Fwd: [SSRI-Research] Science in the Private Interest: Has the Lure of Profits Corrupted

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[sSRI-Research] Science in the Private Interest: Has the Lure of

Profits Corrupted

 

[-- the answer is YES... Do we even have to ask the question???]

 

 

THE NEW YORK REVIEW OF BOOKS

http://www.nybooks.com/articles/16954

 

Volume 51, Number 4 · March 11, 2004

Review

 

The Dawn of McScience

By Richard Horton

 

Science in the Private Interest: Has the Lure of Profits Corrupted

Biomedical Research?

by Sheldon Krimsky

Rowman and Littlefield, 247 pp., $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 know- ledge-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.

 

1.

The idealism of Krimsky and the Pope -some would call it naiveté-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 thalas-semia. 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. "

 

2.

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.

 

3.

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, i.e., 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, pp. 454-465.

 

[2] The NIH is currently embroiled in controversy following allegations,

first reported in the Los Angeles Times on December 7, 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), pp. 29-54.

 

[4] See Robert K. Merton, " Science and the Social Order, " Philosophy of

Science, Vol. 5 (1938), pp. 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 3, 2003, p. 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, pp. 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, pp. 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,

pp. 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 8,

1998, pp. 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, pp.

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, pp. 108-113.

 

[16] See Jason Dana and George Loewenstein, " A Social Science Perspective on

Gifts to Physicians from Industry, " JAMA, July 9, 2003, pp. 252-255.

 

[17] See John Ziman, " Non-instrumental Roles of Science, " Science and

Engineering Ethics, Vol. 9 (2003), pp. 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).

 

--

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