An Update on the Tragic TGN 1412 Trial

Our most recent post on the lack of transparency in the trial run by Parexel of TGN 1412, a drug developed by TeGenero, which left all six participants in intensive care with multi-organ system failure, was here.

This trial has generated tremendous media attention. Thus, we now know a bit more about it, but still not much.

According to TeGenero's website, the drug TGN 1412 is a monoclonal antibody that targeted the CD28 receptor on T-lymphocytes. The drug is not meant to destroy T-lymphocytes, but rather to activate the CD28 receptor. According to TeGenero, the TGN 1412 leads to "pronounced T-cell activation and expansion." Thus, unlike some other monoclonal antibodies used to treat cancer, this drug was meant to change the settings, as it were, of the patient's immune system. This was thus a novel therapy, and hence one whose results might have been unpredictable.

Furthermore, the Times (UK) reported that before the trial was carried out, there may have been reasons to be concerned that this drug might have had adverse effects. The Times article quoted Angus Dalgleish, (who holds the Foundation Chair of Oncology at St. George's Medical School in London, but is also the Research Director for Onyvax, a company that also is developing cancer treatments based on immunology), "I would have told the people doing this trial [on TGN 1412] not to do it because the dangers were so great." He cited studies of a "similar drug," "They should have known they would get a meltdown because this drug was hitting exactly the same immune response pathways." (I have not yet been able to figure out precisely which studies he meant.) Furthermore, the Times quoted Jorg Schaaber, "a member of the German drug industry monitoring group Buko Pharma" (whose web-site is here, but appears to only be in German), that monoclonal antibodies like TGN 1412 carry "considerable risks." Finally, it quoted Michael Seed, a Senior Research Fellow at the William Harvey Institute at Barts and the London Hospital and the Queen Mary's School of Medicine and Dentistry, "The danger is that they are messing around with T regulator cells and we don't know what all the T regulator subsets do. Some will switch things on and some will switch things off."

Furthermore, newspaper reports hint at irregularities in how the trial was conducted. The Times (UK) article suggested that the fees paid volunteers were sufficient to be inducements, rather than just payments for time and expenses. It also alleged that in other trials, Parexel, the contract research organization conducting the TGN 1412 trial, used consent forms so long as to be unreadable, and "pressured" volunteers to sign the form with reading it, "because I felt like I was slowing everyone down." Also, it noted that some trial participants may have been professional research subjects, e.g., one, referred to as a "serial human guinea pig," had reportedly made 60,000 pounds sterling in four previous years from participating in drug trials.

An article in the Telegraph (UK) cited a review article on the effects of monoclonal antibodies to CD28 (Hunig T, Dennehy K. CD28 superagonists: Mode of action and therapeutic potential. Immunol Letters 2005; 100: 21-28 )which noted "massive expansion and functional activation of regulatory T-cells by in vivo treatment with CD28 superagonists," but also revealed gaps in current knowledge about what CD28 activation does, and then asked "does it even make sense to talk of informed consent when the experts themselves admit to sugh gaps in their knowledge?"

Thus, there are reasons to suspect that this trial had not been fully thought through, and that it it was not optimally implemented.

Once again, while hoping that six participants in this trial get better, I also hope this tragedy prompts a re-evaluation of our drug testing procedures, and particularly more transparency in all phases of the process.

A Perspective from Transparency International's 2006 Global Report on Health Care Corruption

To put the various examples of mismanagement, conflicts of interest, and corruption afflicting health care organizations discussed in Health Care Renewal in perspective, I strongly advocate reading Transparency International's Global Corruption Report 2006, which focuses on health care. (We had previously noted the release of the report here, and a Lancet editorial inspired by it, here.)

To get the flavor, I have assembled some key quotes from the beginning of the report.

[Foreward]

Corruption - alongside poverty, inequity, civil conflict, discrimination and violence - is a major issue that has not been adequately addressed.... It leads to the skewing of health spending priorities and the leaching of health budgets, resulting in the neglect of diseases and those communities affected by them; it also means that poor people often decide against life-saving treatment, because they cannot afford the fees charged for health services that should be free. Corruption in the health care sector affects people all over the world.

[Preface]

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care.

[Executive Summary]

But the scale of corruption is vast in both rich and poor countries.
Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly.... The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted the public services.
Corruption affects health policy and spending priorities.

[The Causes of Corruption in the Health Sector: a Focus on Health Care Systems]

Corruption in the health sector is not exclusive to any kind of health system. It occurs in systems whether they are predominantly public or private, well funded or poorly funded, and technically simple or sophisticated.
No other sector has the specific mix of uncertainty, asymmetric information and large numbers of dispersed actors that characterise the health sector. As a result, susceptibility to corruption is a systemic feature of health systems, and controlling it requires policies that address the sector as a whole.
The forms of abuse may differ depending on how funds are mobilised, managed and paid.
The evidence available on corruption in health care systems with direct public provision [of care] is largely focused on informal, or illegal payments for services in developing or transitional economies. This form of corruption has a particularly negative impact on access to care for the poor when they cannot afford these payments.
When public financing is separated from provision, the character of abuses is likely to change, focusing on ways to divert the flow of payments and reimbursements. One central aspect influencing the type of abuse is the payment mechanism....
When remedies are put in place to remedy these problems, efforts to influence regulators becomes a new potential source of corruption. Powerful interest groups, including suppliers, payers and health providers, may ‘capture’ regulators in order to evade their responsibilities, or further their interests at public expense.
Consumers generally lack the organisation and power to discipline other actors by voicing criticism or choosing different health care providers. In addition, abuses can be hidden behind simple administrative inefficiencies....

I would strongly suggest, as they say in the blogsphere, "read the whole thing."

A Window on Human Research Done by Contract Research Organizations

The recent tragic and unprecedented results of a Phase I clinical trial of a monoclonal antibody known only as TGN 1412 provide a new window into the issues surrounding the now heavily commercialized world of drug testing.

The outcome of the TGN 1412 tests have received global attention. Briefly, TGN 1412 is a monoclonal antibody developed by the German company TeGenero AG. An initial test on six volunteers was arranged by Parexel International at their facility at Northwick Park Hospital in London, UK. Six volunteers received apparently the same initial dose of the drug, while two others received placebo. Within hours of receiving the drug, all six complained of fever, and severe pain in their heads. They apparently developed severe swelling of their heads and upper bodies, and then developed multi-organ system failure. All were rapidly admitted to the hospital's intensive care unit.

The particular symptom complex these patients suffered seems to be unprecedented. Previous instances in which everybody who received a new drug rapidly developed life-threatening illnesses are apparently unheard of.

The media have been doing their best to investigate what happened, while the UK Medical and Healthcare Products Regulatory Agency (MHPRA) suspended the trial and is also investigating. Based on newspaper reports available so far, though it is striking what is not known about this drug trial.

We know the company designation for the drug, and its general type (a monoclonal antibody, or protein developed to bind to a specific molecule), but nothing more specific. We do not know what the target molecule was for the antibody, the rationale for its potential therapeutic usefulness, or the results of its in vitro (test-tube) or animal testing. Some of the news reports suggested conflicting results of animal studies. For example, one report in the Times (UK) quoted the girl-friend of one of the trial subjects , "They [the drug company] said there was an oversensitivity in monkeys...." Furthermore, "a dog and some animals had died." But the Times also reported that the Chief Scientific Officer of TeGenero, Thomas Hanke, "refused at a press conference to say whether animals had died during earlier tests. 'There has been no issue on the safety of the drug oanimalsls. This is not relevant.'" In addition, Bloomberg News reported that the CEO of TeGenero, Benedikte Hatz, said "these events were completely unexpected and do not reflect the results we obtained from initial laboratory studies...." Finally, the Independent reported a claim by a lawyer for one of the research subjects that "there is confusion about whether the drug had been testsuccessfullylly and safely on animals before the tests on these volunteers."

We know very little about how the trial was designed. The Times reported "the trial protocol had been agreed with the MHPRA and was carried out 'according to strict ethical and regulatory requirements,' per Parexel. The MHPRA yesterday refused to give precise details, citing commercial confidentiality, and questions to Parexel went unanswered." Some reports suggested that all six volunteers got doses of the drug simultaneously. The Times noted that this practice was not condoned by a textbook it consulted, which instead suggested sequential dosing.

We do not know what sort of oversight or review this trial had received. The Bloomberg report quoted Parexel's claim that it uses "standardized procedures for testing a drug in humans for the first time, based on a protocol approved by ethics committees and regulatory authorities." What ethics committee approved this protocol is unclear.

We have previously posted about how clinical research on human subjects has become more and more an enterprise done by for-profit commercial contract research organizations, (like Parexel), and supervised (in the US, at least) by commercial institutional review boards (IRBs). We posted (go here and see links) about various questionable practices by US based commercial contract research organization SFBC International, which is now under investigation by a US Senate Committee and the US Security and Exchange Commission (SEC). Furthermore, a trial immunosuppressantresant drug carried out by SFBC International's Canadian subsidiary resulted in 20 patients and staff members contracting latent tuberculosis.

Current regulations of clinical research on humans in the US were developed in the days when most research was carried out and directed by faculty members at academic institutions. Now most research is funded by commercial firms, mainly drug and device companies. When such research is carried out in academic institutions, it is performed often under contracts that give considerable control to the commercial research sponsors, rather than to the faculty ostensibly principal investigators. Furthermore, most such research is now carried out by contract research organizations, under contract to the drug or device company, and supervised by commercial IRBs also paid by the commercial sponsor.

Human clinical research has profound health and safety implications both for its subjects, and for any patients who eventually take the drug or use the device under study. Given that, research subjects and future patients deserve complete transparency about the drug or device to be tested, and how the testing will be performed and supervised. Such transparency was obviously not in evidence in the trial of TGN 1412. We need to revise regulation of drug and device testing on human subjects to make it sufficient to protect research subjects and patients in the current era of globalized commercial research.

Do EHR's mean the end of the world?

You might think so after reading an op-ed by Spyros Andreopoulos, director emeritus of the Office of Communication and Public Affairs at Stanford University School of Medicine, that appeared in the San Francisco Chronicle.

While its title refers to privacy issues, the op ed takes a somewhat contrarian view towards the EHR in general and the push for healthcare IT at the federal level, e.g., ONCHIT.

My comments are in blue italic.

Technology and Privacy: Keeping snoops out of our health files
Spyros Andreopoulos
Tuesday, March 14, 2006

Despite a strong push by the Bush administration for the majority of Americans to have computerized medical records within 10 years, I am not sure I want the attending privacy risks.

I don't believe the hype dished out by our government that the odds of my survival after a heart attack would improve because the emergency-room computer would let the doctor connect to the Internet, type in a password, and within a few clicks, view my medical history and begin treatment. Those who write this fiction have never seen a real emergency room in operation.

This observation with regard to the value of EHR in an ED setting seems both extremely narrow and probably inaccurate. Instant availability of prior ECG's, cardiac history, past cardiac enzymes, cath results, meds, other medical history, etc. certainly could affect admission and treatment decisions and hence odds for survival. He follows this narrow objection with a list of benefits, somewhat contradicting his original point conceptually:

I cannot deny the positive benefits for public health in having medical records computerized. They make it easier to track diseases and side-effects of prescribed medications. They can prevent redundant invasive procedures, X-rays, MRI and CT scans and blood tests. Universities, where most clinical trials of new drugs take place, have access to data for research. Billing is more efficient, and bad claims are caught more quickly. If an individual is insured or gets sick in another part of the country, that person's medical history is readily available to another doctor or hospital.

"Positive benefits for public health" seems quite contrained considering the value of this information to care of the individual.

But I am wary at the thought of my medical history floating in cyberspace because we have no system to guarantee protection from hackers, insurers and drug-company marketeers.

This is a valid concern. However, such protection is evolving, not non-existent.

I am also concerned because this new development is going ahead without adequate public participation. According to a 2006 survey by Health Industry Insights, a market-research firm, most respondents (70 percent) are unaware of the federal government's initiative to make electronic medical records available.

ONCHIT and the healthcare informatics community needs to get the word out more fully...

Another concern is cost. One estimate places it at $250 billion, to be offset by economic benefits of an estimated $700 billion that critics consider over-inflated. But these savings, spread over a decade, would go to the insurance industry, while the actual costs of implementing the system will accrue to doctors and hospitals. The new computerized system at Lucile Packard Children's Hospital in Palo Alto, for example, soon to go online, will cost $150 million.

Regarding the $150 million EHR implementation figure, rather than abandoning change as this op ed seems to imply, cost reduction is an area for exploration. From my perspective I am concerned that EHR project budgets may be padded and inflated, along with generous consultant engagements and 'fudge factors' for project delays and cost overruns that should be better managed or prevented from occurring in the first place. It's not as if these issues are immutable, new or unknown.

The deployment of the new technology is also expected to create havoc among physicians with small practices who do not have the know-how, the management staff or capacity to re-engineer their practices according to the wishes of government bureaucrats in the same way as large group practices.

Experts doubt the government will succeed without committing tens of billions of dollars. There is no real sign the Bush administration will provide anything even remotely close to that sum. In Britain, the government's adoption of a similar goal is succeeding because it is driven by a single-payer system funded with an extra $10 billion in government contracts and enforced by mandated computerized standards applying to all hospitals and doctors. Approximately 95 percent of the doctors in the United Kingdom now use computers in their practice, as do most doctors in Sweden and European Union nations compared to a measly 20 percent in the United States.

This seems like a bit of gratuitous Bush-bashing. This initiative is not limited to any one administration, and will be ongoing long after this president, and the next, have left the White House. That clinical IT is "succeeding" in the UK seems a strawman argument. Recent publications suggest the UK initiative is far from "success" at this point in time, and part of the problem is the "enforcement and mandated" issue, e.g., "Terminal care", The Economist; 7/23/2005, Vol. 376 Issue 8436, p52:

Convincing Physicians to Use IT-Britain is Struggling: Many observers of physician behavior have been watching to see how Britain would overcome physician hesitancy to use medical information systems. Many have hoped that the enormous Connecting for Health project would solve this barrier and provide learning lessons for others. According to recent publications, only 21% of physicians were enthusiastic about the project, and usage rates were low. A good grounding back to the basics, build it with them and for them, and maybe, just maybe, they will adopt. Terminal Care, The Economist, July 23, 2005

A statement that "95% of the [UK] doctors are now using computers" fails to mention what computers are being used for. A large percentage of the use is administrative at this point in time.

There was a time when medical records were kept on paper in file cabinets of hospitals and doctors' offices. As electronic records gain ground, insurance companies and HMOs require detailed accounts of patient treatments and expenses to stem health costs. Previously, they asked only for basic information on diagnoses.

That this may have been so is not necessarily a good thing. This works both ways. Among other factors, it can encourage overutilization and fraud. I have observed rampant medical fraud in the worker's compensation system as a result of such undetailed reporting and uncontrolled payments.

The chances for misuse are also greater. Employers could use the information to exclude applicants for employment due to medical history, and insurers to refuse insurance to those who are sick or have genetic predisposition to illness. The pharmaceutical industry is organizing conferences to explore how to "mine" information from electronic records for secondary purposes, including selling services and drugs to patients.

In regard to pharma using these systems to "exploit" consumers by "selling services and drugs" as he seems to suggest, the same systems can likely be used to detect postmarketing drug side effects earlier, avoing the next Phen-Fen, as well as missed opportunities for preventive interventions.

Let's not forget hackers and pranksters. Six years ago, a hacker downloaded thousands of confidential files from the University of Washington in Seattle containing patients' names, health conditions and Social Security numbers.

Polls suggest that 70 percent of Americans fear that there could be more sharing of patients' medical information without their knowledge; computerization could increase rather than decrease medical errors; some people would be reluctant to disclose information to doctors because of worries that it will go into their records, and existing federal protection rules will, in time, be relaxed in the name of efficiency.

While these are valid concerns, to state as fact that "existing federal protection rules will, in time, be relaxed in the name of efficiency" is a bit of a leap. It seems far more more likely the rules will be refined and strengthened as errors occur.

Such fears are not without foundation. Last December's issue of Pediatrics reported, for example, that mortality rates for pediatric patients at Children's Hospital of Pittsburgh increased to 6.5 percent after the implementation of a computerized physician order-entry system, intended to prevent medication and patient management errors. While this finding does not mean causality and may have an explanation, it has stirred debate publicly and in cyberspace.

That doesn't mean clinical IT necessarily will increase errors, and it's more likely that well-designed and well-implemented (i.e., clinician-driven as opposed to businessperson driven) clinical IT will not.

In the mid-1990s, Congress passed the Health Insurance Portability and Accountability Act (HIPPA) to protect patients from privacy violations. The regulations are full of loopholes and Congress may need to tighten the law's provisions.

This seems an internal contradiction in the op ed. As I stated above, this is the more likely scenario, rather than loosening federal protections for increased efficiency.

Under HIPPA, health-care providers have the right to process your insurance claims, discuss your case and send data about you to other specialists, respond to requests from public-health authorities, law-enforcement agencies, and your employer if you are injured at work, and send you fundraising materials. While these provisions may appear reasonable, HIPPA also allows health providers to share information with health-care business associates for the purpose of training their personnel. HIPPA gives patients the right to restrict uses of their medical information. Providers or health plans, however, are not obligated to agree to the restrictions if they state so in their privacy notices that patients sign when admitted for treatment. This is why patients must read the fine print carefully before signing.

Dr. David Brailer, appointed by President Bush to coordinate the move to electronic medical records, is a former software company CEO. In his public statements, he acknowledges the mind-boggling complexity of information systems, but with refinements and proper security systems, he believes electronic records can be made to work and be more secure than paper records.

Brailer is also a clinician with a solid knowledge of healthcare quality issues and metrics, as well as medical informatics, not just a former "software company CEO."

If patient information moves successfully from paper to the computer, as its champions hope, the door to privacy abuses will swing wide open.

"The doors to pivacy abuses swinging wide open" as a result of EHR seems a bit hyperbolic.

One suggested solution is to give patients the right to work with the doctors to decide what is included in his or her record. A small step to be sure, but if the law and doctors were to give patients this amount of empowerment and autonomy, the doctor-patient relationship will have come a long way.

Indeed.

In effect, there are arguments on both sides of the EHR issue. I believe this portrayal of EHR is somewhat over the top with a strong tilt towards the "dark side", as often seems the case from those on the "Left Coast" about a number of issues of public import. In EHR, the "light side" needs to be taken into account to avoid premature discouragement or abandonment of the efforts to improve healthcare quality via IT.

-- SS

Punishing Depression

Academic medical centers (AMCs) are an influential part of the health care system in the US, and around the world. Not only do they take care of numerous, often seriously ill or disadvantaged patients, but also they are leaders in biomedical, and health care research, responsible for training medical students, young physicians, and other health professionals, and called on to provide expertise in health policy. On Health Care Renewal, we have posted unfortunately numerous examples of AMC leadership failing to live up to these missions.

A recent story in the Washington Post gives a particularly worrisome and bizarre insight into how university leadership interact with their AMCs.

In summary, Jordan Nott was an undergraduate at George Washington University. After some stressful life events, he began to experience depression. "Nott began going to the University Counseling Center, he said. He began taking psychiatric drugs and told counselors he thought about suicide but would not act on it ... and he did not attempt suicide." Depression is, of course common, and often afflicts young people. So far, this story is unremarkable.

"About 2 am one sleepless night, sophomore Jordan Nott checked himself into George Washington University Hospital." This hospital is part of George Washington University Medical Center. Part of the stated mission of the medical center is "Enhancing the delivery of compassionate and high-quality healthcare through our education and research activities." Again, so far, this story is not unusual.

As soon as Nott was admitted to the hospital, however, things went seriously awry. "Within a day and a half of arriving there, he got a letter from a GWU administrator saying his 'endangering behavior' violated the code of student conduct. He faced possible suspension and expulsion from school, the letter said, unless he withdrew and deferred the charges while he got treatment. In the meantime, he was barred from campus." "He decided not to argue his case at a school judicial hearing to be held two days after he left the hospital, he said, worried that an effort to fight the charges would fail and leave him with a permanent black mark, and expulsion or suspension, on his transcript. He withdrew, went home to upstate New York, .... Weeks later, he waited for his father and friends to lug things down from his dorm room because, he said, he had been told he could be arrested for trespassing." A Washington Post editorial stated, "'if you come onto campus for any reason, you will be trespassing and may be arrested,' the letter said."

This case has come to light because "Nott sued the university and individuals involved. The school violated federal law protecting Americans with disabilities, the complaint argues."

Thus, allegedly university administrators suspended a student, threatened him with disciplinary action, and threatened him with arrest should he appear on campus, all because he suffered from depression and was admitted to the university's AMC. It is hard to come up with words to describe these managers' behaviors. Perhaps Kafkaesque, medieval, or Stalinist might do. Clearly punishing someone because they are depressed is a gross violation of the medical center's stated mission to provide compassionate care.

Are the managers who punished Jordan Nott the sort of people we want running our great medical institututions?

The threats to free speech and academic freedom, political indoctrination, and kangaroo court justice prevalent on many US institutions of "higher learninig" are well-documented by such groups as the Foundation for Individual Rights in Education (FIRE), American Council for Trustees and Alumni (ACTA), and the National Association of Scholars (NAS). Many of my friends have argued that this sort of mismanagement of higher education may be upsetting, but it has little impact on health care. The case of Jordan Nott suggests the opposite.

"A Level of Self-Interest Here That is Unusual"

We recently posted about the seeming inability of US managed care organizations to effectively bargain down the prices of drugs. Although the whole point of basing health care funding on managed care was to control costs, managed care has not been very successful in keeping down the costs of drugs, devices, or hospitalization. The health care research literature has provided few explanations of these failings.

The Boston Globe reported on an "unusual alignment of forces," as one friend used to say, in the regional health care scene that may help explain this phenomenon.

In a scene right out of the days of the Vault, the secretive group of Boston business executives that for decades influenced public policy, Jack Connors, chairman of Partners HealthCare, convened a March 1 meeting of local powerbrokers to deal with a crisis in the healthcare industry.

Sweeping legislation to expand health coverage and set aside hundreds of millions of dollars in new payments for Massachusetts hospitals appeared near death, a casualty of conflicting agendas and egos on Beacon Hill. It was up to these business leaders to forge a compromise.

"There were a number of us in the business community and in the healthcare field who wanted to be sure that we didn't miss this opportunity," said Peter Meade, executive vice president of Blue Cross and Blue Shield of Massachusetts, and one of the select few invited to the meeting at Connors's advertising agency, Hill Holliday.

''This reflects the transformation of Boston's economy. The biggest players are not the banks and insurance companies, but the hospitals," said Jeffrey M. Berry, a professor of political science at Tufts University.

Business groups say the healthcare executives' intervention in the bill was not a one-time show of muscle. The industry is deeply embedded in the state's economic structure and its political influence probably will continue, they said.

Formally called the Coordinating Committee, the Vault, which disbanded in 1997, consisted of 25 powerful executives who operated in secret and developed a policy agenda for the business community. It first met in a basement vault of Boston Safe Deposit & Trust Co.

But the healthcare power brokers differ from the Vault executives in important ways, Berry said. First, they represent enormous nonprofit institutions instead of for-profit companies. Second, he said, their focus in this case was on complex legislation to benefit their industry -- not on charting broader overall growth and employment strategies.

"There was a level of self-interest here that is unusual in Massachusetts politics," Berry said.

Partners and Blue Cross executives denied their interest in healthcare legislation was motivated exclusively by business concerns. They said they have for years urged expanded access to healthcare through universal insurance coverage.

To make their case, Partners and Blue Cross together spent $850,000 on lobbying and advocacy advertising in 2005. Leading the squad of lobbyists for Partners and Blue Cross is John R. Sasso, who was chief of staff in the administration of governor Michael S. Dukakis. The $109,200 in fees paid last year to Sasso's firm, Advanced Strategies, were split down the middle by the two nonprofits, according to state disclosure reports.

Business groups that were not in on the deal had mixed reactions. For instance, the Massachusetts High Technology Council accused healthcare executives of cutting a deal to enhance their own revenues.

"It appears that the motivation, for certain segments of the healthcare industry, was all about increasing reimbursement," said Christopher Anderson, the council's president.

The US now depends on the managed care model to control health care costs. Managed care is expected to control costs by limiting utilization of services, and the prices paid for particular goods and services. Doing so effectively requires that managed care organizations stay at arm's length from providers and supplies.

Many physicians will attest that their relationships with managed care organizations are certainly at arm's length, if not downright hostile.

Yet this article documents a very cozy relationship between one state's dominant not-for-profit insurer and managed care organization, and its largest and most powerful hospital system.

So how likely is it that Blue Cross will really pressure Partners to reduce utilization or prices?

And if these two organizations are so comfortable, what other organizations that our pseudo-competitive health care system expects to be at arm's length are actually much cozier with each other? Once again, inquiring minds want to know.

A Price Hike for Nitrogen Mustard

The New York Times reported on the recent, staggering increase in the price of a very old chemotherapeutic drug, nitrogen mustard. The drug is used topically for the rare patients with cutaneous lymphoma. When it was manufactured and sold by Merck, the typical price, according to the Times, was $77.50 for a two-week supply.

But Merck sold the rights to nitrogen mustard to Ovation Pharmaceuticals. Ovation Pharmaceuticals' web-site states that the company's purpose is " Advancing medicines by developing, manufacturing, and marketing medically necessary branded pharmaceutical products that satisfy unmet medical needs." Another example of the products it supplies is Desoxyn, its brand of methamphetamine, which is indicated for attention deficit disorder with hyperactivity.

Merck still makes nitrogen mustard, but now Ovation markets it. According to the Times, as soon as Ovation took over sales of the drug, it raised its price to $548.01 for a two-week supply.

The Times noted that "the increases have caused doctors to question Ovation's motives...." The price increase was explained by Sean Nolan, Ovation vice president for commercial development, thus, "It's unfortunate that a price adjustment had to occur. Investment had not been made in these products for years." Yet, as per the Times, "he acknowledged that Merck still made Mustargen [nitrogen mustard] .... He said he was not sure when Ovation would begin producing the drugs, and a Merck spokesman said that Merck would continue to provide drugs to Ovation as long as necessary."

The Times noted that "industry executives increasingly point to intrinsic value of their medicine as justification for prices."

Why the intrinsic value of this 60 year old medication might have recently increased ten times is not obvious.

The Times also noted how drugs for cancer have recently become extremely expensive. For example, "most new cancer treatments are priced at $25,000 to $50,000 annually. In some cases, companies are pushing through price increases on already-expensive drugs. Last year, Genentech raised the price of Tarceva, a lung cancer drug, by about 30 percent, to $32,000 for a year's treatment."

The Times also noted "once a drug company sets a price, government agencies, private insurers have little choice but to pay it. The Food and Drug Administration does not regulate prices, and Medicare is banned from considering price in deciding whether to cover a drug. While private insurers can negotiate prices, they have limited leeway to exclude drugs from coverage based on price...."

I have two thoughts.

One is a hope that even if physicians have no direct power to challenge the pricing of this drug, they will remember how Ovation chose to price this drug when thinking about whether to prescribe another Ovation product.

The other is a question. Given that the whole rationale for managed care was controlling the costs of health care, why has it failed so miserably to control the costs of drugs? If, as the Times said, "private insurers can negotiate prices," why don't they? I suppose doing so may be difficult, given that much of pricing may be driven by Medicare, which is governed by an absurd, in my humble opinion, statutory prohibition of drug price negotiation. But why doesn't managed care at least try to negotiate down the most ridiculous drug price increases? Inquiring minds want to know.

Ironic Postscript: Yesterday, the Times also published an article suggesting that the nation's supply of ventilators (artificial respirators) will be woefully short if a bird-flu epidemic occurs. Meanwhile, MedPundit noted several stories about a global shortage of hospital beds. Perhaps if we paid more reasonable prices for drugs, there would be more money left over for basic health care.

At UMDNJ "The Rules of the Game Have Changed"

As auditors continue to investigate the finances of the University of Medicine and Dentistry of New Jersey (UMDNJ), new problems continue to surface.

We have posted extensively at the troubles at UMDNJ, which now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (most recently here).

The indefatigable reporters at the Newark Star-Ledger have revealed yet another problem, possiblly massive over-billing by UMDNJ of Medicare. " While auditors are still trying to determine the extent of the problem, the amount involved far exceeds the $4.9million in fraudulent billing outlined in a separate federal criminal complaint against UMDNJ in December." " The new billing problems were uncovered last week, as part of an examination of the annual cost reports submitted to the Centers for Medicare & Medicaid Services, according to two officials with direct knowledge of the investigation." "At issue were costs associated with the university's mental health division, University Behavioral HealthCare, and whether UMDNJ-University Hospital padded those costs with its own administrative expenses. If the federal cost reports were inflated, the hospital would be reimbursed at a higher rate than it is legally entitled to receive. The sources said the hospital may have submitted reports that funneled an additional $50million to $70million in unwarranted reimbursements."

Meanwhile, the Dean of one of UMDNJ's two medical schools, Dr Harold Paz, has resigned. His new job will be Senior Vice President for Health Affairs, Dean of the Medical School, and CEO of Hershey Medical Center at Pennsylvania State University. Thus both of UMDNJ's medical schools for the moment will be operating with acting deans.

Furthermore, UMDNJ's new interim president, Bruce C. Vladek, has come on board while putting all his constituents on notice that it will no longer be business as usual at UMDNJ:

People are all on notice that there is no tenure in the management structure of this organization. I feel empowered to restructure the administrative staff of this organization, subject to consultation and approval of the board, however I feel is necessary.
The rules of the game in this place have changed, and they haven't been changed by us. Even though the state is our lifeblood, we cannot, as a matter now of law, engage in some of the kinds of behaviors that have existed in the past. Some of the kinds of things that have (been) reported -- that may have become standard operating procedure in the past -- we cannot do anymore.

It sounds like he has the right idea, but will have a lot of work to do.

But he also noted,

As far as I know, the very, very real problems here are largely isolated from the educational, clinical and research activities of the university.

I do beg to differ somewhat with this. I am sure that UMDNJ has many dedicated professionals and faculty who have been working hard to keep the clinical and academic missions on track. Yet I am not sure how "isolated" they have been from the problems. It must have been demoralizing to work under the previous UMDNJ administration, which has now been revealed as scandal-ridden. I can only hope that their morale is improving now. Hopefully, the new leaders of UMDNJ will be worthy of their trust.

The case of UMDNJ should be a wake-up call for those who thought that business as usual was just a fine way to run the health care system. However, although this case, like that of UCI, has gotten plenty of local attention, it seems not to have been noticed outside of its region, nor in medical, health care, and health policy journals. As far as I can tell, the only place to see these cases juxtaposed is here on Health Care Renewal.

"UCI, Heal Thyself"

A Los Angeles Times editorial (entitled, "UCI, Heal Thyself"), called for the ouster of the Dean of the University of California - Irvine medical school in response to the ongoing difficulties at the institution. (We have posted frequently about UCI, most recently here.)

I will just quote from the editorial:

UC IRVINE SHOULD BE commended for moving quickly to investigate the many patient-care problems at its scandal-plagued medical center — and for getting rid of one of those responsible, Dr. Ralph Cygan, the former chief executive. But now the university must follow up with stronger measures to assure patients and taxpayers that this wayward hospital can still be saved. And the first essential step on the road to recovery is firing the medical school dean, Dr. Thomas C. Cesario.

Cesario has been in charge of the medical school during more than a decade of scandals at UCI Medical Center: the theft of patients' eggs and embryos, the illegal billing of patients for experimental drugs, the improper sale of cadavers, the liver transplant program that recruited new patients while turning down livers because it didn't have a doctor to transplant them. Need we go on?

The first few embarrassments might have been blamed on some rogue doctors, but when there is trouble in department after department, year after year, there's a systemic problem. Regardless of whether Cesario helped create this atmosphere or simply was too inept a manager to recognize and change it, he should no longer be in charge.

UCI Medical Center's managers were so busy thinking about how to make their teaching hospital the next UCLA or Stanford, they overlooked basic patient care. They were so intent on keeping up a good reputation, they ignored or punished whistle-blowers.

There seems to be growing public recognition of the problems of mismanagement of large health care organizations, at least at the local level.

It is still discouraging that this story has not receive much notice in the media outside of California (and as far as I can tell has received no notice in medical, health care, and health policy journals).

Outsourcing Health Care

A post by guest blogger Robert Wachter....

I wrote a couple of pieces in last month's (2/16) issue of the NEJM on the future of medical outsourcing. I had an epiphany after reading Friedman's "The World is Flat" this summer - namely, medicine has been uniquely insulated from globalization because of the physicality of the enterprise (we need to be in the room to examine the patient, read a paper chart, and, in the old days, look at a "film" (remember films). Now with digitalization, all that will rapidly change, as the computers de-tether us and make all kinds of things possible without physical presence.

The two camel's nose examples are international teleradiology (tonite, about 200 hospitals will have their ER CT scans read by radiologists sitting in another country) and e-ICUs (in which intensivists sit in front of monitors, watch patients on closed circuit televisions, follow streams of physiologic data, and sometimes even enter orders into the hospital's CPOE system). Today, the e-ICUs use domestic providers, but you can bet there will ultimately be international entrants to this market as well.

These are just the start - think robotic and laparoscopic surgery. I tried to depict the possible advantages and disadvantages of this model - it'l be your call how well I did. Like all kinds of globalization, the concerns center around ensuring quality (in addition to the domestic job loss); some of these concerns will be quite legitimate, and some will be protectionism in the garb of QA. In the accompanying podcast, the interviewer asked me several times, "how can we ensure quality when the docs are 5000 miles away?" My answer: "how can I ensure quality when my mom sees her doc in Boca Raton?"

Increasingly, quality assessment will be web enabled and involve real-time assessment of practice. Once this happens (and I don' minimize the challenges here), ensuring the quality of the provider in Bangalore may not be fundamentally more complex than doing the same for the one in Bangor.

One thing for sure: fasten your seat belts.

The Journal has made the articles freely available, even for non-subscribers: http://content.nejm.org/cgi/content/full/354/7/661
http://content.nejm.org/cgi/content/full/354/7/662
And the podcast: http://content.nejm.org/cgi/content/full/354/7/662/DC1

Consequences of SFBC International's Clinical Trials: 20 People Get Tuberculosis

We have posted before about the troubles of contract research firm SFBC International We started by posting about allegations that private, for-profit clinical research firms, including SFBC International, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that SFBC International had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices. Furthermore, we discussed how a review commissioned by the company found that a top executive, Jerry Seifer, SFBC International's Vice President for Legal Affairs, threatened participants in clinical studies who had talked to the press with deportation. Seifer, it turns out, had been the subject of past regulatory sanctions by federal regulators. In addition, study participants in a trial of an immunosuppressant drug carried out by the firm's Canadian subsidiary, SFBC Anapharm, acquired tuberculosis after exposure to another participant with active disease, despite their complaints to Anapharm staff. Most recently, we noted that Seifer had resigned, and the company's stock price had fallen.

There is an update on the human consequences of SFBC International's (mis)management of clinical trials. 20 people have contracted latent tuberculosis after being exposed to a patient with active TB during a trial of an immunosuppressant agent at SFBC International's SFBC Anapharm Canadian testing facility, according to CTV. Bloomberg News noted that 11 were employees of the company, while the remainder were patients in the study. CTV suggested that all would have to undergo nine months of therapy (presumably to suppress their latent TB and lower the likelihood it would become active in the future.) An investigation by Health Canada is ongoing. Bloomberg news could not get officials of SFBC International nor of Isotechnika, which made the trial drug, to comment.

CTV interviewed Professor Trudo Lemmens of the University of Toronto, who summed up the major issues.

The pharmaceutical industries want to have drugs on the market and they want to have them on the market quickly.
So they contract research organizations to do the human subject research for them. These companies are paid for the outcome, which is to have the trials done as quickly as possible, and so they have significant financial incentives to recruit human subjects and research them very quickly.

Lemmens also noted that commercial ethics board may not do a good job policing such trials.

While many may be doing a good job, it's possible in the current regulatory system to shop for the most convenient, the fastest and the perhaps most lenient research ethics boards which imposes the least restrictions on your clinical trial.

In response to this case he suggested,

The current Quebec situation underscores the need for the creation of a watchdog to oversee the industry, as well as stronger federal and provincial regulations to establish guidelines and requirements for research ethics boards, Lemmens said.

It sounds like parallel solutions are needed in other countries.

Sadly, this case provides yet another reminder about how skeptical we must be about much of the clinical research now going on that is financed, and now often performed and supervised by loosely regulated corporations. And that is coming from a proud supporter of evidence-based medicine who has long advocated for clinical research, and who put my money where my mouth is by signing up as a trial subject. This sort of story really hurts.

Complexity, Conflicts of Interest, and Cancer Doctors' Decisions About Chemotherapy

The New York Times recently reported on research suggesting the susceptibility of physicians to financial incentives. The research, and how it was reported, illustrate the complexity of untangling issues of conflict of interest affecting physicians and other health care decision makers.

To summarize, the Times reported on a study just published in Health Affairs that found "providers who were more generously reimbursed prescribed more costly chemotherapy regimens to metastatic breast, colorectal, and lung cancer patients." The Times noted that "unlike other physicians, cancer doctors can profit from the sale of chemotherapy drugs in a practice known as the chemotherapy concession." So, "while critics say this creates a potential conflict of interst among oncologists advising patients on treatment, the doctors have said that the profit is needed to pay the high cost of running their practices." The Times then quoted opposition to the notion that physicians' decisions were ruled by conflict of interest from an "executive" [actually, Interim Executive Vice President and CEO] of the American Society of Clinical Oncology, Dr Joseph S Bailes, who said words to the effect that "cancer doctor select treatments only on the basic of clinical evidence." The Times then interviewed the study's senior author, Professor Joseph P Newhouse of Harvard, who argued that "there is little evidence that one chemotherapy drug works better than another, [so] 'the physicians have more control over the agents chosen.'" Bailes countered that "there was clear clinical evidence about which drugs should be used even in advanced stages of the disease and that doctors recommend the most appropriate treatments." But Dr Craig C Earle, another study author, had the last word, arguing that "doctors, despite their insistence that their treatment decisions are based solely on what is best for the patient, are affected by payment policies and other financial influences, including gifts from drug companies...."

So what really is the message, that physicians make appropriate decisions based on the evidence, or that they are influenced by financial incentives, including gifts from drug companies? The Times reported the research results in the context of a tit-for-tat among the articles' authors and the ASCO CEO. By giving the authors more air time and the last word, the Times seemed to slightly favor their point of view.

To try to get a clearer fix on this, I did a quick review of the study itself. [Jacobson M et al. Does reimbursement influence chemotherapy treatment for cancer patients? Health Aff 2006; 25: 437-443. The link is here.]

This was a retrospective cohort study, apparently using physicians as units of analysis. Data was obtained from the Surveillance, Epidemiology and End Results (SEER) cancer registry, and Medicare administrative data. The costs of chemotherapy drugs physicians prescribed for patients with lung, breast, or gastrointestinal metastatic cancer were compared across physicians to the average chemotherapy reimbursements per drug received by the physicians, controlling for some characteristics of the patients seen by them in a fiendishly complex statistical analysis. Reimbursement was not correlated with the rate physicians employed chemotherapy, but was correlated with the Medicare spending per physician on chemotherapy.

So this was not an easy study for rapid critical review. My main concern is that the observational study design was susceptible to study biases. In particular, physicians who received higher reimbursement rates may also have had patient populations who differed, especially in terms of disease severity or patient preferences, from those who received lower rates. These differences, rather than differences in reimbursment rates, could have been the main reason they selected different treatments. The complexity of the analyses makes it harder to assess the study, especially given that their results were presented only in brief summary form.

Do cancer physicians make decisions about specific chemotherapy drugs for patients with metastatic disease based on the evidence and patient preferences, or on financial incentives? I am not sure that the study gives a clear answer (and was not designed to give an either or answer).

For what it's worth, my gut feeling is that most physicians try to make decisions based on evidence, on patients' characteristics and their preferences, but that it is hard not to be influenced by other factors, including financial incentives.

I should also note that the only financial incentives the study analyzed were Medicare reimbursement rates. Conflicts of interest, such as gifts by pharmaceutical firms to physicians, may affect their decisions, but this study was not designed to assess such conflicts. Hence Dr Earle's last comment may reflect his beliefs, and may be true, but does not follow from this single study's results.

Furthermore, just to further confuse the issues, it appears the study and its reporting may also have been affected by different kinds of conflicts of interest. The Health Affairs article does not mention any relevant conflicts of interests affecting the authors of the study. But Professor Newhouse, the senior author, has disclosed in other articles (for example, here) that he has a financial interest in Aetna, Inc, the large, for-profit managed care company (which, in turn, is likely interested in reducing physicians' utilization of expensive drugs). In fact, he is a member of Aetna's Board of Directors. (See Newhouse's most detailed biography on the Harvard web-site, confirmed on the Aetna web-site here.) Thus, he has a particularly strong conflict, since he has a fiduciary responsibility to protect the financial interests of Aetna Inc and its share-holders.

So maybe this is all another argument for what I have said before about conflicts of interest: I suggest developing 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.

60 Minutes Takes On Hospitals' High Prices for Uninsured Patients

There is an old joke in the US that involves completing the phrase "you know you're having a bad day when..." One popular completion is "... there is an interviewer from 60 Minutes knocking on your door." 60 Minutes has become the classic example of high-profile, prime-time investigative journalism.

Last week, 60 Minutes did a feature story on how hospitals attempt to collect huge payments from uninsured patients. This is not a new story for followers of Health Care Renewal. We last posted on it here and here. The gist is that many hospitals in the US, even not-for-profit and/or teaching hospitals whose missions explicitly include caring for the poor, often charge uninsured patients much higher fees than those they accept from insurers (and federal programs like Medicare) for the same services.

The 60 Minutes version focused on two cases. One was that of repairman Carlos Ferlini who fell off a roof, spent 16 days in St. Josephs Medical Center in Burbank, California, and was charged US $246,000. The Ferlini's went for help to KB Forbes, the leader of small not-for-profit, Consejo de Latinos Unidos, who has been protesting how hospitals deal with uninsured patients (see related post here). "Forbes found that, while St. Joseph's was billing Ferlini almost a quarter of a million dollars, it would accept just under $50,000 as full payment from an insurance company for the same treatment." St. Josephs eventually conceded that "Ferlini qualifies for the hospital's Charity Care Program, which would pay for his hospitalization." Note that St. Josephs is part of Providence Health Systems, a Catholic not-for-profit organization whose stated mission is: "Providence Health System continues the healing ministry of Jesus in the world of today, with special concern for those who are poor and vulnerable. Working with others in a spirit of loving service, we strive to meet the health needs of people as they journey through life." Providence Health System recently settled a case involving its aggressive charging of uninsured patients in Oregon.

The second case was Scott Starbuck, a computer consultant who was admitted to the University of Tennessee Medical Center for a mild, uncomplicated myocardial infarction (heart attack). For a three day admission, he was charged $41,000. Starbuck noted he was charged $19,000 just for the insertion of two coronary artery stents, whose manufacturer sold them for $2300 (which may not be a bargain, either). "Then the Starbucks learned that the charge from UT Medical Center for someone with insurance would be $13,800 [total for the admission] - about one-third of what Scott was billed." "The University of Tennessee Medical Center told 60 Minutes that 'patients who receive the same services are charged the same amounts.' That's true, but there's a catch: Federal law does require hospitals to charge every patient the same, whether they have insurance or not. But hospitals can accept different payments from different patients - and they do." UT Medical Center has only agreed so far to discount Starbuck's bill by 25%, according to 60 Minutes. Note that the UT Medical Center's web-site features a letter from its CEO, Joseph R. Landsman, stating, "I say we are totally committed to providing excellent patient-centered care and outstanding customer service to you—our patients—and your families." Furthermore, "But in this complex maze of medicine, we also want to provide a human touch—one filled with caring and compassion."

60 Minutes obtained response from Carmela Coyle, senior vice president for policy at the American Hospital Association, and from Sen. Charles Grassley, (R-Iowa), chairman of the US Senate Finance Committee.

Coyle: "Actually, what hospitals charge for a service is the same for everybody, whether they have insurance or not. What's confusing for everybody is that what a person ends up paying in this country can be very different."

Grassley: "From media reports, from advocate groups, from individuals, and from my own investigation, I think it's very, very widespread. It's an institutional bias against uninsured people. And it's something to be outraged about."

Coyle: "The Senator is very knowledgeable about health care issues. But what's going on is nothing of the sort. I'm saying that the face of what's going on in health care has changed dramatically, literally in the last year."

Grassley: "I've been told bthat they were going to do that. They've told me that. I haven't seen the changes I ought to see. But if I don't see it very, very soon, we'll probably be doing some legislating in that area."

Given that this issue has now attracted major media attention, and that Sen. Grassley is talking about legislation soon, perhaps we can expect some changes, and hopefully fairer pricing for those least able to pay.

In conclusion, what upsets me most about these stories (and similar stories we have addressed previously), is how the hospitals' conduct appears to contradict there stated missions. How can a not-for-profit organization square charging an uninsured patient several times what it accepts from an insurance company for particular services with a mission to help the poor or provide caring and compassion.

Yet another clinical IT controversy: UC Davis

In this article from the Sacramento Business Journal, it appears that the clinical IT efforts at UC are subject to the same types of problems as other areas at UC, as posted by Roy Poses for example here and here.

My comments in blue italic:

Med Center bonus typifies UC executive pay tiffhttp://msnbc.msn.com/id/11693923/
By Kathy Robertson
Sacramento Business Journal
Updated: 7:00 p.m. ET
March 5, 2006

The person in charge of setting up an electronic medical record system for the UC Davis Health System was paid a $42,100 bonus last year despite missed deadlines and other problems with the program.

The bonus came on top of Dr. Thomas Tinstman's base pay of $78,399 and negotiated salary of $205,397, for total compensation of $325,896 last year.
That is a surprising level of compensation for an "Associate Director of Clinical IT." As a Yale-trained medical informatics (clinical computing) specialist, I held a similar role (Director of Clinical IT) at a 1,100-bed regional medical center in the late 1990's, Christiana Care Health System, at a base of ~ $90,000 plus 10-15% bonus potential, which I believe is more standard for the health IT sector. Even At Merck & Co., Inc., running the scientific IT group and internal research libraries of Merck Research Labs, supporting R&D worldwide at the Director level, my base was ~ $125K just two years ago (I started at $111K in 2000) with 20-30% bonus potential in 2003, based on comps performed by Merck's HR team.
Academics often complain about inflated wages in the pharmaceutical sector...
Note that this critique is not about a person accepting a job at that salary level - one negotiates the best deal they can, of course - the issue is the UC system's offering such salaries and consultant contracts.
I should note that in 1996, when I was faculty in the Center for Medical Informatics at Yale School of Medicine, and offered a position as Director of Clinical Information Systems at Yale-New Haven Hospital (at $110K base, by the way) but also seeking industry opportunities in EMR, Cerner, and Tinstman in particular, would not even talk to me about a position. In the meantime, Cerner and Tinstman were discreetly negotiating a generous contract including relocation to the midwest with one of the postdocs I was helping to teach, an OB/GYN with significantly less IT expertise, for a position that sounded like a glorified sales role. (That person left Cerner after a few years.) While this type of behavior is not uncommon, it certainly did not instill confidence in vendors' views about the value of Medical Informatics.
This also brings to mind points about an earlier post on insights into industries that can be gleaned by who they won't hire.
The job performance and pay of one of UC Davis' top faculty members offers insight on how public money is spent on executive compensation at the University of California. The program is under attack by faculty and legislators following revelations late last year of high executive pay, job perks and severance payments.

... Internal documents show the [clinical IT] project -- with the final bill estimated to be anywhere from $75 million to $100 million -- is two years behind schedule and up to a fifth of the budget went to an outside consulting firm whose expense reports are now the subject of an internal UC audit.
Expenses include fitness club membership dues and use of a taxi by one consultant to visit her parent's home in Henderson, Nev.
75 to 100 million dollars for a clinical information system is concerning. That approaches the annual budget of the entire research IT division at a company like Merck. The fact that it is behind schedule may be due to issues I cover in my website "Sociotechnologic issues in clinical computing:Common examples of healthcare IT failure." I would like to hear more about end user reaction to the EMR implementation; while I may be wrong, it would not surpise me to hear about significant dissatisfaction. The issues in clinical IT implementations that are undergoing delays and cost overruns are somewhat predictable.
I am reminded of events at another set of California academic medical centers, the failed merger between Stanford & UCSF, "A thousand MIS personnel cannot merge two healthcare systems?"
... Tinstman, who is associate director for clinical information systems at the UC Davis Medical Center in Sacramento, collected a bonus of just under 15 percent of his total salary. His job is to replace paper patient charts with electronic ones that allow doctors to document care, enter orders, review results and send messages back and forth.
"I think my pay is in line with people who do my type of work and have my experience," Tinstman said. "In fact, it's low."
See my comments above. It might be low -- compared to, say, CIO's in major corporations.

...$14.4 million consultants: Deloitte Consulting Inc. was hired in 2002 to help get the program going. The firm billed UC at least $14.4 million over a period of three years, ending last June. "Deloitte was brought in because otherwise we would have had to hire a whole bunch of new people and then later say, 'You've been very nice but we don't need your services any more,' " Chason explained
I see. Spending millions of dollars that are just overflowing from the coffers at academic medical centers is more important than hiring people for a several-year contract and then laying them off (that too is in doubt, as the need for expansion, modernization, interative refinement, maintenance etc. never goes away, unlike the organizational knowledge gained by consultants when they leave). It's nice to be able to afford to be so polite, even if it does cost millions. I wish all industries were so polite. The norm seems to be mass layoffs without warning - except in the case of altruistic academic medical centers like UC Davis, with discretionary money for expensive consulting engagements seemingly pouring out of the woodwork.
To be blunt: for $14,000,000+ this medical center could have started an entire department of health IT implementation experts and funded them for a several years. I supported a staff of 50+ at Merck as well as purchased extremely expensive scientific and cheminformatic information assets - consuming perhaps three quarters of the budget - on an annual budget of under $13M.
In addition, if consultants were deemed necessary, Deloitte has a healthcare IT consultancy, but it is not their core focus as with other more specialized consultant groups.
... A whistleblower complained of irregularities in the expense reports last year.

It will be interesting to see what UC Davis received for the $14+ million.
This story is reminiscent of what I call the "corporate approach" to clinical IT. That is, implementation of clincial IT under the assumption that clinical IT is but a subspecies of Management Information System. Wrong. Clinical IT and business IT are two different subspecialties of IT. It is essential to have strong involvement in such projects by people who know well the hectic environment of a healthcare organization, where much of the complex labor and improvisation that keeps things running smoothly is hiding in plain sight. Consultants do not provide that level of intimacy.
Coming from a vendor environment (Tinstman was Senior Vice President and Chief Medical Officer at Cerner), it does not surprise me that the approach of using expensive consultants was adopted here. My motto on that issue is "it's absurd to believe that someone else knows your business better than you, and it's even more absurd to believe it's OK for someone else to know your business better than you."
I can only hope there were no back room deals or quid pro quo's related to previous contracts between Deloitte, Cerner, and/or Cerner clients that prompted someone to become a whistleblower. While certainly not making such an accusation, and having no such knowledge or contact with any of the principals, such an occurrence would not shock me. I am concerned since such a revelation would do further damage to the Healthcare IT industry. This technology really is beneficial - but only if done properly, and done well.
-- SS

Pheobe Putney Accuses Whistle-Blowers of "Terroristic" Faxes

A while back, we posted about Phoebe Putney Health Systems, a hospital system in Georgia. The story then was that hospital executives had rung up lavish travel expenses connected with a hospital malpractice insurance subsidiary located in the Cayman Islands. When an Atlanta Journal-Constitution reporter then asked asked Phoebe Putney Chief Financial Officer (CFO) Kerry Loudermilk about these expenses. Loudermilk first said what is lavish "is in the eye of the beholder." He responded to further questions about Grove Pointe, "We own it. We'll manage it the way we damn well want." At the time, I commented that although the hospital system may own its non-profit subsidiary, the hospital executives own neither, and are not entitled to run either any way they "damn well want."

Pheobe Putney is back in the news.

First, the system, using the power of eminent domain through its Hospital Authority, attempted to seize the house of an elderly woman so it could expand its employees' day-care center (see story on AccessNorthGA). The women challenged the system in court. A jury found that Pheobe Putney wanted the house, it would have to pay five times what it offered, plus moving expenses. Meanwhile, in response to this case, Georgia Governor Sonny Perdue is advocating a state constitutional amendment to restrict the use of eminent domain to seize property.

Second, the Atlanta Journal-Constitution reported on a convoluted story of what happened to some people who tried to blow the whistle on Phoebe Putney's financial practices.

It started with faxes called the "Phoebe Factoids," and headlined with the "Top 10 Most Highly Guarded Secrets at Pheobe," which were sent anonymously to a variety of recipients in 2003 and 2004.

As the Journal-Constitution put it, "Pheobe officials were infuriated. The hospital system, through an attorney, hired private investigators who were former FBI agents and aggressively hunted the identity of the faxers. The system's chief executive officer recently compared the fax campaign to terrorism. 'We live in a society that has plenty of terroristic activities,' with hospitals identified as potential targets, said Pheobe CEO Joel Wernick. When an organization is 'bombarded' with faxes, it has an obligation to find out where they're coming from, he said."

Pheobe Putney asked the Dougherty County District Attorney to investigate. DA Ken Hodges convened a grand jury which subpoenad telephone records, but then turned over the records to Pheobe Putney. Apparently based on these records, Pheobe Putney identified local accountant Charles Rehberg as author of the faxes. The Journal-Constitution reported that Pheobe Putney's private investigators then confronted Rehberg, "the investigators blocked his pickup, Rehberg said, and threatened him and his family."

Rehberg was helped by a local physician, Dr John Bagnato. The financial information they found lead them to believe that the hospital and others were "overcharging the uninsured and aggressively seeking payment - therby violating their charitable obligations as tax-exempt organizations." They ended up consulting for attorney Richard Scruggs' lawsuit against not-for-profit hospitals who allegedly overcharged poor patients.

The Grand Jury first indicted Bagnato and Rehberg on felony aggravated assault and burglary counts, as well as misdemeanor counts for making harassing phone calls. The burglary was allegedly at the home of physician James Hotz.

But irregularities cropped up. The Journal-Constitution found out that DA Hodges "received political contributions from Pheobe executives and others connected to Pheobe, and that his wife had been hired by Pheobe Putney Memorial Hospital." Futhermore, the newspaper got statements from people who said that "Hodges' office investigated the faxes case as a 'favor' to the hospital system." Hodges denied connections "between the campaign contributions, his wife's job, and his subpeona actions. And he defended his practice of sharing information." But then "Albany media reported that a bill for the phone records was sent by Hodges' office to a law firm that represents Pheobe." Rehberg's attorney then charged that "Pheobe is financing part of the prosecution."
Furthermore, thew newspaper found out that "there was no police or law enforcement report of a burglary or assault at that [Hotz's] residence.... And the indictment listed no date for the burglary or assault." After Hodges recused himself from the case due to allegations above, Houston County DA Kelly Burke got a new indictment which omitted the felony charges.

Obviously, much of the above consists of charges and counter-charges, none of which have been tested in court. Yet I would submit that at best, the managers of Pheobe Putney Health Systems have used a heavy-handed approach that is ill-suited to its role as non-profit health care provider whose stated core values include "people come first," and "relationships are built on honesty and integrity." Accusing people who sent faxes about financial data of terrorism? Sending ex-FBI agents to investigate the faxes? Paying the District Attorney for records obtained by a Grand Jury?

To repeat, Pheobe Putney managers should be running the organization in accord with its mission to benefit the public, which may not necessarily be the way they "damn well want."

No Human Touch

I approach commenting on developments outside of the US with some trepidation, but here goes...

A story carried by the Times (UK) noted there has been a drastic overhaul of how physicians will be selected for post-graduate hospital training positions (internship and house officer positions, or internship and residency, in the US terminology). A new system, called Modernising Medical Careers (MMC), requires that after applicants submit their usual application and CV (curriculum vitae), they must fill out an on-line form, divided into six sections each requiring two answers of 75 words each. The applicant must discuss his or her educational achievements, how well he or she "matches the General Medical Council's Principles of Good Medical Practice, his or her leadership qualities and abilities to participate in teamwork."

Points will be assigned to each answer by a panel. There will be no attempt to check the accuracy of any answer. Based on the points assigned an applicant, "a computer is used to match applicants with jobs." Applicants will not be interviewed.

This new system provoked a letter written to the Times, signed by 84 academic leaders. The letter stated, "under this plan, our house officers, now known as 'foundation trainees', are being selected anonymously by computer rather than by interview." The letter noted that under the new system, 660 of 6035 UK graduates have not been accepted into a training position. Thus, "our students are understandably bitter, angry, demoralised and confused by a process that has been implemented without adequate consultation and without regard to pleas from the medical profession to continue interviews to select candidates for training." Furthermore, "it is difficult to identify the logic behind MMC." It warned, "despite the obvious failure of this year's selection process, the Department of Health is steaming ahead to procure a new IT system which will be used to select foundation trainees, perhaps wasting 8 million [pounds sterling] of public money."

An accompanying editorial asked, "how can adjudicators possibly assess individuals' character and potential without coming face to face with them?" In addition, "so long as adjudicators are selecting blind, students can massage their answers and attempt to manipulate the system. For instance, applicants simply have to tick a box stating that their spoken English is good enough to communicate with patients and colleagues on medical issues." The results have been, "bright and well-qualified applicants are finding themselves without a berth. At the same time, hospitals have reported a worrying number of trainees turning up for duty with an inadequate command of English or with substandard skills."

Commenting with trepidation.... As the Times editorial noted, it is rather hard to assess an applicants' clinical communication skills just by reading their responses to a web-based form. I have interviewed quite a few internship applicants, so I recognize that it is hard to distinguish among many well-qualified applicants. I value the interview, however, because it does allow me to identify the occaisional candidate who has severe difficulties interacting or communicating with other human beings. Abolishing interviews, in my humble opinion, certainly risks rating candidates by their "ability to talk a good story," as the Times news article put it.

It seems that UK managers have the same fascination with computers that US managers and executives have. It seems so easy and rational to take creaky, human based operations and streamline them by basing them on the web. This removes the need to deal with people directly, and their pesky individual characteristics. It fits with the ideas popular in the 1980s that to improve health care, rational managers had to take over from all too human physicians. But replacing human judgments with computer programs may produce a system that does not respond to human needs.

CMA Journal Slides Down Razor Blade

The Saturday, 4 March '06 Toronto Globe and Mail tells of recent difficulties at the once-venerable Canadian Medical Association Journal.

Not a pretty sight, but one that readers of this blog -- and folks like Dr. Jerry Kassirer, CMAJ ed board member and formerly editor of the New England Journal -- have become sadly inured to.

The bare facts of the controversy are difficult to fully capture here. Apparently, according to journalist Gloria Galloway's Globe and Mail piece, the publisher, one Mr. Graham Morris, fired the editor, Dr. John Hoey, for committing the sin of editorial freedom: scheduling an editorial that looked into certain pharmacists' alleged practice of grilling women seeking the morning-after pill.

Apparently the pharmacists' organization was sufficiently unhappy about the piece (and how did they know about it?) to pressure the publisher for withdrawal. And apparently he acceded. Then, another issue erupted, over practice-privatization, and a critical piece from the editors was overlain by another, less critical one.

It became a trifecta, finally, when the new Acting Editor, Stephen Choi, felt compelled to resign in protest over the Association's rejection of "an editorial governance plan that called for the CMA to accept the independence of the editor-in-chief."

There are lots of ways to read this controversy, and it's best to keep our powder dry until we learn more. But that last step in the trifecta, the CMA's refusal to assure editorial autonomy, may in some ways amount to the likely key in understanding what's going on. A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar. To quote the late great Jack Webb: "The story you are about to see is true; the names have been changed to protect the innocent."

Data on Drug Adverse Effects Delayed: Is It Data Denied?

In an annual report by the US Food and Drug Administration (FDA), the agency admitted that about two-thirds of the post-marketing drug studies it had mandated have never been finished. (See articles in the New York Times, and from the Associated Press.) According to the Times, one such study was mandated in 1955.

In the Times, US Representative Maurice D. Hinchey (Democrat- New York), "said while the agency insisted that it demanded that drug makers prove their medication safe, those demands 'continue to be blatantly ignored by the pharmaceutical industry.'"

In reply, Dr John Jenkins, director of the FDA Office of New Drugs, "emphasized that only 5 percent of promised drug trials were officially considered 'delayed.' In many cases, trials have been pending for more than a decdade but are not considered delayed because the agency never insisted on a specific timeline for them."

The AP quoted Harvard Professor Jerry Avorn, "This new information is an embarassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet"

Demanding post-marketing studies to assess drug safety appears to be a compromise that the agency offered in the face of demands from patient advocacy groups and political conservatives that the agency approve potentially beneficial drugs more quickly, based on relatively limited data from small randomized controlled trials.

I agree that potentially beneficial drugs should be put on the market as soon as possible with the least red-tape. Randomized controlled trials that have adequate statistical power to determine if a drug has benefits when compared to a placebo may not have enough power to determine all its important adverse effects. Thus it may make sense, when a drug offers important benefits beyond any treatment currently available, to allow it on the market without complete safety information, and then to require post-marketing studies, with more statistical power (but perhaps also with more methodologic biases) to assess its adverse effects. But patients and physicians need to know about the all important possible hazards of potentially beneficial medicines to make optimal decisions about whether to use them. So it is crucial that these post-marketing studies get done as quickly as possible.

I don't understand why the FDA has been mandating these studies, but not mandating any deadlines for their completion. Patients and physicians are ill-served by delays (whether officialy defined or not) in accomplishing these studies.

If pharmaceutical companies really want to increase their trustworthiness to patients and physicians, they ought to consider completing all pending post-marketing studies expeditiously. And in my humble opinion, the FDA needs to hold pharmaceutical companies accountable for their failure to complete such studies in reasonable amounts of time.

More About Guidant: "It Is Possible That Physicians and Others May Pull On These Threads"

The New York Times is continuing to investigate the operations of Guidant Corporation. We have previously posted quite a bit about Guidant in the past, focussed on its history of withholding information about possible adverse effects of its devices. (For our more recent posts, go here, here, here, and here.)

The Times' most recent article focuses on newly released documents from an ongoing court case against Guidant. Some key quotes:

As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible.
But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis.
The company's crisis started last May after two doctors in Minneapolis, Dr. Robert G. Hauser and Dr. Barry J. Maron, learned from Guidant executives that an electrical flaw in a company defibrillator had played a role in the death two months earlier of a college student who was their patient. They urged the company to alert doctors about the potential of the device, the Prizm 2 DR, to short-circuit. When Guidant hesitated, they contacted some other doctors and The Times.
Mr. [R. Frederick] McCoy [Jr., President, Cardiac Rhythm Management] struck an upbeat rallying tone in many of his messages. After The Times article about the Prizm 2 DR appeared, Mr. McCoy jotted on a note pad: 'Positive proactive visible,' summing up the company's strategy. In another note, seemingly dismissing the problem, he wrote, 'Nobody calling our decision and action into question.'
But even as Guidant was assuring doctors that it did not plan to recall the device, executives inside the company were less sanguine. On June 2, for example, Dr. Beverly H. Lorell, Guidant's chief medical officer, sent an e-mail message to Mr. McCoy about other company devices that might attract outside scrutiny. Some data about them, she noted, was in a public F.D.A. database.
'Parts of the data for each of the three trends are in public domain and thus amenable to further external scrutiny and discussion,' Dr. Lorell wrote. 'It is possible that physicians and others may pull on these threads in the near future.'
As those threads began to unravel, executives like Mr. McCoy soon found themselves backtracking.
Strikingly, some Guidant executives realized early, according to records, that the crisis might be contained if the company overhauled its disclosure practices and provided doctors with more detailed failure data. But a draft press release, dated June 3, shows that Guidant planned to combine the announcement of such a policy change with a marketing initiative to promote a new product. The release apparently never went out, and five months passed before Guidant issued its new and detailed report on product failures.

It is striking that although some Guidant managers thought that a transparent approach to releasing data about possible product flaws might be best for the company, those in charge circled the wagons.

To make important medical decisions, like those about implanting cardiac devices, patients and physicians need accurate, unbiased data about the possible benefits and harms. Withholding data about the possible harms caused by devices is bad for patients, a threat to physicians' professionalism. And ultimately, it appears to be bad for device makers' bottom lines. (The Times article noted that Guidant's market share for cardiac devices has fallen from 35 percent to 24 percent.)

So, instead of tying up all the threads in secret cloths, health care organizational leaders need to pull on them themselves.

News Flash: Procter and Gamble to Let Researchers See Their Own Data

We have posted frequently, (most recently here) 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.

According to the (UK) Guardian, P&G has made a major concession, "last week [it] confirmed it had written a 'bill of rights' setting out the rights of researchers to have access to all the data relevant to their work, so that they can 'confirm the accuracy of statements and conclusions published with them as co-authors.'"

Pending the reading of the actual "bill of rights," this appears to be a step in the right direction.

Of course, that researchers should be allowed access to data from their own research product, and that they should be able to affirm the accuracy of papers that they have authored seems to be a complete no-brainer. That it is news that a pharmaceutical company has put such statements in writing says something about how low much of clinical research has sunk. That universities, medical schools, and academic medical centers have signed contracts with corporate research sponsors to permit the corporations to control the research data produced by faculty "investigators," and how the data is reported is a scandal. (See systematic evidence provided by the Mello study, and post here).)

Let's see if any other companies are brave enough to follow Procter and Gamble's good example. Let's see if any academic leaders will be emboldened to defend the academic integrity of their own faculty.