Report from the 12th International Anti-Corruption Conference: "Corrupting Health"

Last week, I was privileged to attend the 12th International Anti-Corruption Conference in Guatemala City, Guatemala. It was gratifying to be at a meeting of over 1200 people from over 100 countries who were all focussed on challenging corruption wherever it may be found. Some of the attendees had truly risked their lives to this end. One vivid example was the recipient of the 2006 Transparency International Integrity Award, Peruvian prosecutor Dr Ana Cecilia Magallanes Cortez, who fought corruption at the highest levels in here country's government, leading to the arrest of former president Alberto Fujimori.

A considerable amount of the meeting's program content seemed relevant to the issues we discuss on Health Care Renewal. I will report back on some particular issues in this regard in the near future.

I was also privileged to to participate in a workshop at the meeting on health care corruption. Our workshop leader, Roger Bate, has kindly posted a summary of what we were up to on TechCentralStation, entitled "Corrupting Health."

The summary rightly emphasized the substantial problem of government-focused corruption in developing countries, based on one definition of corruption used by Transparency International, "the use of public office to further private gains."

I must qualify one statement in the summary attributed to me, that "major corruption is estimated to be low in the US in the health sector." Given the definition of corruption above, and certainly relative to the role of governments in health care in developing countries, that statement is reasonable. However, I would point out that an alternative definition of corruption, ethical rather than legal, found in the Executive Summary of the 2006 Transparency International report on global health care corruption, is "the abuse of entrusted power for private gain." By that definition, corruption in US health care may not be so rare. See Health Care Renewal for examples.

Big employers plan electronic health records (and a manned Mars expedition as a warmup?)

The Wall St. Journal article on this is not yet available electronically, so the article below from the magazine "Red Herring: The Business of Technology" will have to do (perhaps not an inappropriate selection for the purposes of this Healthcare Renewal entry!)

Big employers plan electronic health records - and plan to deliver "a jolt to the US healthcare system", according to the WSJ. Will that "jolt", however, be the jolt that's expected?

Regarding the statement in the Red Herring article below that "... an employer-owned medical database for employees open's a Pandora's Box of privacy and ethical issues", as a former practitioner of occupational medicine in the medical department of a large, unionized municipal transit authority where these issues commonly occurred (e.g., over random drug testing and worker's compensation), I agree.

However, that's the least of the problems. A belief that expertise in computing hardware or in mass-merchandising enables such a venture is quite a quantum leap of faith.

Will the big-corporation approach to EMR work? I'd feel more confortable if the corporations had the complexities of healthcare and healthcare informatics within their core competencies.

See this link for some of the issues that won't disappear due to corporate will, as well as my previous post on Microsoft's clinical information technology venture here.

Also see the issues that are ongoing at Kaiser regarding their plans to be king of the EMR (see here and here , and for an alternate view see here). We report, you decide.

Intel, Wal-Mart Plan to become the Bill Gates of EMR

Companies attempt to heal a system that refuses to heal itself, but is Wal-Mart credible on healthcare?

November 29, 2006

By Cassimir Medford

Red Herring

A coalition of businesses including Intel and Wal-Mart will announce a plan that they believe will spur the development of a massive healthcare database in the United States , a digital Holy Grail that has been under debate for more than a decade.

According to Wednesday’s edition of The Wall Street Journal , Intel, which employs almost 100,000 people, and Wal-Mart, the largest private employer in the U.S. , plan to construct a database that will house the health records of their more than 1 million employees.

Hospitals, pharmacies, doctors, and insurers will have access to the database, which will be able to process the medical cost-sharing based on the health plans of the employees.

The healthcare industry has proven adept at adopting medical technology and a little less adept at adopting new drugs, but information technology has emerged painfully slowly in hundreds of systems that don’t communicate with each other.

For the most part, healthcare information systems have remained paper based, with all the errors involved in paper handoffs among doctors, nurses, hospitals, and pharmacies.

... an employer-owned medical database for employees opens a Pandora’s Box of privacy and ethical issues.

Plus the presence of Wal-Mart as one of the commercial leaders of the online patient’s records movement could present some drawbacks.

"Wal-Mart’s track record on the matter of healthcare benefits for employees has been less-than stellar so they are liable to get a lot of negative publicity for this database," said Charles King, principal analyst with PundIT Research.

... Can of Worms

There are also issues around discrimination from the employer, other potential employers, insurance companies, etc., based on an employee’s health records, which will be digitized, organized, and accessible in one place.

“People understand the benefits, but they are concerned about the Big Brother aspects that are troubling to a lot of people,” said Roger Kay, principal analyst of Wayland, Massachusetts-based Endpoint Technologies Associates.

... Under the Intel/Wal-Mart plan, employees will have ultimate control as to who accesses their records, according to the Journal , and they will have full ownership of those records [easier said than done - ed.]

The coalition hopes the healthcare industry will get on board, which could make the database the first or second phase in the general construction of a national patient health records database.

The UK has been trying this in their Connecting for Health government-sponsored national EMR project. They have not been having the best of luck at it:

Blair's barmy army
Times Online.uk

Critics say the government has blown £70 billion hiring management consultants to do the work of ministers and civil servants — badly. By Bryan Appleyard

Next month the National Audit Office is due to produce a report on government use of management consultants. “Don’t hold your breath,” says Neil Glass. Glass, writing as David Craig, is a whistleblower. His book, Plundering the Public Sector, paints a uniformly bleak picture of consultant greed and government incompetence. Since 1997, he says, consultants have cost the taxpayer £70 billion with either zero or negative returns. He doesn’t expect much from the NAO report because the audit manager, the key figure, of the study is Ron SirDeshpande.

Accenture, one of the giant consultancy firms, employed SirDeshpande for almost eight years before he came to the NAO. For Glass, this means he’s just one of the gang and he won’t dare rock the cosy consultancy boat. A spokesman at the NAO sighs: “I know who you’ve been talking to. Ron SirDeshpande works full time for the NAO and his voice is independent.”

Glass snorts.

On September 28, Accenture pulled out of its £1.9 billion contract with the NHS. Connecting for Health (CfH), a huge computer system, was cutting into Accenture’s profits and threatening its balance sheet with up to $450m in write-offs. Launched in 2002 as a project lasting two years and nine months and costing £2.3 billion, CfH has become a 10-year project with a probable cost of £12.4 billion.

Good luck, Wal Mart, Intel et al.

-- SS

The UMDNJ Mess: A Comment from the Front Lines

We have reported frequently about multiple kinds of misconduct by top leadership at the University of Medicine and Dentistry of New Jersey (UMDNJ). In our most recent post we noted how little had been heard from the long-suffering professionals and academics who have been laboring to fulfill UMDNJ's mission despite the turmoil at the top. In response, we got this comment from one such person on the front-lines, who will remain anonymous:

As a member of 'this long-suffering group,' I think you make a good point about talking to us. We've had a couple of town meetings with the governor, but that was before the latest round of scandals and very little about reorganization was discussed.

No one is talking about shutting down the parts of UMDNJ, just the superstructure. The best analogy I can think of is the Soviet Union. The component countries all still exist, they just don't have to worry about the Politburo anymore.

I doubt if you could find one faculty member at the Robert Wood Johnson Medical School who disagrees that UMDNJ should be restructured, and that restructuring should include emancipation of RWJMS from UMDNJ. If they shut down UMDNJ central administration completely, that would have the added benefit of saving money and electricity and relieving traffic congestion and parking around University Hospital in Newark.

We have often suggested that health care organizations require and deserve more representative, transparent, accountable and ethical governance.

In particular, despite being staffed by hundreds of well-trained and accomplished faculty members, it is remarkable how often the governance of medical schools and academic medical centers is top-down, and often in the hands of people with little experience or background in health care. This appears to have been true in the case of UMDNJ.

One wonders if CEOs would stop being "imperial," and would start listening to the talented people who work for them on the front lines, how many problems they would avoid, and how much better their organizations would become at fulfilling their missions?

The American Diabetes Association and Its Pharmaceutical Donors

The New York Times reported last week about potential institutional conflicts of interest affecting the American Diabetes Association. The Times' article's main focus was on the organization's ties to the food industry, especially to makers of highly caloric food:

SnackWell’s Sugar-Free Lemon Creme cookies have nearly as many calories as some sugar-rich cookies. Yet until recently the box featured an American Diabetes Association logo, advertising the cookie as a 'proud sponsor' of the charity’s efforts on behalf of the nation’s 21 million diabetics.

Foods like the Sugar-Freedom Eskimo Pie and Frosted Shredded Wheat have also sported the American Diabetes Association logo over the years. The companies paid the A.D.A. to be associated with a respected voice for healthful eating. The association wanted the money to finance its uphill battle against a widening epidemic of Type 2 diabetes, which is associated with obesity.

To its credit, the ADA has started to rethink its relationship with the food industry.

But in the last year the A.D.A. began rethinking how it raises money from companies, especially from those whose primary business is selling foods and beverages that are high in calories, even if they have created some sugar-free items.

The group has allowed some food company deals to expire and has turned down millions of dollars in new sponsorships.

However, although it received less attention in the article, what may be a more important issue is the ADA's relationships with pharmaceutical companies (quotes below somewhat re-ordered.)

Though they often present the most difficult choices, food companies represent a small segment of the A.D.A.’s corporate support. Pharmaceutical companies remain the largest corporate contributors, but the guidelines have not affected them as much because the A.D.A. has never allowed its logo to be put on specific medicines.

Others remain concerned about the A.D.A.’s relationships with pharmaceutical companies. Their presence is evident throughout the charity, from its annual convention, which is largely underwritten by drug makers, to its board meetings, where pharmaceutical executives have served on the volunteer committees that set policy.

The A.D.A. says its independence is evident because it has often acted against the interests of the pharmaceutical industry. Last month, for example, a panel it appointed to study how to treat people at heightened risk of developing diabetes decided against recommending the use of higher-priced brand-name drugs.

But critics say the drug industry’s influence can be seen in the A.D.A.’s emphasis on the treatment of diabetics, which often involves drug therapy, over efforts to persuade people to change the way they live so that the disease can be prevented in the first place.

Dr. Peter Lurie, deputy director of the Health Research Group of Public Citizen, the government watchdog group, said the influence of pharmaceutical money can be very subtle.

'The question is what happens in the close calls,' he said. 'If you are at more cocktail parties, if you have more mugs from the company in your kitchen, you are just going to be more receptive.'

A.D.A. officials cited an event from several years ago to illustrate their resistance to such influence. An A.D.A. panel found that antipsychotic drugs could help fuel diabetes. The announcement angered a drug manufacturer, Eli Lilly and Company, a longstanding A.D.A. benefactor that stood to lose hundreds of millions of dollars in lawsuits.

Some A.D.A. officials said they believed the company became so angry it sought to have Dr. Kahn fired, a charge the company denies.

Either way, nothing happened. Dr. Kahn, the association’s chief scientific officer, kept his job.

'Show me one instance where money has caused us to do something that is wrong,' Dr. Kahn said in an interview. 'You can’t.'

One starts to wonder whether there is any large US health care non-profit corporation that does not receive a significant amount of funding from the for-proft health care sector.

It may be very hard to prove such relationships have caused not-for-profit organizations like the ADA to do "something wrong," especially if one demands a scientific level of proof of causation.

On the other hand, a not-for-profit that gets a large amount of money from, say, the pharmaceutical industry might be hesitant to be critical of the industry or its products, or prone to give the industry the benefit of a doubt.

But even such relatively subtle biases could put the industrial benefactor's interests ahead of the not-for-profit organization's own mission.

Large, stable funding streams from commercial firms may be tempting, but not-for-profit leaders must ask themselves if they are worth the doubts they ought to raise.

More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ

The latest development in the mess at the University of Medicine and Dentistry of New Jersey (UMDNJ) produced some interesting analysis in the media. As we have discussed previously, the university now is operating under a federal deferred prosecution agreement with 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.) The latest 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.

First, the indefatigable Newark Star-Ledger reported that Dr Jerrold Ellner, the chair of medicine at the UMDNJ Newark campus, was put on administrative leave because he and Ronald Pittore, of the school's legal department, "were identified by the university's federal monitor as key figures in UMDNJ's plan to hire at least 18 local cardiologists as part-time clinical assistant professors."

That event inspired a news analysis article in the New York Times. The points it made included,

As New Jersey’s state medical school has been shaken in the past year by disclosures of widespread financial mismanagement, administrators there have repeatedly defended the institution, the University of Medicine and Dentistry of New Jersey, by insisting that the scandals have affected its treasury but not the quality of care for the more than two million patients it treats each year.

But a federal monitor’s recent accusations that the cardiology unit at the university’s main hospital has been paying kickbacks to doctors for referring heart patients have undercut that argument at a time when the school’s future remains in doubt.

The fact that some of the university’s most prominent doctors now stand accused of taking part in an illegal scheme that involved life-or-death medical decisions is likely to further tarnish the school’s image at a time when state officials are deciding whether to merge the institution with Rutgers University and Robert Wood Johnson University Hospital.

Governor Corzine said on Wednesday that charges about the quality of care being affected by the scandal were deeply troubling — 'It’s really disgusting that the culture allowed for this kind of practice' — but added that he had not decided whether to restructure or disband the school.
But other state officials said the latest round of disclosures would only heighten pressure for a merger.

'This just highlights the disaster of trying to salvage what’s left,' said State Senator Raymond J. Lesniak, a Democrat from Union County who is chairman of a panel examining the future of the school. 'Before, the focus was on enhancing the ability to provide education. But now we’re also talking about direct impact on health care and people’s lives.'

On one hand, it is too bad that this analysis appeared in the Times' regional section. Although one would think that a scandal of this magnitude involving the biggest health care university in the US would attract national attention, as an example of the anechoic effect, it has been treated largely as a regional matter.

On the other hand, the analysis recounts some curious ideas about this case.

The first is that a scandal involving top leaders of the health care university had only financial significance, at least until a top physician leader was involved. Underlying this might be an asumption that the managerial and financial sphere of the university is entirely separate from the clinical and academic sphere. But the mismanagement in the former sphere must have sapped resources from the latter. Furthermore, it is hard to believe that clinical and academic personnel did not sense something wrong in the top management, and at least that the focus was more on the personal interests of the top management than the mission of the university. Such a sense would likely at least have dispirited these personnel, and certainly would not have enhanced their performance.

The second curious notion was that the involvement of a top physician-leader somehow signifies that the institution is now irredeemable, and the only remaining choices are to merge it into another institution, or shut it down entirely. This seems to discount, again, all the hard-working clinical and academic personnel who have been laboring to keep things together at UMDNJ together despite the bad behavior by top management. Maybe somebody should talk to this long-suffering group before any irrevocable decisions are made about the structure of the institution. And again, for better or worse, all should remember that health care institutions are made up of many dedicated hard-working people, besides the top managers. Perhaps again the underlying assumption is that somehow imperial top management is indistinguisable from the institution, the notion that "l'hospital c'est moi."

This notion must be discarded in favor of health care governance that is more representative of the relevant stake-holders, as well as more accountable, transparent, and ethical.

Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine

The latest issue of the New England Journal of Medicine includes an article about Bayer's attempted suppression of data from an observational study of Trasylol (aprotinin). [Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med 2006; 355: 2169-2171] We had first blogged about this case, based on a story reported in September, 2006 in the New York Times, here. Avorn's comments on the case are notable:

The health care system has a hard time performing drug-safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them, and despite the $220 billion we spend on drugs each year, we apparently can't find the resources to provide public support for these studies, even if the results could be of great clinical importance and save millions of dollars.

Avorn suggested:

A good start would be to make a national commitment to publicly supported studies of drug risks so that no company could take possession of critical findings for its own purposes. The results of that research could be discussed openly at an annual conference on the risks and benefits of drugs.

In my humble opinion, it does not make sense to let pharmaceutical (and bio-technology and device) companies be responsible for performing relatively unmonitored studies on human subjects to test their own products. One solution would be to put scientists, physicians, and organizations who are not beholden to such companies in charge of such studies. Another would be much more intense regulation of any human studies sponsored by commercial firms.

At least this issue has now come out in the perhaps world's most prestigious medical journal, so it is squarely in front of doctors, other health professionals, and health policy makers.

But I now realize that Avorn's article, and, for that matter, my previous post, both seemed to avoid the issue of accountability of the drug, bio-tech, and device companies who are currently performing (or funding, and then at least partically controlling) studies on humans. So let me correct that omission.

Also in my humble opinion, as long as commercial firms (e.g., pharma, bio-tech, or device) sponsor, and to any extent control studies on human beings, these firms should be held accountable for any failure to disseminate study findings, even if, and maybe especially if the findings are not favorable to their product. Because their products affect peoples' health and safety, suppressing data about their products' adverse effects, or failure to provide beneficial effects is an affront to any patient who might take or be subject to such products. There should be severe negative consequences for any company that withholds such findings.

Cyberonics' Top Leaders Forced Out Over Back-Dated Stock Options

We had previously posted about the curious way in which Cyberonics' vagus nerve stimulator device was assessed as a treatment for severe depression by a US Food and Drug Administration (FDA) panel. Although a randomized controlled trial failed to show any improvements due to the device that could not be explained by chance alone, after some emotional patient testimonials, the panel voted to approve the device. One panelist later said it was "nuts."

We also posted about questions regarding the authors of an article sponsored by the company about the vagus nerve stimulator. These questions revolved around undisclosed conflicts of interest, and the extent a ghost-author was responsible for the article.

Cyberonics also came to our attention because of questions about stock-options granted to its top executives. Now, according to the Houston Chronicle,

Two top executives have exited Cyberonics, after it disclosed that its stock options problems are much broader than previously reported.

On Monday, investors bid up shares of the Houston-based medical device maker, which said Chairman and CEO Robert Cummins and Chief Financial Officer Pamela Westbrook resigned.

The duo was replaced, on an interim basis, by three people: Tony Coelho as chairman, Reese Terry Jr. as chief executive and John Riccardi as chief financial officer. George Parker was appointed as interim chief operating officer.

The personnel changes came as Cyberonics reported widespread stock option problems in a filing Friday with the U.S. Securities and Exchange Commission.

Before Friday, the company had acknowledged only one instance where stock options were at issue. Those options were given to top executives in June 2004, on the day before the stock market had a chance to react to positive news about a Cyberonics product. Some analysts have described the 2004 options activity as 'make-your-own-luck' grants. Others have called it springloading. On June 9, the SEC began an informal investigation into the two-year-old options.

On Friday, Cyberonics said a board committee that reviewed the company's stock option grants concluded that 'incorrect measurement dates were used for certain stock option grants made principally during the period from 1999 through 2003.'

Cyberonics estimates its financial statements from that period would need to be adjusted to reflect about $10 million in additional 'noncash compensation charges' because of the backdating activity.

It's funny how questionable financial practices seem to go hand-in-hand with dodgy marketing and strange science. In my humble opinion, cases like this suggest the urgent need for better governance of health care organizations, meaning governance that is transparent, accountable, and ethical. But given the way many helath care organizations are currently run, should it be any surprise that costs constantly go up, access constantly goes down, quality is constantly questioned, and health care professionals are increasingly miserable?

Cephalon's Promotion of Actiq

The Wall Street Journal reported the latest story about allegations of company promotions of off-label use of their pharmaceutical products. The allegations were about Cephalon's promotion of Actiq, a formulation of the synthetic narcotic fentanyl provided in a sweet-tasting lollipop. The US Food and Drug Administration had approved the drug for the treatment of intractable pain in patients with cancer. According to the WSJ, (somewhat re-ordered)

From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general.
Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname 'perc-o-pop' on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show 'CSI.' In the first nine months of this year, Actiq sales reached $471 million.

The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer.

The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer.

One person familiar with the investigation describes Cephalon's internal marketing documents as 'infinitely more explicit' in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue.

Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue.

In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors.

According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, 'Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program is a remarkably effective promotional tool' that increased sales by 75 prescriptions a week at little cost.

Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was 'Opioid use in headache.' At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was 'Use of Actiq in opioid-naive patients.' Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug.

In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled 'Actiq in Migraine,' the company instructed its sales representatives to pitch Actiq as 'an ER on a stick.'

What is distressing in the series of stories about promotion of off-label use of drugs (e.g., see our most recent post on the promotion of Neurontin) is the participation of physicians as paid pitch-men, or women. It is true that physicians are free to advocate for any off-label use of drugs they favor. But how can a physician who is paid by a company to give a talk that promotes off-label use of that company's drug deny that he or she is acting like a paid marketer?

At the very least, physicians giving such talks should disclose that they have been paid by the manufacturer to promote their drug. If they find doing so embarassing, maybe they should re-consider why they are giving such talks in the first place. (I would further suggest that promoting narcotics for pay may be particularly embarassing.)

Obviously, physicians in the audience should be properly skeptical of all pharmaceutical, bio-technology, and device marketing, whether it is done by former cheer-leaders or medical doctors.

Death of an Autistic Child: Chelation without Indication

The Pennsylvania State Board of Medicine has brought a formal action against Roy Eugene Kerry, MD, the practitioner alleged to have treated a five year-old autistic child with “chelation therapy” last year, resulting in the boy’s death. According to the Board, Kerry treated the 42 lb. boy on 3 occasions with disodium EDTA, 1 gram, given by “intravenous push” over 5-10 minutes. The boy died during or shortly after the third infusion, reportedly from hypocalcemia—as was predictable based on the action of the drug and the warnings contained in its product information.

HCR has previously commented on the case here, making the point that the boy appeared to have been a victim of “CAM,” not merely of an inadvertent drug error—contrary to what a CDC expert had suggested; and here, adding that the chelationist had almost certainly intended to use disodium EDTA (Na2EDTA), not the calcium-disodium EDTA (CaNa2EDTA) presumed by the CDC expert, because it is the disodium form that is preferred by the American College for Advancement in Medicine (ACAM), the major advocacy organization for such treatments.* Dr. Kerry is a member of the ACAM.

The PA Board order’s Factual Allegations support our contention: “Respondent stated…that Disodium EDTA is the only formula of EDTA he stocks in his office”; he “admits that CaNa2EDTA is available but that he has never used this agent.” The order also suggests that Dr. Kerry failed to establish a diagnosis that would have justified the use of either form of EDTA: hypercalcemia or digitalis toxicity to justify Na2EDTA; lead toxicity to justify CaNa2EDTA.

The order quotes from the boy’s medical chart “maintained by Respondent.” The chart describes the boy as “very energetic” and a “Happy child.” The “current complaint notation reads ‘wants to have iv…edta injection..mother states Tariq autistic due to immunization shots…’” The chart refers to another physician, Dr. Usman, who is said to have told Dr. Kerry that the boy had “a very high aluminum and has not been responding to other types of therapies and therefore she is recommending EDTA, which we do on a routine basis with adults. We therefore checked him to it [sic]…But on testing for the deficiency indicator we find him only indicating the need for EDTA at the present time. Therefore we agree with Dr. Usman’s recommendation to proceed with the treatment.”

We are not told what “testing for the deficiency indicator” means. There is no evidence for the unlikely claim of “very high aluminum,” nor is EDTA the preferred treatment for aluminum toxicity. There is no documentation of mercury toxicity, frequently offered by “alternative” practitioners to justify their contention that immunizations cause autism. EDTA, in any case, is not effective in removing mercury. Nevertheless, Dr. Kerry administered Na2EDTA to the boy “with 3 other assistants and mother controlling him and the papoose board.”

After the first infusion Dr. Kerry sent a “post-provocative” urine sample to a lab. This revealed, according to the Allegations, “minimal elevation of his lead level”—as would be expected for a healthy person following an infusion of EDTA. Kerry recorded his “Initial Impression: Autistic Syndrome, Heavy Metal Toxicity, Candidiasis, Multiple Food Allergies…” There is no documentation to support any of these diagnoses. “Heavy metal toxicity,” “candidiasis” and “multiple food allergies” are conditions freely cited among a small subculture of practitioners as explanations for numerous complaints. We wonder if “testing for the deficiency indicator” refers to the use of an “electrodiagnostic” device, a popular method for making such pronouncements appear legitimate to scientifically naïve patients.

As good a job as the Pennsylvania Board seems to have done in investigating this case, there are some unfortunate misstatements. We wonder if the Board was misled by the CDC’s Dr. Mary Jean Brown, the author of the inadvertent drug error theory. In paragraph 83 the Board charges that “the drug used was the incorrect formula of EDTA in that it did not contain calcium.” In paragraph 85: “the drug used was the wrong type…the patient had a minimally elevated lead level.” Paragraph 86: “…used disodium EDTA to chelate Tariq for metal toxicity which should be treated with CaNa2EDTA instead.” Paragraph 91; “Respondent did use disodium EDTA to chelate Tariq for metal toxicity that should be treated with CaNa2EDTA.”

But these allegations either miss the point or are plain wrong: Kerry didn't give the "wrong type" of chelating agent. He gave the more dangerous of two very wrong agents, and he gave it in the most dangerous possible way. No form of EDTA should have been used because there was no indication for it. To treat an autistic child with EDTA in the absence of demonstrated indications, based on the claim that autism is caused by “metal toxicity,” is without basis in medical knowledge. And there was no evidence, as explained above, that the boy had even a minimally elevated blood lead level or any other “metal toxicity.” By not making these distinctions the Pennsylvania Board, however unwittingly, has offered “plausible denial” of responsibility to those who continue to advocate EDTA for dubious indications.

It is probable that if Dr. Kerry had used CaNa2EDTA instead of Na2EDTA, or even if he had given Na2EDTA as directed by its package insert (slowly over 3 hours), the child would not have died suddenly. But this should not distract the Board, the medical profession, or parents from the real point of the case: quackery killed the boy. Quackery also occurs every time EDTA is given in similar circumstances, no matter which EDTA salt is used, no matter how slowly it is infused, no matter how sincerely the chelationist believes in it, and whether or not it kills its recipient. Ironically, this conclusion would have been unmistakable a mere 17 years ago, when the history of laetrile was still fresh in the minds of most physicians, when “chelation” was on the FDA’s Top Ten Health Frauds list, and before the euphemisms “alternative” and “complementary” had replaced accurate descriptors.

* Rozema TC. The Protocol for the Safe and Effective Administration of EDTA and Other Chelating Agents for Vascular Disease, Degenerative Disease, and Metal Toxicity. Journal of Advancement in Medicine. 1997;10, 1:5-100

IS THERE A BASIC SCIENTIST ON THE BENCH?

One of the innovations in stealth infomercials that pharma has developed is the basic science play. Here’s how it works, illustrated in masterly style by the good people at Corcept Therapeutics.

Since 2001, Corcept has been touting a drug called mifepristone (that’s right, RU486) for treatment of patients with psychotic major depression (PMD). The drug blocks cortisol receptors, and high cortisol was theorized to be a cause of the delusions and hallucinations experienced by patients with PMD.

Corcept got fast track approval for their drug from the FDA on the somewhat specious ground that there are no FDA-approved treatments for PMD. They have published a series of small clinical trials that had negative outcomes. One tiny study (N = 5) had no statistically significant result. A second study of 30 patients had no statistical analyses whatsoever. In another study of 30 patients, the statistical analysis was incorrect. These failures did not stop the Corcept team from talking up the drug’s potential in review articles, book chapters, Continuing Medical Education programs, news reports, and press releases. In quite a few of these promotional “product placements,” the financial ties of the authors with the company were not disclosed.

All that is pretty much par for the course in the academic-industrial complex: clinical key opinion leaders were bought and paid for long ago. Now comes the basic science play. In the August 2006 issue of Journal of Neuroendocrinology, a report describes how Corcept’s drug can reverse the deleterious effect of high glucocorticoid levels on neurogenesis in the hippocampus of rats (1). This finding ties in with some inconclusive evidence that some patients with depression may have reduced hippocampal volume. So, this new basic finding is potentially a big deal for Corcept. Indeed, Corcept provided funding for the study. One fully expects that the company will highlight this new information in future statements.

Looking at the new report, one sees in the Acknowledgements that the first author was supported by Corcept. One also sees that a co-author, E. Ronald de Kloet, failed to disclose his relationship to the company: he is a member of Corcept’s scientific advisory board and, unless he has sold any, the owner of 60,000 shares of Corcept stock. One also sees that this basic science article is careful to follow the company’s marketing message and branding language on the putative efficacy of mifepristone for PMD. For instance, it states, “The glucocorticoid receptor antagonist mifepristone has been shown to rapidly and effectively ameliorate symptoms of psychotic major depression.” These basic scientists also stated, “recent clinical studies have shown that the glucocorticoid-receptor (GR) antagonist mifepristone relieves symptoms of psychotic depression after a remarkably brief treatment period of 4 or 8 days.” None of the cited studies shows anything of the sort. We then read, “… similarly to its clinical efficacy, mifepristone’s effects on adult neurogenesis are rapid and positive, and may therefore be important for its mechanism of action.”

What’s going on here? Could it be that one of Corcept’s basic science consultants has been pulled off the bench to pinch hit for the company? The usual readership of Journal of Neuroendocrinology will know nothing about the clinical trials of the drug and will accept at face value the exaggerated statements of mifepristone’s efficacy in PMD. And now the clinical spokespeople for Corcept can point to a new piece of basic science “validation” of their product. Look for it to be highlighted in the next round of book chapters, review articles in clinical journals, CME events, and press releases.

The company needs pinch hitters right now because they have recently had to announce that two large Phase III trials failed. The house of cards is collapsing: they have been informed by NASDAQ that the company is in danger of being delisted because the share price has gone from $12 at issue in April 2004 to around 80 cents today. All in all, Corcept is a case study in bad outcomes for academic entrepreneurs and their backers. Many investors have been burned. Worse, after going through around $95 million of venture capital and IPO proceeds, not to mention several million dollars of NIMH funding, they have failed to answer the original question: does mifepristone help seriously ill patients with PMD accompanied by elevated cortisol production? Now, as the company enters what may be its final spasm of activity, comes this new corruption of the basic medical science literature.

We have long known that citations of the medical literature are not holy writ, but now they are becoming advertising copy. As George Winokur, former chair of psychiatry at the University of Iowa, liked to joke, the medical literature is like the Bible: people can find in it whatever they are looking for. Some of us learned in our training that when we cite an article in one of our manuscripts, we need to actually read that article, understand its methods, and agree with its conclusions. Had the authors of this stealth infomercial in Journal of Neuroendocrinology scrutinized the clinical trials reports that they cited, even as basic scientists they would have recognized the weakness of the evidence. Thus does the corporate mandate to put lipstick on the pig vitiate even the basic medical science literature.

Reference

(1) Brief Treatment With the Glucocorticoid Receptor Antagonist Mifepristone Normalises the Corticosterone-Induced Reduction of Adult Hippocampal Neurogenesis. By: Mayer, J. L.; Klumpers, L.; Maslam, S.; de Kloet, E. R.; Joëls, M.; Lucassen, P. J.. Journal of Neuroendocrinology, Aug2006, Vol. 18 Issue 8, p629-631, 3p, 1 graph; DOI: 10.1111/j.1365-2826.2006.01455.x; (AN 21447609)

Guidelines in Whose Interest? - Epoetin Revisited

We previously posted about how influential guidelines that suggested aggressive use of epoetin to increase and try to normalize hemoglobin levels in patients with anemia and chronic liver disease were funded by Amgen Inc., the maker of one version of epoetin (Epogen). These guidelines appeared to have influenced the US Medicare program to pay handsomely for aggressive use of epoetin, even though the evidence supporting high doses of the drug was not very clear.

This week, the results of two new randomized trials of other versions of epoetin were published in the New England Journal of Medicine.

Preliminary results of the CHOIR study had been mentioned in our earlier post. In short, CHOIR (Correction of Hemoglobin and Outcomes in Renal Insuffiency) was a randomized controlled trial of epoetin alfa dosed either to normalize hemoglobin (target range of 13.0 to 13.5 g/dl) or maintain it in the 10.5 to 11.0 range.(1) The rate of a composite endpoint (death, myocardial infarction, hospitalization for congestive heart failure, stroke) was statistically significantly higher in the more aggressively treated group (17.5%) than in the less aggressively treated group (13.5%). The rates of death and hospitalization for congestive heart failure were numerically higher in the more aggressively treated groups, and the differences were almost statistically significant. Thus this trial suggested that aggressive use of epoetin actually increased the risk of cardiac complications and possibly death.

The CREATE (Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta) trial was a randomized controlled of epoetin beta dosed either to normalize hemoglobin (13.0 -15.0 target) or maintain it in the 10.5 - 11.5 range.(2) The rate of a somewhat more complex combination endpoint (including cardiac and vascular events, as well as death) was numerically higher in the more aggressively treated group, although the difference between groups did not achieve statistical significance. The death rate was also higher in the more aggressively treated group. The study did show that more aggressively treated patients had somewhat better scores on measures of health status, although their improvements did not appear very large. Thus, this trial at best suggested no advantageous effect of aggressive use of epoetin on death or cardiac events, and was consistent with the possibility that it may have had a disadvantageous effect.

Combined, these two studies raise even more concern that aggressive use of epoetin for patients with anemia and chronic renal disease may do more harm than good.

Following the publication of these articles, the Boston Globe reported that the US Food and Drug Administration (FDA) officially warned against excessively aggressive use of epoetin.

This new data underscores the concerns we raised earlier. Guidelines developed with financial support of pharmaceutical or biotechnology companies may favor aggressive use of those companies' products, even in the absence of strong evidence for such use. At best, this can lead to excess costs and treatment that does patients little good, and risks harming them. In this case, we have now gone from a situation in which there was an absence of strong evidence for aggressive use of epoetin to one in which there is evidence suggesting such aggressive use may be actively harmful.

So the bottom line should be just because a guideline advocates something does not mean physicians should obey. Not all guidelines are created equal. Guidelines that have not been rigorously developed using evidence-based medicine principles, especially when they may also have been affected by conflicts of interest, should be viewed with extreme skepticism. Yet, turning such guidelines into "pay for performance" (P4P) incentives is the latest rage in health care management circles (see post here). Such a rage, however, can be bad for patients and doctors.


References

1. Singh AK, Szczech L, Tang KL et al. Correction of anemia with eopetin alfa in chronic kidney disease. N Engl J Med 2006; 355: 2085-98.
2. Drueke TB, Locatelli F, Clyne N et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355: 2071-2084.

"Sponsored Editorials?"

The blog Clinical Psychology and Psychiatry: A Closer Look just noticed a new pheonomenon, the "sponsored editorial." Apparently, these have appeared in the July and November issues of the Journal of Clinical Psychiatry's paper edition (although not on the web). A jpeg reproduction appears in this Clinical Psychology and Psychiatry post.

The "sponsored editorial" itself features clinical bullet points on akasthisia, and two pull quotes, in a large type face, from suffering patients. On the bottom appears the AstraZeneca logo. No authors are listed.

I want to second Clinical Psychology and Psychiatry's blogger's motion that by printing this as an editorial, albeit "sponsored," the journal appears to be endorsing a marketing message as if it were substantive content. This appears to be the latest addition to our catalog of deceptive marketing practices, and the latest story about how medical and health care journals seem to be supporting the vested interests of their commercial sponsors at the expense of their independence. Misleading physicians by disguising advertising, in this case, as editorial content in a peer-reviewed journal, is liable to distort their medical decision making, and hence is bad for both them and their patients.

Now Kaiser Permanente Hospital Criminally Charged for Patient Dumping

This is getting painful. After Kaiser Permanente was recently in the news for problems with its new electronic medical record system, and allegations of the poor management of the system development process (see posts here, here and here), now the Los Angeles Times is reporting

The Los Angeles city attorney's office filed false-imprisonment and dependent-care-endangerment charges against hospital giant Kaiser Permanente on Wednesday, the first criminal prosecution of a medical center accused of 'dumping' patients on skid row.

The charges stem from an incident earlier this year when a 63-year-old patient from Kaiser Permanente's Bellflower hospital was videotaped as she left a taxi in gown and socks, and then wandered skid row streets.
In addition to the criminal charges, the city attorney filed a civil lawsuit against Kaiser, using a state law on unfair business practices that city prosecutors usually implement against unscrupulous slumlords to force them to clean up their buildings. The suit seeks a judge's order to forbid all Kaiser medical facilities from dumping homeless patients on skid row or impose financial sanctions if it violates the order.

A Kaiser spokeswoman on Wednesday said she was 'very surprised' by the charges.

'I can't understand how these charges would be levied based on what I know of the incident,' said Diana Bonta, vice president of public affairs for Kaiser Southern California.

She said Kaiser had changed some of its practices since the March incident to better serve discharged homeless patients.

[The patient] Reyes also is being represented by the American Civil Liberties Union of Southern California and Public Counsel. Representatives from both organizations said Wednesday that they planned to file a second lawsuit on Reyes' behalf soon.

'This is the first case in the nation where there is a joint effort by government and civil rights groups to halt the practice of hospital dumping,' said Mark Rosenbaum, the ACLU's legal director.

Rosenbaum said that meetings with Kaiser and hospitals failed to yield reform — and that was part of the reason for the court filings. 'It is like they lit a match to the Hippocratic oath,' he said.

Dan Grunfeld, president and chief executive officer of Public Counsel, the largest pro-bono legal firm in the nation, echoed that sentiment. 'This is as stark a case as you are likely to find,' he said. 'You have a relatively older woman in adult diapers and gown dumped on a skid row sidewalk. That is a pretty profound statement. Ms Reyes is not alone. There are a lot of Ms. Reyes' out there. We hope to achieve a systemic change.'

You have to start to wonder if something has really gone systemically wrong with the upper management of the once proud Kaiser Permanente organization, which is still, as best as I can tell, staffed by quite a few dedicated doctors, nurses, and other health professionals. Of course, what we have so far are only allegations. But the story as reported by the Los Angeles Times is very disturbing, and the city attorney obviously thought this case was egregious enough to merit criminal charges. Stay tuned.

Kaiser Permanente's New EMR - An Alternative View

MedInformaticsMD has posted recently about allegations of major troubles with Kaiser Permanente's new electronic medical record, and the management of its development (see here and here).

A physician correspondent at Kaiser, and someone whose judgment I trust, had an alternative view:

I want you to know that the Epic product for KP, HealthConnect, is a fully integrated and very highly functional software that interfaces with Pharmacy, Inpatient & Outpatient records, imaging, lab..............it's unbelievably useful. Not absolutely perfect, but really extraordinary nevertheless. I personally can research referrals with an ability to track diagnostic images, consults, labs, professional notes including progress notes all on one platform. It has been rolled out to most of the Northern California region where we serve well over 3 Million people, and there is nothing that competes with its usefulness. The down time quoted is a gross exaggeration. It has helped me enormously provide fast, accurate decisions in settings in which, in the old work, I would have otherwise wasted precious time getting the right, important information.
The KP CIS system to which some reference was made by JD is to Epic as the Conestoga wagon was to a Ferrari. The fact that he thinks it was a satisfactory system either reflects a lack of understanding or a willful blindness to the needs of clinicians. Furthermore, KP is a nonprofit in the best sense of the word - its margin is used to build new hospitals as mandated by State law to make hospitals earthquake safe and to improve care by doing things like rolling out KP HealthConnect [the Epic product]. These are spectacularly expensive projects in the best of all possible worlds, and are intended to provide advances in improving access to care for vulnerable patients.

This does not address all the issues in our previous posts, but at least makes clear that there was some reasonable rationale for trying to adapt the system to the Kaiser setting.

I would also note that Kaiser has a reputation as one of the best managed care organizations, and one that has remained not-for-profit and generally tried to maintain its focus on its primary mission. It's goood to see that Kaiser physicians are continuing to adhere to its traditions. We will stay tuned to see what turns out about the other issues raised about Kaiser's expensive EMR project.

UMDNJ's Federal Monitor Charges Cardiology Kick-Back Scheme Reached Into All Levels of Administration

The leadership of the University of Medicine and Dentistry of New Jersey (UMDNJ) seems to just keep digging a bigger hole for itself. As we have discussed previously, The university now is operating under a federal deferred prosecution agreement with 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.) The most recent allegations, which surfaced last week (see post here) were that the University were paying community cardiologists as clinical faculty as a reward for them referring patients to the UMDNJ cardiac surgery programs, but not as payment for any substantial teaching duties.

Now the Newark Star-Ledger has just reported that the federal monitor assigned to UMDNJ also averred that "UMDNJ had devised an illegal scheme to pay local cardiologists in private practice for hundreds of patient referrals." But worse,

The report documented nearly $36 million in illegal Medicare and Medicaid payments for procedures on hundreds of patients, in ex change for payments of $5.7 million to physicians since 2002 in ex change for sending their heart patients to UMDNJ's University Hospital.

'Unfortunately, this scheme reached well into all levels of the hospital and University Central Administration, who were complicit first in forming and expediting this illegal plan, and later in covering it up,' said Stern in his report, who said the illegal activity 'persists to this day.'

Noting that administrators were aware of the kickback allegations -- settling a lawsuit for $2.2 million by a whistleblower who claimed he was fired for protesting the illegal scheme -- Stern said UMDNJ violated the terms of the deferred prosecution agreement by not only failing to alert his office to the existence of the whistleblower, but by failing to provide relevant documents and information related to the allegations in the lawsuit.

And still worse,

U.S. Attorney Christopher Christie has begun an investigation into charges that the University of Medicine and Dentistry of New Jersey paid nearly $6 million in illegal kickbacks to 18 cardiologists in ex change for patient referrals.

At the same time, Christie said he was particularly disturbed by findings that UMDNJ had violated a deferred prosecution agreement with the government by failing to cooperate with the university's federal monitor on a five-month inquiry into the matter.

And even worse, the New York Times reported that the federal monitor "accused the university’s interim president, Bruce C. Vladeck, who was appointed by Gov. Jon S. Corzine in the spring to restore credibility, of 'trying to refute, rebut and bury' information about violations of anti-kickback laws. It was the first time that the federal monitor, Herbert J. Stern, had directly criticized Mr. Vladeck."

The hits they just keep on comin' for UMDNJ. The most distressing aspect of the current allegations is that they involve activities that continued after the University agreed to a deferred prosecution agreement, and after the leadership of the University was totally revamped.

If the UMDNJ case do not demonstrate the crying need for transparent, representative, accountable, and ethical leadership of health care organizations, I don't know what case does.

Is an inquiry in order for the IT revelations at Kaiser Permanente?

In "Kaiser Healthcare IT Meltdown?" I wrote:

From my experiences in health IT, I place my bets on the whistleblower's account.

In the East Bay Business Times article "Kaiser reports good results, but CIO quits as problems loom" I read with frank shock this statement by the whistleblower Justin Deal:

"My concerns are the financials," Deal said. "So far we have spent in the
neighborhood of $4 billion to implement HealthConnect, which is an astronomical figure."

Incredible. $4 billion? If that is true, that is indeed an astronomical-sounding figure for health IT, perhaps paralleling the spending of the "Connecting for Health" national EMR project in the UK. (Also see my earlier posting "$70 million for an EMR system?")

Where did $4 billion go, exactly?

Is an inquiry in order? I believe if the details of the Deal letter hold any water, questions need to be asked about this level of expenditure. In fact, perhaps a neutral third-party audit is called for in any case.

On an added note, I find this story of another former IT person at Kaiser Permante that I became aware of in correspondence about my earlier post quite unsettling. It concerns HIPAA issues and the attempts of this person to call possible security breaches to the attention of the authorities, and the resultant misfortunes visited upon her. This tale is reminiscent of some of my own personal experiences in bureaucratic settings.

I would advise Mr. Deal to get himself a top lawyer fast if this example of corporate use of power for warfare with the "little guy" is any indication of what awaits him.

A Lecture about Pay-for-Performance: Leaving the Reader Guessing About Conflicts of Interest

We have discussed before how the band-wagon for "pay-for-performance" has been rolling on inexorably, even though applying this seemingly logical mantra to physicians' practices is fraught with problems. (See our posts here and here.) Potential problems with proposed P4P programs include failure to adjust outcome measures for differences in patient characteristics, leading to perverse incentives; evaluating physicians on processes not under their direct control; using error-filled administrative data; emphasizing performance that saves money rather than improves patients' outcomes; and using measures that apply to only a fraction of medical problems and only certain specialties.

Nonetheless, practicing physicians continue to be subject to harangues that P4P is inevitable, so they might as well just submit to it. Two of my favorite blogs, DB's MedicalRants and Retired Doc's Thoughts, have recently been ranting (here and here) about the latest pitches for "pay-for-performance" (P4P) to appear in respected medical journals.

MedicalRants called these pitches "confusing." That may be an understatement.

Take in particular the article written by one John W Rowe MD, which was derived from the Harvey Kimball lecture Dr Rowe gave to the 2005 American Board of Internal Medicine Summer Conference. [Rowe JW. Pay-for-performance and accountability: related thems in improving health care. Ann Intern Med 2006; 145: 695-699.] Dr Rowe started by saying,

When I started my career in the late 1970s as an academic internist and geriatrician, I was skeptical of pay-for-performance, feeling that standards of care could not accurately assess the real benefits of my care of my frail elderly patients with multiple impairments. I still feel that way today because despite the rapid growth of the evidence base, we continue to measure relatively simple aspects of the process of care rather than measuring outcomes.

Dr Rowe later noted that current P4P metrics cannot evaluate management of chronic diseases or multiple comorbid conditions. To do so, he said,

We will need a much richer evidence base than is currently available.

Furthermore, he noted

Although most current standards are developed to evaluate primary care, specialty care accounts for a disproportionate share of health care costs.

So,

Standards must extend to specialty care and to complex patients with multisystem problems.

But despite acknowledging these problems, he still asserted,

I feel a sense of urgency.

So that P4P "now seems to be a useful strategy to pursue."

So who is Dr Rowe, and why should we heed his call for pay-for-performance, even though even he admits that current approaches have major deficiencies?

Trying to answer that question by simply reading the article turns out to illustrate how inadequate current policies on disclosure of conflict of interest are to cope with our current health care environment, dominated as it is by large health care organizations.

The Annals identifies Dr Rowe as being "from Columbia University, New York, New York." His address is listed as the Mailman School of Public Health there. Thus, his current position seems to be on the faculty of a well-known school of public health.

However, this appearance may be deceiving. See the addendum below for evidence that Dr Rowe is not on the faculty of the Mailman School, but rather arranged a donation to the School from his family foundation, and is currently on the School's Board of Overseers.

Dr Rowe did mention that he has "exprience as the leader of a large academic health science center and as chief executive officer of a major health insurer." The Annals lists his "potential financial conflicts of interest" as "employment: Aetna Inc." and "stock ownership or options (other than mutual funds): Aetna Inc." Thus, is he also a part-time employee of Aetna Inc., a large health insurer and commerical managed care organization, perhaps a part-time medical director, or analyst, who holds a few shares of stock in a retirement plan?

Worldly physicians, but not all Annals readers, may realize, instead, that Dr Rowe is not just a part-time mid-level employee, but is the former chief executive officer (CEO) of Aetna Inc. According to Aetna's most recent proxy statement, Dr Rowe retired as CEO recently, in Feb 14, 2006. However, the statement also reveals he still has a very important position with Aetna. He was has been Chairman of the Board since April 1, 2001, and still holds that position, although he plans to retire at the end of this year. In 2006, his salary was $1.1 million, his bonus was $2 million, his other annual compensation was slightly more than $202,000. In addition, in 2006, he received 911,904 stock options, and long-term compensation of over $4.5 million.

Furthermore, Dr Rowe owns far more than a few shares of Aetna stock. According to the proxy statement, he owns or controls the equivalent of 6,338,393 shares of Aetna stock, just under 1% of the total shares outstanding outstanding.

Thus, the magnitude and intensity of Dr Rowe's relationships with Aetna were hardly revealed by the few words of disclosure provided by the Annals of Internal Medicine, under the journal's current disclosure policy.

If the Annals, or any other medical journal for that matter, wants to let the former CEO, current Chairman, and major stock-holder of a large commerical managed care organization lecture us on pay-for-performance, a topic clearly related to the company's vested interests, that is the journal's right. However, the journal should clearly explain who the authors of its articles are.

Moreover, in my humble opinion, the journal should clearly explain the extent, nature, and magnitude of the financial interests of its authors that could relate to the topics they write about. Failure to distinguish between low-level employment and running the company, or between holding a few shares of stock in a retirement plan and owning 1% of a large company is misleading.

If disclosure is going to be an adequate solution to the conflict of interest issues now pervading health care, it must be complete enough so that readers can judge how much bias such conflicts may cause.

ADDENDUM (11/9/2006) When I wrote the post above, I assumed that Dr Rowe did have an academic appointment at Columbia, given the affiliation and address listed in the Annals of Internal Medicine article. However, as bast as I can tell, this is not so.
Searches of the Columbia University and the Mailman School of Public Health directories did not reveal a listing for him. The Mailman School's faculty list did not include his name. Google searching did show that Dr Rowe is on the Board of Overseers for the Mailman School. In addition, his family foundation has given $500,000 to the school to support the Center for History and Ethics in Public Health.
Thus, Dr Rowe appears not to have any current academic appointment at Columbia University or specifically at the Mailman School of Public Health.
The information given in the article about Dr Rowe's primary affiliation and address now also appears to be misleading.
In my humble opinion, medical and health care journals should list author affiliations and addresses that convey an accurate idea of authors' primary organizational affiliations.

"Tall People Don't Look Good in Orange" - New Allegations of Kick-Backs at UMDNJ

The indefatigable Newark Star-Ledger has uncovered yet another story about mismanagement at the embattled University of Medicine and Dentistry of New Jersey. The university now is operating under a federal deferred prosecution agreement with 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.)

Below is the narrative in the words of the Star-Ledger's story, somewhat re-ordered when necessary.

UMDNJ was struggling to save the cardiac surgery program, which is run out of University Hospital. At the time, the state was threatening to shut the program down because the hospital was not performing the state-mandated minimum number of 350 surgeries required to maintain accreditation -- and its mortality rate was too high.

The failing program threatened the core of the university's medical mission. University Hospital is one of only three state-licensed Level I trauma centers in New Jersey, which deal with the most critically injured. Without a heart surgery program, the trauma designation was also at risk.

According to [former chief of the Division of Cardiology Rohit] Arora, soon after the state issued its warning about the surgery program, the university embarked on a plan to enlist local cardiologists with large practices who could bring more patients to University Hospital.

On its Web site, the university describes the part-time faculty members as a group of dedicated cardiologists who practice in the community:

'These physicians are leaders in their field and hold academic appointments at the New Jersey Medical School and often teach classes. They have unique access to the cutting edge technologies and protocols available at University Hospital and are invited to attend weekly grand rounds and conferences.'

Arora, who was represented by attorney Robert Smith of Shrewsbury, said in an interview that the doctors did nothing in return for their faculty appointments.

'They had pseudo-contracts in my opinion,' he said. 'If you look at their résumés and CVs, these were not doctors who were academic. They were never teachers. They may have done research in their training, but they are not researchers as you get in academic medical centers. They're private practitioners with offices. So the claims on their contracts that this is what they would be doing, and also fulfilling some clinical responsibilities -- these guys were not doing anything.'

Arora said when he complained the program was illegal, he was told by one top administrator, 'we have many lawyers.' Shortly after that, he said, he was denied tenure and demoted. His contract was not renewed.

Others in the cardiology department, though, continued to raise doubts about the new assistant professors.

'I was concerned that these cardiologists were not on campus,' testified Merwin Richard, who worked under Arora and then be came interim director of the catheterization lab after Arora left. 'My concerns were what they were going to do in the division.'

Richard, who later left UMDNJ as well, said he did not know what the local cardiologists were doing, other than bringing in their patients.

In his deposition, Richard said the cardiologists who were hired never taught classes, and ignored invitations to attend grand rounds and conferences. He also testified UMDNJ did not establish any criteria on any teaching obligations for the newly minted clinical assistant professors.

Of 20 cardiologists initially approached, at least nine signed contracts with New Jersey Medical School. Some have since left while others have been retained. There is no evidence any of the physicians misrepresented themselves on their curriculum vitae. The cardiologists without teaching or research experience indicated as much on their résumés, and several university officials said in depositions that the main consideration in recruiting doctors for the program was the size of their medical practice.

[Yet,] the University of Medicine and Dentistry of New Jersey paid at least nine local cardiologists in private practice salaries and stipends as high as $150,000 to become 'clinical assistant professors' in an effort to increase the number of patients in the university's troubled heart surgery program.

The details of this unusual program emerge from sworn testi mony taken in a whistle-blower lawsuit against the school, interviews with former and current UMDNJ employees and internal documents obtained by The Star- Ledger through the Open Public Records Act.

The internal controversy over the cardiologists came to light after the university's former chief of the Division of Cardiology settled a whistle-blower lawsuit in state Superior Court in June, which charged that UMDNJ broke the law and then forced him out when he objected to the plan.

Rohit Arora, now a professor of medicine at Chicago Medical School, said what was going on at UMDNJ was 'immoral and totally unethical.'

Some university officials voiced concern over the criminal implications of the faculty appointments, and the possibility that they could lead to prison sentences under federal anti-kickback laws, or civil penalties under the federal Stark Law that could leave University Hospital ineligible for Medicaid and Medicare funding.

In testimony, one official recalled an offhand comment by a high-level UMDNJ official, who told him, 'Tall people don't look good in orange,' referring to prison jumpsuits.

So, in summary, the article alleged that UMDNJ paid a number of local cardiologists substantial amounts as supposed faculty members, even though they did almost no academics work, almost not teaching, and almost no research, and even though they had very few academic credentials, in the hopes that the cardiologists would refer patients to the university's cardiac surgery programs. The story also includes the now drearily familiar tale of a respected health care professional acting as a whistle-blower, who was then promptly dispatched after he questioned what the managers were doing.

Yesterday, the Star-Ledger reported that the New Jersey state Senate will open an investigation of these allegations, and that the federal monitor who is already overseeing UMDNJ has already been investigating them. Senate President Richard Codey (Democrat- Essex) said, "this is something that's unconscionable. You can't pay somebody to direct patients to your hospital. It's just unconscionable - morally, ethically, and it's criminal."

There isn't too much more to say. The ongoing story of mismanagement at UMDNJ just gets more mind-boggling. The university has become a poster-child for all that has gone wrong with the leadership of health care institutions.

The case of UMDNJ also remains a prime example of the "anechoic effect." As best as I can tell, it still has never been discussed in any major medical or health care journal, and so most health care professionals have likely still never heard of it.

Kaiser Healthcare IT Meltdown?

In what can be described as a classic "I said...he said" account of what could be a multibillion dollar Healthcare IT boondoggle for Kaiser Permanente, see this series of posts as well as this series on the health-IT-industry HISTalk blog. (The corporate ethics blog may have been first to break this story.)

All of the familiar elements are there: allegations of conflicts of interest; IT mismanagement; IT leadership with questionable amounts of clinical and/or medical informatics experience; sudden resignations of senior IT officers; accusations and refutations; and even a 25-year old whistleblower.

Justen Deal, a 25-year-old employee of HMO giant Kaiser Permanente, was placed on administrative leave yesterday after criticizing the company's $3 billion information technology investment and some of its providers, including Epic Systems, in an e-mail he sent to all Kaiser employees and later to the company's board of directors. The San Francisco Chronicle picked up the story, using internal financial information contained in Deal's e-mail that projected a $7 billion loss for the company over the next two years if expenses aren't better controlled. "Kaiser's loss projections came to light after an employee sent an e-mail to 180,000 employees on Friday. In the e-mail, Justen Deal, a project supervisor who has worked for the company for two years, detailed his frustration with Kaiser's electronic health record system, which he considers inefficient and unreliable. Deal was placed on administrative leave Monday. 'What I'm doing is working to ensure the waste and abuse stops,' said Deal, who lives in Los Angeles. 'That's not something you get fired for.'"

HISTalk reports: you decide.

Here is Justin Deal's controversial mass email to 180,000 employees (!), which I reproduce here almost in its entirety (due to the fact that almost every paragraph describes twists and turns that appear salient.) I've highlighted some themes familiar to Healthcare Renewal readers:

Dear Colleague,

Three weeks ago, George Halvorson, our CEO, wrote to tell us that Health Plan and Hospitals are facing significant financial challenges. What Mr. Halvorson did not mention was the magnitude of the financial losses we could see: our internal projections show that we could lose as much as $7 billion dollars in total over the next two fiscal years. Losses of even a fraction of that total will be a threatening blow to our organization and what we stand for, and will significantly compromise our ability to care for our members.

There are many things that are triggering these losses. Among them are accelerating changes to our membership base as more member move towards higher deductible plans, reductions in Medicare reimbursements, and our capital outlays for rebuilding. But the truth is, these issues are only exposing our real financial problem: we're spending recklessly, to the tune of over $1.5 billion in waste every year, primarily on HealthConnect, but also on other inefficient and ineffective information technology projects.

A History of Problems

On George Halvorson's first day here, he cancelled KP’s existing project to implement electronic health records. He wrote off the $442 million KP-CIS system that we had built with IBM. Instead of continuing to build on KP-CIS, Mr. Halvorson selected a company he was quite familiar with, Epic Systems of Wisconsin. Mr. Halvorson had also pushed through the selection of Epic at the health plan he previously had led, in Minnesota. [If this is true, why was a CEO overriding the IT experts? I have seen this type of mismanagement before -- ed.]

Despite internal resistance to this unusual and significant change of course, Cliff Dodd, our CIO, embraced Mr. Halvorson's decision, and both began working to convince key KP leaders that KP-CIS would eventually fail and that Epic was our only option.

What was particularly disconcerting about abandoning KP-CIS was the significant investment we had already made in the system. It was functioning reliably in Hawaii, had been in use in Colorado for years, and was on track for deployment in our Southern and Northern California regions. In fact, only days before Mr. Halvorson was hired, the Kaiser Permanente Partnership Group had reaffirmed its unequivocal support for KP-CIS. Comprehensive plans and agreements were even in place to continue building on KP-CIS.

But Mr. Halvorson was determined that KP would give its business to Epic. Several respected KP executives, who had supported or were directly involved with KP-CIS, saw the writing on the wall and quickly left the organization entirely. Others converted to supporting Epic after extensive ballyhooing from Mr. Halvorson and Mr. Dodd. All the while, our CEO and CIO ignored internal engineering reports which said Epic software would be unreliable for our size and difficult to adapt to our scope.

Instead of heeding those engineering reports, Mr. Dodd brought in a company called Tanning Technology to give an opinion on the viability of Epic within an organization as large as Kaiser Permanente. Mr. Dodd, while serving as an officer of Health Plan, also simultaneously served as a director for Tanning. Ignoring this significant conflict of interest, Mr. Dodd paid nearly $1 million dollars for Tanning Technology to give a favorable report on his and Mr. Halvorson’s predetermined plan to shift KP’s business to Epic. Tanning Technology, shortly thereafter, went belly up.

Despite the fact that Mr. Halvorson was hired for what we believed was his experience in implementing electronic health records, the truth turned out to not be quite so convincing. Mr. Halvorson was previously CEO at a health plan called HealthPartners, in Minnesota. HealthPartners is a little less than a tenth of the size of KP. Although George Halvorson had signed HealthPartners to an expensive contract with Epic Systems just before he left, HealthPartners still hasn't seen the results that Mr. Halvorson had promised. In fact, HealthPartners has faced significant problems with its Epic project, and, so far, the Epic software has only been able to completely cover about half of HealthPartners members.

... A Lack of Accountability

When I first began to uncover this information, I almost could not believe what I was reading. As the impact to Kaiser Permanente became more and more obvious, and when I learned of the sheer magnitude of the potential losses, I knew I had to do something ... So, I gathered all of the information I had collected: the news articles, the SEC filings, the engineering reports, and the Attorney General’s allegations. I put it all in a package, and I sent it, along with a letter explaining what I had found, to Dan Garcia, our chief compliance officer. That was in August. I also sent an identical packet to each member of the Health Plan Board.

I was worried by the seriousness of the issues, but I was heartened by many of the responses I received. Several Board members told me privately how shocked they were to see such terrible evidence and how alarmed they were to see the very negative financial projections. They thanked me for bringing the important information to their attention, and said they would be meeting with Mr. Garcia soon to make a decision on an appropriate course of action.

In putting all these pieces together, though, I missed one key fact that would lead me to seriously question Mr. Garcia’s ability to handle the situation. After sending the information to Mr. Garcia, I learned that Mr. Garcia had also served on the Health Plan Board of Directors for several years, even before he became our CCO. The key piece I missed was significant: Mr. Garcia is the very man who hired George Halvorson, back in 2002.

That presented a serious conflict of interest that I don't believe Mr. Garcia disclosed to the Board when they asked him to investigate, on their behalf, the issues that I had uncovered and report back to them.

I trusted Dan Garcia and his staff. I didn't question his integrity or honesty until he directly instructed me to have no further contact with any Board member. I found his order unusual: several directors had personally told me how concerned they were with these issues, and how thankful they were that this evidence had been brought to their attention. Why would Dan Garcia, who reports to the Board, try to create distance between the Board and me, and try so hard to keep the Board in the dark?

When I found a KP press release from 2001 that pointed out that Mr. Garcia headed the small committee that selected Mr. Halvorson, Mr. Garcia’s strange, and incredibly defensive behavior began to make sense.

Having Their Way

For some reason, Mr. Halvorson and Mr. Dodd were determined to make sure KP switched its business to Epic, regardless of the potentially catastrophic financial impact. Mr. Garcia chose to not stand in their way. And to make sure nobody else objected, Mr. Halvorson began replacing each and every director with handpicked candidates, who I believe he thought he could control.

The fact is, in an interview about a year ago, Mr. Dodd made a statement that puts everything into perspective. He said:

"We had a whole executive committee that was quite committed to [[KP- CIS]]... The board... all the medical directors...each had to be unwound and reset."

And “unwind” and “reset” Mr. Halvorson and Mr. Garcia did. Today, only one person remains on the Board from before 2002. That's an unprecedented turnover in our history, that, I believe, has allowed Mr. Halvorson and Mr. Dodd, with Mr. Garcia's compliance, to mislead Kaiser Permanente into a multi-billion dollar spending spree benefitting Epic Systems, that Wisconsin company that Mr. Halvorson is so familiar with.

Misleadership

Unfortunately, in this process, many of us have been misled, and no matter what happens to Mr. Halvorson, Mr. Dodd, and Mr. Garcia, we will be the ones left to deal with these problems. We put our faith in each of them. Other KP leaders trusted them, and depended on the integrity and accuracy information they provided. Dr. Jay Crosson, the leader of The Permanente Federation, and one of the most respected physician leaders in the country, recently wrote that downtime with Epic's systems has been getting better and better. The truth is, over the past several months, Epic outages have increased from just over 9,000 user hours per month in June to over 59,000 last month. Dr. Crosson, and each of us, have all been told how reliable and wonderful Epic is going to be. Sadly, it’s just not true.

Epic simply cannot scale to meet the size and needs of Kaiser Permanente. And we're wasting billions of dollars trying to make it.

[snip]

... Please, help me fight to protect the future of our organization, the future of Kaiser Permanente, the future of America's foremost healthcare leader.

If you would like to stay up to date, I will try to update a website I have set up, fixkp.org, with the latest information.

Sincerely, and most respectfully,

Justen Deal
Kaiser Permanente

KP's CEO posts a refutation which is also posted at the HISTalk blog; read it at the links above.

If Mr. Deal's allegations are even partially true, however, this spectacular story would exceed in severity most of the worst healthcare IT debacles known (excepting the difficulties the UK NHS's Connecting for Health national EMR project is experiencing that I have linked to in prior posts). I have opined that all the assumptions, methodologies, and practices in health IT design and implementation need a critical examination by experts - and that does not mean by computer experts alone - and massive revision and reform to take into account the complex and unique setting of healthcare.

My own take on the matter? From my experiences in health IT, I place my bets on the whistleblower's account. However, that's just my opinion.

Of note, I did not select EPIC for Christiana Care some years ago due to my concerns about its ability to scale and be customized as needed for various specialties and sites. I do not know if this has changed in EPIC's current EMR products, however.

Finally, this is one 25 year old with real guts.