Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices

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

Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices

Unknown 6/08/2016 Komentar

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.

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What You See Is Not What You Get - Purdue Pharma Executives Pleaded Guilty, but the Oxycontin Billionaires Went Unnoticed

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

What You See Is Not What You Get - Purdue Pharma Executives Pleaded Guilty, but the Oxycontin Billionaires Went Unnoticed

Unknown 3/31/2016 Komentar

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).





 

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

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

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

Unknown 3/25/2016 Komentar

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

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Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

complementary/ alternative medicine deception Donald Trump marketing

Trumped Up "Nutritional" Products - A Cautionary Tale of Immediate Relevance

Unknown 3/04/2016 Komentar

On Health Care Renewal, we frequently discuss deceptive marketing schemes designed to sell tests and treatments whose benefits for patients do not clearly outweigh their harms, and sometimes which are useless or dangerous.  In fact, we have to be selective about discussing such cases, because they are all too common.  Therefore, we tend to focus on cases involving the biggest and most powerful health care organizations, and/or the worst risks to patients.

We have generally not discussed the myriad promotions of dubious "nutritional" tests and therapies, because there are just so many of them, the players involved are generally small, and these products were effectively deregulated in the US by the 1994 Dietary Supplement Health and Education Act.  However, last year we discussed how the marketing of a "nutritional supplement" containing an amphetamine like substance was seemingly facilitated by the revolving door at the US Food and Drug Administration (FDA).

The Trump Network -Background

But a story recently republished by Stat is now suddenly relevant because one of the players involved is now so influential.  It recounted the rise and fall of The Trump Network, a network marketing scheme to sell nutritional products.

Actually, the most colorful version of the background of this story comes from a 2011 article in New York Magazine.  Here is how the network marketing worked, using an example centered around a Trump Network marketer-to-be named Izzo:

He would order the vitamins from a company called Ideal Health. She would earn a commission on the sale and he, in turn, would become a part of her team and encourage other people to buy the vitamins. For those sales, Izzo would earn a commission, as would she (his 'upline'), and then the people he sold the vitamins to would become part of his sales team and would go on to create their own sales teams, who would go on to create their own sales teams, etc., ad infinitum, all of them funneling commissions from their sales up to Izzo and the woman on the phone. As he listened, 'something clicked,' Izzo says. 'I saw the beauty of the business model. And I said, ‘How can I do this, and do this big?’ '

The idea was so big it was picked up by no other than "The Donald" Trump.

'The name is hot!” Donald Trump booms over the speakerphone from his office at 725 Fifth Avenue, where, ever since The Apprentice breathed new life into his brand, he has presided over an ever-diversifying array of businesses. He is, of course, speaking of his own name. “It’s on fire!”

In March 2009, Trump purchased Ideal Health, rebranding it the Trump Network. Though the packaging has now been imprinted with the Trump family crest, the product line is still much the same. There are the two multivitamins: Prime Essentials and the more expensive Custom Essentials, the ingredients of which are determined by the Trump Network–branded PrivaTest, a urine test that claims to determine which vitamins the user needs. There’s also a line of healthy snacks for kids called Snazzle Snaxxs, QuikStik energy drinks, and a Silhouette Solutions diet program. With the Trump investment, the company has added a skin-care line that goes by the seductively foreign name BioCé Cosmeceuticals.

Back then, Mr Trump thought the sky would be the limit.

Next year, the Trump Network plans to add more products and extend its reach to Europe and Asia. The goal, Trump says, is to eventually become bigger than Amway, now an $8.4 billion company and the giant in the field. Whether or not the people of Laos will spring for a skin-care line from a man famous for his perma-tan, some Long Islanders seem convinced.

“People have said, ‘This is Donald Trump’s network-marketing company? I want in,’ ” says Alex, Izzo’s pretty 29-year-old daughter, who quit her job and moved back in with her parents last year in order to become a marketer, as the people in the network call themselves. “I was talking to a woman the other day and she said, ‘If I can’t trust Donald Trump, who can I trust?’ And I said, ‘You’re totally right.’ ”

As Stat noted, Trump helped market the network with great enthusiasm back then.


Donald Trump was ready to make some money on vitamins.

On a Friday night in November 2009, Trump stood before a crowd of thousands at the Hyatt Regency in Miami to launch a new enterprise, The Trump Network. Behind him was a gigantic image of his family crest and an enormous photograph of himself.

'We’re gonna come out with new and different products,' Trump told the crowd. 'They’re gonna be wonderful products.'

Marketing videos that include Mr Trump are still readily available online,



In the video, Mr Trump said"Americans need a new plan. They need a new dream. The Trump Network means to give millions of people a new hope."

The Problems with the Trump Network

Well, how did that work out?

The Stat article described the Network's big product:

The Trump Network asserted that it could use a urine test to recommend customized nutritional supplements, its signature products. It also offered products that purportedly tested for allergies and bone health.

In particular,

The Trump Network sold many health and wellness products, and its main one was a customized nutritional supplement whose composition was determined by a urine test, called the PrivaTest.

A former marketer provided STAT with a kit for Ideal Health’s PrivaTest. It contained a urine collection cup, five test tubes, a cold pack, a biohazard bag, a prepaid FedEx mailing label, and detailed instructions. Customers collected their urine and shipped it to a lab for analysis. That lab analyzed the urine with three tests and produced a report, which was sent to The Trump Network.

The Trump Network bundled the report with a package of pills and shipped it all back to the customer. The pills were marketed as 'Custom Essentials,' formulations based on the results of the test and manufactured by another lab. In all, there were 48 formulations.

According to an archived version of The Trump Network’s website that can still be found online, the PrivaTest, along with a month’s worth of the Custom Essentials, cost $139.95. Retesting was available for $99.95, plus shipping and handling. The company recommended retesting every nine to 12 months.

Other products purportedly tested for food allergies, stress, and digestive health. One claimed to measure 'the balance between your ‘good’ estrogen and your ‘bad’ estrogen.'

The problem is that there is no evidence that these products, particularly PrivaTest, worked in any sense. First, there appeared to be no publicly available data on how the tests worked, what they actually tested, or how accurate they were.  Then there was no data about how the test results could rationally be used to suggest particular mixes of vitamin supplements.  Also, there was apparently no public data about what vitamins were in the potions sent to consumers, their purity, their strength, etc.

Worse, there was no evidence that any of this provided any benefits to the people who ended up taking the vitamins.

To support the necessity of supplements, The Trump Network’s website cited a 2002 article from the Journal of the American Medical Association. The article, it said, 'stated that every adult needs to supplement their nutrition to remain healthy.'

But the article also specifically cautioned against the types of products that The Trump Network sold.  'The Internet and health food stores are filled with promotions for these special-purpose multivitamins, which are often costly,” the article said. “The only evidence-based arguments for taking more than a common multivitamin once a day pertain to the elderly and women who might become pregnant.'

The JAMA article warned against tests that claimed they can help consumers determine which vitamins they should take.

Worse,

While the FDA may not have evaluated the tests or supplements, independent scientists have — and raised many questions.

Cohen, one of several scientists who reviewed materials from Ideal Health and The Trump Network, said that the tests were marketed too broadly and seemed to be 'pathologizing normal human life.'

The website, for example, recommended its “AllerTest” to anyone who had dark circles under their eyes, occasional digestive problems, fluctuating blood sugar, sinus and respiratory problems, or tiredness after eating.

'Does your blood sugar fluctuate?' Cohen said, laughing. 'If your blood sugar does not fluctuate, you are extremely ill. You will not be long on this planet.'

What’s more, the AllerTest did not measure food allergies, as the network’s website claimed it would, according to outside analysis of materials from the testing lab and Ideal Health publications.

The test measured information about an antibody known as immunoglobulin G, or IgG, according to company publications. The antibody is normally produced in the body and not indicative of a food allergy, said Dr. Robert Wood, director of pediatric allergy and immunology at Johns Hopkins School of Medicine.

'There’s no disease condition for which the IgG antibodies have any relevance at all,' Wood said.

So while Mr Trump, his company, and some of his marketers might have made money from the Trump Network, there is no evidence that its products actually provided any health benefits.

Also, in the long run, Mr Trump's grandiose claims about how the riches his new marketers would receive also proved wanting.  Despite Trump's initial enthusiasm, the Trump Network hardly went global,

Regardless of the science, Trump’s name did wonders for Ideal Health in the short term. Former marketers said the company grew significantly in the months following the name change.

Then, the network began experiencing financial difficulties.

'The Trump Network had gotten in trouble financially,' said Bonnie Futrell, a former marketer and 'diamond director' — one of the top-tier marketers in the company. 'They weren’t being able to pay [the lab]. They weren’t paying vendors. They weren’t paying us.'

Futrell said she was involved in discussions with company higher-ups about how to salvage the organization.

On Dec. 31, 2011, the license agreement expired, said Garten, the general counsel for The Trump Organization. It was not renewed.

Note that this story was also summarized in an AP article available via CBS.   The Network's products were also reviewed, not favorably, on QuackWatch.

Summary

The Trump Network sold nutritional testing and products any clear evidence that they provided any benefits to patients, or that they worked at all in any sense.  Some of the products, like the allergy test discussed above, did not appear to be what they were advertised to be.  Since the Network's products and the outcomes of people using them apparently never were the subject of any clinical research, whether the products did any harm is unknown.  Thus, the Network was like many other dodgy efforts to sell totally unproven "nutritional" products.  Its main results seem to have been transferring money from the pockets of the gullible to the marketers, and to Mr Trump himself.  While Mr Trump recruited marketers with boastful assertions of giving people "new hope," that hope was false.

The increasing commercialization of health care, enabled by deregulation justified by market fundamentalism,  now means that health care has become increasingly a means of transferring money from the little people to big corporations, in this example, those corporations owned by Mr Trump, without providing any net health benefit to those whose pockets have been invaded.  This is bad enough.

But at the moment, Mr Trump is considered the front runner for the Republican presidential nomination, although he is attracting more enmity, much of it from the Republican party. It is ironic that Mr Trump seems to be winning support from a lot of "little people" whom he has promised to defend.  Yet it was the little people who marketed the Trump Network and bought its products who were eventually left hanging. 

The Stat article mentioned that some minor candidates for the Republican nomination this year were also tarred with stories about their involvement in questionable health marketing schemes.  And previous major party candidates have certainly had some health care conflicts of interest.  In fact, we discussed that the current First Lady once was a top executive of a big hospital chain, and the last Republican presidential candidate was a leader of a private equity firm that owned numerous health companies.   It may be unprecedented, at least in recent history, for someone who had been directly involved in the shady marketing of dubious health remedies to be a genuine contender for the US presidency.

There are many bigger issues in the current election than health care.  But now we are faced with Mr Trump, who once hawked unsubstantiated health benefits of dodgy nutritional products, and recruited marketers for these products with false promises of wealth to come.  And Mr Trump has some real possibility of  becoming the President of the US, to whom the Department of Health and Human Services, and the Department of Veterans Affairs report.  What damage could such a leader do to health care?  And what other damage could a man who so cavalierly fleeced the little people with his dubious nutritional product marketing scheme  do, especially to the little people who now so unconditionally support him?

Is there a better example showing why we as a society need to completely rethink who gets to become our leaders?  My only hope is we can do that rethinking in time to prevent a disaster. 

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It Has Come to This? - Donald Trump's "Truly Absurd," "Word Salad," "Gibberish" Health Care Policy

deception health care reform health policy politics ppaca propaganda

It Has Come to This? - Donald Trump's "Truly Absurd," "Word Salad," "Gibberish" Health Care Policy

Unknown 2/28/2016 Komentar

Health Care Renewal is officially non-partisan.  We do not endorse candidates for office, or political parties.  That does not prevent us from commenting on policy issues, and on pronouncements and actions by politicians and government officials when they relate to the issues that interest us.

So, we have criticized excessive coziness among politicians and government officials on one hand, and big health care organizations and their leaders on the other.  We have noted conflicts of interest affecting politicians, particularly the revolving door, and other shadings towards corporatism.  We have noted how health care policy discussions may focus on health care financing, while ignoring some of the bigger issues we discuss  (For example, see our discussions of health care reform, and particularly this one of the then new US Affordable Care Act). These include: leadership of health care organizations by generic managers (managerialists) who are unsympathetic or even hostile to the health care mission; deceptive practices involving marketing, the manipulation and suppression of research, stealth health policy advocacy, stealth lobbying, etc; and timidity in regulation and law enforcement, leading to outright impunity of health care leaders.

We have criticized politicians and government leaders of all parties and from all sides of the political spectrum.  For example, in retrospect we criticized the (Democratic) Clinton administration's laissez faire attitude to conflicts of interest at the National Institutes of Health (see summary here and links to older posts).  We criticized flagrant examples of the revolving door involving top Bush adminstration officials (e.g., most recently here), and yet more involving Obama administration officials (e.g., most recently here).

Yet we also acknowledge that most policy discussions by political and government figures are at least well-intended and based in some degree on the facts and knowledge of the health care context (even if we think the results might be misguided, wrong-headed, or tangential.)  So, while health care is not so far the most important issue in the tumultuous 2016 US presidential race, there has been considerable discussion of it.  Most major candidates have staked out health care positions that again appear well-intended and based to some degree on the facts and context (although my point is not to comment on their merits.)

But there has been one major exception. 

The Leading Candidate with No Health Care Plan

Donald Trump currently seems to be the leading Republican presidential candidate.  As reported by the Minnesota Post,

Trump doesn’t have a health care plan. Go to the issues section of his campaign. Really, go there, you won’t believe what you see. A typical campaign website has position papers. Trump has none. The link to 'Issues' takes you to a pretty frightening page of short embedded videos of Trump himself summarizing his positions at a level of detail that you should find insulting.

But he doesn’t even have one of those on health care.

In addition to 'Issues,' the site’s homepage has a pulldown menu called 'Positions.' I don’t get the difference, but who cares? “Positions” are actual written-out position statements, not videos, but only on five issues, none of which are remotely related to health care (nor many other major issues).

So for Trump’s health-care thinking, we have to rely on what he says in debates and speeches and, I suppose, tweets, some of which have been controversial.

The Candidate with No Health Care Policy Advisers

On February 20, 2016, Politico reported that Mr Trump's campaign also apparently has no health policy advisers.  The article noted that Mr Trump had written in one of his books that he would

Lock the best health care policy minds in a room – and don’t let them out until they’ve crafted a plan for providing terrific coverage for everyone.

But he has not said who those advisers might be.  Furthermore, the reporter was unable to determine who, if anyone, is currently advising Mr Trump about health care,

Sam Clovis, Trump’s national policy adviser, insists the campaign is talking with lots of health care experts – but declined to name any of those advisers.

'We have experts around the world who help us on these various topics,' Clovis said in an interview with POLITICO. 'We get very frank and honest input if we do not expose these people to the scrutiny of the press. … As we get further along they might want to come out of the shadows.'

However,

POLITICO scoured the landscape of notable policy wonks – from academics to lobbyists to congressional staffers to think tank fellows – but was unable to find anyone, on either side of the political divide, who acknowledged whispering health care policy tips in the billionaire’s ear. Or for that matter, of hearing of anyone who had talked to his campaign.

'He seems to be a one-man policy shop,' said Michael Cannon, director of health policy studies at the libertarian Cato Institute, and a leading critic of Obamacare.

So Mr Trump has no clear health care plan, and apparently no health care advisers.  Furthermore, reports of what this candidate has said about health care reveals some anomalies, to say the least.

Reducing Pharmaceutical Costs to Zero?

The Washington Post in a "Fact Checker" feature on February 18, 2016, entitled, "Trump’s truly absurd claim he would save $300 billion a year on prescription drugs," quoted Mr Trump three times on the costs of pharmaceuticals,

'We are not allowed to negotiate drug prices. Can you believe it? We pay about $300 billion more than we are supposed to, than if we negotiated the price. So there’s $300 billion on day one we solve.' –Donald Trump, remarks at Plymouth State University, Holderness, N.H., Feb. 7, 2016

'So I said to myself wow, let me do some numbers. If we competitively bid drugs in the United States, we can save as much as $300 billion a year.' –Trump, remarks in Manchester, N.H., Feb. 8

'We’re the largest drug buyer in the world. We don’t negotiate. We don’t negotiate. You pay practically the same for the country as if you go into a drug store and buy the drugs. If we negotiated the price of drugs, Joe, we’d save $300 billion a year.' –Trump, interview on MSNBC, Feb. 17

The problem here is that the $300 billion figure turns out to be ridiculous.  The Post article noted,

To put Trump’s $300-billion-a-year claim in perspective, let’s first note that Sanders cites a 2013 estimate from the Center for Economic and Policy Research that negotiated drug prices would result in savings to Medicare of between $230 billion to $541 billion over 10 years.

So for virtually the same policy, Sanders is claiming savings averaging $38 billion a year — and Trump is promising a figure eight times larger. (Clinton offers no estimated savings.)

What’s going on here? It’s unclear, because as usual the Trump campaign refuses to respond to any queries about Trump’s numbers.

Furthermore,

total spending in Medicare Part D (prescription drugs) in 2014 was $78 billion. So Trump, in effect, is claiming to save $300 billion a year on a $78 billion program. That’s like turning water into wine.

Finally,

It’s possible that Trump is being sloppy and when he discusses Medicare, he really means to say he would force government-led pricing on all prescription drugs. But the numbers don’t add up that way either.

In fact, depending on the source you consult, total annual spending on prescription drugs in the United States is between $298 billion a year to $423 billion. So that would mean Trump is claiming that he can eliminate virtually any cost to prescription drugs. It would suddenly be free!

So Mr Trump's claims made on at least three occasions about the magnitude of savings that would result from his (unoriginal) proposal to have the government negotiate drug prices were mathematically implausible, if not impossible. 

"Word Salad" about the Mandate

Rather right-wing columnist Jennifer Rubin, writing in the Washington Post on February 22, 2016, provided two sets of quotes from interviews with Mr Trump about his position on the "mandate" within the Affordable Care Act (ACA).  Note that the mandate imposes a (relatively modest) extra tax on people who do not have health insurance, providing an incentive to have such insurance.  For example, on "Meet the Press,"

DONALD TRUMP: Well, on the mandate, if you look at the mandate, we had a situation where we were, Anderson Cooper, who’s terrific, by the way, and did a terrific job, but we were talking over each other. Look, I want, we’re going to repeal and replace Obamacare. Obamacare is a total and complete disaster. It’s going to be gone. We’re going to come up with a great healthcare plan, whether it’s healthcare savings accounts, we have a lot of different things. We’re going to get rid of the lines between states, we’re going to have great competitive bidding. But I say all the time, you can call it anything you want. People are not going to die in the middle of the street. People are not going to die on the sidewalk if I’m president, okay?

CHUCK TODD: Well, let me get something definitive from you on this.

DONALD TRUMP: But Chuck, I say that, excuse me, I say that to packed houses with thousands and thousands of people, Republicans mostly, and I get standing ovations. I’m not going to let that happen. If I’m president, we’re not going to have people dying on the streets. So you can call it whatever you want. I don’t call it a mandate, I just say it’s common sense.

CHUCK TODD: No, I understand that. Well, let me ask you this. Do you think that it should be a law that anybody who can afford health insurance has to have it?

DONALD TRUMP: I think, no, I think it’s going to be up to them, okay? I want it to be up to them. But I’m really talking about people that can’t afford it. We’re not going to let people die in squalor because we are Republicans, okay? That’s part of the problem with the Republicans, where somehow they got fed into this horrible position. We’re going to take care of people. But no, people don’t have to have it. We’re going to have great plans, they’re going to be a lot less expensive than Obamacare. They’re going to be private. There are going to be lots of different options. We’re going to have a lot of different options. Right now you have no options. You know why? Because the insurance company controlled Obama because they gave him a lot of money. That’s why you have lines around the states. And you can’t get competitive bidding.

Her summary was:

He insists whatever inanity he said earlier was a mistake, denies he took or takes a liberal position and declares there will not be people 'dying in the streets.' (Does he understand there is a duty now to treat people, but what we are debating is insurance?) Then he ends with assurances he is loved by crowds. Superlatives by the bushel may be funny, but they also substitute for concrete answers. It may seem like a word salad or stream of consciousness at first glance, but it is a salad he tosses up over and over again, each time avoiding close scrutiny.

An article on February 22, 2016, in the left leaning MotherJones stated that Mr Trump had already contradicted his previous approval of the "mandate,"

Trump has now made clear that he doesn't like the individual mandate after all—he just misspoke when he said that to Anderson Cooper a few days ago.

So while Mr Trump has drawn attention to his position on the mandate, that position seems hopelessly incoherent, or as Ms Rubin called it, "word salad."

More "Gibberish"

The Minnesota Post article also noted,

When asked Thursday night under Rubio’s prodding to describe his plan for health care, he said, as he always does, that he wants to repeal the Affordable Care Act and replace it with something 'much better.' Then he says (and this is a direct quote from the debate transcript): 'I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it.' This is gibberish, especially the explanation that 'I think it’s a modern age,' which may have some meaning but I can’t imagine what.

In addition, in the most recent debate, Mr Trump did emphasize that he wanted insurance companies to be able to sell policies across state lines, although his wording was not so clear,

That weird and confusing phrasing — about 'getting rid of the lines around the states,' which Rubio mocked — as best as anyone can tell means that Trump wants national health insurers to be able to offer standardized plans all over the country, instead of having to meet the particular standards and requirements imposed by individual states. Different states require different things of health insurers, which prevents national firms from offering plans in all states.

As the article noted, this is not a new idea, and how much difference this change would make is not clear. Nonetheless, even after being badgered repeatedly, Mr Trump could not add more substance to his health care plan, nor explain how he might get more substance.

With Rubio pressing in and badgering Trump from the sidelines — the same way Rubio was badgered a few weeks ago by Chris Christie and the way Trump often badgers other candidates — and with CNN’s Dana Bash following up, Trump said his three things: Repeal Obamacare and replace it with something much better, get rid of the lines around the states, and don’t let people die in streets. I always assumed that there was more to his plan, but I never came across the details. And, during the exchange Thursday night, it came out that there is no more. Here’s that chunk of the transcript so you can decide for yourself if I’m missing something. (I’ve done a tiny bit of editing for flow.)[italics added for emphasis- Ed]

BASH: Mr. Trump, Senator Rubio just said that you support the individual mandate. Would you respond?

TRUMP: I just want to say, I agree with that 100 percent, except pre-existing conditions, I would absolutely get rid of Obamacare. We’re going to have something much better, but pre-existing conditions, when I’m referring to that, and I was referring to that very strongly on the show with Anderson Cooper, I want to keep pre-existing conditions. I think we need it. I think it’s a modern age. And I think we have to have it. (APPLAUSE)

BASH: OK, so let’s talk about pre-existing conditions. What the insurance companies say is that the only way that they can cover people [who have pre-existing conditions and would be more expensive to cover] is to have a mandate requiring everybody purchase health insurance. Are they wrong?

TRUMP: I think they’re wrong 100 percent. What we need — look, the insurance companies take care of the politicians. The insurance companies get what they want. We should have gotten rid of the lines around each state so we can have real competition. We thought that was gone, we thought those lines were going to be gone, so something happened at the last moment where Obamacare got approved, and all of that was thrown out the window.

The reason is some of the people in the audience are insurance people and insurance lobbyists and special interests. They got — I’m not going to point to these gentlemen, of course, they’re part of the problem, other than Ben [Carson], in all fairness. And, actually, the governor [John Kasich], too. Let’s just talk about these two, OK? Because I don’t think the governor had too much to do with this.

But, we should have gotten rid of the borders, we should have gotten rid of the lines around the states so there’s great competition. The insurance companies are making a fortune on every single thing they do. I’m self-funding my campaign. I’m the only one in either party self-funding my campaign. I’m going to do what’s right. We have to get rid of the lines around the states so that there’s serious, serious competition. And you’re going to see — excuse me. You’re going to see pre-existing conditions and everything else be part of it, but the price will be down, and the insurance companies can pay. Right now they’re making a fortune. (APPLAUSE)

BASH: But just to be specific here, what you’re saying is getting rid of the barriers between states, that is going to solve the problem...

TRUMP: That’s going to solve the problem. And the insurance companies are going to say that they want to keep it. They want to say — they say whatever they have to say to keep it the way it is. I know the insurance companies, they’re friends of mine. The top guys, they’re friends of mine. I shouldn’t tell you guys, you’ll say it’s terrible, I have a conflict of interest. They’re friends of mine, there’s some right in the audience. One of them was just waving to me, he was laughing and smiling. He’s not laughing so much anymore. Hi.
Look, the insurance companies are making an absolute fortune. Yes, they will keep pre-existing conditions, and that would be a great thing. Get rid of Obamacare, we’ll come up with new plans. But we should keep pre-existing conditions.

RUBIO: Dana, I was mentioned in his response, so if I may about the insurance companies...

BASH: Go ahead.

RUBIO: You may not be aware of this, Donald, because you don’t follow this stuff very closely, but here’s what happened. When they passed Obamacare they put a bailout fund in Obamacare. All these lobbyists you keep talking about, they put a bailout fund in the law that would allow public money to be used, taxpayer money, to bail out companies when they lost money. And we led the effort and wiped out that bailout fund. The insurance companies are not in favor of me, they hate that. They’re suing right now to get that bailout money put back in.

Here’s what you didn’t hear in that answer, and this is important, guys, this is an important thing. What is your plan? I understand the lines around the state, whatever that means. This is not a game where you draw maps...

TRUMP:...And you don’t know what it means?

RUBIO: What is your plan, Mr. Trump? What is your plan on health care?

TRUMP: You don’t know. The biggest problem...

RUBIO: ...What’s your plan?

TRUMP: ... You know, I watched him melt down two weeks ago with Chris Christie. I got to tell you, the biggest problem he’s got is he really doesn’t know about the lines. The biggest thing we’ve got, and the reason we’ve got no competition, is because we have lines around the state, and you have essentially....

RUBIO: ...You already mentioned that [inaudible] plan. I know what that is, but what else is part of your plan?...

TRUMP: ...You don’t know much...

RUBIO: ...So, you’re only thing is to get rid of the lines around the states. What else is part of your health-care plan?...

TRUMP: ...The lines around the states...

RUBIO: ...That’s your only plan...

TRUMP ... Excuse me. Excuse me.

RUBIO: ... His plan. That was the plan?...

TRUMP:...You get rid of the lines, it brings in competition. So, instead of having one insurance company taking care of New York or Texas, you’ll have many. They’ll compete, and it’ll be a beautiful thing.

RUBIO: Alright...So that’s the only part of the plan? Just the lines?

TRUMP: The nice part of the plan — you’ll have many different plans. You’ll have competition, you’ll have so many different plans.

RUBIO: Now he’s repeating himself.

TRUMP: No, no, no. I watched him repeat himself five times four weeks ago...

RUBIO:... I just watched you repeat yourself five times five seconds ago...

TRUMP: I watched him meltdown on the stage like that, I’ve never seen it in anybody...

BASH:...Let’s stay focused on the subject...

TRUMP:...I thought he came out of the swimming pool...

RUBIO:...I see him repeat himself every night, he says five things: Everyone’s dumb, he’s gonna make America great again...We’re going to win, win win. He’s winning in the polls...And the lines around the state. (APPLAUSE)

BASH: Senator Rubio, you will have time to respond if you would just let Mr. Trump respond to what you’ve just posed to him...

RUBIO: ... Yeah, he’s going to give us his plan now, right? OK...

BASH [to Trump]:...If you could talk a little bit more about your plan. I know you talked about...Can you be a little specific?...

TRUMP: ... We’re going to have many different plans because... competition...

RUBIO: ... He’s done it again.

TRUMP: There is going to be competition among all of the states, and the insurance companies. They’re going to have many, many different plans.

BASH: Is there anything else you would like to add to that...

TRUMP: No, there’s nothing to add. What is to add?

After being repeatedly asked about the substance of his health care policy agenda, Mr Trump only seems to have repeated the notion of selling health insurance across state lines to increase competition, interrupted by non sequiturs insulting Senator Rubio and insurance executives.  The Minnesota Post writer and I could find absolutely no other content in Mr Trump's , despite repeated inquiries about the substance of his health care plan.

It does seem reasonable to describe Mr Trump's health care policy ideas as gibberish.

Summary 

Health care and public health affect all Americans, and all people around the world.  Health care in the US is more expensive and less accessible than it is in many other developed countries.  For all the money the country spends, there is no clear evidence that the quality of patient care, or patients' outcomes are better than, or sometimes even comparable to those of other countries  The reforms embodied in the Affordable Care Act (ACA, PPACA, "Obamacare') have increased the proportion of insured patients, but insurance remains expensive for many, and insurance coverage now often has major gaps that mean a major illness can bankrupt a middle-class patient.

Furthermore, the law has done nothing to reduce concentration of power in health care.  It has done nothing to make health care leaders more accountable, especially for their organization's unethical or even criminal behavior, decrease their ability to line their pockets regardless of such behavior, and thus reduce their impunity.  It will not obviously decrease conflicts of interest affecting those who make decisions about patient care or health policy, lock the revolving door between government and the health care industry, end manipulation of clinical research to serve vested interests, or suppression of research whose results offend such interests, etc, etc.

So health care policy is increasingly important, and increasingly demands serious discussion.  A US presidential campaign ought to provide some impetus for such discussion, although health care policy is certainly not the only thing that needs to be discussed.

Most presidential candidates have at least attempted a serious discussion of health policy, if not in person, then in position papers or on their web-sites.

However, the currently leading candidate for the Republican nomination does not seem to have serious ideas about health care. Yet he has said "We’re going to come up with a great healthcare plan."  To substantiate such claims, he has repeated a few vague talking points, and when challenged, seems unable to manage any substantive conversation beyond them.  Some of his verbal pronouncements have been nothing short of ridiculous.  

"in the big lie there is always a certain force of credibility...." said a 20th century world leader who inspired adulation, and led to disaster.  

We live in perilous times when a candidate with such reckless approaches to critical problems continues to attract adulation.

ADDENDUM (29 February, 2016) - This post was republished on the Naked Capitalism blog on February 28, 2016.  

ADDENDUM (1 March, 2016) - This post was republished on OpEdNews on February 29, 2016.

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

adverse effects deception Fresenius health care prices impunity legal settlements Merck Pfizer Vioxx You heard it here first

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

Unknown 2/21/2016 Komentar

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. 

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