Showing posts with label legal settlements. Show all posts
Showing posts with label legal settlements. Show all posts

Thursday, 31 March 2016

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

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).





 

Sunday, 21 February 2016

Princess Health and Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly. Princessiccia

Princess Health and Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly. Princessiccia

Amazingly, with a US presidential election looming, there is finally some public discussion here of the impunity of top corporate executives.  Columnist Gretcher Moregenson wrote on February 6, 2016 in the New York Times,

Ho-hum, another week, another multimillion-dollar settlement between regulators and a behemoth bank acting badly.

Then,

As has become all too common in these cases, not one individual was identified as being responsible for the activities. Once again, shareholders are shouldering the costs of unethical behavior they had nothing to do with.

It could not be clearer: Years of tighter rules from legislators and bank regulators have done nothing to fix the toxic, me-first cultures that afflict big financial firms.

Similarly, but more broadly, Senator Elizabeth Warren (D - Massachusetts) published a report in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy." She summarized its main conclusions in a New York Times op-ed,

Corporate criminals routinely escape meaningful prosecution for their misconduct.

Furthermore,

In a single year, in case after case, across many sectors of the economy, federal agencies caught big companies breaking the law � defrauding taxpayers, covering up deadly safety problems, even precipitating the financial collapse in 2008 � and let them off the hook with barely a slap on the wrist. Often, companies paid meager fines, which some will try to write off as a tax deduction.

The failure to adequately punish big corporations or their executives when they break the law undermines the foundations of this great country. Justice cannot mean a prison sentence for a teenager who steals a car, but nothing more than a sideways glance at a C.E.O. who quietly engineers the theft of billions of dollars.

These enforcement failures demean our principles. They also represent missed opportunities to address some of the nation�s most pressing challenges.

In particular, she cited this example involving health care.

When Novartis, a major drug company that was already effectively on federal probation for misconduct, paid kickbacks to pharmacies to push certain drugs, it cost taxpayers hundreds of millions of dollars and undermined patient health. Under the law, the government can boot companies that defraud Medicare and Medicaid out of those programs, but when Novartis got caught, it just paid a penalty � one so laughably small that its C.E.O. said afterward that it 'remains to be seen' whether his company would actually consider changing its behavior.

Note that we discussed the Novartis settlement here.  The case referred to by Senator Warren was just the latest in a series of ethical misadventures by Novartis which led to legal actions in the US and around the world, but feeble penalties.

But while Ms Morgenson wrote about financial institutions, now we can also write:

Ho-hum, another month, another set of multimillion-dollar settlements between regulators and  behemoth health care companies acting badly.

In chronological order, since mid-January, 2016...

For $830 Million, Merck Settled Shareholders Lawsuit Alleging Deceptions by Corporate Management

On January 15, 2016, the Wall Street Journal reported,

Merck said Friday it agreed to pay $830 million to resolve a class-action lawsuit brought by shareholders, alleging the drug maker and its executives made false and misleading statements about the safety of Vioxx between its introduction in 1999 and its market withdrawal in 2004.

The shareholders alleged they paid inflated prices for Merck shares because of the company�s conduct.

Note that if the company misled its shareholders, it also misled health care professionals and the public about the harms of Vioxx,  putting many patients at risk. Of course, the Vioxx case is now old news, but it continues to be an example of a case in which the corporation paid fines, presumably at the expense of shareholders, employees and patients, but in which no one who authorized or directed the bad behavior paid any penalty.

As is typical in such cases,

Merck, which is based in Kenilworth, N.J., said Friday the settlement of the shareholders� lawsuit doesn�t constitute an admission of liability or wrongdoing by the company or individual executives named as defendants in the case.

Merck has paid billions to settle multiple lawsuits related to Vioxx, yet what it paid was much less than the revenue produced by the drug.

The bulk of Merck�s Vioxx-related costs came from its 2007 agreement to pay $4.85 billion to settle thousands of product-liability lawsuits alleging that patients� use of Vioxx caused heart attacks and strokes, and that Merck failed to properly warn people of the risks. Merck didn�t admit liability in that settlement.

In addition, Merck agreed in 2011 to pay $950 million to resolve allegations by the U.S. Justice Department and state governments that the company deceived the government about the safety of Vioxx, and marketed it for uses not included in the prescribing label approved by the Food and Drug Administration.

Merck recorded more than $11 billion in Vioxx sales during the drug�s years on the market from mid-1999 to September 2004.

The company did plead guilty to one criminal charge related to Vioxx.

 As part of the 2011 settlement, Merck pleaded guilty to a misdemeanor criminal violation of a federal drug law, admitting that it promoted Vioxx to treat rheumatoid arthritis before that use was approved by the FDA.

But apparently no Merck manager was ever charged with a crime, much less convicted.  We have discussed the Vioxx case here, and other issues with Merck here.

Note that this settlement comes soon after a smaller settlement in 2015 that was barely mentioned in the press,Merck to pay $5.9 million for misleading marketing of pink eye drug: U.S [Reuters]

For $785 Million, Pfizer Settled Suit Alleging Overcharging of Medicaid

On February 16, 2016, per the Wall Street Journal,

Drugmaker Pfizer Inc. on Tuesday said it reached an agreement in principle to pay $784.6 million to settle a long-running U.S. government investigation of allegations that its Wyeth unit overcharged government Medicaid health programs for the heartburn drug Protonix.

Of course,

Pfizer said the agreement doesn�t include any admission of liability by Wyeth.

Much less did the agreement include any penalties for anyone at Wyeth or Pfizer who authorized or directed the overcharging. Yet some people must have.

Note that this settlement did not seem informed by Pfizer's amazingly lengthy record of legal settlements, and some guilty pleas and/or convictions (for illegal marketing/ misbranding, and for violating the racketeering influenced corrupt organization [RICO]  statute), as most recently summarized here.

Note also, pertinent to the report by Senator Warren mentioned above, every week people pay severe penalties for defrauding Medicaid, Medicare, or other federal health programs.  Today, a quick Google search for "medicaid fraud prison" found such stories from the last month as a woman sentenced to five years in Louisville, and another women sentenced again to five years in Dallas. Yet no person at Pfizer paid any penalty for for practices that deprived the government of hundreds of millions of dollars.  

For $250 Million, Fresenius Settled Lawsuits Alleging it Withheld Information About the its Products' Hazards

Per the New York Times, January 18, 2016,

The world�s largest provider of kidney dialysis equipment and services has agreed to pay $250 million to settle thousands of lawsuits from dialysis patients and their relatives claiming that the company�s products had caused heart problems and deaths.

The settlement was announced by Fresenius Medical Care, a German company whose North American division is one of the two large dialysis providers in the United States.

The lawsuits arose after Fresenius�s own medical office sent an internal memo to doctors in the company�s dialysis centers saying that failure to properly use one of the company�s products appeared to be causing a sharp increase in sudden deaths from cardiac arrest.

But the company did not warn doctors in non-Fresenius clinics who were also using the product, called GranuFlo. It did so only after the internal memo was sent anonymously to the Food and Drug Administration, which began an investigation.

 The company conducted a recall, which was actually a change in the label, not the removal of the product from the market.

Note that this settlement was of allegations not of financial chicanery, but of behavior that put patients in harms way. Nonetheless,

Kent Jarrell, a spokesman for the company, said the initial internal memo was actually incorrect and contradicted by further careful analysis. He said the warning language added to the GranuFlo label in 2012 was eventually removed. GranuFlo, and a related product called NaturaLyte, are used in dialysis machines to help cleanse patients� blood.

In the first case to go to trial, a jury in Massachusetts state court ruled that Fresenius was negligent, for not distributing the memo more widely, but that a patient�s death could not be attributed to GranuFlo, so no monetary damages were awarded, according to Mr. Jarrell and to Christopher Seeger, a lawyer who led the settlement negotiations for the plaintiffs.

But if the initial concern was unwarranted and Fresenius won the first trial, why would it pay $250 million to settle? Mr. Jarrell suggested that a reason was to put the more than 10,000 lawsuits behind it.

'Fresenius deeply regrets the confusion and concern temporarily generated by the November 2011 memorandum,' he said in an emailed statement.

Again, there were no admissions or findings of guilt, no apologies (except for causing "confusion and concern"), and no negative consequences for the corporate managers who authorized or directed the actions in question.  While the FDA apparently issued a recall notice for GranuFlo, no federal agency apparently took action against the company or any individuals within it.    Also, this settlement seemed uninformed by previous settlements made by Fresenius, which were made in 2011 of allegations of false claims, in 2010 again of allegations of false claims, and in 2007 of allegations of restraint of trade (look here).

Summary

We first discussed how legal settlements may serve as markers for misbehavior by large health care organizations, but not as deterrents to future bad behavior in 2006.  Then we wrote ...

 Why do the mainly monetary penalties seem mainly to come out of the hides of stock-holders and consumers, rather than the people who actually made the decisions that lead to the offenses?

In 2008, we wrote,

After all, a fine or settlement paid years later can just be written off as a cost of doing business. Furthermore, although such a payment may have a (minimal) effect on the company's bottom line, it has no real effect on the people whose decisions and actions lead to the problem.

So rather than repeating our usual verbiage about the impunity of health care leaders, let me defer to Senator Warren:

Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims�all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies � and particularly the Department of Justice (DOJ) � rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

Keep in mind that the impunity of health care leaders, especially in contrast with the tough enforcement efforts against small fry health care offenders, not only has a corrosive effect on the fabric of democracy but endangers patients' and the public's health, and makes health care more expensive and inaccessible.

Maybe now that the impunity of corporate leaders is becoming a mainstream topic of discussion, we can start talking about, and then doing something about the impunity of corporate leaders in health care. 

Thursday, 10 December 2015

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

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

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

Suing the Former Synthes CEO

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

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

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

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

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

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

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

Furthermore, 

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

Also,

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

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

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

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

The Synthes Case Up to Now

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

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

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

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

An Almost Anechoic Lawsuit

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

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

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

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

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

Major Clinton Donor Faces 'Criminal Profiteering' Charges

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

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

The Columbia Journalism Review described the Daily Caller as having

carved out a cozy corner of the web in its short life. It�s a place for conservatives to read about the latest liberal scandal and the latest movements in the GOP presidential field.
So presumably if Mr Wyss was uninterested in politics, and did not donate to any remotely left wing causes, the Daily Caller would not have covered the ongoing lawsuit, leaving it totally anechoic.

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

Conclusions

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

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

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

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

Tuesday, 24 November 2015

Princess Health and Their Cheating Hearts - Latest Allergan Settlement Is a Reminder of Merger Participants' Sketchy Pasts. Princessiccia

A Huge, but Sketchy Merger

The announced merger and "tax inversion" of Pfizer and Allergan would be one of the largest corporate marriages in US history.  It has drawn more than its share of criticism.  For example, per the Los Angeles Times, former US Senator and Secretary of State, and current presidential candidate Hilary Clinton said "this proposed merger, and so-called inversions by other companies, will leave U.S. taxpayers holding the bag."

By creating the world's largest drug company, it could certainly further consolidate the US and global pharmaceutical market and raise already high drug prices.  While Pfizer in particular has benefited from US funding of biomedical research, including training of researchers and development of research infrastructure, (see this New Yorker article by John Cassidy) making the company pseudo-Irish may be "unpatriotic," as President Obama said with regard to tax inversions in general (per the Washington Post).

The nature of the merger, creating a company that would be Irish for tax purposes, but effectively run out of the US seems at least intellectually dishonest.  (Note that the CEO of its supposedly Irish component, Allergan, works out of Parsippany, NJ (per Bloomberg, here.)

The main beneficiaries of the merger appear not to be patients, or health care providers, or US taxpayers, but top company executives.  As John Cassidy wrote,

It's hard to avoid seeing the merger as a cynical move designed to boost Pfizer's stock price and generate a windfall for the company's senior managers....

But the latest settlement by Allergan, which I was just about to write about before the merger was officially announced, is a reminder that the companies are a good fit in one sense.  Both have long histories of shady behavior as marked by many legal settlements, and in some cases corporate guilty pleas and convictions.

The Latest Allergan Settlement

The beginnings of the latest Allergan settlement were noted back in July, 2015, but first not even connected to Allergan.  According to the US Federal Bureau of Investigation (FBI),

A former district manager of Warner Chilcott Sales U.S., LLC (Warner Chilcott), a pharmaceutical company based in Rockaway, N.J., pleaded guilty today in U.S. District Court in Boston in connection with a scheme to deceive insurance companies and Medicare so that they would cover the costs of Warner Chilcott�s osteoporosis medications, Actonel and Atelvia.

The idea was to promote two of Warner-Chilcott's products, osteoporosis medicines Actonel and Atelvia, by evading insurance company requirements for physicians to justify their use, given questions about their benefits versus harms, and availability of generic treatments for osteoporosis.

Beginning in 2010 and throughout 2011, Podolsky directed the sales representatives in his district to fill out prior authorizations for physicians who prescribed Actonel and Atelvia using false clinical justifications as to why the patient needed Warner Chilcott drugs and submit them to health insurance companies. In some instances, Podolsky�s sales representatives reviewed patients� medical charts to get the information necessary to fill out the prior authorizations, in violation of the Health Insurance Portability and Accountability Act (HIPAA). Podolsky also directed sales representatives to utilize a website to submit prior authorizations to insurance companies to disguise their identity as pharmaceutical sales representatives. Podolsky and the sales representatives that he supervised knew that they should not be involved in the preparation or submission of prior authorizations.

But Podolsky was not a lone wolf. At the end of October, 2015, the Boston Globe reported more fully on the scheme, and the large settlement made by Allergan, of which Warner-Chilcott was merely a subsidiary. US Department of Justice allegations involved top leaders of Allergan.

The drug reps bought the doctors lunches, dinners, drinks. They paid for speeches the doctors never made. And in exchange, the doctors prescribed drugs that boosted their sales.

Warner Chilcott, a unit of pharmaceutical giant Allergan PLC, will pay $125 million to settle these and other charges in an agreement announced Thursday by US Attorney Carmen M. Ortiz in Boston.

Ortiz said the company ran an elaborate scheme to prod doctors � including in Massachusetts � to prescribe its drugs in exchange for kickbacks.

Warner Chilcott�s former president, W. Carl Reichel, was charged in federal court for allegedly conspiring to pay kickbacks to physicians, and a Massachusetts physician, Dr. Rita Luthra of Longmeadow, was indicted for allegedly accepting payments.

Warner Chilcott illegally promoted at least seven drugs, including the osteoporosis treatments Actonel and Atelvia.

Court documents show that Warner Chilcott representatives promoted their drugs by wining and dining physicians and giving them money and gifts for participating in medical education events. These events often were held at 'upscale restaurants' and contained 'minimal or no educational component.'

The company made fraudulent requests to the federal government and to insurance companies to boost sales of their drugs, the US attorney�s office said, and employees also made unsubstantiated claims about the drugs� benefits.

Note that the charges were of actions that went well beyond financial fraud. They included dishonest marketing and kickbacks to physicians. The alleged actions could have harmed patients, by inducing physicians to prescribe unneeded drugs with known adverse effects.

Note further that unlike many other legal settlements about which we have written in the past, this one did not allow the company to escape by just paying some money and then claim that it did not confirm or deny the charges.  In this case, the company pleaded guilty.

Warner Chilcott has agreed to plead guilty to health care fraud. It will pay a $23 million criminal fine and $102 million to resolve false claims with state and federal governments. The case was brought by two whistle-blowers.

And as noted above, unlike many other legal settlements which did not entail any negative consequences for those who authorized, directed, or implemented the bad behavior, in this case a top executive (although not the highest executive in the overall corporate structure, and not a current executve) was charged with a crime and apparently actually physically arrested (although he has not been convicted of it, yet.)

Meanwhile, Reichel, the former Warner Chilcott president, was arrested in Boston on Thursday.

Prosecutors say in their indictment that Reichel designed a sales and marketing strategy to entice doctors to prescribe his company�s drugs with free dinners and bogus speaking fees. The physicians paid to give speeches often did not speak at all, and instead enjoyed expensive dinners with sales representatives, the indictment says.

Reichel left Warner Chilcott in 2011, according to a news release.

Furthermore, per a Forbes column, Mr Reichel was allegedly involved up to his proverbial eyeballs.

The Reichel indictment says that, while president of Warner Chilcott�s pharmaceuticals divisions from 2009 to 2011, he directed company sales staff to push physicians� to prescribe its drugs by throwing money at doctors� in various ways, such as expensive dinners for doctors and their spouses and 'speaker' fees to attend informal dinners without educational content.

Reichel also allegedly provided sales reps with a separate expense account to buy food and drinks for employees of physicians who prepared prior authorization forms certain insurers required to pay for patients� drugs.

Reichel hired 'Type A crazy' sales representatives, as he called them, who were provided with 'limited training concerning compliance with health care laws and otherwise de-emphasized the importance of compliance to the sales force,' the indictment says.

Of course, the top executive in the overall corporate structure said the usual, as likely written by his public relations spin doctors,

Brent Saunders, the chief executive of Dublin-based Allergan, said in a statement: 'We take seriously our responsibility and commitment to abide by all US and international laws that govern the sales, marketing, education, and promotion of our products, and recognize the tremendous impact that this responsibility has on the customers and patients we serve.'

Finally, two other middle managers involved in the case entered guilty pleas, according to the Department of Justice.

Thus this settlement may be regarded as much tougher than many previous legal settlements involving big health care organizations.

However, its bearing on the huge Prizer-Allergan merger has apparently not so far been publicly discussed.

Allergan's Previous Track Record

It is not that the new Allergan settlement is a one-off.   It needs to be viewed in the context of Allergan's previous history of misbehavior.

That history may be a bit obscure, especially because of Allergan's complex corporate structure.  However, a Wall Street Journal article on the merger provided a bit of Allergan's corporate back story,

Allergan itself is the result of a number of mergers in quick succession. It started off as a generic-drug company called Watson Pharmaceuticals Inc. In 2012, Watson acquired Swiss rival Actavis Group and adopted that name. It also absorbed Warner Chilcott PLC and Forest Laboratories Inc. in multibillion-dollar deals.

Mr. Saunders was CEO of Forest Labs, and became CEO of Actavis after that deal. Shortly after, Allergan�s predecessor was put into play when Valeant Pharmaceuticals International Inc. made an unsolicited offer to buy the California company.

Actavis then stepped in as a white knight and bought Allergan, taking the company�s name.

Allergan and its predecessor companies have an interesting record of misbehavior.  Just perusing Health Care Renewal one can find:

-  Actavis was convicted and fined more than $170 million in 2011 by a Texas jury of misrepresenting prices to the state's Medicaid program (see this post.)

-  In 2010, in case which included allegations that it paid kickbacks to physicians to promote its product, Allergan pleaded guilty to to federal charges of misbranding of Botox and agreed to penalties of about $600 million (see this post).

-  In 2010, Forest Laboratories settled allegations that it deceptively promoted drugs, particularly that it promoted anti-depressant Celexa for children by partially by covering up negative trial results about it.  This likely hurt patients, since anti-depressants like Celexa have been shown to have severe adverse effects, including suicidal ideation, for children.  The company also was charged with giving kickbacks to physicians to promote drugs.  The company pleaded guilty to a felony charge of obstructing justice, and two misdemeanors, including misbranding Celexa and illegal distribution of Synthroid.  The company paid over $300 million in penalties and submitted to a corporate integrity agreement.  (See this post)  The Department of Justice threatened to disbar the CEO of Forest Laboratories, but then inexplicably backed off (see this post). 

So the latest settlement by Allergan subsidiary Warner Chilcott is the fourth major settlement since 2010.  The company and its predecessors have pleaded guilty to crimes, at least once to a felony, and settled cases involving allegations of kickbacks and deceptive marketing practices. 

Pfizer's Previous Track Record

And things really get interesting when one considers Pfizer's track record, which seems much sorrier than Allergan's.  Our latest post, about Pfizer misbehavior was only one month ago (October, 2015).  A  UK judge found that the company threatened health care professionals for using a generic competitor.

Many posts on Pfizer can be found here.   The latest update of Pfizer's troubles since 2000 follows.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,
- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,
- Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).
- The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).

Summary

So the proposed merger of Pfizer and Allergan would truly create a behemouth of bad behavior.  The combined company would have a staggering record of legal settlements, guilty pleas and convictions involving deceptive marketing, fraud, kickbacks, bribes and anti-trust violations, and even an obstruction of justice plea and a RICO conviction.  Yet the managers in charge of the two companies when the bad behavior occurred never had to suffer any negative consequences (although in one current case there is the possibility one executive might be convicted).  Many of these managers have become amazingly rich during the course of their leadership.  Is there any reason to think, absent any unexpected increase in the courage and resolve of government law enforcement, or any unexpected public protest, that the new company will not continue to misbehave as long as its executives are making money from the process?

The Pfizer Allergan merger is the true poster child for the amorality, and consequent dysfunction and decline of modern US and now global health care. As long as top managers of big health care organizations can act with impunity, can avoid all responsibility for their organizations' bad behaviors, and can personally profit wildly from their companies actions, the health care death spiral will continue.  Will we continue to cry out in the wilderness, or will anyone else see the writing on the wall?

A musical moment to partially alleviate the gloom. "Your Cheatin Heart" sung by Hank Williams Jr.



 

Thursday, 12 November 2015

Princess Health and "Dreaming On" - The Illusions of the Leaders of Large Health Organizations, as Illustrated by Medtronic's Founder. Princessiccia

Princess Health and "Dreaming On" - The Illusions of the Leaders of Large Health Organizations, as Illustrated by Medtronic's Founder. Princessiccia


On Health Care Renewal, we have posted story after story about amazingly well paid leaders of big organizations presiding over amazingly bad organizational behavior (including subversion of mission, conflicts of interest, deception, fraud, kickbacks, various other crimes and outright corruption).  Yet the leaders often seem curiously disconnected from what occurs on their watches, while they are sometimes hailed as "visionaries," and at times exude messianic confidence.

Medtronic's Founder on its Sacred Mission

A recent article appearing in an unexpected place provides an example of leaders' excess confidence in their own righteousness.  In the IEEE (Institute of Electrical and Electronics Engineers) Institute was a commentary by Earl Bakken, the founder of medical device/ biotechnology giant Medtronic, modestly proclaiming the "secrets of corporate success."

Keep in mind that while Mr Bakken founded the company, at age 91, while no longer its leader, he proclaimed, " I stay involved with my company."  As such, he remains proud of its mission statement,

In 1960, when corporate mission statements were rare, I wrote one that has never changed. It remains the company�s guiding principle. There are six tenets, but the first one is the most important: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

Starting in the 1970s, I met with all new employees, explained our history and mission, and in each of their hands I placed a medallion imprinted with the mission statement. I encouraged them to live by it�at work and at home.
Note that the official mission also includes,

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service. [ital added]

Apparently, he believes that under the "visionary leadership" and "astute direction" of the current, this mission remains central to the organization.

At Medtronic, we live our mission. It�s the basis for how we behave in relationship to our stakeholders, each other, our communities, and the world. But it also guides our relationships with ourselves. We live the Medtronic Mission every day in truly genuine ways by serving others. I am proud to have a mission that is so deeply woven into the fabric of this company that improves millions of lives throughout the world.

Here�s to dreaming on.

Honesty? Integrity? - the Company's 10 Year Track Record 

I hate to disillusion a 91-year old, but in light of the company's last 10 year track record, as discussed on Health Care Renewal, he does appear to be in a dream world.


Medtronic has provided our blog with lots of material, including some amazing stories about conflicts of interest (starting in 2006, here, here, here, here, here, here, here, here, nad here,) and revolving doors  (here, here, here, and here). 

The company has also made a series of legal settlements of various allegations of infamous behavior, in chronological order...
 
2006

- We discussed detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003.
 - Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look here).

2007

As Bloomberg summarized in 2014,
Medtronic agreed in 2007 to pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators.
 2008

- Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)

2010

Per the Bloomberg 2014 summary again,
The company agreed to a $268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.


2011

-  Medtroinic settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look here).

2014  

In June, we discussed a settlement Medtronic made of allegations that  Medtronic gave kickbacks (that is, bribes) to doctors to get them to use its cardiac devices.

2015

In April, 2015 we discussed three settlements made by Medtronic:
- Its subsidiary EV3 settled old allegations that it coached hospitals how to overbill the US government for procedures using its products
- The company settled allegations it gave kickbacks to physicians to induce them to use its neuromodulation devices.
- The company settled allegations it lied to the US military about US origins of its devices.

(And by the way, we will not belabor the contrast between the statement's committment to "recognize the personal worth of employees," and the gargantuan payments made to certain employees, that is, the top managers, all who got over $3.5 million in 2014, and the "visionary" CEO, who got over $12 million, look here. )

Summary

Someone needs to wake up Mr Bakken.  He may still believe in the mission statement, and wish that it is central to his company.  However, the track record seems to suggest that the mission statement has been honored often in the breach.

Perhaps the problem is that Mr Bakken is really much more detached from the company he founded than he now admits.  However, I worry that this immensely positive spin suggests that he, like many other health care oragnizational leaders, live in some sort of bubble into which no negative karma is allowed to penetrate.  Thus convinced of their own innate goodness, they can provide no check on continuing manifestations of corporate greed, most likely with the solace of the own fortunes they build up. 

IMHO, we need to break up these huge health care organizations which have become so big that those who run them cannot be in touch with what really goes on.  We need to reestablish the accountablity of leaders, and no longer allow them to get credit for all the good that happens, and dodge responsibility for all the bad.  True health care reform would entirely transform health care leadership, so that it can become well-informed, supportive of the mission, unconflicted, less self-interested, honest, and certainly law abiding. 

Thursday, 5 November 2015

Princess Health and What  They Really Think of Us (Swiss Version) - Novartis CEO Would Not Commit to Changing Company Behavior After Latest of Multiple Legal Settlements. Princessiccia

Princess Health and What They Really Think of Us (Swiss Version) - Novartis CEO Would Not Commit to Changing Company Behavior After Latest of Multiple Legal Settlements. Princessiccia

The huge corporations which now dominate global health care are creating amazing records of repeated ethical misadventures.  We last discussed multinational Swiss based pharmaceutical manufacturer Novartis' escapades in early 2014.   Since then, the legal settlements and other legal findings just keep on coming, capped with a big one in late October, 2015.

We will summarize them in chronological order.


Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects

In August, 2014, per the Japan Times, but apparently not reported widely outside of that country.

Novartis Pharma K.K. said it has failed to report at least 2,579 cases of serious side effects to the health ministry, including one that was fatal, related to its drugs for leukemia and other diseases, although employees were aware of the problems.

Of the total, 1,313 cases were related to Glivec and 514 to Tasigna, both drugs for leukemia treatment. Another 261 cases involved Afinitor, a cancer drug, the Japanese unit Swiss drug giant Novartis AG said Friday.

The findings were reported to the Health, Labor and Welfare Ministry the same day.

The marketing staff at Novartis Pharma recognized the side effects but failed to report them to the division in charge, breaking the drug firm�s internal rules, Novartis Pharma said. They were not fully aware of the importance of the problem and higher-ranking officials failed to supervise them properly, it said.

In February, per the PharmaLot blog, the Ministry decided to suspend the company for 15 days, after having issued a business improvement order to it.  More details of Novartis' problems in Japan can be found in the Japan Times.  I cannot find anything to suggest any one in a position of leadership at Novartis faced any negative consequences as a result, however.

Note that by allegedly hiding adverse effects of its drugs, it is possible that the company's alleged actions led doctors and patients to believe the drugs were safer than they really are, possibly leading to overuse of the drugs and resulting in even more adverse effects.  I did not see a discussion of possible patient harm in the discussion of this case.


Novartis Executive Pleads Guilty to Bribing Polish Official

In October, 2014, per a short Reuters (UK) article, and apparently not mentioned elsewhere,

An executive at a pharmaceutical company in Poland who pleaded guilty in a bribery case involving improper payment, works for Novartis, the Swiss drugmaker said on Thursday.

Poland's anti-corruption bureau said on Tuesday two women had appeared in court in a case in which a health fund official was given a tourist trip worth more than $1,000 (620.67 pounds) in exchange for backing the sale of a particular drug.

Both defendants pleaded guilty....

The drug involved was not clear, and the company suggested this was an individual act ("the enquiry relates to an individual and the company is not part of the enquiry.")  Why an individual would do something like this if not to advance her career is not clear, however.  I cannot find any followup coverage of this, nor anything to suggest the supervisors of the executives involved faced any negative consequences.

Again, by bribing an official to promote a particular drug, this case could have led to overuse of the drug, and potentially to patient harm from the drug's adverse effects. 

Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid

In March, 2015, per the PharmaLot blog,

In what the federal government says is the largest such settlement ever reached, Sandoz has agreed to pay $12.64 million to resolve allegations that it misrepresented pricing data on medicines that were provided to the Centers for Medicare & Medicaid Services.

Sandoz, which is owned by Novartis and markets hundreds of generic drugs in the U.S., allegedly misrepresented the average sales price data to Medicare between January 2010 and March 2012, according to a statement from the Office of the Inspector General of the U.S. Department of Health & Human Services.

A Novartis spokeswoman writes that the drug maker did not admit to any liability or wrongdoing. 'Sandoz continues to be committed to providing high-quality, affordable medicines to U.S. patients and conducting business with customers and the government with integrity.' As part of the settlement, Sandoz agreed to provide certification that it established a government pricing compliance program.

As the OIG explains, Medicare uses the pricing data to set payments for most drugs covered under Medicare Part B....

Again, no one who authorized, directed or implemented any price misrepresentation faced any negative consequences.  Futhermore, as often occurs in US cases, the company did not admit any wrongdoing, and provided the usual public relations boilerplate about upholding the highest principles, the allegations leading to the settlement notwithstanding.

Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis

In May, 2015, also per the PharmaLot blog,

Express Scripts  has agreed to pay $60 million to resolve allegations by U.S. authorities that a business unit participated in a kickback scheme with Novartis that caused federal health care programs to pay for a medicine based on false claims, according to court documents and a regulatory filing.

The U.S. Department of Justice alleged that Novartis offered patient referrals to Accredo Health Group, which is a specialty pharmacy run by Express Scripts, in exchange for bolstering refills of Exjade, a drug used for reducing excess iron in patients who undergo blood transfusions....

Apparently other lawsuits involving allegations of Novartis payments to other pharmacies are pending. Note that the events alleged in some of these proceedings may have occurred while Novartis was already subject to a so-called corporate integrity agreement,

a key issue to watch is the extent to which a so-called Corporate Integrity Agreement that Novartis signed in 2010 factors into the proceedings. These agreements typically run for five years and require a company to establish an internal compliance program and report violations.

At the time that Preet Bharara, the U.S. Attorney in New York, announced the lawsuits against Novartis two years ago, he called the drug maker a 'repeat offender,' and the lawsuits noted that the violations alleged in the litigation took place before and after the CIA was signed.

Note that the settlement was with Express Scripts, although it involved allegations of misbehavior by Novartis.  Note also that this settlement throws into doubt one mechanism now widely used by law enforcement in the US to settle cases involving big corporations, the corporate integrity agreement or defererred prosecution agreement.  These are agreements made by corporations not to behave badly again.  Yet this case may yet demonstrate that these agreements do not deter future bad behavior.

Again, so far, this settlement did not involve any negative consequences for who may have authorized, directed or implemented the bad behavior either at Express Scripts or Novartis.

Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

In late October, 2015, a larger settlement, at least in monetary terms, of related issues was announced, per Reuters,

Novartis agreed in principle to pay $390 million to settle U.S. allegations that it used kickbacks to speciality pharmacies to push sales of some drugs, the Swiss company said on Tuesday, hitting third-quarter earnings.

Since this case involved hundreds of millions dollars, it got a bit more coverage than the others.  For example, Bloomberg provided some more specifics,


The payment covers all claims related to the medicines Myfortic, Exjade, Tasigna, Gleevec and TOBI, the company said. The U.S. had sought as much as $3.3 billion from Novartis for Exjade and Myfortic claims, claiming it had referred patients to specialty pharmacies and paid kickbacks in the form of rebates to get those pharmacies to recommend the drugs to patients and to increase sales.

It is customary in such settlements for them to allow the accused corporation to avoid any admission of guilt, often with some statement that the corporation neither confirms or denies the allegations.  In this latest cast, however, while the company issued the usual "neither confirm nor deny" statement, the Novartis CEO appeared to want to deny the allegations despite his willingness to pay so many millions to get them behind him, as per Reuters,

Chief Executive Joe Jimenez told reporters Novartis had made the disputed payments to ensure patients took their drugs, including treatments to prevent rejection of transplanted organs, but U.S. government attorneys disagreed.

'It's something we just believe we want to put behind us,' Jimenez said. Novartis said it neither admitted nor denied liability as part of the settlement.
How the payments or rebates to the pharmacies had anything to do with improving patient adherence is not clear.  Mr Jiminez's expertise in improving patient adherence is similarly not clear.  Per his official company biograpphy, his education was limited to business school, and before becoming a Novartis executive, he ran the Heinz company, makers of the famous ketchup (look here and here).  

Note that if, despite the protestations of the CEO to the contrary, the effect of the company's alleged actions was to over-promote use of the drugs, the results could have been excess adverse effects for patients. 

Furthermore, and despite this possibility, per the Wall Street Journal, the CEO also seemed unwilling to agree that the company would change any of its practices beyond paying the money,

Chief Executive Joe Jimenez said the rebates were designed to induce specialty pharmacies to ensure that patients completed a course of medicine. He added that Novartis still used this 'quite common' practice at specialty pharmacies in the U.S.

'We continue to maintain that specialty pharmacies must continue to play a role in ensuring patient adherence,' he said. 'How that is going to play out as to whether we change our behavior or not remains to be seen.'
This suggests that CEO Jiminez really thinks that the company should pay the money and then continue doing what it pleases, based on the rationale that the payments to or discounts given pharmacies were meant to improve patient adherence, not oversell the drugs.  This may reflect what he really thinks of what his company ought to be doing for, or to us, that is to or for the patients who take the drugs it manufactures. 

 Nonetheless, a public relations release tried to make those comments inoperative.

Some media coverage did not accurately reflect our position and the seriousness of the Company's commitment to working with the government to ensure our behaviors and interactions with specialty pharmacies meet the highest ethical standards. As such, we want to emphasize the following points:

Novartis will make detailed admissions of fact concerning the Government�s allegations as part of the final settlement.

Any reports suggesting that we are not addressing the Government�s concerns or the particular issues on which the litigation focused was not intended by the Company.

We remain committed to working with the government on corporate integrity obligations, including those relating to specialty pharmacies, and conducting our business in an ethical manner that is fully compliant with the law.

We await the statement of facts.  Maybe this statement will prove true, but given that the original statement came from the CEO, to whom the PR people who wrote the satement report, perhaps CEO and former purveyor of ketchup Jiminez meant what he said.  As noted in the Modern Healthcare blog,

Patrick Burns, co-director of the Taxpayers Against Fraud Education Fund, a not-for-profit funded by whistle-blowers and law firms that represent them, said he remains skeptical of the company's intentions.

Burns said Jimenez's original statements smack of disrespect for the U.S. Justice Department and the U.S. attorney general.

'It's a level of arrogance and ignorance which is jaw-dropping,' Burns said. 'You have the CEO coming out and brazenly saying we will not even change our practice. I think this really is the time for the attorney general to show her teeth.'

We also await any such dental findings. 


Summary

This set of misadventures are just the latest in a long series by Novartis.  In March, 2014, we 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.

Nonetheless, the march of its legal cases continues.  Furthermore, after the latest case, the Novartis CEO suggested that he saw no clear need for the company to change its ways, even though his PR people later tried to recast his statements.

So we see that the big health care organizations which now dominate health care globally continue to misbehave, and current legal efforts centering on settlements and fines seem to do nothing to deter continued misbehavior.  Maybe it is time to end the impunity of the corporate managers who have become rich while such behavior continues on their watch.  Modern Healthcare quoted Mr Burns as saying

the financial penalty in this case didn't seem to be enough to fix the problem. He believes the government needs to begin excluding executives such as Jimenez from federal healthcare programs in order to better get its message across that such behavior won't be tolerated.

In the new PharmaLot blog, Ed Silverman was hopeful that things may really be getting ready to change. He first noted, as we have done many times previously,

Over the years, a parade of drug companies has reached settlements, mostly for paying physicians to favor their medicines or illegally marketing products. Rarely, though, do executives suffer any consequences.

Also,

Mostly, the federal government resorts to large fines, even though countless people may have been prescribed medicines unnecessarily � at great expense and sometimes great harm. And drug makers simply treat these penalties as a cost of doing business. The failure to come down harder is sadly reminiscent of the recent financial crisis in which most heads of the biggest banks escaped unscathed.

Lately, however, there are signs the government might be changing its approach toward recalcitrant executives, and such a move is long overdue. After all, if individuals are not held accountable, the senior officials who run these companies have little incentive to play by the rules.

One can only hope, I suppose.  But to conclude as I have so many times before....

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.