Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up.

Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc

In the last week, multiple media outlets picked up the story of the cozy relationship between Abbott Laboratories and a doctor now accused of implanting too many cardiac stents for too much money.  The essentials were, as summarized from New York Times, Wall Street Journal, and Baltimore Sun articles -

Dr Mark Midei was a prolific user of cardiac stents for patient with coronary artery disease (blocked cardiac arteries)

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size. [NYT]

Therefore, hospitals sought him out

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. [NYT]

However, it appeared he performed the procedures on patients who would not benefit from them.

The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007. [NYT]

Nonetheless, Abbott Laboratories had been rewarding him for frequent use of their products

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, 'which is the biggest day I remember hearing about,' an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore. [NYT]

When his over-use was alleged, Abbott continued to use him as a key opinion leader.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. 'It’s the right thing to do because he helped us so many times over the years,' an Abbott executive wrote in a January e-mail cited in the Senate report. [NYT]

Also,

After St. Joseph barred Dr. Midei from practicing there in May 2009, Abbott arranged consultant work for him, according to emails released by the Senate committee.

In December 2009, an Abbott senior vice president wrote in an email that he was 'very open' to having Dr. Midei do consulting 'to see how it might go—either getting the word out in China/Japan, medical or safety work.'

The following month, the Sun reported on the allegations against Dr. Midei and St. Joseph. According to the Senate report, an Abbott executive subsequently said in an internal company email, 'We recommend that we not use Dr. Midei in the U.S. at this time (the press is just too hot).'

Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the report that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email.

Dr. Simonton didn't return phone calls seeking comment.

Abbott sent Dr. Midei to Japan to promote the Xience stent, but bad publicity caused that trip to be cut short in late January, the report says. In total, Abbott paid the doctor $30,623 to help market the Xience, the Senate investigators found. [WSJ]

When the relationship was criticized, Abbott executives responded with threats, or were they jokes?

I called David Pacitti, vice president of global marketing for Abbott Laboratories' cardiac-plumbing division, to ask why he seems to want goons to beat me up in the newspaper parking lot.

'Don't you have connections in Baltimore?????' Pacitti e-mailed a subordinate regarding a January column I wrote on heart-artery stents. 'Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?'

Pacitti and other Abbott execs apparently don't care for suggestions that their expensive vascular devices often do patients little good and that a star Baltimore doctor took their encouragement to be 'truly outstanding' a bit too much to heart. [Sun]

Furthermore,

Pacitti didn't return my phone calls, but an Abbott flack got in touch on Monday.

'We sincerely apologize if this caused you any concern or distress,' the company spokesman said. Pacitti's comment, he said, 'wasn't meant to be taken seriously.'

Yeah, that's what King Henry II said after they whacked Thomas Becket. [Sun]

So here is a particularly vivid case showing how big health care corporations make "key opinion leaders" out of doctors apparently just because they use or prescribe a lot of the company's products, regardless of the doctors' expertise, or ethics.  As we noted before, "key opinion leaders" are seen by corporate marketing executives as fellow travelers or useful idiots (see posts here, and here). It again appears is that all that health care corporate marketers care about is selling product. Whether their pitches are honest or ethical is besides the point. Those who get in their way are treated with contempt, and maybe, just maybe are threatened with violence

The physicians who are flattered at being called "key opinion leaders," or "thought leaders" have got to realize that the marketers think they are chumps. If they think they are providing honest information, or education, they are deluded.

This case has already been widely discussed in the blogsphere.  See, in particular, posts by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and Larry Husten on the CardioBrief blog.

But if that were not enough, on the heels of this story came several more about Abbott Laboratories

Abbott Laboratories Settles, Twice

As reported by the Los Angeles Times, while Abbott was trying to hide Dr Midei overseas, it was also busily negotiating settlements of completely separate charges:

Abbott Laboratories and two other pharmaceutical firms agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid in the latest in a string of nine- and ten-figure health care fraud settlements announced by the Justice Department.

The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing health care providers. The spread, or difference, amounted to kickbacks to the companies' customers, according to Tony West, assistant attorney general for the Justice Department's civil division, who announced the settlements on Tuesday.

In particular,

Abbott, of North Chicago, Ill, agreed to pay $126.5 million to settle accusations that it charged the government inflated prices for products ranging from sterile water and saline solution to vancomycin, an antibiotic.

An Abbott spokesman said the company believes 'that we have complied with all laws and regulations' and settled the case to avoid 'the uncertainty associated with continued litigation.'

At least he did not threaten the Department of Justice officials with an attack by the "Philly mob."

But that is not all. The Wall Street Journal reported that Abbott had to make a second, unrelated settlement:

Separately on Tuesday, the Justice Department announced an unrelated $41 million settlement with Abbott subsidiary Kos Pharmaceuticals Inc. on charges that it paid kickbacks to doctors and other health professionals to encourage them to prescribe or recommend the cholesterol drugs Advicor and Niaspan.

As part of that settlement, Kos entered into an agreement that will allow it to avoid prosecution on criminal charges. 'These actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing,' an Abbott spokesman said.

However, Abbott chose to acquire a company that allegedly chose to pay kickbacks of this sort. The apparent resemblance to Abbott's payments to Dr Midei in the case above are striking.

By the way, the Los Angeles Times article also noted previous black marks on Abbott's record:

Abbott also paid $614 million in civil and criminal penalties in 2003 to end a federal investigation of the company's marketing practices and Medicaid and Medicare reimbursements.

In 2001, TAP Pharmaceutical Products Inc., of Lake Forest, Ill., an Abbott joint venture, agreed to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overbill Medicare.

At the time, the TAP penalty was the largest health care fraud settlement in U.S. history, but it has since been eclipsed by at least two others.

So we once again illustrate how punishing wrong doing by fining large corporations, when the fines are just seen as a cost of doing business, in the absence ofany negative consequences on the real people who authorized, directed, or implemented the bad behavior fails to deter future bad behavior.

This remarkable confluence of cases suggest how rotten are the ethical foundations of even large and previously respected health care organizations. I imagine, though, that as long as these corporations richly reward their executives regardless of the ethics of their actions, and regardless of the long term effects on the organizations' reputations, and as long as their are no externally imposed negative consequences on these leaders, the practices will continue, and will get worse.

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

ADDENDUM (8 December, 2010) - See also comments by Maggie Mahar on the HealthBeat blog, David Williams on the Health Business Blog, and Paul Thacker on the Project on Government Oversight blog.

Bring Back the DSI*? - the Avandia Case as Spy Novel

Starting in 2007, we posted quite a bit about the "Avandia case," which centered on whether Avandia (rosiglitazone, by GlaxoSmithKline), a glucose lowering drug for type 2 diabetes, presented excess cardiovascular risks, and how evidence about these risks was handled. 

Summary

The Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone then available.  Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug which remained unpublished.  These results eventually appeared on a web-site run by GSK. However, this web-site was relatively obscure.  It had not been created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here).

Nissen and Wolski found the site, compiled the results of trials on Avandia it contained, and combined their results with those of the few published trials in their meta-analysis. It is to the credit of Nissen and Wolski that they were able to figure out how to do this. It is not to the credit of GSK that they sat on the data from these trials, only put it on this web-site when compelled to do so, did not make any effort to publicize the web-site, and did not publish a meta-analysis done by company scientists that showed qualitatively similar results to that eventually done by Nissen and Wolski (see post here).
 
I originally thought the case raised two questions:  1 - what are the benefits and harms of rosiglitazone as a treatment of Type 2 diabetes, and therefore for which patients under what circumstances should this drug be used?  2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?
 
But the immediate response to the Nissen and Wolski meta-analysis was a spin cycle that seemed to obfuscate these questions, and the answers to him (see posts here, here, here, and here)
 
A Reconsideration
 
In the last few weeks, several articles about Avandia have appeared in the media, and in medical journals, that reconsider the issues, and in particular, the "Avandia Spin Cycle."  First was a commentary in the European Heart Journal by Dr Steven E Nissen, the first author of the meta-analysis [Nissen SE. The rise and fall of rosiglitazone. Eur Heart J 2010: published online here.]  Dr Nissen provided a narrative history of the Avandia case from his viewpoint, and summarized it thus:

What were the key mistakes and lessons learned from the rosiglitazone affair?

1. The FDA rushed to approve rosiglitazone because of hepatotoxicity concerns about troglitazone, resulting in failure to consider the ‘signals’ suggesting cardiovascular toxicity.
2. An early critic of rosiglitazone was intimidated by company representatives and effectively silenced, a process antithetical to the principals of open scientific discourse.
3. Although early warnings were issued for the risk of heart failure, these warnings went largely unheeded in the face of aggressive marketing and promotion suggesting cardiovascular benefits.
4. No well-designed cardiovascular outcome trials were ever conducted for rosiglitazone, despite evidence suggesting increased cardiovascular risks. The only cardiovascular outcome trial was an open label study driven by a soft endpoint (hospitalization) with low adherence to randomized medications, seriously underpowered, and not completed until 10 years following launch.
5. Although both the FDA and the company were aware of evidence of an increased risk of adverse cardiovascular outcomes, certainly by 2005, neither warned physicians nor the public.
6. When a meta-analysis of rosiglitazone was eventually submitted for publication, the company subverted the editorial review process by stealing a copy of the manuscript and used this advance knowledge inappropriately to unblind an ongoing randomized trial.
7. Approval of diabetes drugs based exclusively upon their glycaemic effects has been short-sighted and scientifically unwise. Drugs that lower blood sugar may have other adverse effects that overcome any inherent benefits.
8. The failure of  50 other PPARs, many for adverse cardiovascular effects, went largely unreported because of negative publication bias. Such knowledge might have warned the medical community about the potential risk of these agents.

Meanwhile, the New York Times published conclusions of some internal US Food and Drug Administration (FDA) reports, and of an investigation by the US Senate Finance Committee. FDA safety officials suggested that Avandia should be taken off the market. Some key points from the Senate investigation were:

The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The Times — sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

'Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,' ....

In combination, the Nissen commentary, and the Senate report nicely summarized what I called the "Avandia spin cycle" above.  It appears that research was suppressed, marketing was deceptive, and critics and whistleblowers were intimidated. 

Finally, Dr Harlan Krumholz published a commentary about the thiazolidinedione drugs (a group that includes rosiglirazone) in Circulation Cardiovascular Quality and Outcomes [Krumholz HM. A perspective on the American Heart Association Presidential Commission Advisory on thiazolidenedione drugs. Circ Cardiovasc Qual Outcomes 2010; 3 available online, link here], and an op-ed in Forbes. The latter sums it all up nicely:

I want to believe in America's pharmaceutical companies. I want to believe that people in these companies believe that the best strategy for success is to do what is best for patients. I want to believe that they are interested in scientific truth and eager to know of any safety issues and ready to share that information with the public.

This week I was disappointed again.

Over the years GlaxoSmithKline ( GSK - news - people ) has repeatedly reassured the public about the safety of its blockbuster diabetes drug Avandia. But this weekend the Senate Finance Committee released a report revealing that inside the company Glaxo's own experts and advisors were raising concerns about whether the drug could cause heart problems all along.

The report, based on more than 250,000 internal documents, provides a rare and unsettling glimpse into the decision by company executives to deflect safety issues--even as their own experts agreed with conclusions of outside researchers who were warning the public about possible harms.

The documents reveal that company researchers were deeply concerned about the cardiovascular safety of the drug as far back as 2003. The pages of the Senate report read like a spy novel: Glaxo receiving confidential documents leaked by a sympathetic academic who consulted for the company; the company embarking on a campaign to intimidate critics who warned about potential safety issues with the drug; and executives pulling strings to release data early from a scientific study that was supposedly controlled by an 'independent' committee of researchers.

So,

The story here is less about the drug--the Senate report breaks no new ground about Avandia's safety issues (even among experts there remains some controversy)--and more about the ethical behavior of a company. What is clear: Glaxo failed to disclose its own concerns even as it sought to discredit outside researchers who were raising questions about the drug.


This type of behavior is eroding the public trust in the pharmaceutical industry.

Policy Implications

Finally, Dr Krumholz concludes with some solutions with which I heartily agree:

The fix is simple: Once a drug is approved, all data relevant to drug safety should be placed in the public domain and independent investigators across the country should be able to use it. There should be big financial penalties for withholding relevant information. Drug studies sponsored by industry must be truly independent--outside of company control. Companies should give outside investigators independence over every aspect of the study. There are too many examples of companies wresting control of clinical studies from their consultant investigators for reasons that seem more related to product promotion than clinical science.

And on all sides there should be a commitment to protect against the intimidation of academics who are willing to raise questions about the safety and effectiveness of company products. The free flow of information about the effects of drugs and medical devices will best serve the public's interest.

Here in the US, the debate over health care reform has reached a new phase. Today the President is hosting an attempt to get bipartisan discussion of reform going again. Now that there is a new opportunity for discussion, I submit that would be health care reformers ought to think about the underlying causes of our continuing problems with rising costs, declining access, stagnant quality, and demoralized health care professionals.

One set of causes that is rarely discussed has to do with the distortion of clinical research by commercial research sponsors with vested interests in the results turning out in favor of their products, and the further distortion of clinical discourse and decision making by the deceptive marketing practices of these same organizations. If we started introducing steps like those suggested by Dr Krumholz into health care reform, maybe we really could decrease costs, increase access, improve quality, and renew professionalism.

*Bring Back the DSI?
To lighten things up a bit, and to explain the title...

When I was in school in the 1960s, I first became a fan of the Hardy Boys mysteries, then the slightly more mature Tod Moran series.  While on the Neiuw Amsterdam (the 1938 version) one day out of Kingston, Jamaica, I viewed Dr No, the first James Bond movie, a sophisticated spy thriller, not a spoof like some later entries in the series.  I later read all the classics, like those by Agatha Christie, Earl Stanely Gardner, Rex Stout, Ellery Queen, etc.  So it should be no surprise that I, like many other schoolboys and girls, collaborated to form an amateur detective and intelligence agency.  But this was the sophisticated 1960s, so we called it the Department of Scientific Investigation (DSI).  We skulked around New York City and its suburbs looking for spies, saboteurs, and common criminals.  Luckily, we never really found any.  As more realities intruded, I gave up any ideas about becoming an investigator or intelligence agent (although I still read mysteries, spy novels, and thrillers to this day, but mainly on airplanes.)  Once I became a physicians, those days in the DSI seemed very remote (although the title does now seem like it ought to be part of the NIH ;-) ).

However, after reading Dr Krumholz's article above, maybe we need to resurrect the DSI.  At least, maybe we health professionals ought to consider how we can become better and more organized watchdogs for the kind of problems revealed in the Avandia case, and in many other cases discussed on Health Care Renewal.

But if any of my old DSI colleagues want to set up a reunion, it would be fine with me. 

ADDENDUM (25 February, 2010) - see also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the Health Care Renewal mill since 2005.  For example, see these posts:

- here about ghost-writing of a Vioxx research publication;
- here, and here about allegations that Merck executives tried to intimidate Vioxx critics;
- here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
- here about how an apparently major clinical trial of Vioxx turned out to be a "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
- here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs. 

Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case).

Merck just announced just the latest settlement of Vioxx related legal actions, as reported by Business Week:

Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.

Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well 'honest communication' with doctors.

'In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,' according to the amended code. 'We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.'

Also,

The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.

Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party.

The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories.

Note that this settlement is only of one type of lawsuit, as described in a Wall Street Journal article,

The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx.

Merck had already settled thousands of lawsuits,

Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.

Merck has lots of other legal actions to go through,

The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.

So the parade of legal actions and settlements thereof continues.  We believe that the scope of this parade provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis.

One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research. 

On Health Care Renewal we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of manipulation and suppression of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an organizational ethics policy, which in turn may have the potential to actually improve behavior. 

On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

What Happens When "We'll Manage it the Way We Damn Well Want"

Back in the early days of Health Care Renewal (2005, to be exact), we first wrote about some very strange actions by the management of Phoebe Putney Health System.  At first, we noted that the Phoebe Putney responded to a reporter's inquiry about lavish travel expenses pertaining to the system's Cayman Islands health insurance subsidiary by saying, "We own it. We'll manage it the way we damn well want."

Then the story got far more convoluted.  In 2006, we wrote about the over the top response to anonymous faxes challenged hospital management's commitment to the institution's mission.  The system CEO compared the fax senders to "terrorists."  After the local district attorney handed over his investigative records to hospital system private investigators, the investigators allegedly threatened a local accountant whom they accused of sending the faxes.  Allegations that the district attorney received campaign funding from and may have had other financial ties to the hospital system surfaced.  The district attorney indicted the accountant and a physician colleague on charges of burglary and assault in the absence of any police report of such crimes.  We commented that regardless of the outcomes of the legal case, the hospital system's management's actions seemed at variance with its stated mission.

Now, in 2010, the case is in the news again.  Since our last post, according to the Atlanta Journal-Constitution, the prosecution of the accountant, Mr Charles Rehberg, and physician, Dr John Bagnato, failed.  The district attorney, Ken Hodges,

provided the information gathered through the subpoenas to Phoebe Putney, which the hospital system used to file a civil suit against Rehberg and Bagnato -- a suit that was ultimately dropped. Rehberg then countersued Phoebe Putney, and that case was settled out of court for an undisclosed sum.

Meanwhile, more ties between Hodges and the Pheobe Putney system turned up:

Hodges' decision to run for attorney general elevated the case from a localized matter to one of statewide import. While still a prosecutor in Albany, Hodges received political contributions from Phoebe Putney executives and individuals connected to the hospital system, and his wife was hired as public affairs manager at Phoebe Putney's hospital in Albany.

Since leaving the prosecutor's office in Dougherty County, Hodges has gone to work for the Baudino Law Group, which represents Phoebe Putney. According to records Phoebe Putney must file with the Internal Revenue Service, the hospital system paid Baudino more than $8 million for the fiscal year ending July 31, 2008, the most recent data available.

Now, it is Rehberg who is suing Hodges, for abuse of power. "Charles Rehberg's suuit essentially accuses him and another prosecutor of filing criminal chargest that they knew to be based on fabricated information." A preliminary hearing took place yesterday.

So, in summary, two individuals sent anonymous faxes that charged that the Phoebe Putney system failed "to fulfill its charitable obligations as tax-exempt entity."  Hospital system executives accused them of terrorism, and hospital system investigators allegedly threatened them.  However, a criminal investigation by a district attorney with alleged financial ties to the hospital system ended without any convictions.  A lawsuit by the system against the individuals was dropped.  A suit by the indviduals against the hospital system was settled by the system.  A suit by the individuals charging that the then district attorney abused his power by basing criminal charges on false information is pending. 

So what did the hospital system's management's actions in this case have to do with the system's stated values? -

Phoebe pursues its mission through a patient-centered environment of care reflecting high standards and promoting a balance of professional preparation and service, continuous improvement and based on core values where:

* PEOPLE come first, are treated with dignity and respect, and diversity of culture and thought is respected.
* RELATIONSHIPS are built on honesty and integrity.
* REPUTATION is built on trust and pride.

In fact, the Phoebe Putney management's pursuit of Mr Rehberg and Dr Bagnato seems diametrically opposed to these values, intended to crush all criticism of management by any means. Once again, we see leaders of once-respected not-for-profit health care institutions whose main goal seems to be consolidating their power and thwarting criticism.

I say again, to truly reform health care, our health care organizations must be lead by those who put the institutions' missions ahead of their self-interest, who manage according to the mission rather than "the way we damn well want."

Captains Outrageous for Cape Anne's Health Care System

While on a brief vacation on lovely Cape Anne, Massachusetts, one of my daily automated Google searches provided an article of local interest. The person nominated to be CEO of the local hospital system had been at the center of controversy while in his previous position as leader of a hospital system in Cincinnatti, Ohio. When I got back, I put some relevant terms into Google, and lo and behold, came up with one of the more complicated and colorful, if unhappy stories about problems with health care leadership and goverance I have seen lately. So, to the tune of "lions and tigers and bears, oh my...."

Let me start with some background, and then to try to tell this story chronologically, noting issues as they came into public view. Northeast Health System is a regional hospital system in northeast Massachusets. It includes Addison Gilbert Hospital in Rockport, BayRidge Hospital in Lynn, and Beverly Hospital. Now bear with me through the amazing details.

Leadership Lacking in Transparency

The system's leadership seems to have recently inspired more than its share of controversy. Hints about the nature of the leadership problem appeared in an editorial in the Gloucester (MA) Daily Times in April, 2008.

Once again, Northeast Health System, the Beverly-based corporation that owns Gloucester's Addison Gilbert Hospital, is trying to have it both ways.

When it wants public support — including public money — it casts itself as serving the public. When it doesn't want the public looking into its affairs, it retreats behind the 'private corporation' wall.

That is not acceptable.

The latest example is Northeast's refusal to provide statistics on its diversion rate of patients from Addison Gilbert to Beverly Hospital during the past three years.

Although the editorial allowed that the diversion statistics might not prove to be that alarming, but

If there is not a problem here, the corporation is simply creating needless concern about it by its failure to be forthcoming.

Unfortunately, this is a continuing pattern for Northeast CEO Stephen Laverty, who apparently sees no problem with accepting subsidies of $500,000 from the state for two years running — subsidies secured in part through Tarr's efforts — but then ignoring reasonable requests for information about the corporation's operations, specifically as it pertains to Addison Gilbert.

Statistics on diversions should not be high-level trade secrets. Laverty must make Northeast more transparent.

Doctors Vote No Confidence

The pot really started to boil in May, 2008. At that point, as reported by the Boston Globe, its medical staff voted "no confidence" in CEO Stephen R Laverty:

In a private meeting, doctors at Beverly Hospital have taken a vote of no confidence in its chief executive, Stephen R. Laverty, citing frustration with his management.

The unusual step, made three weeks ago and acknowledged by hospital officials this week, was prompted by Laverty's alleged lack of communication and support in recent years, said several doctors who attended the April 29 meeting at the hospital.

'There's been a lot of cumulative dissatisfaction with how the physicians have been dealt with over a period of years in a variety of departments,' said Dr. Harriet A. Bering, an oncologist who was at the meeting. 'People had the same frustrations with incidents in which they hadn't been included in the decision-making process.'

A vote of no confidence, oh my. The article was not very specific about what lead to such an unusual step, but did note that doctors "accumulated grievances during Laverty's tenure. For instance, they said they were not properly consulted a few years ago when Beverly Hospital ended a successful cancer treatment program with North Shore Medical Center...." So this part of the story points to a hospital system management that does not see the need to communicate with and be transparent to dedicated health care professionals.

The Pregnancy Pact

In June, 2008, a story about a high school's unexpectedly high pregnancy rate and allegations that girls there entered into a "pregnancy pact" got international attention. The latter allegation was not proven, and although initial coverage did locate the story in Gloucester, MA (e.g., see the story in Time), the role of Northeast Health System was more obscure. Later we learned, in October, 2008, as reported in the Gloucester Times,

Addison Gilbert Hospital risked losing the state grant that pays for the operation of the Gloucester High School Health Center this spring when hospital leaders were reluctant to allow confidential access to birth control at the clinic, according to its former staff.

Debate about prescribing contraceptives erupted within a health center advisory board working on a response to the rise in teen pregnancies in Gloucester this year and turned public when the medical director and nurse practitioner resigned because representatives of Northeast Health Systems, the company that owns Addison Gilbert and runs the clinic, would not consider adding confidential prescription of contraceptives to the care offered.

A pregnancy pact, oh my. But this part of the story speaks to system management that seems unsympathetic to the concerns of its health professionals.

Nurses Vote No Confidence, and Allege a Punitive Culture and Intimidation; Vice President Accused of Art Theft

Also in October, 2008, the nurses also voted no confidence, again per the Gloucester Times in an editorial that provided more hints about the nature of the system's leadership problems,

Conflicts between Northeast Health System CEO Stephen Laverty and his subordinates are, unfortunately, nothing new.

By now, in fact, they have taken on a weary familiarity. After persistent rumors of unrest, a group of subordinates goes public with their frustration and resentment of the CEO. This past week, it was the nurses union, with members at both Beverly Hospital and Gloucester's Addison Gilbert Hospital, that took a 'no confidence' vote in Laverty.

The union is now trying to pressure the board of trustees to fire him, saying Laverty has created a 'punitive organizational culture (with) ... oppressive management practices.' And a 2005 Beverly Hospital citation by OSHA, which surfaced along with the nurses' discontent, gives credence to that claim.

The nurses, of course, are not alone. This past April, it was doctors who took a no confidence vote. In 2006, the Massachusetts Nursing Association filed a formal complaint against Laverty for entering operating rooms unannounced to observe surgeries.

Yet, the response from Laverty is always the same — no response. And his spokespeople offer little more than vague references to 'challenges' and 'competing agendas,' concluding with how proud they all are of themselves.

The editorial allowed, "It's also true that, in any large business, especially one as competitive as health care, there are sure to be conflicts between management and labor." However,

Still, it has to concern the Northeast trustees that every time there is trouble or unrest, Laverty is at the center of it.

It should concern them that morale continues to sink under his style of leadership, which most subordinates agree is a mix of arrogance and intimidation. Effective leaders don't assert their authority by demeaning their subordinates. They lead by building people up, not tearing them down. They lead by inspiring, not breeding resentment.

The truth is, Northeast still inspires shaky confidence among Cape Ann residents for a variety of reasons, including the corporation's out-and-out refusal to share numbers regarding the number of ambulance transport "diversions" from Addison Gilbert to Beverly — and, more recently, Northeast's stewardship over Addison Gilbert's wonderful endowment of artwork.

The recent arrest of a former Beverly Hospital associate vice president — a reported friend of Laverty — on charges of stealing donated art and antiques worth more than $200,000 from the hospital, hardly inspires confidence. And public confidence is one of the most important assets any health care institution has, since its patients are entrusting their health and livelihoods to it.

At times like this, when the public starts asking questions about problems, Northeast officials tend to retreat behind the 'private corporation' wall. It is true that Northeast is not part of the public sector. But it regularly seeks donations from the public. It has received at least $1.5 million in state money, supposedly to support its services to the public, but somehow still finds enough money to pay Laverty well more than $600,000 a year.

The trustees surely should not take the nurses vote as the only credible word on Laverty. But they need to take it, along with other continuing conflicts, very seriously.

Another no confidence vote, a punitive organizational culture and oppressive management, arrogance and intimidation, and art theft, oh my. So here we have much more detail about bad management, punitive, oppressive, arrogant, and ruling by intimidation. We also have allegations of criminal behavior by top managers.

Wait, what was that, a vice president of the system arrested for stealing art from it? In November, 2008, the Boston Globe suggested Laverty's imminent departure, and added more about the art theft.

The current situation comes after years of increasing resentment between Laverty and hospital staff. His internal relationships at the hospital were also damaged by his longstanding association with Paul G. Galzerano, Beverly's former associate vice president for support services. Galzerano sometimes argued with staff members, according to longtime employees, and often threatened them based on his close association with Laverty, according to former nurses.

Galzerano, who left the hospital last year, was arrested in October by Groveland police, who alleged he stole paintings, a grandfather clock, and furniture from Beverly Hospital. The items were found in his home, according to police, who alleged they were stolen when the hospital was undergoing renovations. Galzerano could not be reached for comment yesterday.

Threats by allegedly an art thief, oh my.

Birthing Center Threatened with Closure

But Laverty's departure did not end the controversy. Also in November, 2008, the Boston Globe reported,

A proposal to cease all deliveries at the North Shore Birth Center in Beverly - one of only two hospital-affiliated centers statewide that offer natural birth options - has ignited a passionate protest from women across the region.

With a debate and potential vote by Beverly Hospital's board of trustees expected Tuesday morning, women have been picketing the hospital, circulating fliers, writing letters to board members, blogging and organizing on Facebook, where more than 500 members have already signed on to the campaign.

Service cuts, oh my. After the art work was stolen, the system decided to cut costs by reducing an apparently very popular service.

Specialty Service Cuts, Bed Cuts, and Board Conflicts


An eloquent letter to the Cape Anne Beacon in January, 2009, (and an abbreviated version in the Gloucester Times) by Ms Beverly Quint of Drumlin Road, Rockport, provided much more detail about the legacy of the leadership and governance problems at Northeast Health Systems:

Since November, I’ve heard a number of people say on line at the market, or greeting one another for coffee or waiting for a movie to start, 'Thank goodness he’s gone. Now we can get somewhere without the worry.'

At first I thought they might be talking about the presidential election, but it became clear that most of them felt that anyone leading the country at this time was not expected to perform feats of magic. Then I wondered if they were talking about Father Time, himself, the old guy with the flowing robe and the long beard. It has, in fact, been a year of plunging confidence and quiet desperation. No, people were talking of neither of these; people were and are talking about the exit of Stephen Laverty, the much-criticized CEO of Northeast Health Systems, the corporation that 14 years ago merged with Addison Gilbert Hospital, our community hospital.

I wish I could share my neighbors’ rejoicing at Mr. Laverty’s exit, but I am more worried than ever about the potential loss of our hospital, the lifeline for Cape Ann citizens, isolated as we are from the mainland, connected by two not-always-reliable bridges. Here’s why I’m more worried than ever:

When NEHS announced its merger with AGH, it declared that the merger would benefit both parties. Almost immediately, NEHS began to dismantle AGH, service by service. Nor has NEHS ever made available to the community a detailed accounting of its use of $2 million given by the state Department of Public Health for the protection of emergency surgical and anesthesiologist services at AGH. Here it should be added that NEHS has never given a detailed accounting to the community of other sums taken from AGH, in the form of income from investments, real estate and an art collection estimated at $4 million.

Having downsized AGH’s bed capacity by refusing to use the beds on Steele Two and having sent patients to Beverly for every or no reason and having closed several departments, what remains in Gloucester is a shell. Even as such, we can still call it our community hospital so long — and only so long — as it provides eight services all under one roof, eight services essential for retaining its license. Now even that status for AGH is at risk. And that is why I am more worried than ever. If those eight services go, we lose all — and now they are being plucked at by NEHS. We are at the tipping point, with or without Stephen Laverty.

Let me give you a few examples. One of the eight services essential to our hospital’s survival is the availability of a surgeon 24/7. Instead, NEHS, without announcing it, sends any patient whom they think might need surgery to Beverly Hospital. Till Jan. 1 of this year, we had only one general surgeon based on Cape Ann. Now, again without publicizing it, he will not be available on call for emergency services.

The same is true of anesthesiologists. Without publicizing it, NEHS has not recruited anesthesiologists for AGH, even as it has not recruited surgeons for AGH. This, despite the previously mentioned $2 million received from DPH for bolstering those specialties.

Availability of hospital beds is another of the eight essential services required for AGH to stay alive, but NEHS refuses to open medical-surgical beds on Steele Two, sending patients away from their families, over the bridge instead.

NEHS has also not made an effort to insist that specialists, such as pulmonologists, see hospitalized patients at AGH, but are insisting that patients, instead, be moved to Beverly. As a by-product, this means that patients’ family members — many elderly, many handicapped, many who do not drive —are deprived of a closeness, something that can be emotionally important to patients’ recovery.

For starters, the present board of trustees needs to be questioned on the very high percentage of trustees who are physicians and executives employed by NEHS.

Cuts in surgical and anesthesia services, cuts in beds, shifting of medical sub-specialty services, and conflicted board members, oh my. So whatever the management is doing, it is not increasing services. Also, Ms Quint's letter suggested that conflicted governance may be enabling bad management.

Can It All Be Blamed on the Previous CEO?

In another letter published only last month, in August, 2009, Ms Quint suggested that things had not changed much under an interim CEO,

Not only has the Board of Directors of Northeast ignored a petition by 8,000 Cape Ann residents begging Northeast to disclose its plans and make a commitment in writing. Not only has Northeast ignored a petition by Rockport residents at Town Meeting to be more interactive in commitment to this issue.

Not only has it ignored Rockport selectmen's request to report at regular meetings to which the public could have input.

Not only has it snubbed overtures by state Sen. Bruce Tarr to meet regularly with his Task Force, it has systematically downsized, downsized, downsized Addison Gilbert.

Some of this has been ascribed to the particularly tyrannical nature of former Northeast CEO Stephen Laverty. Yet here is a most recent example that belies Mr. Laverty's personality as the supreme cause of the problems. On July 28, Dr. Henry Ramini, interim replacement for Mr. Laverty, spoke to Rockport selectmen on the status of Addison Gilbert. Did you know Dr. Ramini would be there? Nobody seemed to know.

Even the selectmen — one of whom, I understand, had been on vacation — seemed unprepared to publicize Dr. Ramini's appearance. What I later learned from people who happened to hear Dr. Ramini was that he is a much kinder, gentler appearing person than his predecessor. However, the content of his presentation was not particularly reassuring: He urged the town of Rockport to be nice to any future doctors who might deign to seek employment here.

Again, the suggestion is that there are systemic problems with governance and leadership

"An Ugly Set of Facts"

And that will bring us up to the story that my automated search produced. The candidate to be the new Northeast Health System CEO also has his issues. Per the Gloucester Times from August, 2009,

The man in line to become the next CEO of Northeast Health System is leaving behind a crumbling hospital system in Ohio that has been plagued by lawsuits and controversy.

Supporters of Kenneth Hanover say he does not deserve blame for the breakup of the Health Alliance, a $1.4 billion corporation that he served as president and chief executive officer.

But in two court decisions, judges ruled that the Health Alliance and Hanover failed to live up to a legal obligation to act for the benefit of two of its hospitals, improperly used 'enormous sums' of money to fight the lawsuit and gave bonuses to doctors to prevent them from working at those hospitals.

'The record is replete with evidence that the Alliance breached its fiduciary to (The Christ Hospital),' Judge Ralph Winkler wrote in his decision last year for the Ohio Court of Appeals.

Considering the turmoil surrounding Laverty's tenure at Northeast Health System, it might seem surprising that the organization would replace him with a man with such a controversial background of his own.

The breakup of the Health Alliance became so acrimonious that the Ohio attorney general's office stepped in. In July 2007, in the midst of the legal battle, the chairman of Christ Hospital wrote a letter calling for Hanover to be replaced.

Monica Rimai, the interim president at the University of Cincinnati and a former Health Alliance board member, acknowledged that the lawsuit and the breakup constitute 'an ugly set of facts and we lost.'

Robert Weigel, chairman of Fort Hamilton Hospital, which is in the processing of withdrawing from the Alliance, said Hanover is "one of the smartest men I know." He also said Hanover has a forceful manner than can rub some people the wrong way.

"I have a lot of respect for his abilities and his thinking, but he can be tough to deal with," said Weigel....

An ugly set of facts about the new CEO, oh my. One wonders if the NEHS board had investigated its new CEO candidate's previous performance. On the other hand, maybe the board is most comfortable with CEOs that are "tough [for others] to deal with."

Pregnancy pacts, art theft, no confidence votes, punitive corporate culture, threats and intimidation, closed wards and clinics, slashed services, oh my. You just can't make this stuff up.

On a slightly more sober note, the curious case of Northeast Health Systems is a good example of how governance and leadership can go wrong, and the downstream effect on health services.

Reorganizing the colorful facts above, we seem to start with poor governance, possibly by a conflicted board (per Ms Quint). That board seems most comfortable with aggressive leaders who seem more intent on imposing their will on dedicated, professional staff, rather than working collaboratively, and hiding behind a veil of corporate secrecy, rather than providing the transparency appropriate for a not-for-profit organization whose mission is to to serve the community. Meanwhile, services of all kinds decline, while the community that once supported the organization now regards it with suspicion and alarm.

The current debate about health care reform has focused - to the extent it has focused on anything - on financing and insurance. As we have said many times before, we cannot fix the health care crisis simply by changing financing mechanisms or money flows.

We can only improve health care by improving the leadership and governance of health care organizations, and by rethinking the size and scope of health care organizations. The most crucial part of health care is what goes on between individual health care professionals and individual patients. Yet our system is composed of endlessly enlarging bureaucracies run by self-interested, often clueless, and sometimes dishonest, if not criminal leaders. This must change, unless we want this crisis to get much, much worse.

The title of this post is a weakly satirical bow to the Rudyard Kipling novel set partially in Gloucester, MA.

Was GSK Merely Incompetent About Medical Informatics, Or Is There a Management Directive To Avoid Specialists Who Might Find "Unacceptable" Problems?

At my post "GSK, Avandia and Medical Informatics: More on Why Pharma Fails" I outlined repeated rejection of Medical Informatics expertise by GSK, based on what I believed essentially to be the narrowminded and tunnel-visioned thinking of information technologists and others in pharma. I wrote:

It is my belief that a view [at GSK] of medical informatics professionals as "writers of algorithms to solve business problems" reflects a fundamentally narrow and mechanistic view of the field, or perhaps a mislabeling of the position as being one of Medical Informatics. The lack of a requirement for formal Medical Informatics education and training suggests the latter.

The U.S. Institute of Medicine (IOM) of the National Academy of Sciences seems to agree with that assessment, as I pointed out in another post entitled "IOM gets it regarding Medical Informatics." The IOM recommends:

...that CDER [FDA's Center for Drug Evaluation and Research] build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs. In recognition of the limitations in human resources in the current employment market to meet this role, a combination of advancing professional skills through continuing education and support for academic training programs is needed.

and that

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.

A story in today's Wall Street Journal raises additional questions about what appeared to simply be strategic missteps in talent management (recognition and acquisition of new and/or enhanced skills and emerging fields of value to an organization).

Perhaps these were not strategic missteps at all, but simply a manifestation of a calculated policy set at higher levels to avoid discovering - beyond a certain point and before a certain time - information that might adversely affect a new drug's FDA acceptance, marketing, and sales. This might be accomplished through what might be called "internal capabilities inhibition via talent mismanagement."

The WSJ story today reports on actual directed, purposeful attempts by GSK to suppress possible adverse effects information about Avandia, as well as silence a number of its clinician critics. Those critics had prescribed the drug in good faith to their patients and noted troubling responses in the form of heart failure and pulmonary hypertensive (high pressure in the arteries of the lungs) side effects.

Wall Street Journal
Nov. 19, 2008

Doctors Claim Glaxo Dismissed Worries on Avandia (subscription required)

Drug Maker Tried to Make Physician at Maryland Hospital Stop Talking About Concerns; Company Defends Its Effort

By ALICIA MUNDY

HAGERSTOWN, Md. -- Last year, after news broke that the diabetes drug Avandia was linked to a high risk of heart attacks, reports that the drug's maker had tried to stifle safety questions from a prominent Duke University researcher years earlier provoked a furor.

Now it turns out that the Duke researcher wasn't alone in suggesting a tie to heart problems. A doctor from a small Maryland hospital [Internist Mary Money of Hagerstown, Md.] linked Avandia to congestive heart failure in 2000, but the drug's maker, GlaxoSmithKline PLC, rejected her warning and tried to make her stop talking about it with other doctors and hospitals, according to documents and interviews.

... The Senate and House in 2007 began looking at whether Glaxo suppressed information and threatened the Duke researcher, charges that Glaxo has denied. Now the Senate probe, led by Chuck Grassley of Iowa, is investigating whether Glaxo's efforts to defend Avandia's safety led to intimidation against other doctors who were suggesting possible links to cardiac dangers. Mr. Grassley, the ranking Republican on the Finance Committee, has demanded documents from Glaxo and is expected to release a detailed report on Avandia soon, according to staffers.

Earlier in 2007, a study in the New England Journal of Medicine reported that Avandia could raise the risk of heart attack by 43%. The FDA called for a black-box warning on the drug's label about the risk of congestive heart failure and heart attack.

Dr. Money talked recently about a patient who came to her in 1999 with congestive heart failure. "That fall, I had a woman patient with massive fluid overload and such shortness of breath that she had to sit up at night," she said.

The patient had begun taking Avandia two weeks earlier, and an echocardiogram showed high pressure in the arteries of the lungs. Dr. Money said she took the patient off the drug, and within a few days the symptoms almost disappeared.

In the next few months, Dr. Money and the head of the hospital's diabetes center, Stephen Lippman, found other patients who had similar symtoms.

Dr. Money alerted SmithKline Beecham, the name of the drug maker before a 2001 merger. The company met with her and Dr. Lippman at Washington County Hospital in Hagerstown in April 2000.

The two doctors presented data on 85 of their patients who had used Avandia, according to documents from the meeting. More than half of the patients had significant edema, or swelling, and about half of that group also had high pulmonary pressure and shortness of breath. Three had been hospitalized for congestive heart failure.

The meeting was a waste of time, Dr. Money said. "They came to tell us how wrong we were, not to listen," she said.

Meanwhile, a company consultant who called into the meeting from the University of Pennsylvania dismissed the Hagerstown doctors' echocardiograms as too poor to show anything useful.

"They suggested we were country bumpkins, and practically said, 'Don't worry your pretty heads. We have smarter people than you looking at this, and there's no problem,'" recalled Dr. Lippman, a physician who also holds a doctorate in molecular biology.

A GlaxoSmithKline spokeswoman, Mary Ann Rhyne, said Dr. Money's theories were "unsubstantiated" and she was misinterpreting journal articles to support her case.

The next month, two SmithKline executives wrote to the hospital's chief of staff, calling on him to stop Dr. Money from talking about her concerns to other hospital doctors.

"[W]e respectfully ask that your hospital not involve itself in the dissemination of information which has not been substantially verified, and that you take immediate steps to stop the dissemination of this unsubstantiated information to your medical staff," said the letter, signed by two SmithKline executives, which was viewed by The Wall Street Journal.

In effect, GSK is saying that these clinicians had no "right" to report their "unsubstantiated" findings to anyone without the company's "approval." That is the height of corporate hubris, especially in a country where freedom of speech and freedom of opinion is constitutionally guaranteed.

Unless these clinicians were fabricating their findings with ill intent, they certainly had very right to report their findings to anyone they chose. It is up to those so informed to make up their own minds based on the evidence and on trust.

But I state the obvious.

The company acted in a manner that might be construed as interference with medical practice and communication, and it seems to me potential interference with employment, by going to these doctor's superior. One must ask, who, exactly, did the company believe was required to perform the "substantiation" of adverse events information before the private clinicians could speak to others?

GlaxoSmithKline's Ms. Rhyne said the letter was justified. "When GSK learns about statements by physicians that are inconsistent with the scientific data on its medicines, it has the responsibility to do what it can to correct these inaccuracies," she said.

Resonsibility to whom, exactly? Its shareholders seem high on that list. Where do patients fit in to the taxonomy of corporate responsibility ?

It would seem to me the company also has the responsibility to maximize its ability to identify adverse events as soon as possible and as scientifically as possible, and conduct its talent management activities in a manner to enhance that capability.

Glaxo upgraded the warnings on Avandia's label more than a dozen times between 1999 and the 2007 black box, the strongest level of warning. One change, in 2001, said the drug could lead to excessive edema, which in turn could lead to congestive heart failure.

Better late than never.

Or perhaps not so much. From Alison Bass's blog:

It was not until 2007, after The New England Journal of Medicine published a meta-analysis showing an increased risk of heart failure among patients taking Avandia, that the FDA put black box warnings on the drug. (It's worth noting that researchers would never have been able to do this meta-analysis if not for the New York State Attorney General's lawsuit against GlaxoSmithKline for deceiving physicians and consumers about another of its drugs, the antidepressant Paxil; as part of settling that lawsuit, Glaxo agreed to post the findings of all its clinical trials, including those about Avandia).

Of one thing I am certain: diabetics did not need the additional problems caused by this drug before the black box warnings, when other proven, effective and less expensive therapies were readily available.

Perhaps that warning might have appeared sooner if GSK officials had not taken the stance that the value of Medical Informatics professionals is simply "to write algorithms to solve business problems." I wonder if a strategy of managing the narrative through questionable practices such as bullying and intimidation, while rejecting new fields of scientific endeavor, might be two sides of the same coin. (My own experiences are admittedly anecdotal, but formally trained medical informatics professionals are rare in pharma, and even at Merck I was kept an arm's length from adverse events informatics activities despite pointing out my expertise, for reasons never explained satisfactorily.)

My jobseeking experiences with SKB/GSK on informatics date back to 1996 or so. Rejections were the rule, even in one case in 2000 when I came highly recommended by their own senior internal recruiter after demonstrating the information system I built at a major hospital to detect drug and device adverse events in the field of invasive cardiology, and in 2004 when I again came highly recommended by their own retained British recruiter at Armstrong Craven Ltd.

I therefore raise the question:

Could my experiences and that of other informaticists with special competencies in building clinical IT to enhance adverse events data management have been a manifestation of a larger, somewhat unpublicized strategy? That is, a strategy meant to inhibit or suppress the employment and empowerment of individuals with formal training and expertise in newer scientific domains that might prematurely "endanger" the lifecycle of blockbuster drugs?

Perhaps the talent management activities, minutes, and hiring/layoff practices of relevant GSK departments and divisions should be scrutinized, in addition to the current Congressional scrutiny of specific instances of corporate arrogance as in today's WSJ article.

-- SS

"Docs Ditched After Undesirable Diagnosis"

From the Johannesburg, South Africa Star, this story, entitled "Docs Ditched after Undesirable Diagnosis," has some eerie echoes of the past:

When medical specialists diagnosed at least 10 cases of manganese-specific illnesses at a factory in Cato Ridge, KwaZulu Natal, the Assmang manganese company dumped them 'like hot potatoes'.

They replaced them with a new team of doctors that revised the diagnoses to suggest the sick workers might be alcoholics, drug abusers or victims of Aids.

All 10 workers had also been certified previously by the Compensation Commissioner as being permanently disabled as a result of manganism, an occupational disease caused by exposure to excessive levels of toxic manganese.

Another 27 workers, also earmarked by doctors as possibly suffering from manganism, were also 'cleared' by the new team of medical doctors and some were put back to work.

This emerged on Wednesday during the testimony of Dr Susan Tager to the Department of Manpower inquiry into worker sickness and toxic dust exposure at the factory.

Tager, a senior Johannesburg neurologist who heads the movement disorders clinic at Wits University, expressed surprise that Dr Murray Coombs, a new member of the Assmang expert panel, had rubbished her diagnoses - even though Coombs had not seen or physically examined any of the 10 workers and based his opinion on a review of their medical files. Coombs, from Elixir Corporate Health Solutions, is employed by Assmang as an occupational health consultant.

We have often discussed how health care organizations may try to shut up doctors who might say something that goes against their vested interests. In particular, we have frequently discussed how corporations that sponsor clinical research on their own products have suppressed research unfavorable to these products (see relevant posts here). But it seems like all sorts of organizations now feel free to try to shut up physicians who say things counter to their interests, whatever these may be.

We have also often discussed how health care organizations cultivate physicians who might help them market their products. Again, we have most often discussed how biotechnology, device, and pharmaceutical corporations may cultivate "key opinion leaders," who seem happy to to promote the organization's line, at least while wined, dined and paid well. But it seems like all sorts of organizations now feel free to recruit compliant physicians happy to say what the organizations want.

The eerie echo is of the case of Dr David Kern, fired from his academic position after he tried to present an abstract on a new occupational disease, now called flock workers' lung,(1) in a way that offended leaders of the company whose workers acquired the disease (see summary on the Scientific Misconduct Blog here).(2) That company also recruited a new physician to investigate the disease outbreak,(3) but as far as I can tell, he never put anything on the public record about the results of his investigation, and what happened to the patients with flock workers' lung is unknown.

Thus, both these cases illustrate how directly patients may be affected by companies eager to shut up physicians, especially physicians warning of occupational disease.

References

1. David G. Kern, Robert S. Crausman, Kate T.H. Durand, Ali Nayer, Charles Kuhn III. Flock Worker's Lung: Chronic Interstitial Lung Disease in the Nylon Flocking Industry. Annals of Internal Medicine 1998; 129: 261-272 (Link here.)

2. Shuchman M. Secrecy in science: the flock workers' lung investigation. Ann Intern Med 1998; 129: 341-344. (Link here.)

3. Fulks JR. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337:1314-1319. (Link here.)

A List of Unconflicted Experts Produces an Unexpected Response

We previously discussed an article by Jeanne Lenzer and Shannon Brownlee in Slate The article discussed a show broadcast on many US National Public Radio (NPR) stations which portrayed a rather benign view of the side-effects of anti-depressant medications. Not revealed to listeners was that the show was partially funded by a company that manufacturers such medication, and all the participants in the show had some financial relationships with such companies.

We suggested that the audience deserved to know about such conflicts of interest, and that had the show's producers felt compelled to reveal them, maybe they would have thought twice about not including without such conflicts.

To demonstrate that it is possible to find such experts, at the end of the article, Lenzer and Brownlee noted they had compiled a list of experts who had no ties of any sort to pharmaceutical companies or device manufacturers over the last five years, and were going to make the list available to journalists. (Full disclosure: I am not on that list because I own 3200 shares of one pharmaceutical company, Elan. That alone was enough to disqualify me from the list, which shows how rigorous Lenzer and Brownlee were in selecting unconflicted experts.)

As discussed on the Hooked: Ethics, Medicine and Pharma blog by Dr Howard Brody, Lenzer and Brownlee were both deluged with requests from journalists for this list of unconflicted experts, but also by somewhat ominous demands for the list by people who may be tied to the pharmaceutical industry. Brody noted that it is not unheard of for industry to try to intimidate people it feels are hostile to its interests. (For some of our posts about related cases, look here and here.) He concluded, " industry appears to feel threatened by this list in a way that is quite unprecedented and unexpected. How and why that is so is worth pondering." Stay tuned on this one.

A SLAPP Against Clinical Research?

Posts on the Wall Street Journal Health Blog, the Clinical Psychology and Psychiatry Blog, and by Dr Aubrey Blumsohn on the Scientific Misconduct Blog all picked up on a brief story in the Harvard Crimson about a lawsuit apparently claiming that a clinical research article, and a randomized controlled trial no less, was defamatory. Here is the gist from that news article,

Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).

In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.

HipSaver’s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel’s study to be applied to hip protectors in general.

Robert L. Hernandez, who is representing HipSaver, described Kiel’s article as 'disparaging' and 'grandiose.'

Actually, as quoted by Dr Blumsohn, the JAMA article's conclusions were framed in the typically measured terms of clinical research reports.

In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

[See Kiel DP, Magaziner J, Zimmerman S et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298: 413-422. Link here.]

Of course, if these conclusions were libelous, than practically any scientific article could be considered libelous.

Equally obviously, HipSaver leadership have a perfect right to criticize the Kiel article. But to sue the authors because the company disagrees with their conclusions could have a chilling effect on science. This lawsuit seems to be a deliberate effort to intimidate clinical scientists who dared to collect and publish data which suggesting that commercial products may not be as wonderful as their marketers claim.

If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe.

Furthermore, this lawsuit can be construed as an attack on basic human rights in the US context. In this context, it appears to be a SLAPP, that is, Selective Litigation Against Public Participation. This term was coined to describe lawsuits designed to intimidate people from speaking out about issues of public interest (but in a way that might threaten vested interests.) For more information about SLAPPs, see the SLAPP Resource Center. Also see this article from the First Amendment Center.

Most US states, including Massachusetts, have laws that allow SLAPPs to be countered. For example, in Massachusetts, the law provides (see the SLAPP Resource Center), ]

Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys’ fees shall be awarded to a victim prevailing on the motion to dismiss.

I don't think it is too much of a stretch to apply the SLAPP concept to a lawsuit aimed at the free discussion of the effectiveness of treatments in health care, given that the government indirectly or directly pays for many of these treatments, and that determining the effectiveness of treatments is clearly a public health policy issue.

I fervently hope HipSavers withdraws this ill-conceived lawsuit. If the company persists, I fervently hoped its attempted SLAPP gets slapped down.

Here is another sorry example of how health care, particularly clinical research, is under seige by those with vested interests and private agendas.