Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence.

An article in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against suppression and manipulation of clinical research. In summary,

The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.

More specifically,

The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.  The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.

The email describes a four-pronged campaign that starts with 'mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.

The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.

The argument for continuing to allow clinical trials to be suppressed was to be,

The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.

The Guardian story did not disclose which patient groups were cooperating with this effort.

By the way, the other parts of this strategy involved using scientific associations and academics to push the pharmaceutical companies' agenda,

 Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. 

Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials

In response to queries from the Guardian, GSK said: 'This is not something we are doing. One of the reasons we're involved in this is we want more companies to move towards greater transparency. I don't think it's for us to be mobilising patient groups to campaign on a negative level.'

A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but 'to our knowledge Roche has not been involved in any EFPIA's potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'.

A Lilly spokesman said: 'Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly's integrity in business policy.'

Summary

We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have manipulated clinical research to make their wares look better, and suppressed research whose results, even if manipulated, could not be made sufficiently favorable. This has resulted in making drugs and devices look more efficacious and/or less hazardous than they really are.  See this post for our latest discussion, and information on the latest effort to counter suppression and manipulation of clinical research.

It is not surprising that pharmaceutical companies do not want to have to publish every clinical trial they sponsor, or expose their manipulations of these trials.  Instead, the Guardian article suggests that companies and their trade associations, including the US based pharmaceutical trade association, and several large US companies, and well as large companies based elsewhere, are using a third-party public relations strategy.  Wendell Potter's muckraking book on the US commercial health care insurance industry, Deadly Spin, revealed how similar strategies were used by US based health insurance companies to defeat the Clinton administration's attempt at health care reform, and other measures targeted to make the US commercial health care insurance system more equitable and ethical  (see post here).  Third party strategies are fundamentally deceptive.   

The current alleged use of the third party strategies by pharmaceutical companies to support ongoing suppression and manipulation of clinical research is more than just deceptive.  It is corrupt.

Patient advocacy groups are usually believed to represent patients' interests.  For such groups to support a public relations campaign that could allow ongoing harm of patients (by suppressing and manipulating evidence to prevent it from being used to forestall excess use of ineffective, dangerous drugs) is abuse of their entrusted power.  To do it for money, money used to support these groups, or help underwrite generous compensation for their executives, fits the definition of corruption used by Transparency International - abuse of entrusted power for private gain.

Note that the Guardian provided this viewpoint,

Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry's financial links with patient groups, said: 'It's incredibly ironic that this is a transparency initiative and we've now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner.

'It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There's a hidden agenda here. The patient groups will say they think it's a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.

'Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,' he added.

We have previously noted isolated examples of evidence that particular US based patient advocacy groups were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting medical societies, and many affecting non-profit hospitals and academic medical institutions, and their staff and faculty.  I begin to wonder if most health care non-profit organizations in the US, and now it appears maybe in UK and in Europe, have been paid off to support marketing and/or public relations interests of health care corporations.

This latest example suggests that health care worldwide has become deeply corrupt, even more corrupt than Transparency International's Global Report on health care corruption in 2006, or the those responding to Transparency International's global corruption survey in 2013, could envision.

I only hope that the pile up of new examples - each seemingly worse than the one before - of health care corruption, will be sufficient to overcome the anechoic effect, and create enough global outrage to give us a chance to clean up our corrupt health care before it destroys our health.

ADDENDUM (25 July, 2013) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. 

ADDENDUM (29 July, 2013 - See the comment on the 1BoringOldMan blog. 

Smart ALEC's Strange Bedfellows

 A number of articles in the Nation, plus posts by some of our blogging colleagues discussed the American Legislative Exchange Council (ALEC) and its role in policy, including health policy advocacy.  The lead article, "ALEC Exposed," in the Nation, characterized ALEC as:

a critical arm of the right-wing network of policy shops that, with infusions of corporate cash, has evolved to shape American politics. Inspired by Milton Friedman’s call for conservatives to 'develop alternatives to existing policies [and] keep them alive and available,' ALEC’s model legislation reflects long-term goals: downsizing government, removing regulations on corporations and making it harder to hold the economically and politically powerful to account. Corporate donors retain veto power over the language, which is developed by the secretive task forces. The task forces cover issues from education to health policy.

ALEC and Health Care Reform
Wendell Potter contributed an article about ALEC's position on health care reform. First,

ALEC crafted the Freedom of Choice in Health Care Act, which, despite its Orwellian name, was written to deny the citizens of any state that passed it the freedom to set up such a system. By declaring that Congressional attempts to regulate health insurance at the federal level would be unconstitutional, it would effectively ban not only a federal single-payer proposal but also a federally created health insurance exchange and a federally operated public insurance option.

ALEC

adopted a strategy to shape rather than stop reform. Its top five goals became:

§ Keeping single-payer proposals off the table;

§ Ensuring that the final bill contain a clause requiring all Americans not eligible for an existing federal program to buy coverage from a private insurance company; [note that thus the "mandate" that pseudo-conservative groups like the Tea Party hate seems to have been pushed by big commercial insurance firms, and by some of the Tea Party's backers, not by the "big government" the Tea Party also loves to hate]

§ Preventing the new law from establishing a government-run plan (the 'public option') that would compete with private insurers;

§ Making sure that the reform law is implemented primarily at the state level, to keep the federal government from assuming any significant new oversight of private insurers’ business practices; and

§ Keeping any new regulations and consumer protections to a minimum.

Insurers achieved their first four goals, with ALEC playing a key role in a well-coordinated effort to keep the most progressive proposals from being enacted at the state or federal level.

Corporate Funders and Influencers
The articles in the Nation suggest that ALEC's health policy advocacy is shaped only by commercial health care insurance. However, it appears that ALEC is supported by a much broader spectrum of health care corporations and other corporations whose products affect health care. It's "Private Enterprise Board" includes Mrs Sandra Oliver, First Vice Chairman, Bayer Corp; Mr John Del Giorno, Second Vice Chairman, GlaxoSmithKline; Mr David Powers, Treasurer, Reynolds American; and Board Members Mr Don Bohn, Johnson and Johnson, Mr Jeffrey Bond, PhRMA, and Mr Michael Hubert, Pfizer.

A PRWatch special report on its funding noted:

98% of ALEC's funding comes from corporations like Exxon Mobil, corporate 'foundations' like the Charles G. Koch Charitable Foundation, or trade associations like the pharmaceutical industry's PhRMA and sources other than 'legislative dues.'

In more detail,

Other current ALEC corporate leaders have given an undisclosed sum to ALEC this year and before.

These companies include: CenterPoint 360 (a firm that helps companies 'manage legislation'), Altria (formerly Phillip Morris tobacco), the American Bail Coalition (the trade group for for-profit bail bonds), AT&T, Bayer (aspirin), Coca-Cola, Diageo (Crown Royal and other liquor), Energy Future Holdings (Texas electricity), ExxonMobil, GlaxoSmithKline (Tums and other brands), Intuit (Quickbooks), Johnson & Johnson (lotion), Koch Industries (Georgia Pacific paper products and other brands), Kraft Food (Macaroni and Cheese dinners), Peabody Energy (the largest private coal company in the world), Pfizer (Viagra), PhRMA (the pharmaceutical trade group), Reed Elsevier (Lexis/Nexis legal research), Reynolds American (tobacco), Salt River Project (energy), State Farm Insurance, United Parcel Service, and Wal-Mart (world's largest retailer).

So ALEC supporters include some very strange bed fellows.

Commercial Insurance in Bed with Pharma
ALEC has championed health care positions that seem designed to favor commercial health insurance.  However, it is supported by many corporations with which commercial health insurance ostensibly negotiates at arms length, and whose prices commercial health insurance ostensibly wants to lower.  These include pharmaceutical companies, Bayer, GlaxoSmithKline, and Pfizer, and pharmaceutical/ biotechnology/ device conglomerate Johnson and Johnson, all represented by PhRMA. 

It is very curious, to say the least, that such companies are helping to fund a set of policy objectives all designed to further the interests of commercial insurance companies as listed above.  Perhaps the leaders of drug companies think that commercial insurers are likely to be easier negotiators than would be some future hypothetical "public option," (government run insurance company).  Perhaps the leaders of commercial insurance companies realize that they can more plausibly raise their administrative costs, and the amounts they pay to top executives, when overall health care costs, fueled by pharmaceutical and device prices, are rising.

A UK Company in Bed with American State Legislators

ALEC is supposed to be directed at American state legislatures, and be a membership organization for American state legislators.  It literally includes a graphic of a waving American flag on its home page.  However, it is supported by at least one foreign (UK) pharmaceutical company, GlaxoSmithKline. 

It is very curious that a British company seems to be seeking to influence the US state legislative process. The appropriateness, and the legality of a British company seeking to influence American state legislatures I leave to be judged by others. 

Pharmaceutical Companies (Including Those that Make Smoking Cessation Products) in Bed with Tobacco Companies

ALEC is supported by pharmaceutical companies that all promise to improve health care.  These particularly include those that make or sell products that are designed to improve health by aiding smoking cessation, (GlaxoSmithKline, Johnson and Johnson, and Pfizer).  However,by their side stand two tobacco companies, Reynolds America and Altria, whose products the pharmaceutical companies' products are designed to counter. 

It is very, very curious that smoking cessation product manufacturers would team up with tobacco companies.  Perhaps cynics among the leadership of the drug companies realize that the market for smoking cessation products increases with tobacco sales.  Perhaps cynics among the leadership of tobacco companies think that the knowledge that there are treatments, albeit not very effective ones, to aid in smoking cessation may encourage people to start or continue smoking (an interesting but rarely discussed example of the "moral hazard" that free market economists love to otherwise discuss).  

Summary

So in my humble opinion, the strange bedfellows among health care related corporations funding ALEC suggest 1) how little the health care system functions like anything resembling an ideal free market; and 2) how top organizational leaders may have feel they have more in common with each other than they do with their more lowly employees, customers, clients, and the public at large.

True health care reform would require decreasing the size and power of large health care organizations, and ensuring that their leaders put their mission, and their patients' and the public's health ahead of their personal enrichment.

Hat tip to Naomi Freundlich's post on the Health Beat blog.

Big Door Keeps On Turning - Bi-Directional Interchanges Among Government and Corporate Health Care Leadership

Recently we noted some complex examples of the health care "revolving door," cases of health care corporate leaders who came from government heading back into government.  The first was reported by Politico:

California Rep. Mary Bono Mack has hired PhRMA’s former chief spokesman as a senior adviser, adding another Republican lawmaker to the list of those who have recruited staff members with K Street ties.

Ken Johnson will serve as a senior policy and communications adviser to Bono Mack, chairwoman of a House Energy and Commerce subcommittee. Johnson has deep ties to the committee, having worked for former Republican Rep. Billy Tauzin when he headed the Energy and Commerce Committee.

When PhRMA hired Tauzin months after the Louisiana congressman helped pass the industry-supported Medicare drug benefit, Johnson followed. So it was not surprising that Johnson did not stay on with PhRMA last year after Tauzin stepped down.

In 2009, Tauzin made more than $4.5 million and Johnson pulled in more than $500,000, according to tax records.

Note that Mr Johnson went from an influential government position to a position representing the pharmaceutical industry, and then back to government
In the same vein and in the same article was:

House Speaker John Boehner hired the medical device industry’s chief lobbyist as his policy director.

Meanwhile, the Minneapolis Star-Tribune noted:

Minnesota health executive Lois Quam has signed to lead the multibillion dollar Global Health Initiative at the U.S. State Department.

A State Department spokesman confirmed Wednesday that Quam will be executive director of the initiative.

In 2009, President Barack Obama committed $63 billion over six years to the program aimed at helping developing nations fight disease, improve nutrition and provide more aid for prenatal and postnatal care.

Quam, of St. Paul, is a former UnitedHealth Group executive who co-founded a health consulting firm last year. She is married to Matt Entenza, a former state lawmaker who ran unsuccessfully for governor in 2010.

The appointment reunites Quam with Secretary of State Hillary Clinton. Quam was a senior adviser to Clinton's health care task force in the 1990s.

Note that Ms Quam went from government leadership (in the Clinton administration's abortive attempt at health care reform via an elaborate version of managed care), to corporate leadership (in one of the largest commercial managed care organizations, some of whose exploits are discussed here), then back to government (now leading global health.  As an aside, UnitedHealth has been developing its global presence for years, e.g., see this post about its forays into the UK.)

We last discussed the "revolving door," that is, the easy interchange among leadership in government and health care corporations here.  The brief news items above shows how the door spins continuously, resulting not only in former government leaders ending up in influential, and well-recompensed positions in the health care industry, but also in industry leaders ending up in influential government positions.  In two cases above, people who started out in influential government positions transitioned to health care corporate positions, and then back to government. 

As we noted earlier, the continually revolving door is a sign of the increasingly corporatist nature of the US.  Government and the biggest corporations now seem to see themselves as natural allies, partially because their leadership increasingly forms a cozy combined group.  The big problem, of course, is such an alliance leaves out everybody else, from small business, to individual professionals, to the people at large. 

As I noted earlier, if we want health care to put the needs of individual patients first, we ought to consider ways to make both government and corporate health care leaders more responsive to the people rather than to their combined self-interest.