an attempt at punditry…

Posted on Saturday 29 June 2013

Improving Health With Partnerships Between Academia and Industry
JAMA: Internal Medicine
Viewpoint
by Susan Desmond-Hellmann, MD, MPH
June 24, 2013

AT A TIME WHEN JOBS seem scarce, one role seems to have multiplied: the pundit; never at a loss for a provocative, deeply held view or opinion. And, one of the rapidly expanding punditry themes is focused on the purported “evils” of the pharmaceutical industry and the potential for an associated corrupting influence of money on innovation in health. In his new book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, Ben Goldacre, BA, MBBS, MA, MRCPsych, a British physician and writer, says
    Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments.
This kind of hyperbole ignores remarkable advances in medicine, such as in human immunodeficiency virus/AIDS and cancer care, that are directly attributable to the work done in the pharmaceutical and biotechnology industries. But repetitive negative publicity has had an impact; a recent randomized study of 503 internists showed that industry sponsorship of clinical trials negatively influences physician perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial’s rigor and quality. So why did I accept the invitation to write an article regarding the role of the pharmaceutical and biotechnology industries in innovation [and risk an attempt at punditry myself]?
She will go on the answer some of her own question in the article itself when she describes her "16 years of employment in the pharmaceutical and biotechnology sector [at Bristol- Myers Squibb and Genentech] prior to returning to academia…" And perhaps her career highlights from Wikipedia might give us some insight into why she might agree to write this article:
  • Desmond-Hellmann joined Genentech in 1995 as a clinical scientist, and she was named chief medical officer in 1996. In 1999, Desmond-Hellmann was named executive vice president of development and product operations.
  • Prior to joining Genentech, Desmond-Hellmann was associate director of clinical cancer research at Bristol-Myers Squibb Pharmaceutical Research Institute. While at Bristol-Myers Squibb, she was the project team leader for Taxol.
  • Desmond-Hellmann also has served as associate adjunct professor of epidemiology and biostatistics at UCSF. During her tenure at UCSF, Desmond-Hellmann spent two years as visiting faculty at the Uganda Cancer Institute, studying AIDS and cancer. She also spent two years in private practice before returning to clinical research.
  • In April 2012, Desmond-Hellmann was honored with the Commonwealth Club of California’s 2012 Distinguished Citizen Award for her leadership at UCSF and Genentech.
  • In October 2010, she was elected a member of the Institute of Medicine and inducted into the American Academy of Arts and Sciences.
  • In January 2009, Desmond-Hellmann joined the Federal Reserve Bank of San Francisco’s Economic Advisory Council for a three-year term.
  • She was named UCSF’s first woman chancellor and took the helm of the graduate health sciences university in August, 2009.
  • In July 2008, Desmond-Hellmann was appointed to the California Academy of Sciences Board of Trustees.
  • She was named to the Biotech Hall of Fame in 2007 and Healthcare Businesswomen’s Association Woman of the Year for 2006. Desmond-Hellmann was listed among Fortune magazine’s Top 50 Most Powerful Women in Business in 2001 and from 2003 to 2008. From 2004 to 2006, the Wall Street Journal listed Desmond-Hellmann as one of its Women to Watch.
When Dr. Desmond-Hellmann was nominated for the Chancellorship of UCSF in 2009, Dr. Poses of Healthcare Renewal wrote a post titled Boi-Tech U questioning her qualifications:
    So, on one hand, Dr Desmond-Hellmann, to be charitable, does not have much of an academic track record, at best approximating that of a very junior medical faculty member. She also certainly has no experience in academic administration. In general, people who lead academic medicine often have substantial track records in academics and in academic administration. So, in some sense, Dr. Desmond-Hellmann’s appointment seems to based on the theory of the generic manager. That is, the popular notion in the business world managers can manage anything, any organization, with any mission, in any context. Managing in the complex health care context, especially managing large, complex academic medical institutions, may not be easy for those used to managing elsewhere, even in the health care corporate world. Furthermore, the complex mission of academic medicine, which includes providing excellent care of individual patients, while discovering and disseminating the truth in a spirit of free enquiry, is very different from the mission of a for-profit biotechnology company. How well someone used to the bottom-line mentality of the corporate world would uphold the academic mission is not clear…

After noting the extremely dear pricing for Genentech’s drugs, he did some poking around:
    But, while Dr Desmond-Hellmann was defending pricing drugs that at more than $55,000 a year, and complaining about low industry profits, she was pocketing lavish rewards. According to Genentech’s 2008 proxy statement, [the last available, since the company has been bought out by Roche], her 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, and the top five company executives’ total compensation was equal to about 1.5% of the firm’s total revenues. In 2007, the firm’s stock price declined from 91.30 on 6 January 2007 to 66.38 on 4 January, 2008, or 27%, according to Google Finance. In 2007, she held 1,616,383 shares of stock, or stock options exercisable within 60 days of January 31, 2008. In 2007 she exercised 170,000 stock options, realizing $11,556,663. So perhaps those high drug prices were needed not only to pay for research, but to make top executives, including Dr Desmond-Hellmann, very rich…
She got the job, and by 2012 was working on changing the UCSF relationship with the California system [Chancellor Proposes New Approach to Secure UCSF’s Financial Future]:
    Desmond-Hellmann told the Regents she expects one of the working group’s tasks to be exploring alternative governance strategies that would allow UCSF to benefit from the region’s considerable expertise in health care, biotech industry and business. During her nearly three-year tenure as UCSF chancellor, Desmond-Hellmann has championed forging new industry partnerships to more quickly translate research discoveries for the benefit of patients. In recent years, UCSF has connected growing numbers of scientists with the resources and expertise of pharmaceutical, biotech and high-tech companies to move science and inventions closer to becoming drugs, therapeutics or products to improve health.

    In the future, UCSF could find new revenue streams through efforts such as spinning off successful biotech companies, creating a joint venture for an outpatient pharmacy with a for-profit pharmaceutical company and exploring new opportunities on the technology transfer front. The chancellor noted that Genentech, Chiron and other biotech companies were created based on science that came from UCSF. “Company creation and innovation are part of our DNA,” she told the Regents.

So I guess that’s enough about her question, "So why did I accept the invitation to write an article regarding the role of the pharmaceutical and biotechnology industries in innovation [and risk an attempt at punditry myself]?" in an article titled "Improving Health With Partnerships Between Academia and Industry." We can intuit a lot of the answer. In the Viewpoint article itself, she talks about the dedicated scientists she met in her PHARMA years and about the contributions of industry to medical advances. She gave other reasons for the reversal of conclusions in industry research and cautioned us not to jump to see them as fraud. But then she got to the bottom line of the piece:
Given the challenge of effectively innovating to improve health, we must resist measures that would increase the barriers to effective industry-academic partnerships. Academic faculty members are the very individuals who can best add rigor to the research process, help to make study results more transparent, and facilitate better feedback to all stakeholders. These activities should increase confidence in medical innovations. In addition, we must ensure that communication of research findings is robust and clear. Communications should explain the inherent uncertainty of novel therapeutic approaches, the strengths and limitations of findings as new data emerge, and how new data that contradict earlier data affect best clinical practices. To improve health, increasing industry-academic interactions is vitally important…
Dr. Desmond-Hellmann’s presentation to the Board of Regents last year [Chancellor Proposes New Approach to Secure UCSF’s Financial Future], reveals another motive for her supporting the partnerships between academia and industry, beyond to "improve health":
    She cited the University’s remarkable progress in achieving its three-fold mission of training the next generation of health sciences leaders, leading scientific discovery as one of the top biomedical research institutions in the world and advancing health care as one of the top-10 medical centers in the nation. UCSF received $532.8 million in funding from the National Institutes of Health in 2011, once again garnering the most funds among public institutions in the United States, second overall after private Johns Hopkins University.
The justification for such partnerships comes down to supporting our otherwise difficult-to-fund universities. There’s little question of that need, but the cost has been extraordinarily high:
    The chancellor also explained that UCSF is significantly different from its sister campuses in the UC system since it is the only University dedicated solely to graduate-level programs in the tuition increases an impractical financial solution for UCSF. The chancellor already is working on other fronts – including making a personal contribution of $1 million – to increase financial support to both graduate students and students enrolled in its four professional schools of dentistry, medicine, nursing and pharmacy health sciences… Revenue sources for UCSF’s $3.86-billion budget come primarily from the clinical enterprise [50 percent] and grants to the research enterprise [29 percent], she explained. “UCSF is heavily dependent on two funding sources: our medical center and grants,” Desmond-Hellmann said. “Eighty percent of our revenue comes from these two sources, which both exist in an extremely competitive landscape.”
What university chancellor can afford that kind of donation?

Perhaps on Susan Desmond-Hellmann’s side of the rainbow, industry-academic partnerships might bear some relationship to improved health. And maybe in Oz, the corporate management of Community Hospitals cuts medical costs and improves care [the modern robber barons…]. It might be even be true in Munchkin-land that adding academic key opinion leaders to industry funded and authored clinical trial reports improves their scientific clarity and validity [seroquel: good to the last drop…, rest my case…]. But here in Kansas, those are hypotheticals rarely if ever realized – rather they contribute to soaring medical costs, misrepresented efficacy, undeclared adverse effect burdens, and obscene corporate profitability, not to mention the palpable erosion of our medical ethic.

In many ways, psychiatry currently stands as a testimony to what’s at the end of this yellow brick road. After three decades of generously supporting departments of psychiatry with the fruits of Desmond-Hellmann’s kind of academic-industrial partnerships, the reputation of academic psychiatry is all but spent and the pharmaceutical industry is in full flight. It was a Faustian bargain, not a dream that could be conveniently exited in a State Fair balloon – more like the nightmare you can’t wake up from.

To my way of thinking, the real question is why JAMA: Internal Medicine chose Dr. Susan Desmond-Hellmann to even write this article [she declared no Conflicts of Interest]…
  1.  
    June 29, 2013 | 8:28 PM
     

    Put a wig on Bernie Madoff and you have his female doppelgänger.

    Rude, but gets the point across! A Ponzi scheme just using people as patients for the pyramid of morbidity and mortality.

    As I wrote months ago at my site, how do you shame the shameless!?

    You can’t!!!! Go after what drives them, money and power. Don’t support their drivel and false rhetoric, and do not validate them by going to their conferences nor read their disingenuous academic premises.

    In other words, use your spines and regroup your gonads. Yeah, like half my field gets what I say!

  2.  
    jamzo
    June 29, 2013 | 9:05 PM
     

    fyi…related but separate issue

    Downloaded From: http://jama.jamanetwork.com/ by a World Health Organization User on 05/28/2013

    Personalized Medicine vs Guideline-Based Medicine
    Jeffrey J. Goldberger, MD, MBA; Alfred E. Buxton, MD
    JAMA. 2013;309(24):2559-2560. doi:10.1001/jama.2013.6629.
    Text Size: A A A
    Published online May 27, 2013
    Article
    References

    Two philosophical approaches to the implementation of optimal health care are emerging—the use of evidence-based guidelines and the application of personalized (or “precision”) medicine. Even though both approaches have important merits, they both also can present conflicting priorities that must be reconciled before they can be best leveraged.

  3.  
    jamzo
    June 29, 2013 | 9:06 PM
     
  4.  
    jamzo
    June 29, 2013 | 9:31 PM
     

    hubris

    “academia” speaking up to combat “one of the rapidly expanding punditry themes is focused on the purported “evils” of the pharmaceutical industry and the potential for an associated corrupting influence of money on innovation in health.”

    adds fuel to the fire

    i suspect the author and the publisher of “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” could not be happier

  5.  
    wiley
    June 29, 2013 | 11:22 PM
     

    Yes, Joel, and never give them the benefit of a doubt— they don’t deserve it.

  6.  
    June 30, 2013 | 12:27 PM
     

    In general, the philosophy that “what’s good for business is good for everyone” has held sway in the US for the last 30 years, sacrificing the interests of consumers. Its extension to medicine has been disastrous for patients.

  7.  
    June 30, 2013 | 2:05 PM
     

    Amen to the above comment by Altostrata. There is no place for a business mentality to health care. But, that ship has sailed and found the iceberg.

  8.  
    Peter Parry, child psychiatrist
    June 30, 2013 | 9:28 PM
     

    Hi Micky,
    Just discussing this blog post with our psychiatric registrar (resident in US parlance). She suggests you summarise your findings into a letter to JAMA:Int Med about why indeed was she allowed to write this piece with “no COI to declare”?!
    I and I’m sure others would be happy to co-sign after viewing and discussing draft and background information.
    Great work.
    regards
    Peter

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