New Window on Manipulation of Clinical Research

Some recent articles in JAMA improve our awareness of how research may be manipulated in the interests of the organizations that sponsor it.
Nissen and colleagues reported on a re-analysis of clinical trial data on the new drug muraglitazar (available now only on the web here. The citation begins Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005; 294:) Muraglitazar is a peroxisome proliferator-activated receptor (PPAR) agonist meant to both decrease blood sugar in patients with type 2 diabetes (i.e., those who do not necessarily require insulin therapy) and to increase HDL cholesterol ("good" cholesterol).
Nissen and colleagues used data from five clinical trials that were reported to the US Food and Drug Administration (FDA), but were mostly unavailable in published form. An FDA advisory committee had reviewed this data, and recommended that the drug be approved for treatment of type 2 diabetes.
When Nissen et al re-analyzed the data, however, they found that treatment with muraglitazar seemed to result in more clinically important adverse events than did treatment with an older PPAR-agonist, pioglitazone, or placebo. In particular, the rate of the commonly used combined endpoint, death or nonfatal myocardial infarction (heart attack), or stroke was higher (1.47%) in patients treated with muraglitazar than it was (0.67%) in those treated with either pioglitazone or placebo. Analyses using different combinations of endpoints, or single endpoints all showed higher rates for patients who received muraglitazar (sometimes statistically significant, that is, unlikely to be due to chance alone, and sometimes nearly statistically significant).
Thus, it appeared that the way the data on muraglitazar was analyzed and presented to the FDA made the drug appear less hazardous than would have other analyses.
In an accompanying commentary (also available only on the web here, with a citation beginning Brophy JM. Selling safety - lessons from muraglitazar. JAMA 2005; 294:), Brophy noted:

Generically, there are specific methodological decisions
in the sponsor’s FDA application that may foster an illusion
of safety. The following are several, perhaps unintended
but nevertheless disingenuous, methods observed
in the application that may have contributed to an overestimate
of the safety profile:
1. Selecting a study population unlikely to have adverse
outcomes but nonrepresentative of potential future users (eg,
exclusion of elderly patients, even though more than one
third of type 2 diabetes occurs in this group)
2. Conducting underpowered studies increasing the failure
rate to detect meaningful safety differences (ie, maximizing
rather than minimizing type II errors)
3. In contrast to efficacy determinations, reporting individual
rather than composite safety outcomes to decrease
the likelihood of establishing statistical significance (eg, separate
cardiovascular events from CHF)
4. Limiting preapproval peer-review publication of results
so as to minimize scrutiny and debate of both methods
and results (eg, of all submitted data only 1 study of 340
patients has been published8)
5. Evoking biological implausibility of safety concerns
by the use of surrogate measures (eg, treatment reduces
C-reactive protein [CRP]) implying safety, despite no proof
that CRP reduction is clinically correlated with improved
safety)
6. Recording outcomes only in patients who are fully
compliant with prescribed treatment because this selfselected
group will likely have fewer adverse events (eg,
unknown impact of the nonanalysis of the 15% discontinued
cases)
7. Ignoring the totality of the evidence by excluding consideration
of confirmatory safety signals seen in studies of
similar molecules (eg, CHF and bladder cancer outcomes
with pioglitazone)
8. Diverting attention to unproven but potential benefits
by concentrating on reductions in surrogate laboratory
values (eg, hemoglobin A1C) rather than in meaningful
patient health outcomes.

So based on on Nissen's work, Brophy has provided us with yet another catalog of how research sponsors may manipulate design, analysis, and reporting of results to make them more likely to be favorable to their interests.
This list should be compared to the one developed by Richard Smith in his article in PLoS Medicine (see our post here, and the article here.)
There are some important lessons here:

• Manipulation of research design, analysis and reporting may be more widespread than we realized.
• We need better ways to detect such manipulation, and to then take it into account when using research results to make clinical or policy decisions.
• We need to find ways to discourage such manipulation.

Note: After the study by Nissen et al and the commentary by Brophy were published on the web, Bristol-Myers Squibb released this, indicating that the company was considering whether to do new long-term studies of muraglitazar to assess cardiovascular risk, or terminate drug development.

The Wal-Mart Memo

A memo written by a top Wal-Mart executive proposing ways for the company to reduce its ever-rising health care spending has created quite a kerfuffle. (See coverage in the New York Times here and here, and in the Los Angeles Times here.)

Some of the main points of the memo, written by Executive Vice President for Benefits M. Susan Chambers, were:

• Wal-Mart's health care costs have been rising on average 15% a year since 2002.
• 46% of children of Wal-Mart employees have no private health insurance.
• "Wal-Mart workers 'are getting sicker than the national population, particularly in obesity-related diseases,' including diabetes and coronary artery disease."
• Wal-Mart should consider ensuring that all jobs "include some physical activity (e.g. all cashiers do some cart gathering)." The idea would be to "dissuade unhealthy people from coming to work at Wal-Mart."

Based on this memo, labor leaders have accused Wal-Mart of wanting to offer health care coverage only to healthy people. (See article in the Philadelphia Inquirer.
I have some observations.
This is a new, more vivid example of the perverse incentives that arise out of the curious US practice of having employers provide health insurance coverage to a large number of US employees. This practice arose during World War II, when wage controls lead employers to compete for scarce labor by offering more benefits instead of higher salaries, and was reinforced by the US tax code, which allows employers, but not employees, to deduct the cost of health insurance from income for tax computations. We previously mentioned how some US companies have fired employees who smoke in the privacy of their own homes in order to make their work-force healthier and hence cut their health care insurance bills.
The memo seems to reflect the growing belief that most ills are somehow self-induced. Note that the memo seems to reflect the belief that coronary artery disease (CAD) is mainly a result of obesity. However, the most recognized risk factors for CAD are male sex, increasing age, high blood pressure, cigarette smoking, high total cholesterol, low HDL cholesterol, diabetes, and left ventricular hyptertrophy (from the Framingham study risk equations. See Anderson KM et al. Cardiovascular disease risk profiles. Am Heart J 1990; 121: 1293-1298.) Some of these can be modified, and some may be indirectly related to obesity, but the notion that a thinner work force will necessarily have less CAD, or will generally have lower health care costs, is overly simplistic. I wonder whether the belief in the exaggerated importance of obesity (now redefined to include nearly everyone who is a bit overweight) as a cause of disease arose out of stealth marketing campaigns for anti-obesity drugs, like the Wyeth campaign in support of the ill fated Fen-Phen drug combination. (See our post here, and the article: Elliott C. Pharma goes to the laundry: public relations and the business of medical education. Hastings Center Rep 2004; 34: 18-23.)
Notably lacking from the memo is any consideration of lowering health care costs by bargaining down egregiously high prices for certain goods or services. Yet Health Care Renewal has featured numerous examples of unjustifiably high charges for particular goods and services (See our post entitled "Wooden-Headed Health Care Reimbursement.")

An Update: PhRMA Commissions a Thriller

We previously posted about how the Pharmaceutical Research Manufacturers of America (PhRMA) paid for the writing of a thriller about terrorists poisoning drugs imported from Canada. This story was picked up by two major newspapers, the Los Angeles Times and the Philadelphia Inquirer. New, increasingly bizarre details have emerged:

• The publisher of the thriller, Phoenix Books, is owned by Michael Viner. Viner previous owned Dove Entertainment, which published books on the O. J. Simpson murder trial and the "society madam," Heidi Fleiss. Two of three authors of Dove's book on Fleiss sued Viner for sexual harassment, and the other won an award after she claimed Dove failed to pay her royalties.
• Viner next founded Millenium Entertainment, which published "Burning Down My Master's House by disgraced former New York Times reporter Jayson Blair.
• The writing of the book was supervised by a PhRMA marketing executive, who required that the book's villains be militant Muslims, but motivated by greed, not politics; that the book contain "frilly feminine stuff"; and that it incorporate long passages from congressional hearings.
• Jayson Blair briefly served as editor for Phoenix on the project, but departed the project and the company after a "contentious phone conversation" with author Julie Chrystyn, and allegedly "trying to abuse his expense account."
• PhRMA canceled the book project after paying authors Chrystyn and Kenin Spivack $100,000, but promised them another $100,000 "if they would agree never to speak ill of PhRMA or the drug industry for the rest of their lives. They refused."
• PhRMA Senior Vice President for Communications Ken Johnson called the scheme "idiotic," and insisted that the PhRMA official who sanctioned the book contract was "a lower level employee who acted without authority," for whom the organization is "presently reviewing disciplinary options."
• The employee was actually Valerie Volpe, according to the Philadelphia Inquirer, a "deputy vice president for federal and state affairs," (but documents on the web identify her as "Director of Patient and Professional Relations.)
• The book, entitled the Karasik Conspiracy, is due to be published in December. "The villains of the plot have undergone yet another transformation. They're now a rainbow coalition of Bosnians, Eastern Europeans and Americans, including a stereotypical representative of an American corporation: to wit, a pharmaceutical company."

According to Philadelphia Inquirer reporter Thomas Ginsberg, "This is no pulp fiction farce. Call it bookgate, an impossible-to-make-up public-relations disaster now dogging the pharmaceutical industry." Call it a another, particularly lurid example of how large health care organizations resort to deception and dishonesty to promote their causes.
What argument do they have that physicians and patients should trust them?

Another Stealth Marketing Variant: Advertising Disguised as TV News

The Washington Times reported how government agencies and corporations have paid television stations to insert marketing into news reports, and for endorsements by news reporters. Some of the examples cited were health care related:

• The Washington, DC Department of Human Services contracted with CBS affiliated WUSA to mention the Buddy Check 9 program (to get people to remind friends to perform breast self-examination on the ninth day of the month) during newscasts, and to direct viewer's to the Department's web-site. The Department paid the station $100,000 per year in 2002 and 2003.
• WUSA reporter Peggy Fox participated on broadcast advertising for an anti-obesity campaign, "Lighten Up, Washington, by the Inova Heart and Vascular Institute. The advertising appeared to be public service announcements, but included pictures of the Institute, and the Inova logo.
• George Washington University Hospital sponsored a "High Tech Health" segment durings the 10 PM news broadcast by Fox affiliated WTTG-TV.

Regardless of the content of these messages, delivering advertising in a way to make it look like news is fundamentally deceptive. The Times noted that this practice violates two ethical principles of broadcast news: "TV stations should not use their newscasts to advertise products and services, and news anchors should not appear in paid commercials." It is particularly unfortunate that hospitals and local government health care agencies are the organizations supporting this dishonesty.

Pharmaceutical and Device Companies Involved in Oil-for-Food Scandal

Now that the Volcker report is out about how more than 2000 companies paid bribes to Saddam Hussein's regime in Iraq in order to sell products under the United Nation's oil for food program, it's no surprise that a number of prominent pharmaceutical and medical device companies were involved. So far, these include:

• Astra Zeneca
• Glaxo Wellcome
• SmithKlineBeecham
• Eli Lilly
• Novartis
• Roche
• Serono
• St. Jude Medical

This list was compiled from reports by the Minneapolis Star-Tribune, Swedish Radio, and DowJones.
Another (dubious) cost of doing business

M. D. Anderson Cancer Center Leases Its Name

The Houston Chronicle reported the complex dealings between the M. D. Anderson Cancer Center and private investors involved in the establishment of a new "proton-therapy" center.

The center will focus on providing radiation therapy to cancer patients using high-energy protons, generated by a sophisticated particle accelerator.

The theoretic advantage of such therapy is that it can provide more radiation dose to the tumor, while minimizing the dose to normal tissues, thus possibly improving treatment efficacy while reducing adverse effects. Protons scatter less into normal tissue than do x-ray photons.

On the other hand, according to the Chronicle article, proton therapy has mainly been assessed for treatment of a few relatively rare tumors. The Chronicle did suggest that a recent JAMA article showed that proton-therapy reduced recurrent rates for a more common cancer, that of the prostate. However, review of this article [Zietman AL et al. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA 2005; 294: 1233-1239.] showed that it actually compared two doses (conventional and high) of therapy that combined both standard radation therapy and proton-therapy. Furthermore, although the high-dose treatment lowered patients' PSA levels, assumed to be a measure of local control of disease, compared to conventional-dose treatment, it gave no survival advantage, and high-dose patients had more adverse effects. Thus, this article did not actually make a convincing case that proton-therapy provides better a better benefit/harm ratio than does standard therapy.

The issue in the Chronicle story, however, was not so mainly about whether this therapy should be considered investigational.

Rather, the issue was that the new M. D. Anderson center will actually be a for-profit facility, owned by a group of private investors, that "leases" the M. D. Anderson name. Using the Freedom of Information Act, the Chronicle discovered that the center will be financed and owned by venture capitalists. These include a limited partnership whose largest investor is the Houston Police Officers' Pension System. Another sub-partnership includes Nolan Ryan, a subsidiary of the Landry's Restaurant chain, and Rich Kinder of Kinder Morgan. M. D. Anderson is also a limited parter, having invested $2.5 million out of the $30 million dollar total.

The center will be run by "a company co-owned by Sanders Morris Harris and The Styles Company." A separate article in the Chronicle reported that advisors to the Police retirement system advised "extreme caution" about the investment, particularly because of "the large fees that Sander Morris Harris and developer The Styles Company were getting up front, as well as continuing management fees to them."

"In future years, once the limited partners have recouped their investment plus interest, profits get distributed according to a formula. M. D. Anderson gets 15 percent, but if the center achieves the high return it projects - 58 percent - M. D. Anderson gets up to 25 percent." "It could be a federal anti-kickback violation for a doctor or institution to receive incentive for medical referrals if Medicare and Medicaid is among the insurers, but attorneys said they carefully reviewed the arrangement."

The Chronicle article stated, "M. D. Anderson's center, however, won't be nonprofit. Indeed it will address an institutional problem that is as much about business as health care. Of 12,000 M. D. Anderson patients who will need radiation this year... only 5,000 will complete their multiweek course of treatment at M. D. Anderson." "If patients are sold on proton treatment, not available in their hometown, they have to stay and pay at M. D. Anderson, which means more money for the hospital."

Furthermore, the Chronicle reported that M. D. Anderson promised to "promote" the center as part of the deal. "M. D. Anderson is contractually obligated to its venture partners to 'advertise and promote' the therapy, doing such things as touting its benefits on the Internet. 'They're going to promote this like you'd promote a new model of car at GM,' said Larry Churchill, a professor of medical ethics at Vanderbilt University Medical Center."

M. D. Anderson President Dr. John Mendelsohn replied "We are not promoting this in the hyped-up sense. We're going to be educating." In addition, he noted "I'm convinced that proton therapy is at least as good as standard radiation therapy, and there are preclinical and scientific data that says it's very possible it will be better." Finally, he noted that aggressive treatment is "part of our national culture."

In my humble opinion, this case raises major concerns about institutional conflicts of interest and honesty.

• Will the interest of M. D. Anderson in making money from this venture, and the pressure it will be under from investors conflict with its patient care and academic mission?
• Will a clinical center run by a for-profit management group with no obvious expertise or background in clinical health care or academics put patient welfare and academic integrity ahead of finanacial concerns?
• Will M. D. Anderson's obligation to "promote" this center conflict with its core value "to create a caring environment for everyone?"
• Does leasing its name to a group of private investors fit its core value of "integrity," defined as " We work together to merit the trust of our colleagues and those we serve?"

Stay tuned.

The Physician Brain Drain

In the latest New England Journal of Medicine is an article about the "brain drain" of physicians from less to more developed countries. Specifically, about one quarter of all physicians practicing in the US, the UK, Canada, and Australia were trained in other countries. The majority in the US and the UK were from less developed countries. [Mullan F. The metrics of the physician brain drain. N Engl J Med 2005; 353: 1810-1818.]
A NY Times article suggested that some smaller less developed countries have lost a substantial portion of their total physician supply to the more developed countries. For example, Jamaica has lost 41 percent, Haiti, 35%, and Ghana, 30%. The Times article included an interview with Dr. Ageyeman Akosa, director general of the Ghanian health service, who gave some vivid examples of the effect of the brain drain on his country. He challenged the US, in particular,

One of the most important things the United States can do for global health, frankly, is to educate more physicians in the United States to work in the United States.

What is going on here? The US, of course, spends over a trillion dollars on health care, more absolutely an in terms of proportion of GDP than any other country. Then why can't it educate enough physicians?
A previous post on Health Care Renewal noted how the US short-changes the financing of basic medical education. Other posts (see this one and its links) have noted how the US under-finances primary care and other cognitive specialties, so that fewer and fewer trainees want to go into them.
There is something rotten here, but not in Denmark. The brain drain from less developed countries appears to have resulted from the inability of the US and other developed countries to train and retain enough physicians, particularly in primary care. In the US, in turn, this may result from failure to adequately support medical education, and the focus of almost all US efforts to cut costs on primary care and some other cognitive specialties, leaving their practitioners so poorly remunerated relative to their clinical efforts, so loaded down with bureacracy, and left with so little autonomy that hardly any one wants to go into these fields.
There has been little open conversation in the US about how this has come to pass. Based on our ongoing discussion on Health Care Renewal, I submit that the underlying cause is concentration and abuse of power in health care. Our large health care organizations, often lead by people with little real experience in health care, who may be overly self-interested, and sometimes corrupt, will do everything they can to protect their financial interests. But their mismanagement and outright malfeasance contributes, probably substantially, to the rapid rise of health care costs. But then the only remaining targets for cost-cutting are the hard-working but politically vulnerable, such as primary care physicians.
This has to change, or we will soon find ourselves without any primary care, and hence without a functioning health care system.

The Annals of Internal Medicine Suggests "Exorcising Ghosts"

The Annals of Internal Medicine just published an editorial on ghost-writing and guest writing[1]. The editorial includes a good summary of some recent evidence that ghost-writing affects the reporting and discussion of clinical research. (Note that we have posted extensively on this topic, for example, here, here and here.)
To its credit, the editorial admits that the Annals may have published a ghost-written article about a clinical trial of Vioxx, and noted evidence that up to 16% of past Annals articles may have been ghost-written (although ghost-writing was even more prevalent in the New England Journal). Also to its credit, the editorial summarized the Mello study, showing how officials at medical schools and academic medical centers are willing to sign contracts that allow research sponsors, rather than purported academic investigators, to control the design, analysis, and reporting of clinical research[2]. (See previous post here.)
This editorial is a significant development, the first open, honest discussion of ghost-writing to appear in a large-circulation medical journal (since a 1994 editorial in JAMA)[3]. Hopefully, it will make quite a few physicians, and even some health care policy makers aware of the wide-spread external threats to evidence-based practice, and more broadly, to physicians' core values.
My only criticism of the article is that its proposed remedies focus on journal editors and academic authors. For example, it notes the new Annals editorial policy that would notify an academic researcher's home institution and research sponsor if the researcher had been shown to have allowed ghost-writing of an article he or she ostensibly authored. But this is like notifying the foxes about the recent theft from the chicken-coop.
It avoids confronting how academic institutions and research sponsors may promote ghost-authorship and other deceptive research practices in the first place (as in the Mello paper noted above). The academic's home institution may have acquiesced to this ghost-authorship by signing away its faculty member's rights to control the research and its reporting to the ostensible research sponsor. Furthermore, the home institution may have been pressuring the faculty member to get external support for his or her research in lieu of any institutional support for such scholarship. And, of course, the impetus for ghost-writing often comes from research sponsors eager to promote their own (usually commercial) interests.
So if the goal really is to exorcise ghosts and other kinds of research manipulation, the onus will have to be on the large organizations that benefit from these practices, as well as the sometimes hapless researchers and physicians who get caught up in them.
References
1. Laine C, Mulrow CD. Exorcising ghosts and unwelcome guests. Ann Int Med 2005; 143: 611-612.
2. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.
3. Rennie D. Authorship! authorship! - guests, ghosts, grafters, and the two-sided coin. JAMA 1994; 271: 469-471.

Nature Reports on Conflicts of Interest Affecting Guideline Writers

In the 20 October issue of Nature are results of a study of conflicts of interests affecting guideline writers. The study focused on 90 of the more than 200 plus guidelines in the US National Guideline Clearinghouse in 2004 which listed authors' conflicts of interests. Of these, 66 percent had at least one conflicted author (50% had at least on author on a company advisory board or who was a company consultant, 50% had at least one author whose research was funded by a relevant company, 43% had at least one author who was a member of a relevant company's speakers bureau, 11% had at least one author who owned stock in a relevant company). Of the 685 authors of the 90 guidelines, 35% had one or more conflict (21% - advisory board or consulting position, 22% - research grant, 15% - speakers bureau, 2% - stock). (See this link for detailed results.)
The article noted the example of guidelines for the treatment of anemia in HIV infection. The convening of the guideline writers was funded by Ortho Biotech, which makes the relevant drug, epoetin alpha. All six guideline writers had received speakers' fees or consulting fees from Ortho.
An accompanying editorial suggtested "time may also be ripe for a more radical overhaul of the system, particularly in the United States, where the current financial stakes are highest...." The editorial suggests that a "mechanism could be set up at the US health department... to steer the preparation of clinical guidelines." Furthermore, "if US physicians really want to separate marketing from medicine, they should support its creation."
Whether a government mechanism would be optimal, compared to, say, a private not-for-profit effort supported by practicing physicians, is unclear, at least to me.
But it is clear that the current way to write guidelines, shot through, as it is, with conflicts, cannot be trusted.
Yet these guidelines are promoted as key to improving the quality of care, and are the basis of pay for performance, the latest fashion in quality improvement, error prevention, and cost control. The only performance that may result is that of the stocks of the companies that are paying the guideline writers.

Pharmaceutical research, costs, and prices

The BMJ has an evidence-based look at whether other countries that pay less for drugs are free-riding on research paid for by US consumers:

http://bmj.bmjjournals.com/cgi/content/extract/331/7522/958

Worth a look.

Yet another reason for the Electronic Medical Record...

... To at the very least put an end to absurd, infuriating "I say he did, you say he didn't" arguments in court -- that incidentally reflect negatively on the medical profession and its ability to document patients' histories consistently...

Merck expert defends testimony, lawyer clashes again with judge
JOHN CURRAN
Associated Press

ATLANTIC CITY, N.J. - Defending his opinions during a spirited cross-examination, an expert cardiologist who says Vioxx wasn't to blame for a postal worker's 2001 heart attack acknowledged Wednesday he was unsure whether the man had a family history of heart disease. Testifying for Merck & Co., maker of the since-withdrawn painkiller, Dr. Theodore Tyberg returned to the stand in Frederick "Mike" Humeston's product liability case. Humeston attorney Moshe Horn showed jurors two medical records that said Humeston's family members had no history of cardiac ailments.

Tyberg said he based his testimony Tuesday on a 2002 medical record from Humeston's orthopedic doctor, which said the man's mother died of a heart attack. She was in her mid-70s.

Horn grilled Tyberg over why he didn't tell jurors about medical records, from 1981 and 2001, in which cardiologists said there was no such family history. The latter, from Humeston's hospital visit the night of his Sept. 18, 2001 heart attack, said his mother had cancer.

"That doesn't say she didn't have a heart attack," Tyberg said.

"They didn't say she did, either," said Horn.

... Horn also attempted to undermine Tyberg's assertions that stress, high blood pressure and obesity played a role in Humeston's heart attack, using bits of data from Humeston's medical records to support his viewpoints while Tyberg relied on other details to bolster his.

-- SS

Serono Pleads Guilty

From the Boston Globe, pharmaceutical manufacturer Serono SA will pay $704 million to settle civil and criminal charges. The company's Serono Labs Ltd subsidiary in Massachusetts agreed to plead guilty to conspiracy to market the drug Serostim by "supplying doctors diagnostic software that was not fully approved by the [US] Food and Drug Administration [FDA]. The software, prosecutors said, led to an increase in deman for the drug...." Serostim is an injectable version of human growth hormone approved for the wasting syndrome of AIDS. According to the Globe, "Serono violated federal laws that prohibit companies from making false claims about their products and from offering bribes to win government business such as drug sales whose costs are covered by the federal government."
Michael J. Sullivan, US attorney for Massachusetts, stated, "the pharmaceutical industry will not be allowed to benefit from the criminal misconduct such as that in which Serono engaged, putting patients' best interests second to profits."
The Serono general counsel, of course, said "we are pleased to put the matter behind us." There was nothing in the Globe story to suggest any individuals would pay any penalty for their previous actions.
Conspiracy, false claims, bribery ... just another day at the office here in the dysfunctional world of US health care.
This is now one of very many examples we have posted on Health Care Renewal, just in the last 10 months, of mismanagement and criminal misconduct by leaders of a wide variety of US health care organizations. This has to be part of the explanation of why US health care keeps costing more, becomes less accessible and fails to improve quality, while health care professionals become more demoralized. But where is the outrage?

A New Kind of Ghost-Writing: PhRMA Commissions a Thriller

In the New York Daily News, a truly bizarre story.

It seems that the Pharmaceutical Research and Manufacturers of America (PhRMA), concerned about the increasing popularity of importing drugs to the US from Canada, came up with a scheme to reduce the credibility of this tactic. The Daily News reported that an outside consultant suggested that PhRMA commission a paper-back thriller to dramatize the dangers of imported drugs. The book was to be published by Phoenix Books, and written by ghost-writer Julie Chrystyn.

The plot concerned a Croatian terrorist cell

that uses Canadian web sites to murder millions of unwitting Americans looking for cut-rate pharmaceuticals.

The book was titled, "The Spivack Conspiracy," after Chrystyn's friend Kenin Spivack, who then became a co-writer.

PhRMA suggested several changes in the draft of the first 50 pages, according to Spivack, including

They wanted it somewhat dumbed down for women
They also wanted to change the motivating factor of the terrorists to greed, because they didn't want it to be politics. They wanted lots of people to die.

Eventually, PhRMA pulled out of the scheme. Its executive vice president Ken Johnson acknowledged the plan, but blamed the idea on "an outside consultant," and concluded, "in the final analysis, [we] decided it wasn't the right thing for us to do."

The News reported, however, that PhRMA did make at least one payment to Pheonix Books.

Again, do they expect to build trust in this manner?

We earlier posted about an editorial which called for the recognition of the brutal facts of health care. One such brutal fact is that leaders of large health care organizations do not shrink from using deception to serve their interests. Until we ensure the transparent governance of such organizations, the brutality will continue.

Thanks to PharmaGossip for the tip.

"Pfizer's Fingerprints" on the Kelo Case

We previously posted on the Supreme Court's decision on the Kelo case, which would seem to be off-topic for this blog.

The Kelo case was widely perceived to be about a city (New London, Connecticut) trying to take houses and land by eminent domain to hand the property over to a developer to build an upscale complex. However, we noted that the seizure of land was proposed by the New London Development Corporation, a not-for-profit organization whose leaders had conflicts of interest involving the pharmaceutical company Pfizer. Furthermore, Pfizer favored the upscale development to make the environment around its new research facility in New London more attractive for its workers.

The New London Day just published an article re-affirming Pfizer's involvement in the project. It first noted that a July, 2005 Pfizer press release denied the company's involvement the Kelo case,

Eminent domain has played no part in the development by Pfizer of its Global Research and Development Headquarters in New London CT.
We at Pfizer have been dismayed to see false and misleading claims appear in the media that suggest Pfizer is somehow involved in this [Kelo] matter.

However, the Day responded

But in a recent, months-long review of state records and correspondence from 1997 to 1998 - when officials from the administration of then-Gov. John G. Rowland were helping convince the pharmaceutical giant to build in New Londong - shows taht statement is misleading, at best.

Facts the paper uncovered included:

• That a preliminary plan that included Pfizer's facility and adjacent "high end residential district," offices, businesses, and a marina was drawn up by the firm that designed Pfizer's facility.
• Former state officials confirmed that "the state's agreement to replace the existing neighborhood was a condition of Pfizer's move...." One said, "they would not have done the deal without the commitment to make the surrounding area more livable."
• Former state officials said "it was clear from the beginning of the negotiations with Pfizer that it would be necessary to use eminent domain to clear some of the houses in the Fort Trumbull neighborhood...."

However, Pfizer officials have kept implying that the company was not involved. For example, Nancy Hutson, listed as a "senior vice president" in charge of the Groton and New London laboratories, wrote a letter to the Day about an op-ed piece written by Froma Harrop (mentioned in our previous post), stating,

Ms. Harrop claims that homes in Fort Trumbull were razed because Pfizer wanted the area 'spiffed up.' This charge was examined at length by the Superior Court and dismissed as groundless. Repeating the fib is unfair and hurtful.

Note that Ms. Hutson did not directly refute the charges, but fell back on how the Superior Court found, and managed to claim offense in the currently politically correct manner, by referring to the op-ed piece as "hurtful."

No wonder that the public no longer finds most drug companies worthy of their trust. Although Pfizer's conduct in New London did not directly involve doctors and patients, it should certainly give us pause.

Thanks to Pharma Watch for the tip.

A Little More Realism About Declining Interest in Primary Care

We have posted before about the how fewer doctors in training seem interested in primary care careers. Up to now, the responses from medical organizations, including some that ought to be promoting primary care, have not seemed very direct.

Thus it's a bit refreshing to see a bit more realism in two articles in the latest American Journal of Medicine (which unfortunately requires a subscription).

An article(1) by directors of internal medicine clerkships (hands-on clinical experiences generally during the third year of medical school) noted that "many factors external to the internal medicine clerkship but inherent to internal medicine practice profoundly influence students' career decisions." These include lower income levels for primary care physicians, but more on-call responsibilities, and especially "the high administrative burden," and "the proliferation of third party payers and resulting decrease in practice autonomy."

They allowed that their clerkships can be tweaked to improve them, and perhaps to make primary care look more attractice to students. But they again concluded,

Many of the factors most salient to the career choice process are beyond the scope and control of the clerkship.
Practicing clinicians and thier national organization smust address flaws in the current practice environment that create unmanageable administrative burdens, comparatively low compensation , and time demands that preclude balancing professional obligations with career choices.

In addition, an editorial(2) stated that

the United States faces serious challenges in health care: cost, access, quality, and a projected shortage of caregivers. Rather than acknolwedge these issues, some leaders hope tinkering with the structure of medical education will reinvigorate primary care medicine and help fix a failing health care system.
This optimism is misguided and does not address the real problem.

The authors then listed five paradoxes:

• As the United States spends more on health care, the number of uninsured grows.
• Increased costs and external oversight fail to improve the quality of health care.
• As the need for primary care increases, interest in such careers declines.
• Although society needs well-trained physicians and ground-breaking research, medical schools and teaching hospitals pursue clinical dollars.
• In the nation's capital, political capital is worth more than operating capital.

To begin to address them, they quoted the "Stockdale Paradox," authored by Admiral James Stockdale, the highest ranking military prisoner in the Vietnam War,

You must never confuse faith that you will prevail in the end - which you can never afford to lose - with the discipline to confront the most brutal facts of your current reality, whatever they might be.

However, the editorial is a bit vague about what brutal facts must be confronted. (They only suggested that solutions included an "honest, open discussion," a "more transparent and less fragmented" health care system, more reimbursement for primary care and care of the chronically ill, better performance by medical schools, and having leaders "work together.")
I submit that the missing link here is concentration and abuse of power, which even the authors of this editorial seemed to shy away from confronting.
But we won't here on Health Care Renewal.
Thanks to Retired Doc's Thoughts for the tip.
References
1. Hauer KE et al. Educational responses to declining student interest in internal medicine careers. Am J Med 2005; 118: 1164-1170.
2. Henderson MC et al. Confronting the brutal facts in health care. Am J Med 2005; 118: 1061-1063.

Teaching Anti-Science: "Intelligent Design" and Postmodernism

As noted in an earlier post, the New England Journal of Medicine last week featured a commentary by Robert S Schwartz that worried that the "anti-science movement" of "intelligent design" would soon infect medical schools. [Schwartz RS. Faith healers and physicians - teaching pseudoscience by mandate. N Engl J Med 2005; 353: 1437-1439.]
Schwartz wrote:

the movement to teach intelligent design has spread from school houses to college campuses and university postgraduate programs. I fear that it will soon reach medical schools.
Some might ask why physicians should care about how we educate our children, and what difference it would make if we taught children intelligent design as a counterweight to evolution.... But acquiescing to this anti-science movement would have far-reaching consequences for the development of future generations of physicians, for the likelihood of discovering new therapies, and for understanding health and disease.

I agree with Schwartz that we should worry about students being taught anti-science in K-12 education, college, and graduate school. But if we should worry about the prospects of students being taught "intelligent design," maybe we should worry even more about them being taught post-modernism. After all, intelligent design has not been introduced into many curricula, yet postmodernism now dominates the humanities, and sometimes the social sciences at our most prominent universities.
Epstein provided a useful summary of postmodernism, shorthand for "the amalgam of postmodernism, poststructuralist theory, deconstruction, and political moralism, ... [which] has come to hold sway in large areas of academia." Postmodernism "has its origins in the writing of a group of French intellectuals of the 60s, most preeminently Michel Foucault, Jacques Derrida, Jacques Lacan, and Jean-Francois Lyotard." "Postmodernism rejected aspects of the structuralism legacy, particularly its emphasis on the stability of social structures but retained its focus on language, the view that language provides the categories that shape self, society. This could be extended to the view that all reality is shaped by language; it could suggest that language is real, everything else, constructed or derived from it." "In the latter part of the 70s, many young people whose center of attention was shifting from the movements of the 60s to intellectual work, often in the academy, were avidly reading Foucault. Many were also reading other French intellectuals, including French feminists such as Luce Irigaray, Monique Wittig, the eclectic theorists of society and psychology, Gilles DeLeuze and Felix Guattari, the Marxist structuralist, Louis Althusser, the psychoanalytic structuralis, Jacques Lacan. Through the works of these writers and the debates in which their work was embedded, the poststructuralist ideas that had come to dominate French radical intellectual circles in the late 60s and 70s filtered into parallel intellectual circles in the U.S." So, "there are many academic departments and programs that associate themselves with progressive politics in which the subculture of postmodernism holds sway. This is especially the case in interdisciplinary programs, especially those in the humanities; postmodernism is most likely to be the dominant perspective if the institution is relatively prestigious and if the faculty has been hired since the 60s."[1]
In the central core of postmodernism are radical skepticism about the existence of external reality, and the notion that all truth is socially constructed. For example, postmodernism has been described as questioning "the fundamental philosophical and political premises of the West. It argues that many of the concepts we take for granted - including truth, morality, and objectivity - are culturally 'constructed.'"[2] Lyotard has suggested that postmodernism is a "disbelief in metarecits, or philosophical metanarratives, such as 'Science' and 'Truth'...." So, "everything is contingently good or bad or true or false."[3]
Postmodernist extreme relativism is antithetical to science. As Epstein stated, "because all perception of reality is mediated, because what we regard as reality is perceived through discourse, there is no truth, there are only truth claims. Since there is nothing against which these claims can be measured, they all have the same standing."[1]
Some postmodernists may be frankly hostile to science. Thus in the same issue of Social Text that contained Sokal's famous parody of post-modernist writing about science,[4] Levins wrote, "Modern European/ North American science is a product of the capitalist revolution." "Like bourgeois liberalism in general, it is both liberated and dehumanized. It proclaimed universal ideals that it did not quite mean, violated them in practice, and sometimes revealed those ideals to be oppressive even in theory."[5]
Other postmodernists have challenged fundamental aspects of science education. They have suggested "that students be explicitly disabused of any ideas they might have picked up about the epistemic desirability of reproducible experiments, controlling variables, statistical analysis, and all the other methodological staples of modern science."[6]
Postmodernists have more specifically challenged biomedical science, and its methodological basis. Levins wrote, "We can approach the dominant modalities of chemical therapy in medicine and farming as expressions of the commoditization of knowledge by the chemical industry."[5] Berkwits argued that "the preeminence of clinical epidemiologic research in medicine derives not from its ability to reveal the truth about clinical phenomena, but from an agreement within the medical community for a variety of reasons that it will grant greater authority to statistical expressions of evidence over others." So, the randomized clinical trial (RCT) has achieved its favored status is not that it more likely to produce results that approximate the truth than can other research designs, but because it "emerged from social circumstances to become its own standard of objectivity." So, "in this way, a method which initially served pragmatic social purposes became a self-authenticating criterion for objective clinical truths."[7] Similarly, Kaptchuk argued "In a self-authenticating manner, the double-blind RCT became the instrument to prove its own self-created value system."[8]
Finally, postmodernism undermines logical and rational thinking which is the foundation of science. As Gergen put it, "the texts of postmodernism find the concept of individual rationality deeply problematic, if not oppressive, in its function."[9] Then consider the argument by Social Text editor Bruce Robbins, "truth can be another source of oppression. It was not so long ago that scientists gave their full authority to explanations of why women and African-Americans (not to speak of gays and lesbians) were inherently inferior or pathological or both. Explanations like these continue to appear in newer and subtler forms. Hence there is a need for a social constructionist critique of knowledge."[10] Thus Robbins argued that because some people may say false things, there is no such thing as truth. As Sokal said, "this error is, unfortunately, repeated throughout Robbins' essay: he systematically confuses truth with claims of truth, fact with assertions of fact, and knowledge with pretensions to knowledge." [11] Bouveresse suggested that the tactics of postmodernists include: "start again by making a flamboyant assertion that is either illogical or unsupported by evidence: then, when challenged, pose as a victim and accuse your opponents of being 'flies de la pensee,' [thought cops], 'gendarmes,' and 'censeurs' [censors]." So that "when criticisms, even the most well-founded ones, are directed against intellectuals [postmodernists] of a certain stature, they are considered ipso facto prosecutorial and inquisitorial...."[12]
Anyone with doubts about the reach of postmodernism should look at the descriptions of humanities courses at nearly any highly ranked US college or university.
Schwartz suggested that "leaders of professional societies and prominent academicians should start speaking up" about the prospect that intelligent design may be taught in schools and colleges. In the 1990's, they should have spoken up about post-modernism. A few in the physical sciences and mathematics, such as Alan Sokal and Norman Levitt begin objecting to post-modernism then. It's time for leaders in the health sciences to catch up.

References
1. Epstein B. Postmodernism and the left. New Politics, 1997; 6.[link]
2. Rothstein E. Attacks on the U.S. challenge the perspectives of postmodern true believers. New York Times, September 22, 2001.
3. Sarchett BW. What's all this fuss about this postmodernist stuff? In Arthur J, Shapiro A, ed. Campus Wars: Multiculturalism and the Politics of Difference. Boulder, CO: Westview Press, 1995. Pp. 19-28.
4. Sokal A. Transgressing the boundaries: towards a transformative hermeneutics of quantum gravity. Social Text 1996; 46/47: 217-252. [link]
5. Levins R. Ten propositions on science and antiscience. Social Text 1996; 14: 101-110.
6. Koertge N. Postmodernisms and the problem of science literacy. In Koertge N, editor. A House Built on Sand: Exposing Postmodernist Myths About Science. New York: Oxford University Press, 1998. Pp. 257-271.
7. Berkwits M. From practice to research: the case for criticism in an age of evidence. Soc Sci Med 1998; 47: 1539-1545.
8. Kaptchuk TJ. Powerful placebo: the dark side of the randomised controlled trial. Lancet 1998; 351: 1722-1725.
9. Gergen KJ. Psychological science in a postmodern context. Am Psychologist 2001; 56: 803-813.
10. Robbins B. Anatomy of a hoax. Tikkun 1996; 11: 58-59.
11. Sokal A. A plea for reason, evidence, and logic. New Politics 1997; 6: 126-129. [link]
12. Bricmont J, Sokal A. Modesty, rigor and irony: some remarks on Prodiges et Vertiges de L'analogie: De L'abius des Belles Lettres dans la Pensee by Jacques Bouveresse. Agone 2000; 24: 115-122.[link]

Health Care Bureaucracy

The New York Times reported on the bureaucratic hurdles patients face, especially in regard to paying their health care bills. Some of the quotes in it are priceless:

But become a patient, and you enter a world of paperwork so surreal that it belongs in one of Kafka's tales of the triumph of faceless bureaucracy.

Nothing is as it seems: patients receive statements that often do not reflect what is actually owed; telephone calls to customer service agents are at best time-consuming and at worse fruitless. The explanation of benefits that insurers send out - known as E.O.B.'s - are filled with unintelligible codes.

I'm the president's senior adivser on health information technology, and when I get an E.O.B. for my 4-year old's care, I can't figure out what happened, or what I'm supposed to do - Dr. David Brailer, National Coordinator for Health Information Technology

I understand the words of diagnoses and procedures. But codes? No. Or how things are paid or not paid? I don't understand that - Dr. Blackford Middleton, Harvard Medical School

The number of bureaucrats between the point of service and the final cash reckoning is just incredible. - Dr. Thomas Delbanco, Harvard Medical School

You can't be just sick. You have to be sick and drowning in paperwork. It's comical. It's unbelievable. What if I was an elderly person, or a single person? What if I wasn't healthy enough to handle it? - Cancer patient

I'm paying through the nose for this premium, and when I go to the doctor it's a roll of the dice as to whether or not they'll pay it. It seems like it depends on the mood of whoever happens to be doing the claim that day, or on the phases of the moon. - Patient who received three radically different E.O.B.'s from his insurer for three visits for bronchitis

The article also suggested that 30% of US health care expenditures now goes for administration, although it gave no source for this data. If true, that means the US spends more than $300 billion a year on health care bureaucracy.
Funny, I thought those who proposed managed care said it would save money....
Anyone still doubt that there is something horribly wrong with how many of our health care organizations are run?

Lawsuit Alleges Catholic Healthcare West Over-Charged Uninsured Patients

The Los Angeles Times reported yet more allegations that hospitals charge higher "list prices" for patients least able to pay them, while giving discounts to insured patients. "Activist" K. B. Forbes, who heads Consejo de Latinos Unidos, in Los Angeles, launched a class-action suit against Catholic Healthcare West.
This is a not-for-profit health care system which claims to be "a system of 40 hospitals and medical centers in California, Arizona and Nevada. Founded in 1986, CHW is the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California." The system's mission statement is:

Catholic Healthcare West and our Sponsoring Congregations are committed to furthering the healing ministry of Jesus. We dedicate our resources to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and partnering with others in the community to improve the quality of life.

The lawsuit, however, charged that Catholic Healthcare West overcharged uninsured patients compared with what it charges those who have insurance. One plaintiff was Mirna Esupinian, who was billed $20,296 for a two-day hospital stay for gastritis. The lawsuit claimed that the "average private insurer" would have been billed $5,600, and Medicare, $3,994 for similar care. Estupinian took out a loan to pay her bill. The hospital suggested she raid her son's college savings to pay it.
Another plaintiff is Sergio Pantoja, who was billed $15,897 for a five-hour stay after he was in a hit-and-run accident. Again, the lawsuit claimed an average insurer would have been billed $4,451 for such a visit. Pantoja makes $9,000 yearly as a tattoo artist.
"Forbes said Catholic Healthcare West should have alerted these patients to charity care programs they may have qualified for and should have identified government assistance programs." "Forbes said the tactic preys on the fears of uninsured patients who want to protect their credit and have no idea what the regularly discounted rate is for a procedure."
We have previously posted about how not-for-profit hospitals frequently charge uninsured patients, who are often poor, much higher rates than insured patients. (See this link for a recent post about another suit by Consejo de Latinos Unidos, and an earlier post about the apparently ongoing congressional investigation of this billing practice.) This practice surely is yet another driver of high health care costs.
Worse, it directly undermines the hospital's charitable missions. In the example above, Catholic Healthcare West claims to offer "affordable health care," and to advocate for "our sisters and brothers who are poor and disenfranchised." How can the system's executives possibly square their stated mission with their bills to Ms. Esupinian and Mr. Pantoja?
Health care executives who actually try to fulfill their organizations' lofty mission statements would take us far down the road to the accessible, affordable, high-quality health care everyone says they want.

Johnson and Johnson Sues Amgen for Anti-Competitive Practices in Marketing Aranesp

Various news agencies (see link here for Reuters version as posted by Fox News) have reported that Johnson and Johnson is suing Amgen for anti-competitive practices used to market its durg darbepoitin (trade name: Aranesp), used to reduce anemia, especially for patients undergoing chemotherapy. Johnson and Johnson, maker of competing anti-anemia drug epoetin (marketed as Procrit), claimed that Amgen requires oncology clinics to sign contracts requiring that they purchase Aranesp if they want discounts on its drug used to ameliorate neutropenia, pegfilgrastim (marketed as Neulasta, and previously as Neupogen). Neutropenia, like anemia, is a common side-effect of chemotherapy. The lawsuit charged that Amgen's contract structure "represent anti-competitive business practice that restricts the ability of oncologists to choose treatments best suited to the individual needs of patients with cancer who suffer from anemia related to chemotherapy."
Amgen, of course, replied that "the allegations in the lawsuit are without merit."
I suppose it's nice to see a pharamaceutical company trying to fight anti-competitive practices. The federal government no longer seems very interested in this problem in health care, especially in the form of local markets dominated by few insurers or large hospital systems.
But, again, as is often demonstrated on Health Care Renewal, the power resulting from the size of health care organizations tends to corrupt.
And, of course, if the alleged anti-competitive practices did occur in this case, they would be just another way to push up the prices of drugs, a major component of rising health care costs. (See our recent post here on how much we spend on me-too drugs.)

Medicare's Lax Approach to Fraud by Suppliers of Medical Equipment

A report by the Associated Press (link here to the Washington Post version) documented the lax controls Medicare has in place to combat fraud involving medical equipment. In particular, equipment suppliers who had been suspended from Medicare participation for violating the rules were often quickly reinstated (192 out of 1038 suspended in 2003 were back in business by mid-2004).
Medicare, it turns out, outsources monitoring of these contracts to the National Supplier Clearinghouse. "But investigators said these standards are too weak to effectively screen out frauds." In addition, the Government Accountability Office also charged the Clearinghouse failed to conduct onsite inspections of suppliers.
Medicare spent about $8.8 billion for medical equipment in 2004.
Again, health policy makers complain repeatedly about the high and rising costs of health care, but when it comes to controlling these costs, they generally take a lax attitude to the sorts of fraud and over-charging that we have noted again and again on Health Care Renewal. Instead, most cost-cutting pressure is on physicians, particularly in primary care and the cognitive specialties, acute hospital care, and mental health. For example, Medicare is once again threatening to cut physicians' reimbursement across the board by 4.4%. This will have the greatest negative effect on primary care and cognitive specialists, who already receive relatively low reimbursement rates. What are the priorities here?

Pseudoscience in Medical Schools

In the October 6th New England Journal of Medicine, Deputy Editor Robert Schwartz worries that medical schools may start teaching pseudoscience, in the form of "intelligent design”: Faith Healers and Physicians — Teaching Pseudoscience by Mandate

The dirty not-so-secret is that pseudoscience has already been pushed by medical schools for more than a decade, under the title "complementary and alternative medicine." Look for letters to the editor making this point.

Kimball Atwood, MD    

Why Do We Have Pandemic (Un)Preparedness?

The Washington Post has an editorial today about US pandemic preparedness, or lack thereof. It noted, in particular, that a big obstacle to developing and administering a vaccine for avian influenza is that "American pharmaceutical companies, scared off by liability issues and low profits, no longer make vaccines at all." Additionally, it notes that the country will need to provide "help for US hospitals, which are filled to capacity."
It would be well for editorial writers to ponder why a country that spends more than $1 trillion on health care a year is unable to produce any vaccines, and does not have enough hospital beds to respond to natural disasters.
In general, despite our immense spending, the US has decreasing capacity to provide primary care, to provide acute care, and to provide for public health. Although millions of words have doubtless been written about our ever-rising health care costs, there has been too little enquiry about where all that money is going.
I hardly have all the answers. Yet perusal of Health Care Renewal would suggest that much of the money is not being wisely spent, and far too much fails to provide health care on the ground.
For example, we have put up numerous posts on how we over-pay for some drugs, devices, and procedures, especially those that are new and apparently high-tech, or once were. Most recent examples range from $1600 screws used for spinal surgery (see post here) to currently marketed brand-name prescription drugs whose yearly price increases are far greater than inflation (see post here).
We seem to spend inordinate amounts on management, administration, and bureaucracy, on marketing, and on legal expenses. Regarding the former, the number of health care managers grew over 700% from 1983 to 2000, and there are now more managers in the US than doctors (see post here). The CEO of a not-for-profit health care system can command more than $500,000 in total compensation (see post here), of a not-for-profit managed care company, over $1 million (see post here), and of a for-profit managed care organization, over $100 million (see post here).
All too often, those who run US health care organizations have conflicts of interest. Recent examples include those alleged about the board of the University of Medicine and Dentistry of New Jersey (see post here), advisory panels of the US Food and Drug Administration (FDA) (see post here), top leaders of the US National Institutes of Health (NIH) (see posts here and here), etc., ect. Some have wound up convicted, e.g., recently, the former CEO of the Fletcher Allen health care system (see post here).
Thus, it seems that the excess power concentrated in ever-larger US health care organizations, and mismanagement, conflicts of interest, and even corruption at the tops of these organizations have diverted resources away from actually providing health care to those who need it. We spend more and more on hospital management, but have fewer acute care hospital beds. We have endless supplies of drugs for erectile dysfunction and restless leg syndrome, but not of influenza vaccine.
But we won't be able to address this problem until enough people become aware of it.

Throwing Sunshine On the Regulation of Homeopaths

The Arizona Republic has published a fascinating report on the Arizona Board of Homeopathic Medical Examiners. Some of its main points were:

• Arizona is one of the few states that has a licensing procedure for homeopathy. In Arizona, however, those licensed in homeopathy are not restricted to practicing homeopathy, but are allowed to prescribe medications freely, perform minor surgery, and "practice a wide variety of alternative medicine treatments," including chelation therapy. To be licensed in homeopathy in Arizona, one must have a medical or osteopathic license from another state. The majority of the Board are licensed homeopaths.
• The board has made it a point to attract physicians from other states "who have been disciplined unfairly in other states and whose skills could benefit patients seeking alternative remedies." The Arizona Homeopathic and Integrative Medical Association sought physicians who had been "'oppressed' by medical boards elsewhere." A former chairman of the Arizona Board of Homeopathic Medical Examiners, "There are doctors that have been enlightened as far as natural cures that have been around for hundreds of years, and their medical boards take them up on charges. These doctors are welcomed here to practice integrative medicine."
• The Board has only revoked two licenses in its history. It has licensed several homeopaths with felony convictions in other states. These included Dr. Jeffrey Rutgard, an eye doctor from California who served five years in prison for Medicare fraud; Dr. Rick Shacket, and Dr. Robert Rowen, both of California, "convicted in tax cases;" and Dr. Joseph Collins of New Mexico, convicted of securities fraud.
• The Board dismissed complaints against a homeopath who had a Florida license suspended for "fondling patients;" a Board member who gave "Vitamin C therapy" to a patient with an infected blister who later suffered "acute renal failure;" and a Board member accused of sexual harassment, after the complainant failed to show up at a meeting because of a "family emergency." According to a separate story in the Arizona Republic, the Board dismissed a complaint against a homeopath who injected a patient with "bovine adrenal fluid" for "fatigue," and then, after the patient developed an abscess at the injection site, and complained of pain and swelling, treated it with "acupuncture and message." The patient died of "gas gangrene infection."
• One former non-homeopath Board member said "There have been doctors that they've licensed that I wouldn't send my worst enemy to. They just want one more boy in the band. They don't care."

The Board has not been audited for 20 years, but now state legislators are calling for an audit before the Board faces a "sunset" review next year.
The Lancet recently published a systematic review of homeopathy [Shang A et al. Are the clinical effects of homeopahty placebo effects? - comparative study of placebo-controlled trials of homeopathy and allopathy. Lancet 2005; 366: 726-732.] whose findings were "compatible with the notion that the clinical effects of homeopathy are placebo effects." An accompanying editorial [Anonymous. The end of homeopathy. Lancet 2005; 366: 690.] put it more strongly,

That homeopathy fares poorly when compared with allopathy in Ajing Shang and colleagues' systematic review is unsurprising. Of greater interest is the fact that this debate continues, despite 150 years of unfavourable findings. The more dilute the evidence for homeopathy becomes, the greater seems its popularity.
For too long, a politically correct laissez-faire attitude has existed towards homeopathy....
Surely the time has passed for selective analyses, biased reports, or further investment in research to perpetuate the homeopathy versus allopathy debate. Now doctors need to be bold with patients about homeopathy's lack of benefit, and with themselves about the failings of modern medicine to address patients' needs for personalised care.

It appears to me that the conduct of the Arizona Board of Homeopathic Medical Examiners provides yet another example of a failing government health care regulatory body. I cannot understand why a license to practice homeopathy should entitle its holder to prescribe the conventional medicines that homeopaths supposedly eschew. If it does, however, the holders of such licenses should be held to the same standards as those with conventional medical licenses. Their misconduct should not be excused by their supposed victimization due to the "oppression" of homeopathy. Certainly, the Board should not be "welcoming" physicians from other states who have had their licenses revoked, or have been convicted of felonies.
While the US can spend money and effort supporting repeatedly discredited alternative medicine systems like homeopathy, we don't seem to have the resources to make enough vaccine for avian influenza, much less cover the 40 million plus uninsured Americans. There is something seriously wrong with our priorities.

Most Drug Expenditures for "Me-Too" Drugs

The British Medical Journal just published a significant article about drug prices. (Morgan SG et al. "Breakthough" drugs and growth in expenditure on prescription drugs in Canada. Br Med J 2005; 331: 815-816.)
Some have suggested that rising health care costs are in part attributable to new, innovative, effective treatments. Morgan et al used existing categorizations by the Canadian Patented Medicine Price Review Board to classify all new prescription drugs available in Canada since 1990 as "breakthrough" - "the first drug to treat effectively a particular illness or which provides substantial improvement over existing drug products," to which Morgan and colleagues added later drugs added in the same chemical class; "me-too," other new drugs patented since 1990 that did not provide substantial improvements over existing drugs. Drugs available before 1990 were categorized as vintage brand or vintage generic.
The investigators then broke down drug expenditures in British Columbia from 1996 to 2003 by drug type.
Breakthrough drugs accounted for 6% of expenditure and 1% of use in 1996, and 10% and 2% in 2003.
"In contrast, me-too drugs accounted for 44% of use and 63% of expenditure by 2003."
They concluded, "In British Columbia most 980%) of the increase in drug expenditure between 1996 adn 2003 was explained by the use of new, patented drug products that did not offer substantial improvements on less expensive alternatives available before 1990. The rising costs of using these me-too drugs at prices far exceeding those of time tested competitors deserves careful scrutiny." Furthermore, "given that the list of top 20 drugs in global sales includes newly patented version of drugs in long established categories (that is, marketed before 1990) - such as angiotensin converting enzyme inhibitors, statins, selective serotonin reuptake inhibitors, and proton pump inhibitors - me-too drugs probably dominate spending trends in most developed countries."
This says something very important about the bizarre financial incentives prevalent not only in the US health care system, but throughout at least the developed world. We spend huge amounts on expensive drugs that provide little advantage over cheaper alternatives, and then seem to not have enough money for primary and generalist care, for acute care, to handle unexpected crises, to provide care to the less fortunate, etc., etc., etc. In the US, we seem to have plenty of capacity to treat erectile dysfunction and restless leg syndrome, but not enough capacity to make a vaccine for avian influenza (see this article) . What is wrong with this picture?

The Rush to In-Store Health Clinics

The Wall Street Journal published an interesting article (subscription not required) about what appears to be the latest fashion in US commercial health care, "in-store health clinics."
The major players include the pharmacy chains. "Rite Aid Corp., Brooks Eckered Pharmacy and Osco Drug - have announced plans to open health clinics in the coming months. All three have partnered with a Pennsylvania-based health care start-up called Take Care Health Systems LLC that will lease space inside the pharmacies and operate the clinics." "CVS and Target are working with Minneapolis-based MinuteClinic.... Wal-Mart is working with InterFit Health and other companies...."
The motivation, of course, is money. "While the retailers don't profit directly from the new services, the hope is that the clinics will boost business if patients fill their prescriptions at the store pharmacy, or pick up other items on their way out."
US health insurers seem to "have embraced the concept because the clinics promise considerable savings. While a typical doctor visit for a basic illness costs an insurer about $110, a visit to one of the clinics usually costs under $60." "Some insurers are actively encouraging patients to use the clinics by lowering the co-pay. In Minnesota, companies including Blue Cross Blue Shield of Minnesota and Graco Inc. have reduced or eliminate co-pays for employees who opt to use a MinuteClinic instead of a doctor. Take Care has deals in place with several insurers in Portland."
It is revealing that "the management teams behind both of the leading companies in the field - Take Care and MinuteClinic - have experience in other consumer focused industries. MinuteClinic's new chief executive officer (CEO), Michael C. Howe, is the former president and CEO of the Arby's fast-food chain, and previous worked for KFC. Hal Rosenbluth, chairman of the board of Take Care, is the former CEO of Rosenbluth International, a travel company acquired by American Express Co...."
Take Care, run by the former travel agency executive, is pioneering novel use of computer technology, "a computer software program will be involved in actually diagnosing illnesses. The patient's sign-in information will be transmitted electronically to a computer terminal inside the treatment room.... The software system will eventually generate a diagnosis and recommend course of treatment. If the nurse practitioner disagrees with the computer-generate diagnosis, he or she can opt to over-ride the system."
Some patients seem very happy with the whole concept. The Wall Street Journal quoted on Terri Whitesel, a 56-year old marketing consultant in Minneapolis. "I didn't want to go to the doctor and sit around waiting with a bunch of people who are really sick."
But Edward Hill, President of the American Medical Association, tried to throw some cold water on the concept. "Serious illness sometimes presents with simple symptoms. A cough may be something as simple as a cold, or something as serious as congestive heart failure. The ability to ferret out the 20% of serious illnesses that present with simple symptoms is what we went to medical school for."
I have posted about MinuteClinics before. Dr. Hill's concern that even apparently simple complaints may sometimes stem from serious problems is a real one. It is amplified if, as reported in the earlier post, the in-store clinic may not have adequate facilities for the nurse practitioner to do some basic parts of the physical examination. It is further amplified if the diagnosis and decision making will actually be entrusted, not to a nurse practitioner, but to some piece of computer software, whose accuracy and reliability are unknown.
This report again emphasizes how managed care companies and insurers are quick to try to save money at the expense of primary care, when they seem reluctant to confront high prices of drugs, devices, and procedures, especially those that are seemingly high-technology, regardless of their effectiveness. (Some recent posts about such prices are here, here, here, and here.)
Finally, this attempt to siphon off the least sick patients may further disrupt an already fragile primary care/ generalist infrastructure in the US. Yet in most countries, primary care is the bed-rock of the health care system. In the US, we have less and less capacity to take care of the patients with more than one real illness, or with undiagnosed problems. Will patients with five chronic illnesses (who are not rare) have to go to five different sub-specialists? Will patients with chest pain have to guess whether their problem is cardiac, pulmonary, gastro-intestinal, or musculoskeletal before they can figure out what doctor to see? How will a system without primary care cope with health care crises from terrorist attacks, to hurricanes, to avian flu?
These aren't, of course, the sort of questions likely to be asked by former executives of fast food companies and travel agencies, until they become the patients in question. And by then, it may be too late.