Monday, February 27, 2006

A Tale of Three Ironies: University of Miami's Janitors Still Have No Health Insurance

There are no lack of ironies in an emerging story about the University of Miami.

There has been an ongoing dispute involving the university, and a company called Unicco with which it contracts to provide janitorial services, and the Unicco's local employees. The Service Employee's International Union (SEIU) has been trying to organize the janitors. Recently, in one of its statements, a janitor who has worked for at the university for 25 years and makes $6.80 an hour claimed, "I was here the first time the university formed a committe to talk about our wages. I was making barely over minimum wages then, and I still am now." (See the Miami Herald story here.)

The union has just taken a strike authorization vote. In support of the vote, a worked at the university's down-town medical campus, which includes Jackson Memorial Hospital, said, "I am expected to clean the medical facilities at Jackson without safety equipment, without gloves, without training, and without health insurance, all for $6.40 an hour." (See the South Florida Business Journal article here.)

So the first irony is that the maintenance workers at the University of Miami medical center do not have health insurance provided by their employer.

What makes this story more interesting is how impetus built for the recent escalation of this dispute.

Two weeks ago, the New York Times ran a relevant article (available here, but requires subscription to view.) Was the article about health care policy? Not really. It was a Times Magazine profile in "The Way We Live Now" series about University of Miami President Donna Shalala, the former Secretary of Health and Human Services in the Clinton administration, and one of the principal advocates of Clinton's health care reform plan, which was meant to provide universal health care insurance.

According to the Times, Shalala lives in a 9000 square foot mansion (owned by the university), with mango trees in the garden. She drives a Lexus (hybrid, naturally). She owns a 29 foot boat, but doesn't get to use it much. She has house-hold help who makes her bed for her.

After the Times article was published, a Washington Post commentator wrote,
Note to the Haves: When involved in a labor dispute, skip the luxury home profile.

Then the story hit the blogsphere. Wonkette's post on the story was entitled, "Let Them Eat Mangoes."

So the second irony is obvious.

But there is a third irony.

Not reported by any newspaper, so far, is another responsibility Shalala now has. In her spare time, Shalala is a director of UnitedHealth Group, the parent company for the UnitedHealth managed care organization, and hence has a fiduciary duty to the UnitedHealth. This company's mission statement includes,
UnitedHealth Group is a diversified health and well-being company dedicated to making the health care system work better. The company directs its resources into designing products, providing services and applying technologies that:
* Improve access to health and well-being services;
* Simplify the health care experience;
* Promote quality; and,
* Make health care more affordable.
The benefits received by directors are as follows, per United's 2005 proxy statement,

Directors who are not Company employees receive an annual retainer of $30,000, a $1,500 fee for attending each Board meeting in person ($750 for attending by telephone), and a $1,000 fee for attending each committee meeting in person ($500 for attending by telephone). Directors also receive the standard fee for attendance by telephone if they are unable to attend a meeting, but receive an update by telephone prior to or after the meeting. In addition, we pay the Chairman of each of the Audit Committee and the Compensation and Human Resources Committee an annual retainer of $5,000.
We provide health care coverage to current and past directors who are not eligible for coverage under another group health care benefit program or Medicare.
Non-employee directors also receive grants of non-qualified stock options under the UnitedHealth Group Incorporated 2002 Stock Incentive Plan (the “Stock Incentive Plan”). Under the Stock Incentive Plan (and terms approved by the Compensation and Human Resources Committee with respect to non-employee director grants made pursuant to the Stock Incentive Plan), our non-employee directors receive three types of option grants: (1) initial one-time grants of non-qualified stock options to purchase 36,000 shares of our common stock; (2) quarterly grants of non-qualified stock options to purchase 5,000 shares of our common stock; and (3) conversion grants made pursuant to an election by a director to convert annual retainer and meeting attendance fees into options to purchase our common stock.
The initial grants are made automatically on the date the eligible director is first elected to the Board of Directors and become exercisable over the following three years at the rate of 12,000 shares per year. The quarterly grants are made automatically on the first business day of each fiscal quarter and become exercisable immediately upon grant. The conversion grants are made on the day of each regularly scheduled Board meeting and become exercisable immediately upon grant. The number of shares covered by a conversion option will equal four times the amount of the retainer and meeting fees foregone, divided by the fair market value of one share of our common stock on the date of grant.

According to the proxy, Shalala had received options for 30,000 shares of stock by 2005.

Gotta love those mangoes.

Thursday, February 23, 2006

Blumsohn Tours Washington to Raise Concerns About Pharmaceutical Research Integrity

We had posted a while back about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Blumsohn has been in Wahsington, DC, speaking with the staff of the US Senator Charles Grassley (R-Iowa) about the general problem of integrity of clinical research, prompting some renewed press coverage of this story. A brief Associated Press story summarized the issues involved. The Wall Street Journal (available here without a paid subscription) had another version, including this quote by Grassley

This isn't the first time, I bet it won't be the last, that we hear concerns about drug companies selectively witholding unfavorable clinical trial data. It's a recurring complaint and a detriment to rigorous scientific research.
Meanwhile, the British Broadcasting Service did a long radio feature on the case, (audio available here, but a transcript is not yet available).

It's time for this issue to be back in the spotlight.

The pharmaceutical industry produces many very useful products, which as a physician I frequently prescribe. Now, however, the industry seems to expect stratospheric returns for for some of its newer drugs. Numerous anecdotes, some mentioned previously on Health Care Renewal, however, have suggested that the industry has sometimes manipulated research data to make their latest products appear to be wonder drugs deserving of such high price tags. The industry is currently faced with continuing skepticism and declining trust, which may eventually make it hard to support even more modest pricing. The public, physicians, and the pharmaceutical industry itself would be better served by the industry's clear rededication to clinical research integrity.

UMDNJ's Troubles: An Update

There are yet more revelations about the embattled University of Medicine and Dentistry of New Jersey (UMDNJ), now operating under a federal deferred prosecution agreement and the scrutiny of a federal monitor. (See our last post on UMDNJ here.)

The University has delayed up to $5 million worth of payments for telephone and communications services after improprieties in how these services had been arranged surfaced, according to the Newark Star-Ledger.

And the Star-Ledger also reported new details of political contributions made by UMDNJ, despite state laws limiting the university's political involvement. One vivid anecdote involved a contribution allegedly made by the manager of the university's government affairs department to a congressman favored by the university's Washington lobbyists, which was later repaid to the manager by the university in cash.

Meanwhile, New Jersey Governor Jon Corzine has been trying to make over the leadership of UMDNJ. However, these efforts are not without their own pitfalls.

Corzine nominated three people to the Board of UMDNJ. Previously, several board members had stepped down after their conflicts of interest were revealed. Corzine's nominations included former NJ state Attorney General Robert Del Tufo, Oliver Quinn, the chief ethics officer of Prudential, and "former Princeton University president Harold Shapiro," according to the Newark Star-Ledger. Shapiro, however, may have potential conflicts of interests as well. The Ledger reported that he is on a director of Dow Chemical, a trustee of DeVry University, and is currently on the board of overseers of UMDNJ's Robert Wood Johnson Medical School. Shapiro, however, is also currently a director of the Hospital Corporation of America, and, at least according to his HCA biography, a director of the University of Pennsylvania Medical Center (although I have not found information on the web to to confirm the latter post).

The Star-Ledger also reported that Corzine wants Bruce C. Vladeck, former head of the US Health Care Financing Administration (HCFA) under the Clinton administration, to be Interim President of UMDNJ. However, the Star-Ledger also noted that Vladek's stewardship of HCFA was criticized by the Government Accountability Office (GAO), which also raised concerns about his possible conflicts of interest. An article from the North Jersey Media Group reported that HCFA staff were unhappy with a settlement that Vladek ordered with the Visiting Nurse Service of New York, which was directed by a friend of his; and with one he pushed with the New York City Health and Hospitals Corporation, on whose board he previously served.

As I sometimes say to my patients, complicated problems that took a long time to develop may not be quick and easy to fix.

Wednesday, February 22, 2006

California State Legislators Notice Conflicts of Interest at the University of California

The San Francisco Chronicle reported that California state legislators have begun to pay attention to what the top leaders of the University of California have been doing after hours.

We have discussed the ongoing controversy about generous pay, perks and benefits given to the leaders of the University of California, including those who oversee the system's medical schools and academic medical centers.

The legislators are now concerned that some of their highly compensated university leaders are spending too much time on outside activities, after a report surfaced that University of California - San Diego (UCSD)Chancellor Marye Ann Fox serves on 10 for-profit corporate and not-for-profit organizational boards. California Senator Jack Scott, chairman of the Senate Education Committee, said "there needs to be a limit placed on the number of boards. I don't know what the magic number would be, but the Board of Regents ought to set a limit."

The Chronicle also reported that information about the board service of other UC leaders is beginning to surface, although none also obviously involved a leader of medical school or medical center being a director of a health care company.

More significantly, the legislators are beginning to worry that service on some particular boards might generate conflicts of interest. The Chronicle quoted Charles Elson, director of the John L Weinberg Center for Corporate Governance at the University of Delaware, "if you get on a board expecting a donation [to your not-for-profit institution from the corporation], it is exactly the wrong thing to do. You might argue it is good for your institution, but it is not good for the investors who elected you."

Of course, as we posted earlier, Fox's service on the boards of Boston Scientific and Pharmaceutical Product Development Inc generate another kind of conflict. The medical school and medical center which report to her may deal with these companies, and their competitors, as purchasers and venders. For example, the medical center doubtless purchases a considerable volume of the sorts of devices Boston Scientific makes, and may do externally funded research on such devices as well. These conflicts have potential down-sides for the companies and for UCSD.

Maybe at some point someone in the California legislature or on the state's Board of Regents will notice these conflicts too.

Mismanagement in the OC - the Report on UCI

We most recently posted on the trouble at University of California - Irvine (UCI) here. Now new information has come out about mismanagement at UCI. An independent report commissioned by the university that focused on the now closed liver transplant program. Per the Orange County Register and Los Angeles Times, the report found
  • "Throughout its review, the committee observed a general lack of accountability within the medical school and from an overall campus perspective. The committee observed a laisssez-faire attitude toward many of the red flag issues that ultimately led to the closure of the (liver) program."
  • According to the Register, the committee also "faulted an organizational structure that left a power vacuum at the top, with no medically trained individual responsible for both the school and the hospital."
  • Again according to the Register, "the absence of clear reporting lines and strong management oversight were contributing factors" not only in the failure of the liver transplant program, but in the 1995 fertility clinic and 1999 donated organ program scandals.
  • UCI leaders made statements "that were not wholly accurate and likely misleading."
  • Whistle-blowers were ignored, "legitimate complaints of people were not necessarily addressed in an appropriate way."
Meanwhile, the Los Angeles Times reported that the United Network for Organ Sharing (UNOS) decided to put the UCI kidney transplant program on probation, noting that "the need for the institution to implement changes is evident."
Meanwhile, the Times reported an echo from one of the earlier scandals at UCI. In 1995, two UCI fertility experts, Dr Ricardo Asch and Dr Jose Balmaceda, were accused of extracting eggs and embryos of patients without their permission, and implanting them in other patients who were told that they had been freely donated. Both Asch and Balmaceda fled the US. Asch is apparently now living in Argentina, ina a "chalet surrounded by security guards 24 hours a day in an affluent neighborhood in Buenos Aires." An Assistant US Attorney who handled the case said, "it is my great hope these guys will be brought to justice before I retire."
Again, these findings should be contrasted with claims by members of the UC board of regents that their justification for providing top managers with high salaries and a variety of generous perks and benefits was to attract the very top people (see post here). Maybe the people who demand the highest pay, benefits, and perks are actually less fit to not-for-profit health care institutions.

Tuesday, February 21, 2006

Comments on Health Care That Go Against Stereotypes

Some interesting comments on health care that go against stereotypes....

On the Role of Large Organizations

The effect of the World War II decision [was] to make health insurance policies deductible to employers and tax-free to employees. This tended to tie health insurance to employment and has made individuals dependent on large organizations. Since third parties pick up the tab for most health-care spending, consumers tend not to be cost-conscious. The result has been above-inflation cost increases for health care.
The New Deal and the World War II years produced policies that left people dependent on large organizations. We now learn from the problems of steel pensioners or Social Security recipients, those organizations don't always deliver.

On How to Control the Costs of Pharmaceuticals

Allow Medicare to negotiate drug prices. Reinstitute a requirement that drug companies disclose all known side-effect risks in their advertisements. Eliminate the payment of 'user-fees' for FDA approval. Authorize 'parallel trading' with other developed countries. Ban one drug company from paying another 'not to manufacture'a less-expensive version of a drug. Require new brand-name drugs to be superior than current drugs . . . or no patent!
[But these policy changes] aren't happening because big drug companies have too much power and weak-kneed politicians aren't willing to stand up to them.

The first comments were written by political commentator Michael Barone in the Washington Times. The second set of comments were by local Cranston, RI Mayor and Republican Senatorial candidate Stephen P Laffey, and were noted in the Providence Journal.

Monday, February 20, 2006

Who Should Pay for Replacing Recalled Medical Devices?

The New York Times reported on growing controversy about how recalls of medical devices are handled.
In 2005, a considerable number of cardiac devices, particularly implantable cardiac defibrillators (ICDs), were recalled. (See most recent post here.)
The Times reported that although the device makers covered the cost of new devices to replace potentially defective ones, they did not cover the actual costs of the surgical procedures needed to replace them. "Manufacturers of implantable devices insist that their responsibilities are clearly spelled out in product warranties and that medical costs related to a device's replacement are not covered."
There is apparently some push back from both Medicare, and health care insurance companies and managed care organizations, who end up paying for the replacement costs. "Karen M. Ignagni, the president of America's Health Insurance Plans, a trade group in Washington, questioned why insurers and their customers, 'who are the ultimate payers,' should bear the costs of having devices replaced."
It's nice to see that Medicare and managed care are actually starting to question why they pay so much for the replacement of potentially medical defective devices. Maybe they should also start to question why they paid so much for the implantation of the devices in the first place.

Why Did the FDA Approve the Vagus Nerve Stimulator for Depression?

The New York Times revealed a report by the Senate Finance Committee, chaired by Sen. Charles Grassley (R-Iowa), on the US Food and Drug Administration's (FDAs) approval of a vagus nerve stimulation device to treat chronic depression.
We had previously posted about how an advisory committee to the FDA made the device "approvable" even though the the only relevant randomized controlled trial (RCT) found no significant improvement in patients in whom the device was implanted and turned on compared to patients in whom it was implanted but not turned on. The panel did hear some emotional testimonials on behalf of the device. Dissenters on the advisory committee at the time thought the decision was "nuts."
The Senate Committee found that Dr Daniel G Schultz, director of the FDA Center for Devices and Radiological Health, approved the device despite objections from staff scientists. The Times reported the devices' adverse effects include "voice alteration, increased cough, shortness of breath, neck pain and difficulty swallowing. The device has also been linked to rare reports of death, heart problems and vocal cord paralysis."
Emails from FDA internal reviewers of the device stated, "In my opinion, they do not have adequate data, and I don't understand how this can move forward," and "As an MD interested in science, it seems to me that such an approval would be akin to approving an experimental product."
The device is made by Cyberonics Inc. It's CEO, Robert P Cummins, said it is "the only safe and effective treatment opiton ever specifically developed, studied, F.D.A.-approved and fully informatively labeled for the treatment of chronic or recurrent treatment-resistant depression." It is not clear how he justified his statement that the device is "effective," given the results of the RCT.
Cyberonics, based in Houston, appears to have unique political connections. It includes among its directors former Congressman Tony Coehlo, who a Washington Times editorial recently charged was responsible for setting up the system that allowed the Abramoff scandal to occur.
The device reportedly costs $15,000.
It is not clear whose priorities were served by its approval, nor whether science was trumped by emotion, or something else in this case.

Friday, February 17, 2006

"Corruption in Health Care Costs Lives"

Last week's Lancet lead editorial was insprired by the Global Corruption Report 2006, which focussed on health care, by Transparency International. (The link is here, but requires subscription.) [1]

This is a significant development (and a reminder that anyone interested in the issues discussed on Health Care Renewal should read the Global Corruption Report 2006).

Here are some important quotes.
In recent years, newspaper business pages have been full of examples of corruption and criminal business practices that led to the enrichment of a few greedy individuals.

Yet, one enormous business affecting everyone's life, the health-care sector, which is worth an estimated US$3 trillion per year worldwide and which is mostly funded by taxpayers' money, is strangely exempt from close scrutiny. Very little is known about the extent to which corruption affects health-care systems and providers. The word corruption—abuse of entrusted power for private gain—rarely enters health professionals' vocabulary and is frequently softened to unethical or unprofessional behaviour.

In its annual Global Corruption Report 2006, released on Feb 1, the non-governmental organisation Transparency International shines a spotlight on the health-care sector and concludes that corruption permeates the provision of health care at all levels and in all countries. The health sector is particularly prone to corruption, argues the report, as it constitutes a maze of complex and opaque systems that provide a fertile ground for malfeasance. Transparency International's focus on health is a welcome wake-up call for both developed countries, which are grappling with spiralling health-care costs and increasingly impossible budget control, and for developing countries, which are ravaged by preventable and treatable diseases. Corruption, argue the report's authors, is one of the main reasons why the global community is off target to achieve the health-related Millennium Development Goals.

What is the scale of the problem? In terms of financial costs, it is impossible to state an exact figure, but the estimate goes into tens of billions of dollars per year. The spectrum of corruption ranges from physicians with conflicts of interest advocating a particular treatment for the wrong reasons to aggressive marketing strategies by pharmaceutical companies; from underpaid health workers accepting small bribes from patients to the provision of ineffective counterfeit drugs; from large-scale embezzlement of public-health funds to massive distortions of health policy and funding by corrupt government officials.

Any cure should start with maximum transparency. Donor and recipient governments need to grant easy access to information on health-related projects, budgets, and policies to allow independent and public audits. Codes of conduct need to be adopted by health workers and private sector companies. In this context, the recommendation goes as far as prohibiting physicians from advocating drugs or devices they have a financial interest in and from taking part in speakers' bureaus funded by pharmaceutical companies. Public-health policies should be independently monitored at national and international level and these reports need to be publicly available. Procurement processes should be competitive and transparent. Any transgressions have to be rigorously prosecuted. Whistleblowers from all sectors should be protected.
The Lancet editors have recognized the importance of health care corruption, and particularly that it pervades all countries, that it permeates the leadership of health care organization, rather than just be restricted to low-level employees and invidual practitioners.

It is also important that the Lancet have recognized what we have called on Health Care Renewal "the anechoic effect," that before the Transparency International report, almost nobody in the health care or in health care policy arenas seemed willing to talk about health care corruption other than that perpetrated by low-level employees and individual practitioners. As I noted in my two, but relatively obscure articles,[2-3] numerous cases of conflicts of interest and outright corruption afflicting the leadership of health care organizations have appeared in local media, but never mentioned beyond the local areas affected.

The Transparency International Report and now the Lancet editorial are important steps on the road to increasing awareness of concentration and abuse of power in health care. But we have only just begun.

1. The Lancet. Corruption in health care costs lives. Lancet 2006; 367: 447.
2. Poses RM. A cautionary tale: The dysfunction of American health care. Eur J Int Med 2003; 14: 123-130.
3. Poses RM. The US health care system: dysfunction and hope. Lancet Oncology 2004; 5: 454-455.

Thursday, February 16, 2006

Academic Medical Leaders as Corporate Directors

There is yet one more story out of the University of California.

The San Diego Union-Tribune reported that the Chairman of the UC Board of Regents is upset about the number of corporate boards the Chancellor of UC- San Diego sits on. (We had previously posted on this story here.)

UC-SD Chancellor Marye Ann Fox was reported to be on the boards of ten (that's 10) for-profit corporations and not-for-profit organizations. In response, the Union-Tribune reported, "UC Regent Chairman Gerry Parsky said the system needs to ensure chancellors keep the university as their top priority and that any benefits board memberships may bring to the university aren't outweighed by excessive demands on their time." But, "in the past, regents have deferred to UC President Robert Dynes regarding chancellors' compensation and outside activities."

"Fox, 58, an organic chemist, has said she will not step down from any corporate boards because she considers her service a boon to the university."
All things involved in managing and directing and envisioning for corporate entities are virtually the same things you have to do for universities.
In my humble opinion, however, the bigger issue is not how many boards she serves on, but the clear, substantial conflicts of interest entailed by her service as a Director of Boston Scientific, a medical device manufacturer, and of Pharmaceutical Product Development Inc, a pharmaceutical contract research organization.

As a Director, she has a fiduciary responsibility to look out for the interests of each of these companies, and for the financial interests of their stockholders. Yet as the Chancellor of UCSD, to whom the Medical School and the Medical Center report, she has a responsibility to ensure the quality of the patient care, medical teaching and research at those institutions.

Given that the School and Medical Center doubtless use in quantity the sorts of medical devices that Boston Scientific produces, and doubtless do the sort of research that Pharmaceutical Product Development is interested in, how on earth could she make decisions that always conform to these responsibilities?

And what sort of decisions are her subordinates, managers and executives at the medical school and medical center, likely to make about medical devices and about pharmaceutical research, knowing that they report to a Director of Boston Scientific and a Director of Pharmaceutical Product Development Inc?

In summary, any leaders of medical schools or academic centers, or academic leaders to whom they report, who also are directors of a pharmaceutical, medical device, health care IT, contract research, managed care, health insurance, or other health care related corporation havea clear, substantial conflicts of interest.

These sorts of conflict of interest are orders of magnitude more important than those created by physicians accepting the pens and coffee mugs Brennan et al were so worried about in their article in JAMA. (See post here.)
Yet Brennan et al ignored the existence of these conflicts, which, I must admit, have hardly been discussed on the medical and health care literature.

If we are so worried about pens and coffee mugs (and we should we), why aren't we addressing academic medical school leaders who also sit as directors of health care corporations?

Fox is hardly the only one.

More Opinions About Systemic Problems at the University of California

The media has been offering more opinions about systemic problems in management at the University of California.

The San Francisco Chronicle reported on hearings of the California state Senate Education Committee. The President of the University of California offered this apology.

It is with real regret that I have come to acknowledge that we have not always met the standards others hold us to in matters of compensation and compensation disclosure.
My ethics are upset by this.

It is perhaps true that at times I have been so committed to competitiveness and excellence that I have not been as mindful of the other responsibilities that come with being steward of this public institution.
But the Senators were skeptical, as the Chronicle reported,

Half of the senators on the 12-member committee were outspoken in their criticism, some saying Dynes' apologies and promises of improvements ring hollow considering that UC was in the same situation in 1992.
Sen. Jackie Speier, D-Hillsborough, ticked off a series of reforms recommended to the UC Board of Regents back then by retired Legislative Analyst A. Alan Post.
Dynes conceded that UC has continued to provide several executive perks that Post had urged be eliminated. Those include an executive severance pay plan that UC now says is deferred compensation (and is converting to a retirement plan), an executive auto allowance and a special life insurance policy.
'That was something that was asked of you, and you didn't comply,' Speier said.
And the Chronicle uncovered what could be yet another misrepresentation by UC leaders.

Sen. Jeff Denham, R-Salinas, urged Dynes to impose a salary freeze until the university can finish reviewing and improving its pay practices.
'Why not stop the blatant abuse we have seen and figure it out,' Denham said.
Dynes said UC has already frozen executive pay.
'We have had a salary freeze the past three years,' Dynes said. 'I have had no salary increase in three years.'
In fact, the UC regents in November approved a retroactive pay raise of 2.5 percent for dozens of senior managers, including Dynes. Dynes' pay, for instance, went up $10,000 to $405,000 as of Oct. 1.

And the Daily Breeze found another one,

It took all of 48 hours for University of California President Robert Dynes' vow to begin a new era of honesty and transparency on compensation issues to be undercut by fresh examples of institutional arrogance and secrecy.
On Friday, a Sacramento Bee editorial took up one of the worst sweetheart deals: a two-year, $460,000 contract for a new job with no duties and no office for Celeste Rose, previously a UC Davis vice chancellor. This payoff came even though UC Davis Chancellor Larry Vanderhoef didn't think much of the job Rose was doing as vice chancellor and wanted her gone. The assumption has been that Rose, an African-American, was paid off to head off a lawsuit in which she alleged racial and gender discrimination.
The Bee reported that the deal was cut after members of the California Legislative Black Caucus made inquiries to Dynes' office and Regent Tom Sayles about Rose's job status.
Given Dynes' vow of a new era of openness, his staff would be willing to say which lawmakers intervened, right?
Wrong. Dynes' spokesman, Paul Schwartz, wrote in an e-mail that identifying the lawmakers involved would have a chilling effect on governmental deliberative processes.' He denied UC felt pressured by their intervention.
Said the Daily Breeze, "This isn't transparency. What senior UC officials apparently see as damage control looks like a cover-up to us."

And the Los Angeles Times waded in with a scathing commentary,
Message to UC Execs: If It Won't Look Good in the Newspaper, Don't Do It

The University of California has been proving the Republicans' familiar point: that tax dollars too often are wasted and abused by government.
Democrats aren't even arguing this one. They're equally angry at UC.
'This is a bipartisan tick-off,' says state Sen. Jack Scott (D-Altadena), chairman of the Senate Education Committee.
'I think it's a mentality of elitism, unfortunately, in an insular world.'
Call it a culture — not only of elitism but also of greed and arrogance.
While the university was padding pockets and providing perks for some execs, it was raising tuition regularly for students.
And the Times commentator was so upset he called for what amounts to the nuclear option in academia, cutting the funding of the whole system.
Some at UC have gotten too fat. Maybe Sacramento should cut back on the feeding. Shift some tax dollars from UC to the state universities and community colleges.

That may be a little extreme, since it would punish everyone at UC for the offenses of a relatively small group of administrators.

But maybe it's time to think about tying administrators pay to some real measure of performance (as they frequently propose for physicians' reimbursement).

Pay for performance for health care managers? - what a novel idea.

Trouble in the OC Continues - More on UC-Irvine

The University of California - Irvine just cannot stay out of the news. We last posted about the multiple problems at the UCI medical school and medical center here.

More Revelations About Previously Revealed Problems

The Los Angeles Times dug into some of the older scandals at UCI. These included the “fertility scandal,” in which doctors “had stolen eggs and embryos from women and implanted them in other patients,” “misplaced cadavers, the sale of cadaver body parts without consent, and research violations at Chao Cancer Clinic.” In these scandals, the Times revealed a pattern of managers trying to stifle complaints and intimidate whistle-blowers. Regarding the fertility scandal,
Whistle-blower complaints, state Senate committee hearings and internal
investigations exposed UCI's efforts to limit the investigation and punish those who
reported problems. It was a pattern that would be repeated.
Whistle-blowers said they were warned not to talk publicly and threatened with dismissal.
Three whistle-blowers were paid a total of $900,000 in settlements that required them not to talk about the fertility clinic problems.
'They threatened me not to go to the federal or state government, not to go to the press,' former senior hospital administrator Debra Krahel said. 'They threatened that they would sue me. They go through this pattern of alienating, discrediting, demoting and threatening you.
It's pure harassment, and they've done it over and over. It's never been corrected.'
UCI's attorneys repeatedly tried to limit investigations and public release of information, former employees said.
Andrew Yeilding, at the time UCI's chief auditor, was widely quoted as saying that Diane Geocaris, legal counsel to the chancellor, told him he should not press doctors hard for information. Other administrators told three internal auditors not to set foot on hospital grounds- or even exit the freeway near the Orange facility - or they would face termination, according to depositions and interviews.
In several cases, public comments by administrators were misleading and, occasionally, false. Geocaris, who remains the chancellor's legal counsel, urged the spokeswoman for the hospital, who later quit in frustration, to delay release of records as long as legally possible, according to reports in the Orange County Register.
University attorneys also minimized the number of victims and filed court documents that contained false information
In most of the scandals that have beset the university, employees who tried to uncover wrongdoing suffered consequences.
Several former employees said they had been forced to quit or were fired. Some, like Krahel, said they were labeled troublemakers, portrayed as frequent complainers or deemed substandard workers.
UCI auditors Robert Chatwin and Hebeish, whose jobs were to investigate complaints and scrutinize university programs, said the attitude on campus changed after the fertility scandal. The work environment evolved from 'free, open and supportive' to 'completely hostile and negative,' Chatwin said in a deposition as part of later litigation over UCI's Willed Body Program.
UCI touted a massive overhaul of the program. It hired Iris Ingram as the administrator to provide oversight and ensure that rules were followed. But Ingram said in an interview that people resented her when she tried to enforce regulations. Once UCI was 'in the clear,' she said, her position was eliminated.
The Orange County Register summarized a series of instances in which UCI managers issued misleading statements or “misrepresentations.” The article includes a handy table of six different misrepresentations, which includes the original statements and UCI sources, their refutations and their sources. In its introduction, the article quoted David Magnus, of the Stanford Center for Biomedical Ethics,
If a car company makes a misleading statement about how great a car is, that’s called sales. If a hospital does it, its more like fraud.
We last discussed allegations of problems within the UCI anesthesiology department here. The previously discussed allegations that the leadership of the UCI cardiology division lacked the usual credentials. The Orange County Register reported that its Associate Chief is stepping down from his leadership position as a result. The official announcement was “Dr. [Mani] Vannan has stepped down in an effort to help unify the Division of Cardiology. We appreciate his cooperation with this effort.”

Vannan has no California medical license, and has no sub-specialty board certification in cardiology from any country, according to the Register

We have previously discussed problems besetting the UCI kidney-transplant program here. The Los Angeles Times revealed a new report on the program by the US Center for Medicare and Medicaid Services (CMS) that showed the program “did not ensure nurses and others completed their training or that their training was comprehensive.... The report also faulted the hospital for failing to review the care provided to transplant patients.... One member of the medical staff explained to an inspector that ‘there was no member of the medical staff who either had the expertise or competency’ to do the reviews.”

New Problems

The Los Angeles Times revealed additional problems in the UCI nesthesia Department, this time, in its pain management program. Issues going back to 1997 have left the Department on probation by the Accreditation Council for Graduate Medical Education (ACGME) since then. The Department hired Dr Raafat Mattar 18 months ago “to fix shortcomings listed in 2000 and 2004 accreditation reviews.” However, Dr Mattar “resigned in frustration three weeks ago.” He said the pain progam still “didn’t have enough X-ray machines or access to exam rooms, forcing cancer patients and others in pain to wait as long as two months for treatment.” “Department supervisors promised to solve the problems, but nothing was done, he said.” Nine other faculty have left the Department in the last three

The Los Angeles Times uncovered new allegations about possible nepotism at UCI. (Previous allegations of nepotism at UCI were discussed here.) After UCI medical center CEO Dr Ralph Cygan resigned, Ms Maureen Zehntner, a registered nurse, “formerly second in command” at the medical center, was appointed interim CEO. The Times reported that her brother, Bruce V McGraw Jr, works for UCI as a “network development liaison,” her sister, Veronica J. Hogues, works for UCI part-time as an assistant in the medical school, and her cousin, Kimberly Becker, also works in some capacity at UCI. The Times, consulted Kerry Fields who teaches business law and ethics at USC,
'Why UCI doesn't have a policy against [such hires] is beyond me,' said Kerry Fields, an assistant professor of business law and ethics at USC's Marshall School of Business. 'It saps staff morale and adversely affects recruiting because it sends a clear message that who you know is more important than how you perform.'
What Went Wrong and What To Do About It

In its report on previous scandals at UCI, the Los Angeles Times
provided some opinions,
'We can all be forgiven for occasional lapses of judgment, but the rapidity and extensiveness of this would suggest that there's an endemic management problem,' said Kerry Fields, who teaches business law and ethics at USC's Marshall School of Business. 'There's just too many examples of poor ethical decision-making.'
Former internal auditor Mohamed Abo-Hebeish said UCI 'has lost its conscience, its sense of social responsibility as a public institution.'
Fields, the USC business law and ethics professor, says UCI is looking for quick solutions and not looking deeper into the corporate culture.
He says the university needs a full-time inspector general who will review the organization top to bottom.
He said university officials are using the 'moral minimum' to guide their decisions, doing only what the law compels. 'It's a very shallow application of ethical standards,'
Fields said. 'The law merely states what you have to do. Ethics are what you should

I can only hope that the now numbingly extensive catalog of mismanagement at UCI will prompt a really close look into why such poor leadership was allowed to go on for so long, and some intense thinking about how to prevent such problems in the future.

Clearly, more representative, transparent, accountable, and ethical governance is needed at UCI, and probably throughout the UC system.

And although the details of the problems at UCI are unique, concentration and abuse of power are rampant throughout health care.

Tuesday, February 14, 2006

A Conference on Disease-Mongering

Blimey, more positive news...

If you can get to Australia in April, you can attend the Inaugural Conference on Disease-Mongering to be held in Newcastle, New South Wales, from 11 to 13 April, 2006.
The conference will bring together academics, researchers, health professionals, health managers, journalists, writers and consumers who share an interest and concern over the trend to corporate definitions of diseases with a primary interest in making profits rather than a concern for the public health.

The Conference will feature speakers who are internationally recognized in this field. We are also inviting free papers on any topic related to disease-mongering and medicalisation.
For those who want to submit papers (original research or commentaries), the abstract deadline is March 1.

I am glad these sorts of problems are now coming out into the open. We first have to recognize the problems before we can come up with solutions.

Thanks to PharmaGossip for the tip.

The (US) Citizens Health Care Working Group

It's nice to write about something positive, for a change.

The Citizens Health Care Working Group is up and running. This is a non-partisan effort to get broadly-based input on what has gone wrong with health care in the US, and how to fix it. Several reliable sources have assured me that this is an honest effort that is starting off with no particular axes to grind.

The group welcomes input. So if you have something you want to say to them, you can talk to them electronically using this link.

They are also setting up community meetings to get input in cities around the US. If you are interested in attending, look at this link.

This is an unprecedented opportunity to express your ideas about what's wrong with US health care, and how to fix it. Please consider taking advantage of it.

What Roger Williams Medical Center Must Do To Keep Its License: A Generalizable Framework for Governance of Troubled Hospitals?

The Providence Journal reported major changes in the works for Roger Williams Medical Center.

We have posted several times, most recently here, about the travails of the hospital, which is now operating under a federal deferred prosecution agreement, and whose former CEO has been indicted by a federal prosecutor.

The Rhode Island Health Department convened an extraordinary licensing hearing in which it proposed imposing unprecedented conditions on the hospital for it to maintain its license. These included, "requirements that Roger Williams invite a Health Department representative to all board meetings and file a monthly report. The hospital would also have to give advance notice to both the department and the state attorney general whenever it appoints a new trustee or a new senior administrator, whenever it changes the duties of a senior administrator, and whenever it changes a corporate document."

Of particular interest to me were additional conditions, those
would require Roger Williams Medical Center to hire a forensic auditor to review its finances and an expert in nonprofit corporate governance to recommend changes in the way the hospital is governed. Another condition would have the hospital study the Sarbanes-Oxley Act, an anticorruption law that applies to for-profit businesses, and adopt aspects of the law that are applicable to nonprofits.

Again, these might be part of a more generalizable framework to improve governance of other troubled hospitals and academic medical centers, and even hospitals and academic medical centers that are not troubled, at least outwardly.

USA Today Calls For Managed Care to Enforce Conflict of Interest Rules on Physicians

USA Today has weighed in about stricter standards for physicians' relationships with pharmaceutical and device companies, leaning heavily (as did the New York Times previously) on the recent article in JAMA by Brennan et al.
Unlike the Times, USA Today ladeled blame about evenly on physicians and industry. And the editorial's position on which of the specific rules advocated in the JAMA article should be adopted, I must say, mirrors mine.
But, in my humble opinion, USA Today stumbled badly on the issue of enforcement. The editorial endorsed enforcement by academic medical centers, without raising any questions about whether their leadership is more ethical, or less conflicted than physicians. Furthermore, it also suggested that "managed-care groups can help enforce rules for their participating doctors."
I am willing to believe that newspaper editorialists may be ignorant about how leaders of academic medical centers may have their own conflicts of interest, and in a few particularly bad cases, how they may have been involved in criminal activity (e.g., again, the recent cases of Roger Williams Medical Center, and the University of Medicine and Dentistry of New Jersey, whose previous leadership lead both organizations to submit to federal deferred prosecution agreements.)
But can newspaper editorialists really be ignorant of the conflicts of interest posed by managed care? I guess I should again quote what I wrote in "A Cautionary Tale,"[1]
Physicians, especially primary care physicians, are often exposed to incentives that conflict with professional values. 'Market driven health care creates conflicts that threaten medical professionalism.'[2] Managed care organizations, in particular, provided strong incentives to do less for patients, but at the risk of making physicians into 'double agents,' whose financial incentives are no longer clearly aligned with providing services, but may turn on holding services to some minimum level.'[3] Most primary care physicians feel pressure from managed care to limit referrals and see more patients,[4] and thus are concerned about conflicts of interest and failure to regard the patient’s interests as paramount.[5] Managed care organizations may employ a 'strategy of giving with one hand while taking away with the other, of offering consumers comprehensive benefits while restricting access through utilization review, [which] obfuscates the workings of the system, undermines trust between patients and physicians, and has infuriated everyone involved.'[6]
Putting managed care in charge of enforcing conflict of interest rules for physicians makes even less sense to me than letting leaders of academic medical centers enforce the rules. Instead, again, I suggest that there should be broad rules about conflicts of interest for all people who make decisions that affect health care, with the details of implementation and enforcement adjusted for the context, e.g., adjusted for practicing physicians, academic physicians, academic medical center leaders, managed care managers, etc.

1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14 (2003) 123–130.
2. Kassirer JP. Managed care and the morality of the marketplace. N Engl J Med 1995; 333: 50-52.
3. Shortell SM et al. Physicians as double agents: maintaining trust in an era of multiple accountabilities. JAMA 1998; 280: 1102-1108.
4. Grumbach K et al. Primary care physicians’ experience of financial incentives in managed-care systems. N Engl J Med 1998; 339: 1516-1521.
5. Feldman DS et al. Effects of managed care on physician-patient relationships, quality of care, and the ethical practice of medicine. Arch Intern Med 1998; 158: 1626-1632.
6. Robinson JC. The end of managed care. JAMA 2001; 285: 2622-2628.

Saturday, February 11, 2006

Era of Patent Medicines Not Over: Unpublished Data Might Justify Flu Shot Requirement, Pediatrician Says

A Cochrane review of routine flu shots for infants – which found inadequate evidence for the official recommendation by the CDC and the American Academy of Pediatrics to give flu shots to 6-to-23-month-olds – was attacked in an interesting Washington Post story.

As is usual nowadays, “experts” seized on minimal differences in current therapy from past therapy used in trials. John Bradley, a member of the American Academicy of Pediatrics committee on infectious diseases said the quality of vaccines might vary. [The hormone people are taking the same tack after the negative results of the Women’s Health Initiative on estrogen replacement, saying some other, untested, formulation is likely better.]

Even more disturbingly, Dr. Bradley, director of infectious disease at Children’s Hospital in San Diego, said that the review “fails to account for the fact that much of the efficacy data of vaccines is gathered by drug companies that may choose for business reasons not to publish their findings.” This was a jaw-dropping statement. Isn’t the very essence of a “patent medicine” accepting the word of the company that manufactures it that the substance is medically beneficial?

Doctors and patients should not tolerate this sort of nonsense. According to the article, the Cochrane Review of published studies on children under age 2 found flu shots using killed virus (the recommended sort) no more effective than placebo. If published studies are to be trumped by business-owned unpublished studies that may or may not exist and may or may not be valid, corporations may profit but science - and people - will lose.

The Elephant in the Clinical Computing Living Room

The presence of clinical computing (EMR, CPOE, etc.) in hospitals has the potential to significantly increase the quality of care. This assumes that the IT is designed and implemented properly, not just technically but from the perspective of the complex world that medicine has become.

When healthcare IT is implemented improperly, however, the technology gets an undeserved bad reputation, as opposed to the information technology management responsible for the defects, who seem to get a pass. "IT malpractice" is a term not yet in the lexicon of healthcare, but perhaps it should be. For when patients (and politicians) read stories like the Seattle Times story below, support for clinical IT is injured. This is a shame.

The good news in this healthcare computing near-disaster story: manual systems were in place so that when the computers died, patients lived.

The bad news in this story is the obvious but unmentioned "elephant in the living room," that is: the IT errors that allowed a 20-year-old Walmart employee to hack a hospital, including its ICU systems, and how and why such fundamental errors occurred.

Just how were hospital computers, including those in an ICU, exposed to the hacking of a 20-year-old outsider who worked at Walmart? What type of network architecture was in place? Who designed the hospital computing infrastructure? Who approved it? Why were ICU computers as well as administrative (e.g., pager) computer affected? What were the safeguards? Who was monitoring the IT at this hospital? Were 'cost-saving' measures in effect that facilitated this intrusion?

The young hacker and his juvenile accomplices should not be the only people held accountable. Perhaps the hospital Chief Information Officer and his or her senior management should also be held accountable. If a patient had suffered harm or died as a result of this situation, I would not have hesitated to have been a plaintiff's witness regarding negligence. It seems IT leaders in hospitals, who most often have no clinical background whatsoever, seem relatively immune from accountability, and this portends badly for events to come as the Electronic Medical Record becomes more widespread.
3 accused of inducing ill effects on computers at local hospital

By Maureen O'Hagan

Seattle Times staff reporter

One day last year, things started going haywire at Northwest Hospital and Medical Center.

Key cards would no longer open the operating-room doors; computers in the intensive-care unit shut down; doctors' pagers wouldn't work.

This might have been just another computer-virus attack, a common and malicious scheme that sometimes is done for little more than bragging rights. But federal officials say it was something far more insidious.

It turns out the Seattle hospital's computers — along with up to 50,000 others across the country — had been turned into an army of robots controlled by 20-year-old Christopher Maxwell of Vacaville, Calif., according to a federal indictment issued Thursday. And Maxwell, along with two juveniles, earned about $100,000 in the process, court documents state.

The trio had created a "botnet," a phenomenon that is on the cutting edge of computer crime, federal officials say.

"Their goal was as old as fraud itself," Assistant U.S. Attorney Kathryn Warma said Friday during a news conference. "To line their own pockets."

... Maxwell simply created a program instructing his infected computers, or "bots," to download the adware. The bots then "phoned home" to the adware company, which credits the hacker's account, unaware that he hasn't gotten the computer owner's permission.

Since 2004, Maxwell earned more on botnets than he did at his Wal-Mart job, according to court papers.

[Not mentioned is how hospital and ICU computers were able to be infected in the first place -- SS.]

Difficult to solve

"We're seeing the migration of traditional fraud to the cyber area," said Frank M. Harrill, an FBI expert in computer crime.

It's just as difficult to solve. By the time the computer owner figures out what's going on, the bot-herder has covered his tracks. In fact, some companies are reluctant to even report the attack to authorities because it can prove embarrassing to their business, government officials said.

[In clinical IT, prevention is the best medicine - and perhaps the ONLY medicine -- SS.]

But the Northwest Hospital case played out differently in January 2005. Hospital officials called the FBI immediately, and an agent went to the scene while the attack was in progress. Meanwhile, the hospital used some old-fashioned backup systems. When electronic file transfers didn't work, nurses ran the files up and down hallways. When key cards wouldn't work, they stood guard and inspected ID badges themselves.

No patients were harmed, but First Assistant U.S. Attorney Mark Bartlett said this kind of attack could easily endanger lives.

In all, about 150 of the hospital's 1,100 computers were infected over the course of three days.

150 hospital computers violoated by a 20-year-old and several juveniles? That is inexcusable. Blame Microsoft all you want, but the primary responsibility rests with the hospital MIS (management information systems) leadership.

I have observed less than ideal attitudes towards clinical IT firsthand. The hospital where I was Director of Clinical Informatics in the late 1990's, Christiana Care Health System in Delaware, hung Compaq desktop PC's from the ceilings of small ICU rooms against my advice along with uncovered keyboards and mice, potentially exposing sick patients to dust contaminated with airborne pathogens from inside the machines that was then circulated by the power supply fans - or by clinicians' hands or gloves after data entry.

The IT leader and project team then made a "political issue" out of it, in effect bullying me into silence, when I questioned these decisions and warned of this potential problem. Alternate form factor computers and input devices designed for harsh environments were ignored because "they cost too much" and "were not supported by I.S." I left the organization due to this information technology solipsism and fanaticism, which also included cavalier attitudes towards the Chair of Medicine and towards Invasive Cardiology.

-- SS

Wednesday, February 08, 2006

"Neutralizing," "Discrediting," or Putting Doctors on the "Bad Guys List"

The latest Vioxx trial provided some vivid allegations about how some pharmaceutical marketing folks think about doctors. Per the Associated Press report:

Some Merck & Co. employees put doctors who questioned the safety of Vioxx onto a "bad guys list" to "neutralize" or "discredit" them, according to e-mails and other internal correspondence shown to federal court jurors Monday.

The correspondence given to jurors Monday was to or from Susan L. Baumgartner, who worked for Merck as a consultant, then in market research. In videotaped testimony, she repeatedly said neither she nor anyone she knew at Merck intimidated anyone, and that the terms had nothing to do with intimidation, and were marketing jargon rather than dictionary terms.

In one, a memo from another employee, a doctor's name was included and the note, "See this - for the bad guys list."

"I didn't call it the bad guys list," Baumgartner said.

"Did you write back and say, `What is this bad guys list?'" Birchfield's voice asked.

A bit later, he asked about the phrase "physicians to neutralize."

That, said Baumgartner, meant to provide correct information so those doctors would "come to a neutral or fair position." In a memo with "discredit" under a name, she said her recollection was that the doctor "discredited himself based on his own actions."

"Discredit," Birchfield replied. "Is that future tense or past tense?"
Tell me again why I should take anything from a pharmaceutical (or device, or health care IT, or managed care organization, or hospital) marketer at face value?

At the University of California, More Controversy at a University That "Hates Controversy"

We have posted quite a bit, most recently here, about management troubles at the University of California (UC), and about some of the specific problems afflicting the University of California-Irvine Medical Center.

The San Francisco Chronicle published a long investigative report about how problems with the structure and function of the UC Board of Regents may relate to these troubles. These problems included:
  • The Board, consisting of politicians and citizens appointed by the governor, tends towards cronyism. The Chronicle quoted Prof Bruce Fuller of UC-Berkeley, "it used to be a good old boys club of big men who contributed to the governor (and) who would rubber stamp any proposal put before them by the university."
  • The Board has no staff of its own, and depends on the University President for support.
  • The Board has a culture that tends to suppress dissent. Former Regent Ward Connerly wrote, "most regents value the appearance of collegiality more than any other attribute and can be quite unforgiving of any regent who betrays that trait." Connerly recalled that "staffers from the Office of the President would pass him questions to ask during public meetings that would generate an answer that would bolster the case for the president's cause." Summarizing, he said, "the university hates controversy. There's alwasy been this sheltered culture." State Assembly Speaker Fabian Nunez, who is an ex-officio member of the Board, according to the Chronicle, "find the regents 'orchestrated' [and] agree that the desire to avoid disagreement is damaging the credibility of the body."
Of course, organizations that try to suppress controversy often end up deluged in it. So, meanwhile, the Los Angeles Times reported on more signs of poor management at the UC-Irvine Medical Center.
  • A UC review "confirmed allegations that officials at UCI Medical Center had misled regulators about the hospital's now shuttered liver transplant program...." The review focussed on a meeting that included Dr Ralph Cygan, the hospital's CEO, and Dr Thomas C Cesario, the Dean of the Medical School. The UCI contingent told the United Network for Organ Sharing (UNOS) that UCI had a full-time transplant surgeon, whereas the surgeon in question was based at UC-San Diego and only commuted to UCI at times. The review did excuse Cesario in a way, by implying he was uninformed: there was "no evidence" that he "was involved in or understood the significance of any decision about communications" with UNOS. (See Times article here.)
  • Another Times report noted that "three children of top executives in UC Irvine's medical programs have received jobs with the hospital and medical school in recent years...." Dr David Cesario, the son of Dr Thomas Cesario, was hired by UCI's cardiology division. Dr David Brodsky, who was in charge of electrophysiology in the division, charged that he was driven out to make room for the younger Cesario. The younger Cesario also apparently was the one to suggest hiring Dr Jagat Narula as chief of the cardiology division. We had previously posted about the appointment of Narula, who has no California medical license or US cardiology board certification, here. Dr Kristen M Kelly, Cesario's daughter, also was hired as an Assistant Clinical Professor of Dermatology by Department Chair Gerald Weinstein, who reported directly to the elder Cesario. Former hospital CEO Dr Ralph Cygan's daughter, Anne Cygan, was hired by the hospital as an interpreter, and then promoted to work in patient relations. The Times quoted Professor Kirk O. Hanson from the Markkula Center for Applied Ethics at Santa Clara University, "where there is a pattern of relationships between relatives of senior management and the organization, you have to ask yourself whether senior management is tone deaf to the concerns of conflicts of interest."
The problems at UC, and specifically, at UC-Irvine, remind us of the pervasive, bad effects of unaccountable and conflicted management of health care organizations.

Monday, February 06, 2006

The NY Times on "Seducing the Medical Profession"

The New York Times published a forceful editorial about physicians' conflicts of interests, entitled, "Seducing the Medical Profession."

The editorial took its cues from the recent JAMA article by Brennan and colleagues which advocated tough restrictions on physicians' conflicts of interest (see our post here).

The Times charged that "the medical profession has sold its soul in exchange for what can only be described as bribes from manufacturers of drugs and medical devices." So, "it is long past time for leading medical institutions and professional societies to adopt stronger ground rules to control the noxious influnece of industry money on what doctors prescribe for patients." It seconded the "ban on all gifts, free meals and payments for attending meetings," rejection of "free drug samples," and "ban on consulting arrangements that entail no specific scientific duties" advocated in the JAMA article. It concluded that physicians' "judgment must not be clouded by financial self-interest or the desire to please industrial benefactors."

I agree with a ban on gifts, free meals, payments for meetings, no-show consulting jobs, which represent relatively small, but very prevalent conflicts of interest that may collectively have major deleterious effects on patient care. (I am ambivalent, however, on the issue of free samples, since these can, in an imperfect world, benefit patients who can't pay for their medications).

But I am afraid that the Times editorial reinforces the notion found in the JAMA article that the only important conflicts of interests in health care involve individual physicians' relationships with pharmaceutical and device companies. The Times also silently endorses the idea that the leaders of academic medical centers (AMCs) should police such relationships.

On Health Care Renewal, however, we have shown that conflicts of interest are prevalent everywhere in health care. Furthermore, it is likely that conflicts of interest affecting leaders of health care organizations may have more severe bad effects than do those affecting individual physicians.

Yet the Times and the authors in JAMA kept silent about such conflicts. And the authors in JAMA gave enforcement power to leaders of AMCs while imposing no particular restrictions on conflicts of interest affecting such leaders.

A reminder that major conflicts affect leaders of AMCS appeared a few weeks ago in the London Times (thanks to PharmaGossip for this related post). The international pharmaceutical company GlaxoSmithKline had appointed Dr Ralph Horwitz to be a non-executive director. Horwitz is also Dean of the School of Medicine and Vice President for Medical Affairs at Case Western Reserve University. The appointment was quashed before Horwitz could assume the 60,000 pounds sterling per year position, because GSK felt that an article Horwitz had helped write about adverse effects of over the counter medications containing phenylpropanolamine represented a conflict of interest that could negatively affect GSK. Unsaid was whether having a medical school dean and vice president assume fiduciary responsibilities to the share-holders of a large, for-profit pharmaceutical manufacturer could negatively affect Case Western's academic mission or its patient care.

As I suggested before, we should develop a broad set of principles about conflicts of interest, and generally about business ethics in health care, focused on all transactions with outside organizations with their own vested interests or agendas. These principles should apply to all who make decisions in health care, physicians, other health care professionals, and leaders of health care organizations. The details of the implementation of these principles could vary, so as to apply to the setting and role of each individual.

Another Big Pharma in trouble for "doctoring" information

Merck has been found in breach of the UK drug industry's code of conduct for modifying professional advice distributed to doctors treating high blood pressure, in a way that favored one of its own drugs. See story below.

There has been much in the news about possible manipulation or concealment of clinical trials data by the pharmaceutical industry. However, that industry also devotes considerable resources to medical education and development and provision of medical guidelines to the clinical community.

It is imperative that:

1) Such information development be done in a manner above reproach, which probably means as a non-profit venture with some degree of separation from the company's profit-driven management (such as in the case of the Merck Manuals and Merck Index), and

2) That non-medical people stop being given decision-making authority over clinical matters. Here, a non-medical employee of the British Hypertension Society "had authorized the change [in the guidelines to favor Merck] at the company's suggestion." Lack of medical knowledge, the likely problem here, while a better excuse for such conduct than, for example, illegal financial incentives or improprieties, is still a poor excuse for a non-medical person holding the ability to "authorize changes to clinical guidelines," especially in a medical society. Not mentioned is what happened on the company side. It seems both the company and the society were at fault here.

This reflects a problem I have noted in the Medical Informatics occupation, where the organizational structures in healthcare organizations and pharma place people into informational leadership positions who are lacking what I consider essential education and experience in biomedical information science. Their decisions are usually deleterious to efforts at improving informational provision and flow to clinicians and scientists, and a lot of time is spent devising ways to "work around the Boss."

This is often due in part to conflation of information technology and technologists with information science and information scientists. The two are distinct, but quite common is a profoundly Procrustean belief that being an expert in IT automatically makes one an expert in information science (Merriam-Webster: Procrustean - marked by arbitrary often ruthless disregard of individual differences or special circumstances).

Applied medical informatics work in such settings can thus be described as being "Director of Workarounds to Defective Organizational Structures", since that's what the incumbent spends a lot of their time doing - instead of more creative work that can advance the organization in useful and productive ways.

-- SS

Merck in trouble for doctoring advice

Merck, the US pharmaceuticals company, has been found in breach of the UK drug industry's code of conduct for modifying professional advice distributed to doctors treating high blood pressure, in a way that favoured one of its own drugs.

The Prescriptions Medicines Code of Practice Authority, the UK drug industry's self-regulatory arm, will next week rule against the company for changing guidelines compiled by the British Hypertension Society (BHS), a group of medical specialists.

The incident highlights the close links between pharmaceuticals companies and professional medical associations, which have come under growing scrutiny as part of a broader examination of potential conflicts of interest when drug companies market their products.

The probe was sparked by Des Spence, a Scottish doctor who runs No Free Lunch UK, a group of doctors that lobbies for greater transparency in the links between the medical profession and drug companies.

Mr Spence became concerned about information sponsored by Merck and widely distributed among doctors that described the so-called "ABCD algorithm" for drug treatment developed by the BHS.

The algorithm advises doctors which drugs to use to treat patients based on their age, ethnic background and reaction to different treatments. It recommends the first treatment of choice should generally be ACE Inhibitors, a class of cheap generic drugs.

However, Merck paid for and distributed thousands of cards, posters and computer mouse-mats for doctors for reference in their practices, in which the order and phrasing of the recommended drugs was switched to give greater prominence to its own more expensive patented drug Cozaar, which generated nearly $3bn in sales last year.

Professor Neil Poulter, BHS president at the time, said the "switch" by Merck was "a shame and an error". A non-medical employee of the BHS at the time had authorised the change at the company's suggestion.

Merck UK said it would not be appealing.

Friday, February 03, 2006

More Trouble, But Also a Little Hope, in the OC

The stories about University of California - Irvine (UCI) Medical Center, located in Orange County, California, just keep on coming, but at least now there are some signs of progress.

We have posted often, most recently here, about the continuing problems at the medical center. A chronology of problems there going back over ten years appeared in the Orange County Register. In 1995 - UCI Center for Reproductive Health physicians were accused of stealing patients' eggs and implanting them in other women, one was convicted, two fled the country; 1997 - UCI closed its Organ and Tissue Bank after charges of poor record keeping and storage, also cancer patients were allegedly improperly charged for participation in clinical trials; 1999 - the Director of the UCI Willed Body Program was accused of selling body parts; 2005 - UCI shut down its liver tranplant program after Medicare found mismanagement, poor staffing, and poor surviva; 2006 - problems surface in bone marrow and kidney transplant program.

New Revelations

New problems at UCI keep surfacing.

Proposed rules changes by state regulators now threaten the ability of Dr Jagat Narula, Chairman of UCI' cardiology division, to remain in his job, according to the Los Angeles Times. It had been previously reported that neither Narula nor Associate Chairman Dr Mani Vannan have California medical licenses or US board certifications in cardiology (see our post here). The two had been practicing under a exemption "that allows visiting physicians to practice at teaching hospitals without a California medical license for as long as five years." Apparently this provision had never been intended to apply to physicians in leadership positions, and new regulations will make this intention explicit.

According to the Orange County Register, "a former UCI Medical Center anesthesiologist [Dr Glenn Provost] said in a lawsuit that he lost his job in 2003 because he complained about safety problems, including rushing patients too hastily into surgery to save money." "The lawsuit, filed in Orange County Superior Court in 2005, also alleges that Provost's job was eliminated shortly after he presented a faculty petition about safety issues to the head of anesthesiology." In response, Dr Peter Breen, the head of anesthesiology at UCI, said "quality patient care" is the department's goal, and that internal inquiries have found "no systemic problems affecting patient safety."

Beginnings of Reforms

On the other hand, in response to the multiple problems that are now very public, UCI is beginning to change how it operates, as are other institutions associated with it.

Dr Ralph Cygan, the suspended CEO of UCI Medical Center, resigned, according to the Orange County Register. The Dean of the Medical School Dr Thomas Cesario will now report to a Vice Chancellor for Health Sciences. UCI will also make "the ombudsman a full-time position, moving him to the medical center and instituting a corporate compliants processs to handle issues raised by concerned staff." UCI Chancellor Michael V Drake apologized to those "misled, confused or otherwise served poorly by the statements or actions of anyone representing the university." Apparently referring to allegations that Cygan and Cesario misled the United Network for Organ Sharing (UNOS) about whether UCI had on-site leadership of its liver transplant program, Drake said, "[this is] not what we want to do. We have an organization that works very hard to provide patient care .... What we want to do is work hard to continue to provide services and do everything we can to regain the public trust." He said problems at UCI "are a result in a breakdown in the application of the values that must drive every decision made at the medical center, the School of Medicine, and the entire UCI campus." On the other hand, Drake "didn't think administrators are to blame. 'I think it is a cultural issue. I think it is pervasive in the institution. I don't think it's management. This has to be a cultural overhaul.

Per the San Diego Union-Tribune, Dr Marquis Hart, a surgeon at UC - San Diego who had been commuting to UCI to perform transplants, was "forced ... to step down as director of the [UCSD] Abdominal Transplant Program because of concerns he misled national organ officials about taking charge of UC Irvine's troubled liver transplant program." Per the Los Angeles Times, the reason was "the university has concluded that UCI representatives were not wholly accurate in describing the surgical coverage for the UCI liver transplant program." UCSD Medical Center CEO Richard J. Liekweg said, "we must ensure that the director of our transplant program has the full confidence and support of the public and the regulatory agencies."

Finally UNOS, upset that it had learned very late that improvements promised by UCI leadership in its liver transplant program were not made, has instituted a series of reforms of its own operations, according to the Orange County Register. These include monitoring rates of organ refusals and of deaths on transplant waiting lists; prohibiting a surgeon from being a primary transplant surgeon at more than one program; requiring that hospitals notify UNOS of any negative actions taken against or reviews about them; setting stricter limits on corrective actions taken after reviews find problems in a program; and establishing a confidential communications line for patient complaints.


I believe it is encouraging that reforms are taking place in response to the problems at UCI. I could speculate that these reforms, coupled with those at the University of Medicine and Dentistry of New Jersey (UMDNJ) in response to the scandal there (see last post here), and at Roger Williams Medical Center (RWMC) in response to the scandal there (see last post here), might be the begininings of a trend. If nothing else, it is a little encouraging to see top managers apologizing for previous misdeeds (even by somebody else) and promising improvements. Of course, my little bit of hope is tempered by them qualifying their apologies, e.g., by remarks that administrators are not to blame.

Furthermore, considering the reforms proposed at various institutions begins to provide a framework for better governance of health care institutions (at least, of not-for-profit academic medical centers). For example, two of these institutions, UCI and RWMC, intend to appoint an individual (ombudsman or chief ethics officer) who can operate independently to react to complaints about mismanagement and unethical behavior. Maybe every large health care organization should have such an individual. Of course, having a chief ethics officer might suggest the need for an explicit code of ethics to which that officer can refer.

I live in hope.

Thursday, February 02, 2006

Global Corruption Report 2006 - Focus on Health Care

Transparency International has just published a new and very important report on global corruption, particularly corruption in health care.
I have pasted below the bulletin from PAHO on this, which includes links to the report.
The Health Care Renewal bloggers will be busily digesting the report, and hope to get back shortly with some reaction to it.
Anyone who reads the Health Care Renewal blog should read this report.
Global Corruption Report 2006
Published in London by Pluto Press (ISBN 0 7453 25092).
Transparency International
Launched 1 February 2006,
Global Corruption Report details how corruption deprives millions of access to essential health care and helps spawn drug – resistant strains of deadly diseases
Available online here.

The GCR 2006 focuses on corruption and health. Including expert reports on:
- the risks of corruption in different health care systems
- the scale of the problem: from high-level corruption in Costa Rica to counterfeit medicines in Nigeria to health care fraud in the United States
- the costs of corruption in hospital administration and the problem of informal payments for health care
- the impact of corruption at various points of the pharmaceutical chain
- anti-corruption challenges posed by the fight against HIV/AIDS

It also includes:
- a foreword by Mary Robinson
- detailed assessments of the state of corruption in 45 countries
- recommendations for cleaning up the health sector
- examples of successes in preventing health-related bribery, fraud and corruption
- the latest corruption-related research, including studies on the links between corruption and other global issues such as pollution, gender and foreign investment

The causes of corruption in the health sector: a focus on health care systems
William D. Savedoff and Karen Hussmann, Why are health systems prone to corruption?
William D. Savedoff, A tale of two health systems
Malcolm K. Sparrow, Corruption in health care systems: the US experience
Lisa Prevenslik-Takeda, Corruption in Cambodia's health sector

The scale of the problem
Emilia González, Case study: Grand corruption in Costa Rica
Magnus Lindelow, Inna Kushnarova and Kai Kaiser, Measuring corruption in the health sector: what we can learn from public expenditure tracking and service delivery surveys in developing countries
Omar Azfar and Tugrul Gurgur, Local-level corruption hits health service delivery in the Philippines
Richard Rose, Corruption is bad for your health: findings from Central and Eastern Europe
Helena Hofbauer, ‘Citizens’ audit’ in Mexico reveals paper trail of corruption
Jim Gee, Fighting fraud and corruption in Britain’s National Health Service

Corruption in hospitals
Taryn Vian, Corruption in hospital administration
Taryn Vian, Cash registers inject transparency – and revenue ? into Kennya’s Coast Provincial General Hospital Ana First, Hospital waiting lists open for scrutiny in Croatia
Michael Smith, No bribes for healthy business: India’s Transasia Biomedicals

Informal payments for health care
Sara Allin, Konstantina Davaki and Elias Mossialos, Paying for ‘free’ health care: the conundrum of informal payments in post-communist Europe
Péter Gaál, Gift, fee or bribe? Informal payments in Hungary
Azeddine Akesbi, Siham Benchekroun and Kamal El Mesbahi, Informal payments take a toll on Moroccan patients

Corruption in the pharmaceutical sector
Jillian Clare Cohen, Pharmaceuticals and corruption: a risk assessment
Transparency International, US pharmaceutical company fined for payments to charity headed by Polish health official
Jerome P. Kassirer, The corrupting influence of money in medicine
Harvey Bale, Promoting trust and transparency in pharmaceutical companies: an industry perspective
John R. Williams, Fighting corruption: the role of the medical profession
Dora Akunyili, The fight against counterfeit drugs in Nigeria
Stuart Cameron, Corruption in the Ministry of Public Health, Thailand
Stuart Cameron, Malpractice in the Office of the Drug Controller in Karnataka, India

Corruption and HIV/AIDS
Liz Tayler and Clare Dickinson, The link between corruption and HIV/AIDS
Toby Kasper, Accountability in a time of crisis: corruption and the Global Fund
Kipkoech Tanui and Nixon Ng’ang’a, Corruption in Kenya’s National AIDS Control Council

Press release english español français русский عربي 中文 Executive Summary english español français русский عربي