healthy4u: health care foundations

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) <blockquote class="tr_bq">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.</blockquote> After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco, <blockquote class="tr_bq">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'.</blockquote> The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation, <blockquote class="tr_bq">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.</blockquote> The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business, <blockquote class="tr_bq">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.</blockquote> Also, regarding her career at UCSF,(2) <blockquote class="tr_bq"> 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.</blockquote> Finally, regarding expectations for her performance in the future, <blockquote class="tr_bq">'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.</blockquote> 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 <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> 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) <blockquote class="tr_bq">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.</blockquote> Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to <a href="http://www.sec.gov/Archives/edgar/data/318771/000095013408004633/0000950134-08-004633-index.htm">Genentech's 2008 proxy statement</a>, (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 <a href="http://hcrenewal.blogspot.com/2010/06/smoke-detector-medical-center-leader.html">posted</a> 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 <a href="http://www.gatesfoundation.org/What-We-Do/Global-Policy/Tobacco-Control">tobacco control initiative</a>, with a stated goal: <blockquote class="tr_bq">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. </blockquote> The Lancet articles were silent on this issue.   Questions Whether Industry Partnerships Threaten the University Mission In 2011, I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">posted</a> 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 <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">posted</a> 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 <a href="http://www.pginvestor.com/file.aspx?IID=4004124&FID=19227491&O=3&OSID=9">2013 proxy statement</a>.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a <a href="http://www.pg.com/en_US/brands/global_health_grooming/index.shtml">Global Health and Grooming unit</a>, 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 <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, 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 <a href="http://www.bizjournals.com/sanfrancisco/blog/2014/04/university-of-california-uc-ucsf-janet-napolitano.html">article</a> in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann <blockquote class="tr_bq">ran into opposition when she  <a href="http://pubads.g.doubleclick.net/pagead/adview?ai=B46LUcTVlU4KNFIrUkwT0tYG4DYnY2pwFAAAAEAEgADgAWJmX6YiuAWDJvriM1KSoEIIBF2NhLXB1Yi05NzM2MDkyNjA0Njc3NTE2sgETd3d3LmJpempvdXJuYWxzLmNvbboBCWdmcF9pbWFnZcgBCdoBa2h0dHA6Ly93d3cuYml6am91cm5hbHMuY29tL3NhbmZyYW5jaXNjby9ibG9nLzIwMTQvMDQvdW5pdmVyc2l0eS1vZi1jYWxpZm9ybmlhLXVjLXVjc2YtamFuZXQtbmFwb2xpdGFuby5odG1smALohAHAAgLgAgDqAiI0NjM1L2J6ai5zYW5mcmFuY2lzY28vYXJ0aWNsZV9wYWdl-AL00R6QA-ADmAPgA6gDAeAEAZIFCwgHEAEYByDp888YoAYg&sigh=t4VXjjLVbHw&adurl=http://pagead2.googlesyndication.com/pagead/imgad?id=CICAgKCNn-yIxgEQARgBMggPKtH7CIiUnA%26t%3D10%26cT%3Dhttp%253A//bizjournals.com%26l%3Dhttp%253A//www.bizjournals.com/sanfrancisco/blog/2012/01/susan-desmond-hellmann-ucsf-uc.html">proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system</a>. 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.</blockquote> However, the same article noted that the current University of California President, <blockquote class="tr_bq">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,...' </blockquote>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 <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, 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 <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Letter-from-Bill-and-Melinda-Gates">latest letter</a>, Bill and Melinda Gates stated, <blockquote class="tr_bq">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.</blockquote> 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 <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960702-9/fulltext">here</a>. 2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960706-6/fulltext"> here</a>. 3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link <a href="http://jnci.oxfordjournals.org/content/99/12/910.extract">here</a>. ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM.

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 a...

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Why Did the Global Fund Fire its Inspector General?

The Global Fund to Fight AIDS, Tuberculosis, and Malaria continues to struggle with the issue of health care corruption, an issue we noted <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">here</a> in 2011.  Now as a <a href="http://www.nature.com/news/fresh-start-for-global-disease-fund-1.11857">news story</a> in Nature put it, <blockquote class="tr_bq">It has been a rough couple of years for the Global Fund to Fight AIDS, Tuberculosis and Malaria, the world’s largest funder of international health programmes. Since its creation in 2002, the organization, based in Geneva, Switzerland, has channelled US$24.7 billion to delivering disease-control measures such as drugs, diagnostics and bed nets, saving millions of lives. But the global financial crisis has hit the fund hard, and its troubles mounted in 2011 when allegations of corruption among its grant recipients tarnished its reputation and alarmed donors. Last week, the Global Fund tried to move on, announcing a new leader and unveiling major changes to its funding programme.</blockquote>The Nature news story suggested that the troubles of the Fund all seemed so unfair.  After all, <blockquote class="tr_bq">the fraud allegations, ... [were] largely rehashed audits already made public by the fund itself. A retrospective audit published in July this year suggests that the allegations may have been overblown. It found that, in a sample of grants worth $3.8 billion that were awarded from 2005 to 2012 in 27 countries, just 0.5% of grant funding was lost to outright fraud. Experts say that figure is not exceptional for funding programmes in poor nations that often struggle with corruption.</blockquote>Yet the Nature story suggested that the Fund's intrepid new later "could signal a fresh start, and has been broadly welcomed," leaving the impression that all things may turn out well. Firing the Inspector General However, the Nature story left out one nagging detail.  At the same time the Fund board announced the appointment of Dr Mark Dybul as its new director, it also announced that it had fired the Fund's Inspector General.  A <a href="http://www.ft.com/cms/s/0/2353944c-2f4f-11e2-b88b-00144feabdc0.html#axzz2CnJ2A6D6">report</a> in the Financial Times only included, <blockquote class="tr_bq">It also dismissed John Parsons, its inspector general. Some directors believed Mr Parsons had been too outspoken in conducting public audits that sparked criticism of relatively small amounts of mismanagement and corruption.</blockquote>The impression left was that Mr Parson was mainly guilty of rocking the boat. The New York Times <a href="http://www.nytimes.com/2012/11/16/health/change-rattles-leading-health-funding-agency.html">version</a>, which started by recounting the hiring of Dr Dybul, also made it sound that Mr Parsons was generating too much bad publicity, <blockquote class="tr_bq">The fund also dismissed its inspector general, John Parsons, on Thursday, citing unsatisfactory work. Mr. Parsons and Dr. Kazatchkine had privately clashed. Mr. Parsons’s teams aggressively pursued theft and fraud, and found it in Mali, Mauritania and elsewhere. But the total amount stolen — $10 million to $20 million — was relatively small, and aides to Dr. Kazatchkine said the fund cut off those countries and sought to retrieve the money. The aides claimed that Mr. Parsons, who reported only to the board, went to news outlets and left the impression that the fund was covering up rampant theft. The fuss scared off some donor countries....</blockquote>The AP <a href="http://www.google.com/hostednews/ap/article/ALeqM5jiecT6YSPVq9jPKNW53mkUB-ytXQ?docId=b32b417580964fb3be54830d45d810b8">version</a> also cited the Board's accusation that Mr Parson's performance was "unsatisfactory," but included, <blockquote class="tr_bq">The inspector general's office is supposed to function independently. It was created in 2005 at the urging of the fund's biggest donor, the United States, which has contributed $7.3 billion to date. The board held a contentious closed-door session with Parsons on Wednesday then deliberated into the night after he stormed out. The board chairman, Simon Bland, and the head of its audit committee, Graham Joscelyne, each said they were unconcerned whether U.S. lawmakers might perceive the firing as an infringement on the office. Joscelyne would not elaborate on what Parsons did wrong but cited several reviews of him that were not disclosed. In its latest 6-month progress report, Parsons' office said it had a growing caseload of 142 active investigations, up more than 70 percent from just two years ago.</blockquote> Summary and Comment We posted about the allegations of corruption at the Global Fund <a href="http://hcrenewal.blogspot.com/2011/11/will-freeze-of-global-fund-finally-put.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">here</a> in 2011.  At that time the scope of the problem was  unclear.  Now, at least according to the latest news report, it still is not clear.  On one hand, maybe no more than 0.5% of the budget was compromised.  On the other hand, would that caseload of 142 active investigations reveal more?  Even less clear is the reason that Investigator General Parsons was fired.  The Board did not clarify what about his performance was unsatisfactory.  The AP report implies that doing too little was not the issue.  Most disturbing is lack of any mention of a possible replacement. As we <a href="http://hcrenewal.blogspot.com/2011/02/after-publicity-about-losses-from.html">mentioned previously</a>, the authoritative <a href="http://www.transparency.org/whatwedo/pub/global_corruption_report_2006_corruption_and_health">2006 Global Corruption Report</a> from Transparency International stated that corruption is a major global health problem.  Furthermore, Transparency International's IACC (International Anti-Corruption Conference) in Brasilia just wrapped up.  It's <a href="http://15iacc.org/about/declarations/the-brasilia-declaration/">final declaration</a> included, <blockquote class="tr_bq">We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable. We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk. It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: We are watching those who act with impunity and we will not let them get away with it.</blockquote> Yet, corruption as a global health problem is still mostly ignored. In particular, global health aid programs almost never include pro-active measures to address corruption. In this case, the Global Fund, the world's largest source of such aid, was initially pushed into defensively addressing corruption, but now seems not to be so transparent about the problem. In my humble opinion, unless more transparency soon becomes evident, donors may continue to find reasons not to support the fund. So the leaders of the Global Fund might want to consider becoming more transparent, and making some assurances that they are not out to get whistleblowers, including their own internal watchdogs.  At this point a more pro-active approach might be too much to ask for.

Why Did the Global Fund Fire its Inspector General?

The Global Fund to Fight AIDS, Tuberculosis, and Malaria continues to struggle with the issue of health care corruption, an issue we noted h...

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BLOGSCAN - Another Health Care Foundation Loses Its Way

BLOGSCAN - Another Health Care Foundation Loses Its Way

From Gary Schwitzer's HealthNewsReview blog, an aggregation of stories that shows how the famous Susan G Komen For the Cure foundation h...

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After Publicity About Losses from Corruption, Now Will Any Health Charities Start Anti-Corruption Initiatives?

Over the last few weeks a series of stories appeared about how corruption siphons off money from worthy global health initiatives.  Corruption Depletes Global Fund to Fight AIDS, Tuberculosis and Malaria The <a href="http://www.google.com/hostednews/ap/article/ALeqM5jBNgIu-Vg-_pAVtF6PcN9eSYPfiA?docId=eccd6da0cec34b489a67dfdf80cb933b">story</a> that first got attention was from AP: <blockquote>A $21.7 billion development fund backed by celebrities and hailed as an alternative to the bureaucracy of the United Nations sees as much as two-thirds of some grants eaten up by corruption, The Associated Press has learned. Much of the money is accounted for with forged documents or improper bookkeeping, indicating it was pocketed, investigators for the Global Fund to Fight AIDS, Tuberculosis and Malaria say. Donated prescription drugs wind up being sold on the black market. The fund's newly reinforced inspector general's office, which uncovered the corruption, can't give an overall accounting because it has examined only a tiny fraction of the $10 billion that the fund has spent since its creation in 2002. But the levels of corruption in the grants they have audited so far are astonishing. A full 67 percent of money spent on an anti-AIDS program in Mauritania was misspent, the investigators told the fund's board of directors. So did 36 percent of the money spent on a program in Mali to fight tuberculosis and malaria, and 30 percent of grants to Djibouti. In Zambia, where $3.5 million in spending was undocumented and one accountant pilfered $104,130, the fund decided the nation's health ministry simply couldn't manage the grants and put the United Nations in charge of them. The fund is trying to recover $7 million in 'unsupported and ineligible costs' from the ministry. The fund is pulling or suspending grants from nations where corruption is found, and demanding recipients return millions of dollars of misspent money. 'The messenger is being shot to some extent,' fund spokesman Jon Liden said. 'We would contend that we do not have any corruption problems that are significantly different in scale or nature to any other international financing institution.' To date, the United States, the European Union and other major donors have pledged $21.7 to the fund, the dominant financier of efforts to fight the three diseases. The fund has been a darling of the power set that will hold the World Economic Forum in the Swiss mountain village of Davos this week. It was on the sidelines of Davos that rock star Bono launched a new global brand, (Product) Red, which donates a large share of profits to the Global Fund. Other prominent backers include former U.N. secretary-general Kofi Annan, French first lady Carla Bruni-Sarkozy and Microsoft founder Bill Gates, whose Bill and Melinda Gates Foundation gives $150 million a year.</blockquote>Corruption Depletes Health Alliance International At about the same time, the Seattle Times <a href="http://seattletimes.nwsource.com/html/health/2014098517_uwhealth02.html">reporte</a>d fraud losses at another global health project: <blockquote>Health Alliance International (HAI), which was begun in 1987 by North American doctors and nurses to support the fledgling government in Mozambique, has played a leading role in HIV treatment.</blockquote><blockquote>Focused on strengthening health systems of impoverished and fragile nations, it was awarded the Doris Duke Charitable Foundation's Africa Health Initiative grant, a seven-year $10 million program to help government-run health facilities use data to improve services. The UW departments of Global Health and Industrial Engineering are partners in that project. All but 7 percent of its funding came from the U.S. government, and more than 90 percent of its work was in Mozambique, according to HAI's 2009 annual report. Gloyd said the alliance increased the number of people receiving antiretroviral drugs from about a couple dozen in 2003 to more than 50,000 this year. In late 2009, the alliance applied for what would have been its biggest grant ever — $100 million in funding from USAID over the next five years. Early last year, its application was selected as the best technical proposal. But in the midst of the administrative review in June, a tipster reported problems in an organization employed by HAI. One such program hired local community organizations in Mozambique for home-based nursing care and delivery of basic medical kits. The alliance did an internal audit and discovered irregularities. 'Their own accounting for those kits was quite inadequate, and that came back to bite us,' Gloyd said. HAI shared the findings with USAID and put forth a plan to resolve the issues. But at the end of August, USAID rejected the group's grant application.</blockquote>How Big Is Corruption? There was actually considerable dispute about the significance of the fraud discovered at the Global Fund. On one hand, the losses were a very large proportion of the grants investigated. On the other hand, the total amounts were a very tiny proportion of the total of the fund's outlays. As <a href="http://blogs.cgdev.org/globalhealth/2011/01/massive-corruption-%E2%80%A6in-small-global-health-grants.php">summarized</a> by William Savedoff in the Center for Global Development's Global Health Policy blog: <blockquote>While readers might finish the AP article mistakenly thinking that $14 billion has been stolen (that is, two-thirds of $21.7 billion), it would also be a mistake to read the Global Fund press release and believe that only $34 million is gone. What we’re missing is a way to assess how representative these cases may be. If the Global Fund’s detection system is 100% effective, then these cases are isolated and it is a tiny problem. If the detection system only picks up 50% of cases, then instead of a tiny problem, we’ve got a small one. But if the detection system only finds 5% of cases then—despite the mistaken deduction from the AP article—we really would have a massive billion-dollar corruption problem. The Global Fund should be praised, not slammed, for its investigations and for its openness. But, it also needs to be challenged to find a way to estimate how representative these cases may be.</blockquote> At any case, the Global Fund has promised "new anti-corruption measures," <a href="http://www.google.com/hostednews/ap/article/ALeqM5g6RHeQRJcQJtfXOWPiaNI9YLVung?docId=d22fec0983e042f6868415f3538e2b62">per the AP again</a>. <blockquote>A $21.7 billion global health fund and the U.N.'s main development arm launched new anti-corruption measures Friday in the wake of intense scrutiny from donors and stories by The Associated Press detailing fraud in their grants. Chief among The Global Fund to Fight AIDS, Tuberculosis and Malaria's new measures are plans to create a high-profile panel of experts to examine the fund's ability to prevent and detect fraud in its grants. 'Programs supported by the fund have saved seven million lives and are turning back the three disease pandemics around the world,' said the fund's executive director, Dr. Michel Kazatchkine. He said the fund has 'zero tolerance' for fraud and corruption and was 'responding aggressively when instances of fraud or misappropriation are detected.'</blockquote> That is nice, but I submit these stories are a reminder of how <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> health care corruption is, and how few and ad hoc are the few efforts made to fight it. Much of the coverage of the corruption affecting the Global Fund had a breathless quality as if the authors were shocked, shocked that there could be corruption in health care. In fact, many people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, <a href="http://www.transparency.org/publications/gcr/gcr_2006">Transparency International's Global Corruption Report</a>, asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  It also noted how diverse is health care corruption: <blockquote>In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.</blockquote> It further stated how serious the consequences of corruption may be: <blockquote>Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly.... The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services. Corruption affects health policy and spending priorities.</blockquote> On this blog, our limited resources make us focus mainly on the US, and sometimes other English-speaking countries. Yet we now have in our archives some amazing stories that document various forms of corruption, including numerous allegations of corporate misbehavior ending in <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>, outright <a href="http://hcrenewal.blogspot.com/search/label/fraud">fraud</a>, and other <a href="http://hcrenewal.blogspot.com/search/label/crime">crime</a>. Also, as we have noted before, the <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">US Institute of Medicine has defined conflicts of interest</a> <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.</blockquote> Given that Transparency International's definition of corruption is <blockquote>abuse of entrusted power for private gain</blockquote> One can easily argue that in health care, conflicts of interest defined as above create risks of abuse of power by health care professionals influenced by the private gains provided by their secondary interests. On Health Care Renewal, we have provided a massive set of examples of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and<a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest"> institutional</a> conflicts of interest. There is evidence that about two-thirds of medical academics(1) and academic leaders(2) have significant conflicts of interest. The huge prevalence of conflicts suggests the risk of major corruption. Corruption and Conflicts of Interest as Anechoic So what we all should be shocked, shocked about is how little has been done to fight health care corruption, whether in Mozambique or the US. Note that the Gates Foundation is a major donor to the Global Fund. It has a number of disease or condition specific <a href="http://www.gatesfoundation.org/global-health/Pages/global-health-strategies.aspx">initiatives</a>, and a global health <a href="http://www.gatesfoundation.org/global-health/Documents/global-health-policy-strategy.pdf">policy and advocacy initiative</a>. But it has no initiative to fight corruption and conflicts of interest, or, to put it in positive terms, to promote accountability, integrity, transparency, honesty and ethics. The Doris Duke Charitable Foundation funds Health Alliance International.  It <a href="http://www.ddcf.org/Medical-Research/">funds</a> medical research, and has a specific focus on African health care research.  However, it also has no initiatives to fight corruption and conflicts of interest, or improve accountability, integrity, transparency, honesty and ethics in health care. In fact, one could look in vain for any initiatives about or funding for anti-corruption, or pro-accountability, integrity, transparency, honesty and ethics by any major US charity with health care interests. One can  find very few significant efforts to discuss, teach about, or research ways to fight corruption, or to promote accountability, integrity, transparency, honesty and ethics by academic health care institutions.  (See <a href="http://hcrenewal.blogspot.com/2010/11/who-you-gonna-call-how-should-young.html">this post</a> for how difficult it was to find academic institutions' initiatives to resist conflicts of interest.)  One can count the conferences, meetings, symposia, and courses on such topics on one's fingers. When I last looked, I could count only a single course on fighting corruption at any US medical or public health school ( at Boston University, by <a href="http://sph.bu.edu/index.php?option=com_sphdir&id=239&Itemid=617263&INDEX=771">Prof Taryn Vian</a>). Given the scope of corruption, we should be shocked, shocked at how <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem. So will the Global Fund's losses to corruption inspire the Gates Foundation or any of its major donors to start an anti-corruption initiative? Or even have an anti-corruption symposium? So will the Health Alliance International's losses so inspire the Doris Duke Charitable Foundation?  Will these cases inspire any foundation, or academic health care organization to do anything to fight corruption and conflicts of interest, and to promote accountability, integrity, transparency, honesty and ethics in health care? I am not holding my breath, but I live in hope. Of course, one reason we started Health Care Renewal was to make these issues less anechoic. So hear we go again. PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information. References 1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. (link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>) 2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link <a href="http://jama.ama-assn.org/cgi/content/full/298/15/1779">here</a>)

After Publicity About Losses from Corruption, Now Will Any Health Charities Start Anti-Corruption Initiatives?

Over the last few weeks a series of stories appeared about how corruption siphons off money from worthy global health initiatives. Corrupti...

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Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a conflict of interest: <blockquote>Consider a health care researcher called by a commercial health care corporation's marketing department. The department representative proposes paying the researcher as a consultant to write a scholarly article on a specific policy topic of interest to the company. The implication is that the article should be favorable to the interests of the corporation in this arena. The corporation would be delighted to give the researcher editorial and staff assistance in writing the article and getting it published. Who you gonna call? The researcher is concerned that getting this consultancy might be a conflict of interest. What organization (e.g., appropriate professional society, unit within his or her academic institution, other academic unit, independent not-for-profit organization or NGO, or government agency) should the researcher contact for support and help? Please give at least one specific example, (preferably including a URL), with a brief justification of why that organization might be helpful.</blockquote> I sent the case to a few hundred people on our combined mailing list, to see how they might answer.  Responses came from medical academics, with a sprinkling of practitioners, a journalist, and a well-informed lay-person. Sources of Information: Is It a Conflict of Interest? Nearly everyone thought it would be unethical for a young academic to be paid as a consultant to write a health policy review policy by a company with a vested interest in the subject, and with editorial and staff support coming from the company. I implied (but did not make clear) that the faculty member felt uncomfortable with the situation, was looking either for advice and information, or actual support not to accept a conflict of interest that he or she might have felt pressured to take on. People suggested some sources of information. Most appeared to be useful, but most also were specialized (by clinical specialty, directed at journal editors, directed only at conflicts related to pharmaceuticals, etc)  Those particularly worthy of mention include: - The Prescription Project's <a href="http://www.prescriptionproject.org/initiatives?id=0004">site</a> on medical school conflict of interest policies - The World Association of Medical Editor's (WAME) <a href="http://www.wame.org/conflict-of-interest-in-peer-reviewed-medical-journals">site</a> on conflict of interest in scholarly publication - The PharmedOut.org general resource <a href="http://www.pharmedout.org/topic.htm">site</a> My personal preference for a single source of general information on COIs is the 2009 US Institute of Medicine <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report</a> on same.  (I will add all these links to our side-bar, and note that there are some other relevant links there.) The IOM definition of conflict of interest is: <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interest include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients.</blockquote>So the offer in the above case clearly seemed to present a conflict. The situation presented in my case seemed to present the potential to violate the report's recommendations 5.1 that bans scientific publications "that are controlled by industry," or that "contain substantial portions written by someone who is not identified as an author...." Note, however, that even the IOM report seems not to question the idea that "collaborations between physicians or medical researchers and pharmaceutical, medical device, and biotechnology companies can benefit society — most notably by promoting the discovery and development of new medications and medical devices that improve individual and public health."  It has never been clear to me that collaboration requires payment by one party to the other, or that academic medical institutions ought to be developing drugs and devices (as opposed to discovering knowledge that commercial firms might later use to do so.) Furthermore, the IOM report, while it is moderately tough and comprehensive, did not recommend that detailed public disclosure of all relevant conflicts by all parties to them, or an outright ban on all of the sorts of conflicts that many might think are objectionable. Support to Resist the Proffered Conflict Suggested sources of help resisting pressure to assume an unwanted conflict of interest included local sources: mentors, grants and contracts offices, local conflict of interest/ ethics committees, compliance departments, and research officers. Some people thought their local versions of the above might be helpful. No person seemed sure that any of these options would clearly lead to support if the academic was being pressured by his or her academic superiors. However, I have big concerns about the availability of even these sorts of local support.  We know COIs are very prevalent among individual academics.  About 60% of all academics, and of department chairs have important conflicts according to two articles by Campbell et al.(1-2)  So it might be hard for the young academic to find a mentor or university officer who was not already conflicted. We also know that medical schools and academic medical centers see commercializing their discoveries as taking precedence over their traditional mission of seeking and disseminating knowledge, and providing and improving patient care and public health.  For example, in 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."[caps added for emphasis] Furthermore, <blockquote>Academic medicine… finds itself struggling to create a precarious equipoise between the world and values of commerce and those of traditional public service….</blockquote>Also <blockquote>In our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of academic inventors in the commercial venture; put simply, no participation, no money. It is this demand … that has driven the dramatic increase in medical faculty entrepreneurship.</blockquote> I have seen university conflict of interest policies that include such verbiage in their introductions. The impression is that most academic medical institutions now think that is their mission, maybe their overriding mission, to develop and commercialize drugs and devices. So it might also be hard for the young academic to find a local academic unit that is not affected by institutional conflicts of interest. Indeed, none of the people on our list was sure that their institutions had local authorities or units that could help the young academic in the case above avoid the proffered conflict of interest. A few people suggested external sources of support: e.g., a small medical society, an association of journal editors, a bioethics center. But they too were ambivalent about how helpful they might be. The small medical society would only be helpful for its few members, and the person who mentioned it doubted it could provide more help that citing its own COI policy. The journal editors and their organizations might only be helpful about how the proffered conflict might affect the ability of the faculty member to get the resulting study published. The bioethics center appeared to have heavy institutional conflicts of interest of its own. No one could suggest an independent organization likely to provide effective support to resist COIs to a wide spectrum of academics (or other health care professionals, etc) Summary So this exercise did reinforce one of the assumptions I made when writing the case. Young academics at most US (at least) institutions may have little local support for resisting the extant pressure to become conflicted. There are NO generally useful and effective external sources of such support. I would point out that with all its limitations, the IOM report still called on academic institutions to develop clear guidelines for COIs (3.1, 3.2); ban people with COIs from research on humans (that is, from all clinical research) (4.1); develop educational programs on COIs (5.2); participate in developing continuing medical education that is free of industry influence (5.3); set up a committee on COIs at the board of trustees level (8.1). It also called on the US government to promote research about COIs (9.2). As far as I can tell, that was all pretty much wishful thinking. Despite the prestige of the IOM, almost none of these recommendations have been implemented. (I have heard so far of one university that seems to have implemented watered down versions of some of the IOM recommendations in their own policy. I would love to be told there are more extensive implementations of these recommendations. If there are, please show me the specifics.) Furthermore, there seems to be no effective support for the reduction of COIs from accrediting organizations, professional societies, or foundations that fund health care initiatives. (Again, I would love to be told I am wrong, but if I am, show me the specifics.)  Of course, it appears that most professional societies get extensive support from commercial sources, particularly drug, device, and biotechnology companies, and their leadership often have their own financial relationships with for-profit health care corporations.  Foundations that support health care and medicine may have leaders with similar relationships, and may have endowments disproportionately invested in health care corporations.    Given the pervasive nature of personal and institutional COIs throughout health care, which we have documented on Health Care Renewal , I was saddened, but not surprised by the responses to my query. So many people and so many institutions are making so much money from their industry payments. They will nearly all have excuses so that they can keep accepting the money. Young faculty are unlikely to be able to resist the prevailing culture, especially when it affects so many of their colleagues and supervisors. I know that the people on our email lists are more aware of this than most. But we all should be saddened and ashamed that so little progress is being made. Will academic medical institutions ever again put seeking and disseminating new knowledge, and providing and improving patient care and for the public health ahead of trying to be ersatz drug and device companies? Will professional societies ever again put put their members' core values ahead of pleasing their corporate funders? Will health care foundations ever again put rescuing health care's core values ahead of bland projects meant not to offend health care corporate leaders? References 1. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. (link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa064508">here</a>) 2. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. (link <a href="http://jama.ama-assn.org/cgi/content/full/298/15/1779">here</a>) 3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. (link <a href="http://jama.ama-assn.org/cgi/content/full/284/17/2234">here</a>)

Who You Gonna Call? - How Should a Young Academic Respond to a Proffered Conflict of Interest?

To prepare a workshop on conflicts of interest in health care, I wrote a case of a faculty member offered a proposition that might provide a...

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