Physician ranking shenanigans: do insurers steer patients to cheaper doctors rather than the most qualified?

I've written numerous posts expressing serious concern that executives of large healthcare organizations are strangely reluctant to consider informatics-qualified physicians for leadership positions in healthcare IT, such as at "Leadership Position in Health Informatics: MD's Need Not Apply?" and "Hospital IT: Amateurs welcome."

This observation may unfortunately also apply more broadly. In the Philadelphia Inquirer today, a short summary of a Dow Jones story appeared. The Inquirer article puts the "money question" (pun intended) right up front and is rather blunt about it:

Philadelphia Inquirer, Aug. 17, 2007

Aetna Inc. and Cigna Corp., both Philadelphia, may be deceiving patients who rely on the insurer' physician-ranking programs, steering them to cheaper doctors rather than the most qualified, New York Attorney General Andrew Cuomo said.

The Dow Jones story is a little less blunt than the Inquirer short summary, but nonetheless revealing. Here are some excerpts:

UPDATE: NY AG Cuomo Concerned About Physician Rankings

by Chad Bray of DOW JONES NEWSWIRES chad.bray@dowjones.com

Attorney General Andrew Cuomo said Thursday that his office has sent letters to units of insurers Aetna Inc. (AET), Cigna Corp. (CI) and UnitedHealth Group Inc. (UNH), raising concerns about their physician-ranking systems.

In the letters, Cuomo's office said it's concerned the doctor-ranking programs carry "significant risk of causing consumer confusion, if not deception."

"Transparency and accurate information are essential when consumers make health-care decisions," Cuomo said in a statement. "We will ensure that insurance companies are not obscuring important facts at the consumers' expense."

The letters, dated Thursday, were related to Aetna's "Aetna Aexcel" program and Cigna's "Cigna Care Network" system, which have created networks of specialists based on criteria determined by the insurers.

... In both cases, Cuomo's office has raised concerns about the Aetna and the Cigna programs using claims databases to rank physicians - which his office says don't include all relevant clinical data and can be too small to generate reliable rankings.

That's very interesting. The AG is accusing these insurers of very fundamental violations of good medical informatics/information science practices. The article continues:

"We just received the NY AG's letter, and will review the request for information. We will cooperate fully," said Cynthia Michener, an Aetna spokeswoman, in a statement. "Aetna is fully committed to transparency, including publishing the criteria for the selection of specialty physicians on our member and provider web sites.

In the AG's letter, the following is stated:

The attorney general's office also expressed concern that neither the Aetna program nor the Cigna program discloses the data used to rank the doctors, even to the doctors themselves. "As a result, doctors and consumers have no ability to bring errors in the rankings to your attention so that they may be corrected," wrote Linda A. Lacewell, counsel for economic and social justice in Cuomo's office.

As in clinical trials of pharmaceuticals and medical devices, without extremely robust and thorough disclosures of the underlying data and algorithms, there is ample opportunity to "make the data work for you."

Cuomo's concern was met with the following response as cited in the Dow Jones article :

Tyler Mason, a spokesman for the UnitedHealthcare unit, said Thursday that the company responded to the attorney general's request with extensive information and a 25-page cover letter addressing his questions. "The program is designed to raise consumer awareness of differences among health-care practices that can affect both the effectiveness and cost of care and treatment," Mason said. "Understanding how often a physician adheres to evidence-based clinical guidelines, or how well a hospital treats a particular condition, helps consumers select the doctor or facility that best meets their needs." Mason said the program's methodology is based on "rigorous evidence-based guidelines" and has been honed with opinions from UnitedHealthcare network physicians, expert panels and physicians from national and professional organizations.

That all sounds wonderful, but can reflect a veritable information science cesspool that gives meaning to the "lies, damn lies and statistics" refrain if the data content, definitions, collection methods, and algorithms are subject to even slight defects or bias.

I find this situation particularly interesting.

"Who ya gonna believe?"

Here's how I am informed by my own personal experiences:

The Philadelphia-area HQ of Aetna is very close to one of the Merck satellite office sites where I often put in hours, in Blue Bell, PA, and I passed it regularly on the way home, a 15-minute drive. When the Merck 'Equinox' layoffs of 4,400 occurred in late 2003, I naturally applied to several Aetna positions.

A recruiter in the Connecticut HR offices at Aetna wrote this:

In a message dated 11/12/2003 4:32:01 PM Eastern Standard Time, PassarettiB@aetna.com writes:

Hello Scot,

Thank you for your interest in Aetna. Actually there are 3 positions that I feel you are qualified for. Please call me at your convenience to discuss further. Looking forward to speaking to you.

Regards,

Barbara

One position called for this:

Position Applied For: "Senior Clinical Outcomes Researcher 14972BR"

Designs, conducts and manages the production of health services research, health related quality of life program impact, economics research, models and publications for plan sponsors ... Supports multi-disciplinary teams, including outcomes research, clinical research and marketing staff to support women's health marketing, quality outcomes and cost-savings analyses.

What are we looking for? Strong interpersonal, communication, consultative, and presentation skills; the ability to collaborate and work within multidisciplinary teams, the ability to interact with colleagues at varying levels ... The ability to write in a clear, concise and effective manner to achieve the highest impact on a wide variety of audiences. Strong ability to convey complex concepts and to address major strategic challenges in writing and verbally. Ability to conduct health care intervention evaluations using economic modeling/analytic tools. Strong knowledge and ability to research a variety of qualitative and quantitative databases. Strong ability to analyze therapeutic area specific information to identify current trends and to address unmet challenges.

What is required? PhD in health services research, medical informatics or similar health related area or a Master's degree with extensive hands-on analytical experience.

I did not even get in for an interview:

Subj: RE: Thanks
Date: 11/13/2003 12:46:43 PM Eastern Standard Time
From: PassarettiB@aetna.com
To: ScotSilv@aol.com

Hello Scot, I did hear from one of the hiring managers. Unfortunately, he feels you don't have the statistical background he is looking for. In the meantime, I will keep your resume on file and if I see something that is suitable I'll be in touch. Also, you can always check the www.aetna.com website for opportunities that may be of interest to you.

Regards,

Barbara

I guess nothing "suitable" was ever found, as I didn't hear back from the recruiter.

Another position I expressed interest in was this:

"Business Information Manager"

What are we looking for? Solid understanding of integrated health care data, advanced analytical skills and outstanding consulting skills. Strong, interpersonal, communication, and presentation skills; the ability to collaborate and work within multidisciplinary teams, the ability to interact with colleagues at varying levels. Must be able to describe complex activities and analyses at both a high level and a detailed level for specialized audiences. The ability to write in a clear, concise and effective manner to achieve the highest impact on a wide variety of audiences. Self-starter, creative, resourceful, high energy and flexible.

What are the job responsibilities? Lead or participate in multi-disciplinary teams of clinicians, business and IT managers, and informatics analysts to develop quality metrics, consumer-focused tools for selecting quality health care facilities and providers, and evaluate Aetna's quality, medical management and member-centric programs.

I initially expressed interest in this role but when I discussed its reporting structure in more detail, it being a low-level manager position, I decided against it. I've discussed the issue of marginalization of medical informatics professionals on numerous occasions (ex. here and here) due to defective organizational structures and stereotyping. The question arises as to why a position such as this was graded so low.

Finally, an email I sent a few months later to Aetna's Senior Vice President and Chief Medical Officer describing my background and how the company might benefit from Medical Informatics expertise went unanswered.

Who do I find more credible regarding possible profit-generating flaws in the insurer physician-ranking programs, the Attorney General or the insurers?

As I'd written before in my posting "US senator says FDA needs independent safety office":

... Insights into process flaws, inadequate leadership skillsets, and perhaps even corruption in high-stakes industries can be gleaned by who they won't hire.

Of course, this is a personal opinion colored by personal experience, which should be taken with a grain of salt.

I report, you decide.

-- SS

Will This House Really Be a Home? - UnitedHealth Teams with Big Medical Associations to Pilot-Test the "Advanced Medical Home"

A joint press release from several US physician organizations, including the American College of Physicians (ACP), the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP), and the UnitedHealth Group announced a pilot project to implement the "advanced medical home" concept.

Briefly, according to principles asserted by the AAFP, AAP, ACP, and American Osteopathic Association (AOA), the advanced medical home would have four key characteristics: 1) it would be centered on ongoing relationships among patients and their personal physicians; 2) the personal physician would be the leader of a team that takes responsibility for patient care; 3) the personal physician would take responsibility for the patient as a whole person; and 4) the medical home would provide care coordinated and/or integrated across all elements of the health care system.

According to an ACP monograph, the point of the advanced medical home is to offer "the potential to improve U.S. health care by focusing on strengthening and supporting the patient-physician relationship."

The press release, and a recent item in the AAFP News, provide an outline of the pilot project. Below are key elements.

General description of the medical home to be provided:

Each patient will have the choice to select a personal physician, or “medical home,” who knows his or her medical and family history and coordinates their medical care. The physician will be responsible not only for treating a specific ailment or condition, but also for working with the patient to better manage his or her health care needs and arranging care as appropriate with other professionals. The patient-centered medical home model places special emphasis on preventing disease and improving the care of chronic conditions. It emphasizes behavioral health support and patient education as well as the diagnosis and treatment of acute illnesses. [Press Release]

Implementation of the pilot program:

The pilot program will be launched in Florida with approximately six specially-chosen primary care practices that will employ the model. [press release]

[The practices are] yet to be chosen. [news item]

The pilot programs will include customers insured through UnitedHealthcare commercial insurance.[press release]

How UnitedHealth will be involved:

UnitedHealth Group will support the practices participating in the pilot program by integrating its extensive quality improvement and care management into the practices’ infrastructure. This includes sponsoring 24/7 nurse triage and other solutions that extend access to care, identification of and outreach to those who may need clinical interventions; and educational tools and assistance to help patients better manage their conditions. [press release]

UnitedHealth Group will support the participating primary care practices by helping them incorporate quality improvement and care management systems to increase access. [news item]

How physicians will be reimbursed:

UnitedHealth Group will pay participating physician practices a monthly care-management fee based on projected savings for all patients that select a medical home. In addition, the company will share any excess savings that accrue from the pilot program with the physician practices and -- by way of premium reductions -- with employers.

How results of the pilot program will be assessed:

UnitedHealth Group has commissioned an independent research study designed to evaluate and assess the results of the pilot's experimentation with the patient-centered medical home model of care. [news item]

Expectations of how it all will work:

'We should see improved patient outcomes and overall better value for patients, employers and health plans,' [AAFP President Rick] Kellerman said. [news item]

David C. Dale, M.D., FACP, President of the American College of Physicians, said, 'A key element of the patient-centered medical home model is a commitment to improved quality. Primary care practices should exemplify attributes such as dedication to team care, utilization of clinical information systems, coordination of care with other health professionals and support networks, as well as continuous performance assessment and improvement, among others.' [press release]

Reed V. Tuckson, M.D., FACP, UnitedHealth Group’s executive vice president and chief of medical affairs said, '“UnitedHealth Group and its companies are dedicated to effective, collaborative activities with physician experts and their professional societies that result in enhanced quality and efficiency of care for our customers.' [press release]

The details of this program are still sketchy, but they certainly raise some questions.

• Is the pilot program realistic? - Apparently, the program will be limited to patients covered by UnitedHealth. Most physicians contract with multiple managed care plans and health insurers, and also see patients covered by government programs, and even some patients with no insurance. Patients tend to arrive in the office randomly with respect to their health care coverage, or lack thereof. How could the physicians in the pilot study run a medical home for only UnitedHealth patients, and give "usual care" to all the others? If they try to provide a medical home to all their patients, how will they afford to do so, since no other payer is going to change their reimbursement? If the practices involved only take care of UnitedHealth patients, how would results generalize to other doctors?
• Is the goal to provide better patient care, or to save UnitedHealth money? - Note that Dr Tuckson used the "e-word," that is, efficiency. Is increasing UnitedHealth's profits the primary motive?
• How much will this particular "medical home" model involve handing control of patient management over to UnitedHealth? - Note that the project will entail UnitedHealth "integrating its extensive quality improvement and care management into the practices' infrastructure."
• Is the reimbursement meant to compensate physicians for their and their practices' time, effort, capital investment, and resource use? - Note that the compensation plan seems only to be based on UnitedHealth's "projected savings," and "any excess savings." There was no clear explanation of how reimbursement might relate to the time, effort, and expenses incurred by the participating practices.

The danger, of course, is that this scheme is first meant to save a big for-profit managed care company some money, ahead of any priorities on improving health care quality, or providing fairer reimbursement to primary care and generalist physicians.

The press release concluded with the proclamation in the press release that "UnitedHealth Group is a diversified health and well-being company dedicated to making health care work better." I hope that is so now. In the recent past, UnitedHealth was better known for paying its CEO outrageous compensation (see post here), and inflating his personal wealth to over $1.5 billion (see post here). Its former CEO was forced into retirement, and an investigation of whether the company back-dated his stock options is ongoing (see post here).

But maybe the company is really changing its priorities. And this project is a step in that direction. Time will tell whether this house it trying to build is really a home.

ADDENDUM (20 August, 2007) - See also these comments on the Retired Doc's Thoughts blog.

BLOGSCAN - Exclusive Interview with PharmaGossip's "Jack Friday"

On BrandweekNRX, this post includes an interview with the secretive anonymous writer of PharmaGossip. PharmaGossip is a must read for anyone interested in the reality, good and bad, of life in the pharmaceutical industry. The blog has been vigorous in its pursuit of mismanagement, conflicts of interest, and corruption affecting the leadership of the industry. Thus this interview should be of particular interest to readers of Health Care Renewal, even if it doesn't provide many clues to the identity of "Jack Friday."

BLOGSCAN - Scientist Behind Gleevec Decries Its Price

On PharmaLot, this post summarizes an interview with Brian Druker, one of the scientists responsible for the development of imatinib (Gleevec, manufactured by Novartis). Druker noted that much of the science behind Gleevec was financed by government money, yet Novartis saw fit to charge an extremely high price for this potentially life prolonging drug. The key paragraph:

The price at which imatinib has been offered for sale by Novartis around the world has caused me considerable discomfort. Pharmaceutical companies that have invested in the development of medicines should achieve a return on their investments. But this does not mean the abuse of these exclusive rights by excessive prices and seeking patents over minor changes to extend monopoly prices. This goes against the spirit of the patent system and is not justified given the vital investments made by the public sector over decades that make the discovery of these medicines possible.

Doctor "Pam" Comments on the Crisis in Primary Care

A comment from an anonymous family physician named "Pam" on a recent post about the declining popularity of primary care among medical students is worth publishing on its own (slightly edited).

I'm a family doc who took time off for heavy family responsibilities and am now wanting to go back to work. The environment in which I can practice my skills as a communicator, healer, educator of patients, manager of problems, etc has become toxic, antagonistic toward its nominal aim.

When I left medicine, 5 years ago, I had a thriving solo practice and yet was having trouble getting paid and in turn paying off the bank. Looking at the field now I see all of the same problems (many of them worse) as when I left.

I would hate to discourage an intelligent, idealistic, empathic young person from going into primary care. But the road has become too treacherous.

As for me, I don't know whether to open a boutique practice in my upscale town or do a fellowship leading to specialization, or what. I know I can't practice medicine in the way it's currently prescribed. (I suppose that makes me "noncompliant" in the parlance of the field, though I've caught wind that the new word is "nonadherent." Whatever.)

The root of the problem is political, as you've described in your other posts. As Kevin Grumbach noted in a speech to the Society of Teachers of Family Medicine this year,

". . . fees are not the product of free-market supply and demand. Rather, they are the result of a mechanism for determining relative value units for physician services—which in turn determine fees for Medicare and other third party payers --that is largely controlled by a committee [the RBRVS Update Committee, or RUC] under the auspices of the American Medical Association. . . ."

"This committee has 26 voting physician members nominated by specialty societies; only 3 of these members are primary care physicians. In addition to exerting disproportionate influence over policies such as Medicare fee updates, specialists have the added advantage of having much of their practice costs subsidized."

As they say, go and read the whole thing (or listen to it on your iPod.)

Thank you for your blog.

As we have noted before, primary care and "cognitive" physicians are having a very tough time, mainly because reimbursements are low, and not made for many of the tasks they do to provide coordinated, continuous, comprehensive care, especially for patients with chronic diseases. Meanwhile, they bear a heavy and increasing bureaucratic burden imposed externally, mainly from the govenment, e.g., the Medicare and Medicaid programs, and private health care insurers and managed care organizations. "Pam" makes these points again, vividly and personally.


All this results in pressure to see too many patients in too little time to cover overhead costs.


The practitioners who ought to have enough time to talk to patients, think about their problems, obtain more information about patients or their diseases and complaints, and communicate with other physicians, don't. We know from decision psychology that people subject to time pressure make less optimal judgments and decisions, mainly because they simply don't have time to think enough about alternatives, or the data they have. Thus, handicapping the professionals who ought to provide patients with their "medical homes" likely is a major cause of increased cost, decreased access, and sub-optimal quality.


Yet whenever there are costs to be saved, the first target seems to be primary care physicians. What's wrong with this picture?

I also thank "Pam" for the link to Kevin Grumbach's talk in which he mentions the still not very well known contribution of the RUC to the current reimbursement problems in primary care. We have posted about this here and here. This again raises the question of why the AMA, an organization which professes to represent all physicians, seems to be supporting federal reimbursement policies that are so bad for primary care and cognitive physicians?

Thanks, "Pam." Hope to hear from you again.

"Bling Bling," Poltical Correctness, and the Anechoic Effect

In today's post-modern academic world, everyone is afraid of saying anything that might be the least bit offensive. (See the web-site of the Foundation for Individual Rights in Education, or FIRE, for some amazing examples.)

It seems that that even the most skeptical and iconoclastic health care bloggers may also be fearful of being too politically incorrect.

In this post on the Carlat Psychiatry Blog, David Carlat nick-named Dr Charles Nemeroff "Bling Bling" for the extent of his relationships with the pharmaceutical industry. Carlat soon had to retreat, after being taken to task by one of the editors of his own Carlat Psychiatry Report for being "too personal," apologizing, "I was trying to be humorous, but I'll admit these [writings] come across as mean."

Today, this post on the Clinical Psychology and Psychiatry Blog showed that "Bling Bling" was not an exaggeration. (Nemeroff has also come in for criticism on Health Care Renewal, here, here and here.) But even then, the anonymous Clinical Psychology and Psychiatry blogger worried, "how is a blogger to be entertaining, stick to the facts, and bring important information to readers without crossing the line into being offensive? I don't know."

Yet, in health care, in my humble opinion, the problem is not too many bullying bloggers calling people offensive names. The problem, instead, is a general fear of saying something even the least bit negative about the powers that be, even when the powers that be have done awful things.

Carlat's quick retraction of what amounted to mild sarcasm, and the Clinical Psychology and Psychiatry bloggers fear of being "offensive" are the latest demonstrations that the "anechoic effect" is alive and well in health care.

The term, first coined by Dr Russell Maulitz, describes how even the most vivid cases of mismanagement, conflicts of interest, and even corruption in health care seem to produce no echoes. Two important historical examples that have come up on Health Care Renewal include:

• Cooper Hospital - University Medical Center. In the 1990s, this case featuring briefcases filled with cash, a hospital trustee convicted of murder, and the embezzlement of over $21 million. Yet despite these lurid details, it seemed to get no notice outside of local newspapers. See post here, and details here (starting on page 3).
• Allegheny Health Education and Research Foundation (AHERF) - The CEO of this, one of the first large vertically integrated health care systems, including the US' largest health care university at the time, was called a "visionary," and gave the prestigious John D Cooper lecture at the 1996 AAMC meeting. Meanwhile, he paid himself and his top managers huge salaries (for the time), and threatened his faculty, "don't cross me or you will live to regret it." The health care system eventually went bankrupt, the then second largest bankruptcy in US history, and the CEO went to jail. Yet, excepting what I have written, this case generated only one article in the health care and medical literature. See post here with citations and links.

And there have been numerous recent cases, e.g.,

• HRDI - An organization set up by 30+ CEOs of some of the US leading hospitals, which charged a stiff fee for prospective vendors to get access to them. It was shut down in a legal settlement, which prompted the Connecticut Attorney General to call the organization, "an anticompetitive, secret society." Yet the story never appeared in most of the hospitals' home towns, much less any medical journals. (See post here.)
• Guidant - A device manufacturer which recently was accused of suppressing data about failures of its implantable cardiac defibrillators, and previously pleaded guilty to suppressing data about failures of a vascular graft product. Yet a featured interview of its CEO in a leading health policy journal avoided discussing any of this recent unpleasantness. (See post here.)
• University of Medicine and Dentistry of New Jersey (UMDNJ) - Now the largest US health care university, the university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Yet none of this has appeared in the medical or health care literature.

Try a Google search for the "anechoic effect" and "hcrenewal" to see some other examples.

Yet, local media do not hesitate to report individual physicians disciplined by their state medical boards. Such discipline is on the public record (e.g., here, for my state of RI). Physicians are frequently sued for malpractice. The media run scary stories about medical errors and overpaid physicians.

But when the CEO of one of the country's biggest hospital systems goes to jail, or the biggest health care university in the country agrees to a deferred prosecution agreement, physicians don't talk or write about it.

Carlat's apology for awarding the "Bling Bling" nickname, and Clinical Psychology and Psychiatry's fear of being "offensive" suggests how fearful we are of saying anything even mildly negative about the powers that be in health care.

As Aubrey Blumsohn put it, "the desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things. Does civility matter? In the words of David Kern: When you're in an argument with a thug, there are things much more important than civility. I do not like incivility. Yet, I like thugs even less."

If we can't even talk about mismanagement, conflicts of interest, and corruption in health care, how are we ever going to fix these problems?

California Departin' - University of California President Steps Down

Last year, we posted extensively (e.g., here, here and here, and see contained links backward) about management issues at the top of the sprawling University of California system. Now a large shoe has dropped. According to the Los Angeles Times,

University of California President Robert C. Dynes, whose four years in office have been marked by dwindling budgets and a scandal over compensation for top officials, announced Monday that he will step down by June.

Though praised by associates for his 'extraordinary intellect,' Dynes appears to have lost the support of key members of the UC Board of Regents who believe the 10-campus system must act more aggressively to maintain its excellence.

Dynes, 64, a former chancellor at UC San Diego, said he was stepping down to spend more time with his wife, Ann, a former UC San Diego campus counsel whom he married in March.

In the end, it was the university's compensation practices, including quietly awarding millions of dollars in perks to top executives without the regents' approval, that appear to have hurt him the most.

'After all the missteps and missed opportunities, Dynes has largely lost his effectiveness and his support, both above and below him,' said a university official who insisted on anonymity. 'A great guy in the wrong job at the wrong time.'

The most damaging period for Dynes came last year with revelations that UC had given top administrators millions of dollars in perks and bonuses even as it raised student fees. Many of the payments were not disclosed publicly or approved by the regents, in violation of university policy.

It is a reminder that in the long run, top managers who preside over mismanagement sometimes accrue negative consequences.

BLOGSCAN - the Faults of CME by MECC

On the Carlat Psychiatry Blog, this saltily titled post provides another good illustration of the faults of industry-funded, medical education and communications company (MECC) written continuing medical education (CME), in this case, pushing what would appear to be a particularly hazardous anti-depressant medication, a MAO inhibitor delivered by a patch.

BLOGSCAN - Why Medical Students Don't Like Primary Care

On the Over My Med Body blog, this post explains with brilliant simplicity one reason why medical students choose a variety of specialties over primary care: in specialty clinics, the students can spend enough time with each patient to both comprehend what is going on, and actually learn something. In primary care, the pace is too rapid to think or to learn. The real question is why our health care system requires primary care doctors to spend less and less time with individual patients. One immediate reason is a perverse reimbursement system that pays physicians per visit or procedure, and does not pay enough for office visits to allow primary care physicians to spend enough time to properly take care of patients. See our posts here and here.

How Albany Became Part of Hartford, and Toledo, Ohio, Became Part of Michigan - the US Congress Makes Hospital-Specific Earmarks

We have posted before, (e.g., here) about various peculiarities in the way the US Medicare program (essentially, a single-payer health government health insurance program for the elderly and the disabled) pays for services, particularly physicians' services. Robert Pear, in the New York Times, just disclosed some more peculiarities in the way Medicare reimburses hospitals. In this case, a bill passed by the US House of Representatives mainly to fund health care insurance for children also included multiple specific provisions that would benefit specific hospitals. (Caution, this section is easier to understand if you are thoroughly familiar with US geography.)

Despite promises by Congress to end the secrecy of earmarks and other pet projects, the House of Representatives has quietly funneled hundreds of millions of dollars to specific hospitals and health care providers under a bill passed this month to help low-income children.

Instead of naming the hospitals, the bill describes them in cryptic terms, so that identifying a beneficiary is like solving a riddle.

One hospital, Bay Area Medical Center, sits on Green Bay, straddling the border between Wisconsin and the Upper Peninsula of Michigan, more than 200 miles north of Chicago. The bill would increase Medicare payments to the hospital by instructing federal officials to assume that it was in Chicago, where Medicare rates are set to cover substantially higher wages for hospital workers.

Lawmakers did not identify the hospital by name. For the purpose of Medicare, the bill said, 'any hospital that is co-located in Marinette, Wis., and Menominee, Mich., is deemed to be located in Chicago.' Bay Area Medical Center is the only hospital fitting that description.

The bill, for example, would give special treatment to two hospitals in Kingston, N.Y., stipulating that Medicare should pay them as if they were in New York City, 80 miles away.

The two hospitals in Kingston, N.Y., that are beneficiaries of the bill, Benedictine Hospital and the nearby Kingston Hospital, recently announced an agreement that would bring them together under a single parent corporation.

Neither hospital is named in the bill, but they are the only ones that could qualify. The bill guarantees higher Medicare payments for New York hospitals with a 'single unified governance structure,' located less than three-fourths of a mile apart in a city with a population of 20,000 to 30,000.

Kingston has a population of 22,828, according to Census Bureau data issued this week.

Under the bill, hospitals in three counties of upstate New York — Albany, Schenectady and Rensselaer — are deemed to be in 'the large urban area of Hartford, Conn.'

Under another provision, an unnamed hospital in Burlington County, N.J., would be reassigned to the New York City metropolitan area, where wages are significantly higher. This provision was written for the benefit of Deborah Heart and Lung Center, in Pemberton Township, N.J., more than 60 miles from the bustle of New York City.

Representative Marcy Kaptur, Democrat of Ohio, won extra money for St. Vincent Mercy Medical Center in Toledo. Under the House bill, the hospital would be 'treated as located in the same urban area as Ann Arbor, Mich.,' more than 40 miles away.

Lawmakers did not identify St. Vincent by name, but referred to a hospital with Medicare provider number 360112. That is the identification number for St. Vincent.

Of course, politicians made their excuses.

Nadeam Elshami, a spokesman for Speaker Nancy Pelosi, Democrat of California, said people should keep the big picture in mind.

'It’s easy to criticize individual provisions of large, complex bills,' Mr. Elshami said, but 'the focus should be on the huge number of uninsured children who will be eligible for life-saving health care under our bill.'

Representative Pete Stark, the California Democrat who is chairman of the subcommittee, acknowledged that 'it’s hard to decipher' the cryptic language used in the bill to identify specific hospitals. 'It’s always been thus,” Mr. Stark said in an interview. “I am at a loss to explain why.'

Granting relief to particular hospitals is sometimes a way for Congress to improve 'the equity and fairness' of Medicare payments, Mr. Stark said. Under Medicare, he added, 'you are basically setting prices, and the system is clumsy.'

Clumsy is an understatement. In my humble opinion, this is an illustration first of how removed Medicare reimbursement is from any sense of rationality. Having individual hospitals enjoy increased reimbursement simply because their local congresspeople were able to horse-trade for special favors just lessens trust that any part of the federal process to set reimbursement is fair.

Although, as noted before, we often write here on Health Care Renewal about mismanagement, conflicts of interest, and outright corruption in for-profit health care corporations, the integrity of government paid and government run health care does not seem any better.

Those who think that we can fix the US health care problems by handing more control over to the government need to think twice about how well that really might work.

ADDENDUM (13 August, 2007) - Also see this post on the Health Care Blog.

King-Harbor Hospital Closing

We had previously posted (here, here, here and here) about the ongoing troubles at the medical center formerly known as King/Drew and since renamed Martin Luther King Jr - Harbor Hospital in Los Angeles, after the county hospital went from being flagship hospital for the Charles R Drew University of Medicine and Science to a part of Harbor-UCLA Medical Center. Long viewed as a symbol of progress for poor and minority patients in the city, it had fallen on very hard times, attributed to bad management that for a long time hid behind the banner of the hospital's reputation in the community.

Now the hospital is going to close. Per the Los Angeles Times,

Martin Luther King Jr.-Harbor Hospital shut down its emergency room Friday night and will close entirely within two weeks, a startlingly swift reaction to a federal decision to revoke $200 million in annual funding because of ongoing lapses in care.

The extraordinary developments mark an end to nearly four years of failed attempts to reform the historic institution, treasured by many African Americans as a symbol of hope and progress after the 1965 Watts riots.

The Medicare agency's letter to the hospital, hand-delivered this Friday morning, conveyed a deep sense of frustration that King-Harbor had squandered repeated opportunities to avoid this end. Fewer than five hospitals a year lose their federal funding.

In its final inspection last month, the hospital fell below minimum standards in eight of the 23 areas assessed by the agency.

'While some progress has been made, significant problems persist at MLK-Harbor Hospital,' Herb Kuhn, the Medicare agency's acting deputy administrator, said in a statement. 'Conditions at the facility have placed the health and safety of patients at great risk.'

In fact, reviewers found a host of serious lapses throughout the hospital, some similar to those that county officials swore had been fixed. They included failure to properly clean bronchoscopes -- devices used to look into the lungs -- which put patients at serious risk of exposure to contagious diseases. In addition, the hospital staff also could not demonstrate its ability to respond to a pediatric emergency, failing to locate critical equipment or even properly calculate how much medication to give a critically ill child.

Almost from the start, there were signs that the hospital would not pass.

On their second day at the hospital, inspectors declared that patients were in immediate jeopardy of harm or death after a psychiatric patient was left unattended and cut herself with a scalpel she found in the emergency room.

The story made clear that the closure of the hospital was due to mismanagement and the failures of the political leaders who were ultimately responsible for this county hospital.

The federal decision underscores the failure of Los Angeles County government, which despite slashing services, firing hundreds of workers and paying tens of millions of dollars to consultants, could not assure ensure the basic safety of patients at King-Harbor.

Supervisor Gloria Molina acknowledged as much. 'We keep getting assurances that the personnel there are trained and prepared and ready to deal with this inspection, and unfortunately we failed pretty miserably,' she said.

Some members of the county Board of Supervisors -- all of whom have been in office more than a decade -- said closure is the only option left.

'For too long, the status quo allowed mediocrity to be the norm,' said Supervisor Mike Antonovich. 'There is no excuse or reason that we had to waste tax dollars and continue to support a failed system.'

Supervisor Zev Yaroslavsky said: 'We were given more time than I would have given Los Angeles County if I was the regulator. But we couldn't move far enough, fast enough, and that was the ultimate verdict. I'm not surprised. I'm not sure anybody around here is surprised by the decision they made.'

The story is a stark reminder of the bad effects of mismanagement of health care organizations. Although it seems we most often discuss pharmaceutical, biotechnology, and device manufacturers in this blog, this story makes it clear that government organizations, local or national, are hardly immune from poor management.

The sorry results are too often failed instutions, reduced access to care, and, most sadly, hurt patients.

BLOGSCAN - A Drug Manufacturer Asks a University President to Lobby on its Behalf

On the Scientific Misconduct Blog, Dr Aubrey Blumsohn reprises a key event in the "Nancy Olivieri Case." Recall that Dr Olivieri is a physician at the University of Toronto who nearly forced out of her job after she tried to blow the whistle about unexpected side effects she found during a drug trial sponsored by Apotex. Meanwhile, Apotex, which had promised to make a large donation to the University, asked the University President to lobby the Canadian Prime Minister to quash a legislation which Apotex thought to be unfavorable to its interests. By the way, for a full accounting of the case, see the report by the Canadian Association of University Teachers here.

BLOGSCAN - "Dangerous Ideas"

On The Torch, the blog sponsored by the Foundation for Individual Rights in Education (FIRE), is this post about Steven Pinker's article on the concept of "dangerous ideas," i.e., “statements of fact or policy that are defended with evidence and argument by serious scientists and thinkers but which are felt to challenge the collective decency of an age.” There seem to be a lot of dangerous ideas in health care, including the notion, a la Transparency International's 2006 Global Report, that corruption is a common, systemic, and important problem in health care world-wide. Their dangerousness seems to lead to the anechoic effect.

Newspaper Publisher Joins Board of Medical Center - Just a Potential Conflict of Interest?

The Cleveland Plain Dealer just reported (although right now the web-link is not working correctly) a story that may help explain why stories about questionable management of health care organizations often are anechoic,

Plain Dealer President and Publisher Terrence C. Z. Egger was named Monday a Cleveland Clinic board trustee, an appointment he said will not compromise the newspaper's duty to cover the Clinic impartially.

Egger said in an interview that trustee Chairman Mal Mixon asked him to serve on the 60-member board. He accepted to be involved with the growth engine of the area economy, he said.

The Plain Dealer did at least allow that this new appointment might be controversial.

The newspaper should take steps to assure the public that Egger's role as trustee has no influence on news coverage or editorials related to the hospital, said Bob Steele, a journalism values scholar at the Poynter Institute, a newspaper think tank in St. Petersburg, Fla.

'It's dicey territory,' said Steele. 'You have competing loyalties. And competing loyalties, if not properly recognized and professionally and ethically addressed, can create conflicts of interest [that] can corrode the credibility of either organization.'

It's interesting how the paper chose to quote someone who could not bring himself to say that the newspaper publisher's new position created a conflict of interest, only the potential for one.

News reporters are usually very careful about not having any financial relationships with people or organizations about which they may report (to the point of refusing a cup of coffee from someone who someday might be in a story they would report). Yet when the boss of the newspaper, to whom ultimately all those reporters report, is now also the boss of a major hospital system, that's only a potential conflict of interest.

In fact, the wishy-washy way in which this story was reported suggests just why this sort of conflict is important and troubling. It would take a courageous reporter to write a story critical of the Cleveland Clinic, when he or she knows the newspaper's boss is a leader of the Clinic.

This story does illustrate another mechanism for the propagation of the anechoic effect.

BLOGSCAN - CME as Stealth Marketing

In the Carlat Psychiatry blog, this post shows a telling example of how pharmaceutical companies support continuing medical education (CME) which actually functions as stealth marketing meant to "prepare the ground" for new drugs.

BLOGSCAN - LA Times Series on Physicians and Pharma

On the Hooked: Ethics, Medicine, and Pharma blog is this post linking to an excellent series in the Los Angeles Times summarizing many issues in the relationships among physicians and pharmaceutical corporations.

Hospital IT: Amateurs welcome?

In my prior post "Leadership Position in Health Informatics: MD's Need Not Apply?" early this year, I pointed out in some detail the confusion in many healthcare organizations about medical informatics and the expertise needed for best EHR implementation. I mentioned that sometimes the thinking on this topic within healthcare organizations seemed bizarre, as in Superman comics:

In the Bizarro world, a cube-shaped planet known as "Htrae" ("Earth" spelled backwards), society is ruled by the Bizarro Code, which states "Us do opposite of all Earthly things! Us hate beauty! Us love ugliness! Is big crime to make anything perfect on Bizarro World!". In one episode, for example, a salesman is doing a brisk trade selling "Bizarro bonds. Guaranteed to lose money for you". Later in this episode, the mayor appoints Bizarro #1 to investigate a crime, "Because you are stupider than the entire Bizarro police force put together". This is intended and taken as a great compliment.

I periodically receive solicitations for health IT positions from recruiters at large hospitals.

Here's just the latest two, quite typical of what I receive on a regular basis. Keep in mind that I completed an NIH postdoc in clinical IT, have been a CMIO (Chief Medical Informatics Officer) in a 1000+ bed regional medical center reporting the the Sr. VP for Medical Affairs, been a Group Director of informatics in a multinational pharma overseeing a staff of 50, and am now a professor of informatics and IT (for the second time in my career):

#1, from the largest medical center in the Philadelphia suburbs:

Systems Analyst

Physician Practices Ambulatory EMR systems experience required.

Full-time, including support call rotation

You’ll implement and support clinical systems for Physician Offices for one of the busiest hospitals in the Delaware Valley.

• Familiarity with Eclipsys Sunrise Clinical Manager and/or Ambulatory Care Manager and Misys Vision would be assets
• Experience with project management, electronic medical records, help desk and implementing process changes
• Troubleshooting, problem resolution and creative thinking a plus

"A plus?" Wow. Troubleshooting, problem resolution and creative thinking can probably can come in handy when dealing with clinical IT project management, doctors, process change, and EMR's, especially when doing Help Desk support as a lowly Systems Analyst.

#2:

Description:

Manager of Clinical Support Systems, CPOE, Clinical Manager in CA Hospital.

The successful candidate will have a clinical background (nurse, but not essential) and really know the ancillaries and understand their strategic importance to the execution of all the “in vogue” IT projects like EMR and CPOE. The successful candidate in this role will be very smart and take extreme pride in delivering results!

Why in the name of heaven would anyone seriously think of sending me a JD for a manager-level position, at least two levels below my previous hospital and pharma positions? I also received a personal phone call from this recruiter as well as an email - this was not computer-generated spam.

As in my earlier posting mentioned above, do I see a preference for a nurse again, and that a clinical background is really not essential? Or does the hiring manager mean any clinical background is OK - even perhaps - gasp - a physician? I imagine it also could be useful in such a role to be "very smart" and take pride in one's work.

Infrequently indeed do I see requirements for formal healthcare informatics or IT training. (In some ads, only a bachelor's in IT is called for.)

These ads probably do result in hiring of clinical IT personnel, who clinicians increasingly depend on for tools essential to clinical care (if only in the sense that clinicians are ordered to use them).

I would not enjoy imagining what would occur if neurosurgeons were hired in the same way.

To these organizations, I give the following free advice. Paraphrasing Dr. William Hersh at OHSU's Dept. of Medical Informatics & Epidemiology, "It's unwise spending millions on Electronic Medical Records without investing thousands in Medical Informatics expertise."

Any takers?

-- SS

More Unfortunate Details About Targeted Genetics' Fatal tgAAC94 Trial

Rick Weiss in the Washington Post just published a follow-up report on the death of a study participant in an early phase trial of gene therapy for (apparently inflammatory, probably rheumatoid) arthritis. We had first posted about this here.

In summary, the trial was of tgAAC94, a transgene encoding the receptor for tumor necrosis factor (TNF)-alpha, a cytokine that causes joint swelling in arthritis patients, made by Targeted Genetics. The trial used a viral vector injected directly into an arthritic joint. An NIH review panel that first considered the trial was worried that the new treatment was to be given to not very sick patients, and that the virus could escape from the joint into which it was injected and cause systemic problems.

Oddly enough, Targeted Genetics had bought out Genovo, the company whose gene therapy was associated with the death of a patient in Pennsylvania in 1999.

The new Washington Post report revealed some detail about the death in the tgAAC94 trial.

[The patient] had been feeling fine just a few weeks earlier, save for occasional stiffness from her arthritis.

[The] first shot, administered on Feb. 26, had no noticeable effect, and she wondered whether she got the placebo. But she was excited that the next one would be the real thing....

That happened on July 2, a Monday. She was tired and out of sorts after a weekend of boating with her husband and daughter....

[Her physician] recorded her temperature at 99.6, then gave her the shot.

'The next day she woke up and didn't feel good at all. By afternoon she started vomiting,' [her husband] ... recalled. 'By evening her temperature had shot up to 101.'

She spent July Fourth feverish and vomiting. Her family physician told her it was probably just a virus.

When her symptoms worsened and her temperature hit 104.1 on Saturday, she went to the emergency room. Tests indicated a possible infection and signs of liver damage, but she was sent home for more care from her family doctor....

But [she] ... only got worse, and on Thursday she was admitted to the hospital.

Things went downhill fast, with [her] ... body showing signs of being ravaged by an infection. But tests for standard bacteria and viruses came up negative. With breathing problems and the possibility she might need a liver transplant, she was transferred to the University of Chicago hospital.

[Soon she] was breathing with the help of a ventilator in a Chicago intensive care unit -- her body bloated from internal bleeding, her liver failing -- and no one could figure out what was wrong with her.

Three weeks after ... the injection that she had hoped would cure her, she was unconscious and beyond hope of recovery. With family and friends gathered around, her life support was removed.

Furthermore, the Washington Post article documented a series of problems with how the trial of tgAAC94 was done.

1) The study was presented to the patient as if it possibly could help her clinical condition, even though it was only a Phase I study designed to assess toxicity.

'It was presented to her like this is going to make her knee better,' said [her husband.]

Further in [the study's consent form], after long descriptions of how the product may help, a single sentence states: 'We do not expect you to receive any direct medical benefits from participation in this study.'

2) The patient was persuaded to enter the study by her rheumatologist, Robert Trapp, who was paid by Targeted Genetics to recruit patients, and who administered the consent form to her without giving her an opportunity to take it home and think it over.

Her rheumatologist, [was] Robert Trapp, whose Springfield clinic got payments from Targeted Genetics for each subject he recruited....

Trapp, one of 20 U.S. doctors testing tgAAC94, invited her to join the study on Feb. 12.

There would be two injections, months apart, he explained. The first might be real, or it might be a placebo, but the second would definitely be the test product. She signed up immediately, and Trapp drew several tubes of blood to get the study going.

Two fundamental rules of clinical research were violated that day, experts said. First, consent forms are to be taken home and considered, not signed on first sight. Second, when a patient's own doctor is a principal investigator in a study, someone else is supposed to make the proposal.

3) A lay-person would have found the consent form difficult to understand.

Jonathan Moreno, an expert in the ethics of medical experiments at the University of Pennsylvania, said the consent form used by Targeted Genetics to outline the drug's potential dangers was thick with technical descriptions and thin on explaining 'what's really going to happen.'

'Even a smart person would have a very hard time figuring out what they're talking about,' said Moreno, who examined the form at the request of The Washington Post.

4) The consent form and apparently the whole trial were approved by a not yet identified for-profit institutional review board.

The form was approved by one of the growing number of for-hire review boards that contract with biotechnology companies to ensure studies meet patient-protection standards. Targeted Genetics noted that the review firm it used is accredited and accepted by the FDA. But the use of private boards, as opposed to those run by universities or government agencies, has raised alarms among some medical ethicists since a for-profit review board risks losing repeat business if it is too tough on its clients.

Note that it is not yet clear whether Targeted Genetics directly administered the trial, or whether it was run by an academic institution, or a contract research organization.

5) Targeted Genetics delayed reporting of the patient's illness to the US Food and Drug Administration (FDA).

But Targeted Genetics and Trapp had at first classified the problems as not serious, and later classified them as serious but unrelated to the treatment. So no FDA report was made, and the study went on, with other volunteers unaware of the problems.

Finally, on July 20, a day after Mohr's emergency transport to Chicago and four days before she died, the company sent a serious adverse event' report to the FDA and suspended the study, conceding that her life-threatening symptoms were "possibly" due to the treatment.

In summary, it is too soon to tell if the patient died as a direct result of the gene therapy. It is also not clear whether any of the problems with how the research was designed and conducted were at all related to her death.

However, this tragic case does once again illustrate that commercially funded research is often not designed and carried out as well as it should be.

Furthermore, problems in research design and operation tend to favor the vested interests of the research sponsor. For example, regarding Targeted Genetics delayed reporting of a research participant's serious illness,

That reflects a widespread problem in clinical trials, said Adil Shamoo, a professor at the University of Maryland School of Medicine and editor in chief of the journal Accountability in Research.

'There are no uniform standards for 'adverse events' reporting,' Shamoo said. 'And there is no motivation to report them. . . . No one wants to show their dirty linen.'

Dirty linen can drag down a company's bottom line, and Targeted Genetics, like all companies, puts a lot of work into keeping that line afloat. An interim report on tgAAC94, for example, spoke in June of 'very encouraging results' and evidence of 'clinical benefit,' although, by one measure the company considered key, patients who got high, medium or low doses of the drug did the same as those who got placebos.

'The company was talking about lucrative markets and a promising product much too soon,' said Marcy Darnovsky, associate executive director of the Center for Genetics and Society, an Oakland, Calif.-based public interest group that focuses on genetic technologies.

This is another vivid and very unfortunate case that raises questions whether commercial firms should sponsor, run, or even just influence clinical research designed to test their own products.

Hat tip to the WSJ Health Blog.

After the Wellmark College of Public Health, Can the "Pizza Hut School of Nutrition" Be Far Behind?

We previously posted, here and here, about a proposal to name the school of public health at the University of Iowa the Wellmark Blue Cross Blue Shield College of Public Health, or something like that, after that for-profit insurance company's foundation offered to donate $15 million to the school.

The Des Moines Register is continuing to follow the story. And although the faculty voted against the naming rights, negotiations are underway to keep the idea alive, perhaps letting the school's name be shorted to just the "Wellmark College of Public Health," as if leaving "Blue Cross Blue Shield" off would conceal the ties to a large commercial health insurer with which the university's teaching hospital does considerable business.

It is notable that this story, perhaps because of its vividness, actually is now getting national attention. USA Today ran a short item on it.

And that lead to this priceless title to a column on "The Skinny" on CBS News.

What's Next? Pizza Hut School of Nutrition?

Maybe sarcasm in the national media will have some effect on the educational bureaucrats and corporate executives who now run health care, after scholarly criticism didn't.

Re-Examining the Suppression of the Trasylol Study

We first blogged about allegations that Bayer A.G., the German pharmaceutical company, may have suppressed its own research that showed its drug Trasylol (aprotinin) may have increased risks of severe problems such as congestive heart failure, kidney failure, stroke, and death in 2006 here and here. The St Petersburg (FL) Times just re-examined the story. The new reporting sheds more light on how the research was suppressed, and reactions to the suppression. To summarize....

In 2006, an observational study in the New England Journal of Medicine suggested that Trasylol may have had more adverse effects that previously believed. [ Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-365.] [Free Full Text]

The first author of the study testified at a US Food and Drug Administration (FDA) hearing under adversarial circumstances.

Panelists attacked Mangano's methodology, saying he had not sufficiently accounted for the high-risk nature of patients receiving Trasylol.

In a recent interview, Mangano said he was shocked by the panel's harsh reception of his work.

'The whole thing was a set-up,' he said. 'We did not have anything to gain financially by this. We were making an observation about safety.'

Mangano noted that the chairman of the panel, Dr. William R. Hiatt, has written papers underwritten by Bayer, and that three committee members received waivers to vote because of financial interests in drug companies.

'The system is ridiculous,' he said. 'It's all pro-industry. Who's protecting the patient?'

Only after the meeting was it revealed that Bayer had hidden the results of its own study.

Dr. Alexander Walker, a professor at Harvard School of Public Health, said Bayer hired him six months earlier to review an enormous database of 67,000 bypass patients. The study compared the side effects of Trasylol with those of the two other anti-bleeding drugs.

Walker said his analysis matched Mangano's: Trasylol patients seemed to be at increased risk for death, kidney failure, congestive heart failure and stroke.

When contacted by the FDA, Bayer said it had 'mistakenly' neglected to mention the giant study. The company said the data was "preliminary in nature and raised significant questions on the study population, outcomes and methodology."

That response sounds hollow to several advisory committee members still stung by Bayer's behavior. Dr. Michael Lincoff, vice chairman of cardiovascular research at Cleveland Clinic in Ohio, said that several panelists had commented during the meeting on the need for more data.

'At no point did the Bayer folks say, 'It's on its way,'' he said.

Steve Findlay, a panel member and health care analyst with Consumers Union, said Bayer's actions were 'intentional and very disingenuous.'

'Absolutely no one would say it was in the public interest, or the interest of people having heart surgery, for that information not to be made public.'

'Bayer's action is yet another example, and an egregious one, that shows the lack of transparency regarding important data,' Findlay said. 'We need a system that makes all this publicly available.'

Bayer suspended two unidentified employees following the revelation of Walker's study. It also said it was investigating the incident, a review the company says is still under way.

Mangano's final comments were

You just wonder how many heart failures and strokes are going to happen because this drug is still on the market.

But bringing up drug safety issues is not for the weak-hearted. There are a lot of interested parties that go against you. You just keep moving forward.

We have said it before. We will say it again. To make the best decisions about tests and treatments, patients and physicians need access to the best available data from clinical research. Thus, suppressing research data or results is bad for patients and physicians. It also betrays the patients who originally volunteered to participate based on the understanding that their participation would be used to advance science and health care.

Thus, commercial research sponsors (e.g., drug, biotechnology, or medical device companies) who suppress such data are betraying their public trust. If they cannot be trusted not to suppress data that is unfavorable to their interests, they ought to be banned from sponsoring or controlling research on human beings.

Hat tip to PharmaLot.

BLOGSCAN - Interview with Pfizer Anti-Viral Drug Marketing Whistleblower

On PharmaLot, Ed Silverman posted an interview with one of those at Pfizer who blew the whistle about questionable marketing practices of anti-viral drugs.

BLOGSCAN - Imagine No Commercially Sponsored CME

On the Carlat Psychiatry blog, this post notes that the Accreditation Council for Continuing Medical Education (ACCME), the organization that accredits continuing medical education (CME) providers in the US, just might consider banning commercial sponsorship of CME.

How the Legal Case Against Purdue for Deceptive Marketing of Oxycontin was Nearly Derailed

We recently posted about how Purdue Pharma and its top executives pleaded guilty to "misbranding" the potent narcotic drug Oxycontin. It turns out the pleas bargain was almost derailed. Yesterday, the Washington Post reported,

The night before the government secured a guilty plea from the manufacturer of the addictive painkiller OxyContin, a senior Justice Department official called the U.S. attorney handling the case and, at the behest of an executive for the drugmaker, urged him to slow down, the prosecutor told the Senate Judiciary Committee yesterday.

John L. Brownlee, the U.S. attorney in Roanoke, testified that he was at home the evening of Oct. 24 when he received the call on his cellphone from Michael J. Elston, then chief of staff to the deputy attorney general and one of the Justice aides involved in the removal of nine U.S. attorneys last year.

Brownlee settled the case anyway. Eight days later, his name appeared on a list compiled by Elston of prosecutors that officials had suggested be fired.

Brownlee ultimately kept his job.

Justice Department officials said it was not unusual for senior members to weigh in on major criminal cases, and a spokesman, Dean Boyd, said the department 'encourages healthy internal debate and discussion on complex cases like this one.'

Several former federal prosecutors also said that defense attorneys routinely try to appeal to high-ranking department officials in an effort to derail prosecutions. Still, Brownlee and other former prosecutors said nighttime calls such as Elston's, coming just hours before the end of a long, complex case, are unorthodox, particularly when the department's criminal division already has signed off on a case.

Brownlee said the head of the criminal division had authorized him that afternoon to execute the plea agreement.

This story is now linked to the ongoing controversy about whether the current US Attorney General improperly sought to fire several US Attorneys.

But the implications of this story for health care are additionally troubling. We have posted on many examples of deceptive and/or stealth marketing by pharmaceutical, biotechnology and device manufacturers, and questionable claims and advertising by hospitals and insurers and managed care organizations.

Physicians, particularly primary care physicians, working under increasing bureaucratic restraints and forced to see patients increasingly quickly now must also operate in a swamp of questionable marketing and pseudoevidence. When time is short, it is all too tempting to just prescribe the latest and greatest heavily promoted drug or order the the latest and greatest whizbang diagnostic test.

It is bad enough that corporate executives condone deceptive marketing of drugs and devices. It is worse to hear that government officials who are responsible for law enforcement seemed to want to cut those who were fostering deceptive advertisers and creating pseudoevidence some unjustified slack.

At least the US Attorney on the ground in this case stood up for what was right. But who else has the courage to stand up for some honesty in health care?

More Bloggers Address Pfizer's Marketing of Viracept and Maraviroc

[Revised 4 August, 2007] A complicated story about questionable pharmaceutical marketing practices is now playing out on several other blogs. Basically, the issue is allegations about how Pfizer Inc, the world's largest drug company, marketed two anti-viral drugs, its aging anti-viral drug Viracept (nelfinavir), and the new drug maraviroc. We had previously posted a little about this here and here. But most of the real reporting about the maraviroc issue can be found on Question Authority with Dr Peter Rost, and now on BrandweekNRX, for which Dr Rost is now also blogging. Furthermore, most of the real reporting about Viracept can be found on PharmaLot by Ed Silverman, most recently here (and previously here, here, and here.) And recently the Carlat Psychiatry Blog just did an excellent summary of the story so far.

The main allegations were that Pfizer promoted maraviroc, a new anti-viral drug, before the US Food and Drug Administration (FDA) approved it, and that Pfizer marketing people used continuing medical education (CME), which is, of course, supposed to be educational, as a marketing tool for nelfinavir.

Carlat's summary was "The bottom line: When your marketing plan is always teetering on the edge of corruption, you're gonna get burned. It's only a matter of time."

[Note, the original version of this post did not give adequate credit to the reporting by Ed Silverman on PharmaLot. See his comment below. I hope the new version is more adequate. ]

BLOGSCAN - How MECCs Tweak CME in Favor of their Sponsor's Product

On the Carlat Psychiatry Blog is a post on the "tweaking" of CME published by a medical education and communication company (MECC) in favor of the produce produced by its commercial sponsor.

Another Death in a Gene Therapy Trial

The case of the death of a research subject in an early trial of gene therapy for arthritis raises some eerie parallels to previous cases. So far the case has sparked minimal media attention, so although the news so far raises far more questions than answers, it appears worth summarizing on Health Care Renewal.

As reported by the Seattle Times,

Shortly after suspending a major clinical trial because of serious illness in a patient, Targeted Genetics and federal regulators said Thursday that the person had died.

Whether it was the experimental arthritis drug being tested that caused the illness is not yet known. But the condition 'was related in time to the receipt of a second injection of the product,' the U.S. Food and Drug Administration said Thursday in a statement. The agency is investigating whether the illness was related to the treatment.

'We do not yet understand the cause of death,' said Barrie Carter, Targeted Genetics' chief scientific officer.

Some 127 patients have received an initial dose of the active drug or placebo, including 74 that received a second dose of the drug, Targeted Genetics said. The drug, known as tgAAC94, is designed to be used along with other therapies.

The Scientist provided a little more detail about the therapeutic intervention.

Researchers in the field say the treatment's delivery vector, an adeno-associated virus (AAV), was unlikely to be the culprit.

'Vectors in this class have been used on hundreds of patients over the last 12 years, and are not associated with acute toxicity,' said Terence Flotte of the University of Massachusetts Medical School in Worcester. Flotte has been a principal investigator in several clinical trials of AAV-based gene therapy, but is not associated with the trial in question. 'I've never seen anything like this,' he told The Scientist. 'Whatever this is, it's unusual.'

In the trial, the AAV vector delivered a transgene encoding the receptor for tumor necrosis factor (TNF)-alpha, a cytokine that causes joint swelling in arthritis patients. The receptor, secreted by the target cells, binds to TNF-alpha, to reduce inflammation and protect the joint.

Usually prescribed for autoimmune conditions such as rheumatoid arthritis, the TNF-alpha receptor works by suppressing the immune system. But the protein could also have opened the door to an infection, suggested Flotte.

The Washington Post reported that a US National Institutes of Health (NIH) panel that reviewed the initial project protocol had some serious doubts.

Unlike the vast majority of such proposals, all of which aim to treat diseases by giving patients new genes, the plan to inject trillions of genetically engineered viruses into the joints of patients with arthritis was flagged for a special public review by the federal Recombinant DNA Advisory Committee, part of the National Institutes of Health.

At that Sept. 17, 2003, meeting, representatives of the sponsoring company, Targeted Genetics Corp. of Seattle, listened as a panel of experts wondered aloud why such a novel and possibly risky approach was to be offered to patients who were not especially ill, including some who had not even tried standard treatments.

Reviewers questioned the justification for the study, given that animal studies had found only a 'limited correlation' between the treatment and any improvements in subjects' condition. And they asked for more assurance that the engineered viruses were not going to spread around the body or cause untoward immune system reactions in patients.

Some also expressed concern that the informed consent document the researchers planned to use to describe the risks and benefits to participating patients was not upfront enough about the fact that the study was unlikely to help them and was designed merely to test the new approach's safety.

Even more eerie was the study's ties to a previous failed study of gene therapy. Per the Seattle Times,

The death is the second in the history of gene-therapy trials, experts said. In 1999, 18-year old Jesse Gelsinger, part of a University of Pennsylvania study on an inherited liver disease, died of a massive immune reaction to a gene-therapy treatment.

There's a business link to Targeted Genetics from that case: The UPenn experiment was led by Dr. James Wilson, whose company, Genovo, licensed the technology used in the trial. Targeted Genetics acquired Genovo in 2000 for $66 million in stock.

The company, however, says that there's no Genovo technology in its inflammatory-arthritis drug.

Note further that Wilson, who owned 30% of Genovo stock, reportedly made $13.5 million from the sale of the company to Targeted Genetics, per an article in the Seattle Times "Uninformed Consent" series.

It's too early to tell what this case means, but I do have some comments. Just because a treatment has been used on "hundreds" of patients does not mean that it has no serious acute side-effects. It only means that such side-effects may be relatively infrequent.

I may be overly conservative, but it seems we know a lot less about the sort of treatment used in this trial than we do about many other treatments. Occasionally, other novel treatments that seemed as if they ought to have been safe have not. Recall the TGN 1412 case (see post here) as well as the case of Jesse Geisinger noted above. Thus, in retrospect, it is easy to say that extreme caution in the first trials of the treatment was indicated. Instead, it often seems that people who work at the cutting edge of biotechnology are in a big hurry to develop their products. It is not clear from current reporting the extent that the design of the trials of tgAAC94 reflected the concerns of the 2003 NIH panel.

So we will keep an eye on this one. Some questions to keep in mind, based partly on the TGN 1412 story, are: how was the trial actually designed, what illnesses did subjects actually have, and what sort of informed consent did subjects give? Who actually carried out the trial (I assume it was not Targeted Genetics personnel)? Did previous animal or in vitro studies of tgAAC94 suggest the possibility of any bad adverse effects?

The AMA, "Prescription Data-Mining," In-Store Clinics, and Patients' and Physicians' Interests

OK - I'm back from Geneva and it's time to catch up.

Last weeek, two commentaries from the US east and west coasts slammed the American Medical Association. From the west coast, in the San Francisco Chronicle, Robert Restuccia from the Prescription Project and Lydia Valas from the National Physicians Alliance criticized how the AMA sells information on individual physicians to be used in pharmaceutical company marketing.

One of the less obvious but more intrusive marketing tools is the drug rep's hand-held computer, which contains a detailed profile of your doctor's prescribing history. Armed with the knowledge of each doctor's individual prescribing habits, pharmaceutical sales representatives tailor their pitches to each physician.

The AMA sells information from its physician "Masterfile" to health information organizations that pair the identifying information with prescribing records from pharmacies and sell the whole package to pharmaceutical companies, a practice commonly called "prescription data-mining."

The AMA profits handsomely from this agreement. In 2005, the AMA made more than $44 million from the sale of database products, approximately 16 percent of its budget.

Despite representing less than 30 percent of all U.S. doctors, the AMA keeps identifying information on all licensed physicians - and sells it all. Even so, only 60 percent of physicians surveyed by the Kaiser Family Foundation were aware of the sale of their information. Once told, 74 percent disapproved. Even a survey by the AMA itself found a 66 percent disapproval rate.

A number of policymakers, physician groups and medical societies have come out against this practice in recent years. Leaders include the National Physicians Alliance, the American Medical Student Association, the Vermont Medical Society and the New Hampshire Medical Society. Unfortunately, the AMA has a financial incentive to keep selling this information without regard to how it is being used or the impact it has on patient care and health-care costs.

By continuing to profit from the sale of physician data, the AMA has shown itself to be at best, slow-to-act, and at worst, opportunistic at the expense of professional boundaries. The AMA should put medical ethics before profits and stop licensing its Physician Masterfile for pharmaceutical marketing purposes.

From the east coast, in the Washington Post, Regina E Herzlinger from the Harvard Business School and the Manhattan Institute, criticized the AMA for spending so much effort fighting in-store clinics, but also had more global criticisms.

Physician incomes, when adjusted for inflation, declined 7 percent from 1995 to 2003, while those of professional and technical workers rose. But unlike other professionals -- lawyers, architects, authors and economists -- doctors' work is dictated by the policies of insurers and governments. Increasingly, independent physicians, accountable only to their patients and the Hippocratic oath, have been replaced by salaried doctors who are accountable to the hospitals or insurers that employ them. Salaried physicians are closely policed for productivity, leading to ever-shorter and more numerous appointments per day.

Meanwhile, academic medical journals routinely publish studies that supposedly document the cupidity and ignorance of practicing physicians while lauding the virtues of single-payer health-care systems, such as those in Canada or Britain, in which the physician is paid only by the government. German physicians unhappy with their salaries and work hours under this kind of system had no recourse against their monopolistic bosses but to go on strike last year.

Small wonder that applications to medical schools have declined by nearly 20 percent in the past decade.

You might expect that the AMA would fight the insurers, hospitals, government bureaucrats and ivory tower academics who have diminished physicians' incomes, besmirched their ethical reputations and compromised their professionalism -- but you would be wrong. No, instead, at its annual meeting last month, the AMA declared war on retail medical clinics....

Unfortunately, while the AMA engages in trivial turf warfare, physicians are increasingly forced to become salaried employees of hospitals and insurers and are constrained by recipes for the practice of medicine that are cooked up by government and insurance company bureaucrats.

The cycle is bringing about the imminent collapse of the medical profession -- which gravely endangers our health-care system. We and doctors deserve better advocates.

In my humble opinion, Prof Herzlinger's criticism of the AMA's concerns about in-store clinics is not well justified. (See our last post on such clinics here.) But her more global concerns are substantive. Clearly, a lot of physicians are disgruntled, and as we have posted repeatedly, primary care and cognitive physicians appear to be an endangered species. The increasing domination of medicine by large organizations, including the hospitals and hospital systems and insurance companies and managed care organizations she mentions clearly has a lot to do with these problems. The AMA has, in my experience, at times stood up to the power of these organizations, but not with much effect.

On the other hand, the increasing power of pharmaceutical, biotechnology, and device manufacturers, fostered in part by the complex financial webs these companies have woven to reach individual physicians, academics and academic institutions, and medical associations, also has a lot to do with the problems of health care. The first editorial suggests that the the AMA, representing only 30% of American physicians, but getting 16% of its revenue from the sale of these physicians' data to be used in part by pharmaceutical marketers, may now be too entangled in these webs to always put the interests of patients and physicians first.

For more on the relationships between medical associations and commercial sponsors, see Chapter 12 of the excellent Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, by Howard Brody, and Kassirer JP. Professional societies and industry support: what is the quid pro quo? Perspectives Biol Med 2007; 50: 7-17 (see our relevant post here).