Pfizer's 13th Legal Settlement - Will it be Enough to End the Impunity?

It has been almost two months since we lasted noted misbehavior by giant global pharmaceutical firm Pfizer Inc. With little fanfare, however, a few small news items noted the corporation's latest legal settlements.

Deceptive Marketing of Protonix

The first settlement merited only a few paragraphs from Reuters.  The gist was:

Pfizer Inc will pay $55 million plus interest to settle charges that Wyeth promoted its acid reflux drug Protonix for unapproved uses and made unproven claims about the medicine, the U.S. Department of Justice said on Wednesday. 

The infractions took place between February 2000 and June 2001, long before the world's largest drugmaker acquired Wyeth in 2009 for $68 billion.

A report in the examiner explained that Wyeth did not merely go beyond the label in promoting Protonix, it went beyond the evidence.

Wyeth allegedly promoted Protonix as the 'best PPI for nighttime heartburn' even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. 

Furthermore, the charges were that systemic efforts to mislead were sanctioned by top management:

 The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.

Finally, the government asserted that Wyeth corrupted physicians' continuing medical education in the process:

Finally, the government alleges that Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses. CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications.

According to the complaint, Wyeth spent millions of dollars providing 'unrestricted educational grants' to CME providers, and these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way. Nevertheless, the government alleges that one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of the drug. According to the complaint, the Protonix 'brand team' influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content. In addition, the government alleges that Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called 'branducation.'

So it seemed that the company put on quite an effort to promote what we have called elsewhere pseudo-evidence based medicine, yet, like many other legal settlements involving large health care organizations, this one involved no penalties of any type against the people within the organization who authorized, directed, or implemented the bad behavior. 

 Misleading Marketing of Zyvox, Lyrica 

Another settlement, for a few dollars less, got even less attention.  Fox Business news did report this:

 Pfizer Inc. (PFE) agreed to pay a combined $42.9 million to North Carolina and 32 other states in a settlement of allegations that the drug maker used unfair and deceptive practices in the marketing of antibiotic Zyvox and nerve-pain medicine Lyrica.

I could find no detail about the sorts of deception allegedly involved in the news media.  What little more Fox provided did suggest that this case also involved pitching drugs in instances in which their use was unsupported by good evidence:

The states had alleged that Pfizer had marketed Zyvox as superior to another antibiotic in fighting certain types of infections, though there allegedly wasn't substantial evidence to support superior results for some uses that Pfizer claimed.

The states also alleged that Pfizer marketed Lyrica for some off-label, or unapproved, uses.

There was no hint that again any individual would suffer any negative consequences for this particular set of deceits either.

Avoiding Impunity as a Topic of Polite Discussion

We have discussed a seemingly endless parade of legal settlements by large health care organizations.  In almost none was there any consequence beyond a fine paid by the company, and sometimes a pledge that the company would thereafter behave better.  While these relatively small costs were diffused throughout the organizations, almost never did the people who authorized, directed, or implemented the bad behavior pay any price or suffer any penalty.  Thus we have opined again and again (e.g., most recently here) that these settlements have become just another cost of doing business, and have no power to deter future bad behavior.

In addition, we have noted not only have multiple organizations made such settlements, some organizations have settled again and again.  Yet even in the cases of these multiple organizational offenders, the individuals involved maintain their immunity from any negative consequences.  Thus these are examples of impunity.  

Transparency International declared 23 November, 2012, as the International Day to End Impunity, explained as follows:

At Transparency International we view impunity as getting away with bending the law, beating the system or escaping punishment. Impunity is anathema to the fight against corruption.

However, impunity is one of those concepts which never seems to be a subject of polite conversation in health care, or, as we say, it has become anechoic.  

Therefore, it is fascinating that while these two Pfizer settlements were announced almost simultaneously, each was discussed, such as it was, as if it occurred in a vacuum.  Moreover, it also seems that each settlement was crafted by law enforcers without any attention to the record of the company making the settlement.  Thus, any implications about impunity were avoided.

Pfizer's Multiple Ethical Opfenses

In fact, during the time we have been posting on Health Care Renewal, Pfizer has become one of the great repeat ethical offenders in the health care arena.  Its track record since the beginning of the 21st century, (with yello colored background below, compiled from this post), is remarkable.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,

October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post). Finally, in August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post). 

By my count, the two current settlements would be numbers twelve and thirteen.  Of course, while I believe this list is accurate, it may be incomplete.

Since none of these posts involved any negative consequences for any individuals who authorized, directed, or implemented the bad behavior, or who profited from it, and none involved any changed in the leadership or organization of the company, this becomes an amazing record of the impunity of Pfizer leadership over time and space. 

Will Impunity Finally Lead to Outrage?

Impunity, though, is a concept that is beginning to command some attention.

The Brasilia Declaration which was published at the conclusion of the 15th International Anti-Corruption Conference (hosted by Transparency International) included:

it is clear we all face a common challenge in our work: impunity for those who abuse positions of power. 

If impunity is not stopped, we risk the dissolution of the very fabric of society and the rule of law, our trust in our politics and our hope for social justice.

Activists, businesspeople, politicians, public officials, journalists, academics, youth and citizens who gathered in Brasilia to discuss the threat of corruption made it clear that impunity undermines integrity everywhere.

Whether we are investing collective efforts and resources in fighting poverty, human rights violations, climate change or bailing out indebted economies, we need to give the people a reason to believe that impunity will be stopped.

While the two latest Pfizer settlements barely got media coverage, maybe a $1.9 billion dollar settlement in the US by international banking giant will get more attention.  The charges in this case were not merely deceiving some doctors and patients about drug efficacy and safety.  The company was accused of aiding money laundering by drug cartels, and facilitating rogue regimes get around international sanctions.  As the New York Times reported,

State and federal authorities decided against indicting HSBC in a money-laundering case over concerns that criminal charges could jeopardize one of the world’s largest banks and ultimately destabilize the global financial system.

Instead, HSBC announced on Tuesday that it had agreed to a record $1.92 billion settlement with authorities. The bank, which is based in Britain, faces accusations that it transferred billions of dollars for nations like Iran and enabled Mexican drug cartels to move money illegally through its American subsidiaries.

Unlike Pfizer's slow-motion impunity, this example got attention.  The Los Angeles Times noted,

The massive penalty still was not enough to appease some critics. No bank executives were charged as part of the investigation, leading some analysts to question the government's willingness to hold powerful Wall Street firms accountable.

'It's mind-boggling how they think you can have a financial system and allow this kind of impunity,' said William Black, a former banking regulator who aided federal prosecutors during the savings and loan crisis of the 1980s and 1990s. HSBC 'put the world at enormous risk.'

A NY Times editorial opened,

It is a dark day for the rule of law.   Federal and state authorities have not to indict HSBC, the London-based bank, on charges of vast and prolonged money laundering, for fear that criminal prosecution would topple the bank and, in the process, endanger the financial system.  They have also not charged any top HSBC banker in the case, though it boggles the mind that a bank could launder money as HSBC did without anyone in a position of authority making culpable decisions.

Clearly, the government has bought into the notion that too big to fail is too big to jail.  When prosecutors choose not to prosecute to the full extent of the law in a case as egregious as this, the law itself is diminished.  The deterrence that comes from the threat of criminal prosecution is weakened, if not lost.

So maybe this huge financial case will prove to be the straw that breaks impunity's back.  So I will close by quoting the end of the Brasilia Declaration, in the hope that a few people will take it to heart in the context of health care, as well as in finance.

To take this important struggle forward the international anti-corruption community should promote greater people engagement and find ways to provide greater security for anti-corruption activists.

Reducing impunity also requires independent and well-resourced judiciaries that are accountable to the people they serve.

We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable.

We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk.

It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: We are watching those who act with impunity and we will not let them get away with it.

Global Fund Will Not Suppress Discussion of Health Care Corruption

Some good news to discuss, for a change....

We previously discussed losses from corruption reported by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and by the Health Alliance International here.  At the time, we noted that some experts in health care corruption praised the Global Fund for being transparent about the effects of corruption.

However, last week there was concern that some elements within the Global Fund thought that the best response to losses due to corruption would be hiding them.  As reported by the AP (via CBS): 

A global health fund championed by celebrities and world leaders is considering scaling back its groundbreaking philosophy of full transparency about how it spends billions of dollars in health care in poor countries. Its decision could have broad consequences for the ways international aid groups operate.

Revelations this year by The Associated Press about misspent funds and corruption among recipients of the money — and the donor backlash that has followed — have prompted leaders of the Global Fund to Fight AIDS, Tuberculosis and Malaria to propose scaling back on the investigations that uncovered the problems, and revealing less about them to donors and the public.

But hardly everyone within Fund leadership wanted to abandon transparency:

The Global Fund's internal watchdog fiercely opposes the proposed changes. In its latest progress report, obtained by the AP, Inspector General John Parsons warns the board that a move toward less transparency 'could be interpreted negatively and as a purposeful effort to suppress material information.'

Also,

The president of the board, Ethiopian Health Minister Tedros Adhanom Ghebreyesus, opposes any changes.


'Even the mere appearance of suppression of information is unacceptable. Scaling back, or the perception that we are retreating from, this commitment is something we simply cannot allow,' Tedros said. If anything, he added, 'we should increase our level of transparency.'

Now, it looks like the transparency advocates won, at least in part. As again reported by the AP (via CBS):

A multibillion-dollar fund that fights three killer diseases said Friday that it will make public more detailed information about money it has lost to corruption and mismanagement, but won't release other information critics have sought.

The board of the $22 billion Global Fund to Fight AIDS, Tuberculosis and Malaria met this week to address a backlash among major donors over revelations by The Associated Press that the fund's internal watchdog was turning up losses of tens of millions of dollars of grant money.

Board members decided to publish detailed accounting of losses and money recovered, the fund said, in an effort to distinguish between fraud and other problems such as poor accounting.

However,

The fund will not, however, provide other details from internal investigations and audits that might have made it possible to calculate how much of the money investigated is lost to corruption, or what percentage of the fund's overall disbursements are misspent.

Also,

The fund also is not making public an internal chart obtained by AP showing that in 12 nations where internal audits and investigations reviewed almost $576 million in spending, an average of 8 percent was lost to fraud, undocumented or unauthorized spending.

Still, it is very good news that transparency won out in this case. Maybe the Global Fund leaders' decision will encourage more discussion of the severity of global health care corruption and its negative effects.

On the other hand, it is bad news that even discussion of health care corruption remains controversial. In 2006, Transparency International's Global Corruption Report asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  As we summarized here, the report discussed the scale and diversity of health care corruption, and the severity of its adverse effects.  Yet the very subject of global health care corruption remains as anechoic as many of the specific topics we discuss on Health Care Renewal.

Also, as we have noted before, recently here, there are very few if any meetings about global health care corruption, very few courses on it in medical or public health schools, no institutions specifically designed to address it, and no programs at the foundations and NGOs which are losing money to global health corruption to combat it.  Similarly, there are few efforts to promote accountability, integrity, transparency, honesty, and ethics in health care (aside from this blog and a few other similarly informal initiatives.) 

What is wrong with that picture?

We hope that the willingness of the Global Fund to discuss and admit it has a problem with health care corruption will make health care corruption a little less anechoic, and lead us closer to concrete steps to address it.

PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.

[Posted on Health Care Renewal by Roy M. Poses MD]

Finally, Some Upcoming Events to Announce: PharmedOut Conference, Transparency International Summer Course

In our side-bar to the right we have a section for "Upcoming Meetings and Events."  Sadly, it is often empty.  Perhaps as a result of the anechoic effect, there seem to be few talks, workshops, much less symposia, conferences, and courses on the issues we discuss on Health Care Renewal. 

However, I am happy to now note two upcoming events of interest.

First, and most directly related, is the 2011 PharmedOut.org conference, entitled, "Pharma Knows Best? -Managing Medical Knowledge," on 16-17 June, 2011 at Georgetown University in Washington, DC, USA.  PharmedOut.org is dedicated to addressing how pharmaceutical companies seek to influence medical decision making. 
 
My editorial comment is that pharmaceutical companies, and also biotechnology, device, health care information technology, and health insurance companies spend billions on marketing to try to influence health care professionals and patients to use their products just here in the US, and probably hundreds of millions on public relations to try to influence policy-makers in favor of their interests.  The amounts spent to educate health care professionals and the public about these efforts, and particularly about deceptive marketing and PR, stealth marketing and stealth advocacy campaigns, etc, is minuscule by comparison.  PharmedOut.org is one of the few organizations trying to address the hype and spin.
 
Second is the Transparency International Summer School on Integrity, to be held in Vilnius, Lithuania, on 11-15 July, to provide "intensive anti-corruption training for future leaders."  Unfortunately for the rest of us, enrollment appears to be restricted to "students, graduates, and young professionals" from the post-communist countries. 
 
My editorial comment is that despite the prevalence and importance of health care corruption, as documented by the 2006 Transparency International Global Corruption report which focused on health care, and of the importance of conflicts of interest as risk factors for corruption, there are very few opportunities to teach and learn about these issues anywhere in the world.  (As I once noted, I could only find a single course on health care corruption and related issues in any US university.)  Transparency International has a record of efforts made to directly fight corruption, and to teach about related issues.  Would that such courses be available all over the world.

Fighting Corruption in Health Care - Suggestions from Transparency International

The August issue of the Journal of Epidemiology and Community Health featured a number of articles on conflicts of interest (COI) and medical and public health education and research. One notable contribution included authors from the German chapter of Transparency International (Spelsberg A, Martiny A, Schoenhoefer PS. Is disclosure of potential conflicts of interest in medicine and public health sufficient to increase transparency and decrease corruption. J Epidemiol Community Health 2009; 63: 603-605. Link here, requires subscription.) Transparency International is a major international NGO respected for its stand against corruption, and for transparency and integrity.

The article's major premises deserve quotation:

When Transparency International was founded in 1993, the focus for fighting corruption was mainly on bribes and corruption of civil servants in developing countries. While our definition of corruption was broad from the beginning, that is abuse of power or of a powerful position for personal advantage or benefit, the concept of preventing corruption had to be adjusted more recently.

conflicts between private and professionally consigned interests—be it in public office or in the private sector—create susceptibility to corruption....

Conflicts of interests are now considered as a major gateway for corruption in medicine and public health.They predominantly affect the way that doctors evaluate and use the products of the pharmaceutical and medical device industry by a systematic and ubiquitous exposure during professional life, starting at medical school.

Independent clinical research which can produce reliable results on new drugs or new medical technology has almost vanished and has been progressively replaced by industry-sponsored studies which are dominated by marketing interest of the manufacturers, including misleading selection or extensive falsification of data and results. Consequently, evidence-based guidelines or practice guidance often can no longer be assumed to be unbiased and free of conflicts of interests. Meta-analyses are at risk of being seriously distorted, even after adjusting for publication bias, due to inaccessible, unpublished data on clinical trials or inappropriate, for example non-reproducible, inclusion of such data....

Nowadays, medical expert committees are obliged to disclose conflicts of interests. Nevertheless, rarely is any action taken to control or to exclude advisers or experts with conflicts of interest since the extensive ties to industry of panel members have become the norm. It is therefore illusory to expect that disclosure alone without sanctions will be sufficient to increase transparency and decrease corruption in medicine and public health. Even if adequate sanctions follow, individual professional behaviour may not suffice for reversing the detrimental dependency of the medical and scientific community on industry. By the same token, corporate responsibility endeavours of drug and medical device companies should not remain voluntary efforts without tangible sanctions.

Let me quote below their major recommendations, edited just a bit:

Individual level

Professional codes of conduct for physicians and other health professionals, individual drug and medical device companies, health maintenance organisations, sickness funds, research organisations, etc. The common denominator of such codices consists of the ban of offering/accepting any personal gifts, including food and travel.


Organisational level within the medical system

Codes of conduct for academic medical centres, medical associations, patient and consumer organisations, organisations of healthcare professionals and producers of pharmaceuticals and medical devices. Each institution or organisation in healthcare as well as each professional in these institutions or organisations should be obliged to make any payments, honoraria or other benefits by pharmaceutical or medical device companies transparent.

Public registry of all clinical trials and other research activities involving patients, including post-marketing and pharmacovigilance studies. Publication of all relevant outcomes and results including null results, adverse effects and stopping rules, administrated and monitored by an independent institution such as the National Institutes of Health. Full disclosure of funding agencies, companies and responsible data centres.

Education of healthcare professionals including continuous medical education must be disentangled from commercial interests. The healthcare professional organisations should integrate graduate and continuing medical education in their codes of conduct.

Political level

Drug and medical device approval legislation: necessary prerequisites for starting drug approval process should include a complete and consistent disclosure (including amount) of beneficiaries of involved institutions, experts and organisations.

Implementing an expert anti-corruption agency for health at the national level authorised to take legal action. This includes activities in prosecuting conflicts of interest among health professionals and their institution, since such conflicts often result in rising healthcare expenditures without benefit for the public.
Society level

Monitoring of influence of commercial interests on public health and outcomes of medical interventions: annual reports to the public on health indicators and international comparisons including healthcare expenditures, estimated losses due to corruption and fraud in healthcare and recaptured resources by anti-fraud and anti-corruption measures.

Health Care Renewal readers may find it a useful exercise to compare these recommendations with their local situation. As far as I can tell, here in the US, almost none of these recommendations now obtain. Going through the list:

Individual level - In the US, codes of conduct promulgated by most medical societies do not completely ban accepting gifts. Not all drug and device companies, health maintenance organizations, insurance companies (the equivalent of sickness funds here), and research organizations have visible codes of conduct, and those that exist do not completely ban accepting or giving gifts.

Organizational level - Not all academic medical centers, medical associations, patient and consumer organizations, organizations of health care professionals, and drug and device companies have visible codes of conduct, and those that exist hardly make all payments, honoraria and other benefits completely transparent.

- There is a clinical trials registry. I am not sure if it includes post-marketing and pharmacovigilance trials (readers may be able to help me here). I do not know of any independent institution that monitors in detail the publication of all study results.

- US education, including continuing education of health care professionals is considerably entangled with commercial interests. Codes of conduct relevant to the relationships among industry and education are weak.

Political level - Drug and device regulation does not require complete and consistent disclosure of payments to medical schools, medical centers, and other research organizations which implement relevant research.

- There is nothing resembling an expert anti-corruption agency for health at a national level. Nor do such agencies exist at the US state level.

Society level - There is no systematic ongoing monitoring of commercial influence on public health and outcomes of medical intervention. There are no national reports that cover fraud and corruption and health care.

So as best as I can tell, here in the US, we currently are following almost none of these recommendations.

Maybe in other countries things are a little better. It would be interesting to hear from readers around the globe about this.

As I have repeated again and again, I believe true US health care reform requires improved transparency, and mechanisms to improve integrity and ethics like those suggested by these Transparency International authors.