Media Reports on How Pharmaceutical Companies May Manipulate Information

Newspapers have become interested, again, in the issue of pharmaceutical companies manipulating information supplied to the public or health care professionals.

USA Today published several stories on the pharmaceutical industry. One was on various tactics the industry may used to mislead the public in television direct to consumer advertising, according to the US Food and Drug Administration (FDA). These included:

• Overstating the effectiveness of a drug. For example, a Novartis ad included graphics that implied, according to the FDA, Lamisil is completely effective in eradicating nail fungus. The FDA asserted, in contrast, that clinical trials only revealed a 38% cure rate.
• Advertising a drug for problems other than those for which its use was approved by the FDA. For example, Wyeth advertised Effexor as treatment of mild depressive symptoms, according to the FDA. The drug, however, was only approved by the FDA for major depressive disorder.
• Unsubstantiated claims. For example, Hoffman-La Roche advertised Xeloda, a cancer chemotherapy agent, using testimonials that the drug didn't make patients "too tired" or "too sick." However, the FDA noted "in stark contrast" the number of reports that Xeloda makes people feel sick and tired.

USA Today also ran a story on how pharmaceutical companies may ghost-write articles, and then try to get academics to pose as first authors. (Our last posting on ghost-writing is here, and a posting about how medical schools are willing to sign contracts with research sponsors that allow the sponsors to write up research results, is here.) It included an estimate by Dr. Martha Gerrity, Co-Editor of the Journal of General Internal Medicine, that two to four of the 70-80 manuscripts the journal receives each month may be ghost-written. Dr. Catherine DeAngelis, the Editor of the Journal of the American Medical Association said that before she became an editor, she got one phone call a month asking her to pose as the author of a ghost-written article. The article provides another bit of evidence that ghost-writing may be far more prevalent than most physicians and researchers realized. Yet, as Dr. DeAngelis said, ghost-writing is "manipulation by for-profits to alter what's in the (medical) literature so that they could sell their products."
Finally, the NY Times ran a story suggesting that pharmaceutical companies seem split about whether to submit information to online registries of controlled trials. These registries had been proposed as a way to prevent the companies from hiding unfavorable results of clinical trials.
Some companies, notably Eli Lilly, have apparently been quick to provide trial information to the registries. Dr. Alan Breier, the company's chief medical officer, said "fundamentally, what we're doing is in the interest of patients, and I think that this is the winning model, for academia, for industry, and the future."
On the other hand, some companies, e.g., Merck, Pfizer, and GlaxoSmithKline, have been stingy in the information they have provided to the NIH clinical trials registry, clinicaltrials.gov. Dr. Deborah Zarin, the director of the site, noted, for example, that Merck only said that one trial was a "one-year stury of an investigational drug in obese patients." Failing to provide crucial details, like the name of the drug, would make it impossible in the future to tell if Merck ever published a report of the trial's results.
The Times reported that "executives and press representatives at the companies said generally that disclosing too much information about early-state trials might reveal business or scientfic secrets." On the other hand, Dr. Breir of Lilly felt that it could supply information to the registry while still protecting its intellectual property.
In summary, physicians' efforts to make decisions for patients based on the best available research data are frustrated when companies hide or manipulate research results which put their products in a bad light. Manipulating or hiding research results betrays those patients who volunteered to participate in clinical trials intending to help advance science and improve patient care. Misleading advertising pushes patients to get treatments that are needlessly expensive, and sometimes needlessly hazardous. Too often, pharmaceutical companies seem to have forgotten their high-minded promises to help patients with better treatments in the pursuit of short-term profits.

Editorial Argues Against Softening NIH Conflict of Interest Rules

The question of whether the NIH should soften its now stringent conflict of interest rules re-surfaced in an editorial in the Hartford Courant. Some choice quotes:

"Prodded by newspaper exposes and congressional inquiries, the NIH instituted a series of reforms. Scientists were barred from accepting compensation from the biomedical industry. Also, the NIH's top 7,000 staffers were prohibited from owning stock in individual medical companies, while all other employees were directed to limit their holdings to $15,000."

"The stock restrictions have raised the ire of a group calling itself the Assembly of Scientists, whose members have threatened to leave the NIH if the reforms aren't scaled back. Health and Human Services Secretary Mike Leavitt, who oversees the NIH, said he's considering their request, calling it a would-be 'softening of the conflict-of-interest policy.'

"In truth, it's more like selling out. Fortunes can be made or lost in biomedical stocks, based on the development or demise of breakthrough drugs and treatments. If researchers were allowed to replenish their portfolios with drug industry stocks, the temptations and biases of recent years would return in force. Mr. Leavitt should stand pat. The NIH's conflict-of-interest policy doesn't need any loopholes blown through it. "

Should US Not-For-Profit Hospitals Lose Their Privileged Status?

The Baltimore Sun reports that both the US House of Representatives Ways and Means Committee and the Senate Finance Committee are opening enquiries about whether US not-for-profit hospitals should keep their tax exemptions.
Rep. Bill Thomas (R-California) said, "We really can't tell the difference, all that much, between a for-profit and a not-for-profit. What is the taxpayer getting in return for the tens of billions of dollars per year in tax subsidy?" Sen. Charles Grassley (R-Iowa) said "It's also my job to make sure charities are earning their generous tax breaks. Tax-exempt status is a privilege."
Mark Everson, Commissioner of the Internal Revenue Service, testified "We at the IRS are now faced with a health care industry in which it is increasingly difficult to differentiate for-profit from nonprofit health care providers." The article further explained, "IRS reviews have turned up questions about excessive executive compensation, complex ventures with profitable companies, employment taxes and operations benefiting a private, not public good."
I am not surprised that politicians are beginning to question why supposedly "not-for-profit" hospitals should keep their privileged status. Since I first did the interviews that resulted in my European Journal of Internal Medicine article on health care dysfunction, I have heard about case after case about questionable leadership of large health care organizations, including many that involved not-for-profit hospitals. Just this month, for example, Health Care Renewal postings have included cases of :

• exaggerated and possibly misleading advertising (here and here);
• charging inflated "list prices," since managed care organizations think they are getting a bargain when they apply fixed discounts to whatever the hospitals want to charge, even if poor, uninsured patients are then charged full "list prices" (see here, here, and here); and
• miscellaneous fraud involving Medicaid billing (here), and construction kickbacks (here)

all involving not-for-profit hospitals.
Of course, ending all not-for-profit hospitals' tax exemption would be an exceedingly blunt way to address these problems. I have no doubt that there are many competently and honestly lead hospitals, whose leaders make real efforts to fulfill their missions, and to add real value to their communities. They do not deserve to lose their tax exemptions. However, they risk being thrown in the same bucket with their "bad apple" brethren. Up to now, hospital leaders as a group have not made readily apparent attempts to police their own ranks.
Thus, we need some better watchdog and/or regulatory mechanisms to address ill-informed, conflicted, and corrupt leadership of not-for-profit hospitals, (and of other health care organizations). Perhaps hospital leaders will develop develop a self-policing mechanism. Perhaps these mechanisms could be set up by physicians and other health care professionals, or as part of government regulatory agencies. However, not having these mechanisms means that continuing abuses will tempt politicians to employ indiscriminate, shot-gun approaches which will harm the good apples along with the bad.

A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors

The NEJM article about contracts for clinical trials between academic health centers (AHCs) and pharmaceutical companies mentioned in an earlier post deserves further attention. (The study is available here, and its citation is Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.)

First, let me summarze the study's design. The authors sent a survey to senior administrators in the offices of sponsored research in 122 medical schools. They received responses from 107, for 91% response rate, excluding four schools that did no clinical research. They asked the administrators questions about provisions they would usually allow in contracts between their medical schools and corporate sponsors. The proportions who would allow some particular research practices follow:

• The sponsor will own the data produced by the research - 80%
• The sponsor will store the data and release portions to the investigator - 35%
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
• The sponsor may include its own statistical analysis in manuscripts - 24%
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
• The terms of the clinical-trial agreement are confidential - 62%
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%

In summary, this study suggests that some medical schools will acquiesce to contracts that prevent their faculty from having meaningful control over research projects for which they are the ostensible investigators. Some medical schools will allow corporate research sponsors to manipulate the design, analysis, and interpretation of results to increase the likelihood of getting the results the sponsor wants. For example, 50% of medical schools would allow the corporate sponsor to write manuscripts reporting on study results, and only allow faculty to "suggest revisions." Thus, many medical schools acquiesce to contracts that could allow corporate sponsors to ghost-write articles. Furthermore, more than half of the medical schools acquiesce to contracts that are kept confidential, preventing easy discovery of manipulation of the conduct and dissemination of the research by the corporate sponsor.
(To see specific techniques that corporate sponsors may use to increase the likelihood that research produces the results they want, see our earlier post about the article entitled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies" by Richard Smith.)
To underline the context, in my experience, to do clinical research, most medical school faculty are strongly pressured by their institutions to obtain external funding to support this work. Those who cannot obtain funding within a few years of unemployment often have to find something else to do other than research. However, although faculty are expected to find sources of funding, it is generally the medical schools or academic medical centers, not the researchers, who negotiate research agreements, and although such agreements may bind faculty members, the money paid under their auspices generally goes directly to the faculty member's employer. Thus, individual researchers are under considerable pressure to find grant and contract funding, and to keep their financial sponsors happy, but must work under whatever contract provisions their employers negotiate.
The New England Journal of Medicine article clearly suggests that some medical schools allow researchers to be bound by agreements that allow the study's sponsor to manipulate study design, analysis, and interpretation to make it more likely that the results will be to the sponsor's liking. Since clinical trials enroll real human beings as subjects with the promise that the data they contribute, and the risks they run, will lead to valid scientific results, allowing such manipulation appears to not only likely to produce biased results, but also to be allow unethical exploitation of human subjects, and thus is in conflict with the medical school's scientific and humanitarian mission.
This is yet another illustration of leaders of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
One can only hope that publicizing such practices will lead to more ethical research, and less exploitation of human subjects.
By the way, I do not in any sense mean to blame the research administrators who must try to negotiate these contracts. Note that 69% of the administrators "perceived that competition for research funds created pressure on administrators to compromise on the language of the contract." 24% described the pressure as "great." I do blame the higher leadership of the medical schools for fostering a climate in which money is more important than doing valid, ethical research. This raises several important questions:

• Why don't some medical school leaders enforce clearer ethical standards for clinical research sponsored by industry?
• Are they so worried about getting the money, and so worried that they will lose contracts if they insist on ethical standards?
• Are they so steeped in the exteme relativism of the post-modernist university that they don't believe in such standards?
• Are they so used to violating their own mission to support political causes, as is documented again and again on the FIRE web-site, that they aren't troubled by violating their mission for economic reasons?

Maybe it's time we start trying to address such questions.

Wall Street Journal: Medical Editor Turns Activist On Drug Trials

NEJM editor Drazen returns to the Light Side of the Force. The revelation about academic medical centers willingly accepting ghost-writing or marginalization of their faculty as principal authors is stunning.

JEFFREY DRAZEN, editor of the prestigious New England Journal of Medicine, has prescribed a strong dose of disclosure for the pharmaceutical industry he was once accused of embracing too closely.

This week, Dr. Drazen accused three big pharmaceutical companies of "making a mockery" of a government database designed to provide accessible information about drug trials. He also joined a dozen other medical-journal editors in again warning that they might refuse to publish studies that don't adhere to their disclosure demands. Dr. Drazen has also recently written, and his journal has published, pieces critical of companies suppressing negative information about drug trials.

And the journal today plans to publish a study suggesting that drug companies may be exerting more influence over the supposedly independent academic investigators that they hire to conduct drug trials than had previously been known. The study, a survey of 107 medical-school research centers, shows that half would allow sponsors of their research to draft manuscripts reporting the results while limiting the role of the investigator to suggesting revisions.

... Dr. Drazen's newfound activism is especially striking since he came under fire for his own financial ties to the pharmaceutical industry when he took his current job at the New England Journal five years ago.

"He's been converted," said Marcia Angell, senior lecturer at Harvard Medical School and Dr. Drazen's predecessor as editor-in- chief. "Through painful experience, Jeff is learning what these companies are about. He sees the ugly side that he hadn't seen before -- the bias that company-sponsored research contains, the suppression of results that they don't like, the spin of unfavorable results."

-- SS

"Another Guy Who Ethically Ran Amok": Bellevue Hospital Executive Fired

The New York Times reports yet another hospital chief executive leaving in disgrace. Carlos F. Perez, executive director of Bellevue Hospital Center, was fired after he was accused of taking a loan from a company that did business with city hospitals. The acting director the New York City Health and Hospitals Corporation, of which Bellevue is a part, declared, "We have no tolerance for unethical conduct in our city's public hospitals. This breach of the public trust is a disservice to our patients and the thousands of H.H.C employees."
Perez is the second chief executive of a New York City public hospital to depart under a cloud in the last week. We recently posted about how Joseph Orlando, the executive director of Jacobi Hospital, was fired because his hospital failed to notify hundreds of women about suspicious Pap test results.
A City Councilwoman declared, "I am shocked about the development at Bellevue and the fact that in less then [sic] a week we have lost two of our hospital leaders. It really raises questions to me about management of H.H.C. You had one guy who was not managing his staff, and now you have another guy who ethically ran amok."
Earlier this month, we posted about the firing of Joseph Pisani, the Chief Administative Officer of Westchester (NY) County Medical Center, after it was reported he had been involved in fraudulant practices at Staten Island (NY) University Hospital.
It hasn't been a good month for hospital leadership in New York.
However, this is not just a regional problem. This cluster of cases should remind us how widespread the problem of unethical leadership of large health organizations is. If we want things to get better, physicians must get involved in systematically uncovering incompetent, unethical, and corrupt leadership, while fostering representative, transparent, ethical and responsible health care governance.

Lawyers Sue Hospital Based on What it Advertised

Lawyers have noticed how hospitals are making exaggerated claims about their services, as reported by the Boston Globe.
The story involves the unfortunate case of a patient who died after bariatric surgery (i.e., after a procedure meant to reduce stomach size, and so induce weight loss). In Massachusetts, the law limits the damages collectable from civil suits against not-for-profit organizations, including hospitals, to $20,000. However, in this case, the plaintiff's lawyers are contending that "these stomach banding procedures are profit centers, that the hospitals advertise, they make promises, they do all things businesses do." Based on this argument, they initially asked Beth Israel Deaconess Hospital for a settlement of $8.5 million, and then filed a law-suit naming the hospital, as well as three members of the hospital's anesthesia staff.
The article also noted that other states are abolishing restrictions on the damages that can be collected from hospitals, based on reasoning that "the legal system should not treat hospitals differently than other corporations, especially as hospitals merge into large organizations that increasingly market their products and compete for patients."
Health Care Renewal has posted examples of hospitals (and other health care not-for-profits) acting more like for-profit businesses, and of some hospitals exhibiting unethical business practices. In particular, we have posted about questionable hospital advertising claims here and here. The second link is to a study of advertising done by prominent academic medical centers. The authors concluded, "Many of the ads seem to place the interests of the medical center before the interests of the patients."
The law may be a somewhat blunt tool to change these practices, but if we in health care cannot come up with a more nuanced approach, it is a tool likely to be increasingly employed.

Fewer Physicians Interested in Generalist Careers

There is more information available about the decreasing number of physicians interested in being generalists.
A detailed survey based study of internal medicine residents' career choices just appeared in Academic Medicine, and was discussed in the American Medical News. [The article citation is: Garibaldi RA, Popkave C, Bylsma W. Career plans for trainees in internal medicine residency programs. Acad Med 2005; 80: 507-512.]
The article shows that the proportion of residents who go into general internal medicine has fallen from 54% in 1998 to 27% in 2003 (34% if hospitalists are added to general internists.) Reasons for going into sub-specialties admitted by survey respondents included higher income, and narrow practice area.
The American Medical News did not try to white-wash these results. It quoted a third year resident, chair of the AMA Resident's and Fellow's Section, who is going into gastroenterology because, "I'll be paid what my education is worth," and contrasted that situation with the lot of the general internist who makes "$110,000 a year.... That's a salary someone with less education and training can earn in other fields, without the debt of medical school, years spent training and commitment to a lifetime of being on call."
Steve Fihn, past President of the Society of General Internal Medicine, said "It's a pretty daunting task trying to reverse this trend when the economic forces are so strong."
On the other hand, the ASP Observer featured an article about the results of this year's internship match, i.e., how many medical students chose internal medicine training. The article was mainly positive, since the numbers choosing internal medicine have gone up slightly. "That's good news," since the numbers were dropping from 1998 to 2003.
However, the report also included the observation that internal medicine training program directors report that the proportion of residents going into general internal medicine has dropped from about 50% to about 20-25%, similar figures to those in the article by Garibaldi et al. But Steven E. Weinberger, ACP Vice President for Medical Knowledge and Education, suggested that the solution for dropping interest in general internal medicine would be the ACP's efforts to "fix Medicare reimbursement, for instance, and to help craft new chronic care models.... Creative models of high quality, team-based care offer a real opportunity to address the lifestyle issues." What sort of "chronic care models" he envisions, and how they will help generalists practice medicine, was not very obvious.
So the big question is whether our health care leaders and policy makers will make an effective attempt to reverse the decline of the generalist physician before the species becomes extinct.
At least some show understanding of the severity of stresses on generalists. Dr. Fihn, for example, is frank about the economic incentives.
However, as demonstrated by the issues discussed on this blog, not only are generalists at the bottom of the economic pecking order, they seem particularly impacted by the huge rise in health care bureaucracy, and particularly vulnerable to challenges to physicians' professional values instigated by large organizations lead by leaders with conflicting interests. They will need more than new "chronic care models" to survive these threats.

Guideant's Short Circuit

The New York Times reports yet another story of flawed implantable cardiac defibrillators (ICDs). This time, Guidant Corporation revealed that its ICDs manufactured from 2000 to 2002, can short circuit, fail, and thus become unable to prevent cardiac arrhythmias. Guidant corrected the design flaw that allowed these failures to occur in ICDs manufactured after mid-2002.
However, it only got around to notifying physicians and the public about the problem recently, after the company was informed that the Times was working on an article about the problem. The company's argument was that short-circuits are rare: only 25 cases of short-circuts are known. Furthermore, replacing the ICD requires an invasive procedure, and hence is not risk-free.
However, doctors and patients ought be able to decide about whether to take this risk, based on full disclosure of the relevant data.
This is the third problem with ICDs that has appeared in this blog. The others involved problems in devices manufactured by Access Cardiosystems, and by Medtronic.
The NY Times article notes that ICDs cost about $25,000 a piece, and that Guidant sold about $1.9 billion worth last year. Given the low cost of very sophisticated modern electronics, this unit price seems very high. IT should at least buy unimpeachable reliability. Why managed care has not been able to bargain down the prices of such devices remains an open question. But meanwhile they surely account for some of the seemingly inexorable rise of health care costs.
But regardless of what $25,000 ought to buy, there seems to be no good excuse to hide data about this device's flaws from the public and from doctors.

No More Free Viagra for Sex Offenders

There are so many stories popping up now that I am having a hard time keeping up, but here goes...
Unintended flaws of bureaucratic decision-making department, government agency division:
This is not, repeat not a bad joke.
Per the Associated Press, available in many newspapers, e.g., the Washington Post.
The US government Centers for Medicare and Medicaid Services has begun notifying states that they do not hve to pay for Viagra and other drugs for "erectile dsyfunction" for convicted sex offenders. A New York State audit had shown that 198 convicted sex offenders in that state had received Viagra paid for Medicaid.

From Nevada, More on Hospitals' List Prices

The Las Vegas Review-Journal reported on the high cost of hospitalization in Nevada, where it asserted hospital charges are currently the highest in the US. For example, it compared charges for heart valve replacement at the Cleveland Clinic ($88,273) and the Mayo Clinic in Phoenix ($79,601), with charges at some Las Vegas hospitals: Valley Hospital Medical Center ($233,259), St. Rose Dominican-Siena ($199,179), Sunrise Hospital ($196,908), Desert Springs Hospital ($186,622), and University Medical Center ($156,953).
Bill Welch, head of the Nevada Hospital Association, blamed the high prices on "a high number of uninsured patients, a nursing shortage that drives up salaries, a mental health crisis that sees many people with emotional problems going to expensive emergency rooms for treatment, and a large percentage of patients who go to expensive emergency rooms for primary care."
However, these problems are common across the country.
University of Southern California Professor Glenn Melnick raised the issue of exaggerated list prices. "Raising list charges, which often bear little relationship to the actual cost of services... is a way hospitals also increase the amount they get from insurers, which often use the charges as a starting point in negotiating discounted contracts for their policy holders."
Once again we are hearing about how managed care organizations and insurers, who are often touted as tough agents for lowering health care costs, seem to think they are getting a great deal if they negotiate a fixed discount off wildly exaggerated list prices.
Nevada may be particularly at risk for high list prices because it is a state which attracts tourists. Melnick suggested that hospitals can make "millions" by charging sick or injured tourists full list prices.
Although Nevada hospitals appear not to be unduly profitable, Melnick also suggested that hospitals that are part of inter-state corporations may reduce their apparent profits by paying high prices for services provided by their corporate parent. "For example, if the corporate parent owns all the hospitals in a chain, it will often charge its hospitals high rent. It will do the same thing with the supplies that it buys for the entire chain.""The same goes for legal fees."
In summary, this article corroborates the previous post about California. Hospitals may charge very high list prices, because managed care organizations and insurance companies think they are getting bargains if they negotiate fixed percentage discounts off these prices, and because hospitals can get a away with charging tourists these full prices. Unfortunately, the uninsured are often charged the same high list prices, even if they are the least able to pay. The great variability in prices charged for the same service suggest that some hospitals are making unreasonable amounts of money for particular services even after the managed care organizations' or insurance companies' fixed percentage discount. Furthermore, hospitals can reduce the apparent profitability these prices generate by paying exaggerated rates to their parent health care system for services it provides them.
It's not a system that is likely to be give patients the best care for the most reasonable prices.
Let's see if anyone in managed care or government, who persistently seem to direct their cost-cutting efforts at primary care, will notice where much of their money really seems to be going.

Conflicts of Interest and Jackson Memorial Hospital's Pharmacy Contract

The latest in the hit-parade of hospital management shenanigans, highlighting issues of conflict of interest, is this story in the Miami Herald.
The newspaper's investigation has uncovered a story of dubious management at Jackson Memorial Hospital, a major University of Miami teaching hospital.
In summary, after hospital President Ira Clark had announced his retirement in 2002, in 2003, the hospital's Fiscal Affairs Committee, chaired by Andres Murai Jr, hired Alson L. Cook as Vice President of Logistics, at a salary of $160,000. Cook advocated giving Cardinal Health a five-year, no-bid contract to manage Jackson Memorial's pharmacy, and to control its drug purchasing, worth $85 million a year.
Murai, it turns out, also is President and CEO of Berna Products Corp, a subsidiary of Acambis plc, which sells a typhoid vaccine to Cardinal Health.
The contract between Jackson Memorial and Cardinal in retrospect also had a significant built-in conflict of interest. "One branch of Cardinal was telling Jackson how much to pay for drugs - purchased from another branch of Cardinal," according to the Herald.
Cardinal's staff at Jackson Memorial included project manager Kevin Reece and pharmacy director Marc Calhoun.
In early 2004, G. William Tomecko Jr., the hospital's Associate Pharmacy Director, noticed billing errors in Cardinal's records. He wrote Calhoun, "This will cause serious consternation at the CFO level. We were supposed to reduce costs by $4 million." Tomecko said Calhoun resisted his enquiries, and "took all the documents from me and requested that I not continue to determine the concerns." Calhoun has since left Cardinal.
Tomecko also found invoices from Reece from a strip club, liquor stores, and fishing boat campgrounds. Reece has since been charged with fraud.
Cook, who had gone fishing with Reece, and approved his bills, resigned and moved out of state.
An outside audit showed that the contract with Cardinal, which was supposed to save $4 million a year, actually cost the hospital $15.5 million. The audit identified $3.1 million in incorrect billing, and $5.9 million in patient under-billing.
A million here, a million there, and after a while these add up to serious costs for the health care system....

Support for the "Endangered Primary Care MD"

An op-ed piece in the Boston Globe by Ellen Lutch Bender, the Director of Health Care Strategies for the law firm Brown Rudnick, entitled "The Endangered Primary Care MD," speaks to the adverse consequences of the dominance of health care by ever larger organizations.
Lutch Bender extolled the virtues of primary care doctors whose ideal is "providing care within a patient-physician relationship based on understanding, honesty, and trust." Furthermore, she suggested that the decline in primary care relates to "consolidation [which] has created a concentration of giant market participants whose dominance has decreased competition." As a result, primary care doctors "spend so much time on paperwork that their ability to care for patients is strained. They work at a frenetic pace from dawn to duskc, seing more patients, faster, to meet productivity benchmarks. They operate in a resource-constrained environment that has skyrocketed the cost of managing their practice and racheted down their incomes." Sound familiar?
She concluded that "this trend has serious ramifications, not only to cost and quality of care but also in the potential loss of the heart and soul of the medical profession."
It seems like more and more people are noticing the issues that Health Care Renewal has been bringing up.
...if only they had some solutions to these problems. Unfortunately, Lutch Bender's suggested approach was pretty opaque, "there is enormous opportunity for physicians to think differently and seek innovative alliances with other providers in a way that will spur competition for those courageous and committed enough to protect the relationship between physicians and their patients." Hopefully, she will come up with something more concrete in the future.

Comments by Jacobi Hospital's Former Executive Director: "I Feel Really Good"

The Executive Director of Jacobi Hospital, who was fired because the hospital failed to notify hundreds of women about concerning Pap test results, had these comments for New York Post reporters:

• "I feel good. Everything is wonderful. I feel really good."

When asked if he wished to apologize to the women who were not informed of their abnormal test results, he referred the question to the New York Health and Hospitals Corporation, and slammed the door.
Another example of a hospital leader showing real concern about quality of care, and the concerns of his institution's patients - not.

Secret Hospital "List Prices" Revealed in San Jose

A real health care market would require we have informed consumers who can make rational decisions. We have shown how some hospitals seem to be using marketing to undermine their patients' rational decision making. Meanwhile, patients are often completely in the dark about how much hospitals charge for their services.
A new California law has forced hospitals to disclose previously secret "list prices" for health care services. The San Jose Mercury News reports how hospitals in the San Jose area have wildly varying list prices for the same services:

• Comprehensive metabolic panel (blood test), $149 to $520
• One-day medical surgical stay, $1909 to $3900
• Screening mammogram, $95 to $405

At least one hospital spokesperson was frank about the lack of relationship between "list prices" and actual costs. Jan Emerson, a spokesperson for the California Hospital Association, stated "There's zero connection between costs, charges, and reimbursements. In many cases, to get $5 more from the health plans you have to raise your charges $50 or more."
The hospitals may be using inflated prices as a tool to extract more reimbursement from managed care organizations and insurance companies. These "list prices," however, are not without consequences for patients.
While insurance companies or managed care organizations usually pay just a fraction of these "list prices," the uninsured, who are often poor, may be charged the full prices, and may or may not easily obtain discounts. The article included the anecdote of an uninsured waiter who was charged a total of $43,000 by a not-for-profit hospital and his surgeon for an appendectomy. The hospital later offered him a discounted charge of $21,000, but this was still too much for him to afford. We have posted other examples of hospitals charging the uninsured their full, often stratospheric "rack rates." (Also see this post.)
The article noted that Medicare and managed care organizations often make their reimbursements functions of the "list prices," providing an inducement for hospitals to raise these prices as high as they can.
This last point is important. One would think that managed care organizations, which have been promoted primarily because of their ability to control costs, might have some idea what reasonable reimbursement might be for common health care services, regardless of how high hospitals set their "list prices." However, they seem to think they are getting a good deal if they can achieve a certain percentage discount from whatever the hospital charges, no matter how high it is. (Recall an earlier example of UnitedHealth being willing to reimburse a Tenet hospital $1275 after the hospital charged $2713 for a one-hour physical therapy evaluation session. Presumably this kind of astute bargaining is why the CEO of United Health Group got over $124 million in total compensation in 2004.)
In summary, although a true market for health care requires that consumers have complete pricing information, hospitals have traditionally kept the prices of their services secret. Furthermore, their list prices often seem wildly inflated, because managed care organizations think they are getting a good deal if they can reduce the list prices by what appears to them to be a large proportion. These organizations, who advertise themselves as rational agents of cost-control, seem clueless about how hospitals have manipulated their simplistic schemes to discount their charges.
This is another argument for physicians assuming the role of watchdogs on behalf of their patients, guarding them against the incompetence and self-interest of powerful health care organizations.

Detroit Hospitals' Advertising War

Although pharmaceutical companies have been rightly criticized for pushing marketing rather than science, they are not the only health care organizations that may do so.
The Detroit News reports on an advertising war being waged by area hospitals. What's notable is how some hospitals, as the paper put it, "say hawking hospital services is no different than selling cola or a car." (The quote is of the article, but was not attributed to a particular person by the reporter.)
In particular, Beaumont Hospital has pursued an advertising campaign to get patients to pick a Beaumont doctor. Its web-site has a pop-up that flashes, "Are you at risk for a heart attack? Do you have a Beaumont doctor?"
Beaumont Director of Marketing and Public Affairs Michael Killian defended the campaign, first noting that patients still need to check out their doctors themselves, "Patients ought to ask every question they can, probe into everything that worries them." But he justified the "foreboding" advertising by saying that connecting with patients emotionally is necessary to get them to seek needed care, "People don't make decisions based on fact. They make decisions based on feeling. If you don't connect with somebody emotionally, you don't connect."
Emotional appeals are unlikely to create better informed patients. Cynically advocating decision making based on emotions may bring in more money, but is unlikely to inspire better decision making.
As I stated in my comment below, physicians need to become watchdogs with loud barks and sharp teeth who will protect patients against all kinds of exploitation by all kinds of powerful health care organizations.

Questionable Deliberations on the Vagus Nerve Stimulator to Treat Severe Depression

The NY Times reports on the curious deliberations by a US Food and Drug Administration (FDA) expert advisory panel on the approval of an implanted vagus nerve stimulator as a treatment for severe depression. The committee was informed about the results of a randomized controlled trial which, as far as I can tell after several PubMed searches, has not yet been published.
The Times reports the trial showed that 17/111 patients who had the stimulator implanted and turned on had improvements in "standard measures of disease severity," while 11/110 who had it implanted, but not turned on also improved. This small increase in the likelihood of improvement was not statistically significant, i.e., could have been due to chance alone, rather than be an effect of the device. Furthermore, the absolute benefit increase implied by these data is at most 4.3%. That is, were 100 people to get the device, this data implies only 4 of them might improve because of it, while the rest would either not improve, or would have improved even without it.
Nonetheless, after hearing some emotional testimonials by patients who claimed that the device helped them, the advisory committee voted to make the device "approvable." The panel's chair, Dr. Kyra Becker, said "the feeling was that anything that gives these people hope is potentially worthwhile." However, one dissenter, Dr. Richard Malone, was bewildered by the panel's decision, "I walked out of there thinking I was nuts. It was stunning, but then I find much of life stunning."
The FDA does not have as rigorous standards to approve devices as those to approve drugs. However, when a device costs $15,000, is invasive, cannot be easily removed, and at best seems as if it may help only a small minority of patients, as is the case for the vagus nerve stimulator, the wisdom of these relatively lax standards comes into question.
Another question is why a scientific advisory committee, staffed ostensibly by medical experts, seemed more attentive to testimonials than to the results of a randomized controlled trial. Perhaps we will get some answers from an investigation by the Senate Finance Committee, which apparently is ongoing.

Jacobi Hospital's Executive Director Fired

Another quick follow-up on the story about Jacobi Hospital's failure to notify patients about abnormal pap smear results.
The NY Times reports that in an unusually fast response, the hospital's executive director and deputy director of nursing services have been fired. The hospital's chief operating officer (COO) and medical director have received disciplinary warnings.
Coincidentally, the NY Daily News noted that the hospital's executive director was previously employed at Staten Island University Hospital, which has just settled its second big case of Medicaid fraud.

Is the adversary model the answer?

In his post of Wed 18 May, Roy Poses commented on the PLoS article by former BMJ editor Richard Smith opining that medical journals have been co-opted into Big Pharma's marketing system. Coincidentally, the BMJ reports that the CEO of Merck has resigned, in a move widely seen as a response to the increasingly damaging disclosures about Merck's marketing of Vioxx (though Merck of course denies any connection).

Merck's campaign for marketing Vioxx was clearly a campaign of deliberate deception, with intensive training of detail reps in specific techniques for misleading physicians about the benefits and concealing the risks of the drug. Should we be surprised? No, not really. Consider what is at stake for any drug company marketing a new agent. Hundreds of millions of dollars have gone into its development. Even though the company itself probably hasn't paid for much if any of the actual basic science or discovery, the development of someone else's discovery to marketability costs a bloody fortune. There's no predicting whether it'll be a big seller, a market mediocrity, or a fiasco that proves dangerous but only after all the costs are incurred.

When big money is at stake, people will lie. It's human nature. Are they "bad people"? No, they're people. As the Milgrom experiment and others showed, and WWII gruesomely illustrated, the majority of people can convince themselves that literally anything - no matter how abhorent - is OK. We vastly underestimate in our usual thinking how readily people will believe what's in their interest to believe. Not just a few "bad apples", but the majority of normal people. Further, those few who are squeamish about fibbin' a bit in marketing the product are selected out at low rungs on the corporate ladder in Big Pharma. The upshot is that we just plain have to assume that Big Pharma will lie. Not because they're evil, but because they're humans in a system where extremely strong incentives exist to do so.

So what do we do? Well, we could propose that drug development be placed in the hands of neutral foundations or some similar arrangment that divorces self-interest from the product. Personally, I doubt that will work well though. The nice thing about self-interest is that it really motivates people. Only self-interest will reliably make the majority of people really work hard. Folks just naturally coast a bit if they don't have skin in the game. (You don't need to point to the economic failure of communism to illustrate that point; just check out any organization that has no competitors. Go down to the Secretary of State's office to get your driver's license paperwork, for example.)

So it's time we formally and clearly recognized that doctors and their patients vs. Big Pharma is an adversary relationship. Like prosecutors and defense attorneys, we need each other and society needs us both, but like any good defense attorney we're nuts to trust anything the prosecutor says. (The metaphor is apt, sadly, as the shocking number of falsely convicted men freed from death row or life imprisonment over the last decade demonstrates.) If we want to do the best for our patients, we need to behave adversarially toward Big Pharma. Don't socialize; assume an ulterior motive; if given a paper "proving benefit" look for how it might have been fudged or find out how many negative papers are being kept out of view; never believe industry-funded clinical trials; assume risks are being downplayed and benefits overplayed.

An adversary relationship will put a real crimp in the incomes of quite a few physicians who are used to taking drug money. It'll also raise some serious financing issues for CME, but it's time those came out on the table anyway. Patients deserve much more aggressive protection of their interests than our profession's cozy relationship with Big Pharma has provided. Time to un-cozy.

The "Misconduct" of a Leader with "Gravitas,"

A follow-up on the story of Staten Island (NY) University Hospital's settlement of charges that it had defrauded the state Medicaid program....

According to the NY Times, it turns out that Joseph Pisani, the former Executive Vice President of State Island University Hospital, who was accused of involvement in the scheme to defraud Medicaid, had taken a position as Senior Vice President for financial planning and forecasting at troubled Westchester (NY) Medical Center in 2003, at a salary of $275,000. In 2004 he was promoted to Executive Vice President and Chief Administrative Officer, with a salary of $480,000. At the time, employees and union officials said this salary was excessive given the perilous financial condition of the institution. (The Journal News reported that the hospital has lost $200 million since 2002, and is projected to lose $60 million in 2005.) However, the Chair (in 2004) of the Westchester County Health Care Corporation defended Pisani's salary thus,

• "To get out of this thing, you need good troops, and Joe is really C.E.O material. He has that kind of gravitas and can think outside the box and can think of creative solutions."

Yesterday, when the story of the fraud settlement at Staten Island University Hospital, and Pisani's involvement in it was revealed, Westchester Medical Center fired him. Staten Island University Hospital had announced its regrets over its leaders' "misconduct."
OK, here comes my rant. How many times have we heard about the brilliance of health care leaders (often proclaimed by other health care leaders)? How many times have we heard about their intelligence, their vision, their ability to think outside the box? How many times have we heard about how their brilliant plans will improve care, lower costs, etc., etc.? And how many times do these predictions turn out to be wrong?
My favorite example of the over-hyping of health care leadership: In 1995, Sherif Abdelhak gave the prestigious Cooper Lecture at the American Association of Medical Colleges meeting, later published in the prestigious journal, Academic Medicine. In it he proclaimed how through his brilliant leadership, the Allegheny Health Education and Research Foundation was moving into the brave new world of large-scale integrated health care systems. (Remember, they were all the rage in the 1990's.) In 1997, the ACP Observer reported that Abdelhak was considered a "visionary." By 1998, AHERF was bankrupt, the second largest bankruptcy in the US at that time. Abdelhak was convicted of misappropriating charitable funds, and went to jail. (See my summary of the case here starting on page 5.)
So maybe the next time we hear that some top health care leader is "visionary," has "gravitas," or the ability to "think outside the box" of another, a high degree of skepticism is in order. Maybe we should look for leaders who display some modesty, humility, and realism, for a change.

Jacobi's Missing Test Results

Another problem in New York. The Times reports how Jacobi Hospital, part of the city's Health and Hospitals Corporation, failed to notify hundreds of women of their Pap test results, including some with abnormal results.
Apparently, supposedly to reduce bureaucracy, a single clerk was given the job of scheduling all Pap tests, and notifying all patients of their results. Apparently no one was monitoring the clerks work, so it took a long time for anyone to notice that the notifications of 307 women with abnormal results never got out.
Hospital management seems at a loss to explain why all this happened.
The hospital's executive director (a quaint term in this day and age) has been suspended.
What was left unsaid is whether any physicians were notified of their patient's abnormal results.

Kling on the EMR

A nice discussion by Arnold Kling on Tech Central Station on pitfalls to expect on the road to electronic medical records (EMRs)....
His reminds us that computer systems must be viewed in the organizational context in which they will be employed, and the health care context is a particularly complex one. He then points out two specific problems.
One is that in the current health care system, no one really owns the whole of a patient's medical record. Yet it is hard to understand how an EMR would work if no one is responsible for any given patient's record. Apparently, the Gingrich proposal includes the formation of regional health information networks. Yet if these have no power, their formation will not solve the lack of ownership problem. On the other hand, if they have the power to own the records, they risk becoming "a new and potentially intrusive entrant into the health care system."
Kling suggests instead that primary care physicians should become accountable for each patient's health care (gasp). Of course, right now primary care and generalist physicians are an embattled species, and there is little support right now for improving our lot.
The other, perhaps better known problem is the requirement for a large number of interfaces to support a large number of types of transactions done by a large number of different actors. Kling contrasted this situation with, for example, electronic banking in which the number of different kinds of actors and different kinds of transactions is small.
I don't think Kling has actually described all the important pitfalls. The elephant in this room remains the poorly understood structure of medical and health care data. Simply storing data as text and images would be clumsy, and sacrifices the ability of computers to truly process data. But we may not yet know how to store health care data other than as word processing and image files.
My fear remains that the EMR is just the latest business fad to captivate health care leaders who don't really understand the health care context. Remember mergia mania? And when physicians are forced to cope with clumsy systems that don't really work well in the clinical context, the health care leaders will be onto their next fad. We'll see.

New York Hospital Settles Fraud Charges Twice in Six Years

From the NY Times, Staten Island University Hospital has agreed to pay $76.5 million to settle claims that it fraudulantly billed the state's Medicaid program. This is the second time the hospital has been charged with over-billing Medicaid. In 1999, it paid Medicaid $45 million and agreed to provide free care worth $39 million to settle previous claims. New York Attorney General Elliot Spitzer also issued a criminal complaint against the hospital, but dismissed it in response to the settlement. Spitzer noted "the magnitude and depth of this fraud, and the willingness of the leadership there to tolerate it, was unusual."
The hospital was charged with billing Medicaid for clinic services at a higher rate allowed for clinics that are open only part-time, while it ran the clinics full-time. It was also charged with lying on state financial reports. The investigation found that the hospital had real-estate contracts with a doctor who was allegedly an associate of the Gambino crime family.
Hospital executives who were warned by their lawyer and the Department of Health, CEO Americo Varone, Executive Vice President Joseph Pisani, and Senior Vice President James Walsh, have left the hospital.
The hospital released a statement that "we deeply regret and are embarassed by the misconduct carried out by former executives of the hospital that led to this settlement."
This is just a reminder that pharmaceutical companies are hardly the only health care organizations accused of misconduct, nor are they necessarily responsible for the worst misconduct in health care.

"Medical Journal Are an Extension of the Marketing Arm of Pharmaceutical Companies"

In the latest PLoS Medicine is an article by Richard Smith, former editor of the British Medical Journal, with a title which expresses his main point, "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies."
Smith charged that pharmaceutical companies use publication of randomized controlled trial as a marketing tool. His most important contention is that they do so not by publishing poor quality trials or false data, but by designing trials so they are particularly likely to produce results favorable for the companies' products. Each article may be "one piece of a gigantic and clever marketing jigsaw." He listed the following tactics that pharmaceutical companies may use to increase the likelihood that each trial produces favorable results:

• Conduct a trial versus a treatment known to be inferior
• Use a dosage of the comparison drug that is too low (so it won't work), or too high (so it will have side effects)
• Keep the trial too small to have enough power to show the comparison drug is better
• Use multiple endpoints in the trial, but pick the one that shows a favorable result
• Do multi-center trials, but use only results from the centers with favorable outcomes for the product
• Do multiple sub-group analysis, but only publish those with favorable results
• Frame results for maximum effect, e.g., present relative, not absolute risk

Smith acknowledged that pharmaceutical companies rarely have resorted to suppressing research, but that this is rarely "necessary" since it is usually easy to assure favorable results with the tactics above. Also note that this article was apparently written before the deceptive practice of ghost-writing received more attention (as we noted here.)
His proposed solutions included public funding of trials, especially of the most prominent treatments available for a particular condition. Furthermore, he suggests publishing trials not in journals, but on "regulated" web sites.
My comments:

• Smith's list of tactics to improve the likelihood of favorable trial results is an important summation. But if these are the only tactics we must combat, the solution does not seem so difficult. A reviewer well-trained in the precepts of evidence-based medicine should be able to detect most of these tactics. Pushing for more stringent peer review by better trained reviewers might be enough to solve this problem. Underlying this could be a wider effort to train physicians and researchers in EBM.
• However, I fear that there is more outright dishonesty out there than Smith acknowledged. Some was of the sort demonstrated in the recent ghost-writing stories. (See our posts here, here, here, here and here.) (Also, see a BMJ article which Smith cited that cataloged similar deceptive tactics used by pharmaceutical companies when marketing drugs in Australia.) Combating such dishonesty will require a more active approach.
• Furthermore, one can draw further parallels between dishonest marketing tactics used by pharmaceutical companies and dishonest or unethical practics that have been springing up all over the health care spectrum. Scrolling throught the Health Care Renewal archives ought to show that leaders of all sorts of health care organizations, hospitals and health care systems; managed care organizations and insurers; medical schools and universities; government agencies; not-for-profits; etc., etc., etc have been caught acting unethically or dishonestly. This suggests that improving health care will require a more broadly based effort directed at all kinds of health care organizations and their leadership.
• Finally, marketing can be defined in a rather neutral was as "the process or technique of promoting, selling, and distributing a product or service" (by Webster's Collegiate Dictionary). Yet Smith's article (and some of his quotes from books by Angell and Kassirer) suggest that the word as acquired a more malev0lent tinge, especially in the pharmaceutical context. This suggests we ought to question why this has happened.

FBI Can't Account for its Budget to Fight Health Care Fraud

The NY Times reports that the US Federal Bureau of Investigation (FBI) has been unable to account how it spent money allocated to investigate health care fraud. A 1996 law set aside money for the agency to address fraud against Medicare, Medicaid, and other federal health programs. But in response to a request from Sen. Charles E. Grassley (R-Iowa), the Government Accountability Office found that the FBI "had no effective mechanism in place" to ensure its own compliance with the 1996 law. It also claimed that FBI agents were shifted from addressing health care fraud to counter-terrorism after Sept. 11, 2001. Grassley responded, "It's inexcusable that the government cannot account for millions of dollars set aside to fight health care fraud."
It's sadly ironic that a program meant to fight white-collar financial crime cannot account for its own financing of this effort.
This does seem to fit the disturbing pattern we have noted again and again on Health Care Renewal. "The anechoic effect" is the label Russ Maulitz gave to the silence and indifference with which the mismanagement, or even outright corruption of health care organizations is greeted.
At least the FBI seemed a bit sheepish about how it has been dealing with health care fraud. Its chief financial officer claimed that it is now "one of its top white-collar criminal investigative priorities." We look forward to the echoes.

A Scathing Commentary on California's New Institute for Regenerative Medicine

The Los Angeles Times included a scathing commentary on California's new stem cell research agency. Author Michael Hitzik charged that "the California Institute for Regenerative Medicine has behaved not like the state agency it is, but with the arrogance of a private corporation that happens to be playing with the taxpayers' cash." Hitzik charged that the agency has not yet developed ethical rules or financial disclosure requirements, but it has hired a private lobbying firm, "perhaps the only state agency that pays an outside lobbyist to battle the Legistlature." In addition, Hitzik alleged that the chairman of the agency, "Bay Area real estate developer Robert Klein II.... often seems to assume that anyone who criticizes himself of his agency must be fanatically hostile to embryonic stem cell research, or worse." Furthermore, in challenging lawsuits filed against the agency, Klein claimed that "over half of all California families ... have a member who might benefit from stem cell research." Since no one yet knows what the practical outcomes of stem cell research will be, this claim about how many people will benefit from it is obviously unsubstantiated, and thus is not the sort of claim that should be made by the head of a biomedical research organization. Finally, Hitzik claimed that the Institute "seems determined to start issuing grants within the next few months, possibly before it has in place an operational budget, a full sheaf of ethical standards and conflict-of-interest rules, or, indeed, bond money."
This appears not to be an auspicious start for the leadership of this Institute.

UK Family Doctors' Salaries

The May 14-20 issue of the Economist has a fascinating short article, entitled "Practice Makes Perfect," detailing an extraorindary average boost of 50% since 2002-2003 in UK family doctors' pay.

Why, the reporter asks, is this happening? Because the Labour government and the NHS believe it should. The notion that markets can't level every playing field is still abroad, apparently, in some places where the state takes a role in managing some sector of healthcare.

Which leads one to ask: what's the trajectory in a "purer" market economy--ours--where CMS and other agencies determine so much of what we do, but have no purchase over the maldistribution of specialties. And no purchase, no controls (or none they're willing to exert) over training and retention of primary care physicians.

(Except for, historically, the early Bureau of Health Manpower's decisions, under the Johnson and Nixon administrations, to punch up sheer numbers of trainees, through bricks-and-mortar creation of new schools. Supposedly to address maldistribution, but of course, it didn't work out that way.)

Or are we just out of sync with our UK brethren?

The reason this article is so appealing is that it eliminates a counterfactual I've pondered for years. I noticed a pecking order among specialties--like cardiologists crowing about being the "internist's internist"--based always on cognitive-technical claims, never on greed-fed notions of "grab the brass ring, win prestige."

I always wondered what would happen if, suddenly, magically, people like family doctors and general internists or pediatricians were, in a different universe, compensated as well as or better than their consultant compadres. Would the extraorindary breadth of expertise demanded by these pursuits then, suddenly, magically, begin to attract large numbers of bright people?

This experiment is being carried out right now in the UK. It's the "price signal," baby.

Guilty Pleas in Another Hospital Construction Fraud Scandal

This seems to be a minor epidemic. The Pittsburgh Post-Gazette has reported (here, here, and here) on another scheme involving kickbacks, bribes, and padded construction bills at Mercy and UPMC Shadyside Hospitals. So far, two former managers at Mercy and one at UPMC Shadyside have pleaded guilty.
These may not be particularly spectacular crimes, but they surely must help to drive up costs of health care, diverting money from the actual provision of care to the pockets of the criminals. The extent that each of these cases has a penumbra of demoralization, and hence leads to more costs, and perhaps poorer care and more errors, is unknown, and the issue still is ignored by the health care research and policy communities.

Unintended Consequences of Reducing Junior Doctors' Hours

From the Guardian, a reminder about unintended consequences.... The UK now must limit work hours of hospital house staff to the European Union limit of 58 a week. The previous limits were 72 hours "on call," and 56 working a week. Of course, the European Union regulations were not accompanied by any funds to pay for the work that house-staff could no longer do. The Guardian article describes how limitations on hospital staffing at night may mean that emergencies may not be attended by those physicians with the necessary expertise to handle them optimally. For example, the Guardian recounts how a geriatrician was required to attempt the resuscitation fo a newborn baby. Furthermore, some junior doctors charged they were coerced into falsifying reports of hours worked to avoid onerous penalties on their hospitals.

Guilty Plea in the Illinois Health Facilities Board Scandal

From the Chicago Sun-Times... there has been a guilty plea in the Illinois Health Facilities Planning Board scandal (see our previous post here.) Jacob Kiferbaum has agreed to plead guilty to some charges, and to cooperate with the ongoing investigation. Kiferbaum was one of three indicted for a complex set of schemes allegedly to channel money from hospital construction projects, including those at Edward Hospital in Naperville, IL, and the Chicago Medical School, to the firms of the accused. (Note: the Sun-Times ran a very detailed account of the allegations here.)

"You Smoke? You're Fired"

USA Today summarizes how some companies are firing or refusing to hire workers who smoke while away from work. Meanwhile, the San Francisco Chronicle reports on a study that shows that companies who provide health insurance on average pay smokers less than non-smokers, but no such differential is seen at companies that don't provide such insurance.
Obviously, smoking is an unhealthy habit that increases risk of a number of serious disease. As a physician, I am always encouraging patients not to smoke, or to quit cigarettes. But many patients find it very hard to quit, mainly because the nicotine in cigarettes is highly addicted.
Although I continue to urge such patients to quit, and try to find ways to help them do so, I personally don't think that they deserve to be blamed or shamed.
However, the two stories above seem to illustrate, as I've said before, how companies that pay for their employees' health insurance (presumably with money that would otherwise go the employees as salary) seem to see this transfer of funds a license to control their employees' private behavior. This heavy-handed approach seems like more of an abuse of power to me than a valid approach to public health. As a physician, it's hard enough to try to get patients to quit smoking. For such a patient, losing their job because of the habit adds more than insult to injury.

Wall Street Journal on "Misleading [Medical] Journal Articles"

Today's Wall Street Journal has a (front page in the print edition) article that nicely summarizes some cases of a "Worrisome Ailment in Medicine: Misleading Journal Articles." It includes such cases as the controlled trial of Celebrex that included only six-month data (when the twelve-month data failed to show a benefit). As Jeffrey Drazen, editor of the New England Journal of Medicine put it, editors have "found themselves playing a game of hide-and-seek," including "experiences where authors tried to pitch it, where they were telling you the good news and not the bad."
(NB: the link above should work without requiring a subscription.)

Allegations of Corruption Affecting the South's Largest Hospital

I stumbled over this story while searching for something else. It really isn't new, but it is striking, but not very well publicized.

Last year, a Department of Justice press release revealed that former Georgia State Senator Charles W Walker had been indicted on multiple counts. It alleged two "fraudulant schemes" involving health care.

• "The second scheme to defraud involved Grady Memorial Hospital, Georgia’s largest public hospital, located in Atlanta, Georgia. The indictment alleges that Charles W. Walker misused his public office for private gain and, in so doing, deprived the public of its right to his honest services as a state legislator. The indictment charges that Walker stalled the passage of legislation affecting the Grady’s funding until hospital executives agreed to use exclusively personnel from Walker’s temporary employment agency to work at the hospital."
• "In the third fraudulent scheme, the indictment alleges that Charles W. Walker deceived executives at Georgia’s state medical college, the Medical College of Georgia, into using his temporary employment agency for personnel to work at the hospital and into advertising in the Augusta Focus. Walker deceived college officials by misrepresenting that he did not own his two businesses, a move he took in order to circumvent a state conflict of interest law that generally prohibits state public officials from doing business with state entities such as the medical college. According to the indictment, Walker also breached his fiduciary duty to the public by failing to disclose these transactions, on state-mandated
  financial disclosure forms for public officials, until a media inquiry forced him to do so."

Walker's indictment had been briefly reported in the Augusta Chronicle. In addition, a 2001 article in the Atlanta Business Chronicle had noted Grady Memorial Hospital's worsening financial condition, and the charges made then that "wealthy contractors and trial attorneys are being allowed to rip off the hospital," made by a dissident board member. He also asserted "hospital management is adrift and I don't think they have a clue what they are doing." Furthermore, a Lexis-Nexis search revealed that Walker was fined by the state Senate Ethics Commission for failing to disclose his business relationships with both Grady Hospital and the Medical College of Georgia. The Jacksonville based Florida Times-Union has also followed the story. In 2004 it reported that "the FBI has been asked to investigate claims of witness tampering, intimidation, and even possible attempted poisoning of former Grady Hospital employees who blew the whistle on a sweetheart deal ex-Sen. Charles Walker had with the South's largest hospital." It recently reported that Walker and his daughter will go to trial this month.

How I stumbled on this deserves explanation. A UK publication called The New Criminologist, which proclaims itself "the oldest journal for professionals involved in all aspects of criminology," has a special web-based section on "The Grady Coalition," featuring a large number of articles from a group of apparent whistle-blowers aggrieved over the scandal at Grady. I personally know nothing about this group, and can't vouch for the accuracy of their charges, but their work makes for fascinating reading. And there clearly is evidence from the sources listed above to corroborate at least some of what they have been saying.

If nothing else, this demonstrates that there are an unknown number of stories of alleged corruption of health care organizations have been published in the local news media, but in the absence of any systematic effort to find them, the quantity and impact of unethical and corrupt practices in health care also remain unknown.

How Can a $124.8 Million a Year CEO Make Health Care More Affordable?

An op-ed piece in the Providence Journal about huge pay packages for corporate CEOs mentioned the breath-taking $124.8 million total compensation of United Health Group (parent of United Healthcare) CEO William McGuire. This figure can also be found in the Forbes Special Report on CEO compensation. Here one can find that other managed care CEOs got less fabulous, but still formidable compensation, e.g., Howard Phanstiel, PacifiCare, 3.38 million; Edward Hanway, Cigna, $13.3 million; John Rowe, Aetna, $22.2 million; and Larry Glassrock, Wellpoint, $25.0 million.
McGuire's compensation was so large as to take a measurable part of this large company's net income (5%). Or to look at it from a stock-holder's (and hence, an company owner's) viewpoint, had McGuire, who is an employee, been only paid a cool million, and this money had been distributed as a dividend, it would amount to about a $0.20 per share dividend. (The current dividend is $0.03 per share.) (See company data available from Forbes as well.)
To look at it from a United employee's viewpoint, had McGuire, who is an employee, been only paid a cool million, and this money had been distributed to employees, each of the 40,000 employees could have received a bonus larger than $3000.
To look at it from the viewpoint of the health care system, the $124.8 million total compensation of a single United employee could pay the salaries of 833 general internists at current typical salaries. Or the $124.8 million could run one reasonable size community hospital for a year.
United Health Group's mission statement is "the company directs its resources into designing products, providing services and applying technologies that improve access to health and well-being services; simply the health care experience; promote quality; and make health care more affordable." (See this fact sheet.) Rather, it seems to be directing a good chunk of its resources into salaries of top management employees. How a $124.8 million CEO salary can be reconciled with a mission to "make health care more affordable" is completely beyond me.

Indictments in Alleged Scheme Involving Illinois Health Facilities Planning Board

The Chicago Sun-Times reports that the former head of the Illinois Health Facilities Planning Board, Stuart Levine, and two local businessmen, P. Nicholas Hurtgen, formerly of Bear Stearns, and construction executive Jacob Kiferbaum, have been indicted for "influence peddling, kickbacks, and other corrupt actions" that affected local health care organizations. In one instance, they are accused of threatening Edward Hospital in Naperville that the Board would not approve its expansion plans unless the hospital were to use their firms to construct and finance the project. The hospital refused, and its application for expansion was rejected. Another alleged scheme involved Chicago Medical School. (An article from the Sun-Times from June 30, 2004, no longer available on the web, stated that Levine and Kiferbaum were on the school's board of trustees, and that Kiferbaum's company had been involved in large school construction projects. )
Setting aside, for the moment, the question of whether these indictments will result in convictions...
We have reported quite a few stories involving alleged or proven corruption of leaders of health care organizations. Since we have no mechanism in place to comprehensively search the news media for such cases, and since many such cases may go unreported, it is likely that all we have posted amounts to the tip of the iceberg.
What little survey data we have also suggest that unethical business practices in health care may be very widespread. For example, as we have previously posted, 53.8% of the respondents to the survey done by the American College of Physician Executives felt that a health care organization in their community was involved in unethical business practices.
It thus seems reasonable to ask how much effect all the episodes of unethical behavior and corruption have had on health care costs, access and quality. But I have yet to see any serious effort made to answer this question. (If someone else has seen one, please let me know.)
It also seems reasonable to ask why there is so little response to these episodes from the medical and health care communities. For example, although the Illinois Health Facilities Planning Board story first surfaced almost a year ago, I have not been able to find any response to it from a medical or health care organization. (If someone else has seen one, again, please let me know.)

Merck Move Shows Industry Adrift on Leadership Expertise

Slowly, surely, the need for biomedical expertise in healthcare leaders is being realized, at least in the investment community. When will hospitals and managed care organizations begin to understand the same lesson?

Merck Move Shows Industry Adrift

By Melissa Davis

Senior Writer, TheStreet.com, 5/9/2005

When Merck crowned a new CEO last week, some disappointed investors saw fresh evidence of an entire industry that has yet to get its priorities straight.

Merck chose an insider without a background in medicine at a time when observers agree that the company desperately needs to focus on developing new drugs. Moreover, Merck made its selection even after its glory faded under a previous nondoctor, Ray Gilmartin.

Richard Clark, tapped last week to replace the embattled Gilmartin, is no master of drug research or even the marketing activities that, to the dismay of some, now seem to drive the industry. He has instead spent his 33 years at Merck concentrating on such areas as manufacturing and information technology.

"That was the best they could get?" asks Peter Cohan, an investment strategist who praises Merck's last physician CEO -- Roy Vagelos -- in his book The Technology Leaders. "It is hard to see how a manager lacking experience in drug development can help revive the critical pipeline of new drugs that contributed to the success of this once great company."

Further, provocative opinions in the article on the clinical trials process may shed some light on why there are few medical informatics specialists in pharmaceutical leadership roles. The field may be viewed as too critical of data manipulations:

... Public leaders have begun to question how companies manage to gain regulatory approval of drugs like Vioxx and then turn them into wildly profitable blockbusters. And they have come to recognize the industry's incredible influence -- over drug development, approval and even consumption -- in the process.

Vera Hassner Sharav, president of the Alliance for Human Research Protection, has been warning about such powers for years.

"The companies design the drug trials," Sharav says. "They select the subjects. They maintain and interpret the data. They select which parts get published. They choose who will become the reviewers in the prestigious medical journals. And they pick 'key opinion leaders,' who they pay handsomely" to promote the drugs.

"It's perfect," she concludes. "They have it made."

Read the whole thing.

-- SS

Government getting serious on EMR

This press release shows our government is starting to get serious about computerized patient records (I am steering away from the term "electronic medical records." My ham radio transceivers are electronic in nature; medical records don't contain vacuum tubes, transistors, resistors or capacitors as far as I know.)

Let's hope that included in the bipartisan call for addressing "systemic obstacles and misaligned incentives that have hindered health information technology adoption" are the sociotechnical (people and skills) issues that are a direct cause of healthcare IT failure.

My support of this initiative will include pointing out that one poorly-addressed but critically important benefit of widespread computerized patient records will be better real-time societal health surveillance, for example, detecting harmful pharmaceuticals via improved postmarketing surveillance before things get out of hand. Better health surveillance is also more than just a handy capability to have in times of potential bioterrorism or other epidemics.

CAUCUS CO-CHAIRS TO INTRODUCE MAJOR HEALTH I.T.
LEGISLATION
Your Action Needed to Support Legislation to Bring Health Care
into the Information Age

On Wednesday, May 11, 21st Century Health Care Caucus co-chairmen Rep. Tim Murphy (R-PA) and Rep. Patrick Kennedy (D-RI) will introduce legislation to dramatically increase the use of information technology to improve the quality, safety, efficiency, and coordination of health care. They need your help to pass this bill this year.

Health IT offers the promise of better health outcomes for patients, by catching conflicting prescriptions, providing reminders to improve timely prevention and other recommended care, and better public health monitoring. It can streamline doctors' practices by easing compliance with reporting requirements, simplifying billing and eligibility checks, and providing more patient information at the point of care. It can eliminate wasteful duplication of testing and provide new research capabilities. But despite the promise, health care has been slow to move into the information age due to a number of systemic obstacles.

The 21st Century Health Information Act will be the first bipartisan bill to address the systemic obstacles and misaligned incentives that have hindered health information technology adoption. It is of pragmatic scope in these tight budgetary times but maximizes limited federal dollars to bring about real systems change. It appeals across the political spectrum, from Newt Gingrich to Hillary Clinton.

There is enormous interest in health IT in Washington, but until now there has not been anything around which support could coalesce. With the introduction of the 21st Century Health Information Act, meaningful action on health IT is possible this year, but it will take concerted effort.

What You Can Do:
1. Send a Letter of Support. The cosponsors are trying to get as many letters of support from organizations across the health care spectrum, including patients, physicians, hospitals, other providers, health plans, employers, vendors, and others. You can email letters to michael.zamore@mail.house.gov (Kennedy) and michael.baxter@mail.house.gov (Murphy).

2. Issue a Press Release. Help get word out about the bill and the importance of health IT by issuing a press release on May 11. By applauding introduction of the bill and explaining how health IT will impact your organization or your organization's role in rolling out health IT, you can amplify the importance of this legislation while potentially working your organization into media coverage of the bill introduction.

3. Call or Email Members of Congress. Immediately after introduction, we will begin seeking cosponsors to demonstrate that this is legislation with broad, bipartisan support. Phone calls and emails to Members of Congress and their health staffers encouraging cosponsorship of the 21st Century Health Information Act are critical. There can never be too many phone calls or emails.

4. Write a Letter to the Editor or an Op-Ed. By following up May 11 with a letter to the editor or op-ed to your local newspaper about the importance of health IT and the 21st Century Health Information Act, you can help create an echo effect that amplifies the message and helps build support.

Thank you for your efforts to make health care ever better, safer, and more efficient. We look forward to passing the 21st Century Health Information Act with your help.

Addendum - I sent this letter to the congressmen:

Dear Congressman Murphy and Congressman Kennedy,

I sincerely applaud The 21st Century Health Information Act that you are co-chairing.

As a Medical Informatics (clinical IT) specialist who has designed and implemented clinical IT in hospitals domestically and in overseas settings, I can assure you this initiative will have a return on investment in future years in greatly improved quality of care, increased efficiency, reduced waste, and reduced costs.

I have promoted this issue since the mid 1990's and have written extensively on systemic obstacles and misaligned incentives that have hindered health information technology adoption ("sociotechnologic issues"), e.g., at my website "Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Failure" at http://home.aol.com/medinformaticsmd/failurecases.htm .

In addition, as Merck's former Director of Scientific Information Resources, I would also like to point out that a national computerized patient records infrastructure will enable large-scale health surveillance. This capability will enable much more rapid post-marketing surveillance of new drugs, helping avoid debacles such as the VIOXX and Phen-fen accidents, as well as earlier detection of natural or man-made (i.e., bioterrorism) epidemics.

If I can assist this initiative in any way, please let me know.

-- SS

Hospitals need better security

Another strain on limited hospital budgets is in the making, in a very concerning way:

Intruders try to gain access to hospitals' off-limit areas

In Indianapolis and elsewhere, authorities have reported cases, uncertain of motives.

Associated Press

VALPARAISO, Ind. -- Cases of unauthorized people trying to gain access to restricted areas of hospitals in Indiana and across the country puzzle federal authorities and security officials.

Recently, on the same day an Indianapolis hospital reported suspicious people trying to enter its emergency department, two professionally dressed people carrying clipboards walked into the outpatient campus of Porter hospital in Valparaiso, saying they wanted to tour the facility. The two left when challenged.

Earlier, during a two-week period starting Feb. 26, people claiming to be inspectors from the Joint Commission on Accreditation of Healthcare Organizations tried to enter hospitals in Boston, Los Angeles and Detroit. The three incidents had no apparent relationship beyond the tactics of the intruders.

Indiana Department of Health spokesman Andy Zirkle confirmed that one Indianapolis hospital had reported an incident but would not elaborate. He directed further questions to the U.S. Department of Homeland Security and to the FBI, but neither agency confirmed the incident.

A day after the March 22 incident, a former safety officer at St. Vincent Hospital and Health Services in Indianapolis, Thomas Huser, sent an e-mail to health care security officials across the state saying men had tried to gain access to the emergency departments at three separate hospitals, which were not named, The Times of Northwest Indiana reported in a story Sunday.

Huser's e-mail also said that information found in a car at one of the hospitals indicated one of the men was on the FBI Terror Watch List. He said he received the information from another hospital.

FBI Special Agent Wendy Osborne said information regarding the watch list would not be shared with the hospitals.

Porter hospital Security Director Jim McClanahan said any hospital has to balance security against the public's need for access. Porter has 28 security workers filling about 17 full-time jobs. They patrol outside and respond to reports of people wandering into areas where they do not need to be.

But the first line of security over such a sprawling institution is often the doctors, nurses and volunteer auxiliary members. A member of a hospital auxiliary had cornered the pair that walked into the Valparaiso Outpatient Campus and forced them to leave, The Times reported.

Mark Forstneger, spokesman for the Joint Commission on Accreditation of Healthcare Organizations, said the intruders masquerading as inspectors more likely were looking for drugs or privileged information about patients than pursuing any plot against national security.

"There are a lot of things that hospitals have that are desirable," Forstneger said.

The joint commission is a nonprofit organization that judges the quality and safety of care at 15,000 hospitals and health care institutions around the country. It receives one or two reports each year of people claiming to be inspectors, the newspaper said.

University of Pennsylvania Allies with Tai Sophia Institute

The Philadelphia Inquirer reports that the prestigious University of Pennsylvania Medical School has announced a partnership with a local center for complementary and alternative medicine (CAM), the Tai Sophia Institute, and in parternship will begin to offer a masters degree in CAM.
The article quotes 86 year old Arnold Fishman, a pulmonologist, who has "enjoyed a long, achievement filled career in evidence-based medicine," advocating for the alliance, "my interest is: what are the new frontiers?" He further noted, "The message from consumers is quite clear." "Medicine cannot supply all that consumers feel they want."
But Robert Baratz, a skeptic about CAM, challenged this, saying the University is "attempting to capitalize on the so-called dynamics of the marketplace."
The Tai Institute's Institutional Values include

• "Operate from a declaration of oneness, a unity with all creation."
• "Make all judgments and decisions in the context and light of the seven (past 3, future 3, and present) generations."

The Tai Institute offers acupuncture and herbalist services. Its web-site states

• "Individuals using traditional acupuncture treatments often find relief from concerns including headaches, chronic fatigue, depression, allergies, back pain, digestive disorders, joint pain, sleeping problems, infertility, menstrual disorders and other symptoms."
• "Acupuncture is helpful for many concerns from headaches to joint pain. It has also been found effective for severe chronic conditions where pinpointing the cause has been difficult to determine. Those who receive ongoing treatment for maintenance and the promotion of good health have told us that they: • Tend to get sick less often and recover more quickly• Have improved stamina and vitality• Are better managers of their own health• See reductions in long-term health care costs and tend to visit physicians less often• Enjoy deepened more harmonious relationships with others "

The web-site presents no evidence to support these claims. I doubt they are well supported by data from well-designed randomized controlled trials. For a more skeptical view of acupuncture, see this page from Quackwatch.
Regarding herbal therapies, the Tai Sophia web-site states:

• "Botanical healing, used for thousands of years, is used specifically to support the healthy structure and function of the body. It works to promote vitality, balance, and longevity. "

Again, The Institute does not present evidence that, in particular, using herbs causes people to live longer. Although I will allow that some CAM remedies may turn out to have benefits that outweigh their harms, I see no reason to believe that this is true for any particular such remedy until it has been tested in well-designed controlled studies. I can see value in medical schools teaching students about patients' use of CAM, and performing well-designed research on CAM. However, the University of Pennsylvania's alliance with an Institute that seems to be a fervent, uncritical promoter of CAM seems at odds with the the scientific basis of medicine that medical schools, of all institutions, should uphold. I hope the University will come up with a clearer explanation for what it is doing than the purely consumerist approach described in the Inquirer's article.
[Full disclosure: I did a Kaiser Fellowship in General Internal Medicine at the University of Pennsylvania, where I got training in, among other subjects, clinical epidemiology.]