[A-List] The Dawn of McScience

[Bill Totten <shimogamo@xxxxxxxxxxxxx>]

by Richard Horton

New York Review of Books, Volume 51, Number 4 (March 11 2004)

Review of the book "Science in the Private Interest: Has the Lure of
Profits Corrupted Biomedical Research?" by Sheldon Krimsky (Rowman and
Littlefield, 247 pages, $27.95)

One of the most striking aspects of John Paul II's papal leadership has
been his frequent and outspoken forays into science, especially the life
sciences. His positions on abortion, sexuality, and contraception have
alienated vast numbers of Catholics and non-Catholics. Many people had
seen his tenure in the Vatican as an opportunity for progressive
leadership on issues ranging from AIDS in Africa to the reproductive
rights of women. They have been disappointed. But his staunch orthodoxy
has had one unexpected, and some would say beneficial, consequence - a
decisive opposition to the commercial exploitation of science.

In a letter to the apostolic nuncio in Poland on March 25 2002, John
Paul II condemned the "overriding financial interests" that operate in
biomedical and pharmaceutical research. These forces, he wrote, prompted
"decisions and products which are contrary to truly human values and to
the demands of justice".  His particular target was "the medicine of
desires", by which he meant those drugs and procedures that are
"contrary to the moral good", serving as they do the pursuit of
pleasure rather than the eradication of poverty. In an especially
thoughtful passage, he wrote that

the pre-eminence of the profit motive in conducting scientific research
ultimately means that science is deprived of its epistemological
character, according to which its primary goal is discovery of the truth.
The risk is that when research takes a utilitarian turn, its speculative
dimension, which is the inner dynamic of man's intellectual journey,
will be diminished or stifled.

Sheldon Krimsky, a physicist, philosopher, and policy analyst now at the
Tufts University School of Medicine, puts it more bluntly. In Science in
the Private Interest, a strongly argued polemic against the commercial
conditions in which scientific research currently operates, he shows how
universities have become little more than instruments of wealth. This
shift in the mission of academia, Krimsky claims, works against the
public interest. Universities have sacrificed their larger social
responsibilities to accommodate a new purpose - the privatization of
knowledge - by engaging in multimillion-dollar contracts with industries
that demand the rights to negotiate licenses from any subsequent
discovery (as Novartis did, Krimsky reports, in a $25 million deal with
the University of California at Berkeley). Science has long been ripe
for industrial colonization. The traditional norms of disinterested
inquiry and free expression of opinion have been given up in order to
harvest new and much-needed revenues. When the well-known physician
David Healy raised concerns about the risks of suicide among those
taking one type of antidepressant, his new appointment as clinical
director of the University of Toronto's Centre for Addiction and Mental
Health was immediately revoked. Universities have reinvented themselves
as corporations. Scientists are coming to accept, and in many cases
enjoy, their enhanced status as entrepreneurs. But these subtle yet
insidious changes to the rules of engagement between science and
commerce are causing, in Krimsky's view, incalculable injury to society,
as well as to science.

This escalating corrosion of values derives from a sharp change in the
political climate during the 1970s. University administrators came to
see their faculties as an undervalued resource. To counter what was seen
as a culture of financial passivity, the Patent and Trademark Amendments
(Bayh-Dole) Act of 1980 enabled universities to claim entitlement to
inventions made with the support of federal funds. Suddenly university
deans found themselves sitting on a mountain of unrealized income.
Scientists took to their new commercial calling with relish. Surveys
reveal that a high proportion of researchers have ties to the industries
whose products they are investigating. <1>   Many have argued and some
no doubt believe that money could never influence their scientific
independence. But Krimsky makes a telling comparison of journalists and
public officials, two groups for whom monetary conflicts of interest,
now endemic in science, are anathema to their professional ethics.
Instead, and this is surely a remarkable double standard, scientists
absolve themselves from the dangers of often deep financial conflicts
(such as company directorships, equity ownership, research grants,
honoraria, and travel costs) by the simple means of disclosure.
Reporting a payment, a gift, or other interest has become a panacea,
especially in medical journals, allowing scientists to wash their hands
of criticism.

This situation cannot be justified. Krimsky writes that "the
relationship between conflicts of interest and bias has been downplayed
within the scientific community to protect the entrepreneurial ethos in
academia". But the damage inflicted by the influence of profit on the
purpose of science has spread far beyond the university. The federal
advisory committees that dispense funds now give private interests
priority over public ones. If committee members receive substantial
payments from industries, this should in principle disqualify them from
decisions affecting those industries. In the case of vaccine policy, for
example, Krimsky quotes a 1999 US House of Representatives Committee on
Government Reform, which concluded that conflict of interest rules on
FDA and CDC advisory committees had "been weak, enforcement has been lax,
and committee members with substantial ties to pharmaceutical companies
have been given waivers to participate in committee proceedings". <2>

Even scientific journals, supposedly the neutral arbiters of quality by
virtue of their much- vaunted process of critical peer review, are owned
by publishers and scientific societies that derive and demand huge
earnings from advertising by drug companies and from the sale of
commercially valuable content. The pressure on editors to adopt
positions that favor these industries is yet another example of the bias
that has infiltrated academic exchange. As editor of The Lancet I have
attended medical conferences at which I have been urged to publish more
favorable views of the pharmaceutical industry. For Krimsky, "the idea
that public risk (that is, publicly supported research) should be turned
into private wealth is a perversion of the capitalist ethic". The Pope
would probably agree.


The idealism of Krimsky and the Pope - some would call it naivete -
could be a misleading guide in matters of scientific value. The notion
that there was once some golden age of universal, communal,
disinterested, and perfectly skeptical science, to use Robert Merton's
famous tacit presuppositions about scientific cultures, is nonsense.
Bertrand Russell was right when he argued that for as long as human
beings have embarked on the activity we call science, their inquiries
have had the twin functions of helping us to do as well as to know. <3>
As Merton himself admitted, "Readiness to accept the authority of
science rests, to a considerable extent, upon its daily demonstration of
power". <4>

Yet this allegedly inescapable connection between science and technology
has been challenged by a strain of historical study, one omitted by
Krimsky, that finds a clear division between scientific inquiry and its
more practical applications. For example, the American historian Steven
Shapin, in his forceful exploration of the basis for scientific
knowledge in the seventeenth century, <5> links the origins of English
experimental philosophy with the cultural importance of truthfulness -
"the gentlemanly constitution of scientific truth", as Shapin puts it.
He argues that our personal knowledge of the world depends to a large
degree on what others tell us. Our understanding therefore has a moral
character, based as it must be on trust. In constructing a body of
reliable individual knowledge, trustworthy people are crucial. In the
seventeenth century, the concept of the gentleman embodied these notions
of trust. "Honor" was the key to believing someone's testimony. Lying
was seen as incompatible with a civilized society. A series of social
conventions followed from this claim - the importance of face-to-face
conversation, the centrality of "epistemological decorum".

In view of these conditions for truth, an opposition was bound to emerge
between gentlemen and the trading classes. The merchant sought private
advantages that created strong motives for lying.   Deceit was pervasive
in mercantile activities. Shapin quotes Erasmus: "their lies, perjury,
thefts, frauds, and deceptions are everywhere to be found". And Robert
Boyle, who discovered fundamental laws on the behavior of gases, "found
by long and unwelcome experience, that very few tradesmen will, and can
give a man a clear and full account of their own practices; partly out
of envy, partly out of want of skill to deliver a relation intelligibly".
Secret scientific knowledge and commercial exploitation of discoveries
thus have a long and much-abhorred history within science, whatever
scientists might claim in order to justify themselves today.

Still, most scientists and academic leaders will reject this negative
attitude toward collaborations between science and industry. The
argument for partnership seems entirely reasonable. Science aims to
acquire knowledge but needs money to invest in research. Industry wants
to develop products for a profit, but needs a sound base of knowledge on
which to do so. In other words, both activities need each other. Their
interests are complementary. As the costs of basic science and clinical
research have soared, thanks largely to the technological and
organizational complexity of modern research, so universities have
become more dependent than ever on the deep pockets of industry. The
standard line advanced by corporate leaders is that these partnerships
have been crucial to recent major advances in diagnosis and treatment of
disease. <6>

But something changed dramatically in the early 1980s to push academia
and industry closer together. These forces were not accidental, and
whatever today's rhetoric of complementarity and synergism might suggest,
their consequences are not benign. The emerging biotechnology industry,
based as it was on new techniques developed from molecular and gene
biology, became the driving force behind this marriage of opportunities.
The federal government enacted a list of statutes that mandated the
National Institutes of Health (NIH) to cooperate with the private sector.
Concerns were raised long ago by some academics about this changing
landscape of science. Writing in 1991, William Raub, then acting
director of the NIH, commented that

the American body politic traditionally has erupted in anger when
publicly financed activities yield undue private gain, when information
intended for the many becomes the exclusive possession of the few, when
personal goals are advanced at the expense of national ones, or when the
prospect of profit breeds dishonest dealing. <7>

A decade later, many of these predictions have come true. When
scientists ask colleagues to share their data, genetic discoveries, for
example, are frequently withheld. <8>  This proprietorial approach to
new research findings is an increasing trend, especially in commercially
sensitive disciplines. Lack of collaboration with other scientists
prevents investigators from confirming and extending new discoveries.
Contractual agreements between medical schools and industry sponsors of
new research are also vulnerable in this culture of covert inquiry. The
agreements fail to ensure that clinical trials follow widely agreed-on
ethical practices, such as full protection of the patients enrolled in
the study. <9>  Contracts frequently contain no requirements for
independent committees to monitor research and its safety. The access of
an investigator to the trial's data is often not guaranteed. And usually
there is no agreement that a trial's results will be published. These
poor standards impugn the integrity of the entire field of biomedical
research. And they put the well-being of patients at risk.


One now well-known case documented by Krimsky shows these difficulties
all too clearly. <10>  In the 1990s, Nancy Olivieri worked at the
University of Toronto and at the city's Hospital for Sick Children on a
drug to treat a rare blood disorder called thalassemia. Her work was
sponsored by the Canadian Medical Research Council and a pharmaceutical
company called Apotex. She discovered that the drug was not as effective
as the company had originally hoped. Worse, the drug appeared to have
very serious adverse effects. When Olivieri indicated her wish to
publish her findings and inform the patients in her care of the drug's
potential dangers, the company threatened her with legal action.

Krimsky describes how the hospital and university, which should have
been the first to offer her protection from this outrageous intimidation,
were the last to defend both her freedom to report her findings and her
duty to act in the best interests of the patients under her care. Indeed,
the hospital began an inquiry that failed to give Olivieri a fair
hearing and other protections of due process. Astonishingly, she was
fired. All this went on while the university was itself engaged in
discussions with Apotex about a $12.7 million donation by the company to
the University of Toronto. The president of the university was lobbying
the Canadian government on behalf of Apotex. As Krimsky points out, a
gift of this size "would make any university exquisitely attentive to
the interests of the donor".

After a further long and acrimonious investigation, Dr Olivieri was
cleared of any alleged wrongdoing. Her reputation was restored and her
position reestablished. But the case ignited a furious debate within
medicine about the moral responsibilities of investigators, their
academic freedom, and the vital importance of strong institutional
mechanisms to resist commercial forces that put stock value before
professional ethics.

These institutional mechanisms are currently fragile. The purpose of the
universities that support extensive research programs is changing -
inevitably and inexorably, say some of its leading analysts <11> - to
meet an ever-greater need for money. More funds are necessary to secure
top faculty, build new facilities, and finance scholarships. University
administrators feel they have no choice: they have to move away from a
mission based on the education of students to be informed and capable
democratic citizens; instead, they have to concentrate more on producing
people who can contribute to a "knowledge economy".

The problem is not only institutional. An extraordinary culture of gift
giving now exists within scientific research, a culture that has altered
the way in which new discoveries are shared and debated. Take virtually
any major medical conference - for example, the three annual gatherings
of cardiologists hosted separately by the American College of Cardiology,
the European Society of Cardiology, and the American Heart Association.
It is now entirely usual, among the many thousands of participants, for
air fares, hotel costs, registration fees, and evening entertainment
(dinner, theater, music) to be paid for by corporate sponsors, usually
the pharmaceutical industry. <12>  In return for this largesse, the
conference organizers will hire space for an enormous trade exhibition
at which the sponsors are allowed to display their products, services,
and promotional material, while offering even more gifts, such as golf
balls, pens, bags, computer equipment, games, toys, and clothes to its
captive audience.

These meetings are usually billed as scientific conferences. It is true
that keynote lectures, together with symposiums at plenary sessions and
parallel meetings, make up a substantial proportion of the program. <13>
But the visitor cannot help being struck by the scandalous bargain that
has been made between professional societies and industry - namely that,
in order for science to be reported and discussed among a professional
society's membership, sponsors will be given free rein to market their
products to attending physicians. The venality of those taking part in
this corrupt covenant is difficult to square with a profession that is
quick to squeal at the mere suggestion of government intrusion into the
delivery of health care. Any claim that the science and practice of
medicine are disinterested is utterly groundless.

About a quarter of scientists working in medical research have some sort
of financial relationship with industry. And, not surprisingly, there is
a strong association between commercial sponsorship and the conclusions
scientists draw from their findings.  Scientists who argue in favor of a
particular product are more likely than their neutral or critical
colleagues to possess a financial stake in the company that is funding
their research or the product they are studying. <14>  And, for the most
part, these conflicts of interest are not reported when research is
either presented at scientific meetings or published in medical journals.

Indeed, medical journals have become an important but underrecognized
obstacle to scientific truth-telling. Journals have devolved into
information-laundering operations for the pharmaceutical industry. Here
is how it works. A pharmaceutical company will sponsor a scientific
meeting. Speakers will be invited to talk about a product, and they will
be paid a hefty fee (several thousand dollars) for doing so. They are
chosen for their known views about a particular drug or because they
have a reputation for being adaptable in attitude toward the needs of
the company paying their fee. The meeting takes place and the speaker
delivers a talk. A pharmaceutical communications company will record
this lecture and convert it into an article for publication, usually as
part of a collection of papers emanating from the symposium. This
collection will be offered to a medical publisher for an amount that can
run into hundreds of thousands of dollars.

The publisher will then seek a reputable journal to publish the papers
based on the symposium, commonly as a supplement to the main journal.
The peer-review process will be minimal or nonexistent, and is sometimes
not even the responsibility of the editor -in-chief of the parent
journal. Publication of the supplement appears to benefit all parties.
The sponsor obtains a publication whose content it has largely if not
wholly influenced, but which now appears under the imprint of a journal
that confers on the work a valuable credibility that the company has
bought, not earned. The publisher receives a tidy high-margin revenue
from the deal.

Why is this practice wrong and dangerous?  The scientific quality of
research in the thousands of industry-sponsored supplements published
each year is notoriously inferior to the research published in properly
peer-reviewed scientific journals. <15>  The process of publication has
been reduced to marketing dressed up as legitimate science.
Pharmaceutical companies have found a way to circumvent the protective
norms of peer review. In all too many cases, they are able to seed the
research literature with weak science that they can then use to promote
their products to physicians.

Derek Bok, a former president of Harvard University, describes the
damaging effects of this pervasive commercialization of science in his
important report on academia, Universities in the Marketplace. The
concerns of research, he argues, have become skewed toward answering
questions that are concerns of industry, not of the public. Secrecy
disrupts a productive collegiality among scientists, leading to waste
and inefficiency as investigators are forced to duplicate the hidden
work of others. Opinions are rented out to the highest bidder. A
nefarious web of incentives is introduced into research. And, most
worrying of all, public confidence in medicine, science, and the academy
is undermined. Knowledge is just one more commodity to be traded.

The short-term effects of introducing a business culture into the
academy may be so subtle that they will go unnoticed until it is too
late to reverse their long-term consequences. As Bok writes, bit by bit

commercialization threatens to change the character of the university in
ways that limit its freedom, sap its effectiveness, and lower its
standing in the society ... The problems come so gradually and silently
that their link to commercialization may not even be perceived. Like
individuals who experiment with drugs, therefore, campus officials may
believe that they can proceed without serious risk.

Is science, and especially biomedical science, now hopelessly
compromised by its apparent dependence on industry? The optimists who
deny that it is tend to fall into one of two camps. First, there is the
growing view that science must be reclaimed for the public interest.
Krimsky argues this case vigorously. For him, public interest science is
"research carried out primarily to advance the public good".  The values
of public service in science need to be strengthened. Independent voices
of dissent must be protected. The constraints on a scientist's freedom
to think, write, and investigate must be kept to a minimum. The business
values of efficiency, assembly line production, and the quest for
utility need to be tamed.

How is this to be done? Krimsky and some other reformers believe that
whether in the academy or in the clinic, there should be a sharp
separation between knowledge producers and wealth creators. All personal
interests must be declared. If investigators have a direct financial
stake - such as substantial stock ownership - in the outcome of research,
they should not take part in it. And academic institutions with
investments in particular corporations should not accept grants from
those same companies. To this set of prescriptions, one might add that
the gift culture of science should be substantially if not totally
curbed. A gift of any kind may introduce unrecognized bias that cannot
be ameliorated by either disclosure or limiting the size of the gift.
<16>

An alternative view is that a dissolution of the partnership between
science and commerce is neither possible nor desirable. Science is not
merely about generating knowledge. It is about innovation. Businesses
are increasingly "outsourcing" their research and development costs, ie,
allocating them to academic and other research institutions with which
they make contracts. Universities have long had a valuable and
justifiable part to play in fostering research into new medical remedies.
Those scientists who wish to be entrepreneurs should be encouraged to
develop an interest in their invention, not prevented from doing so. The
crucial point is that rules should be put in place to ensure that these
more commercially minded investigators are not permitted to conduct
human research without tough independent oversight. In this way, the
powerful incentives that drive scientific advance would be protected,
while their more undesirable risks would be managed.

For such oversight to occur, however, universities, professional
organizations, and scientific publications will have to improve many of
their current practices and take a more demanding position toward
private companies. It is far from clear either that this is what the
universities and professional organizations want to do or that there
will be any effective sources of public pressure to make them change
their ways.

Instead of possibly choking off innovation by legislating against the
judicious commercial development of scientific research, a better way to
proceed, according to John Ziman, a respected philosopher of science, is
to let this work proceed unhindered while at the same time protecting
the "non-instrumental" functions of science that are currently under
threat. <17>  Ziman argues that the erosion of traditional scientific
values-such as the principles that research should be driven by
curiosity and by the desire to advance scientific knowledge-has created
a new "post- academic science", a science that seeks an immediate
economic payoff.  Sustaining some form of non-instrumental science -
which practically means not routinely applying the litmus test of wealth
creation to every new idea or hypothesis - is important not only for
inquiry into fundamental theoretical questions but also because society
needs a model of independent critical rationality for the proper conduct
of democratic debate, judicial inquiry, and consumer protection. But
non-instrumental science can only be protected by organizations whose
funding decisions are determined by disinterested scientists themselves,
whether in university departments, charitable foundations, or government
agencies such as the National Institutes of Health.

While Ziman's partial solution to the threat posed by private-interest
science certainly sounds more practical than Krimsky's desire to turn
back the entire tide of commerce, it also poses its own dangers. In a
brief and tantalizing epilogue to his social history of truth, Steven
Shapin speculates about the way trust and credibility are manipulated in
the modern era. He notes that

we are told things about the world [today] by people whom we do not know,
working in places we have not been. Trust is no longer bestowed on
familiar individuals; it is accorded to institutions and abstract
capacities thought to reside in certain institutions ... We trust the
truth of specialized and esoteric scientific knowledge without knowing
the scientists who are the authors of its claims ... The gentleman has
been replaced by the scientific expert, personal virtue by the
possession of specialized knowledge, a calling by a job, a nexus of
face-to-face intervention by faceless institutions, individual free
action by institutional surveillance.

If personal virtue has indeed given way to impersonal expertise, and if
moral character has become secondary to institutional prestige, it would
be wrong to conclude that the connection between public trust and the
integrity of the individual scientist has been wholly erased. But it has
often become subject to a new set of institutional authorities. And this
is a source of contemporary anxiety.

For if expertise is found to be shaped by motives of personal gain (as
it increasingly is) and if the reputations of institutions are stained
by private advantage (as they increasingly are) then trust will be as
vulnerable to commercial corrosion now as it was to ungentlemanly
behavior in the salons of seventeenth- century English experimentalists.
<18>  If these influences go unchecked, Thomas Hobbes's injunction
"against the lucrative vices of men of trade" could well become the
dismal epitaph for modern science.

Notes

<1>  See Justin E Bekelman et al, "Scope and Impact of Financial
Conflicts of Interest in Biomedical Research", JAMA, January 22 2003,
pages 454-465.

<2>  The NIH is currently embroiled in controversy following allegations,
first reported in the Los Angeles Times on December 07 2003, that money
received by some of the agency's top scientists has biased research
decisions. NIH director Elias Zerhouni has responded quickly by setting
up committees to investigate these "important" claims.

<3>  See Bertrand Russell, "General Effects of Scientific Technique",
The Impact of Science on Society (Routledge, 1985), pages 29-54.

<4>  See Robert K Merton, "Science and the Social Order", Philosophy of
Science, Volume 5 (1938), pages 321-337.

<5>  See Steven Shapin, A Social History of Truth (University of Chicago
Press, 1995).

<6>  See Sidney Taurel, "Hands Off My Industry", The Wall Street Journal,
November 03 2003, page A14.

<7>  See William F Raub, "The Emerging Partnerships Among the National
Institutes of Health, Academic Health Centers, and Industry", Preparing
for Science in the 21st Century (Association of Academic Health Centers,
1991).

<8>  See Eric G Campbell et al, "Data Withholding in Academic Genetics",
JAMA, January 23 2002, pages 473-480.

<9>  See Kevin A Schulman et al, "A National Survey of Provisions in
Clinical-Trial Agreements Between Medical Schools and Industry Sponsors",
New England Journal of Medicine, October 24 2002, pages 1335-1341.

<10> See Jon Thompson, Patricia Baird, and Jocelyn Downie, The Olivieri
Report (James Lorimer, 2001).

<11> See Derek Bok, Universities in the Marketplace (Princeton
University Press, 2003), and Daniel Callahan, What Price Better Health
(University of California Press, 2003).

<12> Few physicians are prepared to discuss openly their links with
industry. A rare exception was recently provided by a UK professor of
medicine, Edwin Gale. See his "Between Two Cultures: The
Expert-Clinician and the Pharmaceutical Industry", Clinical Medicine,
November/December 2003, pages 538- 541.

<13> Although a variable but often considerable proportion of the
"scientific" content is promotional too-typically in the guise of
sponsored satellite symposiums at which speakers, in exchange for
substantial fees, will lecture to a specially invited audience with a
particular product in mind.

<14> See H T  Stelfox et al, "Conflict of Interest in the Debate Over
Calcium-Channel Antagonists", New England Journal of Medicine, January
08 1998, pages 101-106.

<15> See Lisa A Bero et al, "The Publication of Sponsored Symposiums in
Medical Journals", New England Journal of Medicine, October 15 1992,
pages 1135-1140; and Paula A Rochon et al, "Evaluating the Quality of
Articles Published in Journal Supplements Compared with the Quality of
Those Published in the Parent Journal", JAMA, July 13 1994, pages
108-113.

<16> See Jason Dana and George Loewenstein, "A Social Science
Perspective on Gifts to Physicians from Industry", JAMA, July 09 2003,
pages 252-255.

<17> See John Ziman, "Non-instrumental Roles of Science", Science and
Engineering Ethics, Volume 9 (2003), pages 17-27.

<18> The signs are not encouraging. In the UK, for example, a recent
report urges government to strengthen the encroachment of commerce into
science. See "Lambert Review of Business - University Collaboration" (HM
Treasury, 2003).

http://www.nybooks.com/articles/16954 (pay site)