Friday, October 14, 2011

Logical Fallacies to Support Putting a Major Academic Medical Center into the Contract Research Organization Business

Two uncritically positive biographical features on UCSF Chancellor Susan Desmond-Hellmann MD appeared within the last two weeks, one in the New York Times, suggesting the game is afoot.  That game appears to be the Chancellor's new strategic direction for the university. 

A New Strategy for "Increasing Collaborations" with Industry

Per the NY Times, the university has just made a huge investment in bricks and mortar,
the school’s gleaming new building for stem-cell research and its enormous new waterfront campus, Mission Bay, which is becoming a medical and biotech empire.

Now, perhaps to pay for it,
Dr. Desmond-Hellmann hopes to supplement the usual sources of income like patient fees, grants and tuition by increasing collaborations between the university and the biotech companies that have sprung up in the Bay Area — many of them spinoffs from research that began at the university.

Dr Desmond-Hellmann described the general direction thus:
Her vision for the university is to make it 'the world’s pre-eminent health sciences innovator.' That means 'unparalleled' care for patients, brilliant faculty and staff paid enough to stay and fast translation of scientific discoveries into treatments.
That seems worthwhile, if quite a bit vague.
Making "Collaboration," "Innovation," and "Translation" More Explicit

An article in Xconomy sounded similar themes, but was more explicit. First, Dr Desmond-Hellmann said,
I’m sticking my neck out there and saying the world is changing very quickly, and yet our aspiration at UCSF is to be a world leader in health science innovation

So it is time to jump on the bandwagon,
The old way of doing things doesn’t really work anymore.

But the Xconomy article was more explicit about what sort of changes she envisioned, what innovation she had in mind, and what "translation" means in this context:
Often, some of the best research ideas would get handed off from academia to a company at a very raw stage of development. But few venture capitalists are funding startups at this early stage of development these days, and Big Pharma R&D has always tilted more heavily toward D than R. The economy has put more pressure on companies to tilt that balance even further away from research, and more toward late-stage development that has a chance to bear fruit in the near-term.

Universities need to recognize this is how things are. If they want to truly translate their innovations into products that help patients, they will have to carry the research a little further downfield themselves. Some Big Pharma companies have already shown they are willing to sponsor this kind of on campus work at UCSF and elsewhere.

Working in collaboration with pharma companies is definitely a part of the future of advancing health, Desmond-Hellmann says. Financially, these deals are small potatoes, and aren’t going to close any budget gap. Even if UCSF researchers made a breakthrough cancer drug that generates billions of sales per year, it would likely only throw off a royalty stream to the university worth a few million a year—nice, but not exactly a big deal for a multi-billion-dollar institution.

Instead, the collaborations are about improving the flow of basic research through development. Pharma companies need new products to preserve and grow their bottom lines, and they aren’t doing so hot at inventing them on their own. When budget cutters ask questions about how taxpayer dollars are spent on campus, academic centers need to be able to say something like, 'We discovered a breakthrough drug that helps people live longer, better lives,' instead of just 'We got a cool paper published in Nature.'

Just to underline that,
Big Pharma R&D operations, rich as they may be, are feeling the same pressure to make cuts as universities. What’s needed now are the creative partnerships, where someone knowledgeable about the whole process (like maybe a Desmond-Hellmann) steps in and finds a way to more seamlessly bring together these two factions around what they have in common.

And the brave new world is almost here already,
UCSF has struck a number of creative partnerships with companies like Pfizer, Sanofi, and Bayer, which are being closely followed at other universities. UCSF has also found a way, with the help of some big-time philanthropy, to break ground on two ambitious projects—a $1.5 billion hospital complex and a $200 million neurosciences research facility in the Mission Bay district. There in the same neighborhood, the university has also continued to support QB3, an incubator where academic scientists are starting companies that test whether their ideas just might have what it takes to become new drugs, devices, or diagnostics.

So let us try to make Dr Desmond-Hellmann's new direction clear: what she meant by innovation and translation was doing contract research and development for big pharma and big biotech. The goal is not just to discover new knowledge, but to develop new products.  That should bring in a lot of money, which can pay for all sorts of fancy new buildings.

A New Direction Supported by Logical Fallacies

The problem is, as I hinted above, the arguments for this new direction were mainly based on logical fallacies.
Begging the Question

Note that the key argument in support of turning the university into a pharma/ biotech research and development shop was, "if they [universities] want to truly translate their innovations into products that help patients," they must develop those products themselves.  This begged these questions:
-  Should they want to develop products?
-  Why are they the only ones who can do so? 

These questions were never asked in either article, perhaps because their answers are obviously "no."  Universities' missions are to discover and disseminate knowledge.  Developing and marketing products are not part of their missions.  Furthermore, there are lots of corporations that ought to be able to develop and market pharmaceuticals and devices outside of universities.

Appeal to Common Practice/ Bandwagon

Another argument in favor of Dr Desmond-Hellmann's radical new plan was "universities need to recognize this is how things are," in that "the old way of doing things doesn't really work anymore." This is an example of two logical fallacies, the appeal to common practice, and maybe the bandwagon fallacy more so. An assertion is made that the world is changing, the change cannot be stopped or even questioned, so we all just have to climb on the bandwagon.

Straw Man and Begging the Question (Again)

The Xconomy article also noted:
Some academics sneer at this late-stage research/early-stage development work. It’s a cultural attitude Desmond-Hellmann wants to change. 'There’s a technical competence in taking a discovery from a lab and turning it into a medicine. It’s embarrassing that people don’t honor that technical competence. You sometimes hear it called 'applied' or 'obvious' or some other pejoratives. But it’s my expertise. I do take that personally. There is a technical competence. It needs to be understood, put into curriculum, and valued.'

Here Dr Desmond-Hellman seemed to be using the straw man fallacy, by setting up unattributed arguments against her cause that she could easily refute.

Meanwhile, however, another question she begged was what exhibiting such technical competence has to do with the mission of the university. As we will discuss further below, the mission of a university is to discover and disseminate knowledge. "Technical competence" may be required to do so, but exhibiting technical competence per se is not the goal. (Consider: if the university had faculty members who were competent amateur automobile mechanics, would it fulfill the mission to establish a university automobile repair business using these faculty members' technical competence?)

Another implied begged question was: if this competence ought to be a subject taught at the university, how would the need for such teaching require the university to do contract research and development for industry?

Appeal to Authority

Both articles also seemed to try to support Dr Desmond-Hellmann's ideas by emphasizing first that she had "a stunningly successful career in the pharmaceutical industry," perhaps so described because her "years in pharmaceuticals left her, by her own account, 'very, very wealthy," (It did allow that at the end of her career at Genentech, after she had become president of product development, "her compensation (base pay, stock and other payments) was more than $8 million a year. She also owned hundreds of thousands of shares of Genentech stock, worth $95 a share.")

Also, despite her apparent membership in the top one percent of the population in terms of income, the Times article took pains to note "she is so nice," and again, "she's a very nice person."

So the implication is that because she is successful, rich, and nice, her arguments and ideas must be correct.  This seems to be an appeal to authority.
Questions That Should be Asked

Neither the author of the NY Times article nor the author of the Xconomy article sought to ask her any of the questions that were begged, or to otherwise raised by Dr Desmond-Hellmann's grand plans.  So let me try.

How Does Becoming a Contract Research Organization Fulfill the University's Mission?

However her new plans are described, they entail hiring out the university's facilities and faculty to develop new products, drugs and perhaps devices. Yet the university's mission is to discover and disseminate knowledge. How will proprietary research and development fulfill that mission? 

In fact, there are reasons to worry that the new focus on for-hire drug research and development will undermine the mission.  Any new knowledge produced is likely to be labelled trade secrets. Faculty who work as drug and device development contractors will not be teaching students. Students caught up in drug and device development will be working for big corporations, possibly without pay, and without any ownership of anything they may discover in the process.

How Will the Resulting Institutional and Individual Conflicts of Interest be Managed?

If the university becomes dependent on being paid for drug and device development, can university faculty remain unbiased teachers and researchers? Will they not feel pressured to show favor to the products, policy goals, and leadership of the corporations that are paying them?

Why Would Faculty and Students Want to Participate in a Contract Research Organization Cloaked in Academic Robes?

Will faculty want to be labelled as contract workers? What will that do for their academic credibility? Will students want to be educated by people beholden to specific corporations and corporate projects?

Should Patients Want Care from a Contract Research Organization?

How will they be confident that the drugs they are prescribed and the devices used in procedures they undergo are not chosen because their doctors and nurses feel beholden to the corporations that make them?


UCSF's new multimillionaire ex-biotechnology executive Chancellor seems determined to push the university into a much closer relationship with the drug, device and biotechnology industry. In fact, she seems to be advocating that the university should become, in effect, a contract research organization to service this industry. So far, this radically new direction seems to be provoking no questions, much less dissent, even though the public justification for it was apparently based on a string of logical fallacies.

However, it is not clear how taking one of our major academic medical centers in this commercial direction will not harm, much less benefit its mission.

For 30 odd years in the US we have been making health care more commercial, and have to show for it the world's most expensive but hardly the world's best health care system. This increasingly inaccessible system which provides care of uncertain quality has made the one percent who run it very rich.

Those of us in the 99 percent need to question how making it even more commercial will do any of us any good.

Post-Script: You Can Take the Executive Out of Biotech, But You Can't Take Biotech Out of the Executive

When Dr Desmond-Hellmann first become UCSF Chancellor, we questioned how someone steeped in the culture of commercial biotechnology could distinguish that culture from the academic mission? (You heard that question here first.)  The answer now seems to be that her current ambitions substantially blur the academic mission with the pursuit of money and commercial success.

Maybe one reason for this blurring of distinctions is that Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.

ADDENDUM (5 November, 2011) - As per Reuters,
Consumer products maker Procter & Gamble Co and Israeli drugmaker Teva Pharmaceutical Industries Ltd on Thursday gave details of a joint venture they have created to sell over-the-counter medicines.

The joint venture, which was initially announced in March, will combine Teva's expertise in drug marketing with P&G's expertise in branding to expand their presence in the $200 billion consumer healthcare industry.

So P+G is becoming more of a health care company, increasing concerns about how her position as a director of the company, which gives her fiduciary responsibility for its finances, may influence her in her role as Chancellor.


Steve Lucas said...

Maybe the goal is to accomplish something like the following:

Here we have an “expert panel” advocating the use of an expanded group of biomarkers to determine early or more aggressive treatment of lipid issues. The only problem is the recommendations are ghostwritten, none of the listed doctors have any experience in research and all of the funding comes from pharma companies who will benefit from increased sales of products.

This is just the type of collaboration we need in our academic centers. Want to keep you job? Sign off on this research that will make everyone but you millionaires.

Steve Lucas

Anonymous said...

She has been willingly bought.

Now I see why they ousted then UCSF Dean David Kessler, MD (former FDA Commissioner) for pointing out financial irregularities to her soon to retire predecessor, Chancellor Bishop.



email from (former) Dean Kessler:

“ Shortly after arriving at UCSF as Dean, I discovered a series of financial irregularities that predated my appointment. I reported these issues to appropriate university officials at the time, and have endeavored to work with the university ever since to solve these problems. The university characterized me as a whistleblower. During the summer, Chancellor Bishop requested my resignation. I continued to try to solve these problems. Yesterday, Chancellor Bishop terminated my appointment as Dean, effective immediately…”

Afraid said...


Anonymous said...

She's still an advisor for Genentech? Was that HER incubator? Certainly no COI here! She advocates/advises a company whose founder stole rDNA insulin discovery/ technology from UCSF, set up a fledgling company, created all sorts of litigation issues among UCSF, Genentech, City of Hope and Eli Lilly before finally selling the technology to Lilly? [BTW, Lilly went on to duopolistically control the diabetes market . . . and wonder of wonders, created Zyprexa (that diabetes-causing psychotropic medicine) to synergistically 'grow their business.'] I'd call this stellar bona fides!

InformaticsMD said...

email from (former) Dean Kessler:

Incredible. You'd think you were reading about the mafia, not an AMC.

-- SS

Anonymous said...

As a friend likes to remind me the advantages of a non-profit are no taxes, and no pesky shareholders. In this case we have the added advantage that student’s tuition and donor money pay for the physical plant and provided a never ending supply of workers at no cost in the form of students.

Now about those profits, sorry fees. Well, first a bigger salary for the UCSF Chancellor and her senior staff. Look out Gordon Gee; you will no longer be the highest paid university President.

Then we attract the very best in corporate, sorry, academic researchers. They of course will need above average compensation packages.

So we then have the creative writing department ghostwrite the research report. The marketing department then gets a shot at setting up the marketing and sales material.

Production can be shipped off shore and handled by students on their off year foreign experience.

Yep, it is really tough to make a profit when you highjack a major university and have access to free research, a free physical plant, and no personnel cost since you can use students and call it an unpaid internship.

Yep, tough, and California can issue some more bonds, and raise tuition, to help support higher education.

Steve Lucas

Anonymous said...

Organized crime - Corporate Health Care

Spuds - Potatoes

Matthew Holt said...

C'mon guys. This ship sailed 30 years ago when Genentech was founded out of UCSF. The connection between academic research and biotech has been glued at the hip ever sense.

The real question is why is UCSF building 3 specialist hospitals including a childresns in an area that already has plenty, in a micro-area that has 3 (yes one, two three) pediatricians for the entire quarter of San Francisco that has by far the most kids.

Roy M. Poses MD said...

Matt Holt,

You are right that this all began with the Bayh-Dole act in the early 1980s. But just because it's been going on for a while doesn't mean it is good for anyone (other than the well-connected insiders).

Is there any evidence that all this lucrative "collaboration" has lead to to better drugs and devices? It has seriously deflected academic medicine from its mission.