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 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 Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing Doctors. Princessiccia

Princess Health and Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing Doctors. Princessiccia

boards of directors bribery conflicts of interest deception executive compensation health care corruption impunity marketing Novartis

Gusty 09:40 Add Comment

Umpteenth verse, same as the first...

As just reported by Bloomberg,

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker�s Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group�s recreational activities such as a Niagara Falls excursions, $150 in 'walking around' money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club.  It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without "admitting or denying the findigs." In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

'The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,' Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case.  Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders.  Yet this evidence remains anechoic, even given the apparent recidivism involved.  For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership.  At that time, our post included these section headings covering 2014-15:

-  Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
- Novartis Executive Pleads Guilty to Bribing Polish Official
- Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
- Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
- Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis' previous record.   In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also,  in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here)   Other Novartis misadventures from 2010 and earlier appear here.  So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers.  Meanwhile, Novartis executives continue to be paid handsomely.  The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty.  Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7  million in 2013-14 just to US physicians.    The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University,  Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School.   I am unaware that anyone of them have publicly raised any concerns about Novartis' recent misadventures, although I am also unaware whether anyone has publicly asked them such questions. 

No wonder that ordinary US (and other countries' citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders.  No wonder that someone of them are seeking the protection of some of those powerful insiders.  But I digress...

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first...

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care.  There are calls to avoid unnecessary, and sometimes harmful care.  Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction.  Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients' and the public's health ahead of personal gain.

Our musical interlude ("second verse, same as the first,") Herman's Hermits, Henry VIII

Princess Health and Health Care Corruption Workshop Slides Now Online. Princessiccia

Princess Health and Health Care Corruption Workshop Slides Now Online. Princessiccia

health care corruption

Gusty 11:47 Add Comment

Slides from the workshop entitled Defense Against the Dark Arts - Understanding and Challenging Health Care Corruption given by Dr Roy Poses and Dr Wally Smith at the Physicians for a National Health Plan (PNHP) meeting, October, 2015, in Chicago, IL, US, are now online here. There also is a link to the slides on our Past Meetings and Events page.

Princess Health and Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption. Princessiccia

Princess Health and Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption. Princessiccia

boards of directors conflicts of interest health care corruption

Gusty 12:27 Add Comment

Not to toot our own horn too loudly, but in the last week, Health Care Renewal bloggers have appeared in print three times.

Prevalence of Board Level Conflicts of Interest

We recently posted on a British Medical Journal article on the prevalence of what we originally termed "a new species of conflicts of interest," that is, conflicts of interest involving membership in boards of directors of for-profit health care corporations.  A shortened version of this just appeared as a (not very) "rapid response" in the BMJ here.  (Note though that the official date of the response was October 3.)

The New England Journal Series Calling for Rethinking the Problem of Conflicts of Interest

After the New England Journal of Medicine published an editorial and three commentaries earlier this year suggesting that concerns about conflicts of interest in health care may have been overblown, we pointed out that many of their arguments were supported by logical fallacies.  The Canadian Medical Association Journal has been publishing a series of news articles about the issue.  The latest one, published on November 17, 2015, ended by quoting HCR blogger Roy M Poses MD.

Health Care Corruption

On November 16, 2015, the Corporate Crime Reporter published a front page interview, "Roy Poses on Corruption in American Healthcare,"  The interview is listed here,  and summarized here but the full transcript apparently is not available online, but only in print and via subscription.  (Link to interview updated on 19 November, 2015).  

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.

Princess Health and Innovations form the Safra Center Ending iCorruption Conference. Princessiccia

Princess Health and Innovations form the Safra Center Ending iCorruption Conference. Princessiccia

conflicts of interest health care corruption hospital systems pharmaceuticals regulatory capture

Gusty 12:23 Add Comment

I had the pleasure of attending the Ending iCorruption Conference, the capstone conference for the Edmond J Safra Research Lab on Institutional Corruption, held at the Harvard Law School on May 1-2, 2015.  The conference included much material relevant to health care corruption and related topics, and provided some innovative approaches that could be used to address these issues.  I list these below, with citations or links when available.  At some point in the future, all conference proceedings should be available on video from the Safra Center.

Uncovering Data on Conflicts of Interest

Unearth: Using PubMed to Uncover Conflicts of Interest Affecting Clinical Research

Unearth is a browser extension now available for Google Chrome, and soon to become available for other browsers, e.g., Firefox.  It works on PubMed searches, scraping funding and conflict of interest data from the body of articles and adding them to abstracts.  We have often discussed such conflicts of interest, and their relationship to manipulation of clinical research.  Unearth could make such conflicts more salient, making it easier to discriminate unconflicted from conflicted research.  (See this post on the Bill of Health blog.)  This application was developed during the Safra Center Hacking iCorruption Event.

Open Think Tanks: Uncovering Think Tank Funding

Think tanks often publish findings on and make recommendations about health care.  However, think tanks are often opaque, and any institutional conflicts of interest they have may not be easily apparent.  Open Think Tanks currently shows donations from government entities outside the US to US based think tanks.  Enhancements to include various kinds of private donations are likely in the future. This application was also developed during the Hacking iCorruption Event.

Finding Unconflicted Academics

As we have discussed, the majority of medical academics have conflicts of interest, which may affect their research, teaching and patient care.  Yet these conflicts are not always disclosed.  Furthermore, finding experts without conflicts is not easy.  ProfessorCert is a website that allows academics who have no conflicts of interest to register as such.  The website was developed by the Academic Independence Project. 

Improving Integrity

Putting Consumers in the FDA and Other Regulatory Agencies

We have frequently discussed regulatory capture, how government health care regulatory agencies, like the US Food and Drug Administration (FDA),  often seem to end up more concerned about the financial health of those they are supposed to regulate than patients' and the public's health.   Harvard Prof Daniel Carpenter, collaborator in Safra Center research,  talked about the problem of  "cultural capture" of regulatory agencies, in which the regulators' thinking is influenced by outside vested interests.  He proposed that regulatory agencies need to put consumers, or presumably other stakeholders like unconflicted health care professionals, "into the room."  

Putting Ethicists in the C- Suite

We have frequently criticized the leadership of hospitals and hospital systems.  In particular, we have discussed instances in which these leaders seem to have gone directly against the mission of their own organizations, which we termed mission hostile management. Safra Lab Network Fellow James Corbett, now Senior Vice President for Centura Health, proposed that ethicists who also understand the language of finance and management be present among the top leadership of hospital systems.  

Licensing Executives

As noted above, a major theme of the Health Care Renewal blog is the shortcomings of the leadership of large health care organizations.  Top leaders often have business training, but may be ill-informed about health care, and ignorant or unsupportive of  or even hostile to its values.  Wellesley College Professor Emerita Ann Congleton's 2014 article in the Journal of Business Ethics, entitled Beyond business ethics: an agenda for the trustworthy teachers and practitioners of business, proposed requiring that corporate executives, including executives of health care corporations, be licensed in order to lead their organizations.  I proposed licensing of leaders of large health care organizations as early as 2008 (here).    

Pharmaceutical Research Uninfluenced by the Pharmaceutical Industry

Because clinical research meant to evaluate drugs or devices sponsored by  manufacturers of the relevant products has shown to be frequently manipulated, or even suppressed, many people have suggested banning such sponsorship and direct influence of such manufacturers.  (For example, see the book and blog, both entitled "Hooked," written by Dr Howard Brody, and see Health Care Renewal blog posts, e.g., here.)
Safra Center Network Fellow and Rowan University Professor Donald Light's book in press, Good Pharma, basically offers proof of the concept that high quality clinical research on pharmaceuticals can be accomplished without industry money or influence, albeit in Italy, at the Mario Negri Institute. 

Summary

The project on institutional corruption at the Safra Center produced a burst of innovation meant to address this pervasive project, and thus provided much of value to those who want to challenge health care corruption.  I hope this innovation will turn out to be truly disruptive.  It is regretful that this project has come to an end.  We can only hope others pick up the banner.  

Princess Health and "God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door. Princessiccia

Princess Health and "God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door. Princessiccia

amphetamines conflicts of interest FDA health care corruption revolving doors You heard it here first

Gusty 08:58 Add Comment

Who is watching the watchers?  A story this week involving "speed" like drugs added to "dietary supplements" suggests how far the once respected US Food and Drug Administration has fallen.

An Amphetamine-Like Drug Spiking "Nutritional Supplements"

The story began with a paper by Cohen and colleagues published a relatively obscure medical journal, and then picked up by the news media.(1)  The main points of the article were:

BMPEA (beta-methylphenylethylamine) is a compound first synthesized in the 1930s as a "potential replacement" for amphetamines.  Animal tests revealed amphetamine-like properties.  The compound was never tested on humans, and never marketed.

But,

BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labelled as containing �Acacia rigidula�, even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.

However,

More than two years after the FDA's discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.

So Cohen et al undertook to identify "nutritional supplements" said to contain acacia rigidula and test them for BMPEA.  They found 21 such supplements, all of which tested positive. The authors then recommended,

that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.

Note that while the power of the FDA to regulate "nutritional supplements" is limited by a 1994 law, Cohen and colleagues wrote that it

is tasked with identifying and removing mislabelled, adulterated, and dangerous dietary supplements from the marketplace.

Since BMPEA is apparently not found in nature, and was not sold prior to 1994, putting BMPEA in a "dietary supplement" appears to be adulteration. 


The Risks of BMPEA in Nutritional Supplements

The study was then picked up by the media.  In the Los Angeles Times, Pieter Cohen, the lead author of the journal article,

said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA's failure to act is 'completely inexcusable.'

Furthermore, in a CBS report,

BMPEA has not been tested in humans, but led to increased blood pressure in cats and dogs.

'These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,' Cohen said.

The point is that while it has never been tested fully on humans, there is every reason to suspect that BMPEA acts very similarly to amphetamine, colloquially called "speed."  Amphetamines, as we discussed here, have dangerous side effects, including severe blood pressure elevations, and increased risks of stroke, myocardial infarction (heart attack), and other cardiac events.  The drugs also have a high potential for abuse. 


Why Did the FDA Do Nothing? 

Despite the likely riskiness of BMPEA, the FDA did nothing when it found it in numerous dietary supplements in 2013, and has not indicated that it will do anything now.  According to the LA Times,

FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.

'While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,' she said.

In a Consumers Report item, Dr Cohen responded to that,

'It�s mind boggling,' said Pieter Cohen, M.D., the Harvard physician who is the lead author of the new study, published online in the journal Drug Testing and Analysis. 'The companies think they have complete impunity. They assume the FDA will do nothing about it. And they�re right.'

A post in the NY Times Well blog reiterated, 

Under federal law, dietary supplements � with some exceptions � can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.

Yet while the FDA had authority to do something, it did nothing.

Was the Revolving Door the Reason?

Back in 2014, we posted about two transitions through the revolving door by the FDA official in charge of the regulation of nutritional supplements.  We reproduce the relevant section of the post below:

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency�s Center for Food Safety and Applied Nutrition.

But,

The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.

While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not then question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

In 2014, the Times drew no conclusions about Mr Fabricant's career trajectory.  However, this time

But public health experts contend that the F.D.A.�s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency�s top officials overseeing supplements � including one currently on the job � were former leaders of the largest supplement industry trade and lobbying group.

Daniel Fabricant, who ran the agency�s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.�s supplement division also comes from the trade group.

'To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,' said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Also, the new Well blog post noted 

Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency�s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.

Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency 'has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.'

Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had 'an excellent safety record.'

'The industry itself supports and has implemented strong self-regulatory mechanisms,' she said in an industry news release at the time.

Summary

To summarize, from 2011 to now, the leadership of the part of the FDA that is supposed to regulate dietary supplements was dominated by former top executives of the Natural Products Association, the trade organization for dietary supplement manufacturers.  In 2013, FDA scientists found that multiple dietary supplements contained BMPEA, a compound closely related to amphetamines, and hence potentially dangerous and addictive, although it had never been tested on or previously used by humans.  Although the FDA had authority to do something about this apparent adulteration of these products, it so far had done nothing.  Thus it appears that the currently legal revolving door that allows government regulation to be run by people who come directly from the industries that government is supposed to regulate could be responsible for exposing people to dangerous, addictive drugs.

Remember, BMPEA is a first cousin of amphetamine, amphetamine is "speed," and as the drug epidemics of the 1960s and 1970s showed us, "speed kills."  So a plausible argument is that the revolving door, as relevant to FDA, has enabled manufacturers of nutritional supplements to become the "pusher man," a la the Steppenwolf sound track of Easy Rider,


As we noted here, some experts consider the revolving door per se to be corruption, not merely conflict of interest.  The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy.  Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.   

So it is surprising that today (13 April, 2015), the New York Times published an editorial inspired by the BMPEA case, which concluded

consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

As a minimum, that would be a good start.  Unfortunately, even a NY Times editorial hardly guarantees action.  At least, however, the problem of the revolving door as a danger to patients has gotten a little less anechoic.

As we last wrote, 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.

ADDENDUM (20 April, 2015) - This post was republished on Naked Capitalism. 


Reference

1.  Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamins isomer whose efficacy and safety in humans has never been studied, beta-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.  Drug Testing Analysis 2015; DOI: 10.1002/dta.1793  Link here.

Princess Health and The Troubles at Cooper Continue, Lately Gruesomely, But Will Its Leadership and Governance Change This Time? - Part I: Historical Background. Princessiccia

Princess Health and The Troubles at Cooper Continue, Lately Gruesomely, But Will Its Leadership and Governance Change This Time? - Part I: Historical Background. Princessiccia

anechoic effect boards of trustees conflicts of interest Cooper Hospital/ UMC crime governance health care corruption hospital systems leadership

Gusty 09:41 Add Comment

Allegations of Murder-Suicide by a Hospital System CEO

This will be a hard series of posts to write. It wa triggered by the latest, and perhaps most gruesome chapter in the troubled history of the leadership of Cooper Health, the largest hospital system in southern New Jersey (known locally as South Jersey).  As reported by the Philadelphia Inquirer on March 28, 2015,

Cooper University Health System CEO John P. Sheridan Jr. stabbed his wife to death, set their bedroom on fire, and then took his own life, authorities have concluded, closing a six-month investigation into the deaths that shocked New Jersey's political and civic communities.

The Somerset County Prosecutor's Office announced its results in a news release Friday, citing forensic evidence and a lengthy probe that included more than 180 interviews.

But it offered no conclusive motive to explain why Sheridan, described by family and friends as mild-mannered, would brutally stab his wife and kill himself.

'Many possible scenarios and theories were considered,' the prosecutor's office said in a statement after months of virtual silence. The evidence 'supports the conclusion that John Sheridan fatally stabbed Joyce Sheridan, set the fire, and committed suicide.'

The Story in Context: a Long History of Leadership and Governance Problems 

We have often discussed bad leadership of health care organizations, and written a lot about the contrast between the munificent compensation paid to non-profit hospital CEOs and the lack of evidence justifying such pay.  However, a murder-suicide allegedly perpetrated by the CEO of a large non-profit hospital system is way at the tail of the curve of questionable managerial behavior.

But it turns out that Cooper Health System has a very long record of leadership and governance troubles.  The current chapter is the latest, and possibly most gruesome, in this sorry series.  However, the context of this history has been lacking in the recent coverage, which has been so far limited to local media.  The history deserves a more complete discussion, and maybe then it could lead to some reconsideration at least of this one institution's leadership and governance, and perhaps the larger troubles in leadership and governance in health care.

Thus this post will summarize the history that I could find up to 2005.  A second post will summarize more recent history up to and through the terrible deaths of John and Joyce Sheridan.  

In the interests of full disclosure, I started my faculty career at what was then Cooper Hospital - University Medical Center, the main teaching hospital for the University of Medicine and Dentistry of New Jersey (UMDNJ) - Robert Wood Johnson Medical School (RWJMS) branch at Camden, NJ.  During my four years there, 1983-87, I was impressed with the dedication of the physicians, nurses and other health care professionals there.  However, even given my naivete at a young faculty member, the leadership of the institution, which was one of the early adapters of the generic management model,  seemed strange.  Little did I know how strange it was.

In the late 1990s, when I became seriously concerned about what I know call leadership and governance problems in health care, I ran into some folks from South Jersey who told me that Cooper had a tumultuous history since I left.  I got around to researching it, leading to an article in our local American College of Physicians newsletter.  The article, to which I had linked here, is no longer available on the internet.  So I have reposted it below, with some minor modifications, put in square brackets .  Again, the history is of major problems with leadership and governance at Cooper that had inspired no reconsideration by 2005.

The Curiously Quiet Case of Cooper�s Corrupt CFO

Embezzlement by Top Management

    In 1994, two powerful executives at Cooper admitted their guilt in an elaborate embezzlement scheme.  In 1978, John H. Crispo, the owner of Financial Management Corporation Inc., to keep his contract with the hospital, began paying monthly kickbacks of $2500-$10,000 to John M. Sullivan, the Cooper Executive Vice President for Finance.  Sullivan then referred delinquent hospital accounts for collection to a new company Crispo set up.  In turn, Crispo repaid him $340,000 in more kickbacks.  Sullivan recruited Cooper�s Controller, P. John Lashkevich, and the three devised a scheme to defraud the hospital using fabricated bills, established a fictitious company to launder money, and falsified tax returns.  A prosecutor claimed �Mr Sullivan blew this money on wine, women, parties, and a lavish lifestyle,�which included trips with girlfriends to the Plaza Hotel, and jewelry shopping at Tiffany�s.  Sullivan had driven a Porsche, and lived in a $700,000 house.  The conspirators also bought cars, boats, and racehorses.

    Other conspirators were also found and prosecuted.  Helene Weinstein admitted to helping establish a shadow company as a conduit for Sullivan to send money from the hospital to his estranged wife, Elarba Pagan.  Pagan was accused of receiving money sent by Sullivan from Cooper to another firm.  Weinstein testified that Pagan carried �briefcases of cash from the hospital to shop in New York for $1500 shoes.�  Also, Cooper�s Vice President for Finance, Robert Schmid Jr, admitted embezzling money from Cooper to pay for home improvements. Finally, Thomas J. Damadio admitted helping launder up to $600,000 stolen from Cooper, and evading income taxes.  

    Sullivan was sentenced to 55 months in federal prison, Lashkevich, 25, Pagan, eight, Weinstein, three years of probation, Damadio, six months of house arrest.  Crispo died before serving prison time.

The Internal Report, and the Murder Conviction of One of Its Authors

    After these stories became public in 1994, Cooper�s Board of Trustees established a special committee to investigate its financial operations, which included Peter E. Driscoll, Chairman of the Board, Kevin G. Halpern, Chief Executive Officer (CEO), and a local Rabbi, Fred Neulander.  The hospital pledged to make its investigation public, but then fought to keep it secret.  Its report was finally released in 1998, after a discovery motion in a civil lawsuit.  Prior to then, the Philadelphia Inquirer had revealed numerous financial conflicts of interest affecting Board members,  including those on the special committee.  For example, Cooper paid the law firm of Archer & Greiner, of which Driscoll was a senior partner, $2.1 million over three years from 1993-96.

    The report revealed that the conspiracy had bilked the hospital of at least $21.8 million from 1987 to 1994, while �Cooper has been the victim of a massive crime wave.�  It stated Sullivan, Lashkevich, and Crispo �had unrestrained and absolute control of virtually all the important financial functions at Cooper and they took full criminal advantage....� It also noted that �employees who became suspicious and questioned the accounting practices or tried to alert management were intimidated, transferred, or dismissed by the high-ranking executives.�  Furthermore, it suggested �the ability to bypass or defeat controls grew from an institutional culture that delegated and outsourced too much responsibility, without developing effective controls....� The report also raised questions about how the internal investigation was conducted.  It noted that Driscoll and Halpern �often locked horns with [the other] committee members....�  Driscoll had objected when other board members called for an independent investigation.  Halpern and Driscoll resigned their positions within days of the forced release of the report.


    One member of the special committee became particularly notorious.  Soon after the internal investigation was set in motion in 1994 Rabbi Neulander�s wife had been murdered.  Soon after, Neulander had failed a polygraph test when questioned about it.  He then resigned his clerical position after his extramarital affairs with members of his congregation were revealed.  In September, 1998, he was charged with hiring the �hit men� who committed the murder.  In 2002, he was convicted  and sentenced to life in prison.

The Aftermath, Financial Woes and Impact on Patient Care

    By 1997, Cooper was in financial trouble, although none of its managers ever admitted a connection to the conspiracy and resulting losses.  However, during a related civil lawsuit, Cooper officials alleged �the hospital�s general operating fund was depleted� by the conspiracy.  Cooper began merger discussions with several partners, including AHERF, although none were ultimately successful. Physicians started leaving in 1997, when all but one full-time cardiologists announced their resignations.  Cooper revealed a $16 million loss for 1998, the largest ever incurred by a New Jersey hospital.  Its bonds were down-graded to junk. The hospital then announced that it would stop accepting uninsured patients for elective treatments, departing from its historic mission of charitable care.  Losses continued in 1999, again totaling $16 million, leading to additional budget cuts.  [CEO Halpern and Chairman of the Board Driscoll resigned within days of each other in 1999, both denying their actions were related to the report.]  By 2000, the hospital had cut its work-force to 3100, from 4000 in early 1999. and had closed various clinical sites and units.  Only thereafter did Cooper began posting budget surpluses.  [By 2002, more physicians quit Cooper en bloc, and the hospital was on its second new CEO since Mr Halpern.]

 The Lurid Stories Remain Anechoic

    The only published reaction to Cooper�s woes came from the related legal proceedings.  The prosecutor in Sullivan�s trial claimed that his thefts were so big that they �threatened the financial stability of the hospital,� and �hurt the image of the city as a whole.�  At Pagan�s sentencing hearing, Judge Joseph H. Rodriguez stated �society could not tolerate a system in which hospital executives �rake millions off the top� that were intended for medical care for the poor.�

    It does seem likely that Cooper�s scandals had major effects on its patient care and academic missions.  Yet, I could find nothing  published about such effects.  Despite the luridness of this case, I also found no reaction from local or national medical groups, from academic organizations, accrediting groups, or government agencies.

Summary

In 2005, I wrote,...  The case of Cooper�s corrupt executives can be viewed as the forerunner to the even more massive bankruptcy of AHERF [Allegheny Health Education and Research Foundation, see posts here].  One can only speculate that learning the lessons of the Cooper case could have mitigated the AHERF disaster.  However, as noted in my last article,  the lessons from AHERF are also not widely known.  Yet, as George Santayana wrote, �Those who cannot learn from history are doomed to repeat it.�

As I will address in another post, events at Cooper after 2005 also generated few echoes, up to the latest tragedy.  These events did not suggest much had been learned from the events through 2005. 

So the unfortunate, and sometimes terrible case of Cooper Health has become one of the longest running examples  - starting in 1978 - of the troubles with leadership and governance of large health care organizations, the bad effects of these problems on health care and the values of health care professionals, the lack of public attention to and discussion of these problems and their effects, and the failure of organizations to address on their own their problems with leadership and governance.

True health care reform, as we have said endlessly, requires governance that is accountable, transparent, true to the organization's mission, and honest, ethical, and without conflicts of interest; and leadership that understands health care, upholds its values, is honest, ethical, and without conflicts of interest, is transparent and open, and is willing to be accountable and subject to appropriate incentives. 

References

Embezzlement....

Lewis L. Former official gets jail term for bilking Cooper: John M. Sullivan was sentenced to 55 months - the scheme netted $4 million.  He spent his take lavishly. Philadelphia Inquirer, April 26, 1996.

Graham M. New panel at Cooper plans review: embezzling of $3.8 million by two former top aides and a vendor prompted the study. Philadelphia Inquirer, July 27, 1994.

Lewis L. Ex-hospital executive gets 2 years: he helped steal $4 million from Cooper Hospital - his lawyer said the investigation was going to spread.  Philadelphia Inquirer, November 9, 1996.

Graham M, Turcol T. Inquiry widens into finances at Cooper Hospital: a federal grand jury subpoenaed several officials this month - the inquiry was spurred by testimony from two former Cooper executives indicted for fraud. Philadelphia Inquirer, February 27, 1996.

Lewis L. Woman admits role in bilking Cooper Hospital. Philadelphia Inquirer, September 6, 1996.

Lewis L. Ex-hospital executive admits theft: Robert Schmid Jr. pleaded guilty to embezzling about $50,000 from Cooper Hospital. Philadelphia Inquirer, September 24, 1996.

Lewis L. More charged in theft at hospital: six people have now been indicted in the embezzlement at the Camden facility. Philadelphia Inquirer, December 12, 1996.

Lewis L. Ex-wife of jailed Cooper Hospital official sentenced in scam: Elarba Pagan bought $1,500 shoes with medical center money, her business partner said. Philadelphia Inquirer, July 2, 1998. P. B5.

Lewis L. Business owner pleads: Thomas J. Damadio said he helped Cooper Hospital executives launder stolen money.  Philadelphia Inquirer, January 18, 1997.

The Internal Report...

Anonymous. Cooper forms committee. PR Newswire, July 26, 1994.

Graham M. FBI is probing Cooper Hospital for violation of securities laws. Philadelphia Inquirer, April 3, 1997.  P. A1.

Hollreiser E. Cooper urged to release audit results. Philadelphia Business Journal, May 30, 1997.

Graham M. Hospital gives state its audit: Cooper complied after the state threatened to withhold funding - the report will be kept secret.  Philadelphia Inquirer, May 14, 1997, P. B1.

Graham M. N.J. finds nothing amiss at Cooper: the Attorney General�s office reviewed an internal hospital audit - no criminal wrongdoing was uncovered. Philadelphia Inquirer, July 11, 1997. P. A1.

Graham M, Cusick F. Listing Cooper�s board deals: companies associated with the hospital�s trustees have gotten some of its largest contracts. Philadelphia Inquirer, June 15, 1997. P. A1.

Anonymous. Report says Rabbi failed polygraph on wife�s death. The (Bergen County) Record, September 5, 1996.

Burney M. Rabbi charged in wife�s killing. Associated Press State & Local Wire, September 10, 1998.

Mulvihill G. Judge declares mistrial in case of Rabbi charged with arranging wife�s murder. Associated Press State & Local Wire, November 13, 2001.

Bell T. Rabbi found guilty of murder in wife�s 1994 death. Associated Press State & Local Wire, November 20, 2002.

Mulvihill G. Jury spares life of rabbi in wife�s murder; faces life in prison.  Associated Press State & Local Wire, November 22, 2002.

The Aftermath...

Uhlman M. Cooper talks with Allegheny: the Camden hospital wants a partner, and the Pa. chain plans a further push into South Jersey. Philadelphia Inquirer, May 20, 1997. P. C1.

Gerlin A. Philadelphia hospital raids New Jersey system�s cardiology staff.  Philadelphia Inquirer, September 27, 1997.

Kastor JA. Governance of Teaching Hospitals: Turmoil at Penn and Hopkins. Baltimore:  Johns Hopkins Press, 2004. P. 41.

Goodman H. As Cooper suffers loss, it says care won�t suffer. Philadelphia Inquirer, February 11, 1999.

Rizzo N. Cooper Hospital announces cuts in staff. Associated Press State & Local Wire, March 18, 1999.

Goodman H. Cooper Health system cuts 103 employees: financial problems were cited - about 400 jobs could be lost this year, and uninsured care will be curtailed. Philadelphia Inquirer, March 19, 1999. P. A1.

Anonymous. As losses mount, Cooper Hospital�s debt rating falls. Associated Press State & Local Wire, April 16, 1999.

Goodman H. Cooper�s debt rating tumbles as losses rise: the 1998 figure is twice as bad as estimated - the poor rating means the hospital must pay more to borrow. Philadelphia Inquirer, April 16, 1999. P. B1.

Kent B. In Camden, a hospital finds itself seriously ill: Cooper, the city�s biggest employer, has �heavy losses.�  New York Times, May 9, 1999.

Anonymous.  Cooper Hospital announces more cuts in staff.  Associated Press State & Local Wire, May 20, 1999.

Anonymous.  Camden hospital posts $16 million loss: president sees turnaround.  Associated Press State & Local Wire, February 23, 2000.

Kiely E.  Cooper Hospital to forgo charity-care payments - the state will not reimburse the Camden facility for uninsured patients for four months - the reason: the beleaguered hospital received the money from the state in advance last year.  Philadelphia Inquirer, April 11, 2000. P B1.

Anonymous.  Cooper Hospital president quitting.  Philadelphia Business Journal, January 15, 2002.

Anonymous.  Hospital company sues six departing surgeons.  Associated Press State & Local Wire, July 4, 2002.