Princess Health and Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices. Princessiccia

Princess Health and Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices. Princessiccia

anechoic effect deception health care corruption manipulating clinical research marketing pharmaceuticals suppression of medical research Transparency International

Gusty 07:28 Add Comment

Health Care Corruption as a Taboo Topic

Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

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

The report did not get much attention.  Since then, health care corruption has been nearly a taboo topic in the US.  When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries.  On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here).  But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries.  Health Care Renewal was practically the only source of coverage in the US of the survey's results.

Transparency International's New Report on Corruption in the Pharmaceutical Sector

Now Transparency International (TI) has tried, and Health Care Reenewal will try again.  In June, 2016 Transparency International published a new report entittled

Corruption in the Pharmaceutical Sector

The report's executive summary states:

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.

In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,

Manipulation of Clinical Research

We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients.  The TI report included: 

As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.

Suppression of Clinical Research

We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests.  The TI report included:

Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.

Manipulation of the Dissemination of Clinical Research

We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients.  For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:

The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.

Deceptive Marketing

We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm.  In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks.  The TI report included:

There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company�s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.

Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors� prescribing habits and encouraging off-label, unlicensed use to increase sales.

Other Topics

Finally, the report mentions such issues as the revolving door, regulatory capture, etc, etc, etc

A Striking, and Strikingly Anechoic Report

Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption.  That is a sentiment rarely heard in the US, and one that appears nearly taboo.  

Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries.  Let me note the important exceptions, however.

I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1)  The only substantial news article I could find on the report was also from the UK, in the Independent.  Its sub-title is worth repeating:

Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people

Also, there were brief articles in Reuters, and in (web-only) FiercePharma.  That is about it so far.

The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion.  Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the TI Report itself,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.


I might as well repeat myself once again.  As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

Reference

1.  Torjesen I.  Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.

Princess Health and New Jersey Confidential: the Almost Secret Membership of the RWJ Barnabas Health Board. Princessiccia

Princess Health and New Jersey Confidential: the Almost Secret Membership of the RWJ Barnabas Health Board. Princessiccia

anechoic effect boards of trustees conflicts of interest hospital systems RWJ Barnabas Health UMDNJ

Gusty 08:28 Add Comment

A Hospital System Tries to Hide its Board of Trustees

The US Internal Revenue Service mandates disclosure of the membership of boards of trustees of non-profit corporations.  Nonetheless, as reported by New Brunswick (NJ) Today, the leadership of the newly formed RWJ Barnabas Health system has been doing their best to keep the membership of its board of trustees secret.

The new organization created to function as the state's largest hospital chain is refusing to tell the public who serves on their Board of Trustees,...

To elaborate,

The two hospital networks officially combined to form a new conglomerate, the state's second largest employer, in a deal that was finalized on March 31.

But since then, the new group has refused to identify its board members, after stalling for nearly two weeks.

'Thank you very much for your interest. It is a policy at RWJBarnabas Health not to share the names of the Board of Trustees" read a peculiar April 12 email response from an anonymous address affiliated with Barnabas, B4@barnabashealth.org.

The anonymous email address has not responded to follow up inquiries from this newspaper, including one urging them to make the 'smart choice' and 'be transparent.'

This goes against at least the spirit of the law.

'If the organization has been recognized by the IRS as tax-exempt under one of the subsections under 501(c), there are a number of documents that organizations must make available that would include board lists,' said the leader of the Center for Non-profits.

The initial application, and the three most recent annual filings, must be made available for inspection or copying by members of the public at their place of business, according to the IRS.

In general, any organization that files a Form 990... must make its three most recent Form 990's and its Form 1023 available for public inspection without charge at its principal place of business,' reads the Center's website.

'All parts of the return, schedules and attachments must be made available during regular business hours at the organization's principal office and at any regional offices having 3 or more employees.

There is an exception to the requirement if a non-profit chooses to make the documents widely available by posting them on the internet.

The anonymous email address that cited the policy of having a secret board, and the media contacts listed on the press release announcing the merger between RWJ and Barnabas, have not responded to questions about whether their healthcare organization is in compliance with the IRS rules regarding making the forms available to the public.

This obviously also is a remarkable rebuff to those in health care who advocate maximum transparency.

A Futile Attempt at Secrecy

Some good investigative reporting by New Brunswick Today penetrated the flimsy veil set up by hospital system leadership. The system chairman turns out to be one Jack Morris:

Documents provided by the NJ Department of Treasury show that controversial developer Jack Morris was made the Chairman of the RWJ Barnabas board.

Morris is a close friend and ally of former State Senate President and convicted felon John Lynch, Jr., who ruled New Brunswick as Mayor from 1978-1990, and some contend still is a key player in statewide politics.

Morris had previously served as Chairman of the Robert Wood Johnson University Hospital (RWJUH) Board of Directors. Morris is also tied to Cooper Hospital Chairman George Norcross, the state's most notorious unelected political boss.

The vice-chairman is actually Marc Benson.

another real estate mogul was named the RWJ Barnabas board's Vice Chair, according to the documents, which were filed with the State Treasurer in November 2015, nearly half a year before the merger was finalized.

Marc Berson founded the Millburn-based 'Fidelco Group' in 1981, a 'private investment owner-developer of residential, commercial, retail, and industrial properties in New York, New Jersey, Florida and Ohio,' according to a press release announcing his election as Chairman of the Barnabas Health Systems board in 2014.

As for the rest of the board, they are,

The other 18 secret board members are:

Robert L. Barchi, (Rutgers University, New Brunswick)
 James C. Salwitz, MD (Robert Wood Johnson University Hospital, New Brunswick)
Murdo Gordon (Bristol-Myers-Squibb, Princeton)
Susan Reinhard (AARP Public Policy Institute, Washington, DC)
Nicholas J. Valerani (West Health Institute, La Jolla, CA)
John A. Hoffman (Wilentz, Goldman, & Spitzer, Woodbridge)
Alan E. Davis, Greenbaum (Rowe, Smith & Davis LLP)
Robert E. Margulies, Esq. (Margulies Wind, Jersey City)
Kenneth A. Rosen (Lowenstein Sandler PC, Roseland)
 Lester J. Owens (J.P. Morgan Chase, New York, NY)
James Vaccaro (Manasquan Savings Bank, Wall)
Albert R. Gamper, Jr. (Caliber Home Loans, Inc., Far Hills)
Anne Evans-Estabrook (Elberon Development Corporation)
Gary Lotano (Lotano Development, Inc., Toms River)
Steve B. Kalafer (Flemington Car and Truck Country, Flemington)
Brian P. Leddy (former Chairman of RWJUH Rahway, Cranford)
Joseph Mauriello (formerly of KPMG, Chester)
Richard J. Kogan (formerly of Schering-Plough Products, Inc., Short Hills)

Why the Futile Effort to Make Board Membership Secret?

It is certainly striking that a big non-profit hospital system would try to conceal the membership of its board of trustees.  One might think the leadership should be proud of the board members, and the board members would be happy to advertise their community service.

This did not seem to be the case here.  Once more we see how the new overlords of health care reflexively seem to choose secrecy over transparency, deliberately creating the anechoic effect which we have frequently discussed.

Perhaps the board wanted to avoid undue attention to the political connections of its new chairman, one of which  was to a"convicted felon," and another of which was to Mr Norcross, whose apparent conflicts of interest in his role in the governance of a former UMDNJ hospital were discussed here. Parenthetically, an article in NJ.com on the merger noted that this new hospital system is a descendant of the now dissolved University of Medicine and Dentistry of New Jersey, UMDNJ (look here), an organization whose extensive troubles kept Health Care Renewal very busy in past years.

Perusing the list of the members of the board reveals two people with pharmaceutical connections that could be conflicts of interest, a few people with health care affiliations, but no obvious affinity for the patients and public in New Jersey whom the new hospital system is supposed to serve, and many lawyers and business people with no obvious affinity for the values of health care professionals.

However, as summarized by the National Council for Nonprofits,

the board of directors have three primary legal duties known as the 'duty of care,' 'duty of loyalty,' and 'duty of obedience.'

...

In sum, these legal duties require that nonprofit board members:

Take care of the nonprofit by ensuring prudent use of all assets, including facility, people, and good will; and provide oversight for all activities that advance the nonprofit�s effectiveness and sustainability. (legal 'Duty of due care')

Make decisions in the best interest of the nonprofit corporation; not in his or her self-interest. (legal Duty of loyalty')

Ensure that the nonprofit obeys applicable laws and acts in accordance with ethical practices; that the nonprofit adheres to its stated corporate purposes, and that its activities advance its mission. (legal 'Duty of obedience')

So it is not obvious that these board members are particularly familiar with the nuances of the mission of a large academic hospital system, which includes delivering excellent patient care that puts individual patients first, particularly ahead of board members' self interest, and of its academic role, seeking and disseminating the truth.  One wonders what sort of governance this sort of board will provide.  Maybe the hospital leadership wanted to forestall such questions by keeping board membership as obscure as possible.

Speaking of the anechoic effect, while the new RWJ Barnabas Health system will be a very major player in NJ health care, and while trying to keep the board members of a non-profit health care system is rather a remarkable action, so far, only one local newspaper, and now your humble blogger seem interested.  This is yet another example of the anechoic effect.

Comments

We have been writing now for a long time about the tremendous and growing dysfunction of US health care.  Some now obvious reasons for its problems are poor leadership of ever larger and more powerful health care organizations, and failure of existing governance bidues to exercise stewardship over these organizations.  We have discussed numerous previous problems with boards of trustees of non-profit health care organizations here.  We have noted that board member may have conflicts of interest, and are often rich business executives who may be more interested in preserving the power and wealth of their fellow executives, including those generic managers who know often run large health care organizations, than defending vulnerable patients.  These problems are compounded by the anechoic effect: information and opinions which might offend those currently in power and who stand to benefit most from the current system is kept very quiet, treated as a taboo subject, that is, made to have no echoes.  This new case again suggests that these problems are not going away.

How many times must we say this?....   True US health care reform would vastly increase transparency, not just of prices, but of leadership and governance.  True US health care reform would put the operation of US health care organizations more in the hands of people who have knowledge and experience in health care, and are willing to be transparent and accountable to support health care professionals' values.  Furthermore, oversight and stewardship of these organizations should represent the patients and public which the organizations are supposed to serve. 

Princess Health and What You See Is Not What You Get - Purdue Pharma Executives Pleaded Guilty, but the Oxycontin Billionaires Went Unnoticed. Princessiccia

Princess Health and What You See Is Not What You Get - Purdue Pharma Executives Pleaded Guilty, but the Oxycontin Billionaires Went Unnoticed. Princessiccia

anechoic effect conflicts of interest deception health care corruption legal settlements marketing narcotics Oxycontin Purdue Pharma

Gusty 09:36 Add Comment

What you see if often not what you get.  

Nine years ago, three top executives of Purdue Pharma pleaded guilty to criminal charges of "misbranding" Oxycontin.  The case appeared to be a landmark.  In previous years, top executives of large health care corporations rarely faced legal consequences when their companies misbehaved.  Yet in the Purdue Pharma/ Oxycontin case, things were not what they seemed.  Maybe that is why this case never did yield a new era of accountability for top corporate health care leaders.

Background - the Oxycontin Guilty Pleas

In 2007, we posted about the executives' guilty pleas.  Relying on the New York Times coverage, we noted that the Department of Justice charged that the company used aggressive, deceptive marketing, including claims that Oxycontin had little potential for addiction, even though they then knew otherwise.  Unlike many other settlements, the executives and the company admitted their dishonesty, although they were not apparently charged with fraud.

In a statement, the company said: 'Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health care professionals that were inconsistent with the F.D.A.-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information.'

'We accept responsibility for those past misstatements and regret that they were made,' the statement said.

While no executives went to jail, the three who pleaded guilty,

Michael Friedman, the company�s president, who agreed to pay $19 million in fines; Howard R. Udell, its top lawyer, who agreed to pay $8 million; and Dr. Paul D. Goldenheim, its former medical director, who agreed to pay $7.5 million.

appeared to be the top leaders of the company.  So, at the time I concluded,

At least in the Purdue Pharma/ Oxycontin case top company leaders were prosecuted, pleaded guilty, and will personally have to pay substantial financial penalties. Maybe this will convince the leaders of health care organizations that deceptive marketing practices may not be in their long term interests. Up to now, it may have been too easy to be swayed by the enormous profits deceptive marketing can bring, and regard fines paid by the company as just a cost of doing business.

No Lasting Effects

I was much too optimistic.  Alas, we have since documented numerous legal settlements, and other cases of at least alleged bribery, kickbacks, or fraud, in which the top organizational leaders who authorized or directed the questionable conduct never suffered any consequences for their actions.  That is, they demonstrated impunity.

Meanwhile, Purdue Pharma has been in the news since 2007, and not in a good way.  In particular, we noted that the company seemed to keep up manipulative, if not deceptive marketing efforts on behalf of its narcotic product.  In 2010, Canadian medical students protested that their "education" about narcotics and pain management was influenced by Purdue marketing (look here).   In 2012, we noted that a leading "key opinion leader" who had a key role promoting the liberalized, if not reckless use of narcotics to treat all sorts of chronic pain, and had financial relationships with numerous narcotic pharmaceutical manufacturers, including Purdue Phrama, later admitted that it was all "misinformation."  Yet this aggressive promotion of narcotics was likely a major factor in the ongoing narcotic epidemic which has killed thousands in the US.  And in January, 2016 we described how opposition to new CDC guidelines that suggested much more conservative use of narcotics seemed to be funded, if not orchestrated by narcotic pharmaceutical manufacturers, notably including Purdue Pharma.  Finally, there have been many other stories about Purdue Pharma about which we failed to post.

One would think, however, that a company that admitted to a crime, and whose three top executives lost their jobs and also pleaded guilty to crimes, would at least change its ways, even if these guilty pleas and admissions did not inspire more attempts to hold top corporate health care leaders accountable.

An Assumption about Unaccountable Hired Mangers

But it turns out that some obvious assumptions that I and probably many other people made about the Purdue Pharma cases of 2007 were wrong.  I implicitly assumed when I wrote my 2007 post that the three Purdue Pharma executives who pleaded guilty were the top leaders of the company.

Furthermore, as we have discussed elsewhere, the top executives of large, for-profit publicly held corporations, like most pharmaceutical companies, have become largely unaccountable.  They may seem to exist in a bubble, in which they are hailed as visionaries, and paid exceedingly well no matter how their organizations perform.  (Look here).  However, many top hired corporate managers have mainly become "value extractors."

These executives are nominally accountable to their corporate boards of directors, which are supposed to represent the owners of the companies.  However, most large pharmaceutical companies have numerous stockholders, who have no easy avenue to organize.  Many of their stockholders, in turn, are mutual funds, retirement funds, etc whose shares in turn are owned by thousands more.  These numerous, dispersed "owners" have little influence on corporate boards, who often functionally are dominated by cronies of the top management.

So when the three top Purdue executives pleaded guilty, at least it looked like in this case the unaccountable hired executives had been made accountable, if not to their boards of directors, at least to the courts.

But Who Owned Purdue?

But what you see is not always what you get.  There was a hint buried in the NY Times article,

Between 1995 and 2001, OxyContin brought in $2.8 billion in revenue for Purdue Pharma, a closely held company based in Stamford, Conn. At one point, the drug accounted for 90 percent of the company�s sales.

As part of the plea agreement, Purdue Frederick, a holding company for Purdue Pharma that is also closely held, pleaded guilty to a felony charge of misbranding OxyContin.

The article did not further discuss the meaning and implications of the twice used phrase, "closely held."  I confess I missed it entirely.  However, it seems to have meant that rather than being a public corporation with numerous, dispersed stockholders, the owners of Purdue Pharma and its parent were a smaller group, perhaps a group who should have been accountable for the actions of their executives.  However, the NY Times did not further describe this group.  Neither did reports in other outlets, such as the Wall Street Journal, CBS, or Time. Nor did a variety of other news stories that mentioned Purdue Pharma through 2010.

The Oxycontin Billionaires

There were a fewother clues available in 2007, but would have not been easily found at that time.  After the case's resolution was disclosed, an article appeared in the Corporate Crime Reporter (but was presumably only available at that time by subscription.)

Purdue is a privately held, very secretive company based in Stamford, Connecticut.

It�s controlled by the Arthur Sackler family. Arthur Sackler is the guy who, before he delivered OxyContin, brought to you the marketing for Librium and Valium. Walk on the mall in Washington and you walk by the Freer Gallery of Art and Arthur Sackler Gallery.

Art brought to you by Oxy.

New York Times correspondent Barry Meier is probably the most plugged in journalist on the topic. A couple of years ago, he wrote a book detailing the problem titled Pain Killer: A 'Wonder' Drug�s Trail of Addiction and Death (Rodale Books, 2004.)

So apparently Purdue Pharma and Purdue Frederick were privately held, the Sackler family held a controlling interest, and the Sackler family were rich enough to have their name attached to an art museum.

The relationship between the Sackler family and Purdue got no other attention I could find until 2010.  In March of that year, another member of the family, Dr Mortimer D Sackler died, and his NY Times obituary led off with evidence of his wealth, and philanthropy,

Mortimer D. Sackler, a psychiatrist who was a co-owner of the pharmaceutical company Purdue Pharma, makers of the controversial painkiller OxyContin, and whose lavish gifts to the Guggenheim Museum, the Metropolitan Museum of Art and Columbia University made him one of New York City�s most prominent benefactors, died March 24 in Gstaad, Switzerland. He was 93 and had homes in London, Gstaad and Antibes, France.

The obituary also provided evidence of a direct relationship among the Sacklers, Purdue, and the development of Oxycontin.

The Sackler brothers were all doctors, and all businessmen as well. In 1952, while the three were working at the Creedmoor state psychiatric hospital, Arthur financed the purchase of a small drug manufacturer based in Greenwich Village, the Purdue Frederick Company, which Mortimer and Raymond Sackler ran as co-chairmen and which later became Purdue Pharma, now based in Stamford, Conn.

Then,

by the mid-1990s Purdue Pharma was still a small drug company. But with a new product, OxyContin, a powerful, long-acting, narcotic painkiller, the company hoped to join the ranks of industry giants. Indeed, by 2001 sales of the drug had reached nearly $3 billion and accounted for 80 percent of Purdue Pharma�s revenue.

An obituary in the London Telegraph quantitated the wealth that the Sacklers obtained from Purdue a bit more,

The lavish scale of Sackler's generosity was indicated in The Sunday Times's "Rich List" for 2008, which noted that while he and his family owned a �500 million stake in the pharmaceutical business, Purdue Pharma, huge charitable contributions had cut their wealth to �300 million. Yet few knew much about the Sacklers apart from their association with the cultural institutions that bear their name.

However, I could find no echos of this story beyond these obituaries, and certainly none that prominently made their way into the health care world.  In late 2011, about ten percent of a long piece by Fortune on Purdue made the Sackler's ownership and wealth clear, but did not discuss the implications.

The story only began to echo a little in 2014.  That year, the prospect of a trial of a civil lawsuit against Purdue filed in the state of Kentucky, one of the most hard hit by the narcotic epidemic, promised to shake things up.  A long Bloomberg story on the lawsuit was the first to suggest that the very wealthy Sackler family might bear some responsibility for how Purdue marketed Oxycontin, and the results on patients' and the public's health. 

Kentucky lawyers plan another first for Purdue: They want to elicit testimony from the company�s board, which is dominated by members of the Sackler family, the wealthy philanthropists who own the company and have until now remained largely untouched by the controversy tied to the blockbuster drug that netted their business billions of dollars.

It underlined the tightness of the ties between the Sackler's and Purdue. The family does not merely own a controlling interest, but dominates the company's governance.

Purdue today is owned through holding companies and family trusts for the benefit of Mortimer and Raymond Sackler�s families, according to Raul Damas, a company spokesman. In all, nine members of the Sackler family are Purdue directors. In January, Raymond Sackler announced the appointment of Chief Executive Officer Mark Timney. None of the Sacklers has been named in the Kentucky suit.

Raymond, who remains on the board, and his children have been the most involved in the family business. His son, Richard, a physician, worked at Purdue for three decades before being named president in 1999. Now retired, he remains a director. A grandson, David Sackler, sits on the board and runs a family investment fund, Summer Road LLC, in New York. Raymond�s other son, Jonathan, is a director, too.

By the way, the Bloomberg article also detailed another point (which had been mentioned in the obituaries and the CNN article). One member of the Sackler family was behind the aggressive, deceptive marketing campaign that sparked so many sales of Oxycontin. In fact, this Sackler brother could be viewed as the father of modern aggressive, deceptive pharmaceutical/ biotechnology/ device corporate marketing.

Raymond and Mortimer ran the company together. Arthur, the oldest, appears to have been primarily an investor and adviser.

Considered the father of modern pharmaceutical marketing, Arthur Sackler created the first medical-journal advertising insert to promote a drug and pushed for hiring sales reps long before they became as common in physicians� waiting rooms as out-of-date magazines. Purdue used many of Arthur Sackler�s tactics when it introduced OxyContin, a time-released dose of the opioid oxycodone, in 1995.

CNN had gone into a bit more detail on Arthur Sackler's previous work:

Arthur, joined a small advertising agency that specialized in marketing pharmaceuticals. (He also funded his brothers� purchase of Purdue, according to a 2003 book by New York Times reporter Barry Meier called Pain Killer: A Wonder Drug�s Trail of Addiction and Death.) Arthur was so successful that in 1997 he was one of the first people named to the Medical Advertising Hall of Fame, whose website credits him with helping 'shape pharmaceutical promotion as we know it today.' As early as the 1950s he was experimenting with TV marketing, and according to the entry, Arthur�s scientific knowledge and ability to expand the uses for Valium helped turn it into the first $100 million drug ever. Arthur�s philosophy was to sell drugs by lavishing doctors with fancy junkets, expensive dinners, and lucrative speaking fees, an approach so effective that the entire industry adopted it.

So at least this article credits Dr Arthur Sackler, of Purdue Pharma, with being one of the creators of the web of conflicts of interest that has ensnared many medical professionals in the last decades.  Who knew?

Just to ice this cake, in later 2015, it became apparent that the Sacklers did not merely become wealthy from Purdue profits and Oxycontin sales. They became fabulously wealthy. Forbes listed the Sackler family that year as one of the 20 richest US families, estimating their combined wealth as $14 billion.

The Sackler family, which owns Stamford, Conn.-based Purdue Pharma, flew under the radar when Forbes launched its initial list of wealthiest families in July 2014, but this year they crack the top-20, edging out storied families like the Busches, Mellons and Rockefellers.

How did the Sacklers build the 16th-largest fortune in the country? The short answer: making the most popular and controversial opioid of the 21st century � OxyContin.

Purdue, 100% owned by the Sacklers, has generated estimated sales of more than $35 billion since releasing its time-released, supposedly addiction-proof version of the painkiller oxycodone back in 1995. Its annual revenues are about $3 billion, still mostly from OxyContin. The Sacklers also own separate drug companies that sell to Asia, Latin America, Canada and Europe, together generating similar total sales as Purdue�s operation in the United States.

Forbes estimates that the combined value of the drug operations, as well as accumulated dividends over the years, puts the Sackler family�s net worth at a conservative $14 billion.

Perhaps if the Kentucky lawsuit had gone to trial, these echos would have gotten even louder.

However, in December, 2015, Purdue settled the suit for $24 million, admitting no liability, and keeping the Sackler name out of the limited press coverage (although see this in STAT by Ed Silverman.)

I, for one, only found out about the Sackler / Purdue linkage when STAT published a followup in March, 2015.  It turns out that in the run up to the Kentucky trial, a member of the Sackler family was actually deposed.  This may have been the only direct discussion of the Oxycontin case by a member of the family.

The settlement required the attorney general to 'completely destroy' or return to Purdue all documents it received from the company or from any other party through a subpoena. The attorney general was given 60 days from the Dec. 18 agreement to comply. The agreement also prohibits the attorney general from sharing the documents with any other entity investigating or litigating against Purdue.

The attorney general�s office destroyed millions of pages of documents within the 60-day period, according to spokesman Terry Sebastian.

While the attorney general destroyed the records in its possession, copies of some of those records remain under seal in the Pike County courthouse, including the Sackler deposition.

The STAT article noted that millions of pages of records from other Oxycontin litigation were destroyed or returned to the company as stipulated by previous settlements. This time,

STAT is making a motion to intervene in the settled Kentucky lawsuit. The motion was sent to the Pike Circuit Court Monday via overnight courier.

The motion argues that STAT and the public have a constitutional right to the records that trumps Purdue�s interest in keeping them secret. The motion also states there is a substantial public interest in the case, citing the epidemic of drug addiction and related crime stemming from the abuse of OxyContin in Kentucky and other states. STAT is requesting the court make the documents available immediately.

We will see how this attempt to shine a little light on the long running Oxycontin story goes. I am not optimistic, since this long-running case has vividly shown how those who have the biggest vested interests in keeping our commercialized, overutilizing, over-marketed health care system going can use money and influence to keep it all so anechoic.

Summary

So now we see, dimly, reasons why the penalties handed out to "top" Purdue Pharma executives for the deceptive "misbranding" of a dangerous narcotic failed to end the impunity of top health care leaders.  Those supposed "top men" were not really the top.

Just like in "Raiders of the Lost Ark,"




They were hired managers with fancy titles who worked for a secretive family which owned Purdue Pharma, which was apparently directly involved in the engineering of the aggressive, deceptive, "misbranding" sales campaign which sold so much Oxycontin, which became fabulously wealthy from the ownership of the company, and which managed to conceal their relationship to the company from nearly all prying eyes.  So far, the family seems to either have befuddled or intimidated law enforcement sufficiently to prevent any direct consequences from befalling them.

This case vividly demonstrates, first, how those who have personally gained the most from our current dysfunctional health care system have often brilliantly covered up what they were doing (part of what we have called the anechoic effect).  As long as we do not know where the money goes, and how it is made, we do not know what needs to be done to make things better.  True health care reform requires bright sunlight to be shown on how the health care sausage is made, who makes it, and how they profit from it.  As long as we the people let ourselves stay in the dark, we will continue to endure our woefully overpriced, inaccessible, mediocre quality, and all too often frankly corrupt health care system.  

A piece this long and heavy deserves a musical interlude. Here is a live performance by the Dramatics of "What You See Is What You Get," (if only that were the case here).





 

Princess Health and A Small Challenge to Impunity - Lawsuit Against Former Synthes CEO Proceeds. Princessiccia

Princess Health and A Small Challenge to Impunity - Lawsuit Against Former Synthes CEO Proceeds. Princessiccia

anechoic effect impunity Johnson and Johnson legal settlements Synthes

Gusty 11:52 Add Comment

Numerous allegations of bad behavior by big health care organizations, some apparently causing patient harm, have resulted in legal settlements, sometimes of criminal charges.  Yet rarely do the individuals who apparently authorized, directed, or implemented the bad beahvior suffer any negative consequences.  In particular, the top executives on whose watch the bad behavior occured seem to have impunity.

Suing the Former Synthes CEO

So it is news that a lawsuit will proceed against the former CEO of medical device company Synthes,  alleging actions that led to the death of a patient.  The basics were reported by the Daily Caller,

Hansjorg Wyss ... will face charges of running a 'criminal profiteering enterprise' through the illegal use of a drug and in violation of federal patient safety rules that resulted in the death of a 67-year old woman....

Washington State Superior Court Judge Dean Lum agreed Oct. 30 that Wyss, a Swiss billionaire ... can stand trial under the state�s racketeering laws for leading a criminal enterprise that caused the death of Reba Golden. She died during an illegal drug test conducted by Wyss�s company in 2007.

The Washington suit charges Wyss, the former CEO of a Pennsylvania-based medical device company called Synthes and his co-defendants with murder in the second degree as a class A felony, second degree assault and criminal profiteering under the Washington Criminal Profiteering Act.

Wyss faces a statutory civil penalty of $250,000 for each violation, amounting to $9.2 million for 'personal injury to and death of Mrs. Golden.' He is charged in 37 violations.

The plaintiff is Reba Golden�s daughter, Cynthia Wilson, whose mother died in 2007 on the operating table after Synthes organized illegal 'market tests' for at least 50 persons across the country of an untested bone cement substance that the Food & Drug Administration banned for use in the spine.

Ultimately, five patients died during the illicit drug testing. Synthes failed to report the deaths to the FDA, as required by law, until the third fatality occurred.

Furthermore, 

Wyss 'entered into a criminal enterprise to perfo'rm illegal and experimental surgeries on patients,' Daniel Hannula, Golden�s attorney, told The DCNF.

Also,

'Mr. Hansjorg Wyss was the controlling stockholder and ranking executive of Synthes and Norian Corporation and the leader of a criminal enterprise,' the complaint states. 'The criminal enterprise engaged, for profit, in a pattern of criminal profiteering activity,' enticed by the prospect of a company forecast of $3 million in after-tax profit for the first year of sales.

Judge Davis agreed case was about profits, saying their behavior was 'generated by a desire to realize the immense profits.'

Hannula told the DCNF, 'they completely ignored what was required of them in order to get their product to the market as quickly as possible because they recognized that this was a market of huge financial potential.'

These are only allegations, of course. However, again, it is very rare for any top executive of a health care organization to personally face a lawsuit for his or her organization's conduct, no matter how bad that conduct may be. 

The Synthes Case Up to Now

We already knew that Synthes' conduct was particularly bad. We last discussed the Synthes case in 2011.  The case was already extraordinary in that it resulted in criminal convictions of several high-ranking Synthes executives.  At that time we wrote:

Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see this post).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this "off-label" use died.  This scheme was alleged to have been directed by 'person no. 7,' whom journalists identified as the company CEO, Hansjorg Wyss (see post here.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post here).

In 2011, Wyss agreed to sell Synthes to Johnson and Johnson, itself a company with a very chequered past (look here), thus making himself into a multi-billionaire, and one of the world's richest men.  (Currently, Forbes lists Wyss as number 240 on its list of the world's richest, estimating his fortune at $6.1 billion.)

The case then slipped into relative obscurity, although Fortune ran a long-form article on it in 2012, which called it a "medical horror story."

An Almost Anechoic Lawsuit

Because of the unusual nature of the ongoing lawsuit, one might expect that it would generate some public discussion.  One would be wrong.  The litigation against Mr Wyss so far has received almost no media coverage, demonstrating the ongoing anechoic effect.  We previous defined  the anechoic effect, as the phenomenon that information or discussion that could challenge or discomfit the powers that be in the US health care often generates no echoes.  

To date, I could only find coverage of the ongoing lawsuit against Mr Wyss in the Daily Caller.  And ironically the Daily Caller did not appear to cover this case because it specializes in malfeasance in health care.  It seemed to cover it because it may have indirectly reflected negatively on prominent members of the US Democratic Party.

Actually, the main focus of the article I quoted above was not health care.  It was that Mr Wyss appears to be a supporter of Hilary Clinton, the currently leading Democratic candidate for the US presidential nomination, and of ostensibly left-wing causes.  I put an ellipsis in the first sentence of the article to allow me to focus on its health care aspects.  What I removed was not a description of Mr Wyss not as an extremely rich former CEO of a medical device company, but as

Hansjorg Wyss, a prominent Clinton foundation donor and wealthy bankrolled of liberal activist groups, will face charges of running a 'criminal profiteering enterprise'....

And the article's title similarly did not mention health care at all: 

Major Clinton Donor Faces 'Criminal Profiteering' Charges

The Daily Caller actually specializes not in health care malfeasance, but in issues of interest to the right wing.  As Politico reported in 2014, Tucker Carlson, described as a "conservative pundit, who founded the Daily Caller, has said

What I despise most about the legacy media isn�t just that they�re mindlessly liberal, though they are.

The Columbia Journalism Review described the Daily Caller as having

carved out a cozy corner of the web in its short life. It�s a place for conservatives to read about the latest liberal scandal and the latest movements in the GOP presidential field.

So presumably if Mr Wyss was uninterested in politics, and did not donate to any remotely left wing causes, the Daily Caller would not have covered the ongoing lawsuit, leaving it totally anechoic.

But whether of not the Daily Caller had an axe to grind when making its choice to report on the ongoing litigation against Mr Wyss, why did every other media outlet to ignore the story?  Perhaps again the rule is in general it is simply not done to publicly discuss what might excessively embarass the people who have gotten very rich from the currently dysfunctional health care system?

Conclusions

The just revealed story of the lawsuit against the extremely rich former CEO of Synthes does suggest that perhaps individuals injured by our curent dysfunctional health care system could use the legal system to try to challenge those who get rich from enabling such injuries.  Or not, because the outcome of this lawsuit is uncertain.

Furthermore, the initiation of this lawsuit again reminds us that those who lead large health care organizations, and may profit mightily from them, regardless of the effects on patients' and the public's health, remain beyond the law.  It is not clear why the US Department of Justice chose not to even attempt to prosecute Mr Wyss, although they apparently believed he was responsible for directing the actions that led to patient deeaths.  But his impunity mirrors that granted to just about every top health care manager who authorized or directed corporate bad behavior that endangered patients. 

This impunity is further enabled by how anechoic stories of bad leadership of health care organizations, even of apparently criminal or corrupt leadership, are.  As long as most health care professionals and the public at large remain unaware of the dark side of health care, they are unlikely to seek light to shed upon it.

True health care reform would encourage open, widespread discussion of all aspects of health care dysfunction, particularly bad behavior by those who profit most from it, and would encourage health care leadership that puts patients' and the public health first, is willing to be accountable for its actions, is transparent, honest and ethical. 

Princess Health and Round and Round It Goes - Former US Secretary of Health and Human Services Joins Humacyte Board. Princessiccia

Princess Health and Round and Round It Goes - Former US Secretary of Health and Human Services Joins Humacyte Board. Princessiccia

anechoic effect conflicts of interest corporatism DHHS revolving doors

Gusty 09:17 Add Comment

The latest example of the health care revolving door was made barely public just before the US Labor Day holiday.  Per the Triangle Business Journal,

Humacyte Inc., a biotechnology company based in Research Triangle Park, has beefed up its board of directors by adding former U.S. Secretary of Health and Human Services Kathleen Sebelius and life sciences industry veteran Dale Sander.

The 11-year-old Humacyte develops novel human tissue-based investigational products that are being developed for potential commercialization for applications in regenerative medicine and vascular surgery. Sebelius adds a significant amount of heft to the company�s now eight-person board.

From 2009 to 2014, she served as the 21st Secretary of the HHS, leading the effort to pass and implement the Affordable Care Act. She�s also been named by Forbes as one of the 100 most powerful women in the world.

Prior to serving as secretary of HHS, Sebelius served as governor of Kansas, two terms as the Kansas insurance commissioner and four terms in the Kansas legislature.

'Secretary Sebelius is undoubtedly one of the most distinguished health care industry leaders of our time and we are honored to have her join our organization,' said Carrie Cox, chair and chief executive officer of Humacyte, in a statement. 'Her tenure in the public sector, and deep understanding of the rigors of the regulatory process and policy will provide unique perspective and insight to support our goals to improve care for Humacyte�s first application for patients with End Stage Renal Disease.'

Comments

I will just raise a tired, ironic eyebrow in response to a lawyer, politician, and government leader with no direct biomedical or health care training or experience, and no apparent health care industry experience being called a "distinguished health care industry leader."

The big issue here is, of course, the revolving door.

It now seems that any randomly selected top US government official who has responsibilities directly related to health care could turn out to be a past or future health care corporate lobbyist, consultant, board member, or executive.  The revolving door is now well established between the US government and the country's huge and growing corporate health care sector.  Recent (2015) examples include:
-  a former Director of the Center for Medicare and Medicaid Services who was a Columbia/ HCA executive and who became the CEO of America's Health Insurance Plans (a trade and lobbying group) (look here)
-  various officials involved trade agreements (that heavily affect health care) who came from or went to industry (look here).
-  some US Food and Drug Administration officials who were involved in the lax regulation of amphetamines in "natural" products who came from or went to the "natural" supplements industry (look here).
- Etc, etc, etc

But the latest example is a big one, since it involves the top US health care official, the Secretary of the DHHS.

As we have said endlessly, the ongoing and increasing revolving door phenomenon clearly suggests excess coziness between industry and government, now to the extent that industry and government leaders of health care are becoming interchangeable.  This suggests that health care is increasingly run by this cozy ingroup, who very likely put their own interests ahead of those of patients and the public.

This is at best crony capitalism, and makes a mockery of that famous sentence in President Lincoln's Gettysburg Address:

government of the people, by the people, for the people, shall not perish from the earth.

The revolving door is clearly a kind of conflict of interest.  Government officials who can look forward to extremely lucrative employment in health care industry (regardless of their actual experience in health care or the health care industry) may be much more inclined to seem friendly to the industry while in office.  Government officials who just came from industry are likely to maintain their industry mindset and be mindful of their industry friends.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Finally, the revolving door on its currently massive scale starts to look like corporatism (or corpocracy), "the organization of society by major interest groups."  One variant of corporatism prominent in the last century was fascism (on the model of Mussolini in Italy).  Of course, many of us in the US ought to see corporatism as antithetical to how our government and society is supposed to function - supposed to function.

Thus, the revolving door in health care seems like it ought to bear scrutiny.    Yet most examples of the revolving door are very anechoic, being noted mainly in the business media, and usually barely there.  I have seen almost no notice of it in the health care, health policy, or medical literature.  (For example, so far Ms Sebelius' new job has appeared in a corporate press release and a single article in a local business newspaper, as far as I can tell.)

So once more with feeling...  The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large

Princess Health and Northwestern Upholds its "Brand," Never Mind Free Speech and Academic Freedom. Princessiccia

Princess Health and Northwestern Upholds its "Brand," Never Mind Free Speech and Academic Freedom. Princessiccia

academic freedom anechoic effect bioethics censorship free speech mission-hostile management Northwestern University

Gusty 11:35 Add Comment

Threats to free speech and academic freedom in health care were a major concern when we started Health Care Renewal.  Such threats may now be less anechoic, but do not seem to have diminished.

Censorship and the Resignation of Alice Dreger

The latest example was at Northwestern University. The basics of the case appeared in the Chronicle of Higher Education. Alice Dreger just resigned her position of 10 years as "a clinical professor of medical humanities and bioethics."

What prompted her departure was the fallout over an article by William Peace, who at the time was a visiting professor in the humanities at Syracuse University. Mr. Peace wrote an essay for an issue of the journal, Atrium, that Ms. Dreger guest-edited. The essay is a frank account of a nurse who helped Mr. Peace regain his sexual function after he was paralyzed.

According to Ms. Dreger, Eric G. Neilson, vice president for medical affairs and dean of the university�s school of medicine, tried to censor the essay. The essay is straightforward in its description of sex, and includes multiple mentions of 'the dick police,' but the purpose is to illuminate what went on in the era prior to disability rights and studies.

As Mr. Peace writes, the unconventional approach of the unnamed nurse 'injected a compassionate eroticism that made me a better man.'

In her letter, Ms. Dreger writes that the university allowed the essay to be published online only after she and Mr. Peace threatened to talk publicly about what they saw as censorship. She writes that she was 'disgusted that the fear of bad publicity was apparently the only thing that could move this institution to stop censorship.'

Now the essay is out there, for all to see, 'dick police' and all. So what does Ms. Dreger want?

She asked the university to acknowledge that attempting to remove portions of the essay was a mistake and to promise not to do so in the future. 'They never acknowledged that the censorship was real,' Ms. Dreger said in an interview. 'I wanted a concrete acknowledgment and assurance that my work would not be subject to monitoring.' That, she said, would have been enough for her to remain.

The idea that institutions must acknowledge wrongdoing is central to Ms. Dreger's academic work.

More details about university managers' alleged attempts to control the content of an academic journal emerged in an article in the local newspaper, that is, the Chicago Tribune.  The managers wanted to appoint their own oversight committee to control journal content.

The journal Atrium stopped publication after faculty objected to the new oversight committee, which [University spokesman Alan] Cubbage has described as 'an editorial board of faculty members and others, as is customary for academic journals.'

Note, however,  that editorial boards are usually appointed by journal editors, not managers or executives.

Also, as noted in an article in Inside Higher Ed,

Dreger, who guest-edited the 'Bad Girls' issue [in which the controversial article first appeared], said that soon after publication, medical school administrators asked Atrium�s editors to remove the essay from the web, because the content was considered inflammatory and too damaging to the new Northwestern Medicine 'brand.' (Northwestern Memorial Health Care recently acquired Northwestern�s Feinberg School of Medicine faculty practice and merged with Cadence Health to operate under the Northwestern Medicine banner.) The editor, another faculty member, refused to single out one article for censorship and took down the journal�s web archive instead.

Furthermore, the university administration's reaction to the publication of the article prompted another resignation,

The controversy prompted the resignation of Kristi Kirschner, a former clinical professor humanities and bioethics at Feinberg, in 2014. Kirschner, now an adjunct professor of disability and human development at the University of Illinois at Chicago, told Inside Higher Ed earlier this summer that the alleged censorship had a 'chilling effect, antithetical to the idea of the university.'

As for that "chilling effect,"

A university spokesman declined to comment on Dreger�s case on Tuesday, saying it was a personnel issue. He also declined to answer general questions about censorship or the status of Atrium, which recently had its funding reduced, causing the journal to be canceled.

Atrium�s editor, Katie Watson, an assistant professor of bioethics and medical humanities, declined an interview but said the funding cut was not related to the 'Bad Girls' issue or censorship.

She referred additional questions to a post she wrote for Peace�s blog, Bad Cripple, in June, in which she said that she was disappointed with Peace for taking certain details of the case public, and in which she confirmed that a university content oversight committee meeting had been 'disheartening.'

"[T]he medical school required me to allow a vetting committee to review my editorial choices and veto them if they were perceived to conflict with other institutional interests," Watson wrote.

So note that the allegations of censorship have come from at least three separate faculty members at Northwestern, and from the author of the censored article, a faculty member at another institution.  Furthermore, on university spokesperson has contradicted these charges.  

Previous Mysterious Events at Northwestern

Of further concern is that this case may be part of a pattern.

Two years ago we wrote (here and here) about another case, albeit mysterious and convoluted, at Northwestern in which a faculty member, Dr Charles Bennett, resigned after being accused of mismanaging the finances of a government grant.  However, although he was responsible for the scientific management of the project, university managers, nor Dr Bennet, were responsible for its finances.  While the university settled allegations of financial mismanagement, and a university staffer pleaded guilty to related charges, a university statement implied that it was mainly Dr Bennett's fault, per the Cancer Letter

'As the settlement makes clear, the covered conduct in the settlement involved allegations focused on Dr. Charles Bennett, and grants for which Dr. Bennett was the principal investigator,' Northwestern officials said in a statement.

In addition,

The statement was signed by Northwestern President Morton Schapiro, Provost Daniel Linzer, and Vice President for Medical Affairs and Dean of the Feinberg School of Medicine Eric Neilson.

Note that the Vice President and Dean Neilsen above was the same Dean who Prof Dreger accused of trying to censor her journal.

Suspicions were raised at that time that the treatment of Dr Bennett might have been somehow related to how he made himself unpopular by authoring research that suggested Aranesp, a blockbuster Amgen epoetin drug, was much more dangerous than it seemed.  The Cancer Letter had interviewed one of Dr Bennett's collaborators,

[Michael]  Henke confesses to wondering whether the many powerful enemies Bennett made in the pharmaceutical and biotechnology industries have struck back.

'We shouldn�t feed paranoia,' Henke said. 'However, given the exclusively positive experience when collaborating with his group, makes me wonder whether this litigation might follow some very particular other issues.'

And recently the editor of the Cancer Letter, and the author of the above article, has been fighting subpeonas from Amgen intended to make him reveal his sources of negative information about Aranesp, (look here and here).

As far as I can tell, the questions I raised about the case of Dr Bennett (look here and here) have never been answered.

Nonetheless, the case of Prof Dreger has also been rather anechoic.  It was also covered by the Times of London Higher Education Supplement, and inspired comment from FIRE, but has otherwise not gotten national media attention, or any apparent coverage in medical or health care journals.  

Sometimes you may be paranoid, and sometimes someone may be out to get you.
Summary and Comments

So, to summarize, multiple sources suggested that top Northwestern Medicine leadership attempted to censor an academic publication edited and led by university faculty.  After publication of an article apparently controversial for its sexual content, but which likely also brought up valid issues about compassionate treatment of disabled patients versus traditional ethical concerns about boundary issues for health professionals, university leaders imposed an oversight committee which apparently was more concerned about the instiution's "brand" and other "institutional interests" than about free discussion of important health care issues.  The chilling effects of this attempt at censorship seemed to include resignations by two faculty members, and the demise of the journal.

Thus it appears that the managers were putting public relations and revenue concerns ahead of the fundamental academic values of free speech and academic freedom, thereby threatening these values.  In a post on Bioethics.net, Craig Klugman reminded us,

 According to the American Association of University Professors (1940):
'Academic freedom is essential to these purposes [the search for truth and its free exposition] and applies to both teaching and research. Freedom in research is fundamental to the advancement of truth.'

Cary Nelson, president of the AAUP and an English professor says that academic freedom:
'Gives both students and faculty the right to express their views � in speech, writing, and through electronic communication, both on and off campus � without fear of sanction, unless the manner of expression substantially impairs the rights of others or, in the case of faculty members, those views demonstrate that they are professionally ignorant, incompetent, or dishonest with regard to their discipline or fields of expertise.'

Even the American Society for Bioethics & Humanities, which is known for not taking positions on 'substantive moral and policy issues,' does take positions to support academic freedom and has done so in the past.

Since 1940, the notion of academic freedom has been a core tenet of university and faculty life. The idea was born in response to centralized governments telling researchers what they could and could not study and what they should and should not teach.

So free expression and academic freedom remain under threat in academic health care institutions. These threats seem in part to stem from managers' continuing inclinations to put commercial concerns ahead of the academic mission, perhaps fueled by prodigious amounts of money waved around by health care corporations looking to make their marketing appear more scientifically based.  These threats may be partially enabled by the anechoic effect, a sort of second order self censorship, so that cases of censorship are another kind of recent unpleasantness that get little public attention.

Students, health care professsionals, and faculty members who care about medical education and research ought to be asking some hard questions about the leadership of their organizations.  It looks like Northwestern students, trainees, and faculty members could have lots of questions to ask.

As we have said until blue in the face, true health care reform would enable leadership of health care organizations that upholds and is willing to be accountable for putting patients' and the public's health first, and leadership of health care academic organizations that also puts honest, transparent research and education ahead of commercial interests.   

Princess Health and The Real Dark Side of Health Care: Health Care Corruption. Princessiccia

Princess Health and The Real Dark Side of Health Care: Health Care Corruption. Princessiccia

anechoic effect Annals of Internal Medicine health care corruption medical journals professionalism

Gusty 14:35 Add Comment

The editors of the prestigious Annals of Internal Medicine just stated they they were shocked, shocked to find out that physicians occasionally express disrespect for patients when the patients cannot hear or see them.  The occasion was an editorial signed by three editors whose title included the phrase, "shining a light on the dark side of health care."(1)  The editorial referred to an anonymous narrative that recounted two incidents from the past.(2)

Two Alleged Incidents of Physicians' Expression of Disrespect for Patients

The first incident, discussed second hand, was of a obstetrician who made a sexist comment about a patient, who was under anesthesia, presumably unconscious, and being prepared for surgery.  The second incident, presumably less recent, was of an obstetric/gynceology resident who, after performing an emergency procedure that saved a woman from potentially fatal acute hemmorhage, performed an impromptu dance routine that appeared to disrespect the patient's ethnicity, until stopped by the anesthesiologist who issued a profance rebuke.

The names of the people involved, the hospitals in which these incidents occurred, and even the years when they happened are unknown.  The Annals did not publish anything suggested their veracity was corroborated.

There was no apparent harm to or direct effect on any patient as a result of either incident.  Of course, both alleged incidents suggested very disrespectful expression by the two physicians.  Their actions appeared unprofessional.

The Editorial Reaction

As noted above, the editorial called the incidents examples of medicine's "dark side."  It further said they may make "readers' stomachs churn," referred to "medicine's dark underbelly," and "repugnant behavior," and characterized the narrative as "disgusting and scandalous," and having the potential to "damage the profession's reputation."  The editorial characterized the the behavior of the obstetrician in the first incident as "highly disrespectful," and said it "reeked of misogyny and disrespect," while the second "reeked of all that plus heavy overtones of sexual assault and racism." 

That is certainly extreme language.  The editors appeared shocked, shocked that any physician could ever express disrespect for a patient, even when the patient could not possible be aware of that.  Nonetheless, of course, the behavior alleged to have occurred was certainly inappropriate and unprofesional, and cannot be condoned.

The Media Reaction

The two articles got considerable publicity, and media coverage also made the incidents out to be extremely sordid, using words like,"disturbing," "astonishing," "unsavory," (albeit also "boorish,") (LA Times); "criminal," "vulgarity," (MedPage Today); "appalling," "troubling," (NY Times); and  "misogynistic," "abhorrent," (US News and World Report).  I must note that some of the news coverage did reflect doubts that the two Annals of Internal Medicine articles represented some horrendous catastrophe, raising issues such as the humanness of doctors, so that some may be "prone to sociopathy and criminality;" the stress of some medical emergencies leading to letting off steam, or poor attempts at humor; and doubts about the representativeness and validity of the two alleged anecdotes.

Nonetheless, it seemed to me that the Annals articles and the media coverage did suggest an impending crisis due to the sordid behavior of perhaps numerous doctors, and at least the tone of the media coverage they provoked suggested the need for immediate action.

Was the Outrage Justified?

However, first keep in mind that these two incidents involved two individual doctors, one a trainee.  There are approximately 800,000 physicians in the US.  They are human.  Is it any surprise that some are "bad apples," and that others occasionally behave badly?  There is nothing in the two articles to suggest that these incidents reflected more organized, systemic actions.

Furthermore, the articles seemed to ignore the fact that mechanisms, perhaps not flawless, are already in place to address unprofessional behavior by physicians, even if no one involved in the published narrative may have used them.  In the US, physicians are subject to discipline from state licensing boards.  They may be reported to those boards for unprofessional behavior.  The boards can sanction physicians in a variety of ways, up to and including permanent loss of license.  Both alleged incidents apparently occurred in teaching hospitals.  Attendings and residents at teaching hospital must answer to department chairs, medical school deans and hospital staffs.  So mechanisms for policing such behavior exist, even if they may have not been used in this case.  A look at state medical board websites reveals that that physicians are often sanctioned for bad behavior that disrespects or even endangers patients. 

Finally, the Annals of Internal Medicine used very strong language, involving churning stomachs, reeks of misogyny, sexual assault, and racism, dark underbellies, etc.  Was this a proportionate response to two anonymous cases that did not involve allegations of direct patient harm?

The Real Dark Side

Readers of Health Care Renewal know that we often discuss systemic problems in health care, often involving the leadership of large health care organizations, that may produce real harms to patients' and the public's health, but for which no good policing mechanisms seem to exist.  Worse, these problems seem to be a taboo topic in health care policy discussions, and in medical journals, like the Annals of Internal Medicine.

In my humble opinion, the Annals' editorial outrage would ring less hollowly if it was accompanied by even greater outrage at such more extreme problems. 

Let me start with a recent example.

Example: the Anechoic AllTrials US Launch

Very recently we discussed how the launch of new US AllTrials initiative got almost no notice.  Specifically, even though a sponsor of the initiative is the American College of Physicians, that organization's publication, the Annals of Internal Medicine, did not comment on it.  (A search of the journal using the term AllTrials produced no results.)

However, the AllTrials initiative means to tackle the problem of suppressed clinical research.  We have long discussed how research may be systematically suppressed when its results do not please its commercial sponsors.  Particularly, trials of drugs or devices that do not produce favorable results may be suppressed by their sponsors, usually the companies that make the drugs or devices.  Such suppression breaks trust with and therefore hugely disrespects the patients who volunteered to participate in the trials, who believed they were contributing to science and public health.  Suppressing data that drugs and devices may be ineffective and harmful may endanger patients by letting them be treated by such drugs and devices in the illusory belief that they are safe.  Yet where is the outrage about such dishonest behavior by large and powerful health care organizations that disrespects, and more importantly, endangers patients?

Health Care Corruption

When a pharmaceutical, biotechnology, or device company withholds results of a clinical trial to makes its product look better and enhance its revenue, that is an example of health care corruption.

Transparency International defines corruption as

Abuse of entrusted power for private gain

When health care corporations run clinical trials, we entrust them to do honest research and be worthy of the trust of their research subjects.  Withholding the results to enhance revenue is therefore abuse of that entrusted power for private gain.

Health Care Corruption as a Taboo Topic

This blog focuses on the US, and we  now have in our archives some amazing stories that document various forms of health care corruption in the US, including numerous allegations of misbehavior by large health care organizations ending in legal settlements, and examples of outright fraud, bribery, kickbacks and other crimes.  Some large and profitable health care corporations have made numerous such settlements over recent years.  (For example, see the track record to date of Pfizer Inc here and that of Johnson and Johnson here.)

Much of this bad behavior was meant to sell drugs, devices, or clinical services, often in situations in which their benefits did not outweigh their harms.  For example, we just discussed the latest settlement by Amgen of allegations that it promoted an epoetin (Aranesp) "off-label" for cancer patients not on chemotherapy.  Such "misbranding" was not merely a technical violation, since it has been shown that use of the drug in this situation increases mortality.   Such bad behavior thus likely harmed numerous patients.

Furthermore, efforts to police these kinds of corruption have been weak and scattered.  Most cases have ended with legal settlements that at most involve fines to corporations, yet the fines are rarely big enough to significantly affect their overall revenues.  While the corporations themselves may be thus punished, the people who actually authorized, directed or implemented the bad behavior are usually unscathed.  So as we have discussed frequently, such attempts at justice are unlikely to deter future bad behavior.

In fact, people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, the Transparency International Global Corruption Report focused on health care corruption, and asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  It also noted how diverse is health care corruption:

In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.

It further stated how serious the consequences of corruption may be for patients and public health:

Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly....

The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services.

Corruption affects health policy and spending priorities.

Occasionally, something is published about health care corruption in the US in the medical literature.

- In 2009, qualitative interviews by Pololi et al in the Journal of General Internal Medicine produced many striking anecdotes suggesting corruption in US academic medicine. Four of the interviews were with faculty whose leaders allegedly used deception for personal and professional gain (i.e., �a situation of major unethical use of funding,� �fraudulently creating data for a research project,� �we�re lying to the people who are doing our school evaluations, we�re putting things on paper that we do that we don�t do,� �that�s what I think he felt he had to do�hide money, lie about money, or at least cook the books a little bit.�)(4)  These results produced few echoes, particularly not any strident editorials about the need to address corruption.
- In 2011, an article in the Lancet suggested that "there is more corruption in the G8 countries than in the whole of Africa," but for any health care professional to acknowledge that would be "professional suicide" (see this post).(3)
- Finally, in 2013, a Transparency International survey showed that 43% of Americans believe their health care system is corrupt.  Yet this received no media attention, and to my knowledge has never been mentioned in a major US medical journal.  (Look here.)

So health care corruption remains a largely taboo topic.  (On Health Care Renewal, we call corruption "anechoic," since evidence of health care corruption produces few echoes.) 

The Annals of Internal Medicine, like most major medical journals, has long avoided discussion of health care corruption, and how systemic corruption harms patients' and the public's health.

Of course, the unwillingness to discuss global health care corruption, health care corruption in the US, and the relationship of health care corruption in the US to corruption in other sectors may arise from the fear, as stated by one person interviewed in Charles Ferguson's documentary Inside Job, that discussion could lead to investigation, and investigation could "find the culprits".

Summary

It is perfectly fitting and proper for the Annals of Internal Medicine to call attention to various kinds of unprofessional behavior by physicians and health care professionals, such as sexist, disrespectful expression, even if such behavior is already subject to sanctions by medical boards, accrediting organizations, etc. In my humble opinion, however, if such disrespectful comments by physicians should generate outrage, corrupt behavior by large health care organizations that may harm patients and the public health, and which often goes largely unchallenged by civil authorities, should deserve more outrage.

Of course, it is one thing to criticize individual physicians, and ask physicians to "call out our colleagues" who behave unacceptably.

It is another to call out large, powerful, wealthy organizations and the executives who have become rich running them.  Such executives command well funded marketing and public relations departments, and corps of attorneys ready to take on perceived critics.

But if we really want better health care and public health, we all have to step up.  In particular, I urge the editors of the Annals of Internal Medicine, and other major health and medical journals to take on health care corruption as vigorously as they would take on physicians' expressions of "misogyny and disrespect."

ADDENDUM (26 August, 2015) - This post was republished on the Naked Capitalism blog. 

References
1.  Laine C, Taichman DB, LaCombe MA. On being a doctor: shining a light on the dark side.  Ann Intern Med 2015; 163: 320.  Link here.
2.  Anonymous.  Our family secrets.  Ann Intern Med 2015; 163: 321.  Link here.
3. Horton R. Offline: ten commandments, G8 corruption, and OBL. Lancet 2011; 377: 1638. Link here.
4. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med. 2009;24:1289�95. Link here.