healthy4u: contract research organizations

For Whom the Door Revolves - from For-Profit Contract Research Organization Leadership to Surgeon General?

The new nominee to be US Surgeon General is Dr Vivek Murthy, as <a href="http://www.boston.com/lifestyle/health/blogs/white-coat-notes/2013/11/14/obama-nominating-vivek-murthy-harvard-and-brigham-and-women-surgeon-general/eo6mit1nNtLpUxE6VrizLJ/blog.html">announced</a> in the Boston Globe White Coat Notes blog in November.  A Boston Globe <a href="http://www.bostonglobe.com/metro/2013/11/15/murthy-obama-choice-for-surgeon-general-who-likes-practice-outside-hospital-walls/KwrWaarq2lkrDMy1vXLNEP/story.html">article</a> a few days described not only his "healthy lifestyle" which included ingestion of "unflavored almond milk, raw carrots, and high-protein grains," as well as the practice of yoga, but how he has <blockquote class="tr_bq">strived to use his medical degree to help patients beyond the hospital walls through starting health care companies and nonprofits. His supporters hope that his record stands out....</blockquote> While the US Surgeon General has little power, occupants of the office have tried to use it as a bully pulpit, often for public health issues.  For example, <a href="http://www.surgeongeneral.gov/about/previous/biokoop.html">Dr C Everett Koop</a> was known for his campaign against smoking, and his advocacy for public health measures to combat HIV.   Most previous Surgeons General came from academic, public health, and/or practice backgrounds (Dr Koop was Physician-in-Chief of the Childrens Hospital in Philadelphia; his successor, Dr Antonia Caremello was in academic pediatrics, private practice, and at the NIH; then Dr M Jocelyn Elders also came from academic pediatrics, etc.) Dr Murthy superficially seems to come from this tradition.  The Globe article noted his "professional life as a Brigham and Women's Hospital [a prestigious Harvard teaching institution] physician." However, Dr Murthy was also described by the official statement nominating him to be surgeon general as "Co-Founder and Chairman of the Board of TrialNetworks, formerly known as Epernicus, since 2007."  The Globe called it a "software start-up company in Needham ... to help drug developers efficiently collect information from clinical trials." But wait, an <a href="http://www.usatoday.com/story/opinion/2013/12/03/obama-health-care-surgeon-general-murthy-column/3863603/">op-ed</a> in early December in USA Today called him a "self described passionate entrepreneur" and "a part-time physician and a full-time businessman."  In fact, the TrialNetworks web-site describes a company that <blockquote class="tr_bq">provides sponsors and CROs the industry's only <a href="http://www.trialnetworks.com/platform/overview">Clinical Trial Optimization System</a>. Using this modern and intuitive cloud-based technology, customers such as Merck & Co. and Infinity Pharmaceuticals are able to transform the quality and efficiency of clinical operations at each stage of a trial from feasibility through closeout. Companies ranging from biotechs to Top-10 pharmas have implemented the TrialNetworks platform for use in Phase I-IV trials by more than 25,000 site staff in 60 countries.</blockquote>Thus, TrialNetworks is a form of for-profit contract research organization in that it is apparently paid by drug and biotechnology companies to help them do clinical trials and other clinical research. Its website includes <a href="http://www.trialnetworks.com/customers/overview">customer testimonials</a> from  Merck, Biogen Idec, Infinity Pharmaceuticals, and Ariad Pharma. So apparently Dr Murthy, if approved, may be the first US Surgeon General to come through the revolving door from a leadership position in a company that is a variant on the for profit contract research organization theme, an organization that supports clinical research by the pharmaceutical industry, and has major pharmaceutical and biotechnology corporate clients.  As we have discussed, most clinical research is now sponsored, and effectively run by for-profit drug, biotechnology and device companies, and is devoted to efforts by these companies to assess their own products, often ostensibly as required for regulatory approval, but often influenced by marketing considerations.  Unfortunately, the domination of clinical research by those with vested interests in having the research turn out in favor of their own products has resulted in many examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of the research</a>, and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression </a>when that manipulation has failed to produce the desired results. So the obvious concern about Dr Murthy would be whether he would use his bully pulpit only to support patients' and the public's health,  or would his prior experience in a leadership position in commercially sponsored pharmaceutical research influence him in favor of that industry's priorities? As we have discussed, US health care is now dominated by for-profit corporations, and these organization can command the effort of multi-million or billion dollar marketing and public relations divisions to sell their products and the policy positions they favor.  These organizations hardly are in need of more bully pulpits.  Yet it seems that this new appointment will further increase the influence in government of big health care business, rather than that of health care professionals, patients, and the people in general. Sadly, it seems that Dr Murthy's nomination is just the latest example of how leadership of health care in government and in the corporate world now overlaps, and how the role of "pure" health care practitioners and health care academics in government has waned.  As we <a href="http://hcrenewal.blogspot.com/2013/10/former-fda-commissioner-cms.html">previously noted,</a>  the system in which government and big corporations largely overlap in terms of their leadership and presumably goals is called <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a>.  One can argue that such systems end up being run primarily for the benefit of corporate and government insiders.  Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders. I would note that neither the currently controversial and now operational Affordable Care Act, nor any of its opponents schemes for alternatives addresses this issue. by Roy M. Poses MD for Health Care Renewal

For Whom the Door Revolves - from For-Profit Contract Research Organization Leadership to Surgeon General?

The new nominee to be US Surgeon General is Dr Vivek Murthy, as announced in the Boston Globe White Coat Notes blog in November. A Boston Globe article a few days described not only his "healthy life…

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10 Dec 2013

More than Just a Conflict of Interest? - Should Rutgers University's Own Contract Research Organizations Report to the Board of Covance?

Transparency International's 2013 global survey showed that over 40% of Americans think the country's health care is corrupt (see <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">this post</a>).  <a href="http://www.transparency.org/">Transparency International</a> defines corruption as abuse of entrusted power for private gain.  It is likely that one reason many US citizens feel this way is that they have become aware of the web of conflicts of interest that now permeates health care. The Institute of Medicine <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">defined</a> conflicts of interest in medicine as occurring "when an individual or institution has a secondary interest that creates a risk of undue influence on decisions or actions affecting a primary interest."  Since the primary interest of physicians is to provide good care that puts patients' interests first, and the primary interests of academic medicine are to provide education and research of quality and integrity, conflicts of interest affecting physicians or academic medical institutions increase the risk of abuse of the entrusted power defined by these primary interests. The most striking conflicts may occur when one person simultaneously runs two different health care organizations whose missions and interests are at odds.  For example, we have been documenting <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">since 2006</a> how some top leaders of academic medicine simultaneously sit on boards of directors of health care corporations.  Thus, <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">for example</a>, the dean of a prestigious medical school may sit on the board of a large pharmaceutical company.  That person is supposedly responsible both for the honest education of students, including unbiased education about the use of drugs, and for a company whose revenue depends on selling more drugs at higher prices. Rutgers University President, Director of VWR International and Covance Such conflicts attracted little public notice when we first blogged about them, but now occasionally attract more attention.  For example, the NorthJersey.com just <a href="http://www.northjersey.com/news/education/Barchi_draws_pay_from_two_companies_that_do_business_with_Rutgers.html">reported</a> on the conflicts affecting the President of Rutgers University, which includes two medical schools and many other academic health care components, <blockquote class="tr_bq">As he leads the transformation of the state’s flagship university into a medical research hub with national aspirations, Rutgers University President Robert Barchi is also collecting hundreds of thousands of dollars for privately advising two firms that do millions of dollars of business with Rutgers related to scientific research.</blockquote> In particular, <blockquote class="tr_bq">both firms have a business relationship with Rutgers. Those relationships predate Barchi’s appointment. They could expand, however, with Rutgers’ recent merger with most of the University of Medicine and Dentistry of New Jersey. Rutgers has paid VWR International, a publicly traded lab supply company, and its subsidiaries a total of $15 million since 2008, records show. It is on pace to pay the company $2 million this calendar year, even though a contract with the firm expired in 2012. A university spokesman said the deal was extended, but an official who handles public records requests said a copy of the extension was not on file. Covance Inc., a pharmaceutical research firm, has been paid about $100,000 by Rutgers since 2008. It supplies products and services used in biological research. Those two companies paid Barchi a combined $317,000 in fees and stock awards last year to sit on each company’s board, part-time advisory positions he has held more than seven years. Barchi has also accumulated stock in both companies — in the case of Covance, worth the equivalent of $2.5 million as of Friday, according to corporate filings. The annual fees supplement Barchi’s annual pay at Rutgers, which is worth up to $747,000 after bonuses. </blockquote> Dr Barchi argued that since he had disclosed these relationships to the university board of governors, it is all good, <blockquote class="tr_bq">'I disclosed my membership on the board fully during the search process, both on my résumé and in discussions with Rutgers board of governors members,' Barchi wrote in a statement issued in response to questions and an interview request submitted through a spokesman. 'Rutgers University recognizes the value of having its chief executives serve on corporate boards. ... Recognizing the potential for a conflict, however, since becoming president at Rutgers I have not been involved in any decisions at Rutgers involving' the companies. </blockquote> Members of the university governing board did not seem too troubled either. <blockquote class="tr_bq">'It was fully disclosed,' said Gordon MacInnes, a member of the governing board. 'I don’t see any inherent conflict.' </blockquote> However, NorthJersey.com found some people who thought there could be a real issue since the university has direct financial relationships with both companies on whose board Dr Barchi sits. <blockquote class="tr_bq">Cary Nelson, a past president of the American Association of University Professors who has written a dozen books on higher education policy and conflicts of interest, said Barchi’s arrangement 'is not an ambiguous case, unfortunately,' calling it a clear conflict. There’s a danger of impropriety, Nelson said, even if Barchi never actively exerts influence on behalf of the companies he advises. For example, officials who make large buying decisions for the university may choose contracts with the companies to curry favor with the president or because they 'don’t want to make waves,' he said. Nelson is the co-author of an extensive report for the professors’ association due out at the end of this year that will suggest university policies to avoid such problems. 'What we say is that no administrator should serve on a corporate board or have any kind of financial relationship with a company that does business with the university,' he said. 'That’s a fundamental principle that has to be honored.'</blockquote> Public Notice Unlike some cases we have previously discussed (for example, <a href="http://hcrenewal.blogspot.com/2006/01/california-nightmares-more-troubles-at.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">here</a>), this one produced an immediate kerfuffle, if not an uproar.  The New York Times reported on it.  Already editorialists (e.g., <a href="http://news.google.com/news/url?sr=1&sa=t&ct2=us%2F0_0_s_7_0_t&usg=AFQjCNHWcgGT8g4KHN66hDJCq4_ZGE-0aQ&did=c47cdb7d453db56d&cid=52778199768898&ei=vpPlUaCzI4jcggfD9wE&rt=STORY&vm=STANDARD&url=http%3A%2F%2Fwww.northjersey.com%2Fnews%2Fopinions%2F215623061_The_Record__Barchi_and_boards.html">here</a>) and a few politicians (look <a href="http://www.nj.com/news/index.ssf/2013/07/rutgers_president_barchi_faces_calls_to_resign_from_paid_posts_on_corporate_boards.html">here</a>) have called for Dr Barchi to step down from his corporate board positions. For example, <a href="http://www.northjersey.com/news/Rutgers_president_Barchis_side_pay_draws_criticism_from_lawmakers_experts.html">per</a> again NorthJersey.com, <blockquote class="tr_bq">'This is a two-way financial arrangement that creates a textbook example of a conflict of interest,' said Senate Majority Leader Loretta Weinberg, a Teaneck Democrat, who called on him to resign from his advisory posts for the companies, VWR International and Covance Inc. 'The president of the university is on the payroll of companies that are paid millions of dollars by the school. Even if Mr. Barchi avoids direct involvement in business decisions between Rutgers and these firms, the appearance of a conflict could undermine his credibility at a key time in the evolution of the university.' </blockquote> Some Additional Perspective Dr Barchi's conflicts of interest have drawn considerable more coverage than similar conflicts of other academic health care leaders whom we have discussed in the past. Unlike these previous cases, they have also provoked upset, if not some outrage. Yet there could be more outrage, because this case is actually worse than it has been so far publicly described. First, the public discussion seems not to have taken into account the nature of Dr Barchi's responsibilities to VWR International and Covance.  He is not on advisory boards to these two companies, as implied by the initial NorthJersey.com report.  He is a member of both these companies' boards of directors. As we <a href="http://hcrenewal.blogspot.com/2008/05/worse-variant-of-new-species-of.html">noted in 2008</a>,  the issue goes beyond just the often generous payments board service entails. The important consideration is that directors of public for-profit corporations have a duty to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   (Many people would now argue that many current corporate directors function more like cronies of top management than representatives of the shareholders). But the important message is the boards of directors are responsible for the governance and overall direction of the company.  For example, the 2<a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1hSFIwY0RvdkwyRndhUzUwWlc1cmQybDZZWEprTG1OdmJTOWtiM2R1Ykc5aFpDNXdhSEEvWVdOMGFXOXVQVkJFUmlacGNHRm5aVDA0T0RFNU16YzVKbk4xWW5OcFpEMDFOdz09JnR5cGU9MiZmbj04ODE5Mzc5LnBkZg==">013 Covance proxy statement </a>includes, "The Board of Directors provides oversight of senior management in its operation of the Company."   The members of the board have a fiduciary duty to align with the companies' interests which goes beyond whatever loyalty their compensation from the company ought to inspire.  Thus, the extreme conflict between, for example, one person's roles as a university president responsible for education, including unbiased education of physicians about drugs,  and a director of a drug company ought to be obvious. Dr Barchi, is not a director of a drug company, but the director of a contract research organization.  The description of Covance in the NorthJersey.com article above was incomplete.  In fact, the Covance web-site describes the company as "one of the world’s largest and most comprehensive drug development services companies."  In particular, Covance functions as a contract research organization (CRO).  Its work includes running clinical research for pharmaceutical and biotechnology companies, including "Early Patient Studies,Clinical Development (Phase II-III)." As university president, Dr Barchi is simultaneously responsible for educating students about clinical research, and for the integrity of clinical research performed within the university.  More acutely, however, he actually is responsible for several contract research organizations that appear to be competing with Covance. As more clinical research has been taken over by CROs, some academic institutions have decided to compete directly with CROs.  In particular, Rutgers University, in particular, seems to have its own CROs.  First, as <a href="http://shrp.rutgers.edu/dept/biopharma/">proclaimed </a>by its Biopharma Educational Initiative, "Rutgers Biomedical and Health Sciences is one of the largest health care research institutions in the US with our own (emerging) contract research organization."  The Rutgers Clinical Research Organization <a href="http://cro.rbhs.rutgers.edu/aboutUs.html">asserts</a> "Rutgers CRO connects industry, patients and academic collaborators with the University's state-wide academic resources."  Meanwhile the Rutgers New Jersey Medical School Institute of Genomic Medicine <a href="http://njms.rutgers.edu/genesweb2/services.cfm">states</a> "the IGM functions as an academic contract research organization (CRO) dedicated to biomarker discovery and the clinical evaluation of biomarkers.". Thus, not only does Dr Barchi's role in the governance of Covance seem to present a conflict with his role in upholding the integrity of research at Rutgers, but it could conceivably be anti-competitive.  While one may question whether university's should directly compete with CROs, as long as they do, it seems they ought not to be run by those responsible for the governance of the CROs with which they are ostensibly competing. Summary As the web of conflicts of interest that entangles health care becomes more visible, the risks of corruption that it generates become more obvious.  I hope as disclosure improves, public outrage about health care corruption will increase.   Ultimately, true health care reform requires more than disclosing conflicts of interest. The IOM  <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report </a> on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry.  This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts.  However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research. Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=40518">on the University Diaries blog.</a> See also the <a href="http://loathingbioethics.blogspot.com/2013/07/what-does-rutgers-president-have-in.html">comments </a>by Dr Carl Elliott on the Fear and Loathing in Bioethics blog.   ADDENDUM (24 July, 2013) - see additional comments <a href="http://www.margaretsoltan.com/?p=40606">here</a> and <a href="http://www.margaretsoltan.com/?p=40613">here</a> by Prof Margaret Soltan on the University Diaries blog.

More than Just a Conflict of Interest? - Should Rutgers University's Own Contract Research Organizations Report to the Board of Covance?

Transparency International's 2013 global survey showed that over 40% of Americans think the country's health care is corrupt (see this post). Transparency International defines corruption as abuse of…

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16 Jul 2013

"Conspiracy Theory" Proven - Taking UCSF Private

Students and faculty at the University of California have come up with a vivid, and prescient example of how the hired executives and bureaucrats have taken over higher and health care education.  "Run in the Interests of the Administration" Two weeks ago, the Orange County Register <a href="http://www.ocregister.com/news/faculty-334335-tuition-system.html">reported</a>: <blockquote>Over the past few months, the University of California has raised undergraduate tuition by 18 percent, awarded raises of as much as 23 percent to a dozen high-ranking administrators and announced a possible 81 percent tuition increase over the next three years. Students haven't taken the news well. At campus rallies across the state, thousands of students and their faculty supporters have decried the actions, staging raucous rallies and 'Occupy'-style sit-ins that in some cases have ended in clashes with law enforcement. They've also descended en masse on UC regents' meetings, disrupting proceedings and even forcing officials to retreat to a private room. Behind the angry chanting and acts of civil disobedience is a growing sense that the 10-campus UC system is no longer a public institution accessible to the middle class, but rather a sprawling bureaucracy of hospitals and auxiliary research institutions buffeted by an ever-expanding roster of administrators. The problem, as the student activists see it, is that none of these functions translates directly into expanded course offerings or improved student-to-faculty ratios, even as their tuition dollars help sustain the system. 'The university is now being run in the interest of the administration,' said UC Irvine student activist Anne Kelly, a Ph.D. candidate in earth system science. 'They're promoting their own internal growth, asking us to sacrifice with higher tuition – but administrators have had raises.'</blockquote> In higher education, as well as in health care education and in health care in general, the pattern is the same: rising costs without any obvious increase in quality or quantity of services. As in health care, however, the pain never seems to extend to administrators/ managers/ bureaucrats/ executives. Worse, as their numbers grow, these insiders seem to run organizations more for their own benefit, and less for the mission. One Manager Per Faculty Member Furthermore, UC faculty have data: <blockquote>The students' growing frustration is fueled by UC employment data that show that almost three-fourths of UC's 152,500 employees last year were designated 'non-academic personnel,' according to an annual UC employment report. In the report, UC characterizes the growth in its non-academic staff as the inevitable byproduct of 'an increasingly complex university system that 'requires greater professionalization of its staff, who must meet higher technical and competency standards.' Non-academic personnel includes everyone from custodians and food-service workers to accountants and plant operators. [The question begged is whether it was the managers and executives that caused this complexity - Ed.] UC Davis horticulture researcher Richard Evans, who has independently analyzed UC personnel data, offered a different take on the data, publishing a tongue-in-cheek piece for UC faculty in 2010 entitled 'Soon every faculty member will have a personal senior manager: Is this a good way to spend money?' 'Data available from the UC Office of the President shows that there were 2.5 faculty members for each senior manager in the UC system in 1993,' Evans wrote in his piece. 'Now there are as many senior managers as faculty. Just think: Each professor could have his or her personal senior manager.' In his analysis, Evans compared the number of UC employees classified as either 'senior management' or 'managers and senior professionals' with the number of tenure-track UC faculty members. As of spring 2011, UC employed 8,144 senior managers, managers and senior professionals, and 8,521 tenure-track faculty members, according to the latest available UC data.</blockquote> This pattern is similar to that seen in some data we discussed a long time ago about the ever rising numbers of administrators/ managers/ bureaucrats/ executives in health care.  In 1988, Alain Enthoven advocated in <a href="http://www.amazon.com/gp/product/0444703594/102-6581115-0444916?n=283155">Theory and Practice of Managed Competition in Health Care Finance</a>, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a>). Health care went from being controlled by clinicians to controlled by a growing volume of managers.  Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved. A "Conspiracy Theory" About the Privatization of the University At the University of California, the Register reported that there is a "conspiracy theory" about the next step to increase the domination of the managers: <blockquote>The salaries and size of UC's administrative staff, in particular, have fueled conspiracy theories among students and faculty that the system has deliberately sought to 'privatize' itself – in other words, to compete with private universities on all fronts, from the scope of its non-instructional programs to executive compensation to the amount of tuition that students pay. Three years ago, the head of a UC faculty group advanced the privatization theory in a multi-part series called 'They Pledged Your Tuition.'</blockquote> Of course, the administrators denied, sort of, anything so far-fetched: <blockquote>For its part, UC denies all such allegations, saying that while the university has arguably become privatized, outside influences beyond its control are entirely to blame. "It is not something we advocate, not something we want,' Klein said. But, 'he added, 'times have changed; the economic model has changed.'</blockquote> Not Just a "Conspiracy Theory" - UCSF Chancellor Advocates Privatization It only took two weeks, however, for the notion of administrators taking the university private to go from "conspiracy theory" to official plan. Yesterday, the San Francisco Chronicle <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/01/19/MNF11MR2KE.DTL">reported</a>, <blockquote>UCSF Chancellor Susan Desmond-Hellmann told the regents, delicately, that she wants out. Under her proposal, UCSF's medical school, hospital, clinics and research facilities would remain a public university connected to UC, the chancellor assured the regents. But the tendrils connecting the two entities should be thinner than they are today. Desmond-Hellmann said she envisions a relationship like those of UC Hastings College of the Law, Lawrence Livermore National Laboratory and Lawrence Berkeley National Laboratory, which contract with UC for health and pension services. While ultimately accountable to the regents, they are autonomous with their own boards of directors. Referring to 'alternative governance models' and 'examining UCSF's financial relationship with UC,' the chancellor and campus executives talked of their ambition to become the world's leading innovator in the health field - a goal better achieved, they hinted, without the rest of the university weighing it down.</blockquote> To <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> readers, that UCSF would be proposed as the first part of the University of California to privatize should not come as a shock. After all, Chancellor Desmond Hellmann came not from academia, but from the world of for-profit biotechnology. She was a former president for drug development for Genentech. Two and one half years ago I <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> that "hiring a lavishly compensated top executive from a biotech firm known for its high drug prices to run a public health sciences university does considerably blur the line between academic medicine and the health care industry." Furthermore, three months ago I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">noted</a> that Dr Desmond Hellmann seemed be advocating that the university's focus turn to product development, so that it would start to emulate a contract research organization. Now it appears that Dr Desmond Hellmann wants to traverse the line between government and the private sector, so that the organization could "make a ton of money," and "focus on spinning innovations into business deals," according to the San Francisco Chronicle. What any of this has to do with the university's fundamental mission to discover and disseminate knowledge, and with this health care university's mission to take the best possible care of its patients is not clear. Summary Turning UCSF into a private, quasi contract research organization might conceivably yield some good research and drug development. Why a formerly academic organization would be better at this than a purpose-built CRO is hardly proven. Whether UCSF recast as a CRO would yield better research, leading to better patient outcomes than would have resulted if it continued as a state government sponsored health care university is also hardly proven. Turning UCSF into a quasi CRO, however, would likely be very much in the self-interest of its administrators/ managers/ bureaucrats/ executives who would be freed from any constraints on their incomes, and the disclosure of same that were previously obligated by the messy representative democracy to which they formerly had to answer. On the other hand, it is hard to conceive of how such a privatization would be good for students or patients. In fact, it is not the least bit clear why a medical, nursing, or other health professional student would want to study within what would basically be a contract research organization. It is also unclear whether patients seeking care from such an organization could trust it to put their interests, rather than the organization's revenue and the self-interest of its administrators/ managers/ bureaucrats/ executives first. We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals. Turning one of our once proud and  prestigious state government sponsored academic medical institutions into a private contract research organization would be a powerful symbol of our final national health care decline. Let us hope that the students and faculty whose "conspiracy theory" about privatization proved true will now mount a more effective protest before UCSF falls into the muck.

"Conspiracy Theory" Proven - Taking UCSF Private

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22 Jan 2012

Quintiles to More Heavily Directly Invest in the Drugs Which it Evaluates - But Not to Worry, Says an Expert?

The Associated Press just <a href="http://www.google.com/hostednews/ap/article/ALeqM5jbIAnadjVl8lbQLqzQgrd0T3mPzwD9DSRKEO0">reported </a>on the latest trend in commercially sponsored clinical research, direct investment by contract research organizations (CROs) in the development of specific drugs by particular pharmaceutical or biotechnology companies. Here is the background in the article: <blockquote>Pharmaceutical companies previously did all their own research and testing and submitted the results to the Food and Drug Administration for approval to put a medication on the market. Since the 1990s or so, Big Pharma has farmed out more and more of that testing to companies like Quintiles Transnational Corp., which grew quickly to meet the demand.</blockquote>Now Quintiles is branching out... <blockquote>Now Durham, N.C.-based Quintiles is the world's biggest contract research organization, and more than ever, it's using its deep pockets to entwine itself with the pharmaceutical companies, fronting them cash and services for a piece of the profits once a drug is approved. Quintiles, which was created in 1982, upped the ante last month, saying it wants to invest even more in potential drugs as pharmaceutical companies grapple with the down economy. Quintiles is hoping its new investments will produce enormous payoffs in the future,.... Quintiles' decision to become more aggressive in taking investment risks comes at a time it's betting drug makers can use the resources it can offer, both cash and services. 'They're both currency for managing risk and having skin in the game,' said Ron Wooten, a Quintiles executive vice president who heads the company's capital investment group. Controversy over creating the drug investment unit in 2000 was key in pushing Quintiles founder Dennis Gilling and several private-equity firms to buy out shareholders for $1.75 billion and take the company private again in 2003. Wall Street analysts complained they couldn't estimate what the drug investments were worth, prompting Gilling and others to decide the company's stock was undervalued. The private company no longer publishes its profits. It claims revenues of about $3 billion a year. That's also about what Quintiles has invested in other drug companies.</blockquote>Furthermore, <blockquote>Quintiles appears to be uniquely positioned to both invest in and test potential medications. None of the half-dozen major shareholder-owned contract research organizations will have a drug-investment division after Wilmington, N.C.-based Pharmaceutical Product Development Inc. spins off its unit in a few months, Coldwell said. The payoffs for the risk of developing a drug can be huge. In 2002, Quintiles took a chance on Eli Lilly and Co.'s antidepressant Cymbalta. Quintiles said it invested $125 million in cash, then spent another $400 million on a sales force of more than 550 after the product launch. Cymbalta is now Lilly's second-biggest drug. Quintiles said it's brought in more than $700 million so far for a stream of royalties lasting to 2012. Japan's Eisai Co. is hoping Quintiles' money and experience helps it double the number of potential treatments it can put through testing simultaneously</blockquote> The article raised a concern that "the buffer between drug makers and testers are again blurred." But not to worry.... Here is the response from Quintiles, <blockquote>Wooten, the Quintiles executive, doesn't see his company's increased interest in bringing drugs to the market affecting its testing objectivity. Instead Quintiles is the outsider turning a hard eye on which pharmaceuticals will become profitable. 'It allows you to really get to the essence of the data that you're looking at instead of what you hope it says,' he said. There isn't 'the natural bias that you would have with your own babies.'</blockquote> Furthermore, the AP reporter got reassurances from a noted academic expert in the area, <blockquote>The FDA preserves the integrity of testing in a landscape already pockmarked with potential conflicts of interest that include company-sponsored academic research and investigators testing drugs while owning shares in companies that own the drug, said Kenneth Getz, a senior fellow at Tufts University's Center for the Study of Drug Development. The FDA's view is that any company with a financial stake in a potential drug will face similar scrutiny from the agency. 'It's assumed,' FDA spokeswoman Karen Riley wrote in an e-mail, 'that drug/device/biologic companies who sponsor trials of pending products have a conflict because they will gain if the product is approved.' Besides, pharmaceutical companies have navigated the tricky territory that comes with testing, Getz said. So have the companies like Quintiles that have taken on the outsourced work, he said. 'These potential conflicts of interest are ever-present, and the real question is how do companies manage these potential conflicts effectively,' he said. 'These are massive, massive companies that have thousands of staff that are not generally aware of a conflict of interest at a corporate level. They are paid to do a quality job that meets internal and regulatory guidelines or they are not going to keep their jobs.'</blockquote> Here on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, we have discussed how the <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> that are now pervasive in health care can adversely affect clinical care, teaching, and research.  We have looked at how clinical research sponsors, who have a vested interest in having the results favor the products and services they sell, may <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> the design, implementation, analysis, and dissemination of research, and when all else fails, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppress</a> unfavorable results.  We have also looked at problems with the ethics and quality of research done by <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, who are, after all, paid by companies again with vested interests in selling particular products or services. Given all that, one may argue that having contract research organizations invest in particular drugs or devices which they are also evaluating through clinical research may not make things much worse.  However, at the least, it seems to me that it further obfuscates conflicts of interest that may lead to biased research results, dishonoring the patients who volunteered for the trials, and biasing the information on which patients and physicians make decisions. Finally, I should note how Quintiles new investments in specific drugs was defended in the article.  The article quoted Quintiles executive vice president Ron Wooten suggesting that Quintiles might be able to be objective in making the original decision to invest in a drug. He conveniently did not address what might happen after the investment was made, when Quintiles was performing, analyzing, and reporting clinical research on a drug or device in which it had invested. The article also quoted Kenneth Getz, the Senior Fellow at Tufts, who seemed unconcerned about the issue.  What the article did not mention is that the Tufts Center for the Study of Drug Development, at which Mr Getz is based, <blockquote>receives unrestricted grants from pharmaceutical and biotechnology firms, as well as companies that provide related services to the research-based industry (e.g., contract research, consulting, and technology firms). These grants represent approximately 40% of Tufts CSDD’s operating expenses. </blockquote>per the Center's <a href="http://csdd.tufts.edu/about/financial_disclosure">web-site</a>. Another <a href="http://70.42.48.93/printpage.asp?ref=http://70.42.48.93%2FAbout%2FResearchStaff.asp">page on the web-site</a> lists Mr Getz's qualifications, <blockquote>Kenneth A. Getz is a senior research fellow at the Tufts CSDD. Considered an expert on the investigative site and CRO markets, R& D management, ECT solutions adoption and clinical research volunteerism,.... Mr. Getz is the founder and chairman of CISCRP .... He holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor's degree, Phi Beta Kappa, from Brandeis University. Mr. Getz worked for over seven years in management consulting, where he assisted biopharmaceutical companies in planning and implementing drug development strategies. He is also the founder and former CEO of CenterWatch.</blockquote> Note that Mr Getz seems to have no training in biomedical science, medicine, or health care.  Furthermore, CISCRP (the Center for Information and Study on Clinical Research Participation), has an advisory board (see their web-site <a href="http://www.ciscrp.org/patient/who.html">here</a>) that includes representatives of pharmaceutical companies (Vertex Pharmaceuticals, Biogen Idec, and Roche), and contract research organizations, (PPD Inc, and particularly, in this case, Quintiles). The vast <a href="http://www.ciscrp.org/patient/supporters.html">list</a> of the Center's "supporters" include a catalog of drug and biotechnology companies (including Abbott Vascular, Amgen, AstraZeneca, Biogen Idec, Daiichi Sankyo Pharmaceutical Development, Eli Lilly, Forest Laboratories, Genentech, Genzyme, GlaxoSmithKline, Janssen, Johnson and Johnson, Merck, Novo Nordisk, Novartis, Ortho-McNeil, Pfizer, Roche, Sankyo, Sanofi-Aventis, Serono, Shire, Takeda, and Wyeth), and contract research organizations, (including Covance, Parexel, PPDI, and notably again, Quintiles.) So the other lesson from this bit of news is how the information the public, health care professionals, and policy makers  receive about health care policy is frequently shaped by people with horses in the race, but that such influences are rarely disclosed.  This article included an interview with a single apparently academic expert who provided reassurance that the conflicts of interest discussed in the article were not really so worrisome.  This expert, however, failed to disclose his own extensive, albeit somewhat indirect ties to a variety of corporations that might benefit from the conflicts discussed as the main topic of the article, including corporations that were directly involved in them (Quintiles and Eli Lilly).  Maybe because the reporter thought that the expert was unbiased, there was no attempt to find a contrasting opinion. So I say again, again, again, health care professionals, policy  makers, and people in general need to be extremely skeptical of most of the apparently unbiased pronouncements made about medical and health care policy issues in the media.  It would be a small step toward a more transparent discussion if those who expressed opinions would also fully disclose in detail their relevant conflicts of interest.

Quintiles to More Heavily Directly Invest in the Drugs Which it Evaluates - But Not to Worry, Says an Expert?

The Associated Press just reported on the latest trend in commercially sponsored clinical research, direct investment by contract research organizations (CROs) in the development of specific drugs by …

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17 Feb 2010

Sham Studies and the Commercial IRBs that Approve Them, and Sham IRBs and the Government Department that Registers Them

We have occasionally posted about the activities of for-profit contract research organizations (CROs). These are commercial entities that conduct human research, including clinical trials for pharmaceutical, biotechnology and device companies. More clinical research is being done by such CROs rather than by academic investigators. CROs seem to operate under the radar of most physicians, academics, and policy makers, but sometimes stories surface that raise questions about them. For example, we discussed the trials by SFBC International (now <a href="http://www.pharmanet.com/">PharmaNet Development Group</a>) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-sfbc-internationals.html">here</a> and links backward); and the trial by <a href="http://www.parexel.com/">Parexel International </a>in London that put most of its subjects in intensive care (see post <a href="http://hcrenewal.blogspot.com/2006/08/parexel-blues-again.html">here</a>, with links backward). Last year, as we discussed <a href="http://hcrenewal.blogspot.com/2008/06/clinical-trials-torture-economy.html">here</a>, two articles questioning the ethics of research done under the auspices of CRO appeared in two major medical journals. In academia, human research is supposed to be overseen by institutional review boards (IRBs). Research done by CROs is also supposed to be overseen by IRBs, but the IRBs that do so are often also commercial. Despite concern that commercial IRBs may be tempted to lower their standards to get more business, commercial IRBs have flown even lower under the radar than have CROs. However, last week, a story appeared about how a "sting operation" tested one commercial IRB with amazing results. Here are excerpts from <a href="http://online.wsj.com/article/SB123811179572353181.html">the article by Alicia Mundy in the Wall Street Journal</a>, <blockquote> The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects. Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions. 'We realized it was a terrible risk for the patient … It is the worst thing I have ever seen,' an Argus IRB reviewer said, according to a slide shown at the hearing. <a href="http://www.coastirb.com/">Coast IRB </a>LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, 'Adhesiabloc.' </blockquote> The GAO also ran an experiment to see if the US Department of Health and Human Services (DHHS)would register a truly dubious commercial IRB <blockquote> The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included 'April Phuls' and 'Timothy Wittless,' which lawmakers said should have signaled irregularities to HHS. The department registered the IRB. </blockquote> On one hand, these anecdotes suggest, along with the stories discussed above, that CROs and the commercial IRBs that are supposed to oversee them deserve further scrutiny. Beyond that, one wonders if it is good for society for human research, including experiments involving drugs and devices, to be done by commercial firms dependent for their income on the companies that make these drugs and devices, overseen by other commercial firms also dependent on these same companies. The fundamental conflict is embodied by <a href="http://www.coastirb.com/page.asp?id=2&name=About">Coast IRB's self-description</a>: <blockquote>as an advocate and a catalyst for an ever-stronger pharmaceutical industry, ethically and economically. </blockquote>which also <blockquote>recognizes the vital importance of our role in protecting individuals in all clinical studies and in continuously raising the bar on professional standards. </blockquote> How can the company be an "advocate" for the industry while simultaneously protecting the people exposed to the industry's still experimental drugs? See also <a href="http://www.gooznews.com/archives/001363.html">comments</a> on the GoozNews blog.

Sham Studies and the Commercial IRBs that Approve Them, and Sham IRBs and the Government Department that Registers Them

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31 Mar 2009

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