Princess Health and Phooled Again - More Settlements Suggesting Bad Behavior by Big Pharma/ Biotech. Princessiccia

Princess Health and Phooled Again - More Settlements Suggesting Bad Behavior by Big Pharma/ Biotech. Princessiccia

adulterated devices bribery Bristol-Myers-Squibb crime deception deferred prosecution agreement Genzyme intimidation legal settlements Pfizer Sanofi-Aventis

Gusty 11:09 Add Comment

Once again, here is a roundup of cases showing big multi-national pharmaceutical and biotechnology companies are up to their usual tricks.

Presented in alphabetical order...

Bristol-Myers Squibb Settles Charges of Bribery of Chinese Hospitals.

The best version of this I could find was in USA Today, in early October, 2015,

Pharmaceutical manufacturer Bristol-Myers Squibb has agreed to pay more than $14 million in fines to settle charges that its joint venture in China paid cash and other benefits to state-owned hospitals in exchange for prescription sales, the Securities and Exchange Commission announced Monday.

After its investigation, the SEC found that the New York-based company violated the Foreign Corrupt Practices Act in its dealings with Chinese hospitals and doctors and 'reaped more than $11 million in profits from its misconduct.'

Bristol-Myers Squibb neither admitted nor denied the findings, the SEC said.

The details, such as they were:

Chinese sales representatives at BMS China, the Chinese joint venture that is majority-owned by Bristol-Myers, paid bribes � including cash, jewelry, meals, travel, entertainment, sponsorships and other gifts � to health care providers between 2009 and 2014 to generate more sales. And Bristol-Myers Squibb 'failed to respond effectively to red flags' indicating such practices, the SEC said.

Apparently, some lower level Chinese employees were fired, although it is not clear whether they were involved in bribery, or in whistle-blowing about it, but top company management did not look too hard to see who might have authorized or directed the bad behavior,

Several BMS China employees who were fired by the company made claims that faked invoices, receipts and purchase orders were widely used to bribe health care providers. But Bristol-Myers Squibb did not investigate their claims, the SEC said.

Bristol-Myers Squibb was aware of improper payments as early as 2009, when an internal audit highlighted the problem. But the company was 'slow to remediate gaps in internal controls' over dealing with Chinese health care providers and monitor payments to them, the SEC said.

Needless to say, no one who might have authorized or directed the bad behavior, and who conceivably might have personally gotten bigger bonuses based on the revenue it brought it, suffered any negative consequences. Despite the settlement, of charges of bribery, no less, company public relations produced the usual,

We have resolved this matter with the United States Securities and Exchange Commission, and are committed to the highest standards of business integrity, vigilance and ethics across our organization.

Well then, that clears it up.

I cannot find any information about what BMS allegedly bribed the hospitals to do, and hence can draw no conclusions whether patients may have been harmed by receiving inappropriate medications.

UK Judge Found Pfizer Threatened Health Professionals

The most thorough coverage of this was, amazingly, in a medical journal, namely the British Medical Journal (Kmietowicz A. Pfizer loses UK patent for blockbuster pain drug after threats to doctors.  Brit Med J 2015; 351: h4918.  Link here.)  The background was,

The patent for the use of Lyrica for epilepsy and generalised anxiety disorder expired in July 2014, and manufacturers of generic versions already have licences for these two indications. But the manufacturer, Warner-Lambert (a subsidiary of Pfizer), holds a 'second medical use' patent for the use of pregabalin to treat peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound.

Lyrica is one of Pfizer�s most successful products, with global sales in 2013 of some $4.6bn (�3bn; �4.1bn).

So apparently Pfizer set out to scare physicians away from prescribing generic pregabalin [generic Lyrica].

In his 174 page ruling Mr Justice Arnold said, 'Since late September 2014, Pfizer has taken extensive steps to try to ensure that generic pregabalin is neither prescribed nor dispensed for the treatment of pain.' This included sending a letter to the BMA and pharmacists stating that doctors and pharmacists risked infringing the patent if they supplied generic pregabalin for the pain indication and that this would be an unlawful act.

A letter sent to clinical commissioning groups in December 2014 was described by Arnold as 'calculated to have a chilling effect on the sales of Lecaent [the version of pregabalin made by Actavis].'

These letters would be seen by the recipients as a threat, said Mr Justice Arnold.

The Justice ultimately "overturned Pfizer's UK patent for pregabalin for pain control," in part because the "company made 'groundless claims' that its patent for Lyrica would be infringed if doctors did not specify Lyrica as opposed to a generic alternative when prescribing...."

This case was apparently only about the patent (and is subject to appeal), so it appears no one who apparently tried to authorize, direct or implement apparent intimidation of health care professionals with "groundless threats" will suffer any negative consequences.

This case does not seem to involve any obvious harms to patients.  However, "groundless threats" to health care professionals could have obviously demoralized them and clearly challenged their autonomy and professional values.

Sanofi Again Settles Charges of Misbranding Seprafilm

We discussed the first civil settlement the company made of this case in 2014 here.  A relatively clear summary of the new settlement was given by Reuters in September, 2015.

Genzyme Corp agreed to pay $32.59 million, admit wrongdoing and enter a deferred prosecution agreement to resolve U.S. criminal charges over its marketing of the surgical implant Seprafilm, the Department of Justice said on Thursday.

The biotechnology unit of French drug company Sanofi SA (SASY.PA) was accused of two misdemeanor counts of violating the federal Food, Drug and Cosmetic Act from 2005 to 2010 by allowing Seprafilm to be adulterated and misbranded while being sold. Sanofi bought Genzyme in 2011.

Seprafilm is a clear film used to reduce abnormal internal scarring that can cause organs and tissues to stick together following pelvic and abdominal surgeries known as laparotomies.

But the Justice Department said some sales representatives taught surgeons how to turn Seprafilm into a 'slurry' for use in increasingly popular laparoscopic surgery, even though U.S. regulators had never approved the film for that use.

According to papers filed with the federal court in Tampa, Florida, Genzyme admitted and accepted responsibility for the facts underlying the two criminal counts.

The two-year deferred prosecution agreement calls for improved oversight, and steps to halt Seprafilm sales for off-label uses. If Genzyme complies, the government will dismiss the charges.

Note that at least in this case, there was some admission by the company of the truth of the facts charged, and no protestation that "we adhere to the highest standards of integrity," or some such.

It seems possible that the use of the Seprafilm slurry in patients without clear evidence of its safety or effectiveness may have lead to patient harms, but I cannot find clear discussion of this.

Summary

So while big health care corporations, especially large drug and biotechnology companies, are always protesting how their main goal is to benefit patients, and how they support health care professionals, here are more cases in which it appears they at best set out to manipulate patients and health care professionals to maximize revenue.

Note that this is hardly the first time any of these companies have apparently misbehaved.  See our previous posts on BMS, on Genzyme (now a Sanofi subsidiary), and on Pfizer.  Note that our last discussion of the ever troubled Pfizer was only one month ago.

We have discussed endlessly how the march of legal settlements and other legal rulings affecting big health care corporations has raised questions about whether they are in it for patients and health care professionals, or just for the money.  That almost none of these legal actions has resulted in any real consequences for the individuals within the corporations who profited most from the misbehavior has allowed health care corporate managers' continued impunity, and has suggested how cozy health care corporate managers and goverment regulators and law enforcement officials have become, partially through the mechanism of the revolving door.

While these latest three cases have appeared, the mainstream media have begun to feature more discussion about how widespread managerial and corporate misbehavior is fueling the decline of the global economy, and perhaps of global society.  For example, as discussed in srticles in The Guardian, and more recently in the New York Times, Nobel Prize winners Robert Shiller and George Akerlof's new book, Phishing for Pfools: The Economics of Manipulation and Deception, suggests that widespread bad behavior in supposedly "free," and mainly unregulated markets can cause all sorts of evil.  In the Guardian, Shiller used the examples of how

 Most of us have suffered 'phishing': unwanted emails and phone calls designed to defraud us.  A 'phool' is anyone who does not fully comprehend the ubiquity of fishing.  A phool sees isolated examples of phishing, but does not appreciate the extent of professionalism devoted to it, nor how deeply this professionalism affects lives.  Sadly, a lot of us have been phools - including Akerlof and me, which is why we wrote this book

As Shiller wrote in the NYT, while he is a "free market advocate,"

we both believe that standard economic theory is typically overenthusiastic about unregulated free markets. It usually ignores the fact that, given normal human weaknesses, an unregulated competitive economy will inevitably spawn an immense amount of manipulation and deception.

Shiller and Akerlof believe that various kinds of manipulation and deception are enabled by technological advances, and that they are contagious,

When you realize that your competitor has used sophisticated and effective marketing tricks, then you will fall behind if you don�t follow suit.

This is really not a new idea,

In 1918, Irving Fisher, the Yale economist, argued that what people maximize in their actions is something that could better be described as 'wantability' rather than utility, for they are subject to temptation and mistakes in the vast array of purchases they make, leading profit-maximizing marketers to take advantage of them on a systematic basis.

In the first half of the 20th century, such critiques were of general interest. But they are little discussed today.

In the Guardian, Shiller warned that failure to address this problem in the financial sector could lead to "a new Dark Age." I fear that we are already close to a dark age for health care.

Similarly, in the Wall Street Journal, of all places, Charles Moore, the authorized biographer of Margaret Thatcher, and former editor of the conservative UK Daily Telegraph, wrote:

The relationship between money and morality, on which the middle-class order depends, has been seriously compromised over the past decade.  Which means that the mass bourgeoisie (a phrase that Marx and Engles would have thought a contradiction in terms) start to feel like the new proletariat.

Furthermore,

To the extent that people cheat in markets, they are not real markets, any more than antifreeze labeled 'wine' is real wine.  Too many advocates of markets have allowed themselves to be suborned into becoming apologists for business.  And too many businesses now operate as if their responsibilities are only to themselves and not to consumers.

See the above examples, and all we have written about bribery, kick-backs, fraud, other crime, and corruption to show how prevalent cheating is in health care.

Shiller concluded,

Marx did have an insight about the disproportionate power of the ownership of capital. The owner of capital decides where money goes, whereas the people who sell only their labor lack that power. This makes it hard for society to be shaped in their interests. In recent years, that disproportion has reached destructive levels, so if we don�t want to be a Marxist society, we need to put it right.

I would add that if we do not put these things right in health care, ending up with a Marxist system will be the least of our worries.

So as a start, to quote Shiller, we need more

heroic effortsw of campaigners for better values, both among private organizations and advocates of government regulation

Who will step up?

Our musical diversion, "Won't Get Fooled Again," the Who, 1978 live version:

Princess Health and How the Anechoic Effect Persists: The Case of the Continued Punishment of Dr Elliott . Princessiccia

Princess Health and How the Anechoic Effect Persists: The Case of the Continued Punishment of Dr Elliott . Princessiccia

academic freedom adverse effects anechoic effect free speech intimidation manipulating clinical research mission-hostile management University of Minnesota

Gusty 13:02 Add Comment

We have frequently discussed the anechoic effect, how evidence and opinions that challenge the dysfunctional status quo in health care, and that might discomfit those in power in benefit from it, have few echoes.  One major reason for the anechoic effect is that people are afraid to speak up because thus disturbing the powers that be may have bad consequences for the speakers.   

A December 21, 2014 article in the Minneapolis Star-Tribune updated an ongoing example of how the leaders of health care may seek to silence their critics.  The article updated the career trajectory of Dr Carl Elliott, a psychiatrist physician and bioethicist at the University of Minnesota who dared challenge the university's handling of the untimely death of a patient in a university run clinical trial.

Background - the Dan Markingson Case

We first blogged about this case in 2011.  The case itself dates from 2003, and first got media attention in 2008.  A good quick summary appeared in the Center for Law and Bioscience blog out of the Stanford Law School. 

Dan Markingson � a vulnerable, psychotic young man � was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up).  A UMN [University of Minnesota]  doctor enrolled him in the study despite having just determined that Dan 'lack[ed] the capacity to make decisions regarding [his] treatment,' rendering it highly unlikely that Dan could have given valid informed consent to participate.  As Dan's mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial � at one point asking  'Do we have to wait until he kills himself or someone else before anyone does anything?'  But the UMN co-investigators in the drug study refused to terminate his participation.  Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.

Dr Elliott, an expert in bioethics who had concentrated on issues such as the effect of conflicts of interest and commercial influences on clinical research, started probing the death of Mr Markingson after the 2008 media reports.

Some of what Dr Elliott found appeared in a May 23, 2014 article in Science. He concluded that previous efforts to investigate the death of Mr Markingson were flawed.

 Elliott came to believe that every investigation�not only by FDA but also by the Minnesota Board of Medical Practice, the university's IRB, and its general counsel's office�had been flawed or incomplete. FDA did not seek Weiss's perspective, the views of Markingson's caseworker, or interview staff at the halfway house who had interacted with Markingson, for instance. (FDA would not comment on the Markingson case for this story.) Nor did the agency examine conflicts of interest. Weiss's lawsuit was dismissed not on its merits, but because the university's IRB and Board of Regents were deemed immune from liability thanks their role as state employees. (The judge did argue that informed consent was obtained appropriately, because Markingson had signed the consent form and had not been declared mentally incompetent by a court.)

Furthermore, he found reasons to think that the problems with the trial in which Mr Markingson died were not unique.  He and a colleague

heard from other individuals who insisted that they had been harmed in UMN psychiatric drug trials or had witnessed others' mistreatment. One man said he had worked in the psychiatric units of the hospital where Markingson was treated. Another identified herself as a counselor for teenagers. Elliott heard from parents, who said their son or daughter had enrolled in a study under pressure.

Thus, Dr Elliott and others concluded that the university should do a thorough investigation of the case,

In November 2010, eight faculty members, including Elliott and [McGill University bioethicist Leigh] Turner, wrote a letter to the university's Board of Regents, requesting an independent, university-commissioned investigation into the Markingson case.

The Punishment of a Dissident

As the Science article noted, former Minnesota Governor Arne Carlson said that the

university hired Elliott because it 'found him to be one of America's most outstanding bioethicists. The moment he comes up with something that is sensitive to them, he becomes the village idiot.'

In fact, as we noted in 2013, in a 2012 post in the Center for Law and Bioscience blog, not only did university officials rebuff the call for a new, thorough investigation of the untimely death of Mr Markingson, but the university general counsel, who had been operating at the heart of this case, appeared to threaten the leading bioethicist dissident, Dr Carl Elliott:

 After Carl Elliott, the University of Minnesota bioethicist, refused to drop the matter, [university chief counsel] Rotenberg asked the university�s Academic Freedom and Tenure Committee to take up the question of '[w]hat is the faculty[�s] collective role in addressing factually incorrect attacks on particular university faculty research activities?' � a question that appeared both to accuse Elliott of 'factually incorrect attacks' and to call for some unspecified action to 'address' them.  Other faculty, including the president of the Minnesota chapter of the American Association of University Professors, viewed this as an attempt to intimidate Elliott into silence.  If so, it backfired.  The story ended up in the press, putting the Markingson case back in the public eye and once again making the University of Minnesota look really bad.

The December 21, 2014 Star-Tribune article reported that university administrators seem to be out to get Dr Elliott once again. First, it interviewed the university's chair of psychiatry,

[Dr S Charles] Schulz, the department chair, says he can�t even bear to read Elliott�s published accounts anymore. 'It�s too painful,' he said.

Both he and Olson say that Elliott gives only one side of the story and that he ignores the facts that don�t support his case.

'I think [people] believe that because Carl Elliott is a professor of bioethics and a member of the Center for Bioethics, that he must be telling the truth,' said Olson. But 'he�s not pursuing this in an academic way. I don�t think it�s conduct that becomes a faculty member and a peer.'

What is not academic or unbecoming about investigating the death of a vulnerable psychiatric patient during a clinical trial is not clear. Then,

University officials have not been amused. They accuse Elliott of whipping up hysteria with 'false and unfounded' allegations, and undermining research efforts in the process. And while the university hasn�t tried to fire him, it has reprimanded him for 'unprofessional conduct,' a move that he�s now challenging under the tenure code.

Again, rather than investigating the death of Mr Markingson, or at least responding to specific allegations, university administrators have set about to punish their own distinguished faculty member who wondered why a vulnerable patient died during a university run clinical trial. 

Finally,

So far, academic freedom has protected Elliott�s job. But last winter, the university claims, he crossed a line. It accused him of using a 'fabricated letter' in a speech about the Markingson case at Hamline University and demanded that he issue a retraction.

The 2004 letter, addressed to Weiss, Markingson�s mother, appears to be from a university lawyer disputing her right to her son�s medical records. The U says it�s a forgery; Elliott says he doesn�t believe it, and he refused to issue a retraction. He called it an attempt to discredit Weiss, adding: 'I won�t be part of it.'

Elliott received a letter of reprimand in August from Dr. Brooks Jackson, the current dean of the Medical School, citing him for 'significant acts of unprofessional conduct.' The reprimand is on appeal.

The evidence that the letter was a forgery was not apparent.  Yet while they pursue their own faculty member for his investigation of Mr Markingson's death, university managers still apparently have not addressed the many problems in the university's version of the story of Mr Markingson's death, from the fragmentary nature of previous investigations to the problems just revealed in a Scientific American blog with the knowledge of an expert witness for the university in the lawsuit brought by Mr Markingson's mother against it.  

Summary

Dr Carl Elliott is a respected physician bioethicist who has uncovered problems with commercial contract research organizations doing human research (see our blog posts here and here), and has written a critically acclaimed book, White Coat, Black Hat (reviewed here by Dr Howard Brody on his blog.)  Yet his previous work counted for naught when he dared look into possibly unethical clinical research done at his own university.  As noted in the Star-Tribune article,

Within the U�s Center for Bioethics, where he has worked since 1997, he says the tension is so palpable that he dreads setting foot in his office. He does most of his work from coffee shops.

In my humble opinion, it appears that top university managers have put their personal interests ahead of the mission of their university, the role of their faculty members in upholding that mission, and even the welfare of patients who put their trust in the university's academic medical center.  The hard life that Dr Elliott has lead since he started to challenge his own university's administrators show how the anechoic effect is generated.  As long as leaders of academic medical institutions, and other health care organizations can put their own interests ahead of the mission, health care professionals and other academics who object are likely to have their lives made miserable, possibly lose their jobs, or worse.  How many will have both the courage, and the resources to stand up for what is right under such a threat.

True health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (30 December, 2014) - Post corrected.  Dr Elliott trained as a physician but is not a psychiatrist.

ADDENDUM (30 December, 2014) - also see comments on the 1BoringOldMan blog. 

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

free speech intimidation medical devices

Gusty 14:11 Add Comment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Princess Health and Secrecy and Censorship. Princessiccia

Princess Health and Secrecy and Censorship. Princessiccia

intimidation secrecy

Gusty 07:05 Add Comment

On June 6 I wrote a post entitled "Secrecy," and concluded "we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.It is time to end this secrecy. "
Since then, in the last 16 days, the following stories about secrecy have appeared on Health Care Renewal:

• Louis Sherwood, A top Merck executive, now retired was accused of trying to intimidate physicians and researchers who had publicly questioned the safety of Merck's Cox-2 inhibitor Vioxx, now withdrawn from the market, or whether data about Vioxx was being withheld. (See post here.)
• A Pfizer executive who had spoken out publicly in favor of drug re-importation charged that the company shut down his cell phone and email. (See post here.)
• After Guidant found out that one of its models of implantable cardiac defibrillators (ICDs) had a defect that may cause them to fail, it kept the flaws a secret until the company found out that the NY Times was writing an article about the problem. (See post here.) It similarly concealed flaws in two other models of ICDs. Finally, it shippped old ICDs with the inventory out of inventory without notifying their recipients that the company had started making improved version without the flaw. (See posts here and here.)
• CIGNA threatened a physician author with legal action because he published a satirical piece in a humor magazine. The threat was based on a provision in CIGNA's contract with the physician's hospital that forbade "disparaging" language. (See post here.)
• Kaiser-Permanente sued a former employee for revealing in a blog that the managed care organization had posted real patient data on a web-site being used to develop an electronic medical record. (See post here.)
• Eli Lilly filed one of its sales representatives after he published a book detailing his exploits prior to working for Lilly as a "slacker" sales representative for Pfizer. (See post here.)

These posts demonstrate that the urge to censor seems to be widespread in health care. The would-be censors noted above included pharmaceutical companies, a device company, a for-profit managed care organization, and a not-for-profit managed care organization. They sought to censor expression critical of their products and practices ranging from outcomes data, through academic and popular opinion, to satire. Their means of censorship ranged from simply keeping information to themselves, to threats, threats of law-suits, and law-suits filed.
These 16 days demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?

Princess Health and Secrecy and Censorship.Princessiccia

Princess Health and Secrecy and Censorship.Princessiccia

intimidation secrecy

Gusty 07:05 Add Comment

On June 6 I wrote a post entitled "Secrecy," and concluded "we should cultivate transparency and openness in health care. It is hard to conceive of legitimate reasons to keep hospitals' prices, contracts between medical schools and research sponsors, and contracts between doctors and managed care organizations secret. On the other hand, it is easy to think of how such secrecy could hide unethical business practices, and potentially even abuse of patients and corruption.It is time to end this secrecy. "
Since then, in the last 16 days, the following stories about secrecy have appeared on Health Care Renewal:

• Louis Sherwood, A top Merck executive, now retired was accused of trying to intimidate physicians and researchers who had publicly questioned the safety of Merck's Cox-2 inhibitor Vioxx, now withdrawn from the market, or whether data about Vioxx was being withheld. (See post here.)
• A Pfizer executive who had spoken out publicly in favor of drug re-importation charged that the company shut down his cell phone and email. (See post here.)
• After Guidant found out that one of its models of implantable cardiac defibrillators (ICDs) had a defect that may cause them to fail, it kept the flaws a secret until the company found out that the NY Times was writing an article about the problem. (See post here.) It similarly concealed flaws in two other models of ICDs. Finally, it shippped old ICDs with the inventory out of inventory without notifying their recipients that the company had started making improved version without the flaw. (See posts here and here.)
• CIGNA threatened a physician author with legal action because he published a satirical piece in a humor magazine. The threat was based on a provision in CIGNA's contract with the physician's hospital that forbade "disparaging" language. (See post here.)
• Kaiser-Permanente sued a former employee for revealing in a blog that the managed care organization had posted real patient data on a web-site being used to develop an electronic medical record. (See post here.)
• Eli Lilly filed one of its sales representatives after he published a book detailing his exploits prior to working for Lilly as a "slacker" sales representative for Pfizer. (See post here.)

These posts demonstrate that the urge to censor seems to be widespread in health care. The would-be censors noted above included pharmaceutical companies, a device company, a for-profit managed care organization, and a not-for-profit managed care organization. They sought to censor expression critical of their products and practices ranging from outcomes data, through academic and popular opinion, to satire. Their means of censorship ranged from simply keeping information to themselves, to threats, threats of law-suits, and law-suits filed.
These 16 days demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?

Princess Health and CIGNA Can't Take a Joke. Princessiccia

Princess Health and CIGNA Can't Take a Joke. Princessiccia

CIGNA confidentiality clause free speech health insurance intimidation

Gusty 12:50 Add Comment

The Associated Press reported (see the Washington Post version) that the Dr. Douglas Farrago, the physician who edits the humor magazine Placebo Journal was threatened with legal action for publishing a satirical piece on managed care. The parody was of a patient satisfaction survey, by the imaginary "SICKNA Healthcare" managed care organization, signed by "W. E. Sucque" from the "Medical Thievery and Health Policy Division."
After the piece was published, his employer, Sisters of Charity Health System, received a call from CIGNA Healthcare's lawyers demanding the Farrago "cease and desist." Apparently, CIGNA Healthcare's contract with the hospital system bars physicians from "any false or disparaging communications which could, or are likely to interfere with or otherwise damage any of CIGNA's existing or potential contractual relationships." CIGNA spokesperson Lindsay Shearer suggested that the complaint arose from offended CIGNA employees, "our employees work very hard to provide high quality service to our members, our clients, our providers. And when they see stuff like that it upset them."
Perhaps CIGNA really does have some employees who are easily offended. Perhaps they were educated at some of the insitutions of higher learning, so well documented by FIRE, where a slightly offensive remark is grounds for charges under the local "speech code." (See this link for examples.)
However, it was CIGNA's lawyers, not its line employees, who went after Dr. Farrago. So maybe the company's heavy-handed approach to suppressing free expression will generate more bad publicity for it than Farrago's parody could ever have done.
I agree with Farrago's take on this, "If my hospital, who has allowed me the freedom to be creative, gets bullied to fire me over this then it proves that HMOs are really running our health care system."
File this one under "intimidation and coercion," sub-category "attacks on free expression."

Princess Health and CIGNA Can't Take a Joke.Princessiccia

Princess Health and CIGNA Can't Take a Joke.Princessiccia

CIGNA confidentiality clause free speech health insurance intimidation

Gusty 12:50 Add Comment

The Associated Press reported (see the Washington Post version) that the Dr. Douglas Farrago, the physician who edits the humor magazine Placebo Journal was threatened with legal action for publishing a satirical piece on managed care. The parody was of a patient satisfaction survey, by the imaginary "SICKNA Healthcare" managed care organization, signed by "W. E. Sucque" from the "Medical Thievery and Health Policy Division."
After the piece was published, his employer, Sisters of Charity Health System, received a call from CIGNA Healthcare's lawyers demanding the Farrago "cease and desist." Apparently, CIGNA Healthcare's contract with the hospital system bars physicians from "any false or disparaging communications which could, or are likely to interfere with or otherwise damage any of CIGNA's existing or potential contractual relationships." CIGNA spokesperson Lindsay Shearer suggested that the complaint arose from offended CIGNA employees, "our employees work very hard to provide high quality service to our members, our clients, our providers. And when they see stuff like that it upset them."
Perhaps CIGNA really does have some employees who are easily offended. Perhaps they were educated at some of the insitutions of higher learning, so well documented by FIRE, where a slightly offensive remark is grounds for charges under the local "speech code." (See this link for examples.)
However, it was CIGNA's lawyers, not its line employees, who went after Dr. Farrago. So maybe the company's heavy-handed approach to suppressing free expression will generate more bad publicity for it than Farrago's parody could ever have done.
I agree with Farrago's take on this, "If my hospital, who has allowed me the freedom to be creative, gets bullied to fire me over this then it proves that HMOs are really running our health care system."
File this one under "intimidation and coercion," sub-category "attacks on free expression."

Princess Health and Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx. Princessiccia

Princess Health and Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx. Princessiccia

academic freedom free speech intimidation Merck Vioxx

Gusty 08:29 Add Comment

The Philadelphia Inquirer reported a series of allegations that a top Merck executive threatened and intimidated physicians who questioned the safety of its Cox-2 inhibitor drug Vioxx, now off the market.
Louis M. Sherwood, who retired as a Senior Vice President of Medical and Scientific Affairs for Merck, had been known as "the epitome of an upstanding guy, smart and well-respected." The Inquirer reported that "Sherwood earned accolades from both worlds [academia and industry]. At retirement in March 2002, he was given two lifetime achievement awards, one from industry physicians and one from medical-schol professors."
Nonetheless, evidence discovered in one of the cases against Merck revealed:

• Lee Simon, a former Harvard faculty member, after lecturing about the risks of Vioxx, said he was threatened by Sherwood: "he would hurt my career if I continued to lecture." Sherwood also charged that Simon was biased against Vioxx. However, the Inquirer reported that Simon's "boss at Harvard, Steven Weinberger, now a Vice-President at the American College of Physicians in Philadelphia, confirmed getting Sherwood's call but said it had 'nothing to do' with Simon's promotion." Weinberger stated, "Lou Sherwood was not at all threatening me." Yet, John Yates, Sherwood's successor at Merck, contacted Simon, and said, according to him, that Sherwood's behavior "would never happen again, that it was unnecessary, that it was not the behavior of Merck." [Note that Dr. Weinberger has appeared in Health Care Renewal posts in the past, here, here, and here, on the subject of declining interest in primary care, which he has suggested is due more to shortcomings in how medical schools promote the field to students and due to inadequate current "chronic care models" than to pressures faced by practicing physicians, including external threats to their core values.]
• M. Thomas Stillman, from the University of Minnesota Medical School, also questioned the safety of Vioxx. A Merck "sales executive" described him as a "vocal adversary of Merck and Vioxx" in an email. A memo documented that Sherwood had "complained to Stillman's boss." Yates also called Stillman to apologize.
• Gurkirpal Singh, from Stanford University, questioned whether data about Vioxx was being hidden. A memo by Sherwood described Singh as "perceived as an advocate for Searle," which was then the manufacturer of the competing drug, Celebrex. The Inquirer reported that Sherwood called Singh's supervisor, Professor James F. Fries, at home, labeled Singh "anti-Vioxx," suggested Singh would "flame out," and threatened Fries with "consequences for myself and for Stanford," according to Fries. Fries wrote Merck to complain, noting all the above cases and those of two other researchers. Fries then got a call from David Anstice, President of the Human Health-Americas division of Merck, saying that Sherwood's behavior was "not the norm," and promising to take action.

These are serious allegations, involving apparent efforts by a pharmaceutical company to stifle free speech and academic freedom to suppress unfavorable comments about the company's products. Such behaviors threaten core academic and scientific values. If physicians and researchers cannot openly discuss scientific findings, science will not advance. If they cannot openly discuss possible harms to patients, patients may be harmed.
Unfortunately, if these allegations are true, they will become just another entry in the sorry catalog of threats to free speech and academic freedom in medicine, (which may relate to the many threats to free speech and academic freedom in colleges and universities, such as those that have been documented by FIRE.)
Physicians and scientists must learn how to defend themselves against such threats, or science, and worse, patients will suffer.

Princess Health and Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx.Princessiccia

Princess Health and Allegations That Merck Threatened Researchers Who Expressed Doubts About Vioxx.Princessiccia

academic freedom free speech intimidation Merck Vioxx

Gusty 08:29 Add Comment

The Philadelphia Inquirer reported a series of allegations that a top Merck executive threatened and intimidated physicians who questioned the safety of its Cox-2 inhibitor drug Vioxx, now off the market.
Louis M. Sherwood, who retired as a Senior Vice President of Medical and Scientific Affairs for Merck, had been known as "the epitome of an upstanding guy, smart and well-respected." The Inquirer reported that "Sherwood earned accolades from both worlds [academia and industry]. At retirement in March 2002, he was given two lifetime achievement awards, one from industry physicians and one from medical-schol professors."
Nonetheless, evidence discovered in one of the cases against Merck revealed:

• Lee Simon, a former Harvard faculty member, after lecturing about the risks of Vioxx, said he was threatened by Sherwood: "he would hurt my career if I continued to lecture." Sherwood also charged that Simon was biased against Vioxx. However, the Inquirer reported that Simon's "boss at Harvard, Steven Weinberger, now a Vice-President at the American College of Physicians in Philadelphia, confirmed getting Sherwood's call but said it had 'nothing to do' with Simon's promotion." Weinberger stated, "Lou Sherwood was not at all threatening me." Yet, John Yates, Sherwood's successor at Merck, contacted Simon, and said, according to him, that Sherwood's behavior "would never happen again, that it was unnecessary, that it was not the behavior of Merck." [Note that Dr. Weinberger has appeared in Health Care Renewal posts in the past, here, here, and here, on the subject of declining interest in primary care, which he has suggested is due more to shortcomings in how medical schools promote the field to students and due to inadequate current "chronic care models" than to pressures faced by practicing physicians, including external threats to their core values.]
• M. Thomas Stillman, from the University of Minnesota Medical School, also questioned the safety of Vioxx. A Merck "sales executive" described him as a "vocal adversary of Merck and Vioxx" in an email. A memo documented that Sherwood had "complained to Stillman's boss." Yates also called Stillman to apologize.
• Gurkirpal Singh, from Stanford University, questioned whether data about Vioxx was being hidden. A memo by Sherwood described Singh as "perceived as an advocate for Searle," which was then the manufacturer of the competing drug, Celebrex. The Inquirer reported that Sherwood called Singh's supervisor, Professor James F. Fries, at home, labeled Singh "anti-Vioxx," suggested Singh would "flame out," and threatened Fries with "consequences for myself and for Stanford," according to Fries. Fries wrote Merck to complain, noting all the above cases and those of two other researchers. Fries then got a call from David Anstice, President of the Human Health-Americas division of Merck, saying that Sherwood's behavior was "not the norm," and promising to take action.

These are serious allegations, involving apparent efforts by a pharmaceutical company to stifle free speech and academic freedom to suppress unfavorable comments about the company's products. Such behaviors threaten core academic and scientific values. If physicians and researchers cannot openly discuss scientific findings, science will not advance. If they cannot openly discuss possible harms to patients, patients may be harmed.
Unfortunately, if these allegations are true, they will become just another entry in the sorry catalog of threats to free speech and academic freedom in medicine, (which may relate to the many threats to free speech and academic freedom in colleges and universities, such as those that have been documented by FIRE.)
Physicians and scientists must learn how to defend themselves against such threats, or science, and worse, patients will suffer.