Pay for Malfeasance?

"Pay for Performance" (P4P) is the current fashion in health care management. It is claimed that P4P will improve quality and reduce costs. The burden of most P4P efforts falls squarely on physicians, especially primary care and other "cognitive" physicians, groups who are already faltering under considerable external stress. We most recently posted about P4P here, here and here.

Yet although "pay for performance" is an attractive concept, all things being equal, it hardly reflects how things work in the rest of the global >$2 trillion health care system.

Take, for example, the recent case of Schering-Plough (see our post here). The drug company just settled civil and criminal charges for about $435 million. Yesterday, the Wall Street Journal provided some additional coverage (here, but requires subscription).

According to the Journal, penalties in the recent settlement were divided. "Schering-Plough, of Kenilworth, N.J., will pay $255 million to settle related civil accusations. Its Schering Sales unit will pay a $180 million criminal fine." In addition, "Schering Sales agreed to plead guilty to one count of criminal conspiracy for making false statements regarding its price for Claritin as negotiated with a health plan and for lying to the Food and Drug Administration about its promotion of Temodar and Intron A. Except for that plea, Schering-Plough neither admitted or denied other wrongdoing alleged in the settlement." So, "'With this agreement, we are putting issues from the past behind us,' Brent Saunders, senior vice president of global compliance and business practices, said in a statement." The Journal noted, "A company's criminal conviction or guilty plea can often be fatal. But in its health-care cases, the government has repeatedly reached settlements that exact a guilty plea while avoiding the direst consequences. The guilty plea from Schering Sales means it can no longer sell drugs to the government, but its marketing functions have been taken over by other parts of the company, which are permitted to continue doing business with Medicaid and Medicare. Schering Sales 'is an entity whose sole purpose is to plead guilty in these matters,' said Mr. Saunders. 'Schering-Plough takes responsibility for the actions of the past while not putting patients in a position where they can't get important medications,' he said.

I certainly understand the public's interest in continuing the production of beneficial pharmaceuticals. But what is striking about this case is that no individual at Schering-Plough took responsibility for the company's admittedly criminal conduct.

A search revealed that the former CEO of the company, Richard Jay Kogan, did retire early in 2002 after a variety of allegations about the company's conduct surfaced. But as far as I can tell, he paid no other penalty, presumably getting to keep all his retirement benefits, stock options, etc. After Kogan left, the new CEO, Fred Hassan, made many management changes, so presumably other top managers retired early, or were even fired. However, I could find no record of anyone paying a clear penalty for the company's admitted criminal behavior, or for the losses that it incurred due to that behavior. Of course, it's possible that relevant law-suits are pending.

Some commentators have said that executive pay has gotten so ridiculous, and has so little relationship to any measure of performance, that it should be called "pay for pulse." (For example, see this commentary on the "5 lousy CEOs who got fabulous pay," including one famous pharmaceutical company CEO.)

So what would you call the failure of companies to apply negative incentives to executives who have presided over criminal behavior: "pay for perpetration?" "Pay for malfeasance?" I'll take some suggestions.

I am aghast at the hypocrisy that touts pay for performance for primary care doctors as a solution to all our problems, while silence reigns about pay for malfeasance by health care executives.

WHAT YOU CAN DO? - If you own stock in a public for-profit health care company that has recently admitted to misconduct or has had to make a huge financial settlement in response to civil litigation (see the Health Care Renewal archives for examples), demand changes in your company's governance such that negative incentives apply to the leaders responsible for these problems.

If you are a physician, demand that P4P must apply to the whole health care system if it is to apply to physicians.

And maybe everyone should write their congresspeople demanding better regulation of the leaders of health care organizations, at least sufficient to hold people responsible for their worst decisions.

"Money-Driven Medicine"

I don't get to do a lot of book reviews, possibly because I don't have a lot of time to read whole books. However, I have just finished one book that may be of particular interest to people interested about threats to physicians' core values, especially from concentration and abuse of power.

Money-Driven Medicine by Maggie Mahar (New York: HarperCollins, 2006) takes a broad look at what has gone wrong in US health care. Especially good are its sections on:

• The History from the Beginning of Medicare Through the 1990s - Mahar briskly starts with the background of Medicare, providing some important insights along the way. Of particular interest was how the AMA was originally equally opposed to "socialized medicine," and "corporate medicine." The organization, however, used up most of its political capital fighting the former, and hence was unable to resist the latter. Another fascinating tale was how commercial managed care arose (or was perverted?) from the original not-for-profit model, perhaps inadvertantly fueled by the demise of federal money that only went to not-for-profit HMOs.
• For-Profit Hospitals: the National Medical Enterprises Case - Mahar gives a detailed history of the case of National Medical Enterprises, a large, for-profit hospital chain that specialized in psychiatric hospitals and substance abuse facilities in the 1990s. NME was charged not only with run of the mill offenses like over-billing, but more exotic ones like kidnapping patients. NME eventually settled with federal authorities in 1994 for $379 million, and plead guilty to a variety of charges. Of course, no one went to jail, and the CEO walked away with a golden parachute. Thus, this case looked like the perfect precursor to newer cases discussed on Health Care Renewal. More striking, and what I hadn't realized, was that NME did not disappear. It didn't either go out of business or get swallowed up by some larger company. It simply changed its name - to Tenet Health, a company which has not been featured positively on this blog, and which seemed to repeat, in a broad sense, all the mistakes it had made before under a different name.
• Medical Devices: the Johnson & Johnson Charite Spinal Disc Case - Mahar again demonstrated that those ignorant of history are doomed to repeat it by narrating the more recent case of J&Js Charite spinal disc prosthesis.

Other chapters deal with the cost of competition, the hazards of over- and under-treatment, and the issues of quality, all worth reading.
In my opinion, the book's biggest weakness is its failure to dig into the causes of what it repeatedly identified as a fundamental problem, the irrational reimbursement system. However, given all that the book does address, that is a quibble.
In summary, Money-Driven Medicine provides vital background, clearly narrated, and should provoke a lot of thought about how we got ourselves into this mess, and maybe about how to get out of it.

After Revelations of Undisclosed Conflicts of Interest, a Journal Editor Steps Down

In July, we briefly posted about several cases in which articles published in prominent journals were discovered to have been written by authors who had relevant, but undisclosed conflicts of interest. One of those cases we summarized thus:

• An article was published in Neuropyschopharmacology in July about vagus nerve stimulation as a treatment for depression [Nemeroff CB, Mayberg HS, Krahl SE. VNS therapy in treatment-resistant depression: clinical evidence and neurobiological mechanisms. Neuropsychopharmacology 2006; 31, 1345–1355.] The Wall Street Journal discovered that eight of the article's nine authors had financial ties to Cyberonics Inc, the manufacturer of the device. The ninth author is an employee of the company, which was disclosed." (See previous post on Cyberonics here.)

In August, Bernard Carroll posted in more detail. He noted that the case involved more than the failure to disclose possible conflicts of interest, but also that one of the authors of the first draft the article was a hired writer, whose role was not fully disclosed; that "the review carefully followed the corporation's marketing message and branding language"; and that Cyberonics produced a press release touting VNS therapy featuring Nemeroff, but without revealing his financial relationships with the company.

Now the Wall Street Journal, and The Scientist reported that Nemeroff, who not only wrote the article in question, but was the Editor of Neuropsychopharmacology, will be stepping down from that role in December, "in part, based on the recent adverse publicity to the journal and the ANCP [American College of Neuropsychopharmacology]."

The Scientist also noted that "This isn't the first time that Nemeroff has hit the headlines for undisclosed financial ties. In 2003, a review he coauthored in Nature Neuroscience neglected to mention significant financial interests in three therapies that were reviewed favorably (including owning the patent on one of the treatments), prompting the Nature Publishing Group to widen its disclosure policies."

The Scientist quoted Clare Stanford, past President of the British Association for Psychopharmacology, "I don't believe for a minute that the fact the paper was funded by a company would have influenced his conclusions. It is unfortunate that he has had to stand down over this incident which is largely a reflection of the scientific community's paranoia rather than any failing of his professional integrity."

Is this all paranoia? We should note that cognitive psychological research suggests that even small gifts affect peoples' cognition. Research to this effect was one motivation for a widely publicized call for physicians to reject even gifts like pens and coffee mugs (see post here). If such small gifts to practicing physicians are so worrisome, what about more substantial conflicts affecting clinical researchers, or medical journals? Of course, the effects of conflicts of interest on judgments and decisions are often unconscious, so that those with conflicts really do believe that these conflicts do not affect them, perhaps explaining some of the resistance to even disclose conflicts. (See a summary from the Wall Street Journal via the Pittsburgh Post-Gazette.)

However, research summarized by Carl Elliott in the Journal of General Internal Medicine (see post here) suggested that disclosure is not the answer, and may make things worse. More cognitive psychological research suggested that people discount the amount of bias caused by conflicts of interest, and that disclosure may cause those with conflicts to be even more biased. Thus Elliot wrote, "the solution to the bias created by conflict of interest is not simply to disclose the conflict, which makes bias even worse. Rather, the solution is to eliminate the financial conflicts."

Amen.

Sometimes There Are Consequences

A depressingly large number of the posts on Health Care Renewal deal with cases of mismanagement, conflicts of interest, and even corruption that infrequently seem to result in proportional consequences to those responsible.

There have been a few recent exceptions, to a degree.

UnitedHealth Foray Into Running British GP Practices Blocked

We had previously posted about attempts by UnitedHealth in the UK to take over practices formally run by local GPs. These attempts seemed to be facilitated by bureaucratic bidding requirements that emphasized being able to produce reams of business-speak more than ability to deliver good patient care.

The Times (UK) just reported that the High Court has now blocked one of these attempts, the same one used as an example in our post. The Court found that the Primary Care Trust (PCT) which put the contract out for bid "had a duty to consult [with the local community] and they did not properly perform it." The PCT now must again put the contract out for bid.

"Naturopathic Physician" To Go To Jail

We had previously posted (here and here) about a local "naturopathic physician," who claimed to be able to treat a variety of conditions, including ones as serious as metastatic cancer, with harmless and effective natural treatments. Curran purported to do "live blood analyses," which lead to diagnoses of such things as "parasites" in the blood.

The Providence Journal just reported that Curran will be going to jail for 12 1/2 years. The judge said that Curran was "not your run of the mill scam artist," but "the worst of the worst," who "scared the living daylights out of people." At the trial, it turned out that not one of approximately 300 people who had the "live blood analysis" was given a clean bill of health.

Scrushy Must Re-Pay His Bonuses

Although former HealthSouth CEO Richard Scrushy was acquitted of federal fraud charges, we previously posted about his conviction by a state court for bribery, conspiracy, and mail fraud. Now the Associated Press has reported that Scrushy must also re-pay $47.8 million in bonuses he received from the company during years when the company was actually losing more than $400 million. The judge said, "without annual net income, Scrushy could not have had the opportunity to earn the target bonuses."

Summary

In my humble opinion, we need to restructure the health care system so that there are negative incentives for bad behavior, and that these incentives are proportional to the badness of the behavior. Individual health care professionals are subject to strict licensing requirements and can be sanctioned by state boards in the US for behavior that is short of criminal. However, the leaders of the biggest health care organizations can often walk off with golden parachutes even after egregious behavior, save for those few who end up with criminal convictions. Somehow, we need to ensure that there are big negative incentives for health care leaders, like Scrushy, who put lining their own pockets ahead of fulfilling their organizations' missions.

Schering-Plough Settles, Again, Again

'Tis the season to settle, so it seems...

Multiple media sources just reported that Schering-Plough has settled civil and criminal charges. Representative coverage is by the Boston Globe, and AP via the Houton Chronicle. The essence, quoted from the AP, follows:

Schering-Plough Corp. on Tuesday agreed to pay $435 million and plead guilty to conspiracy to settle a federal investigation into marketing of its drugs for unapproved uses and overcharging Medicaid for certain drugs.

Kenilworth, N.J.-based Schering-Plough said it will pay $255 million to resolve civil aspects of the previously disclosed investigation. A subsidiary, Schering Sales Corp., will pay a criminal fine of $180 million and plead guilty to one count of conspiracy to make false statements to the government. The agreement is subject to court approval.

Schering-Plough said the settlement resolves an investigation by the U.S. Department of Justice and the U.S. Attorney's Office in Boston that began before a new management team took over at the company in April 2003.

'With this agreement, we are putting issues from the past behind us,' said Brent Saunders, senior vice president for compliance and business practices.

The agreement comes two years after Schering-Plough agreed to pay $346 million to settle charges that it paid a kickback to a big health insurer to protect the market for its allergy drug, Claritin.

U.S. Attorney Michael Sullivan, who announced Tuesday's settlement in a news conference in Boston, said health care corruption 'erodes public confidence, compromises the patient/physician relationship and adds costs to important government programs.'

Investigators found evidence that Schering-Plough marketed drugs for so-called 'off-label' uses.... One such drug was Temodar, which the Food & Drug Administration in 1999 approved to treat anaplastic astrocytoma, a type of brain tumor, in patients who hadn't responded to other drug regimens. Sullivan said Schering promoted the drug to treat several other types of brain cancers and cancer that spread to the brain from elsewhere, which the FDA had not approved.

Saunders said the company has agreed to plead guilty to making false statements in marketing Temodar, related to its sales people promoting the drug to doctors for uses other than the approved one.

Investigators said they also found evidence of unapproved promotion of Intron A for the treatment of cancer on the surface of the bladder.

Drug manufacturers are required to report their best price on drugs provided to commercial customers, including HMOs, to the Health Care Financing Administration and to pay rebates to the Medicaid program to make sure Medicaid obtains the benefit of that low price.

Prosecutors said that from April 1998 through 1999, Schering Sales reported a false best price to HCFA to avoid paying millions of dollars in additional rebates to Medicaid.

The investigation also found evidence of pricing manipulation involving K-Dur, used to treat stomach conditions.

Notet that this was the second biggest settlement by Schering-Plough in two years. According to the Globe, it was the third big settlement in five years. The total that the company will pay out from all will be "about $1.3 billion."

It all is becoming so familiar, almost wearisome, yet the questions remain. Why do the mainly monetary penalties seem mainly to come out of the hides of stock-holders and consumers, rather than the people who actually made the decisions that lead to the offenses? And after all the indictments, prosecutions, settlements, and convictions involving large health care organizations, when will academics, policy makers and politicians, much less company CEOs and other organizational leaders admit we have a systematic problem here?

St Barnabas Settles

The New York Times reported on how yet another hospital system has settled federal charges that it over-billed Medicare.

The system in question is the St Barnabas Health Care System in New Jersey. According to the Times, the background is:

The problems began a decade ago, when hospital administrators around the country —facing cuts in reimbursements from managed care companies — turned to a handful of accounting firms that promised to help them maximize their financing from Medicare, the nation’s health insurance program for the elderly.

By exploiting loopholes in the complex formula that Medicare uses to reimburse providers for their most expensive cases, known as outliers, many hospitals’ federal aid doubled, quadrupled or increased 10 times.

As recently as the early 1990’s, St. Barnabas — which was named after a martyr who sold his possessions to help the poor, but is not run by the Roman Catholic Church — operated with a low-key business approach usually found at institutions that are licensed as nonprofit.

Faced with pressure from managed care insurance plans and the prospect of federal health care reform, the system’s chief executive, Ronald J. Del Mauro, voiced determination to firm up St. Barnabas’s financial stability. He preached a strict devotion to the bottom line and engineered a bold set of mergers and acquisitions.

The Times then described the allegations about how the hospital system inflated its Medicare billing.

According to depositions by a St. Barnabas consultant and two former employees, which were filed in the settlement, the drive for profits soon affected the Medicare billing, and hospital administrators found a way to capitalize on a loophole in the formula Medicare used to determine reimbursements in outlier cases.

One part of the equation was based on a hospital’s retail charges: the amount paid by the small percentage of patients who do not have insurance. By rapidly increasing retail charges for procedures often covered by Medicare, St. Barnabas got a steep increase in federal aid. As a result, its Medicare payments for outlier cases jumped to $287 million in 2002 from $85 million in 1998.

A consultant hired to work with St. Barnabas said in a sworn deposition that the hospital’s top executives held meetings to plan a “corporate directive” to increase federal aid by raising the prices charged to Medicare patients. The consultant, James T. Monahan, said that St. Barnabas had routinely added hidden charges to the room-and-board fees of Medicare patients and tried to conceal the windfall profits it was receiving from Medicare, in part by overstating its debt.

Mr. Monahan, who later filed a whistle-blower complaint under which he stands to gain millions of dollars from the legal settlement, declined to be interviewed for this article.

In settling the government's charges, the St Barnabas system admitted no guilt. "Ellen Greene, a spokeswoman for St. Barnabas, described the situation as the result of a misinterpretation of Medicare’s complex rules." Although federal prosecutors originally contended that the system over-charged Medicare by "at least $630 million from 1995 to 2003," the settlement requires payments of only $265 million. The prosecutors did not demand more apparently because they feared "a harsher fine might run the St. Barnabas health system out of business."

Legal actions in this case are apparently not over.

Two people who had been questioned by Justice Department investigators said they had been asked for documentation on how Mr. Del Mauro and two other top administrators at St. Barnabas are paid.

Mr. Del Mauro gets no compensation from St. Barnabas Hospital Center, according to its public filings, but he and two other senior administrators are paid officers of SBC Management, a profit-making company that does business with the hospital center. That sort of arrangement is common in the hospital industry.

In 1998, Mr. Del Mauro received $613,000 from SBC, according to documents on file with the I.R.S. His compensation was $4.7 million in 2003, the last year St. Barnabas received the huge Medicare overpayments. In 2004, it was $4.2 million.

On one hand, this case is a reminder that the excessively complicated Medicare reimbursement rules make disputes over payments more likely, and make it easier for hospitals (and physicians) to find loop-holes.

On the other hand, it is a reminder about how previously staid, low-key not-for-profit hospitals began to look and act more like "go go" for-profits, partially because they faced seemingly formidable competition from go go for-profit hospital chains. And as the character of not-for-profits changed, the actions of their leaders changed, possibly in response to their suddenly enlarging incentives, such as the six-fold plus increase from 1998 to 2004 in the St Barnabas' CEO's salary.

Yet the effect of such changes in corporate culture on health care costs seem to be overlooked. And although everyone seems to wonder why health care costs seem to continually rise, no one seems to want to discuss the somewhat understandable resistance of highly-paid people to any decreases in their standard of living?

The Post-Modernist View: Evidence-Based Medicine as Fascism?

As many of you realize, I am an advocate of evidence-based medicine (EBM), roughly defined as medicine based on critical review of the best availalble evidence from clinical research, combined with clinical judgment, knowledge of biology, and patients' values and preferences. (See also: "Evidence-Based Medicine: What It Is and What It Isn't" from the 1996 British Medical Journal for a better explanation.)

Some of us who advocate EBM see it as an antidote to health care based on dogma, ideology, or commercial interest.

Unfortunately, although EBM has generated a lot of enthuisiasm among its advocates, it has been a hard sell in the larger health care world. I have always suspected one reason for this is that EBM potentially challenges ideas, programs, and products in which people believe, or in which people have vested interests. If you really believe gizmo X works, or if you make a lot of money selling gizmo X, you may not be enthused about a rigorous review of the evidence that suggests that maybe gizmo X doesn't work so well.

In any case, by 2002, only about one-third of US and Canadian internal medicine residencies included any time for EBM (Hatala R, Guyatt G. Evaluating the teaching of evidence-based medicine. JAMA 2002; 288: 1110-1111.) In 2004, "now most medical programmes in the United States attempt to teach EBM, although few succeed...." ( Del Mar C, Glasziou P, Mayer D. Teaching evidence based medicine: should be integrated into current clinical scenarios. Brit Med J 2004; 329: 989-990.)

Thus my jaw dropped when I saw an article entitled "Deconstructing the evidence-based discourse in health sciences: truth, power and fascism." (Full citation: Holmes D, Murray SJ, Perron A, Rail G. Deconstructing the evidence-based discourse in health sciences: truth, power and fascism. Int J Evid Based Healthc 2006; 4: 180-186.) This article has already created quite a bit of buzz among those who are skeptical about post-modernism, and those who advocate for EBM, i.e., people like me.

The paper is written in the usual turgid post-modernist style, with all the expected bowing and scraping to Foucault, Derrida, Lyotard, Deleuze, Guttari, etc, the tortured sentence structures, and the obscure ("interpellated"), and sometimes apparently made-up words ("hysterisation").

The paper includes some almost hilarious accusations. As noted above, providing effective teaching of EBM in medical schools and post-graduate medical education has been difficult. In medical schools that I have seen, EBM advocates are a minority, sometimes embattled. Yet Holmes et al accuse EBM of being so powerful that "in a number of faculties of health sciences ... the dominant paradigm of EBHS [evidence-based health science] has achieved hegemony." Moreover, according to Holmes et al,

Rather than risk being alienated from their colleagues, many scientists find themselves interpellated by hegemonic discourses and come to disregard all others. Unfortunately,privileging a single discourse (evidence-based medicine (EBM)) situated within a single scientific paradigm (postpositivism) confines the researcher to a yoke of exactly reproducing the established order. To a large degree, the dominant discourse represents the ladder of success in academic and research milieus where it establishes itself as a weapon used against those who praise the freedom of scientific inquiry and the free debate of ideas.

Say what? I'm sure all those who struggled to get a few hours of EBM instruction into about one-third of internal medicine residencies by 2002 will be gratified to know that they are supposed to be on "the ladder of success in academic and research mileius." The notion that someone thinks EBM has been used to suppress free speech is just plain mind-boggling, although post-modernism has certainly been used to justify the suppression of free speech. (See, for example, the title essay in There's No Such Thing as Free Speech, and It's a Good Thing, Too by Stanley Fish.)

If anyone knows of such an institution, please tell me about it so I can apply there for a job.

Holmes et al also asserted that EBM advocates get "institutional promotions and accolades, public recognition, and state contracts of all kinds." Huh? Boy, I sure have missed out, and so have many of my friends and colleagues. At least in the US, EBM has not exactly been high on the priority list for federal government funding. (To add further irony, the article by Holmes at al was funded by one of those "state contracts of all kinds." Their paper was funded by the Canadian government, through the Canadian Institutes of Health Research- Institute of Gender and Health.)

But the paper goes from hilarious to nasty (which is why I don't believe that it was a hoax or a parody). The paper literally accuses advocates of evidence based health of being fascists,

Drawing in part on the work of the late French philosophers Deleuze and Guattari, the objective of this paper is to demonstrate that the evidence-based movement in the
health sciences is outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of microfascism at play in the contemporary scientific arena. The philosophical work of Deleuze and Guattari1 proves to be useful in showing how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm – that of post-positivism – but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore acting as a fascist structure.

Them's close to fightin' words.

Holmes and colleagues then specifically accuse the Cochrane Collaboration of being a fascist organization,

The classification of scientific evidence as proposed by the Cochrane Group thus constitutes not only a powerful mechanism of exclusion for some types of knowledge, it also acts as an organising structure for knowledge and a mechanism of ideological reinforcement for the dominant scientific paradigm. In that sense, it obeys a fascist logic.

Furthermore,

Fascism is not too strong a word because the exclusion of knowledge ensembles relies on a process that is saturated by ideology and intolerance regarding other ways of knowing.

To get more of tthe flavor of Holmes and colleagues arguments,

A starting point for health sciences would be to promote the multiplicity of what Foucault describes as subjugated forms of knowledge (savoirs assujettis): these forms of knowledge are ways of understanding the world that are ‘disqualified as non-conceptual knowledges, as insufficiently elaborated knowledges: naïve knowledges, hierarchically inferior knowledges, [and] knowledges that are below the required level of erudition or scientificity’ These forms of knowledge arise from below, as it were, in contradistinction to the top-down approach that characterises the hegemonic thrust of EBHS. For Foucault, a subjugated knowledge is not the same thing as ‘common sense’. Instead, it is ‘a particular knowledge, a knowledge that is
local, regional, or differential’

In our view, this positive process begins with a critique of EBHS and its hegemonic norms. As we have argued, according to postmodern authors, these norms institute a hidden political agenda through the very language and technologies deployed in the name of ‘truth’. Again, Foucault sums up this position in his critique of modern medicine: ‘Medicine, as a general technique of health even more than as a service to the sick or an art of cures, assumes an increasingly important place in the administrative system and the machinery of power’ Here, in such an ‘administrative system’ and a ‘machinery of power’, we find a classic allusion to what Hannah Arendt defines as totalitarianism or fascism, as we defined it earlier.

That should make Hannah Arendt, a true foe of totalitarianism, spin in her grave.

Finally, Holmes et al compared the language of EBM with "Newspeak" in 1984. I invite readers to read the article by Holmes et al, compare it to some article that is reasonably typical of those that advocate for EBM (such as the one from the 1996 BMJ linked above) and decide which is more like Newspeak.

The pity is that post-modernism's word-play mumbo jumbo and its cults of personality seem to be a great way for academic institutions to distract themselves from what is really going wrong with health care, the real threats to our professional values of the sort we have documented on Health Care Renewal.

Recovering from the brain fever induced by reading about "colonised (territorialised) science," "regimes of knowledge," "interpellated academics," and the "hysterisation of the female body," one might speculate: Has post-modernism been deliberately encouraged by some academic leaders, possibly those with the most severe conflicts of interest, to distract us from concentration and abuse of power in health care, the pervasiveness of conflicts of interests in health care organizations, and unethical and even illegal behavior by health care leaders?

If so, it's working.

ADDENDUM (25 August, 2006). See also the commentary in the Guardian (UK) by Ben Goldacre.

More on Physicians' Conflicts of Interest Down Under

The Internal Medicine Journal (from Australia) just published an article that adds to our knowledge about conflicts of interests affecting physicians. (McNeill PM, Kerridge IH, Henry DA et al. Giving and receiving of gifts between pharmaceutical companies and medical specialists in Australia. Intern Med J 2006; 36: 571-578.)

The article is based on a survey of a one-half random sample of Australian specialists, excluding surgeons and anesthetists. Results from this survey have been reported before. The response rate, conservatively estimated, was 39%.

This article focused on the proportions of physicians who had been offered and who accepted various items of value from pharmaceutical companies. The survey also enquired whether physicians had requested such items.

Over 90 percent were offered food or items for the office, and of those, 90 percent accepted. About half were offered items for personal use, or journal or texts, and of those a little more than half accepted. Almost two-fifths were offered funding for travel or various payments, and of those more than two-thirds accepted.

Funding for travel was offered for symposia, educational or CME meetings, and occasionally for product launches. Most of those offered travel support were not speaking at these meetings. Travel support was estimated to be the most expensive of offers made to physicians, with a median value of Aus $ 3000. (Other items were valued mostly in the tens to hundreds of dollars.) A relatively small number of physicians admitted to requesting various things, notably travel support.

The investigators also found that "medical specialists who had conducted industry-supported research within the previous 12 months ... were more likely to be offered gifts and activities and the gift items and activities were probably of a higher value than those offered to other specialists." Furthermore, "clinicians who were active (within the previous 12 months) as consultants to the industry ... or as members of industry advisory panels ... were more likely to be offered items and activities of a higher value than others" and "to accept such items." In addition, "active industry-supported researchers were also much more likely to seek funding for activities other than research, ...as were clinicians who are active as consultants to the industry or as members of an industry advisory panel."

The authors suggested that codes of ethics should be tightened regarding gifts and travel support.

I would note that this article suggests that relatively low-level potential conflicts of interest affecting physicians are very common. The sorts of financial interactions described in this article may affect physicians' decision making. Although I would guess that relatively small financial interactions have relatively small effects on average on individuals' decisions, the cumulative effect of such very common interactions may be substantial. Thus, I would support much more stringent restrictions on interactions like these among physicians and pharmaceutical companies.

Parenthetically, note that many of the financial interactions among leaders of medical organizations, especially academic medical organizations, and other organizations that we have discussed on Health Care Renewal (for example, here and here) involve substantially larger amounts of money, and may also involve other forms of commitment. For example, being a member of a board of directors of a US public, for-profit health care company may involve total yearly reimbursement over US $100,000, plus a fiduciary obligation to the company and its stock-holders. Presumably, such major interactions are likely to have much more profound effects on decision making than $100 worth of food, or even $2500 worth of travel support.

The AOL kerfuffle: information technology vs. information science, a distinction lost at industry's peril

While not directly related to medicine, the leadership issue below has great relevance towards the success or lack thereof in clinical information technology such as the EMR.

(It is worth noting that the multibillion-pound national EMR project in the UK is on the ropes at present, in no small part due to similar leadership issues, with MP's in the UK calling for the program's dissolution, see "NHS IT 'would be better' without £6bn scheme.")

Early in informatics training it was made clear that de-identifying personal information required much more thought and consideration than simply removing names and ID numbers.

Below is an example of a major corporate mishap causing significant loss of corporate reputation and good will for AOL due to inappropriate leadership and a syndrome of inappropriate confidence in technologists:

AOL Reviews Privacy Policy After Shake-Up

AUG 22, 2006 06:53:46 AM

AOL on Monday announced steps it is taking to prevent another security breach like the one in which subscriber search query results recently were posted online.

Also Monday, the company accepted the resignation of its chief technology officer (CTO). Maureen Govern "has decided to leave AOL effective immediately," said Jon Miller, president of AOL, in an e-mail message to employees that was provided to the IDG News Service. Govern, who was named CTO in September 2005, oversaw the research division responsible for the data release. In addition, a researcher and a manager in the research area were fired, according to an AOL spokesman who declined to be named.

I believe this story illustrates one of the risks of allowing information technology-centric personnel to lead information science projects, especially projects with sensitive social implications, instead of leadership by information scientists with true information science/library science/informatics training. Clinical IT (EMR, CPOE, decision support, etc) is a prime example of this problem.

One lesson that should be learned from the AOL case is that mastery of information technology does not imply (and often precludes) mastery of information science. I believe this distinction has become blurred and even lost in industry. I have observed this same issue impair clinical computing projects, as well as pharmaceutical R&D (rationing of essential cheminformatics tools by leaders of solely an information technology background comes to mind).

It is stunning to observe that this issue is entirely missed in the press, which calls for more education on "information privacy" issues but misses the issue of core competencies and the distinction between IT and information science entirely.

It's as if surgery mishaps during operations performed by the surgical tool designers were critiqued only on the basis of the person doing the cutting needing more education on anatomy.

The credentials of this former AOL Chief Technology Officer, from google cache of the AOL bio:

As Chief Technology Officer, Maureen Govern, directs the company's technology agenda and ensures that technology strategy aligns with and supports AOL's business priorities. She also oversees a global organization responsible for development and engineering, network infrastructure, data centers, and internal business systems and computing. With a proven track record of managing technology services for large companies, Govern joined AOL in 2005 from Convergys Corp., a provider of world-class billing, customer care, and HR services. There she served as Chief Technology Officer and was responsible for technology leadership; identifying out front, disruptive technologies for the Convergys Customer Management and Information Management Groups; overseeing Convergys Labs, R&D, and IT infrastructure; and serving as spokesperson on technology issues.

Before joining Convergys, Govern served as Vice President of Advanced Technology Development for Motorola's Global Telecommunication Solutions Sector, and was responsible for Motorola's cellular architecture, performance analysis, and advanced radio and network technology development. Previously, she held senior positions at Bell-Northern Research and NYNEX Science and Technology. She began her career as a member of the technical staff at Bell Laboratories in 1978.

Govern holds a Masters of Science in Operations Research from Stanford University.

Information science credentials, nil.

-- SS

Addendum Aug. 23:

A colleague informs me that it was information science people in an information retrieval research group that released the data. They had previously published a paper about this data set at http://www.ir.iit.edu/~abdur/publications/pos-infoscale.pdf. The chain-of-command for ultimate sign-off on the release is unclear.

This raises one of two questions common to HCrenewal stories: a question of competence of the releasers, and/or a question of warnings of competent people perhaps being overruled by those of higher rank. It would not surprise me if the situation was the latter. This could explain the dismissal of the CTO.

Addendum Aug. 24:

Here is a link to an article with more information and more links about the AOL search data kerfuffle. The links within the article provide more information on the "information scientist" background of the apparent PI of this project:

... over 12 years of research and development experience in computer science. He has worked as both a researcher and a developer, which has given him a great perspective on balancing software design with innovation. During this time he has fifteen patent applications filed and over 70 publications in magazines, scientific conferences, journals and book chapters covering many computer science topics like networking, operating systems, system scaling, and information retrieval.

I have made the observation that:

While computers make excellent tools or vehicles for medical informatics work, they do not define the field, nor are they required in medical informatics. This helps to clarify a common misconception. Medical informatics is not the equivalent of "computers in medicine." Using a computer in some medical way, such as by publishing a web site on some medical topic or running a hospital MIS (management information services or "I.S.") department, does not necessarily make an individual a "medical informaticist."

The danger of releasing this type of search data, queries from a consumer search feature of AOL, are rather obvious. (Who has, for example, never typed their name or the names of friends and associates into a search engine?) I think the AOL case supports an extension to my observation:

Using a computer to do something with information does not necessarily make an individual, even one with a degree in computer science, an information scientist.

Medical informatics education, on the other hand, is primarily about creating competent information scientists. That is an important distinction that unfortunately is not well-understood in the healthcare industry.

A Multi-Dimensional Web

The important article in the Annals of Internal Medicine on the stealth marketing of Neurontin (see post here) was accompanied by an editorial (Henney JE. Safeguarding patient welfare: who's in charge. Ann Intern Med 2006; 145: 305-6.)

Its author, Dr Jane Henney, put the onus on physicians to address conflicts of interest involving pharmaceutical companies.

Steinman and colleagues' article provides numerous examples of conflicts that arise when physicians receive compensation or other benefits from manufacturers in exchange for assistance with the marketing of drugs for off-label uses. The burden of managing these conflicts is the responsibility of the physician. The first and foremost principle of conflict management is disclosure. Whether the audience is a single patient or a group of fellow physicians, when the physician has accepted financial or other support (for example, slide preparation) from a manufacturer and has not told the audience about the arrangement, then that physician has gone over the line.

Steinman and colleagues' article on gabapentin marketing and promotion points out in stark detail that no patient is well-served when a manufacturer engages in practices, whether inside or outside the law, that involve physicians in activities in which conflicts are present. But physicians are not passive participants: They can say 'No.'

We have recently posted about arguments that disclosing conflicts of interest in health care may not be sufficient to manage all their ill effects, and could possibly even enhance such effects.

Ironically (a word that I seem to be using a lot), Henney's editorial itself illustrates the ambiguities created by disclosure. In her introduction, she discloses, "I have been privileged to serve in a variety of roles, including that of oncologist, principal investigator, study manager, senior academic administrator, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), and as board member for 3 Fortune 500 and Global 500 companies (AstraZeneca PLC, 2001 to present; AmerisourceBergen Corporation, 2002 to present; and Cigna Corporation, 2004 to present). "

This disclosure immediately raises questions about why the solution she advocated for the problem of stealth marketing indicated by the Neurontin case was merely disclosure, rather the abolition of particularly important conflicts of interest. Was she speaking as an academic leader of a medical center, or as someone with ficuciary responsibility to the stock-holders of a large pharmaceutical company (Astra-Zeneca), a company that acts as a middle-man between pharmaceutical manufacturers and patients and providers, including hospitals and academic medical centers (AmerisourceBergen), and/or a health insurer/ managed care organization (Cigna)?

Furthermore, all the organizations she leads ostensibly have conflicting interests, forming a multi-dimensional web. The role of these conflicting interests in controllling costs is at the heart of arguments for market based health care. In theory, pharmaceutical companies to maximize their profits want to maximize drug prices and prescribing volume. Companies that convey drugs to users and providers want to maximize profits by minimizing drug prices. Academic medical centers want to maximize their surpluses by minimizing the prices they pay for drugs and other goods and services, while maximizing their reimbursement from insurers. Insurers want to minimize reimbursements for drugs and reimbursements provided to hospitals. In theory, the competition resulting from these competing interests should control costs.

However, Dr Henney is one example of how the leadership of organizations with such ostensibly competing interests overlap. Does this mean that these organizations are not likely to negotiate as vigorously as the theory suggests? Does this suggest a reason why health care costs have not been controlled by the market model? And does this suggest that US health care diverges even more from an ideal free market than was heretofore believed?

Inquiring minds want to know.

The Stealth Marketing of Neurontin

The Annals of Internal Medicine just published an important paper on pharmaceutical company marketing practices. (Steinman MA, Bero LA, Chen MM, Landefeld CS. Narrative review: the promotion of gabapentin: an anlysis of internal industry documents. Ann Intern Med 2006; 145: 284-293.)

The background is that gabapentin (Neurontin) was approved as adjunctive treatment for complex partial seizures, and later for post-herpetic neuralgia. "In 2004 the Pfizer subsidiary Warner-Lambert settled litigation and admitted guilt in connection to charges that during the 1990s it violated federal regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses." As a consequence of the related litigation, a large number of documents about how Parke-Davis (the original manufacturer) marketed gabapentin became available, and were reviewed by Steinman et al.

Notable marketing practices employed are summarized below.

Continuing Medical Education

Teleconferences - "'Medical education drives this market!!' noted the author of a Parke-Davis business plan." Specific tactics included setting up "educational" teleconferences whose real goal was "to increase Neurontin new prescriptions by convincing non-prescribers to begin prescribing and current prescribers to increase their new prescription behavior." Furthermore, "In some cases, Parke-Davis helped establish the agenda and was able to surreptitiously monitor teleconferences in progress." Physician moderators were given, in at least one instance, an agenda which emphasized "how Neurontin evolved into a first line therapy option in your practice." Moderators were paid directly by Parke-Davis.

Speakers Bureaus - "Sales employees were encouraged to 'expand the speaker base—identify and train strong Neurontin advocates and users to speak locally for Neurontin'" A lecture series was meant to improve "public relations within the neurology community, etc., as well as [to impact] the volume of Neurontin new prescriptions" Speakers included department chairs and directors of clinical programs. "Members of the speakers bureau were invited to special meetings, where, in addition to lectures on the clinical use of gabapentin, they were updated on promotional strategies for the drug."

Programs Funded Through "Unrestricted Educational Grants" - These grants were made to "medical education and communication companies" [MECCs]. Although officially Parke-Davis did not control the content of resulting activities, "these same medical education companies also worked for Parke-Davis in several other roles, such as organizing teleconferences, coordinating advisory boards and consultants meetings, and conducting tactical planning to promote gabapentin. Because of these relationships, medical education companies had incentive to develop educational programs that were consistent with Parke-Davis's marketing goals and to control content in a way that reflected favorably on the sponsor." Furthermore, in one instance, "Parke-Davis representatives were invited to a curricular development meeting , recruited physicians to participate in the course , and followed attendance counts at each program meeting." Also, "Parke-Davis also sought to provide unrestricted educational grants to locally organized symposia at which it expected gabapentin to be favorably discussed. One memo recommended the following: 'Assist in the organization of a [major university hospital's] pain symposium ... .We will probably write them an unrestricted educational grant to help fund the project. In return, they will discuss the role of Neurontin in neuropathic pain, among other topics. They do have a very favorable outlook toward Neurontin.'"

Advisory Boards and Consultants Meetings - Although the ostensible purpose of such activities were to obtain feedback from physicians, for which they were paid, "other aspects of meetings were conducted in a manner more suggestive of promotional intent. For example, attendees at one consultants meeting were invited largely because of their high rates of anticonvulsant prescribing, and sales representatives were given 'trending worksheets' to track prescribing behavior before and after the event; at the meeting, 'participants were delivered a hard-hitting message about Neurontin'. Some meetings resembled educational conferences, with dozens of participants and an agenda dominated by lectures from physician 'faculty'. Other meetings seemed to focus on cultivating relationships with thought leaders, as in one meeting at which lecture notes for the regional business director notified attendees that 'we would like to develop a close business relationship with you'. Attendees were carefully selected. "As described by a medical education company that organized meetings, 'it is [our] policy to complete a literature search to determine who authors favorable articles on the topics outlined'".

Publications Strategy

"Parke-Davis employed a 'publication strategy,' the goal of which was to use research not as a means to gain FDA approval for new indications but 'to disseminate the information as widely as possible through the world's medical literature', generating excitement in the market and stimulating off-label prescribing despite the lack of FDA approval. This strategy focused primarily on expanding gabapentin use in neuropathic pain and bipolar disorders, for which detailed decision analyses projected the greatest revenue potential."

This strategy included suppression of research whose results were unfavorable to Parke-Davis interests. "As stated in a marketing assessment, 'The results of the recommended exploratory trials in neuropathic pain, if positive, will be publicized in medical congresses and published'. Similarly, in discussing 2 nearly identical trials that yielded conflicting results on gabapentin as seizure monotherapy, the 'core marketing team' concluded that 'the results of [the negative trial] will not be published'. (The positive trial was published, but we could not locate the negative trial on a PubMed search.)"

The strategy also included ghost-writing. "Beyond publishing its own clinical trials, Parke-Davis expanded the literature on gabapentin by contracting with medical education companies to develop review papers, original articles, and letters to the editor about gabapentin for $13 375 to $18 000 per article, including a $1000 honorarium for the physician or pharmacist author. For example, one 'grant request' from a medical education company to Parke-Davis proposed a series of 12 articles, each with a prespecified topic, target journal, title, and list of potential authors (to be 'chosen at the discretion of Parke-Davis'). This proposal noted that 'all articles submitted will include a consistent message ... with particular interest in proper dosing and titration as well as emerging [off-label] uses,' mirroring Parke-Davis promotional goals for the drug. In this case Parke-Davis requested that authors prepare articles and submit them for peer review. However, in another instance the medical education company offered substantial assistance in the development of manuscripts, reporting in a status report that at [the author's] request, we did an extensive literature search and submitted selected articles to him for reference ... . We have offered him help in identifying and collecting his appropriate cases, analyzing data, writing a manuscript, or whatever he needs'." Furthermore, "article sponsorship was often not disclosed, with 6 of 7 articles not acknowledging receipt of an honorarium from the medical education company (although 1 of these acknowledged support from Parke-Davis)."

Key Opinion Leaders and Clinical Trials as Marketing Opportunities

"Engaging physicians in the research process had potential benefits for Parke-Davis beyond the publications themselves, providing an opportunity to engage thought leaders, reward key physician customers, or influence prescribing. Marketing strategy documents stated that 'the list of key influencers should be ... kept aware of the availability of research opportunities in clinical trials' and recommended the 'funding of smaller studies ... with our key customers for investigation of Neurontin and pain'. Among the 40 thought leaders described, 5 requested or were allocated research funding ranging from $32 000 to $75 000 per person. "

"One notable example of the confluence between promotion and research was STEPS (Study of Neurontin: Titration to Effectiveness and Profile of Safety), an uncontrolled open-label study in which physicians were instructed to begin adjunctive gabapentin therapy in their patients with epilepsy and to keep increasing the dose until their patients were seizure-free, or until a maximum dosage of 3600 mg/d (twice the maximum FDA-approved limit) was achieved. More than 700 physicians were enlisted to participate, enrolling an average of 3 patients each (with a $300 payment for each patient enrolled). The published report of the study stated that it 'examined the effectiveness of gabapentin' in this dose range. However, company documents described the goal of the study as to 'teach physicians to titrate Neurontin to clinical effect' and 'to give neurologists the opportunity to titrate to higher doses (>1800 mg) when needed', central promotional goals at the time. Described as a 'key activity' for the implementation and support of marketing goals, 'indicators of success' for the study included increases in market share and use of higher doses of gabapentin. At least 6 of 9 authors of the published report had substantial financial relationships with Parke-Davis; they had participated in a total of 263 activities sponsored by Parke-Davis between 1993 and 1997, with requested or allocated payments ranging from $11 450 to $69 000 per author."

In summary, the documents reviewed showed how one pharmaceutical company (now merged into Pfizer Inc) disguised marketing activities as communications between physicians, continuing medical education programs, publication of scholarly articles, and clinical research. Although many of the activities involved physicians, often academic physicians, who were selected because of their favorable opinions of Neurontin, and/or encouraged to convey the company's marketing themes, that the company was involved in these activities, or that the physicians were paid or coached by the drug company was not made clear to the physicians who were the activities' targets.

Although this story involves only one company marketing one drug, it fits with other accounts of stealthy and deceptive marketing practices used by pharmaceutical companies and other health care organizations, and with other accounts of the willingness of some academic physicians to participate in such marketing activities while holding themselves out to be disinterested academics, not paid marketers.

For example, we have previously discussed how pharmaceutical companies have used MECCs to develop ghost-written articles that were later published as if they were disinterested scholarship. (See, for example, posts here and here.)

The additional evidence provided by Steinman et al suggests that deceptive marketing practices implemented with the assistance of academic physicians are more common than previously thought.

Physicians must be increasingly skeptical about educational and scholarly activities that may be disguised efforts at drug marketing.

Shame on the companies that have implemented such stealth marketing programs. Shame on the academic physicians who have taken money to help them out without revealing their financial interests to their physicians colleagues.

WHAT WE CAN DO?

I realize that sometimes the "bad news" conveyed on Health Care Renewal can be numbing, especially in the absence of a clear idea of what one can do in response to the bad news.

In this case, I have some opinions on what physicians can do.

Physicians should avoid any continuing medical education activity that appears to be biased in favor of particular products or in the interests of particular manufacturers. Physicians who end up attending such activities should at least aggressively challenge any bias they perceive.

Academic physicians, at a minimum, should disclose any financial ties they have to commercial firms that may affect their professional or scholarly communication. Ideally, physicians should refuse any financial arrangements that could convey even the appearance of participating in stealth marketing efforts. Academic physicians need to remember that their goals are honest teaching and research. If they want to go into marketing, they should go to work honestly for firms engaged in marketing.

Conflicts of Interest in Clinical Research - Bold Thinking in the Journal of General Internal Medicine

The Joournal of General Internal Medicine has published a significant study and an important editorial on conflicts of interest affecting clinical research.

The article (Weinfurt KP, Friedman JY, Allsbrook JS et al. Views of Potential Research Participants on Financial Conflicts of Interest: Barriers and Opportunities for Effective Disclosure. J Gen Intern Med 2006; 21:901-906.) reported on research that used focus groups to question patients and prospective patients about their understanding of and preferences concerning disclosure of potential conflicts of interest (COI) affecting clinical research in which they might participate. Parenthetically, although the participants were given explanations of numerous species of COI, some significant ones were omitted, notably service by researchers on boards of directors of the companies sponsoring research, and conflicts affecting contract research organizations and for-profit institutional review boards (IRBs). The study produced some disturbing findings, particularly:

• Some participants were initially unaware that such conflicts could even exist.
• Participants found certain kinds of more complex financial relationships hard to understand even after considerable explanation.
• Some participants did not want to hear about conflicts because they were afraid doing so would remove their illusions that the researchers were trustworthy.
• Participants noted that extremely sick patients might be too desperate to care about COI.

The commentary (De Vries R, Elliott C. Why Disclosure? J Gen Intern Med 2006; 21: 1003-1004.) began with a discussion of some recent cases in which "financial interests have arguably placed subjects at risk." These included the TGN 1412 trial run by Parexel for the now bankrupt TeGenero (see our most recent post here), and trials run by SFBC International (see our most recent post here).

The editorial's summary of the effects of financial interests on clinical research was notable:

Medical research, once largely the province of academic researchers working in universities, has become a multinational corporate enterprise. Only about a quarter of clinical research now takes place in academic settings; academic researchers themselves have considerable financial ties to industry; and even the ethics review of clinical trials has become a major commercial enterprise.

How can a research subject be sure that the emphasis on 'return on investment' will not translate into a dangerous trial?

Summarizing the results of the study by Weinfurt et al, the editorial then suggested that "it is not irrational" for research subjects to "distrust disclosure as a remedy for conflicts of interest."

It then went on to summarize some recent research by cognitive psychologists. Cain and colleagues' experiments showed that disclosure of conflicts of interest did not lead those to whom the disclosure was made to be appropriately skeptical of advice provided by those with the conflicts. Even more important, after making disclosure, those with conflicts tended to say things that appeared even more biased by their own conflicts, as if "disclosure had given them moral license to exaggerate." The psychology researchers concluded "the solution to the bias created by conflict of interest is not simply to disclose the conflict, which makes bias even worse. Rather, the solution is to eliminate the financial conflicts."
So, "the important ethical question raised by conflicts of interest is not, as Weinfurt and his colleagues seem to assume, 'should researchers disclose?' but rather 'why has disclosure become such a popular way of managing financial conflicts of interest in medicine?'" Furthermore, "a more cynical explanation of the popularity of disclosure suggest that it is a 'remedy' for financial conflicts of interest that allows those conflicts to stay in place. Thus it does nothing to threaten the existing funding arrangements for clinical research."
Finally, "what is being overlooked here is the need to protect the welfare of potential research subjects. The real problem raised by industry-funded research is that the pursuit of financial gain might leader researchers to place subjects at risk in dangerous studies."

Bravo to the Journal of General Internal Medicine for publishing something so bold.

In my humble opinion, De Vries and Elliott are exactly right. Full disclosure, which is rarely practiced, might tell us about the extent of conflicts of interest affecting research, but it does nothing to manage these conflicts. The only real way to manage these conflicts is to eliminate them.

We need to drastically revise our system of funding clinical research. Clinical research should not be directly funded by, supervised, or implemented by organizations with a financial stake in the outcome. We need to develop a funding mechanism that funds clinical research as a resource that benefits all the people, and a cohort of researchers who will do their work well and honestly, devoid of financial arrangements with organizations that might benefit if their results turn out one way or the other.

Six Viagra Prescriptions and You Get One Free - the Latest Pharma Marketing Ploy

Reuters (via the Boston Globe) described the latest trend in drug marketing - offers such as "coupons, rebates, and similar promotions." Examples include an offer from Pfizer Inc for a free prescription of Viagra (sildanafil, for "erectile dysfunction,") for every six filled; a free trial offer of a seven days supply of the sleeping medication Ambien (zoldipem tartrate) from Sanofi-Aventis; and free music downloads for (mainly adolescent) patients who filled prescriptions of acne drug Differin (adapalene), made by Galderma Laboratories (which now advertises other special offers).

Not unexpectedly, these new marketing ploys have drawn criticism. "Coupons 'can increase the patient's desire to take a drug that may or may not be the most suitable drug ... This is not shampoo,' said Susan Sherry, deputy director of Community Catalyst, a Massachusetts-based group that has joined 22 others seeking a Food and Drug Administration ban on the giveaways."

An US Food and Drug Administration (FDA) notice, later withdrawn for unknown reasons, stated, "prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are."

Harvard Professor and pharmaceutical industry critic Dr Jerry Avorn said, "All that does is get them used to being on the expensive drug."

There is little to add to Avorn's summary comment, "the same symptom we have seen in the drug industry for years - the ascendancy of marketing over science. They are getting so preoccupied with marketing, and unfortunately they seem to be less successful in coming up with creative drug solutions."

Maybe we would be better off with health care organizations run by people who understand and care about health care, rather than marketers or bean counters?

Yet More Trouble in the OC - A Psychiatrist Gets Into the Act

I went away for a few days of vacation and all heck broke loose again. I will try to keep up with this and subsequent posts.

The Los Angeles Times reported a new story about complex relationships between a faculty member at the University of California - Irvine medical school and a variety of commercial firms. We had posted a few months ago about various management problems at the same institution, involving its liver transplant service, cardiology division, and bone marrow transplant service, (see posts here and here) which lead the new chancellor of the campus to "acknowledge a failure of leadership and accountability." (See post here.)

The Times focused on the actions over almost 20 years of Dr Steven G Potkin, Professor of Psychiatry and Human Behavior.

1989
“UCI investigated Potkin for the first time in 1989. Doctors there told administrators that Potkin was inappropriately billing Medi-Cal for patients in research trials. Bills submitted for patients in Potkin’s studies had been turned down three times by Medi-Cal....” One psychiatrist alleged that Potkin planned “to fool Medi-Cal into reimbursing the department for unauthorized expenditures.” Other affadavits alleged that Potkin “directed staff to keep two sets of records, disguising the names of the drugs that patients were receiving on the version made available to Medi-Cal.”

However, “UCI eventually launched an audit.” It found “ no improprieties. Interviewed by the Times, Potkin “denied the billings were inappropriate.”

1997

The Times reported that “in 20 of Potkin’s [research] studies, he arranged for drug companies to channel some funding directly to the firm Pacific Clinical Sutdies.... Pacific Clinical Studies was owned jointly, by Potkins brother Ralph, a pulmonary care doctor, and a trust in their parents’ names.” Then, “one Potkin client, Janssen, a drug firm in Titusville, N.J., became ‘increasingly uncomfortable with the payments it was making to PCS and stopped making them.... Janssen... was worried because of the arrangement’s similarity to a case in which the chairman of the psychiatry department at the Medical College of Georgia pleaded guilty to diverting research funds....” But again, “the UCI audit, completed in September, 1998, concluded that Potkin’s actions did not technically violate the university’s nepotism policy, since PCS got the money from the drug companies rather than from UCI. However, the audit suggested that PCS ‘may have been established’ to avoid paying university overhead....” Later, [UCI medical school Dean] Cesario and Fredric Wan, then vice chancellor for research, told Potkin that PCS could no longer work on clinical trials for the university. Potkin said in an interview that UCI knew about PCS’ involvement....” But a university spokesperson said that Potkin “did not reveal its [PCS’] ties to his family.”

2004
“In 2004, Potkin and psychiatry department co-chairman William E. ‘Biff’ Bunney applied to the university board that monitors human research to test an Alzheimer’s drug for Precis Pharmaceuticals, a small company in Waltham, Mass. The request was not immediately approved. The professors went ahead anyway, using a private company they had previously formed to conduct research at an assisted living facility.... The professors had a previously signed agreement with the university allowing them to consult on clinical trials through their company but no to work as principal investigators on a study through the firm.” Then, “Thomas Cesario, the dean of UC Irvien’s medical school, took swift action. In a Dec. 8, 2004, memo, Cesario told the psychiatrists that he had learned of their outside trial and that they were violating UCI policies. ‘We require this study be halted immediately until further notice,’ he wrote.’ In the interview, Potkin said he “moved the study out from under UCI’s auspices because of a shortage of psychiatry beds available for research.”

Even though Potkin’s research efforts were investigated three times in the last three decades, no one apparently discerned any pattern until the Times article. In fact, the Times article characterized Potkin as “one of UCI’s biggest stars. The 60-year old psychiatrist is among the university’s most prolific researchers. He brings in lucrative contracts from some of the world’s biggest drug companies and has presided over as many as a dozen clinical trials at a time. "

The Times reporter interviewed Dr Mike Samoszuk, a former pathology professor at UCI who now works for “the medical device industry of a drug company.” He opined that the “university’s thirst for research funding may have caused it to look the other way when ethical lapses were discovered. ‘Even though clinical research is a noble and worthy activity, it’s very easy to lose your moral compass if your primary goal is the dollar amount of grant funding that you generate.’....”

It seems the more one looks, the more management problems one finds at the UCI medical school.

This saga is another example of the complex financial relationships that pervade medical schools and academic medical centers. Such relationships raise concern about the degree that research going on at these institutions is unduly influenced by the financial interests of those who run it. It also increases skepticism about the extent that faculty and administration have become distracted from their academic mission and their professional values by the lure of easy money from industry, coupled with ongoing pressure from the university to bring in more "external funding."

If you are an academic physician getting such money, it is time to think about how much your reputation and your values are really worth. If you are an academic administrator who has been pushing your faculty to better “support their salaries,” no matter what the source, it is time to think about how much your institution’s reputation and values are worth. And it is time for all of us to wonder why academic medicine has become so focussed on making money, and figure out how it can become otherwise.

A More Entangled Web: the UnitedHealth Case

More issues are surfacing regarding the question of whether stock options given to top executives of UnitedHealth Group were back-dated. We have posted frequently on this topic, most recently here (and see links within to earlier posts.

According to multiple news sources, (see, for example, this article by Melissa Davis in TheStreet.com), UnitedHealth has delayed its latest quarterly report "due to possible accounting changes that could prove material in nature. The changes, if necessary, would reflect the rising value of options issued to company employees -- including massive grants to CEO William McGuire -- and drive up reported expenses as a result." Several analysts proposed that this delay indicates more severe problems with the stock options than were heretofore anticipated.

Bloomberg News noted that the board of directors that approved the huge grants of stock-options to UnitedHealth CEO Dr William McGuire was itself particularly well compensated, especially in terms of stock options.

UnitedHealth's 10 non-executive directors held $230 million in stock as of March 21, according to the health insurer's most recent proxy. Director Richard Burke, who joined the board in 1977, had $169 million in shares, while Douglas Leatherdale owned $47 million. The directors, including former New Jersey Governor Thomas Kean and former Fannie Mae chief executive officer James Johnson, held more than 3.1 million stock options, whose underlying value is about $175 million.

Each UnitedHealth director makes at least $400,000 a year, counting pay and exercisable options, according to Jesse Fried, a professor at the law school of the University of California at Berkeley. The Corporate Library, a Portland, Maine-based governance group, says UnitedHealth had the eighth-best- compensated board in the nation in 2004, with total compensation of $5.4 million.

The outside directors are paid in a combination of cash and options grants. According to the April 7 proxy, they get an annual cash retainer of $30,000, plus payments for each board and committee meeting attended. They also get an initial one-time option to buy 58,000 shares, plus quarterly options to buy 8,000 shares, or 32,000 options a year for each year they serve.

The initial grants are exercisable over three years, while the quarterly grants can be exercised immediately. The price of the initial options is set by the closing price of UnitedHealth stock on the day the director is elected, which is at the annual meeting. The price of the quarterly options is set by the closing price of UnitedHealth shares the first business day after the quarter ends, the proxy says.

As of March 21, the three members of the compensation committee -- Johnson, 62, the chairman, Mary Mundinger, 68, dean of Columbia University's school of nursing, and William Spears, 67 -- held a total of more than 1.1 million options, the company's proxy shows. Spears also held $3.7 million in stock and Mundinger held $1.8 million.

Some commentators suggested a discrepancy between the magnitude of the board members' compensation and the extent of their efforts supervising McGuire and other top executives. For example, Patrick McGurn, Executive Vice President of Institutional Shareholder, said,

This is the no-show board of all time in terms of the job they did in overseeing compensation.

They handed the reins over to management and played the roles of cheerleader.

Finally, the Pioneer Press has been investigating other potential conflicts of interest affecting the UnitedHealth board of directors. These conflicts are important because,

With options under scrutiny at more than 80 companies so far, regulators and prosecutors haven't the resources to conduct full-blown forensic probes of every company. They often rely on companies' own internal inquiries to do the initial digging that helps authorities decide whom to pursue most vigorously. In addition, the companies rely on these internal probes, either to show the public they've been diligent or to defend against shareholder suits.

In these probes, 'if the government catches wind of issues affecting independence, they will naturally be more skeptical and less trusting of the process and the results,' said W. Scott Sorrels, an Atlanta attorney who has conducted investigations for corporate boards in the past. Sorrels, not speaking of any particular company, said, 'We advise companies to avoid any appearance of impropriety so you don't have the situation blow up in your face six months down the road after the investigation is done.'

One conflict affected board of directors member Thomas H. Kean, former governor of New Jersey, who was a member of the compensation committee.

The same day as the [May 1] board meeting, some UnitedHealth directors and executives were supporting a campaign by Kean's son for a U.S. Senate seat from New Jersey. Some of them attended a fundraiser for Tom Kean Jr. that day, in UnitedHealth's home state of Minnesota.

It isn't clear whether McGuire and his wife attended but each donated $2,000 to the cause. So did Richard T. Burke, who sits on a special board committee that is overseeing the options investigation. All told, UnitedHealth-affiliated donors have contributed $25,000 to the campaign.

When the donations to the Kean Senate campaign were described to former SEC Chairman Harvey Pitt, he said they struck him as 'ill-advised and strange' and something that could be seen as an attempt to influence a witness because of the senior Kean's role on the compensation committee.

A spokeswoman for the Kean campaign said the fundraising came at a 'UnitedHealth breakfast' hosted by Minnesota Republican Sen. Norm Coleman, and there was absolutely no effort to curry favor with the elder Kean. The former New Jersey governor didn't return calls seeking comment.

Another involves board compensation committee member William Spears,

One longtime UnitedHealth comp-committee member, William Spears, is a money manager with the New York firm Spears Grisanti & Brown LLC. The firm appears to manage money for McGuire's family foundation. In tax filings covering two recent years, the foundation put the name of Spears' firm atop a list of its securities transactions. A partner in the firm, Christopher Grisanti, said privacy regulations barred him from saying whether the foundation was a client. Spears didn't return messages seeking comment.

Another involves board compensation committee member Mary Mundinger. We have previously posted about Mundinger, since she is also a Professor and Dean of the School of Nursing at Columbia University. We proposed that Mundinger's fiduciary duties to the shareholders of UnitedHealth may be at odds with her duty to uphold the mission of Columbia University and its School of Nursing. The university's academic medical center must undoubtably deal with managed care organizations that compete with UnitedHealth, or with UnitedHealth directly.

Another longtime member of the health insurer's compensation panel is Mary Mundinger, dean of the Columbia University nursing school. Mundinger has championed the idea that nurse practitioners can provide high-quality primary care, and in the mid-1990s she shepherded a pioneering project to create a nurse-practitioner clinic in New York. The support of health insurers was critical to getting patients to use it, and UnitedHealth was among several insurers to sign on. In media interviews at the time, UnitedHealth officials spoke approvingly of her project.

The anecdote again illustrates the complex relationships between Mundinger's academic work and her duties to UnitedHealth.

There are at least two major issues here for health care.

One is the continued and ever more glaring contrast between UnitedHealth Group's stated mission, to

* Improve access to health and well-being services;

* Simplify the health care experience;

* Promote quality; and,

* Make health care more affordable.

and the largesse it granted to its top leaders, executives and board members.

The second is the more and more apparent web of conflicting interests that entangles many health care organizations who are ostensibly supposed to be operating at arms' length. This web is of particular concern when it entangles leaders of academic medicine with simultaneous duties to uphold the interests of corporate stockholders. The interests of the stockholders may be at variance with the missions of the academic leaders' institutions. (And note that the UnitedHealth Group board of directors includes Donna Shalala, the President to the University of Miami, and hence the leader to which the university's medical school and academic medical center reports, and Gail Wilensky, a well-known health services researcher at Project HOPE.)

Missing the Target

In the Times (UK), an eloquent critique of target setting in the National Health Service by Raymond Tallis:

in the case of the NHS, target-mania is not only damaging in the long term, but also a direct threat to patient safety.

Last month’s report by the Healthcare Commission on the outbreaks of infectious diarrhoea in Stoke Mandeville hospital, in which 334 patients fell ill and at least 33 died, makes instructive reading. Managers, we learnt, overrode the advice of the expert clinicians on their own staff and thus failed to isolate infected patients to control the outbreak. This active mismanagement was driven by a need to meet targets, in particular the requirement to clear patients from the accident and emergency department within four hours. Patients in A&E with infections were admitted to open wards rather than isolation facilities, which were in short supply.

Will this kind of evidence be the death knell for targets and, more importantly, for the arrogance — political power mistaking itself for technical expertise — that lies behind them? Like many bad ideas, targets are intuitively attractive.
In practice, the impact of targets has been damaging and must bear some of the blame for the failure of the vast and welcome increase in NHS funding to deliver a proportionate increase in care.

It is sometimes forgotten that if one kind of activity is prioritised then all others are “posteriorised”. For example, the initial focus on coronary heart disease meant that development of services for cardiac arrhythmias andnon-cardiac conditions was held back. Conditions that are not prioritised still have to be treated. Secondly, priorities determined by the discomfort of a minister at the dispatch box may not match clinical priorities. Thirdly, meeting targets will itself become the overall priority: resources are commandered for this even if it is not cost-effective. The collateral damage to the care of patients with non-targeted conditions will be all the greater.

The greatest damage will be to aspects of care that cannot be measured — human kindness, listening and talking that patients value enormously and that are so important in chronic disease. When targets are set the measurable always displaces the immeasurable.
There are other less obvious, but no less serious, adverse effects of centrally determined targets. The implicit contempt for the competence and motivation of the professionals in the service is profoundly demoralising. A recent study by Frank Blackler, of Lancaster University, confirmed what one might have expected — that the target culture has led to poor leadership and paralysis among hospital trust managers. And it is not difficult to imagine the impact on clinicians who are at the receiving end of its puerile simplifications, remote from the complex realities of clinical care.

The assumption that clinicians will not try to improve their services without political “incentivisation” — carrots and Semtex — is profoundly irritating, not to say exasperating, for those who have being trying to improve their services for many years and found the experience to be rather like riding a bicycle up a sand dune. To be finger-wagged into doing something that one has been endeavouring to do without support is almost as bad for morale as being forced to act on priorities determined by political rather than clinical need.
And then there is the dangerously distracting effect of changing targets — one aspect of the unending “redisorganisation” of healthcare. The Healthcare Commission criticised the management of Stoke Mandeville for “taking their eye off the ball”. More likely they were transfixed by a particular ball — the political agenda — that was in constant, unpredictable motion.

Targets are also corrupting, creating a parallel world of delivery that is remote from the real world. In the Soviet Union, when targets for screw production were set in terms of the numbers of screws produced, factories manufactured millions of screws the size of iron filings. Target met. When targets were set according to weight, the factory workers produced one massive screw. Target met. It is hardly necessary to say that this did not add to the wealth of the country.

As the saying goes, read the whole thing.

In case anyone thinks that this issue is relevant only in the UK - the currently fashionable "pay for performance" (P4P) movement in the US is a sub-species of target setting. (See previous post here and here.) Maybe we in the US should look at the British experience before rushing off to implement P4P.

Disclosing Conflicts of Interest: A Story Involving JAMA, Harvard Medical School, Baxter International, Cytyc

We have recently posted about cases in which JAMA (see post here) and the journal Neuropsychopharmacology (see post here) published articles whose authors did not fully disclose conflicts of interests that might have influenced what they wrote. Dr Cathy DeAngelis, the Editor of JAMA, just wrote an editorial calling for fuller disclosure of such conflicts of interest (full citation: DeAngelis CD. The influence of money on medical science. JAMA 2006; )

Some key quotes:

There can be no doubt that editors of peer-reviewed medical journals must always place the interest of patients above all else. Every published article eventually can and should affect patient care. Therefore, all articles that we publish must be ethically sound, valid, reliable, and credible (ie, reflective of work that is performed, written, reviewed, and edited in a manner that is unencumbered by financial pressure). With that in mind, it is important to discern the necessary and honest interests of for-profit companies from the potentially corrupting influence of commercial interests.

In some instances, the marketing goal of a company dominates the scientific aspect of the company-funded research. There have been a number of high-profile examples of such research irregularities involving for-profit companies, such as the refusal to provide all study data to the study team, reporting only 6 months of data in a trial designed to have 12 months of data as the primary outcome; incomplete reporting of serious adverse events; and concealing clinical trial data showing harm.

For-profit companies also can exert inappropriate influence in research via control of study data and statistical analysis, ghostwriting, managing all or most aspects of manuscript preparation, and dictating to investigators the journals to which they should submit their manuscripts.

How do editors preserve the integrity of their journals while ensuring that they serve as vehicles for dissemination of scientific information that could help clinicians provide better care for their patients? First and foremost is to ensure that all published articles are scientifically sound and as objective and unbiased as possible by using rigorous peer review and careful editorial evaluation. Another important aspect is to ensure that readers are aware of the authors' financial relationships and potential conflicts of interest so that these readers can interpret the article in light of that information.

Most remarkable about this editorial was that in it Dr DeAngelis singled out the Harvard Medical School.

Because we are so adamant and open about disclosure of financial interests, it is not surprising that we are being made aware of nondisclosures by authors and by readers. Somewhat surprising was that 3 consecutive cases of nondisclosures, all of which raised the interest of the mainstream press, involved authors from Harvard Medical School. To his credit, the dean of Harvard Medical School has informed me of his plan to send a letter enclosing the disclosure requirements for JAMA (plus our July 12, 2006, editorial) and those for the New England Journal of Medicine to all 8000 Harvard Medical School faculty members. In addition, he indicated that he will work with his faculty to enhance Harvard Medical School's current policies on financial relationships with for-profit companies (Joseph B. Martin, MD, PhD, oral communication, July 18, 2006).

A news article in the Boston Globe actually reported that Dr DeAngelis called Dr Martin and said, "Joe, do something with your kids." "Kids" here refers to the distinguished faculty of the Harvard Medical School.

In my humble opinion, it's good that some of the pervasive conflicts of interest in health care are starting to get more public scrutiny. Although disclosure of conflicts of interest do not negate all the problems they cause, full disclosure would at least make all aware of the scope of the problem

That's where the irony comes into this story. Dr Martin, in addition to his day job at Harvard, is a member of the board of directors of Baxter International, which describes itself as "a global healthcare company that, through its subsidiaries assists healthcare professionals and their patients with treatment of complex medical conditions including hemophilia, immune disorders, kidney disease, cancer, trauma and other conditions." Dr Martin is also a member of the board of directors of Cytyc, which makes a variety of diagnostic and therapeutic devices for use in gynecology. Dr Martin's official Harvard on-line biography does not mention these affiliations. Dr Martin did report these affiliations when writing, for example, an article for the New England Journal of Medicine about academic collaboration with industry (Moses H, Braunwald E, Martin JB, Their SO. Collaborating with industry — choices for the academic medical center. N Engl J Med 2002; 347(17):1371-5.) How Dr Martin simultaneously manages his fiduciary responsibilities to maximize financial results for the stock holders of Baxter International and of Cytyc and his leadership responsibilities at the Harvard Medical School is not clear.

So it would seem that full disclosure about conflicts of interest in health care really should begin at home.