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GMW:_The_Dawn_of_McScience

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Wed, 21 Apr 2004 11:51:02 +0100

 

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" 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... 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.... Universities have reinvented themselves as

corporations. "

---

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

Review: The Dawn of McScience

By Richard Horton

The New York Review of Books

Current issue, Volume 51, Number 4

 

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 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. 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. "

 

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, 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 - see:

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

 

 

 

 

 

 

 

 

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