Showing posts with label Genentech. Show all posts
Showing posts with label Genentech. Show all posts

Tuesday, September 07, 2021

More Large Health Care Corporations Are Again Funding Politicians Who Threatened Representative Democratic Governance

Introduction: Health Care Corporations' Political Contributions: From Bipartisan to Trumpian

 At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and political organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 


 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates. In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians. In March, 2019, we discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post, and this July 7, 2021, post).

Now yet another report shows continuing support by large health care corporations for Republican legislators who supported the nullification of the election.

 Health Care Corporate Funding of Politicians Who Would Overturn an Election

On August 17, 2021, Popular Information published The January 6 Corporate Accountability Index.  It promised to be results of a comprehensive monitoring efforts of corporate pledges to make changes in their political giving to the "147 Republicans who voted to overturn the election, setting the stage for the riot." It included several categories of pledge violations.  Its results included some of the companies who went back on their pledges as described in our April and July posts.  It also included many more companies that did not make it to previous reports.  The relevant results by category were as follows

Corporations that pledged to suspend donations to the 147 Republican objectors but directly donated to those Republicans

Not included in previous reports: none

Included in previous reports: Cigna, Eli Lilly

Corporations that pledged to suspend donations to all 147 Republican objectors but violated the spirit of the pledge

Not included in previous reports: 

"After January 6, Genentech [part of the "Roche group'] said it would suspend contributions to Republican objectors. Genentech donated $15,000 to the NRCC and $15,000 to the NRSC on June 30."

"After January 6, Sanofi said it would suspend contributions to Republican objectors. Sanofi donated $15,000 to the NRSC on 3/17."

Corporations that pledged to suspend all PAC donations and then directly donates to the 147 Republican objectors

Not included in previous reports:

DaVita 

Included in previous reports: Abbott Laboratories, Gilead, Novo Nordisk

Corporations that pledged to suspend all PAC donations and then indirectly donated to the 147 Republican objectors

Not included in previous reports:

Baxter International

Included in previous reports: United Healthcare

Corporations that pledged to reevaluate their donation criteria after January 6 and directly donated to GOP objectors

Not included in previous reports:

Amgen, Laboratory Company of America

Corporations that pledged to reevaluate their donation criteria after January 6 and then indirectly donated to the 147 Republican objectors

Not included in previous reports: none

Included in previous reports: CVS

Discussion

As we said before, most health care corporations publish high-minded aspirational statements that promise pluralism, support of the community, and of our representative democratic society.  For example, Sanofi Pasteur claims:

Sanofi’s social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people
However, the new data revealed above, and data discussed in our two previous posts showed that leaders of  more and more large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would challenge election outcomes in the absence of very clear evidence of election irregularities seem s to violate high-minded corporate pledges of inclusiveness like those above.   

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top managers corporations, particular individuals can control political funds far beyond what they would  be able to control as private persons, and to do so quietly and sometimes anonymously.  Corporate leaders may thus be able to promote their own interests through their corporations' political giving.  Those interests may go beyond just personal enrichment.   Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, authoritarian, even openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

Leaders of large corporations now appear willing to wield large amounts of political power leveraged by the organizations they control.  Yet until recently they may have been able to do so without disclosure to society at large.  That society may be greatly affected by this power, but when it can be wielded quietly, have had little say in who has it and its uses.  

We as health care professionals, policy makers, patients and members of the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. If they are not doing this in our interests, our we need to make sure things change.

Wednesday, November 07, 2018

Pharmaceutical and Other Health Care Corporations Funnel Dark Money to Republicans to Defeat "Leftward" Democratic Candidates - Partisanship Trumps Social Responsibility


Introduction - Health Care Corporations Profess Social Responsibility

As we noted recently, large health corporations, which must deal with patients, health professionals, and government regulators, usually profess their social resonsibility.  For example,

Biotechnology firm Genentech, now a subsidiary of giant Swiss biotechnology and pharmaceutical company Roche, has an elaborate web page about how the company seeks to do good.  Some quotes:

we’re passionate about applying our skills, time and resources to positively impact the patients we serve, the scientific community and the places where we live and work.

Also

We approach giving back the same way we approach discovering medicines: we start by looking for the root cause of a problem and then we explore how we can contribute to a solution.

And particularly

We believe that the best work happens when everyone has a voice.

Similarly, giant American pharmaceutical company Eli Lilly espouses these core values

Three long established core values guide Lilly in all that we do:

Integrity: We conduct our business consistent with all applicable laws and are honest in our dealings with customers, employees, shareholders, partners, suppliers, competitors and the community.

Excellence: We pursue pharmaceutical innovation, provide high quality products and strive to deliver superior business results.

Respect for People: We maintain an environment built on mutual respect, openness and individual integrity. Respect for people includes our concern for all people who touch or are touched by our company: customers, employees, shareholders, partners, suppliers and communities.

Of course, in the policy arena, large health care corporations also tend to advocate for policies that are to their financial advantage.  Furthermore, top executives of large corporations have been known to donate to political candidates who favor their policy positions, although they used to consciously spread their donations out to all parties and many candidates to avoid any appearance of partisanship, while making themselves visible to whomever might be in power.

However, as the current US political chaos leads to more journalistic investigation, there is increasing evidence that large health care corporations have been secretly backing policy positions that do not correspond to their high-minded public statements about corporate social resonsibility, and are becoming quite political, even partisan in the process.  They do so through the use of dark money




Pharmaceutical Companies, Other Health Care Companies - and a Tobacco Company - Join Effort to Attack Left-Wing Politicians

On November 5, 2018, Lee Fang wrote about how big corporations, including big health care corporations, enthusiastically financially supported a dark money operation that specifically targeted "progressive" or "socialist" candidates:

Republican operatives and representatives from America’s largest business groups — alarmed at a wave of upset electoral victories by Alexandria Ocasio-Cortez and other avowed democratic socialist candidates — have been plotting to stem the tide of left-wing Democrats sweeping the country.

Andrew Wynne, an official at the Republican State Leadership Committee, spoke to business lobby leaders in July, encouraging them not to ignore the latest trends within the Democratic Party. He called for Republicans’ allies to enact a unified plan to defeat progressives in this week’s midterm elections.

'Recent elections have proven the leftward shift,' said Wynne. 'An anti-free market, anti-business ideology has taken over the Democratic Party, particularly this year during the primaries.'

Wynne was particularly exercised about the primary victory by Democrat Alexandia Ocasio-Cortez:

'Alexandria Ocasio-Cortez captured the energy of these voters to win a congressional nomination in New York, defeating the incumbent who many thought could be the next Democratic speaker of the House,' Wynne continued.

He noted that the defeated incumbent in the Ocasio-Cortez race, Rep. Joe Crowley, a moderate Democrat and former chair of the business-friendly New Democrat Coalition, 'was someone who the business community could have a conversation with on the Democratic side.' On the other hand, Wynne warned, Ocasio-Cortez would not be so receptive to business lobbyists.

Of course, these sentiments coming from a Republican operative are not surprising.  What was surprising was how Mr Wynne wanted to fund efforts to comabt these supposedly left-wing politicians.

Officials from the Republican State Leadership Committee, which assists Republicans in capturing power on the state level, explained during the call that they expected to raise $45 million in direct contributions and $5 million to $7 million through an allied dark money group for election campaigns this fall.

The group is organized under the IRS’s 527 rules and operates in a manner similar to Super PACs: It can raise and spend unlimited amounts from individuals and corporations. The latest disclosures suggest the group is well on track to bring in significant corporate support for electing Republican state officials.

Koch Industries, Crown Cork & Seal, Genentech Inc., ExxonMobil, NextEra Energy, Range Resources, Eli Lilly and Co., Marathon Petroleum, Reynolds American, (a tobacco company which is a subsidiary of British American Tobacco), Boeing, General Motors, and Astellas Pharma are among the companies that have already provided at least $100,000 to the committee.

Many of those companies are from industries that have long contributed to GOP causes, including resource extraction, financial services, tobacco, retail, for-profit education firms, and private health care interests.

Furthermore, the Republican State Leadership Committee has been collecting money from other dark money organizations which in turn are funded in part by health care companies:

Several of the largest donors to the Republican State Leadership Committee are themselves dark money groups. The Judicial Crisis Network, a 501(c) nonprofit that does not disclose its donors, has given $1.5 million to the group. The ABC Free Enterprise Fund, a dark money affiliate of a lobbying group that represents non-union construction companies, gave $100,000.

The U.S. Chamber of Commerce has given $1.7 million to the committee. The chamber, notably, does not disclose its donors but has been financed in the past by Goldman Sachs and Dow Chemical, among other major American and foreign companies.

We recently discussed the health care industry contributions to the US Chamber of Commerce, which came from PhRMA, Pharmaceutical Research and Manufacturers of America, the pharma trade association, and from specific companies, including contributions of at least $100K from: Aetna, Abbott Laboratories, AbbeVie, Amgen, Anthem, Celgene, Cigna, CVS, Eli Lilly, Express Scripts, Johnson & Johnson, Merck, Mylan, Procter & Gamble, and UnitedHealth.

So a lot of big health care companies, most of whom profess their devotion to the greater community and social responsibility, have been funneling considerable money as quietly as possible into an effort to thwart one particular group of politicians, that is, candidates from the leftish wing of the Democratic party.

So much for Genetech's claim:


We believe that the best work happens when everyone has a voice.

Or for Lilly's claim:

Respect for people includes our concern for all people who touch or are touched by our company: customers, employees, shareholders, partners, suppliers and communities.
 
Discussion and Summary

This is now the fifth time we have discussed the role of dark money in health care.

- In 2012 we discussed a case of "dark money" being used to conceal sources of support for particular health policy and political positions.

- Earlier this year,  we discussed the case of huge pharmacy chain CVS,which proclaims its "social responsibility," and its policy of only making charitable contributions to improve "health and healthcare nationwide."  Yet CVS was donating to America First Policies, a supposed non-profit group devoted to promoting the partisan agenda of President Trump, including "repealing and replacing Obamacare," and immigration policies such as building the "wall" and deporting  "illegal immigrants." (Note that these CVS dark money contributions were separate from those discussed above.)

- In September, we discussed how the pharmaceutical trade organization, PhRMA, and some large drug companies donated money to a dark money organization to combat a state initiative to limit pharmaceutical prices, but also to the American Action Network (see above) to "repeal and replace" the Affordable Care Act (ACA, "Obamacare") despite their previous support for and then current neutrality on the ACA.

- In October, we discussed how many health care corporations were donating to dark money groups, predominantly groups, like the US Chamber of Commerce, devoted to distinctly right-wing causes, almost all lately related to the Republican party and in sympathy with the Donald Trump regime.

Health care corporations recent and current funding of dark money groups seems to openly conflict with the corporations' promises of social responsibility.  The slanting of these efforts towards one end of the political spectrum, one party, and now the current president suggest that these corporations may have partisan agendas.

Note that without the various ongoing investigative efforts mainly inspired by the actions of the Trump administration, we would have little idea that this was going on.

May such investigations continue and intensify.  Maybe the recent elections, which gave the opposition to the Republican party and Trump control of the US House of Representatives, will lead to more such investigations.

Furthermore, the increasing knowledge of these corporate actions raises a big question: cui bono? who benefits?

It is obvious why a pharmaceutical company, for example, might want to defeat legislation that would lower its prices.

It is not obvious why it would want to consistenly support actions by one party, or by people at one end of the political spectrum, even if some such people seem "anti-business."  After all, for years big corporations and their executives openly gave money to both US parties and their candidates, apparently in the belief that this would at least allow more visibility for the corporations' priorities no matter who was in power.

Now, the most obvious theory is that the new practice of secret donations only in right-wing, Republican, and/or pro-Trump directions, which must be orchestrated by top corporate management, and which are not disclosed to employees or smaller corporate shareholders, are likely made to support the top managers' self interest more than the broad priorities of the corporations and their various constitutencies.

Thus not only is more investigation needed, at the very least, "public" corporations ought to fully disclose all donations made to outside groups with political agendas.  This should be demanded by at least the corporations' employees and shareholders, but also by patients, health care professionals, and the public at large.

Meanwhile we are left with the suspicion that top health care corporate management is increasingly merging with the current administration in one giant corporatist entity which is not in the interests of health care, much less government by the people, of the people, and for the people.


Thursday, July 14, 2016

Abort, Retry, Fail - Billionaire Bill Gates Opines, Sans Evidence, on ... the Efficacy of Hepatitis C Treatment?

If you needed advice about the technical characteristics of computer operating systems you probably would not go to your doctor for it.  So why would you seek the opinion of a software company mogul about the efficacy of pharmaceuticals?

Software Mogul Bill Gates on the Pricing and Efficacy of Antiviral Drugs for Hepatitis C 

Nonetheless, per Bloomberg, last week Bill Gates pontificated about drugs for the treatment of hepatitis C.  When apparently asked about the priorities of the Bill and Melinda Gates Foundation, Mr Gates said

market forces were working properly in hepatitis C, invoking Gilead Sciences Inc.’s treatments Sovaldi and Harvoni, which have been criticized by insurers and politicians as too expensive at $1,000 a pill or more for 12 weeks of treatment, before discounts and rebates.

While Gilead is the market leader, it’s now facing competition from Merck & Co. and AbbVie Inc., forcing prices lower.

'Curing hepatitis C, this is a phenomenal thing, and now you have multiple drug companies competing in terms of the quality and the price of that offering,' he said.

More broadly, Mr Gates defended the high prices of drugs in the US, partly because:

The drug companies are turning out miracles....

Not a Wonder Drug, According to the Clinical Research Evidence

Mr Gates, it seems, has not done a critical review of the data on the new antiviral treatments for hepatitis C.  In fact, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts herehere, and here.)

Why Do Rich People Who Run Foundations Tout Expensive Drugs?


Yet there is something about hepatitis C and the newer treatments of it that seems to inspire rich people who run foundations to sound like marketers for Gilead, sans evidence to support their viewpoints.  About one year ago, former US President Bill Clinton, now a leader of the well-publicized Clinton Foundation and of the now apparently independent Clinton Health Access Initiative, said something similar, as we posted here:

Clinton pointed to new hepatitis C drugs, Sovaldi and Harvoni, which are sold by Gilead Sciences for more than $80,000 for a 12-week program of treatment. Those medications often cure a disease that can cause liver disease and eventually lead to transplants or death, which are expensive, too. But the sticker price on the drug has caused a backlash by payers and patients.

'Who wants to let somebody's liver rot? Nobody,' Clinton said. 'Who's got $80,000 to spend? Not many. And if you're a small businessperson and you're in a small pool [of employer-based insurers], are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them.'

So what is going on here?  In a general sense, it may be that people who have become very rich, and have held very high level executive positions, start to believe they are expert on everything, especially in a country increasingly dominated by market fundamentalism/ neoliberalism in which money is touted as the ultimate measure of everything important.  But more specifically, Mr Gates may also be spending too much time with the top brass of his foundation, who may be all too used to hawking expensive drugs.

Former Pharmaceutical and Biotechnology Executives Running Supposedly Charitable Foundations

In particular, the current CEO of the Gates Foundation is Dr Susan Desmond-Hellmann.  When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I suggested that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  During her previous service as President of Drug Development at Genentech, Dr Desmond-Hellmann had defended the then sky high pricing of bevacizumab.  Of course, Dr Desmond-Hellmann, as a top executive, personally profited from such pricing.  In her last year at Genentech while the company was still independent, her total compensation was over $8,000,000.  As we discussed in 2014, while she was at UCSF, questions arose about her committment to public health when it was revealed she and her husband had large stock holdings in the tobacco company Altria.  Yet she continued to dismiss the importance of her many apparent conflicts of interest.

Also, in 2011, prior to the hiring of Dr Desmond-Hellmann, as we discussed here, a PLoS Medicine article by Stuckler et al(3) suggested a revolving door between the leadership of the Gates Foundation and of pharmaceutical and biotechnology companies,

Members of personnel also move between the Foundation and pharmaceutical companies. For example, in April 2010, a former Merck senior vice president, Richard Henriques, became the chief financial officer of the Gates Foundation. At least two other members of the Gates Foundation leadership have transferred from the leadership of GlaxoSmithKline to sit on the Foundation’s board of directors, including Kate James, the chief communications officer, and Tachi Yamada, until February 2011, the head of the Foundation’s global health program. Similar patterns were observed with the other foundations studied.


Foundations Promoting the Biotechnology and Pharmaceutical Agenda

Dr Desmond-Helmann has continued to use her bully pulpit at the Gates Foundation to promote high-tech medicine that uses the newest, most expensive drugs.  For example, in an interview in December, 2015 in the Washington Post, she promoted "precision public health" which would emphasize the supposed "innovation, that speed, that ability to use big data" characteristic of precision medicine brought to public health.  However, "precision medicine" has so far not been proven to fulfill its promise to benefit patients.

In addition, in May, 2016, a Wall Street Journal article noted that she has led the Gates Foundation to invest in commercial biotechnology firms,

Dr. Desmond-Hellmann cited a $52 million investment by the foundation in CureVac, a German biopharmaceutical company, as the type of partnership that could produce new tools against epidemics. CureVac is developing vaccine technologies based on messenger RNA that would instruct the body to produce its own defenses against infections. The funding, which the foundation announced in 2015, is for construction of a manufacturing facility; the foundation said it would provide additional funding to develop vaccines for several infectious diseases.

Are these investments the best way to provide better global health care?  An aside in the Bloomberg article suggests they may be more about making money.

The foundation reported in May that it had received an unexpected boost to its endowment when a stake in a small biotechnology firm, Anacor Pharmaceuticals Inc., sold for $86.7 million -- about 17 times the fund’s original investment. While the foundation had invested in Anacor to encourage the company’s work in neglected diseases, Anacor shares took off after its toenail fungus drug was approved.

I am sure that toenail fungus is not a major public health problem anywhere, much less in the developing world.

The tragedy here is that the Gates Foundation, which appears to be the largest private foundation in the US (and the world), has a huge impact on global health, and yet its leadership is squandering its moral authority in the pursuit of the pharmaceutical/ biotechnology agenda.  A review of a new book out about the foundation in November, 2015 in the Intercept noted that the book's author

spends much more time discussing whether the Gates Foundation is protecting the patents of pharmaceutical companies and whether it is making common cause with Monsanto to spread genetically modified crops in Africa

In January, 2016, the  Global Policy Forum put out a report that, per a Guardian article,  accused

organisations like the Bill and Melinda Gates Foundation, the Rockefeller Foundation and others are promoting solutions to global problems that may undermine the UN and other international organisations, says the report by the independent Global Policy Forum, which monitors the work of UN bodies and global policymaking.

Futhermore, the report asserted,

 Through their multiple channels of influence, the Rockefeller and Gates foundations have been very successful in promoting their market-based and bio-medical approaches towards global health challenges in the research and health policy community – and beyond.

More specifically, an article in the Independent accused the foundation of having a

ideological commitment to promote neoliberal economic policies and corporate globalisation


The report, per the Guardian, also accused the foundation of conflicts of interest,

The report also questions why the Gates foundation invests heavily in companies like Monsanto and Bayer. 'In addition to its grant-making activities, the Gates foundation has recently stepped up its support for the biotechnological industry directly.'

Also, similar to the PLoS Medicine article cited above(3)

'There is a revolving door between the Gates foundation and pharmaceutical corporations. Many of the foundation’s staff had held positions at pharmaceutical companies,' the report adds.

More dramatically, per the Independent,

the Gates Foundation 'often appears to be a massive, vertically integrated multinational corporation, controlling every step in a supply chain that reaches from its Seattle-based boardroom … to millions of end-users in the villages of African and south Asia.'

Furthermore, per the Intercept book review article, the larger problem is that the Gate Foundation and its CEO are largely unaccountable,

Bill and Melinda Gates answer to no electorate, board, or shareholders; they are accountable mainly to themselves. What’s more, the many millions of dollars the foundation has bestowed on nonprofits and news organizations has led to a natural reluctance on their part to criticize it. There’s even a name for it: the 'Bill Chill'  effect.

I would note parenthetically the foundation's board of trustees only includes Bill and Melinda Gates, Mr Gates' father, and Mr Warren Buffet.  Most large foundations have considerably larger boards of trustees, with at least some diversity in family membership and backgrounds.

In an interview with the Financial Times in March, 2016, Dr Desmond-Hellmann made a hash of addressing the accountability issue:

Accountability is another concern. To whom do these multibillion-dollar foundations answer?

For once, Dr Desmond-Hellmann’s confident responses falter. In reply to a suggestion that trans­parency is not the same thing as accountability — putting everything online means you can see what the foundation is doing, but does not mean that it is being held to account — she seems uncharacteristically stuck for words.

'The way that people can hold us accountable is to look at what we achieved as a foundation through our collaborations,' she says, quickly regaining her poise.


So even the foundation's CEO cannot say to whom, and how she is accountable.


Conclusions

So maybe Bill Gates' seemingly ill-informed apologia for the extremely high drug prices charged in the US, and his lack of understanding of the evidence about the efficacy, or lack thereof, of some of these high priced drugs is a small humorous story that indicates just the tip of the iceberg.  It appears that in our current market fundamentalist, neoliberal world, foundations may be more about promoting the commercial interests of their board members and officers than about improving the lot of humanity.  Yet for the most part they may succeed in obfuscating what they are doing through the haze of marketing and public relations.

True health care reform would first make transparent the web of institutional and individual conflicts of interest that seems to tie together nearly all big health care organizations, and open discussion of how to make health care organizations better serve health care rather than the narrow financial interest of their top leaders.

Graphic Interlude

A "blue screen of death"



 References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3.  Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020.  doi:10.1371/journal.pmed.1001020.  Link here.

Thursday, February 11, 2016

Bio-Tech U, Version 2 - Current Board Member of Four Biotechnology Companies, Fomer Pfizer Director, Former Genentech Executive to be President of Stanford

Stanford University will soon have a new president.  According to the New York Times,

Stanford University’s incoming president, Marc Tessier-Lavigne, has developed a career that successfully melds science, business and academia.

Although he is now coming off a stint as president of Rockefeller University in New York starting in 2011,  his business connections are extensive.

A Genentech Executive

The NYT noted,

He may be best known, though, for his work at Genentech. As the No. 2 executive in research, he oversaw 1,400 scientists in one of the most innovative and successful companies in the biotech industry, known for the groundbreaking cancer drugs Avastin, Rituxan and Herceptin.

To expand that, his brief CV on the Rockefeller University website included,

1991 - 2001  increasingly senior faculty positions at UCSF
2001 - 2003  professor at Stanford

2003 - 2008  senior vice president, research drug discovery, Genentech Inc

2008 - 2009  exectuive vice president, research drug discovery, Genentech

2009 - 2011  chief scientific officer, Genentech

Member of Multiple Biotechnology Corporate Boards of Directors, Chairman of One

However, his involvement with the pharmaceutical and biotechnology industries hardly ends there.  He currently is on four biotechnology corporate boards of directors.  These include:

Agios 

For which he received compensation of $374,926 in 2014, according to the 2015 proxy statement.  His holdings in the company were then 130,122 shares.

Juno Therapeutics Inc

For which he received compensation of $30,000 in 2014, according to the 2015 proxy statement.  His holdings in this company were then 175,000 shares Series A2 convertible preferred.

Regeneron Pharmaceutical

For which he received compensation of $1,764,032  in 2014, according to the 2015 proxy statement.  His holdings in this compary were then 34,716 shares.

Pfizer, then Denali Therapeutics

Also, in 2011, he became a member of the board of directors of Pfizer, Inc.  He left in 2015 when he co-founded, and became chairman of the board of a new biotechnology company, Denali Therapeutics.  In 2014, according to the Pfizer 2015 proxy statement, he received compensation of $300,000.  His holdings in the company then were 104 shares of stock, and 24,307 stock units

He remains as chairman of the board of Denali, according to the company website.  Since this company is privately held, I could not find any information about the compensation or holdings of board members.

Discussion

To summarize, the incoming president of Stanford, on of the most prestigious American universities, one of the foremost US sites for biomedical research, and home to an equally prestigious medical school and academic health center, spent most of the last 15 years heavily involved with the pharmaceutical and biotechnology industries.  He was a top Genentech executive for eight of those years, served as a director of the then biggest US pharmaceutical company, and currently is a member of the boards of directors of four biotechnology companies, and is chairman of one of them.  He earned nearly $2.5 million dollars from these directorships in 2014, the last year for which such data is public, and owned hundreds of thousands of shares of stock in these companies.

How he had the time to executive all his fiduciary responsibilities as a director of four health care corporations while being the president of Rockefeller University, and apparently continuing to do his own research boggles the mind.  

However, Stanford's incoming president is a perfect example of how health care is now run by an interlocking group of insiders who have personally profited massively from their situated influence.   

So in whose interests will he act as president of Stanford?  The New York Times cited those who hailed his scientific prowess.

According to Susan K. McConnell, a professor of biology at Stanford, Dr. Tessier-Lavigne was responsible for a 'long list of amazing discoveries' involving identifying molecules that guide the growth of nerve connections in the developing brain.

On the other hand, he had important affiliations with two biotechnology companies that were known for leading the charge for stratospheric drug prices as much as they were known for developing innovative drugs.  By coincidence, or not, he was a top executive for the same company, Genentech, as was Dr Susan Desmond-Hellman, who later became the leader of the University of California - San Francisco.  As we noted here, Dr Desmond-Hellman was a public defender of such pricing, in particular, of the then (2007) stratospheric $55,000 a year price of bevacizumab (Avastin).

Prof Tessier-Lavigne also is currently on the board of Regeneron, which became known for charging $1850 per montly dose of Eylea, a drug for macular degeneration, while paying its board members and executives proportionately large amounts.  As we noted above, Professor Tessier-Lavigne got over $1.75 million in 2014 for his board service, and in 2014, the company's CEO received over $36 million.

In an interview with the NY Times, professor Tessier-Lavigne said,

We do have to ensure access [to Stanford], broadly, both in terms of access for people who are disadvantaged socioeconomically and, of course, diversity

But how easy would it be for a man with his biotechnology corporate connections and the riches they produced for him to step into the shoes of disadvantaged, diverse students (or patients)? 


When asked about his corporate background, he told the NY Times,

that before taking the reins at Stanford in September, he will review all his corporate relationships with the board to determine whether any conflicts of interest exist.

That suggests doubt about the existence of such conflicts. But as we first wrote in 2006,

Medical schools and their academic medical centers and teaching hospitals must deal with all sorts of health care companies, drug and device manufacturers, information technology venders, managed care organizations and health insurers, etc, in the course of fulfilling their patient care, teaching, and research missions. Thus, it seems that service on the board of directors of a such public for-profit health care company would generate a severe conflict for an academic health care leader, because such service entails a fiduciary duty to uphold the interests of the company and its stockholders. Such a duty ought on its face to have a much more important effect on thinking and decision making than receiving a gift, or even being paid for research or consulting services. Furthermore, the financial rewards for service on a company board, which usually include directors' fees and stock options, are comparable to the most highly paid consulting positions. What supports the interests of the company, however, may not always be good for the medical school, academic medical center or teaching hospital.

Last year, Anderson et al documented the prevalence of such board level conflicts of interests, and wrote,(1)

previous guidelines have emphasized the relationships of clinicians and researchers with industry, but institutional conflicts of interest, which arise when administrators, including executive officers, trustees, and clinical leaders have a financial relationship with industry, are increasingly recognized and pose a unique set of risks to academic missions.

If Professor Tessier-Lavigne has doubts whether his current service on four biotechnology boards of directors, as chairman of one of these companies, as former board member of Pfizer, and as former executive of Genentech could create any conflicts of interest, the students, faculty, patients and alumni of Stanford should be very wary of what direction he will take their university.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.

Reference
1.  Anderson TS, Good CB, Gellad WF.  Prevalence and compensation of academic leaders, professors and trustees on publicly trade US healthcare company boards of directors: cross sectional study.  Brit Med J 2015; 351:h4826.  Link here

Monday, May 05, 2014

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)

Two Somewhat Redundant Lancet Articles

Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)

After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, before being poached by Arthur Levinson, the then Head of Research and Development at Genentech. Levinson was convinced Genentech had a strong pipeline of anticancer therapies, and brought Desmond-Hellmann on board to help guide them through to approval. The pipeline went stratospheric, and took Desmond-Hellmann with it. By 2009 she had been promoted to President of Product Development, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.

After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco,

Over the next 5 years, Desmond-Hellmann instituted wide-ranging reforms at UCSF, including aggressively cutting administrative waste and putting a greater emphasis on partnerships with the biotech and pharmaceutical sectors, coming in for some criticism in the process. 'Some of the press suggested one of Sue's goals was to take UCSF out of the public system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was very proud of the public mission of UCSF, and had no intent to alter that.' Mindful of how damaging perceived conflicts of interest could have been to her credibility during her time at UCSF, Desmond-Hellmann says she 'specifically avoided being on pharma and biotech boards'.

The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation,

it is Desmond-Hellmann's ability to forge partnerships and her wide network of contacts, rather than her knack for cutting administrative overheads, that will have seemed most attractive to the Gates Foundation as it looks to speed up the process of translating research into results.

The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business,

Soon after joining the Taxol team, Desmond-Hellmann was leading it; the kind of progress that was bound to catch the eye of Genentech's then Head of Research and Development Arthur Levinson. What happened next is part of pharmaceutical folklore, as Desmond-Hellmann helped to mastermind one of the most profitable drug-development pipelines in history, including the approval of two of the first targeted cancer therapies, for Genentech.

Also, regarding her career at UCSF,(2)

 Desmond-Hellmann from embarking on a programme of structural reforms to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain concerns in academia, about conflicts of interest, privatisation. I think what helped most was that I was clear in my actions that I did and do value that UCSF is a public institution, and I think my actions spoke and speak for themselves', she says. But Desmond-Hellmann is robust in her defence of the importance of public—private partnerships for driving innovations that ultimately benefit society.

Finally, regarding expectations for her performance in the future,

'There are a lot of people who are looking to the foundation, and in the world of philanthropy there's a lot of visibility to the Bill & Melinda Gates Foundation, so I certainly feel accountable and responsible for doing a good job.' But, she asserts, 'I'm up for it'. With a track record that ranges from clinical research, global health, and the sharp end of commercial drug development, she seems to be made for it.

So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO.  Both articles made the same points,
-  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs
-  Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest
 -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO.

What the Articles Did Not Say

When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I suggested that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor.  In particular,

Defending $55,000/ Year Bevacizumab

As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3)

And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development, at AACR.

Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost.

The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326.

Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, said Genentech spokesperson Edward Lang.

What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have 'hovered close to zero' throughout the life of the industry.

Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to Genentech's 2008 proxy statement, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income.

Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent.  The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people.

Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO. 

Investments in Tobacco Stocks

As I posted in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000.  When this made public, they abruptly sold the stock.  The head of the UCSF tobacco control center then said,  “I do find that kind of shocking, but at least she got rid of it,...”

The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a tobacco control initiative, with a stated goal:

to reduce tobacco-related death and disease in developing countries by preventing the initiation of new smokers, decreasing overall tobacco use, and reducing exposure to secondhand smoke.

The Lancet articles were silent on this issue.  

Questions Whether Industry Partnerships Threaten the University Mission

In 2011, I posted about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop.  At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships.  The Lancet articles did not mention any substantive concerns about this issue.

Dismissing Concerns about Conflicts of Interest

In 2012, I posted about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies.  In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "start a company or work with a company to commercialize a product."  She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products.  The Lancet articles were silent on these issues.

Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas

As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies.  These, of course are not the only sorts of for-profit corporations who have health care agendas.  This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's 2013 proxy statement.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a Global Health and Grooming unit, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has also owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just reported, it will soon sell this unit to private equity.   So while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care.  (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.)  The Lancet did not mention this issue. 

Privatizing UCSF

Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)    

However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private.  However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system.  This week, an article in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann

ran into opposition when she  proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system.

The autonomy coming from the separation, Desmond-Hellmann argued at the time, would have meant that the sole graduate-level-only campus in the 10-campus UC system would no longer subsidize UC undergrad programs. It also would have translated into UCSF having more control over the money it generates from its medical center and other operations.

However, the same article noted that the current University of California President,

dismissed as 'loose talk' a more than two-year-old plan for UCSF to weaken its ties to the larger UC system. 'UCSF is firmly part of the system and will remain so,...'
The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been.  Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.  

Summary

We have often discussed the anechoic effect, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations.  This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals.

The Lancet is one of the largest circulation and most prestigious medical journals.  The Gates Foundation is one of the biggest foundations working in the health care sphere.  In their latest letter, Bill and Melinda Gates stated,

Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and poor health in developing countries, and the failures of America’s education system.

Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before.  That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect.

I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest.  It would be more reassuring, however, if they could be confronted directly rather than obfuscated.  As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute.

As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests. 


References

1.  Holmes D. New CEO takes the reins at the Gates Foundation.  Lancet 2014; 383: 1440.  Link here.
2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link here.
3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link here.

ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM. 

Wednesday, February 15, 2012

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared in yesterday's Wall Street Journal.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.)

The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began,
Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.

Then it stated that the interviewee:
has no such qualms.

The defense of this lack of qualms was heavily based on logical fallacies.

Biased Sample or Hasty Generalization

The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked:
What are the trickiest conflicts of interest to navigate?

The answer was:
Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?
This may be tricky, but is arguably not the most tricky kind of conflict of interest.

The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote ­Risperdal as a safe and effective medication." (See this post.)

Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) biased sample, if not, it appears to be a hasty generalization.

The interview also included a few other choice logical fallacies that went unchallenged by the interviewer.

False Dilemma

The interviewer asked:
What do you tell professors who won't work with drug or biotech companies?

The response was:
I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.

Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative.

The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a false dilemma.

Straw Man

The interviewee worked another argument into the same paragraph:
When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'

I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the straw man fallacy.

Summary

So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies. 

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, herehere, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

In 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power.

The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just named one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look here). 

She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted here, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche. 

As we noted previously, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see this Reuters article). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.]
Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Wednesday, December 28, 2011

Legal Settlements Have Become So Common that They are Barely News

Legal settlements by big health care organizations have become so common that those of less than blockbuster size barely seem to qualify as news.  They have become "dog bites man" stories.  For example, the following stories barely got noticed in the media (presented chronologically).

Novartis Settles Price Misrepresentation Suit for $150 Million

This story was mentioned as an aside in a a news story covering a settlement by Watson Pharmaceuticals in September.  In slightly more detail, it has only appeared in PharmaLot in November.  In a very small nutshell,
the Sandoz unit of Novartis earlier this week agreed to pay $150 million to settle lawsuits filed by the states of Florida and California, as well as a whistleblower, to settle charges that it deliberately misreported pricing information in order to hike reimbursements from Medicaid.

By the way, per the settlement document, the allegations were that Novartis' subsidiary knowingly maintained, set or reported "false, fraudulent, and/or inflated Reported Prices," yet, as is typical of nearly all settlements, the settlement "shall not constitute or be construed as an admission of fault, liability, or unlawful conduct."

Roche Settles Off-Label Promotion, Physician Kickback Suit for $20 Million

This story was reported briefly in some blogs, including again PharmaLot, and in the most detail in the San Francisco Business Times. The basics of it were:
Genentech Inc. will pay $20 million to settle a whistleblower lawsuit around off-label marketing of the cancer-fighting drug Rituxan.

It only took eight years since a whistle-blower raised the issue:
John Underwood, ... was a senior manager of sales development from the start of Genentech’s oncology franchise in 1997.

When Underwood filed the suit in July 2003 in U.S. District Court for the Eastern District of Pennsylvania, he was a senior hospital systems specialist for Genentech.

This suit is actually of particular interest because it was not just about off-label promotion,
Genentech, the suit claimed, retained doctors to act as independent speakers on behalf of Rituxan and its off-label uses, paid kickbacks to doctors that were disguised as consulting payments, 'exerted significant pressure' on sales reps to increase off-label uses of Rituxan, and devised and conducted 'selling skills workshops' for sales reps devoted to non-label uses,

What’s more, the suit claimed, Genentech invited doctors to attend “medical education seminars” at 'luxurious locations' and gave financial incentives to sales reps to get doctors who sold the most Rituxan to attend the events.

These were serious allegations, involving allegedly direct efforts by the company to subvert physicians' ethics by tying their decisions for individual patients to payments for prescribing specific products whatever the benefits and risks of those products for those patients.  The allegations suggested that "consulting payments" to physicians may be nothing more than disguised bribes, and that the companies making these payments may be quite conscious of this. 

Nonetheless, as usual,
Genentech, the South San Francisco-based U.S. subsidiary of Swiss drug giant Roche, did not admit wrongdoing....

So, as in the famous recent Citigroup case (see this post), the settlement obfuscates the crucial question, did the corporation involved commit illegal acts? It seems likely that what they did was in some sense unethical, since they were willing to pay millions not make the matter go away.

By the way, one member of the Executive Committee of Genentech at the time these events were allegedly occurring is now the Chancellor of the University of California - San Francisco (See our post here). Maybe concerned students or faculty might ask her what really went on.

CVS Caremark Settles Fraud Suit for about $20 Million

As reported briefly in the Los Angeles Times,
Pharmacy and prescription drug management company CVS Caremark Corp. has agreed to pay nearly $20 million to settle three lawsuits involving allegations that the company defrauded pension systems in three states, including California’s giant pension fund, attorneys said.

The whistleblower lawsuits, filed by two former CVS Caremark pharmacists, accused the company of reselling returned drugs, changing prescription orders to make them more expensive and submitting false reports about how long it took to fill prescriptions.

Not the least bit surprisingly, the company did not admit liability in the settlement, and had no comment for the Times. Ho, hum, another big company paying millions to make allegations of fraud go away... nothing to see here, so we will just move on.

Merck Settles Fraud Suit for $24 Million

This story was picked up by AP, so a very brief version of it did appear in a variety of locations. A longer version was published by the Boston Globe,

At this point, it should be no surprise that it took a long time to get to this settlement, eight years in fact, just as in the case above,
Merck & Co. has agreed to pay $24 million to the state Medicaid program to settle long-running civil charges that it charged too much for some drugs, in the largest single-case Medicaid fraud settlement in Massachusetts history.

The agreement, unveiled yesterday by Attorney General Martha Coakley’s office, closes out a 2003 lawsuit....

Again, the allegations were of fraud,
Coakley said her office’s Medicaid fraud division wanted to hold accountable drug companies that defraud taxpayers.

Again, "hold accountable" did not translate into establish the allegations as true,
Ron Rogers, a spokesman at Merck corporate headquarters, said the drug company did not admit liability or wrongdoing in the settlement. He said Merck agreed to resolve the claims to put the matter behind it.
Nothing more to see here, so we will move on again.
Summary

Every month, it seems that more settlements are announced of cases alleging all sorts of wrongdoing by major health care organizations. Very often, the allegations are of wrongdoing that appears serious to the uninitiated. For example, most of the above cases involved allegations of fraud, and one involved allegations of kickbacks, that is, bribes to doctors.

Yet, in every one of these cases -
- The monetary penalties were barely more than pocket change for the corporations involved.
- The payments were made by the organization as a whole, and hence would disadvantage many people who were not involved in and did not benefit from the specific actions alleged. Such de facto victims of the settlement included company shareholders, employees, and probably patients (who may have paid prices raised to pay for settlements), and the public (who may have indirectly paid these higher prices through insurance premiums or taxes.)
- The organization did not have to admit any facts, leaving the record foggy, and clouding the chances for any people who might have been hurt by the actions to take legal action.
- No people who actually authorized, directed, or implemented the apparent bad behavior suffered any negative consequences.

Thus, these settlements, like many others we have discussed, did not appear to be any major deterrent of future bad behavior.

These settlements do provide a public, if largely ignored, record that suggests how a miasma of sleazy behavior, if not outright corruption has settled over health care. These settlements do provide the context for many pithy questions that could be asked of health care organizational leaders, if anyone dared to do so. The settlements do suggest a need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.