VCU, Philip Morris, and the "Recent Unpleasantness"

While I lived in Richmond, Virginia from 1987 to 1994, one could still find some people who referred to the US Civil War as the "recent unpleasantness." Similarly, we have noted the "anechoic effect," how cases involving deficient ethics, poor leadership, and flawed governance in health care occurs produce few echoes. Many important cases and issues that have been discussed on Health Care Renewal have never appeared in medical or health care journals. Many specific cases have never been publicly discussed at the institutions in which they originated. Some specific cases have never appeared in the national news media. Some specific cases have not been covered even in the relevant local news media.

Here is a case in point, from Richmond, Virginia. The Richmond Times-Dispatch, the only major newspaper in that city, just reported that the President of Virginia Commonwealth University (VCU), Eugene P Trani, is recovering from coronary artery bypass grafting (CABG) surgery. We wish President Trani a speedy recovery. But buried in that article is the only mention that has ever appeared in the Richmond Times-Dispatch of the recent unpleasantness about research contracts between VCU and tobacco company Philip Morris. Here it is:

Trani was scheduled to be on a two-month sabbatical at Harvard University's Taubman Center for State and Local Government through mid-August. In his note to the university community, he said he returned to Richmond after his first month because the university was 'experiencing a number of recent challenges.'

Recent controversies have brought VCU some unwelcome attention.

There have been questions about whether a research agreement with Philip Morris USA was in accordance with traditional accepted research guidelines and policy.

A university Task Force on Corporate Sponsored Research will hold a town-hall meeting tomorrow to hear from faculty and students on the research issue.

We have discussed this "recent challenge" on Health Care Renewal. Briefly, the New York Times reported last month that VCU has been doing research under contract with Philip Morris USA. Contract provisions forbade the university from even revealing the existence of the contract itself. By classifying all products of the research as "proprietary," the contract seemed to bar university faculty from publishing or publicly discussing the research without permission from Philip Morris. Such provisions apparently violated not only the university's stated policies, but its fundamental mission. Furthermore, it appeared that the university's coziness with Philip Morris might relate to its President's leadership role for a company in the tobacco industry. President Trani, it turns out, is on the board of directors of Universal Corp, which buys, processes, and ships tobacco. For a university President who also leads a medical school and academic medical center simultaneously to be responsible to the stock-holders of a tobacco company seems quite a major conflict of interest, given that tobacco products clearly cause much disease, disability, and death in the absence of any health benefits.

But to the Richmond Times-Dispatch, all this seems just to be some recent unpleasantness.

The cone of silence that seems to confine much unethical behavior, poor leadership, and poor governance in health care has disabled medicine's and society's ability to address these problems.

SCHATZBERG, STANFORD and the AMERICAN PSYCHIATRIC ASSOCIATION

14 July 2008

SCHATZBERG, STANFORD and the AMERICAN PSYCHIATRIC ASSOCIATION

The chairman of psychiatry at Stanford University, Dr. Alan Schatzberg, is still in the news for his problems at the boundary of commerce and academia. The New York Times reported that Dr. Schatzberg believes constraints on researchers trying to develop drugs “will mean less opportunities to help patients with severe illnesses.” Just as patriotism is the last refuge of the scoundrel, so patient welfare is the last refuge of the dodgy medical entrepreneur.

What exactly does Dr. Schatzberg mean by “constraints”? Does he object to transparency as a “constraint”? Would he feel “constrained” by the need to disclose his stock sales to his academic institution? The Stanford Daily commented recently that Stanford policy “requires that faculty members divulge any and all financial gains made through outside interactions that could have bearing on what they are doing on campus.” One reason for this requirement is so that the institution can disclose these financial dealings to NIH, which funds Dr. Schatzberg’s academic work that dovetails with his corporation’s research. It is difficult to reconcile Dr. Schatzberg’s protestations of compliance with the non-reporting of his stock sale valued at over $100,000 (not to mention his efforts to sell stock valued at $7-11 million).

Would Dr. Schatzberg and his corporate associates feel “constrained” by the requirement to disclose their competing financial interests when touting the company’s drug in scientific journals, textbooks, educational media, and press interviews? The record is clear that they have repeatedly failed to do so.

Would Dr. Schatzberg and his corporate associates feel “constrained” by the canons of science that frown on exaggerated claims and hyperbole in the service of their business enterprise? The record is clear that they have repeatedly overstated the evidence for their drug’s prospects. These exaggerated claims were touted by the corporation when raising capital.

Would Dr. Schatzberg feel “constrained” by the societal expectation to refrain from gaming the entrepreneurial reward system? He appeared to believe he was entitled to cash out $7-11 million of other people’s money before actually producing anything of redeeming social value.

If this is what Dr. Schatzberg means by “constraints” then his fitness for the office of president of the American Psychiatric Association needs to be reconsidered.

Can We Fix Medicare While Pretending the RUC Does Not Exist?

There has been much media discussion of how the US Congress just forestalled an across-the-board cut in Medicare's payments to physicians that threatened to markedly decrease access to care. There was some discussion that this was just a temporary fix, but more fundamental solutions would be difficult. Some of the media discussion made some points that previously went unsaid, including:

• Medicare fixes payments to physicians - For example, a Wall Street Journal editorial noted, "As a virtual monopoly, Medicare uses a complex formula to set reimbursement rates for thousands of services. In short, it controls prices. That's why doctors are supposed to eat a pay cut, even though everyone knows this would prompt more doctors to stop seeing Medicare patients."
• Changing the system would be difficult, because it might mean some people would make less money - For example, a New York Times article noted, "lawmakers are pleading with physicians’ groups to come forward with a comprehensive proposal. But that could be difficult because any new formula would almost surely produce winners and losers among doctors."

Those are two good points that start getting at some basic parts of the problem. But even this new clarity seems to miss other fundamental questions, most notably: how did the current Medicare system of fixing prices end up doing so in a way that is so unfavorable to primary care and other cognitive physicians' services, and so favorable to surgery and other procedures?

How the current system arose is no longer a mystery, and was certainly a work of mankind, rather than the supernatural.

As we have discussed before (here, and see this post with links backward), based on several key published articles,(1-4) it is the RBRVS Update Committee (RUC) that seems most responsible for the current state of affairs. Medicare payments to physicians are based on the Resource Based Relative Value System (RBRVS). RBRVS was put in place in the early 1990s, mainly to try to restore then present imbalance in payments that already favored procedures over primary care and cognitive services. Medicare apparently gave the RUC de facto authority over how the system would be updated. The updates the RUC put in place over the years generally involved increasing payments for specific procedures over time, even though most procedures actually get easier to do in the years after their development, and the volume of procedures was increasing much faster than that of office visits. This probably was related to how representatives of specialties that emphasize procedures dominate the membership of the RUC, (although the names of individual members of the RUC, and its deliberations are kept secret). Since the Medicare payment system requires that the overall payments to physicians grow no faster than inflation and the increase in the elderly population, increases in costs due to increasing prices and volume and procedures lead to across-the-board cuts of all payments, which mainly hurt payments for office and hospital visits.

What is mysterious is why Medicare relies on the RUC to the exclusion of any other input; how the AMA can claim the RUC is merely an "advocacy group," rather than the de facto controller of payments to physicians; what individuals are currently RUC members and what goes on during its proceedings; why do managed care organizations and health care insurers base their payments to physicians so slavishly on the RUC governed Medicare fee schedule; and why, outside of a few academics and bloggers, is discussion of the RUC so scanty?

Any real attempt to reform the fundamental inequities in what we pay for health care, inequities which have driven our over-use of procedures and high-technology and devalued thoughtful compassionate, continuing, comprehensive, and continuous care, must address the bizarre and mysterious way payments are fixed. To do so, health care policy makers and the public at large will first have to acknowledge and publicly discuss the problem. It should not be only a few academics and bloggers who are willing to talk about it.

References

1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (link here)
2. Maxwell S, Zukcerman S, Berenson RA. Use of physicians' services under Medicare's resource-based payment system. N Engl J Med 2007; 356: 1853-1861. (link here)
3. Newhouse JP. Medicare spending on physicians - no easy fix in sight. N Engl J Med 2007; 356: 1883-1884. (link here)
4. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (link here.)

A Bad Week in Court for US Health Care Organizations

It was a busy week in court for some US health care organizations.

Just before the US Independence Day holiday, news reports indicated that a jury in Alabama found that two large pharmaceutical firms, GlaxoSmithKline and Novartis, had defrauded the state. For example, per the Associated Press,

A state court jury on Tuesday found two major pharmaceutical companies defrauded Alabama in a long-running Medicaid drug pricing scheme and ordered the firms to pay more than $114 million in damages.

The jury found that GlaxoSmithKline should pay the state $80.8 million in compensatory damages and that Novartis should pay about $33.7 million in similar damages.

The state claimed the two companies charged the Medicaid program one price for drugs while offering discounts and special prices to other companies.

The companies had denied any fraud, contending they followed proper procedures in setting drug prices.

This week, St Louis University settled a law-suit by a whistle-blower who charged the university had defrauded the federal government by overcharging for public health research grants. Per the Associated Press, via the Kansas City Star,

St. Louis University has agreed to pay $1 million to resolve a whistleblower lawsuit claiming its School of Public Health tried to defraud the government, officials said Tuesday.

The lawsuit claimed the school overstated faculty time spent on projects involving federal grants.

The government will dismiss the lawsuit and the university will be subject to increased scrutiny in annual audits of federally funded research, U.S. Attorney David Nahmias said.

Nahmias said Andrew Balas, former dean of the School of Public Health, will receive $190,000 of the settlement for his role.

Balas alleged in the initial lawsuit in May 2005 that supplemental income of certain faculty members was inflated by claims of time they spent on grants received from the U.S. Centers for Disease Control and Prevention in Atlanta.

An investigation revealed that grants from the National Institutes of Health and the Department of Housing and Urban Development also were involved, with similar inflation of hours worked, Nahmias said.

University spokesman Clayton Berry issued a news release denying that the school schemed to defraud the government but said it agreed to settle to avoid legal costs.

Balas first tried to stop the improper billings within the university but was forced to resign for refusing to go along with them, said his attorney, Michael Sullivan.

Sullivan said the university’s evaluation of Balas’ performance as dean was '100 percent positive' in 2003, one year after he was lured from another school.

'Only weeks later, after protests from university employees who were profiting from the unlawful payments and wanted more, the university made sure Dean Balas knew that he was no longer welcome,' Sullivan said.

Finally, the former CEO of Transkaryotic Therapies, a biotechnology company, settled a lawsuit by the US Securities and Exchange Commission (SEC) that claimed he misled investors. Per the Boston Globe,

A former Transkaryotic Therapies Inc. executive agreed to pay more than $1.1 million to settle claims that he misled investors about problems facing the Cambridge biotech company's flagship drug, the government said yesterday.

The Securities and Exchange Commission accused former Transkaryotic chief executive Richard F. Selden, 49, of inflating the company's stock by making optimistic statements about the drug Replagal, which was intended to treat a rare disorder called Fabry's disease, while hiding the fact it failed a key clinical trial and that he knew federal regulators were likely to reject the company's application to market the drug. The SEC said the Food and Drug Administration told the company on several occasions that it needed further trials to win approval, something the company didn't tell investors before Selden sold 90,000 shares of company stock.

Ultimately, Transkaryotic's drug stumbled in the United States, and Selden was fired in February of 2003. British drug maker Shire PLC bought the company, known as TKT, for $1.6 billion in 2005....

The SEC sued Selden three years ago, accusing him of pocketing $1.6 million in illicit profits from selling the stock before telling investors the company's experimental drug was in trouble.

To settle the suit, Selden agreed to pay a penalty of $125,000 and give up $714,800 in profits from selling 90,000 shares of stock, plus $326,617 in interest.

Even I am sometimes amazed at the frequency of legal judgments and settlements involving accusations of fraud, or other dishonest or deceptive behavior by the leadership of health care organizations. Here were three, involving two pharmaceutical companies, a major university and school of public health, and a biotechnology company announced in the last 9 days. This indicates the pervasiveness of sleazy behavior amongst the leadership of all kinds of health care organizations.

It appears to me that there are more such judgments and settlements occurring that involve health care organization than involve other kinds of organizations and companies, although I have never seen any systematic data about this. This is particularly disturbing since one would expect that health care leadership ought to be held to a higher standard, than say the leaders of trash-hauling firms and used car dealerships.

Commercial Fund-Raises May Keep More Than Half the Money They Collect Ostensibly for Health-Related Charities

An article in the Los Angeles Times analyzed how much money a variety of charities, including some well-known health related charities, spend on commercial fund raising. In summary,

A Times investigation found hundreds of other examples of charities that pocketed just a sliver of what commercial fundraisers collected in their names. Some didn't get a dime or even lost money.

According to a comprehensive review of state records filed over a decade, the problem of paltry returns extends well beyond what has been reported in recent years among benevolent societies for police, firefighters and veterans. It affects charities large and small, well-known and obscure. It spans a range of causes, including child and animal welfare, health research and opposition to drunk driving.

In more than 5,800 campaigns on behalf of charities that were registered with the state attorney general from 1997 to 2006, the fundraisers reported taking in $2.6 billion. They kept nearly $1.4 billion -- about 54 cents of every dollar raised.

For-profit campaigns, which often employ telemarketing, mass mailings or one-time events, account for a small fraction of $223 billion in charitable giving each year in the United States. But they collect significant sums and help shape public perceptions of charities. Pairing computer-controlled dialing systems with low-wage workers, such firms can reach a large number of people in a short time.

The Times included a data-base which listed for each charity "all commercial fundraising campaigns reported to the state from 1997 through 2006, excluding those involving thrift store sales or vehicle donations. The data cover both California-specific efforts and national campaigns that included solicitations within California."

A few well-known national health care charities on the list received less than half the money their commercial fund-raising campaigns collected:

• American Diabetes Association 35.1%
• American Lung Association 31.8%
• Susan G Komen Breast Cancer Foundation 37.6%
• Arthritis Foundation (San Diego Area Chapter) 37.4%

Note that many more received barely more than half. Many more obscure health related charities also received less, sometimes much less than half.

So, if you get annoyed by those telemarketers who call you to raise money for a health care charity (despite your listing on the national "do not call list"), you have reason to be. Donations to some health care not-for-profits mainly benefit the fund-raisers they hire, rather than the causes the ostensibly support.

Once again, this demonstrates that some health care organizations seem to do a better job enriching the well-connected than fulfilling their missions.

WellPoint Settles, But Has It Become "Too Powerful to Take on?"

We just posted about the latest travails of the UnitedHealth Group, a for-profit managed care organization founded by one of the early advocates of managed care as the cure for health care problems. Lately, the company has been better known for the lavish compensation it gave its former CEO.

Another large, for-profit managed care organization/ health insurer has also lately been in the news, and not in favorable terms. We have previously discussed how Wellpoint Inc and/or its subsidiaries:

• misplaced a computer disc containing confidential information on 75,000 policy-holders (see post here)
• settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see post here)
• was fined for cancelling individual insurance policies (again in California) after their holders filed claims (see post here)
• was found to have mis-handled at least half of its revocations of individual policies (see post here)
• was accused of asking physicians to tattle on patients' problems that could be grounds for post-hoc revocation of their insurance policies (see post here).
  

Last week, the Associated Press (via the San Francisco Chonicle) reported that Wellpoint is so well known for its fierce legal tactics that the California agency which was supposed to fine it for its practices of cancelling individual health policies post-hoc never collected the fine.

California regulators admitted Thursday that for more than a year they didn't even try to enforce a million-dollar fine against health insurer Anthem Blue Cross because they knew they would be outgunned in court.

In early 2007, the Department of Managed Health Care pledged to fine the state's largest insurer for 'routinely rescinding health insurance policies in violation of state law.'

But it never did.

The department's director, Cindy Ehnes, said Thursday that, when it comes to rescissions, the agency has succeeded in forcing smaller insurers to reinstate illegally canceled policies and pay fines, but Blue Cross is too powerful to take on.

'In each and every one of those rescissions, (Blue Cross has) the right to contest each, and that could tie us up in court forever,' Ehnes said of about 1,770 Blue Cross rescissions since Jan. 1, 2004.

'They have the largest number of rescissions, so as a practical matter for the department it does present some practical challenges that are different from a Health Net (of California) or a PacifiCare,' referring to providers who, along with Kaiser Permanente, have made settlements with the state to reinstate health care coverage.
That means that although Anthem Blue Cross has the highest number of alleged illegal rescissions, it may face the least regulatory consequence simply because of its sheer size and its skill in legal intimidation.

Note that Anthem Blue Cross is now a Wellpoint Inc subsidiary.

Once this story came to light, the Associated Press again reported (per the San Francisco Chronicle),

California health insurance regulators are scrutinizing 1,770 patient policies canceled by Anthem Blue Cross to see if they can impose a penalty stiffer than a $1 million fine they announced but never enforced last year.

Each case of a canceled policy carries the possibility of a $200,000 maximum fine against the state's largest insurer, which could dwarf the now-abandoned 2007 fine.

Meanwhile, the company agreed to settle a set of lawsuits related to its policy cancellations (per the Los Angeles Times),

Anthem Blue Cross parent WellPoint Inc. agreed Monday to pay $11.8 million to settle claims from about 480 California hospitals that it failed to cover the bills of patients it dropped after they were treated -- a controversial practice known as rescission.

The hospitals, including most private and public facilities in California, say they provided emergency and authorized care to patients who were, at the time of treatment, Blue Cross members in good standing. Only later, they contended, did Blue Cross drop the patients and renege on its obligation to pay their bills.

So once again, we note a big health care organization whose actions seem to directly contradict its ostensible mission. The Wellpoint Inc statement of "Our Commitments" includes,

At WellPoint, we are dedicated to improving the lives of the people we serve and the health of our communities. From the boardroom to the mailroom, every associate is expected to honor the company's commitments to our diverse customers, fellow associates, shareholders and the communities we serve - helping us become the most trusted choice among consumers.

Our business strategies mirror our commitment to providing affordable quality care to our members and the public. In line with our vision to become the most valued company in our industry, we must:

* Bring affordable quality health care and coverage to medically underserved communities
* Educate people to take an active role in their own health
* Work with our health care partners to improve quality of care
* Help shape public policy that makes health care more affordable and more accessible

Say what? How in the world does this company expect to be "the most trusted choice" given its track record above? How does cancelling policies post-hoc after their holders get sick "make health care more affordable and accessible?"

Note that WellPoint seems to rival its main competitor, UnitedHealth Group, in the extent its actions contradict its ostensibly lofty ideals.

This sorry tale suggests another point. As health care organizations grow ever bigger and more powerful, they effectively become less accountable. Effectively, might makes right. Note that the initial response of state regulators to just one set of Wellpoint's problems was that the company has just too big, powerful and aggressive to take on.

This has become the story of our health care system. Increasing concentration of power leading to ever stronger and less responsible and accountable vested interests. It will take united action by health care professionals and the public to fix this mess.

UnitedHealth Settles

We had posted often (see these posts here, here, and here from 2006 with links backward) about the hugely lavish compensation afforded to the Dr William McGuire, former CEO of UnitedHealth Group, one of the largest US insurers/ managed care organizations, and how this remuneration stood in stark contrast to the (older version of the) stated mission of UnitedHealth Group:

UnitedHealth Group is a diversified health and well-being company dedicated to making the health care system work better. The company directs its resources into designing products, providing services and applying technologies that:
- Improve access to health and well-being services;
- Simplify the health care experience;
- Promote quality; and,
- Make health care more affordable.

Most recently, controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here). More recently, McGuire agreed to pay back some of those options, although that settlement would reportedly leave him with more than $800 million worth of options at the time (see post here).

Once again, it seems that in retrospect, Dr McGuire's conduct stood in sharp contrast to the lofty sentiments expressed in UnitedHealth's mission statement. It also stood in stark contrast to the lavish praise once heaped upon him. A 2006 Pulitzer Prize winning article in the Wall Street Journal quoted UnitedHealth director and Dean of the Columbia University School of Nursing Mary Mundinger, "We're so lucky to have Bill. He's brilliant."

The latest consequence of how UnitedHealth was lead appeared last week. As reported by Bloomberg News,

UnitedHealth Group Inc. agreed to the biggest settlement of lawsuits involving backdated stock options and said the company would trim 4,000 jobs after its membership fell and expenses for providing medical coverage rose.

UnitedHealth, the largest U.S. health insurer, said today it would pay $912 million to end two class-action cases over grants of stock options to executives.

The proposed legal settlements announced today consist of $895 million to the plaintiffs in a group led by the California Public Employee's Retirement System, and $17 million to a group of plaintiffs led by Matthew Zilhaver and Sascha Lynn.

The UnitedHealth settlements, if approved by all parties and the courts, would end these two lawsuits with no admission of wrongdoing by past or current company officials, said UnitedHealth Chief Executive Officer Stephen Hemsley today on a conference call with analysts.

In December, McGuire agreed to increase to more than $600 million his repayment of benefits after an investigation of stock options that investors claimed in another lawsuit were illegally backdated. That settlement hasn't been approved by the court. Federal securities and criminal investigators are still probing the matter.

Another day, another settlement (by a big health care organization accused of unethical practices.)

At one time, managed care was touted as the cure for the US chronic health care problems of increasing costs, declining access, and stagnant quality. UnitedHealth, in fact, can trace its roots to Dr Paul Ellwood, one of the leaders of the Jackson Hole Group and a leading proponent of managed care. The transformation of a company with "innovation ... in [its] DNA" to a company that seemed to spend a lot of its resources enriching its then CEO suggests a common theme in what has gone wrong with US (and global) health care. Organizations hyped as solutions to the problems turn into vehicles for enriching their insiders.

Maybe the current woes of UnitedHealth will lead to health care organizations with more accountable, representative, transparent and consciously ethical governance, given incentives to actually provide good health care rather than perform clever financial manipulations that benefit the well-connected.

More Watchdogs Who Did Not Bark: the UCU Ignores Dr Blumsohn

We posted first here in 2005, then here, here, here, here, here, here, here and here about the story of Dr Aubrey Blumsohn's dispute with Procter and Gamble (P&G) and the University of Sheffield in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Some of the analyses done by P&G seemed biased in favor of the drug. Despite repeated attempts, P&G would not give Blumsohn access to the raw data of the project. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him. As far as I can tell, he eventually lost his academic position at the university, and has not been rehired. Also as far as I can tell, these events have never been the subject of open hearings at the university, or of investigations by any outside body.

This week, Dr Blumsohn, who now has quite a following (currently #53 on the Healthcare100 hit parade) for his Scientific Misconduct Blog, posted about the lack of response to a letter he wrote in 2005 to the UK Association of University Teachers (AUT), which later merged with another organization to form the University and Colleges Union (UCU). He also noted that the UCU has failed to respond for an even longer time to the case of a faculty member at another university who was dismissed apparently after her research (about the politically controversial topic of the characteristics of people seeking asylum in the UK) was found to be "incompatible" with that university. It is unclear why the UCU has ignored two cases in which universities sacrificed their faculty members' academic freedom to avoid offending the powerful. It is disgraceful that the case of Dr Blumsohn has never been publicly revisited at the University of Sheffield, and never been investigated by any academic or medical organization.

What befell Dr Blumsohn has been a continuing motivation for us to at Health Care Renewal. Sadly, it is hardly the only case of medical and health care academics who suffered because because what they said or wrote, no matter how true, offended those in power. Credible medical and clinical science will not long survive when scientists cannot draw conclusions that threaten vested interests. Academic medicine's credibility will not long survive in the absence of academic freedom.

Key Opinion Leaders, Drugs for Smoking Cessation, and Transparency as a Cause of "Confusion"

A perspectives article from the April 1 issue of the Annals of Internal Medicine has provoked a slowly growing controversy. (1) Let me summarize the main points of the article before getting to the controversy.

As the title, "the case for treating tobacco dependence as a chronic disease," suggests, the authors argue "for some smokers, long-term pharmacotherapy [which] is the difference between tobacco abstinence and lifelong smoking," based on the argument that smoking is like a chronic disease.

They called for long-term use of pharmacologic treatments for tobacco addiction, including nicotine replacement therapy (NRT), buproprion, and verenicline, asserting that these drugs are safe and effective, and have "proven benefits." Such proven treatments, therefore, ought to be used long term.

Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed.

Rather than considering cessation medications as a short-term aid in smoking cessation, these medications should be covered in the same manner as the treatment of other long-term illnesses and conditions, such as asthma, depression, and diabetes....

However, their enthusiasm for pharmacologic treatment for smoking cessation, even in the short-term, seems to go beyond the evidence. That evidence shows that the "proven benefits" of these treatments do not accrue to the majority of patients receiving them. For example, in one widely disseminated study comparing verenicline, buproprion and placebo, the proportions of patients who were abstinent for one year (the duration of follow-up) were 21.9% for verenicline, 16.1% for bupropion, and 8.4% for placebo. Although the most effective drug, verenicline, more than doubled the continuous abstinence rate compared to placebo, the large majority of patients treated with that drug, 78.1%, did not achieve continuous abstinence, even for one year.(2) In another recent study, patients given verenicline were somewhat more likely to be abstinent at the end of a year (26.1%) than those treated with nicotine patches (20.3%), although the difference did not reach statistical significance.(3) However, again the great majority of patients treated with either medicine were not continuously abstinent, even for one year.

Thus, most smokers treated with drugs will not remain abstinent from smoking, even for one year. Furthermore, I am aware of, and Steinberg et al did not cite any data from controlled trials about the safety or effectiveness of any pharmacologic treatments of tobacco addiction for patients followed for more than one year. There is no reason to suspect that these drugs' effectiveness over the long-term would be any better than their rather marginal effectiveness when when used short-term.

In my humble opinion, Steinberg et al might have been able to make a case for controlled trials of these drugs' use that would follow patients for more than one year. But they presented no evidence to support the clinical use of these drugs, much less insurance company reimbursement for them, for time periods longer than those found in the published trials.

So why did these authors make arguments that went beyond the evidence?

Soon after the article came out, Adriane Fugh-Berman and Douglas Melnick, writing in the Bioethics Forum, noted:

The most important section of this article is the conflict of interest statement. The two authors who have advanced degrees are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline, and Celtic Pharma. Pfizer makes varenecline (marketed under the brand name Chantix) and Nicotrol, a nicotine nasal spray. GSK makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (buproprion, which GSK also sells as an antidepressant under the name Wellbutrin). Novartis makes Thrive, a nicotine chewing gum ('thrive,' which means to prosper or flourish, seems a rather peculiar association for a delivery system for an addictive drug.) And Celtic Pharma is developing TA-NIC, a nicotine vaccine.

Furthermore, last week, an article in BusinessWeek provided more information about the financial ties of two authors of the Steinberg et al paper.

In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix. The company also selected Foulds and Steinberg to be 'key opinion leaders,' sending them to talk to doctors about Chantix over fancy dinners and paying them each $900 per presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.

Steinberg received a $30,000 grant from Pfizer in April 2007 to study the effect of Chantix on patients forced to forgo cigarettes while hospitalized for other illnesses. He says this was his first research grant from a drug company. (The Robert Wood Johnson Foundation separately provided $300,000 for the hospital study.)

Steinberg, according to BusinessWeek, denied that he is influenced by his ties to Pfizer:

Adamant that his work for Pfizer and other drug companies poses no problem, he adds: 'We look at the data, and we look at our own clinical experience.'

While the authors disclosed the nature but not the effect size of their financial relationships in the Annals of Internal Medicine article, they were not so forthcoming to their patients. Per BusinessWeek,

Both doctors stress that it's not standard practice to tell patients about potential conflicts.

On the Web site for UMDNJ's smoking clinic, it's not easy for a layman to find disclosures. There is no clearly labeled list of companies that pay Foulds and Steinberg that is directly accessible from the home page. There are links to journal articles, some of which reveal industry ties. But getting the information takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix.

Foulds includes a broadly worded disclosure on his blog, but doesn't name companies for which he consults.

Finally, neither author saw the need to provide more disclosures to patients.

Telling patients more about industry ties 'would just puzzle them,' Foulds says.

Steinberg sees no need to be more forthcoming. His passion for helping people quit is fueled by treating numerous cases of high blood pressure and other problems precipitated by smoking.

To add a final touch, Cathryn M Clary, vice president for external medical affairs for Pfizer, "fears too much transparency will cause confusion,"

The more information that's out there, the more difficult it will be for patients to process

There has been a good deal of discussion about drug, biotechnology and device companies paying "key opinion leaders" to help market these products (for example, see these posts here and here). And there has been a good deal of indignation that it is an affront to physicians to judge the content of medical education they provide based on who paid for it (see this link.)

Although the case of the Annals article is essentially only an anecdote, it does suggest an association between payments to key opinion leaders, and opinions that are more enthusiastic about the payers' products than the evidence seems to warrant.

Furthermore, it suggests that key key opinion leaders and the companies who sponsor them may dismiss transparency about their financial relationships as a cause of "confusion." If patients really are too naive to understand the implications of payments by drug and other commercial firms to key opinion leaders, would the KOLs and their patrons prefer that government step in to protect these poor, naive patients from such relationships they cannot understand? That is what their attitude seems to invite.

References

1. Steinberg MG, Schmelzer AC, Richardson DL, and Foulds J. The case for treating tobacco dependence as a chronic disease. Ann Intern Med 2008; 148: 554-556. Link here.
2. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al. Verenicline, and alpha-4-beta-2 nicotinic acetylcholine receptor partial agonist, vs sustained release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006; 296: 47-55. Link here.
3. Aubin HJ, Bobak A, Britton JR, Oncken C et al. Verenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax 2008. Link here.

BLOGSCAN - Evidence? We Don't Need No Stinkin' Evidence

The New York Times recently reported on the rush to use advanced CT scans for cardiologic diagnosis, in the absence of much evidence that this expensive technology works. Merrill Goozner on GoozNews, and Matthew Holt on the Health Care Blog offered some pithy comments. My jaw dropped at this quote in the Times article:

It's incumbent on the community to dispense with the need for evidence-based medicine.

As Goozner wrote, when self proclaimed experts (perhaps key opinion leaders) are convinced they are right, they don't need no stinkin' evidence.

ADDENDUM (2 July, 2008): Dr Wes also weighed in, with considerable skepticism. His post is an excellent primer about how the test is actually done, its drawbacks, and the lack of evidence supporting its use except in special circumstances.

BLOGSCAN - Why Are Conflicts of Interest Important?

On the PharmaLot blog, Ed Silverman interviewed Eric Campbell about why conflicts of interest are important in clinical research and medical education:

It matters because patients rely on the advice and the wisdom of their doctors in making health care decisions. And they rely on the fact that their doctor has their best interests at heart and that academic science is true and unbiased and not influenced by commercial pressures. So when conflicts of interest exist, it brings into question the basic trust and value of these relationships. It’s important for Americans that institutions take these relationships very seriously, and that they’re disclosed and watched and monitored. Remember that not all academics, but many are opinion leaders in medicine - they lead a specialty, head a professional association and are well known. If one of them makes a presentation about a beneift of a drug, it can influence the reaction of doctors in the audience and the doctors they know. So it’s important to know the nature of these relationships. Disclosure becomes a necessary step but it’s not a sufficient step.

More Multi-Million Dollar Orthopods

Starting last year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

I was surprised how little attention this issue received in the media, given the size of the payments involved, and the extensiveness of the lists of those who received them. Demonstrating the anechoic effect, the issue received almost no attention in any medical or health care publications. Yet every now and then, the story resurfaces.

This week, it resurfaced courtesy the Philadelphia Inquirer, which published two related articles. The most vivid was about a lawsuit filed by a patient who received artificial hip implants that failed. MedInformaticsMD quoted relevant parts of the article and commented on some issues related to the above story here.

The Inquirer also published a companion story with background information on payments made by hip and knee implant manufacturers. Reporter Josh Goldstein took the opportunity to look into payments made to other Philadelphia area surgeons.

Locally, 29 doctors and others received a total of $7.9 million last year. Most of that money went to two of the region's busiest and most prominent orthopedic surgeons.

Richard H. Rothman, founder of the Rothman Institute at Thomas Jefferson University Hospital, received nearly $3 million last year from Stryker. A Rothman spokesman said most of that money came in royalty payments for a hip Rothman helped design.

The other surgeon, Robert E. Booth Jr., who practices at Pennsylvania Hospital, received nearly $2 million from Zimmer Corp., the company that makes the so-called gender knee for women. Booth is one of eight patent holders on it.

Both doctors declined to be interviewed. Through spokeswomen, they said they disclose their company ties to patients. There is no indication that either have engaged in any wrongdoing.

Indeed, many patients seek out surgeons like Booth and Rothman, who help design implants, precisely because they are known as pioneers in the field.

At 72, Rothman, the former chairman of orthopedic surgery at Jefferson, remains busy, replacing more than 600 hips and knees a year. Implants cost as much as $7,500 each.

According to Stryker's disclosures, the company paid Rothman $2.9 million in 2007. In addition, Rothman received $316,885 in "corporate assistance" for research, $52,906 in air travel, $4,705 for ground transportation, and $1,757 in meals.

'The vast majority of payments Dr. Rothman receives from Stryker are royalties for the Accolade hip implant,' said a statement provided by the practice he founded, the Rothman Institute.

At Pennsylvania Hospital, Booth, one of the nation's busiest knee surgeons, routinely replaces a knee in under a half hour - 12 to 14 a day, or about 1,200 a year.

Last year, Zimmer paid Booth $1.9 million, plus $35,729 in air travel, $3,135 for lodging, $1,214 for meals, and a $6 gift.

Susan E. Phillips, a senior executive at the University of Pennsylvania Health System, said Booth's contract with Zimmer prevents him from discussing royalties.

The articles focused on the question of whether these sorts of humongous payments were disclosed to patients, or whether they affected direct patient care by the surgeons who received them.

Since some breathtakingly huge payments were made to apparently very influential surgeons, I wondered if the surgeons disclosed such large payments to other doctors who might be influenced by their words.

In the articles I was able to quickly access published by Rothman during 2007, I found some disclosures of his relationship to Stryker, but none that revealed their magnitude. (These do not constitute a complete sample of his publications, just what I could easily obtain on the web.)

Lettich T, Tierney MG, Parvizi J, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: two- to seven-year results. J Arthoplasty 2007; 22 (Suppl 3): 43-46.

Richard H. Rothman MD, PhD and ... are consultants for Stryker orthopedics.

Pour AE, Parvizi J, Sharkey PF, Hozack WJ, Rothman RH. Minimlly invasive hip arthoplasty: what role does patient preconditioning play? J Bone Joint Surg 2007; 89: 1920-1927.

In support of their research for or preparation of this manuscript, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Stryker.

I was able to access one article written by Booth in 2006, and one in 2004. Again, neither revealed the magnitude of his relationship to Zimmer.

Lonner JH, Jasko JG, Booth RE. Revision of a failed patellofemoral arthroplasty to a total knee arthroplasty. J Bone Joint Surg 2006; 88: 2337-2342.

In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from Zimmer, Inc. In addition, one or more of the authors received payments or other benefits or commitment or agreement to provide such benefits from a commercial entity (Zimmer, Inc.) Also, a commercial entity (Zimmer, Inc.) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or non-profit organization with which the authors are affiliated or associated.

Bezwada HP, Nazarian DG, Booth RE. Acetabular wear in total hip arthroplasty. http://www.emedicine.com/orthoped/TOPIC371.HTM.

Nothing to disclose.

In my humble opinion, a disclosure that a journal article's author received some sort of "grants" or "payments" from a company does not quite have the impact of a disclosure that the author received millions of dollars in royalties. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for joint replacement, or for replacement in specific circumstances or with specific products, might just have been a bit influenced by making millions of dollars a year in royalties from specific joint implants.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from royalty payments enough to make a doctor quite rich? Inquiring minds want to know.

Seeing the Trees But Missing the Forest: On Another Insidious Effect of Payment to Doctors by Medical Device Companies

As a Medical Informaticist with experience in building very specialized information systems for highly specialized medical areas (e.g., population genetics & birth defects; invasive cardiology), certain issues are readily apparent that I believe get missed by others studying the nasty phenomenon of physician payments by medical device makers and merchants.

One issue that emerges is the insidious effect such payments may have on the "nuances" and "creative license" a physician might take on reporting the data.

In fact the entire clinical trials process becomes suspect, perhaps even more so than in pharmaceutical industry. Here is why.

The following story appeared today in my local paper, the Philadelphia Inquirer:

"After hip replacements, a lawsuit: Implant company paid Penn surgeon consulting fees."

Fed up with the constant pain in her hips, Katrina McKenzie took her surgeon's advice and had them replaced with experimental implants. [Civil docket report here - ed.]

The 31-year-old from Galloway, N.J., who agreed to participate in a clinical study, knew there was a risk that her new hips could fail.

But she didn't know that the manufacturer financing the study, Smith & Nephew, was also paying her surgeon tens of thousands of dollars a year as a consultant.

In recent years, such payments to doctors from medical implant manufacturers and drug companies have become increasingly controversial.

Some leading orthopedic surgeons receive six- and seven-figure payments annually, in the form of royalties, consulting deals and speaking fees from the makers of artificial hips and knees.

... Garino and Penn responded, in court filings, that McKenzie received good care and that the payments had no effect on her treatment.

"On the merits of the medicine, we are going to vigorously defend this case," said Susan E. Phillips, spokeswoman for the Penn health system....

In his deposition, Garino said that while Smith & Nephew sponsored the study, he did not receive any direct financial benefit. The company paid Penn for the surgeon's time and expenses.

However, under questioning from one of McKenzie's lawyers, Garino acknowledged that he was being paid for other work by Smith & Nephew - which he did not disclose.

At the time of McKenzie's surgery, Garino estimated, he was making "$20,000 to $50,000 annually" as a Smith & Nephew consultant.

Note the statement made by the treating surgeon that "the payments had no effect on this patient's treatment."

Let me show how such a statement, if it is being reported correctly, is disingenuous at best and downright sleazy at worst.

I shall do this via a series of questions. First, however, read this case study on the difficulties of building specialized information systems to evaluate complex new treatments and technologies: link.

My questions are:

• Who builds the datasets and analytics used in evaluation of new medical devices such as the implants mentioned in the Inquirer article? This is a extremely complex process, filled with nuance and "devil in the details" issues due to the complexity of biomedical science.
  
• Is it the device vendor/merchant?
• Could that be a problem in terms of the dataset elements, definitions, terminologies, data quality, and other factors affecting the transparency of results?
• Are medical informatics professionals - that is, experts formally trained in this activity - or others with comparable expertise involved at the vendor shop or at the healthcare organization then deploying the new devices?
• If not, why not?

In fact, a comprehensive dataset to study invasive cardiology alone ran several hundred data elements. It took months of effort working with a team of committed invasive cardiologists to develop the dataset to match the clinical realities of the field, as well as teach quality recordkeeping (i.e., each clinician needed to have the same understanding of what was meant by each term, down to a fine grained level).

Each case was reviewed by a neutral "data quality" evaluator as well before entered into a robust database with advanced metrics, again developed and refined over several months by the same team.

As the medical informaticist, I steered the development based on my knowledge of biomedical information science, relational database technology, and of medicine. That raises more questions:

• What training do the surgeons who implant orthopedic devices get in recording their data?
• Who does this training? What are their backgrounds?
  
• What motivations might they have to "go easy on the reporting", i.e., blur their findings and and "which box they check on the data collection form" when a potentially bad thing happens? In medical data, this is easy to do, even innocently, let alone when one has motivation - e.g., when one is being paid handsomely by the device maker or seller and consciously or unconsciously seeks not to harm the gravy train.
  
• Do neutral QC person(s) check for this possibility?
• If not, why not?
  

I suggest to malpractice attorneys that they seek answers to these questions. It is negligent for a device manufacturer and medical center not to employ the very best "standard of care" regarding clinical datasets, in my opinion.

There are certainly many, many issues surrounding the quality of pharmaceutical clinical trials data, which to a certain extent are done in a secretive manner. Device trials are likely worse.

Who polices clinical trials data for, say, the new implants that caused the patient in the Phila. Inquirer article her problems?

The answer likely will not be pretty.

In summary, payments to doctors not only may affect their judgment on which devices to use and how often, but also on reporting the issues (using datasets that themselves may be compromised by vendor involvement). "Reportable" issues are often very subtle and amenable to being masked by "spin", "blur" and "invisibility."

I believe this issue is under-represented in considering the effects of payments to doctors, and in litigation when bad things happen.

This needs to change.

-- SS

STANFORD, SCHATZBERG and CORCEPT THERAPEUTICS: RECOGNIZING and MANAGING CONFLICTS

STANFORD, SCHATZBERG and CORCEPT THERAPEUTICS: RECOGNIZING and MANAGING CONFLICTS

The case of Stanford University and Dr. Alan Schatzberg, chairman of Stanford’s department of psychiatry, has been in the news for a week. Senator Grassley raised concerns about conflicts of interest, reporting of same, and Stanford’s policies. In play are a company called Corcept Therapeutics that Dr. Schatzberg founded, and a drug called Mifepristone or RU 486 that is in clinical trials for a severe form of depression. Interest in this case is especially high because Dr. Schatzberg is the president-elect of the American Psychiatric Association. Daniel Carlat, Clin Psych, and University Diaries have had cogent commentaries on the wider implications of this breaking issue.

The University issued a statement in response to Sen. Grassley. This statement asserted that Dr. Schatzberg has fully complied with the University’s rigorous conflict of interest policy and that Dr. Schatzberg “has not been involved in managing or conducting any human subjects research involving Mifepristone, a pharmaceutical that Corcept licenses for the treatment of psychotic major depression.”

Stanford’s account of Dr. Schatzberg’s arm’s-length role in Stanford’s NIH-supported studies of RU 486 (mifepristone) for depression is questionable, if not disingenuous. Dr. Schatzberg’s patent application filing for use of RU 486 in depression occurred in 1997, and he founded the corporation Corcept Therapeutics in 1998. He was a member of the board of directors from 1998 to 2007. He has chaired the corporation’s scientific advisory board since 1998.

There is reason to believe that Dr. Schatzberg had a key role in Stanford’s clinical trials of Corcept’s drug reported in 2001, 2002, and 2006. He was a co-author on all three publications, and there was no disclaimer about his role until 2006. This disclaimer is hardly credible. As Principal Investigator on the NIH grants, Dr. Schatzberg was expected to supervise the junior faculty and research staff at Stanford who recruited, assessed, and treated patients in the studies of RU 486. He was responsible for the choice of outcome measures, about which questions have been raised. He was responsible for the quality of the reported data analyses, which were, frankly, inexpert, when they were provided at all. Above all, he was responsible for the tone of the NIH-supported Stanford publications that claimed Corcept’s drug is effective.

If there were any doubt that Dr. Schatzberg’s hands were all over these Stanford studies, one only has to see the record of his leading role in responding to scientific critiques of their design, execution, analysis, and interpretation. He was clearly the manager.

Moreover, the record is clear that Corcept relied on the NIH-supported Stanford publications for positive claims to enable the corporation to raise capital (well over $100 million by now, with nothing to show for it). Corcept’s own Phase III clinical trials have been uniformly negative. For this strategy to succeed, the Stanford trials had to be portrayed as positive. As Paul Jacobs detailed in the San Jose Mercury News in 2006, using independent statistical experts, Dr. Schatzberg and his Stanford/Corcept colleagues made seriously exaggerated claims for the drug’s efficacy in their 2001 and 2002 publications. These exaggerated claims have been assiduously repeated by Dr. Schatzberg, by Stanford faculty members answerable to him, and by academic members of Corcept’s scientific advisory board in many scientific journals and textbooks. All these testimonials are compromised. The effect of these repeated, unjustified, claims is to raise the profile of the corporation and of the drug. It amounts to public relations and branding through academic outlets. Roy Poses on this site has dissected the scientific credibility of claims for the utility of RU 486 in depression.

Far from being removed from the scientific debate about Corcept’s drug, Dr. Schatzberg has had the leading role in “selling” the story to the scientific community, in “defending the brand” against scientific criticisms, and in providing his corporation a plausible story line to attract new capital. It was Dr. Schatzberg who talked about how the drug “may be the equivalent of shock treatments in a pill” in a 2002 Stanford press release. There is no clear boundary between Dr. Schatzberg’s NIH-supported academic roles and his service to the corporation he founded. As for not being involved in the management of the Stanford projects, Dr. Schatzberg acknowledged to Paul Jacobs of the San Jose Mercury News “that he has considerable influence over the junior faculty members doing the studies. As chairman of psychiatry, he helps set their salaries and can affect their career advancement. And he continues as a co-author of the resulting papers.”

I have already commented on Dr. Schatzberg’s efforts to sell large parcels of Corcept stock during the company’s IPO attempts. Had these efforts been successful, Dr. Schatzberg would have benefited by $7-11 million, while still retaining over 2 million shares of Corcept stock. This aspect of the issue troubles many people. In our capitalist system, considered so necessary for developing innovative drugs, nobody complains when an entrepreneur makes a fortune inventing a useful product. Dr. Schatzberg’s apparent intent, however, was to reach for the reward before contributing any product of redeeming social value. The prospects of RU 486 succeeding as a useful treatment of psychotic depression are close to zero. People view such behavior as gaming the system. Moreover, under Stanford’s existing rules, these projected stock sales might never have been reported.

Are these significant conflicts of interest? Yes. Have they “influence(d) the conduct of medical research” at Stanford (quoting now from Stanford’s June 24 statement)? Yes. Dr. Schatzberg’s NIH grants dovetail with the efforts of his corporation, and the corporation used data from the NIH-grant-supported projects for commercial promotion. Had the corporation not existed, these particular grants likely would not have been initiated or would have had different scientific emphases. Has Dr. Schatzberg’s research “been compromised by his financial stake”? Yes. His academic publications on depression and RU 486 are compromised by exaggerated and self-serving claims for his corporation’s drug. Senator Grassley is right: it is time for Stanford to get real about corporate-academic boundaries.

An Open Letter to Merck CEO Richard Clark: on Merck's Mission to Rediscover the Wheel

Preliminary notes (as background to better illustrate the context of the Open Letter, below):

I found the recent article "Merck's Informatics Mission" in the journal Bio-IT World enlightening. It resulted in an Open Letter to Merck CEO Richard Clark, reproduced below these notes.

I believe what I have to say is important to the Company. While I hold no financial stakes in it or in other pharmas whatsoever, I live in a Merck community a stone's throw from the West Point site. The fate of Merck is the fate of my community.

As readers of healthcare blogs know, I have frequently written about the lack of formally-trained Medical Informatics specialists in the pharmaceutical industry. See "An Open Letter to Senator Grassley", "Why Pharma Fails", "Drug industry officials see room to improve safety - or do they?", "FDA's hefty bonuses seek to retain workers" and "CRO's: we don't need Medical Informatics here" as examples.

I do not believe ignoring an NIH-supported informatics subspecialty (Medical Informatics) -- which Merck and other pharmas seem to do quite effectively, allowing IT and bioinformatics territoriality and ego to run unchecked -- and adhering to the "data processing" paradigms of the past are a good strategy for an "Informatics Mission" in an industry in serious trouble. I do not believe such an approach is fair to stockholders, institutional investors, and patients. I once fought this scenario as an insider; now I describe it as a service to others who might wish the pharma industry to perform better.

As a Medical Informatics specialist, I also observed that it seemed difficult for pharma IT personnel to grasp the difference between information science and information technology, resulting in direct harm to R&D (see "Conflation of Information Science and IT: Sure path to R&D failure"). Expertise in IT does not imply or confer expertise in information science, but the belief that the two are identical is canon in industry.

As a practical result of this 'canon', IT personnel generally lead all information activities in pharma. Such leadership models are based on the historical and, I believe, now obsolete premise generally held by the technology-naive (often senior management) that "if it's information, the IT people do it."

The priorities in Medical informatics are biomedical information science and use of information by people, not IT. We see IT as a tool, but are not awed by it and do not "worship at its altar." IT is a facilitator in biomedicine, not an enabler.

Knowledge of these differences between technologists and information scientists is growing. For example, my college, the iSchool at Drexel, is one of the growing consortium of iSchools:

The iSchools are interested in the relationship between information, technology, and people. This is characterized by a commitment to learning and understanding the role of information in human endeavors. The iSchools take it as given that expertise in all forms of information is required for progress in science, business, education, and culture. This expertise must include understanding of the uses and users of information, as well as information technologies and their applications [note the order of these issues - ed.]

In this context, I am writing this open letter to Merck CEO Richard Clark:

----------------------------------------------------------------

The letter:

Dear Mr. Clark,

I found the recent article " Merck's Informatics Mission" in the journal Bio-IT World fascinating - and frightening.

Right at the opening of the article, it is stated:

After five years at the helm of Merck's basic research IT group, Ingrid Akerblom [Ph.D. in biology] calls her move to the clinical side "quite an eye opening experience."

In other words, Mr. Clark, this is a "new experience" for a novice in clinical medicine and clinical IT. It causes me, as a Medical Informatics specialist, to ask why your IT leaders are calling the clinical side "quite an eye opening experience" (a stunning admission). Worse, they are not seeking help from those who have expertise in clinical medicine, EMR's and related clinical IT, Medical Informatics experts.

I suggest Merck's Informatics Mission might better be run with increased attention to state of the art talent management. I wish to make you aware of issues that may prevent that.

Please review my letter published in the same Bio-IT World six years ago, in 2002 when I was Director, Published Information Resources & The Merck Index in MRL:

http://www.bio-itworld.com/archive/081302/letters.html

Medical Informatics MIA

I enjoyed reading the article " Informatics Moves to the Head of the Class " (June Bio·IT World). Thank you for spotlighting the National Library of Medicine (NLM) training programs in medical informatics and bioinformatics, of which I am a graduate (Yale, 1994).

Bioinformatics appears to receive more media attention and offer more status, career opportunities, and compensation than the less-prestigious medical informatics.This disparity, however, may impede the development of next-generation medicines. Bioinformatics discoveries may be more likely to result in new medicines, for example via pharmacogenomics, when they are coupled with large-scale, concurrent, ongoing clinical data collection. At the same time, applied medical informatics, as a distinct specialty, is essential to the success of extensive clinical data collection efforts, especially at the point of care.

Hospital and provider MIS personnel are best equipped for implementing business-oriented IT, not clinical IT. Implementing clinical IT in patient-care settings constitutes one of the core competencies of applied medical informaticists.

Informatics specialists with a bioinformatics focus — even those coming from the new joint programs — usually are not proficient in hospital business and management issues that impede adoption of clinical IT in patient care settings. Such organizational and territorial issues are in no small way responsible for the low utilization of clinical IT in patient care settings.

It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data.

Further information on these issues can be found in the book Organizational Aspects of Health Informatics: Managing Technological Change , by Nancy M. Lorenzi and Robert T. Riley (Springer-Verlag, 1995). Various publications from the medical informatics community, such as the American Medical Informatics Association (www.amia.org) and the International Medical Informatics Association (www.imia.org), are also useful.

Also review what the Institute of Medicine of the National Academies had to say:

Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate (The Future of Drug Safety: Promoting and Protecting the Health of the Public, IOM, 2006)

In that same year, Gartner had this to say:

Biopharmas that ignore the opportunity to use analytical tools to proactively review contradictory sources of study information (for example, pre- and post-approval clinical data sets, as well as registries) will miss essential signals regarding product safety. Yet today, only a small percentage of biopharmas routinely utilize personnel with medical informatics backgrounds to search for adverse events in approved drugs (Gartner Predicts, 2006).

The IOM and Gartner are referring to those with formal education and experience in Medical Informatics, not personnel who use the name because they do something with computers in biomedicine (see "What medical informatics is not").

While I know a number of people mentioned in the Bio-IT "Informatics Mission" article and respect their specific skills, I must point out that the "clinical side" is "not an eye opening experience" to those formally trained in Medical Informatics. It is our natural environment.

Mr. Clark, did you know that as far back as 1969, EMR and Medical Informatics pioneer and program funder Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, wrote the following? "Computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

Surprisingly, there has been little change in this issue in thirty-five years. Today the IT personnel and non-medical managers (e.g., non-degreed IT staff, BS or MS in computer science, MBA's, even PhD's) who by custom and tradition are assigned leadership roles in EMR and clinical data research initiatives via control of critical decisions, budgets and resources, often lack clinical experience and insight. Yet, as Medical Informatics researchers Nemeth & Cook wrote more recently in 2005,

"The technical work that clinicians perform is hiding in plain sight. Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it" (Hiding in Plain Sight: What Koppel et al. tell us about Healthcare IT” (Nemeth & Cook, Journal of Biomedical Informatics 2005;38:262-263, link to pdf).

Specifically, personnel of an information technology background, with little or no background in the biomedical sciences, often are positioned by senior management as enablers, rather than facilitators, of such initiatives. They retain a major say in what is -- and is not -- done, and in the tools provided to perform clinical care and biomedical R&D.

Also noted in the "Merck's Informatics Mission" article are Bioinformatics specialists. Please read my 2002 article, Mr. Clark, and note that Bioinformatics is not Medical Informatics, and IT is not Medical Informatics. Medical Informatics is its own specialty, funded by NIH for at least the past two decades.

Training the Next Generation of Informaticians - A Report from the American College of Medical Informatics. J Am Med Inform Assoc. 2004 May–Jun; 11(3):167–172 (pdf at this link).

Essentially, your IT and Bioinformatics colleagues will spend the next several years learning and re-learning all the lessons of Medical Informatics that those in the field learned 10-15 years ago (e.g., at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare IT Failure" at this link), at Merck's and shareholder's expense. They will make mistakes, take wrong turns, miss subtle issues, and drive up costs and timelines while missing opportunities, at the expense of the business.

EMR's, clinical IT, 'real-world' (as opposed to controlled clinical trials) clinical data and the often subtle and sociotechnically complex issues around them are neither simple nor easily learned, most especially by non-clinicians. See here for just one recent example of unforeseen complexities (unforseen by those who do not understand the issues, that is) surrounding IT in clinical settings.

At the end of the Bio-IT World article are a series of questions posed, as in the following examples. I comment:

... in the clinical sample area, combining the results data from clinical samples with the associated patient data, what's that platform?

[Mr. Clark, could this be the wrong question, based upon an IT person's technology focus as opposed to, say, a focus that is about facilitating people in interacting with data? Is a "platform" the answer, or is an advanced approach to the problem the answer? We in medical informatics thought about these issues long ago.]

... I know there are new commercially available things coming out like Azyxxi from Microsoft

[Mr. Clark, do you think there is a possibility this may be the wrong paradigm for this type of activity? Do you think there is a possibility that Medical Informaticists with practical experience in Clinical Data Repository implementation supporting concurrent medical care in large medical centers might actually be knowledgeable, in a very strategic sense, regarding these issues?]

... So we need to be looking at what's out there, what's the gap, and do we put something together ourselves?

[Mr. Clark, why is a 100-plus-year-old pharma company even asking such a question, especially without formal Medical Informatics expertise?]

... We're embarking on an electronic medical records (EMR) strategy looking for signal detection among other uses.

[Mr. Clark, what took so long? Who, exactly, has research and applied EMR experience there? Do your people assume that clinical IT is merely a subspecies of research or management information systems, the intricacies to be learned on-the-job by people unfamiliar with clinical IT? If so, which appears likely, on what do they base this assumption?]

... Those are things that are just starting to be reinvested in, figuring out how do we leverage that information, how do we get that connected?

[Mr, Clark, why is your Company"just starting" on this? Why are your people attempting to re-discover the wheel? ... More generally, do you believe there might be those who are able to, through experience, suggest answers to these and many other questions being asked by non-medical IT and bioinformatics personnel regarding your "Informatics Mission?"]

It seems to me that re-learning from scratch what others have learned from years of experience is not a very cost-effective strategy. It is not the type of research a company that advertises itself as "research-driven" should be performing, in my opinion.

At the same time, formally-trained Medical Informatics professionals are severely under-represented in pharma, including Merck.

In fact as part of the Research Information Systems talent management committee, I asked for the term "Medical Informatics" to be made part of Merck's HR lexicon (it was apparently missing), and made recommendations for the hiring of more Medical Informatics specialists. My advice did not seem to go over well among the non-clinical IT personnel present. No actions were taken on the advice.

From a personal perspective, I advised the VP of Research IT about my underutilized background in clinical IT, to no avail.

One reason is probably basic territoriality, Mr. Clark. This is common in the highly competitive and ego-driven IT fields. Self-serving groups form and act both unconsciously and deliberately to keep out potential competitors. I teach an actual graduate course on just these issues at a major university in your own neighborhood, Mr. Clark:

INFO780: Organizational and Sociological Issues in Health IT syllabus is at this link .

Has anyone at Merck taken this course or one like it, Mr. Clark? The issues taught are relevant not just to clinical settings, but to R&D IT as well. In fact, has anyone at the Company taken any graduate or postdoctoral courses in Medical Informatics such as the graduate healthcare informatics certificate I architected, or had applied Medical Informatics experience in, say, an ICU, clinic or medical office? If not, why not?

While competitive territorial behavior is understandable, I do not believe IT and Bioinformatics personal interests and vanity should outweigh corporate and shareholder obligations to hire the best talent for work at the intersection of clinical medicine and computing.

Yet, I've been told directly by a Merck official that "we don't need Medical Informatics here" in attempting to be rehired after the Equinox layoffs of Nov. 2003. Ironically, this was a senior person in the area of drug safety and adverse events surveillance, and said this not long before Vioxx's tumultuous withdrawal from the market. I was seeking to provide help in improving the adverse events database and analytical tools.

He told me "we don't need Medical Informatics" as I was showing him my work in building from the ground up a highly specialized EMR for invasive cardiology (link) to detect, among other issues, device adverse events and complications in a cardiac cath lab performing 6,000 procedures/year.

This sounds like an aversion to clinical IT expertise to me. Can you provide a better explanation for this apparent boycott, Mr. Clark?

Remember the failed CRISP clinical trials IT initiative, Mr. Clark? Where people and $100 million got turned into "crispy critters?" Medical Informatics professionals such as myself were trying to get into pharma then, to no avail; same responses then as now, including your company. We could have prevented this debacle from ever occurring:

In the 1990s, Merck struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco.

"This project ran into a lot of problems," says one former manager who was involved near the beginning of the CRISP project ... Merck significantly underestimated the challenge, according to a former Merck executive who was involved in the early phases ... The task of creating this software led the programmers into unfamiliar territory.[Not unfamiliar to Medical Informaticists - ed.]

Not only did they [IT personnel leading the project] have to learn new programming techniques, but they were continually frustrated in their effort to build a single system that would work for all trials. The real problem was that the data to be collected varies significantly with the nature of the medicine being tested and the malady it addresses.

[Remarkable of them to discover that basic principle all on their own, taught in Medical Informatics intro courses, at a mere cost of $100 million - ed.]

The cause of this debacle was not mysterious to those in Medical Informatics. Oh, wait ... you didn't have any of those specialists working at the Company.

Will another CRISP occur, Mr. Clark? Why or why not? Are you certain?

Perhaps another reason for what effectively appears to be a boycott of an entire discipline is found in your eRecruiting system. My own CV which is strongly focused on Medical Informatics is on file in Merck's e-Recruiting system.

Yet that system seems to only send frivolous alerts, implying it is badly mistuned (and also implying informatics experts are invisible to your internal recruiters). I get alerts like this one:

A job opening consistent with the job interests you expressed in your profile for a SAP Security Analyst--Merck & Co.,Inc.-INF003774 has just been posted in our Career Section.

I know little of SAP and SAP security, and SAP is mentioned nowhere in my CV. In fact, "Medical informatics", "clinical IT" and common words such as "Director" (Merck management, level 4) and "MD" appear. Why are alerts regarding "analyst" (low level) positions even being sent under such conditions, when Merck's own management-grade title is prominent in the CV? How many other people and specialties does this phenomenon affect?

Also see here wherein I describe other frivolous alerts I've received and how I've let my former HR colleagues at Merck know about this problem, to no avail.

In effect, the Bio-IT World article speaks more loudly not of state of the art informatics but of suboptimal talent management , which in the taxonomy of business falls under the subject heading of "mismanagement."

While I somewhat admire Merck's readily apparent belief in technological self-sufficiency and the strong self-assurance of its IT leadership, I do believe it falls under the general heading of "arrogant ignorance." I believe that mindset has gotten Merck and other pharmas in trouble before.

I do not believe your "Informatics Mission" strategy best serves patients, shareholders, institutional investors, and others. I believe those stakeholders need to look into these issues.

-- SS