With 10 Health Care Executives on it Board, US Chamber of Commerce Defends Big Tobacco Abroad

Tobacco, especially smoked in cigarettes, is generally recognized by health care professionals as having health hazards that greatly outweigh its benefits to society.  Therefore, most health care organizations discourage tobacco use, and many have developed tobacco free policies.

However, the tobacco industry has its powerful supporters.  A recent NY Times investigative report, and a report entitled "Blowing Smoke for Big Tobacco," documented how the US Chamber of Commerce has defended the interests of tobacco companies overseas.  The apparent paradox here is that the leadership of the US Chamber of Commerce includes leaders of large health care organizations.  So far this paradox has not been explained by the parties involved.

How the US Chamber of Commerce Promotes Tobacco Interests Abroad

The NY Times Articles

On June 30, 2015, the NY Times published a wide ranging report on the pro-tobacco activities of the US Chamber of Commerce,

From Ukraine to Uruguay, Moldova to the Philippines, the U.S. Chamber of Commerce and its foreign affiliates have become the hammer for the tobacco industry, engaging in a worldwide effort to fight antismoking laws of all kinds, according to interviews with government ministers, lobbyists, lawmakers and public health groups in Asia, Europe, Latin America and the United States.

The U.S. Chamber’s work in support of the tobacco industry in recent years has emerged as a priority at the same time the industry has faced one of the most serious threats in its history. A global treaty, negotiated through the World Health Organization, mandates anti-smoking measures and also seeks to curb the influence of the tobacco industry in policy making. The treaty, which took effect in 2005, has been ratified by 179 countries; holdouts include Cuba, Haiti and the United States.

Facing a wave of new legislation around the world, the tobacco lobby has turned for help to the U.S. Chamber of Commerce, with the weight of American business behind it. While the chamber’s global tobacco lobbying has been largely hidden from public view, its influence has been widely felt.

Letters, emails and other documents from foreign governments, the chamber’s affiliates and antismoking groups, which were reviewed by The New York Times, show how the chamber has embraced the challenge, undertaking a three-pronged strategy in its global campaign to advance the interests of the tobacco industry.

In the capitals of far-flung nations, the chamber lobbies alongside its foreign affiliates to beat back antismoking laws.

In trade forums, the chamber pits countries against one another. The Ukrainian prime minister, Arseniy Yatsenyuk, recently revealed that his country’s case against Australia was prompted by a complaint from the U.S. Chamber.

And in Washington, Thomas J. Donohue, the chief executive of the chamber, has personally taken part in lobbying to defend the ability of the tobacco industry to sue under future international treaties, notably the Trans-Pacific Partnership, a trade agreement being negotiated between the United States and several Pacific Rim nations.

'They represent the interests of the tobacco industry,' said Dr. Vera Luiza da Costa e Silva, the head of the Secretariat that oversees the W.H.O treaty,...

The NYT asked the Chamber of Commerce for a response, and got only

The U.S. Chamber issued brief statements in response to inquiries. 'The Chamber regularly reaches out to governments around the world to urge them to avoid measures that discriminate against particular companies or industries, undermine their trademarks or brands, or destroy their intellectual property,' the statement said, adding, 'we’ve worked with a broad array of business organizations at home and abroad to defend these principles.'

The chamber declined to say if it supported any measures to curb smoking.

"Blowing Smoke for Big Tobacco"

Two weeks after the first NY Times article, a group of nine organizations including Campaign for Tobacco Free Kids, Corporate Accountability International, and Public Citizen released a report on the US Chamber of Commerce pro-tobacco actions. A summary article in the Huffington Post written by representatives of the latter two organizations included,

Our report and a two-part New York Times investigation shows that, while the Chamber throws its weight around in many Global South countries to protect its corporate members' interests, Big Tobacco has also pushed it to adopt particularly aggressive and radical positions in order to undermine the cascade of public health laws being passed as a result of the success of the global tobacco treaty.

In particular,

For tobacco control advocates familiar with this deadly industry's tactics, the Chamber's work in this space comes as no surprise. Internal documents tell us that as the tobacco industry lost its public credibility, it began to use third parties to advocate on its behalf.

Case studies in our report, from Africa to Latin America, make it clear that Big Tobacco is doggedly pursuing this strategy with the U.S. Chamber and its affiliates in Global South countries. In countries the tobacco industry has targeted around the world, the Chamber is delivering threatening letters that cast doubt on the science behind tobacco control, exaggerating exaggerate the economic impacts repercussions of proven measures like tobacco taxation and crying wolf about explosions in illicit trade. In pursuing these actions, the Chamber and its AmCham affiliates are exporting well-documented tobacco industry tactics to block health laws around the globe.

And as the New York Times points out in its investigation, (and then advocates that countries resist in their recent editorial: Tarred by Tobacco), these tactics are in some cases drafted by Big Tobacco executives themselves.

Who Runs the US Chamber of Commerce?

A 2010 MotherJones article noted that the US Chamber of Commerce as having a "name that evokes Main Street and Little League teams," and its history of "taking a moderate, nonpartisan approach."  So who is responsible for the US Chamber of Commerce becoming a tobacco advocate, at least outside of the US?

First, the Chamber has become more the creature of the biggest corporations than small businesses.  The MotherJones article noted that recently

The Chamber's politics became synonymous with its biggest corporate donors.  [Chamber President Tom] Donohue established special accounts for companies that feared taking controversial public stands, allowing them to anonymously funnel money to the Chamber, which advocated on their behalf.

Furthermore,

The Chamber claims that 96 percent of its members are small businesses, yet its self-seleted board includes just 6 representatives from small businesses, 1 from a local chamber, and 111 from large corporations.

Among these large corporations, tobacco corporations seem to be particularly influential.  The NY Times article noted,

The increasing global advocacy highlights the chamber’s enduring ties to the tobacco industry, which in years past centered on American regulation of cigarettes. A top executive at the tobacco giant Altria Group serves on the chamber’s board. Philip Morris International plays a leading role in the global campaign; one executive drafted a position paper used by a chamber affiliate in Brussels, while another accompanied a chamber executive to a meeting with the Philippine ambassador in Washington to lobby against a cigarette-tax increase. The cigarette makers’ payments to the chamber are not disclosed.

Yet the Chamber's governance also ostensibly includes health care viewpoints.  Its current board includes 10 member who are executives of large health care organizations:

- Richard Bagger Senior Vice President, Corporate Affairs & Strategic Market Access, Celgene Corporation, [biopharmaceutical company] Summit, NJ
- John Cannon Executive Vice President & Chief Administrative Officer, Health Care Service Corporation, [health insurance company] Chicago, IL
- Ken W. Cole Senior Vice President, Government Relations, Pfizer, Inc., [pharmaceutical company] Washington, DC
- Wayne S. DeVeydt Executive Vice President and Chief Financial Officer, Anthem, Inc., [health insurance company, formerly Wellpoint] Indianapolis, IN
- Ralph de la Torre, MD Chairman and CEO, Steward Health Care System LLC, [for-profit hospital system, owned by Cerberus Capital Management] Boston, MA
- Fuad El-Hibri Executive Chairman, Emergent BioSolutions Inc. [biopharmaceutical company] Gaithersburg, MD
- Daniel F. Evans, Jr. President & Chief Executive Officer, Indiana University Health, [non-profit hospital system] Indianapolis, IN
- Gregory Irace President and Chief Executive Officer, Sanofi US Services Inc., [US subsidiary of French pharmaceutical company] Bridgewater, NJ
- Paul J. Klaassen Founder, Sunrise Senior Living, Inc., [for-profit provider of nursing care, hospice care, etc] Arlington, VA
- Elaine R. Leavenworth Senior Vice President, Chief Marketing and External Affairs Officer, Abbott Laboratories, [pharmaceutical and device company] Abbott Park, IL

These organizations ostensibly are all about promoting or sustaining individual or population health.  Executives of these organizations serving on the board of the US Chamber of Commerce are responsible for the governance and stewardship of the Chamber.  How could they square the missions of the organizations which the lead, and their responsibility for the Chamber's pro-tobacco stance?

The Health Care Organizations Dodge the Question

The answer to that question is elusive.

The NY Times article stated,

It is not clear how the chamber’s campaign reflects the interests of its broader membership, which includes technology companies like Google, pharmaceutical giants like Pfizer and health insurers like Anthem.

An accompanying NY Times editorial added,

Health insurance and hospital companies that are members of the U.S. Chamber of Commerce find themselves in an uncomfortable situation. Publicly, these companies support policies designed to reduce smoking, but the chamber, as Danny Hakim recently reported, has opposed anti-smoking measures around the world.

The controversy appears to have surprised health-related businesses like Anthem, one of the nation’s biggest health insurers, and Steward Health Care Systems of Boston, which have executives on the board of the chamber. 'If the chamber is in fact advocating for increased smoking, we do not agree with them on this public health issue,' a spokeswoman for Steward said in a statement to The Times.

In an article in the Indianapolis Business Journal, J K Wall recounted how he tried to get a substantive response to the NY Times article from Indiana University Health, whose President is on the Chamber board,

Indiana University Health CEO Dan Evans is one of the most anti-smoking health care executives I know.

Just a few months after I started covering health care for IBJ in 2007, Evans told me in an interview that Indiana employees 'should snatch the cigarettes out of their co-workers mouths and say, ‘Hey, you’re costing me money!’'

However, Evans was not available, and the only response was this statement from a spokesperson

We are proud of the many programs we have in place for smoking prevention and cessation, as well as health promotion and screenings for our team members, patients and members of the community. IU Health has been and will continue to be a leader in Indiana to prevent and curtail the use of tobacco products.

IU Health is a member of many diverse state and national organizations to support our public policy goals including the U.S. Chamber of Commerce and the Indiana State Chamber of Commerce. We are talking with U.S. Chamber leadership about the facts surrounding recent stories in the NY Times and will strongly encourage the U.S. Chamber to review its international programs to ensure they are consistent with its own stated policy to oppose smoking and promote wellness.

Similarly, a follow up story in the New York Times documented this response from Anthem, (formerly Wellpoint), whose Executive Vice President and CFO is on the Chamber board,

Anthem said it was 'dedicated to helping people quit smoking and has led the charge to end tobacco use.'

'Anthem has shared its strong, longstanding position with the chamber and will continue to address our concerns with the chamber directly,' the statement said.

Likewise, the Times noted this response from

Greg Thompson, a spokesman for the Health Care Service Corporation, said in a statement last week: 'We are convinced that ending smoking may help people live longer, enjoy a better quality of life and reduce costs in our health care system.'

'This is a point of view we have advocated for decades and made clear to organizations that we support.'

Those seem to be the only public responses from companies whose leadership is represented on the Chamber of Commerce board. They all ignored the main issue.  None of them seemed informed by the role their companies' executives on the Chamber of Commerce board play.  None of the executives or the companies for whom they worked acknowledged any accountability for the Board's vigorous foreign campaign of pro-tobacco activities.

The Times did note that Chamber of Commerce member CVS, which is not specifically represented on the Chamber board, and which recently stopped selling tobacco products, withdrew from Chamber membership. But as a simply a member of the Chamber, it had little direct responsibility for the Chamber's actions.

Discussion

US health care is increasingly dominated by large organizations.  Most of these organizations like to portray themselves as warm and fuzzy supporters of individual and population health.  For example, Pfizer has a statement of responsibility which begins

As a member of today’s rapidly changing global community, we are striving to adapt to the evolving needs of society and contribute to the overall health and wellness of our world.

Anthem's statement includes

Anthem is dedicated to delivering better care to our members, providing greater value to our customers and helping improve the health of our communities.

Yet on Health Care Renewal, we have documented actions by leaders of health care organizations that directly contradict their lofty mission statements, and may have threatened patients' or the public's health.

In its aggressive international promotion of tobacco interests, the US Chamber of Commerce appears to be promoting the use of products that directly threaten individual's and the public's health.  Even though the Chamber protested that it was merely reaching out

to governments around the world to urge them to avoid measures that discriminate against particular companies or industries, undermine their trademarks or brands...

their protestation ignored how tobacco is a different product than that of nearly all industries.  It seems inherently dangerous to patient's the and public's health even when used as intended, and has no known health or societal benefits that even partially compensate for its risks.  Therefore, what is the argument not to discriminate those who make and promote such an inherently dangerous product from those who make products that do not threaten health, or provide obvious benefits that may compensate for their risks?

It is obvious why tobacco companies might want the Chamber's support.  What, however, could be the rationale for executives of corporations pledge to promote health to preside over the international promotion of tobacco?

The executives on the Chamber board, and their companies have not as yet even tried to provide an answer.

Thus, in the absence of better responses, in my humble opinion the presence of health care executives on the US Chamber of Commerce board is another example - an important one - of mission-hostile actions by top leaders of US health care organizations.

As we have said far too many times - without much impact so far, unfortunately - true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

6:47 PM

All the President's Trade Negotiators - Revolving Doors, Regulatory Capture, and Health Care Corporate Friendly Trade Agreements

This week's spectacle in Washington, DC was a nearly unanimous Democratic minority in the Senate blocking a proposal for expedited consideration of multinational trade agreements favored by the Republican majority, but also by the Democratic President and his trade negotiators (look here).  Democrats mainly based their actions on perceptions that the trade agreements favored multinational corporations  over people.

While trade agreements may seem to be another, albeit international species of wonkery, these agreements could have major effects on patients' and the public's health.  Since these concerns have been essentially ignored by the US medical and health care literature, (although they have appeared in UK journals, Australian, and New Zealand journals in English), they I will discuss them below. Worthy of further discussion is the possibility that these potential threats to health care and public health may arise not just from ideological disagreements, but also from health care corporations' increasing capture of government, facilitated by the conflicts of interest generated by the revolving door. 

Corporate Friendly Trade Agreements

The US has been negotiating two major multinational trade agreements, the Trans-Pacific Partnership (TPP) and the Transatlantic  Trade and Investment Partnership (TTIP) for years. 

In a March, 2014, commentary, renowned economist Joseph E Stiglitz summarized the objections to the these proposed trade agreements.  His greatest fears were that such agreements

will benefit the wealthiest sliver of the American and global elite at the expense of everyone else.

This seems surprising, since most people think of trade agreements solely in terms of their effects on tariffs, not a big concern for health care and public health professionals.  However, Stiglitz noted

Tariffs around the world are already low. The focus has shifted to 'nontariff barriers,' and the most important of these — for the corporate interests pushing agreements — are regulations. Huge multinational corporations complain that inconsistent regulations make business costly. But most of the regulations, even if they are imperfect, are there for a reason: to protect workers, consumers, the economy and the environment.

What’s more, those regulations were often put in place by governments responding to the democratic demands of their citizens. Trade agreements’ new boosters euphemistically claim that they are simply after regulatory harmonization, a clean-sounding phrase that implies an innocent plan to promote efficiency. One could, of course, get regulatory harmonization by strengthening regulations to the highest standards everywhere. But when corporations call for harmonization, what they really mean is a race to the bottom.

 In the US, and other developed countries, there are lots of regulations that have major effects on health care and public health.  Changes in these regulations, or their implementation, could have major effects again on health care and the public health.  So those interested in health care and public health ought to be concerned about how such trade agreements could affect such regulation.

International Tribunals Could Trump National Law
One of Stiglitz's concerns was  that the trade agreement would allow international tribunals that could override national law, particularly law promoting public health:

What we know of ... particulars [of the TTP] only makes it more unpalatable. One of the worst is that it allows corporations to seek restitution in an international tribunal, not only for unjust expropriation, but also for alleged diminution of their potential profits as a result of regulation. This is not a theoretical problem. Philip Morris has already tried this tactic against Uruguay, claiming that its antismoking regulations, which have won accolades from the World Health Organization, unfairly hurt profits, violating a bilateral trade treaty between Switzerland and Uruguay.

In fact, Philip Morris has also used such tribunals to overturn Australian laws meant to discourage smoking for public health purposes.  The details of the Philip Morris case summarized in May, 2015 in an article by Lauren Carasik in  Foreign Policy, show the major public health implications of such trade tribunals,

In 2011, Australia passed a tobacco-control law to discourage smoking. It required cigarettes to be sold in plain packages with prominent warnings, with brand information relegated to the bottom of the box. Touted as 'one of the most momentous public health measures in Australia’s history' by the country’s health minister, the law was meant to deter a habit that will ultimately kill 1.8 million current Australian smokers, according to a recent study. After the country’s highest court upheld the constitutionality of the anti-smoking law, tobacco giant Philip Morris claimed that it violated the company’s corporate rights and launched a suit using a little-known provision called investor-state dispute settlement (ISDS). The case is pending, as is a similar case against Uruguay. A similar tobacco-control measure in New Zealand is on hold pending the outcome of these cases.

So these examples suggest that national laws meant to promote the public health could be challenged in these trade tribunals by multinational corporations based on these laws' postulated effects on corporate profits, regardless of the laws' public health rationale or legality in their own countries. 


Furthermore, a letter to the Lancet(1) noted,

Investor state dispute settlement (ISDS) provisions allow investors to sue governments if policy changes or even court rulings substantially affect the value of their investment, yet do not allow governments to sue investors for breaching the right to health.   ISDS processes constrain governments' abilities to regulate on the basis of the precautionary principle, or even to implement health policies on the basis of established evidence. These processes can have a chilling effect on efforts to address key health issues, such as alcohol, the obesity epidemic, and climate change. In New Zealand, the fear of costly ISDS litigation is already constraining government regulation on tobacco plain packaging.

Thus, creation of such international tribunals could favor financial concerns of multinational corporations over individual countries' governments' attempts to promote health care or public health. So, while these undemocratic tribunals are touted as a way to reduce non-tariff trade barriers, an editorial in the British Medical Journal(2) asserted,

Yet these barriers are some of our most prized social and environmental standards, including regulations on food safety, pesticide residues, and toxic chemicals....

Not only would these tribunals we able to override national laws, their operation would lack procedural safeguards.  Demonstrating that opposition to these trade agreements is also multinational, an article in the UK Independent in October, 2014, noted,

Critics say the tribunals, held under the so-called Investor-State Dispute Settlement (ISDS) system, subvert democratic justice, giving power over foreign citizens to big companies. Hearings are held in private, in international courts at the World Bank in Washington DC, bypassing the legal system of the country being sued, meaning details are often impossible to uncover. In some cases the very existence of the case is not made public.

In addition, per the article in Foreign Policy,

Critics like Global Trade Watch, a division of Public Citizen, a consumer advocacy organization, say the ISDS system is anti-democratic. Sen. Elizabeth Warren (D-Mass.) called for the ISDS language to be stripped out of the deal, writing in the Washington Post in February, 'If a final TPP agreement includes Investor-State Dispute Settlement, the only winners will be multinational corporations.' The problem is that the ISDS system lacks many procedural safeguards fundamental to the rule of law. The tribunals, run by the World Bank and the United Nations, are three-judge panels composed of highly paid private lawyers picked from a limited pool by states and corporations; individual lawyers can switch between serving as judges and advocates on behalf of corporations in different cases. And there is no comprehensive code of judicial conduct guiding the panelists on matters such as conflicts of interest.

Although the panels adjudicate disputes worth millions or even billions of dollars, they are not accountable to any elected body. Moreover, there is no system of precedent binding judges to an established body of decision-making, making it difficult for the parties to discern the applicable standards and their likelihood of success. And finally, there are no appeals, either within the ISDS system or externally, on the merits of decisions. An annulment is only possible for limited procedural errors, and those proceedings are heard before a different panel drawn from the same pool of professionals.

Under the system, states are deprived of the right to resolve these disputes since corporations can proceed directly to the tribunals without exhausting domestic remedies. But this privilege is not reciprocal: Corporations are not subject to suit in the tribunals by those harmed by their actions. Foreign companies are thus granted expanded rights without corresponding responsibilities.

Finally, in May, 2015, the United Nations special rapporteur on promotion of a democratic and equitable international order suggested that the proposed international tribunals would undermine human rights and violate the UN charter (per this Guardian article).

Further criticism of the tribunals came from the UK Labour party Shadow Health Secretary (as of April, 2014) who felt it would leave British general practitioners "powerless to resist legal challenges from US health giants with huge financial resources in the event of a contractual dispute (per the Independent).

To summarize thus far:  international trade agreements being pushed by the US government could set up trade tribunals that could reverse national laws meant to protect health and safety.  Such tribunals would not follow the procedures used, for example, in US courts, and could not be held accountable by individual governments.  Various aspects of these tribunals, and recent actions involving tribunals already set up by earlier trade agreements suggest the process may be heavily biased in favor of the financial interests of multinational corporation, and against patients' and the public's health.  Thus, health care and public health professionals ought to be alarmed about new agreements that could set up new tribunals, or expand the reach of existing tribunals.


Intellectual Property Rights vs Access to Health Care

Another set of problems affecting patients' and the public's health  are provisions in trade agreements favoring corporate "intellectual property" over access to drugs, devices and health care.  Stiglitz wrote in 2014,

America has been fighting to lower the cost of health care. But the TPP would make the introduction of generic drugs more difficult, and thus raise the price of medicines. In the poorest countries, this is not just about moving money into corporate coffers: thousands would die unnecessarily. Of course, those who do research have to be compensated. That’s why we have a patent system. But the patent system is supposed to carefully balance the benefits of intellectual protection with another worthy goal: making access to knowledge more available. I’ve written before about how the system has been abused by those seeking patents for the genes that predispose women to breast cancer. The Supreme Court ended up rejecting those patents, but not before many women suffered unnecessarily. Trade agreements provide even more opportunities for patent abuse.

To date, most of the details of the proposed trade agreements have been kept secret, but as noted on the PLoS Medicine blog in December, 2013, by Reshma Ramachandran and David Carroll,

Last month, Wikileaks posted the complete Intellectual Property (IP) Chapter of the secretly-negotiated Trans-Pacific Partnership Agreement (TPP) confirming public health advocates’ worst fears of the agreement’s impact on patients worldwide.

In particular,

The Wikileaks posted text revealed that the USTR and Obama Administration have decided to aggressively prioritize the interests of multinational pharmaceutical and medical companies over patients worldwide and at home. In fact, according to emails submitted to Intellectual Property-Watch under the Freedom of Information Act, the USTR has actively solicited the input of industry groups, giving them special access to the negotiating text while consumer and health groups have had to resort to requesting special meetings with negotiators. 

So,

Indeed, the recently leaked TPP chapter reflect these corporate interests as evidenced by the still-included provisions. In the text, the USTR has proposed a number of provisions that will further strengthen patents and data exclusivity for pharmaceuticals. Such provisions will bar the entry of generic competition into the market allowing for brand-name drug companies to retain their monopoly market and set drug prices at exorbitantly high prices. These provisions include:

- Lowering patent standards allowing for “evergreening” or the granting of patents for newer forms of existing medicines including new formulations or minor modifications even in the absence of a therapeutic benefit

- Mandating that surgical, therapeutic, and diagnostic methods must be patented making medical practitioners in TPP member states liable for infringement and restricting their choices for treatment

- Imposing data exclusivity on all pharmaceuticals, including biologics with the minimum period for this class to be set at 12 years (despite the fact that the White House is publicly in favor of a 7 year data exclusivity period and the FTC has stated that there is no need for any data exclusivity period at all) thereby not allowing drug safety regulators from accessing clinical data to grant market approval for generic and biosimilar drugs

-  Adjusting patent term periods to account for “unreasonable delays” including patent prosecution periods ranging from two years to more than four years extra further delaying generic drug entry into the market

- Adjusting patent term periods for regulatory approval periods allowing for patent extensions for both new pharmaceutical products as well as methods for producing or using new pharmaceutical products halting any potential innovation

- Linking patent status and drug marketing approval causing drug regulatory authorities to take on the additional task of early patent enforcement, allowing for bogus patents to be a barrier to generic drug registration Such proposals go beyond current U.S. and international law including the World Trade Organization’s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

Additionally, the TPP has the potential to jeopardize millions of lives in the participating countries by driving up the costs of medicines significantly. Even in the United States, there has been a public outcry from physicians regarding the high cost of medicines. Earlier this year, over 100 oncologists came together to write a perspective piece in the journal Blood calling the prices of brand-name cancer drugs “astronomical, unsustainable, and perhaps even immoral.” The United States health care system has in fact greatly benefited from the entry of generic competition. On May 9, IMS Health released a report entitled Declining Medicine Use and Costs: For Better or Worse?, which found that many Americans had forsaken much needed doctor visits, medicines, and other treatments as they struggled to afford health care. In light of this, it is appalling that U.S. negotiators would continue to push provisions that would further exacerbate the cost burden of healthcare for patients not only abroad, but at home. 

Public Citizen particularly criticized the provision for patenting procedures,

Medical procedure patents raise healthcare costs. Health providers, including surgeons, could be liable for the methods they use to treat patients. Essentially, except for when a surgeon uses her bare hands, surgical methods would be patent eligible subject matter under the U.S. proposal.

Additional concerns about the potential of new trade agreements to increase the price of medicines and health care, and limit access to them, came, per Ramachandran and Carroll, from Doctors Without Borders, the American Association of Retired Person, and the International Federation of Medical Students.  More recently, such concerns were stated by amfAR re access to and costs of HIV medications (reported on Vox), and were restated by Doctors Without Borders (reported by the National Journal).

Perhaps more US health care professionals and public health advocates would be speaking out if they understood the problem.  However, concerns about how new proposed trade agreements could affect health care and public health have been notably anechoic in the US.  I could find absolutely no discussion of them in any moderate or large circulation US health care or medical journal.  There has been discussion in English language medical and and health care journals, but in journals that are relatively obscure, or published outside of the US, for example, see articles by Greenberg and Shiau(3), and Thow et al(4).  Note that the former wrote,

academic public health has failed to appreciate the serious risks of the TPP[A] and has not responded to its threats. 

Keeping concerns that the new trade agreements could threaten patients' and the public's health out of public discussion may be just the latest example of what we have called the anechoic effect, because it looks like it may be no accident that these proposed trade agreements favor multinational corporations over patients' and the public's health.  There is evidence that at least the US governmental process for negotiating these agreements was heavily influenced by the interests of these corporations, but not by the interests of patients or citizens. 

Revolving Doors, Regulatory Capture Generate the Momentum

There are thus strong reasons for health care and public health professionals to oppose the rush to approve the new trade agreements (the TTIP and TPP).  Despite these concerns, and the increasingly vocal opposition from many US legislators, the current administration has forged ahead with its proposal to "fast-track" their approval, only to be suddenly blocked, and by its supposed compatriots in the Democratic party.  There are lots of explanations for this, but two that got only a little notice but seem particularly germane to Health Care Renewal are the influences of the revolving door and cultural regulatory capture.

The case for these was best made by a November, 2013 article in the Washington Post by Timothy B Lee,

the U.S. negotiating position also had an unmistakeable bias toward expanding the rights of copyright and patent holders.

Those positions are great for Hollywood and the pharmaceutical industry, but it's not obvious that they are in the interests of the broader U.S. economy. To the contrary, critics contend that the rights of copyright and patent holders have been expanded too much. Those concerns do not seem to have swayed the trade negotiators in the Obama administration.

Two major factors contribute to the USTR's strong pro-rightsholder slant. An obvious one is the revolving door between USTR and private industry. Since the turn of the century, at least a dozen USTR officials have taken jobs with pharmaceutical companies, filmmakers, record labels, and technology companies that favor stronger patent and copyright protection.

A more subtle factor is the structure and culture of USTR itself. In its role as a promoter of global trade, USTR has always worked closely with U.S. exporters. That exporter-focused culture isn't a problem when USTR is merely seeking to remove barriers to selling U.S. goods overseas, but it becomes problematic on issues like copyright and patent law where exporters' interests may run directly counter to those of American consumers.

Lee provided extensive examples of how US trade officials transited the revolving door to and/or from the pharmaceutical industry.

On May 3, 2004, the United States and Australia signed a bilateral trade agreement. The agreement included a section on intellectual property that had numerous provisions favorable to pharmaceutical manufacturers. For example, it barred generic drug makers seeking approval for their drugs from citing safety or efficacy information originally submitted by brand-name drug makers for a period of five years after the information is submitted, making it more difficult for generic drug makers to enter the market.

The lead American negotiator was Ralph Ives, who was promoted to Assistant USTR for Pharmaceutical Policy soon after the negotiations concluded. He was aided by Claude Burcky, Deputy Assistant USTR for Intellectual Property. Less than three months after the Australia agreement was signed, the Sydney Morning Herald reported that both men would take jobs at pharmaceutical or medical device companies. Their new employers stood to benefit from some of the pro-patent-holder provisions of the treaty. Ives took a job at AdvaMed, a trade group representing medical device manufacturers. Burcky moved to the pharmaceutical and medical device company Abbott Labs.

Since then, Abbott has hired two other USTR veterans, Andrea Durkin and Karen Hauda, according to the women's LinkedIn pages. Another USTR official, Kira Alvarez, has gone through the revolving door twice over the last 15 years. Her LinkedIn profile indicates that she served at USTR from 2000 to 2003, spent four years at the pharmaceutical giant Eli Lilly, and then returned to USTR in 2008 as Deputy Assistant USTR for Intellectual Property Enforcement. She was there for five years before she took a job at AbbVie, a pharmaceutical firm that spun off from Abbott earlier this year.

According to his official biography at the site of the Biotechnology Industry Associaiton, Joseph Damond 'was chief negotiator of the historic U.S.-Vietnam Bilateral Trade agreement' during his 12 years at USTR. He then spent five years at the Pharmaceutical Research and Manufacturers of America before moving to BIO. Justin McCarthy went through the revolving door in the other direction. According to a USTR press release, McCarthy was responsible for intellectual property issues at the pharmaceutical company Pfizer from 2003 to 2005 before he was hired at USTR. He now works at a lobbying firm.

Lee also suggested that the US Trade Representative has been culturally captured by industry through its use of advisory panels made up of industry members, but not, for example, clinicians, public health advocates, or interested members of the public.

The agency has established 16 industry trade advisory committees to provide advice about the complex issues USTR deals with in the course of its negotiations. As the name suggests, the ITACs are designed to gather feedback from industry groups. There are no public interest groups, academics, or other non-industry experts on ITAC 15, which focuses on "intellectual property" issues.

And that matters because groups with ITAC seats have access to confidential information about the U.S. negotiating position that isn't available to the public. Sherwin Siy, an attorney at the advocacy organization Public Knowledge, has had multiple meetings with USTR representatives during the course of the TPP negotiations. But he says it was difficult to give USTR meaningful feedback because he didn't know what positions U.S. negotiators were advocating.

'They're willing to sit in a room with us and listen to our objections and our issues and be very polite,' Siy says. But 'whether or not that actually means anything is at best a black box.'

When USTR wants technical advice on transposing U.S. law into international agreements, it naturally turns to the industry representatives on the ITACs. And it stands to reason that the advice the agency receives in response would be a bit one-sided. Where U.S. law is ambiguous, industry groups naturally gravitate toward interpretations of U.S. law that favor their employers' interests. And because public interest groups and independent experts aren't allowed to see proposed language (aside from occasional leaks), the agency may not even realize that it is exporting a warped interpretation of U.S. law.

The pro-industry cultural bias has caused consternation among even well-known libertarians, as Lee noted,

'USTR sees itself as an advocate for U.S. exporter interests,' says Bill Watson, a trade expert at the Cato Institute. 'It's trying to negotiate market access for particular U.S. industries that ask for it. That bias leads USTR to think that because U.S. companies want more IP protection abroad, it's in their interest to negotiate that.'

So it seems quite clear that the US agency that negotiates the new international trade agreements may be staffed by people who came from affected industries, including pharmaceutical, device and biotechnology companies, and privileges advice from such companies.  Thus the agency appears to suffer from conflicts of interest due to the revolving door, and from regulatory capture induced by its bias in favor of advice from industry over that from clinicians, public health advocates, or interested members of the public.  This suggests why it appears that this government agency has actively been promoting trade agreements that favor industry interests over patients' and the public's health.

It may be that top US executive branch officials, all the way up to the President of the US, have been very ill-served by relying on an agency subject to such conflicts of interest and regulatory capture.

Summary

We have frequently written about the revolving door phenomenon, and its effect on government agencies and officials who regulate and control many aspects of health care. Recently, we wrote about how the revolving door risks corruption, and can lead to regulatory, and even state capture.

In 2011, we even wrote about how the revolving door may affect US trade negotiations, and thus important aspects of aspects of global health care.

Government officials affiliated with all major political parties have been known to transit the revolving door.  The recent cases we have documented have tended to be more about the party that currently controls the executive branch, of course.  But now, we seem to have documented how the revolving door has lead to a supposedly liberal president proposing trade agreements that seemed heavily biased towards corporate rather than popular interests, and thus suffered an embarrassing defeat at the hands of his party compatriots in the legislature.  The president seems to have been particularly ill-served by employees of the executive branch whose previous or potential revolving door transits have made them sing the tunes of industry rather than of the people they are supposed to be serving.  This suggests that in the long run, nobody but the participants in the revolving door ultimately benefits from their rotary transitions.

Instead, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

ADDENDUM (19 May, 2015) - This post was republished in OpEdNews.

ADDENDUM (29 May, 2015) - This post was republished in OpenHealth News.

References

1.  Freeman J, Keating G, Monasterio E at al.  Call for transparency in new generation trade deals. Lancet 2015; 385: 605-605, link here.
2.   Hilary J.  The Transatlantic Trade and Investment Partnership and UK healthcare.  Brit Med J 2014; 349: g6552, link here.
3.  Greenberg H, Shiau S. The vulnerability of being ill-informed: the Trans-Pacific Partnership agreement and global public health.  J Pub Health 2014; 36: 355-357, link here. 
4.  Thow AMT, Gleeson DH, Friel S. What doctors should know about the Trans-Pacific Partnership agreement.  Med J Aust 2015; 202: 165-167, link here.

9:30 AM

What Big Drug and Biotechnology Companies Will Not Tell Us - Transparency International on Corporate Reporting

Drug companies are entrusted to provide pure, unadulterated medicines.  Increasingly drug companies are now entrusted with doing research, including experimental studies, on human beings, and providing education to doctors and patients.  Ordinarily, trust requires confidence in transparency. However, a new report suggests that large multinational drug and biotechnology companies are not very transparent.

Transparency International just released a report on the transparency, or lack thereof, of the 124 biggest multinational corporations.  The report detailed how well these companies disclosed their internal anti-corruption programs, their subsidiaries, affiliates, and joint ventures, and their financial data broken down by the countries in which they operate.  In summary, the overall results for disclosing anti-corruption programs were mediocre, and for disclosing organizational structure and country-by-country financial data, they were dismal.

The report is highly relevant to health care.  It included the biggest multinational health care corporations, all drug and/or biotechnology companies: Abbott Laboratories, (based in the US), Amgen (US), AstraZeneca (UK), Gilead Sciences (US), GlaxoSmithKline (UK), Johnson and Johnson (US), Merck and Co (US), Novartis (Switzerland), Novo Nordisk (Denmark), Pfizer (US), Roche Holding (Switzerland), Sanofi (France), Teva Pharmaceutical Industries (Israel).

The report has so far received little media coverage.  In the US, several news services provided brief  summaries.  Somewhat more substantial articles came from Reuters, the Wall Street Journal's Risk and Compliance Journal, and CNBC.  None gave specifics about health care.  Coverage from other countries, e.g., Germany by Deutsche Welle, and the UK by the Guardian, was more detailed but also did not specifically mention health care.

Therefore, I will summarize the rationale and assessment methods used by Transparency International for its three dimensions of transparency, and then show results from the 13 health care corporations.

Disclosure of Anti-Corruption Programs

The rationale for addressing this area was:

Global companies have legal and ethical obligations to conduct their business honestly. This requires
commitment, resources and the ongoing management of a range of risks – legal, political and reputational – including those associated with corruption. The implementation of a comprehensive range of anticorruption policies and management systems is fundamental to efforts to prevent and remediate corruption within organisations.

Transparency International believes that public reporting by companies on their anti-corruption programmes allows for increased monitoring by stakeholders and the public at large, thereby making companies more accountable

Evaluation of disclosure of anti-corruption programs was

based on 13 questions, which are derived from the UN Global Compact and Transparency International Reporting Guidance on the 10th Principle against Corruption. This tool, based on the Business Principles for Countering Bribery, which were developed by Transparency International in collaboration with a multi-stakeholder group, includes recommendations for companies on how to publicly report on their anticorruption programmes.

Note that the project addressed only reporting of anti-corruption programs, not their implementation or effectiveness.

For this and the other two dimensions of transparency, responses were converted into a 0% to 100% scale, with 100% being the best possible result.

Organizational Transparency

The rationale was:

As many of the recent corporate scandals have shown, acts of corruption are very often aided by the use of opaque company structures and secrecy jurisdictions.  But the use of offshore companies and their lack of transparency are posing increasing risks for global companies as well as for their shareholders, employees and local communities.

So,

Companies can mitigate the risks posed by lack of transparency and ownership arrangements by shedding more light on their corporate structures and by making basic financial information public on a country-by-country basis. This allows stakeholders to have a clearer understanding of the extent of a company’s operations and makes the company more accountable for its activities in a given country, including assessing whether it contributes financially in a manner appropriate to its level of activity.

The measurement strategy was,

Transparency International researchers consulted publicly available documents such as annual reports and stock exchange filings for information about company subsidiaries, affiliates, joint ventures and other holdings. The information sought included corporate names, percentages of ownership by the parent company, countries of incorporation and the countries in which the companies operate.

Country-by-Country Reporting

The rationale included:

The importance of country-by-country reporting was first recognised in the extractive sector as a way to ensure that revenues from natural resources are used to foster economic and social development rather than line the pockets of kleptocratic elites.

So,

country-by-country reporting ... [is] a recognised building block for corporate transparency and as a tool for countering tax avoidance.

In addition, country-by-country reporting provides investors with more comprehensive financial information about companies and helps them address investment risk more effectively.

The items measured were disclosure of revenue/sales, capital expenditures, pre-tax income, income tax, and community contribution in each country in which the company operated.

Results for Health Care Corporations

Company                      Total  Anti-Corruption P  Org Structure  by-Country

Abbott Laboratories    40             81                           38                3
Amgen                          37             85                           25                0
AstraZeneca                37             88                           19                3
Gilead Sciences           26             54                           25                0
GlaxoSmithKline          52            96                           50               11
Johnson and Johnson  26           65                           13                0
Merck and Co               42           77                            50                0
Novartis                        38            77                           38                1
Novo Nordisk               39            81                           38                0
Pfizer                             35            92                           13                0
Roche Holding              33            62                           38                1
Sanofi                            38            77                           38                0
Teva Pharmaceutical  35            85                            19                0

Again, only one company, GlaxoSmithKline, achieved an overall score of barely better than 50%.  All the others had lower scores.  Only two companies achieved a 50% score on disclosure of organizational structure, and only one achieved a score of better than 10% for disclosing country-by-country results.  The Transparency International report noted that the health care companies got particularly bad scores for disclosing organizational structure, averaging 31%, the third worst performance by economic sector.


Summary

 The drug and biotechnology companies generally did a fairly good job disclosing what their anti-corruption programs were supposed to do.  However, note that the Transparency International report did not assess how well these programs were implemented or enforced.  That this concern is not academic is underscored by some of these companies disreputable track records.  Some have long histories of legal actions, including billion dollar plus legal settlements, some of which were of allegations of fraud or kickbacks, and some have been convicted of crimes.  See the records of, for example: Abbott Laboratories (look here and here), Amgen (here), AstraZeneca (here), GlaxoSmithKline (here), Johnson and Johnson (here), Merck (here), Novartis (here), Novo Nordisk (here), Pfizer (here), Roche (here), Sanofi (here), and Teva (here).

Moreover, the companies did not do a good job disclosing their organizational structures, and hardly any bothered to report any financial results broken down by country.

We have frequently discussed health care corporations' deceptive marketing, induction of conflicts of interest, including those of supposed "key opinion leaders" who often are marketers in academic or professional clothing, and manipulation and suppression of clinical research.  There has been an ongoing procession of legal settlements involving health care corporations, often involving allegations of, and sometimes convictions for fraud, kickbacks, bribery, or other crimes.  There have even been some cases in which drug companies have failed to assure that their products are pure and unadulterated, their most basic mission.  Thus many are distrustful of drug and biotechnology companies, and large health care organizations in general.

So, as Transparency International's report noted, to rebuild trust,

integrity must be central to these efforts. Those efforts, in turn, can only become fully credible if they are undertaken with a sustained commitment to ethical behaviour and transparency across companies’ operations.

In my humble opinion, a basic premise of true health care reform would be that health care organizations become sufficiently transparent to restore basic trust in them. 

11:44 AM

Abbott Pleads Guilty, Settles for $1.6 Billion, but No Individuals Suffer Negative Consequences

Once again, another big US health care organization is set to make a (monetarily) huge legal settlement.  As reported by Bloomberg, Abbott Laboratories will settle allegations about its marketing of Depakote (valproic acid), nominally an anti-seizure medication:

Abbott Laboratories (ABT) (ABT) said it will pay $1.6 billion to settle federal and state claims resulting from an investigation into its epilepsy medication Depakote, the second-largest drug-marketing settlement in U.S. history.

The company will pay $800 million to resolve civil allegations split among federal and state governments, $700 million for a criminal penalty, the Justice Department said in a statement. Abbott marketed the drug, approved for epilepsy, bipolar mania and migraine prevention, for unapproved uses including dementia, the U.S. said.

Note that we discussed preliminary reports of this settlement here.

Huge, but not Compared to Sales

The story included all the obligatory pieces. The settlement is huge, the second largest such financial settlement made by a drug company. However, compared to the money made by the product in question, it was not so large, as noted by the Wall Street Journal,

Depakote was once one of Abbott's best-selling drugs, racking up $1.6 billion in sales for 2007, before patent expirations cleared the way for cheaper generic copies.

A Guilty Plea, of Sorts

The settlement did require the company to

plead guilty to a criminal misdemeanor violation of a federal drug law

per the WSJ, but not to a felony. Nor did it appear that any individual would be charged with anything in connection with this settlement.

Admitting to Deception, Covering Kickbacks

This was so even though the allegations involved more than "misbranding." In fact, the Bloomberg story stated that the company admitted to active deception of physicians and health professionals,

'Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use,' the Justice Department said in its statement today.

Abbott also marketed the drug to be used with certain antipsychotic drugs to treat schizophrenia, 'even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use,' the Justice Department said.

In addition, the settlement also "covers" allegations of what amounts to bribery.

The settlement also covers allegations that Abbott paid kickbacks to health-care professionals and long-term care pharmacy providers to induce them to promote or prescribe Depakote, the Justice Department said in its statement today.

We Promise Not to Do Such Bad Things for Five Years

Yet despite these implications of massive deception and bribery of health care professionals, the only other punishment is a sort of probationary period during which the company promises not to do such things, per the WSJ.

Under the settlement, Abbott agreed to a five-year probationary period. During this term, Abbott will report any probable violations of the Food, Drug and Cosmetic Act to the probation office, according to the Justice Department.

Also, its chief executive will certify compliance with this reporting requirement, and its board will report annually on the effectiveness of the company's compliance program.

In addition, Abbott agreed not to compensate sales reps for off-label sales and take other steps during the probationary period.

A Bland Admission of Nothing

As is customary, an Abbott spokesperson provided a bland, positive statement that admitted no wrong-doing, per the WSJ,

'We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement,' Abbott General Counsel Laura Schumacher said in a news release. 'The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements.'

Previous Misbehavior

Apparently not taken account into stories about or the crafting of the current settlement was Abbott's previous record of legal misadventures:

Obstructing Justice - In 2003, an Abbott subsidiary settled civil allegations and pleaded guilty to obstructing a federal criminal investigation of its marketing practices, resulting in fines of $614 million (mentioned in this post, and see the Los Angeles Times.)
Suppressing Reports of Drug Contamination - In 2009, the FDA charged that an Abbott subsidiary failed to report bacterial contamination of an optic product (see post here).
Blocking Generic Competition - In 2010, Abbott settled with the New York state Attorney General allegations that the company conspired to block generic competition for its lipid lowering drug TriCor (see Reuters and our post here).
Inflating Charges - In 2010, Abbott also settled with the US Justice Department for $421 million charges that it defrauded Medicare and Medicaid (see post here).
Paying Kickbacks to Doctors - In 2010, an Abbott subsidiary also settled with the US government charges it paid kickbacks to physicians to prescribe other cholesterol lowering drugs (see post here).
Anti-Competitive Pricing Practices - In 2011, Abbott settled lawsuits alleging that its anti-competitive practices inflated prices of anti-viral drugs (see post here).

More Richs for the CEO

Despite this now long record of ethical missteps, the Abbott CEO gets richer every year. In 2009, his total compensation was over $26 million (see this post). According to the company's 2012 proxy statement, his pay has gone down ever so slightly, from $25,564,283 in 2010 to $24,010,902 in 2011, but still approximately 480 times the median earning of a US family.

Summary

The march of legal settlements progresses. Despite its showy finery of legal language, it fails to include meaningful negative consequences for any individuals, and particularly for those who authorized, directed or implemented unethical actions. It provides the illusion of financial punishment of the organizations involved. However, the amounts paid, albeit large, never approach how much money was brought in by the bad behavior. Furthermore, the costs are diffused among many employees, and for publicly held for-profit corporations, among the nominal owners, the stock-holders. Yet the top executives who personally gained the most almost never have had to answer for the misbehavior, and despite of, or perhaps because of the misbehavior continue to collect voluminous compensation.

Despite promises of tougher action, nothing seems to be changing in this parade. However, without real penalties for individuals involved in bad behavior, expect to deterrent of future bad behavior.

So once more,.... if we really want to reform health care, we must make the leaders of health care organizations accountable for their organizations' effects on patients' and the public's health, and make sure they get reasonable, not royal compensation reasonably related to their organizations' performance, including ethical performance.

2:00 PM

An Original Excuse

The Associated Press just published a story about another company which apparently failed to report adverse events associated with its product:

Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.

The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.

The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.

Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.

Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.

Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall.

What is most striking is the company's rationale for not reporting:

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago.

That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.

The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.

2:26 PM