healthy4u: patient advocacy groups

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<a href="http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials"> article</a> 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 <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research. In summary, <blockquote class="tr_bq">The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs<a href="http://www.guardian.co.uk/science/drugs" title="More from guardian.co.uk on Drugs"></a> trials.</blockquote> More specifically, <blockquote class="tr_bq">The strategy was drawn up by two large trade groups, the <a href="http://hcrenewal.blogspot.com/search/label/PhRMA">Pharmaceutical Research and Manufacturers of America (PhRMA)</a> 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 <a href="http://hcrenewal.blogspot.com/search/label/Roche">Roche</a>, <a href="http://hcrenewal.blogspot.com/search/label/Merck">Merck</a>, <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">Pfizer</a>, <a href="http://hcrenewal.blogspot.com/search/label/GlaxoSmithKline">GSK</a>, <a href="http://hcrenewal.blogspot.com/search/label/AstraZeneca">AstraZeneca</a>, <a href="http://hcrenewal.blogspot.com/search/label/Eli%20Lilly">Eli Lilly</a>, <a href="http://hcrenewal.blogspot.com/search/label/Novartis">Novartis</a> 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.</blockquote> The argument for continuing to allow clinical trials to be suppressed was to be, <blockquote class="tr_bq">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.</blockquote> 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, <blockquote class="tr_bq"> 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. </blockquote>Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials <blockquote class="tr_bq">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.'</blockquote> Summary We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have<a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research"> manipulated clinical research</a> to make their wares look better, and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed research </a>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 <a href="http://hcrenewal.blogspot.com/2013/06/a-call-to-restore-integrity-of-clinical.html">this post</a> 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 <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a>).  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, <blockquote class="tr_bq">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.</blockquote> We have previously noted isolated examples of evidence that particular US based <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">patient advocacy groups</a> were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting<a href="http://hcrenewal.blogspot.com/search/label/medical%20societies"> medical societies</a>, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">many affecting</a> non-profit hospitals and academic medical institutions, and<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest"> their staff and faculty</a>.  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 <a href="http://hcrenewal.blogspot.com/search/label/Transparency%20International">Transparency International</a>'s <a href="http://www.transparency.org/whatwedo/pub/global_corruption_report_2006_corruption_and_health">Global Report on health care corruption in 2006</a>, or the those responding to Transparency International's <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">global corruption survey in 2013</a>, 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 <a href="http://brodyhooked.blogspot.com/2013/07/the-astroturf-speaks-out-more-industry.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.  ADDENDUM (29 July, 2013 - See the <a href="http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/">comment</a> on the 1BoringOldMan blog.

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 artic...

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For Whom Does the Center for the Protection of Patient Rights Advocate?

We have occasionally discussed the cases of  some patient advocacy organizations which seem to be influenced by substantial financial support from the health care industry.  For example, look <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/NAMI">here</a>.  Related are "astroturf" organizations, which promote policies that may be favored by their industrial sponsors (e.g., <a href="http://hcrenewal.blogspot.com/2007/11/cultivating-astroturf.html">here</a>.) Background on the Center for Protection of Patient Rights The topic of this post is the Center for Protection of Patient Rights, which may have started out as something like an astroturf organization, but seems to have become something even more interesting.  The Center, which, by the way, seems not to have a web-site, was the subject of an <a href="http://www.latimes.com/news/nationworld/nation/la-na-secret-money-20120528,0,7342535,full.story">investigative report</a> in the Los Angeles Times in May, 2012.  Here is the article's description of how the Center began, <blockquote class="tr_bq">The Center to Protect Patient Rights was created in April 2009, just as the debate over the healthcare bill was heating up. The group's mission was to 'protect the rights of patients to choose and use medical care providers,' according to its corporate paperwork, filed in Maryland. While never surfacing publicly, the center sent more than $10 million in its first year to groups such as Americans for Prosperity, which took a lead in protesting the measure. 'I think they saw what we were doing and liked it,' said Tim Phillips, president of Americans for Prosperity, which got $4.1 million. He said he did not know the source of the center's funding and declined to comment on whether it still supports his group.</blockquote> So this group supported an advocacy position about health care reform, so perhaps it could be considered an astroturf organization, were we to know it was funded by the health care industry.  Many astroturf organizations do reveal support from particular corporations.  However, at the time the Los Angeles Times published the report, the source of the Center's funding was unknown.  Secretive Leadership Furthermore, while astroturf organizations may be eager to get more public notice, presumably so they can further their advocacy, the Center seemed oddly secretive.  Its executive director and president is one Sean Nobel.  However, as the LA Times article noted, <blockquote class="tr_bq">Noble did not respond to repeated phone calls and emails. Courtney Koshar, a Phoenix anesthesiologist and the organization's only other director, did not respond to requests for comment. And a Phoenix doctor who once sat on its board said he couldn't remember who asked him to join. 'I honestly played very little role,' said Dr. Eric Novack, who headed an organization called the US Health Freedom Coalition that received nearly its entire budget — $1.7 million — from the center to help pass a state ballot measure that aimed to block President Obama's healthcare overhaul.</blockquote> Support for Political Organizations, not Health Care Advocacy Even more curiously, despite its name, the most of the Center's spending was not for advocacy about health care reform, but went to organizations that  seemed to have little or nothing directly to do with health.  As the Times reported, <blockquote class="tr_bq">During the 2010 midterm election, the center sent more than $55 million to 26 GOP [Grand Old Party, that is, Republican Party] -allied groups, tax filings show, funding opaque outfits such as American Future Fund, 60 Plus and Americans for Job Security that were behind a coordinated campaign against Democratic congressional candidates.</blockquote>It seemed that these grants were used for nothing that directly related to health.  For example, <blockquote class="tr_bq">The largest share of the center's money went to American Future Fund, a Des Moines-based group started by onetime GOP congressional aide Nick Ryan. The fund, which ran campaigns against two dozen Democrats in the 2010 election cycle, spent $23 million that period, tax filings show, with nearly $13 million coming from the center. Its biggest target was an up-and-coming Iowa Democrat, Rep. Bruce Braley. In August 2010, American Future Fund launched an ad falsely claiming that Braley supported building a mosque at the former World Trade Center site in New York — the beginning of a $2-million fusillade that included radio ads, robo-calls and nine mailers. </blockquote> A list of the recipients of the Center's 2010 grants was also publised in the LA Times <a href="http://spreadsheets.latimes.com/cppr-funding/">here</a>. Where Did the Center Get its Support? Just before this week's US election, the plot thickened.  The LA Times <a href="http://articles.latimes.com/2012/nov/05/local/la-me-secret-donors-20121106">reported </a>that because of the Center's obviously political activities in California, an effort was made to determine its source of funding, but that came up short. <blockquote class="tr_bq">After a frantic court battle, state election officials succeeded Monday in forcing an Arizona group to disclose the identities of contributors that provided $11 million to a California campaign fund. But the revelations added little clarity for voters. The mystery donors turned out to be other nonprofits, whose individual contributors remained secret. The money started with the Virginia-based Americans for Job Security and was transferred to a group called the Center to Protect Patient Rights. Over the course of a few days in October it was sent to the Arizona group, Americans for Responsible Leadership, and then transferred again to California. Finding the source of the money 'becomes daunting,' said Derek Cressman of Common Cause, an activist organization that filed the original complaint about the donation. 'How many layers can you drill through?'</blockquote> Note that in 2010, the Center for Protection of Patient Rights gave money to the Americans for Job Security, but in 2012, the latter organization gave money to the former - curiouser and curiouser.  Allegations of Illegalities, Including Money Laundering It turns out the Americans for Job Security has been in trouble before for activities that seemed contrary to state election law: <blockquote class="tr_bq">Americans for Job Security, one of the nonprofits involved in the $11-million donation, was investigated by Alaskan officials for its role in a 2008 mining referendum. Authorities concluded that the organization's 'sole purpose is to allow individuals and corporations to financially support various causes without having to disclose that financial support.' That investigation showed how a wealthy landowner sent $2 million to the group, which then funneled most of it back to Alaska to try to fend off construction of a mine near the landowner's property. Americans for Job Security agreed to a settlement, paying a $20,000 fine and pledging 'not to engage in similar activity' again in Alaska.</blockquote> In addition, the Mercury News<a href="http://www.mercurynews.com/elections/ci_21932215/fppc-releases-names-donors-who-made-secret-11"> reported</a> allegations that the fund transfers by the Committee for the Protection of Patient Rights were illegal. <blockquote class="tr_bq">two conservative groups, Americans for Job Security and the Center to Protect Patient Rights, are part of a tangled web of so-called dark donors who operate largely out of public view, shielded by their status as nonprofit advocacy groups that are supposedly not involved primarily in politics. While the groups have been identified, however, individual donors who have bankrolled them remain a mystery. But 'this isn't going to stop here,' said Ann Ravel, chairwoman of the Fair Political Practices Commission, the state's political watchdog. 'They admitted to money laundering. We agreed to do this without an audit because we wanted to get information to the public before the election. But we in no way agreed this would preclude further action.' The FPPC determined that the Arizona group, Americans for Responsible Leadership, had violated California campaign law. Money laundering -- sending money through multiple sources to conceal the original donor -- is a misdemeanor. But a conspiracy to commit money laundering is a felony. It was not clear Monday whether the FPPC or the state Attorney General's Office will pursue criminal charges.</blockquote> Summary So the answer to the question posed in the title of this post is unknown.  At this point, there is nothing public that indicates for whom the Center for Protection of Patient Rights advocates.  However, it is hard to conceive that its advocacy is for patients.  So rather than merely being an astroturf organization (a health care policy advocacy group funded by industry money), the benignly named Center for the Protection of Patient Rights appears to be a dark money group whose goals may have allegedly included money laundering to facilitate vast monetary influence on political campaigns by people and organizations whose identities remain secret. We have often discussed the role of deception in health care, including <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing</a>, <a href="http://hcrenewal.blogspot.com/search/label/stealth%20health%20policy%20advocacy">stealth public policy advocacy</a>, and <a href="http://hcrenewal.blogspot.com/search/label/stealth%20lobbying">stealth lobbying</a>.  Now we see health care being used as a vehicle for political deception, stealth political campaigns being disguised as stealth public relations campaigns.  The convolutions of the deceptions induce dizziness.  Of course, this is the opposite of the sorts of transparency health care professionals and academics ought to support, and patients and the public ought to demand.  How will we ever improve health care when health care organizations are used to hide layer upon layer of deception? Real improvements in health care require health care leadership dedicated to transparency, honesty, and accountability.

For Whom Does the Center for the Protection of Patient Rights Advocate?

We have occasionally discussed the cases of some patient advocacy organizations which seem to be influenced by substantial financial suppor...

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The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris <a href="http://www.nytimes.com/2009/09/02/business/02drug.html">writing</a> for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available <a href="http://www.nytimes.com/packages/pdf/politics/20090831MEDICARE/20090831_MEDICARE.pdf">here</a>. Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose. Continuing Medical Education Overall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)" One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increased level of speaker programs, maintain level of teleconferences and peer selling." Under "Marketing Tactics" was a long section on "Continuing Medical Education." It covered various venues for CME such as internet/electronic CME, "sponsoring symposia at major meetings," "regional CME symposia" which would "serve a number of medical specialties," "sponsorhips of scientific sessions," etc Production of Scholarly Articles The "Publications" section of "Marketing Tactics" noted "publications will be geared toward psychiatrists, PCPs, .... Articles will appear in several formats, including original reports, review articles, and journal supplements." Thought Leaders and Consultants Under the "Continuing Medical Education" section of "Marketing Tactics," and then in the "Advisor Relations" section, there were numerous references to what "thought leaders" would do, including - "present new data" at "symposia at major meetings" - act "as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional strategies and tactics." - sit on the "Lexapro Exectuive Advisory Board" to "keep our advisors apprised of the commercial development ... of escitalpram." - sit on the "Primary Care Advisory Board" to "obtain critical feedback and recommendations on educational and promotional strategies and tactics...." Role of Medical Centers Under the CME section of "Marketing Tactics," we see that "academic health centers" would help develop "regional CME symposia." Under the "Sponsorship" section are plans to fund the "Professional Relations Group in their mission of establishing mutually beneficial long-term relationships with appropriate professionals and associations." Specific plans included funding the Department of Psychiatry and Behavioral Sciences at Emory Medical Societies The "Sponsorship section" also noted that these relationships "will also provide the basis for advocacy development and issues management, and will establish an appropriate environment for commercial and policy activities." Under the CME section of "Marketing Tactics, we see that "medical associations and professional societies" would help develop "regional CME symposia" Also in this section is the note that "smaller, more prestigious societis do not accept industry-sponsored symposia." So instead, "sponsorship of a study groups or plenary sessions is recommended. Marketing will work with the professional relations group regarding potential opportunities." Appendix VII, "Professional Associations of Priority" noted funding provided for guideline development by a "collaboration between APA, AAFP and ACP" for "chronic depression in primary care practice;" by AAGP for guidelines for late-life depression; multiple guidelines developed by AMDA; The appendix also noted that Forest supports ACNP "annual programming, and is a founding sponsor of it's newly created International College of Geriatric Pscyhopharmacology (ICGP)," is a "Corporate President's Circle Sponsor of AAFP," became a "corporate sponsor of ACP in FY03," became "a Corporate Sponsor of AMDA for the last few years," Also, it noted that Forest has "expanded its involvement" with APA for "lobbying of State Health Departments...." Disease Advocacy Organizations Also in Appendix VII, Forest was identified as a "Corporate Sponsor of NAMI," a "major Corporate Sponsor of NMHA," and a "major Corporate Sponsor of DBSA." Summary We have often heard from pharmaceutical, biotechnology, device and other health care corporations that they are only involved in education to disseminate accurate information for the good of society. We have often heard from physicians and academics who consult for such corporations that their advice is sought about clinical, scientific, and technical issues. We often hear from academic medical institutions, medical associations and disease advocacy groups that the money they get from such corporations does not influence the content of their educational and scientific work. Yet here we see, in considerable detail, that in the case of one drug company's promotional efforts for one drug, - The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate. - Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development." - Medical associations are funded by marketing "for commercial and policy activities." This suggests that health care corporations develop financial relationships with physicians, academics, academic institutions, medical and professional associations, and disease advocacy groups to support marketing first. This allows the corporations to advance marketing disguised as education, research, and other high-minded and apparently selfless activities by professionals, not-for-profit organizations, and dedicated inviduals. Such marketing, of course, is DECEPTIVE and DISHONEST. It also is in conflict with the professionals' ideals, and the missions of the medical and professional assocations and disease advocacy groups. The physicians, other health care professionals, and not-for-profit organizational leaders involved may rationalize these activities as consistent with their mission and professionalism, but such rationalizations are at best self-delusion. No one knows how representative the Lexapro marketing plans are of the marketing of other drugs, devices and health care services. The only way to find out would be to force many other corporations' marketing plans into public view. The Lexapro documents suggest that society would benefit if many more marketing plans were made public, but that such publication might generate a wave of revulsion about how deceptive marketing of health care goods and services has become, and the extent that health care professionals have betrayed their professional ideals, and academic medical institutions, professional and medical societies, and patient advocacy groups have betrayed their missions. I submit that we will not truly reform health care without making the marketing of health care goods and services honest, getting health care professionals to give up their financial relationships with health care corporations to reclaim their professionalism, and getting academic medical institutions, professional and medical societies, and patient advocacy groups to give up their financial relationships with health care corporations to reclaim their missions. See additional comments on how the marketing plan was meant to promote CME <a href="http://carlatpsychiatry.blogspot.com/2009/09/forests-promotional-objective-use-cme.html">by Dr Daniel Carlat</a> on the Carlat Psychiatry Blog.

The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Labo...

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