Hired Education

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<http://www.prospect.org/web/view-print.ww?id=9046>Hired Education

A hidden culprit in the drug scandals: the increasingly corporatized

university.

http://www.prospect.org/web/page.ww?section=root & name=ViewPrint & articleId=9046

 

By

<http://www.prospect.org/web/page.ww?name=View+Author & section=root & id=113>Jennif\

er

Washburn

Issue 02.10.05

 

 

 

M. Michael Wolfe, a gastroenterologist at Boston University, admits he was

duped by the Pharmacia Corporation, the manufacturer of the blockbuster

arthritis drug Celebrex. (In 2003, the company was purchased by P zer.) In

the summer of 2000, The Journal of the American Medical Association asked

Wolfe to write a review of a study showing that Celebrex was associated

with lower rates of stomach and intestinal ulcers and other complications

than two older arthritis medications, diclofenac and ibuprofen. Wolfe found

the study, tracking 8,000 patients over a six-month period, persuasive, and

penned a favorable review, which helped to drive up Celebrex sales.

 

But early the next year, while serving on the Food and Drug

Administration’s (FDA) arthritis advisory committee, Wolfe had occasion to

review the same drug trial again, and was abbergasted by what he saw.

Pharmacia’s study had run for one year, not six months, as the company had

originally led both Wolfe and the Journal to believe. When the complete

data was considered, most of Celebrex’s advantages disappeared because the

ulcer complications that occurred during the second half of the study were

disproportionately found in patients taking Celebrex.

 

“I am furious,” Wolfe told The Washington Post in 2001. “I looked like a

fool. But ... all I had available to me was the data presented in the

article.” Remarkably, none of the Journal study’s 16 authors, including

eight university professors, had spoken out publicly about this egregious

suppression of negative data. All the authors were either employees of

Pharmacia or paid consultants of the company.

 

Celebrex, an anti-in ammatory drug similar to Vioxx, is once again in the

news due to concerns that it may be associated with the same cardiovascular

risks that caused Vioxx to get yanked from the market. In recent months,

we’ve heard a great deal about con icts of interest at both the FDA, the

agency that approves drugs for public safety, and the National Institutes

of Health, where publicly funded scientists moonlight as consultants for

the very companies that manufactured the drugs they are testing. Still

largely ignored, however, is the role played by the once-autonomous ivory

tower and the university scientists who, either knowingly or unknowingly,

facilitate the pharmaceutical industry’s manipulation of drug testing by

lending it an aura of objectivity.

 

Today, market forces are dictating what is happening in the world of higher

education as never before, causing universities to look and behave more and

more like business enterprises. Instead of honoring their traditional

commitment to teaching, disinterested research, and the broad dissemination

of knowledge, universities are aggressively striving to become research

arms of private industry. Faced with declining government funding, they are

avidly seeking to enhance their role as “engines” of economic growth,

promising state legislators and governors that they will help drive

regional economic development by pumping out commercially valuable inventions.

 

This radical rede nition of the university’s mission can be traced back to

the economic stagnation of the 1970s. Propelled by heightened competition

from Germany and Japan, Congress passed landmark legislation in 1980 that

allowed universities to automatically retain the rights to intellectual

property stemming from taxpayer- nanced research. The intent of the

legislation, popularly known as the Bayh-Dole Act (its sponsors were

Senators Birch Bayh and Bob Dole), was to stimulate innovation and speed

the transfer of federally nanced research to industry. What it accomplished

in the process was the introduction of a dangerous new pro t motive into

the heart of the university.

 

As a result, schools now routinely operate expensive patenting and

licensing operations to market their faculty’s inventions, extracting

royalty income and other fees in return. They invest their endowment money

in risky startup rms founded by their professors. They run their own

industrial parks and venture capital funds. They publish newsletters

encouraging faculty members to commercialize new research by launching

independent, faculty-owned companies. Star professors consult for, or hold

equity in, the same rms that manufacture the drugs they are studying, while

also often accepting generous fees to join corporate advisory boards and

speakers’ bureaus. Sometimes these professors even hold the patent to the

drug or device being tested. In a study of 800 scienti c papers published

in leading journals of medicine and molecular biology, Sheldon Krimsky, a

professor of public policy at Tufts University, found that slightly more

than a third of the lead authors based at research institutions in

Massachusetts had a signi cant nancial interest in their own reports. So

pervasive are such ties that journal editors now frequently complain that

they can no longer nd academic experts who do not have a nancial interest

in a drug or therapy the journal would like to review.

 

Research suggests that publicly funded science, most of it performed at

universities, was a critical contributor to the discovery of nearly all of

the 25 most important breakthrough drugs introduced between 1970 and 1995.

If university scientists lose their independence, who will perform this

pathbreaking research and objectively evaluate the safety and effectiveness

of drugs already on the market? Con icts of interest are more than an

academic concern. When it comes to health policy, they pose a serious

threat to public health.

 

* * *

 

With the possible exception of business schools, the nation’s medical

schools have been more in ltrated by industry than any other sector of the

university. Pharmaceutical companies sponsor daily lunches for medical

students at which they market their latest drugs; they ply professors with

fancy dinners, gifts, luxurious trips, and free prescriptions designed to

in uence medical decisions and prescribing habits. The drug industry also

spends millions of dollars nancing clinical drug research at the academy,

but increasingly this money comes with many more strings attached. After

conducting a thorough review of the medical literature for The New England

Journal of Medicine in 2000, Thomas Bodenheimer, an internist at the

University of California, San Francisco, concluded that academic

investigators were rapidly ceding to industry control over nearly every

stage of the clinical research process.

 

In the past, for example, it was common for university scientists to

initiate the research protocol. Now, studies are frequently conceived and

designed in the company’s own pharmacological and marketing departments,

thus removing this formative stage of the research from academic hands

almost entirely. The company then shops the study around to various

academic institutions (and a growing number of competing for-pro t

subcontractors that run clinical trials) in search of investigators to

conduct the research. As university medical schools have grown more

dependent on industry grants to sustain their operations, their professors

have become increasingly willing to accept an industry-initiated protocol

without modi cation, even though the study may be largely designed to

secure a company’s market position. Should a professor reject the study or

insist on changes, another university scientist will very likely be more

solicitous.

 

Industry also encourages the use of ghostwriters on scienti c papers. This

means an article or review bylined by a prominent academic might in fact

have been written by a medical-communications company working for the

drugmaker, with the “author” paid an honorarium to attach his or her name

to it. When Wyeth-Ayerst sought to boost market demand for Redux, one part

of the once highly popular “fen-phen” diet-drug combination, the company

hired a company called Excerpta Medica to help draft the manuscripts and

pay doctors to review and sign the articles. One of the many doctors who

signed Excerpta’s papers was Richard Atkinson, a renowned obesity expert at

the University of Wisconsin-Madison. Atkinson denied having any knowledge

of Excerpta’s connection to Wyeth, but as an independent academic, he

nonetheless agreed to lend his name to a company he apparently knew little

about. (Excerpta maintains that all its authors were told of the company’s

association with the manufacturer.) In a deposition on January 15, 1999,

Wyeth-Ayerst executive Jo Alene Dolan admitted that her company had written

the article for Atkinson, stressing that all drug companies ghostwrite

articles. Shortly before the article could be published, Redux was pulled

from the market because of its association with serious heart and lung

problems.

 

Scientists who perform industry-sponsored research are also asked routinely

to sign legal contracts requiring them to keep both the methods and the

results of their work secret for a period of time. Research conducted by

David Blumenthal and Eric Campbell, health-policy researchers at Harvard

University, suggests that data withholding and publication delays have

become far more common over the last 25 years, particularly in molecular

biology, medicine, and other life-science disciplines, where commercial

relationships have grown dramatically in recent years. In a survey of 2,167

life-science faculty, Blumenthal found that nearly one in ve of them had

delayed publication for more than six months to protect proprietary

information.

 

Industry also manipulates academic research by suppressing negative studies

altogether. Recently, it came to light that a whole class of popular

antidepressants -- including such heavily prescribed drugs as Paxil,

Zoloft, and Prozac -- are largely ineffectual in treating childhood

depression and actually increase the risk of suicide. One of the main

reasons this information was not available to doctors and the broader

public, it turns out, is that the academic investigators who led these

studies either allowed industry to bury their research or were complicit in

downplaying negative ndings in their own published papers. How prevalent is

such corporate meddling? The question has received surprisingly little

scholarly attention, but what research does exist is not encouraging. One

survey of major university-industry research centers in the eld of

engineering, for example, found that 35 percent would allow corporate

sponsors to delete information from papers prior to publication.

 

* * *

 

But all the blame for the eroding objectivity of university researchers

does not rest with industry. Universities themselves are complicit: They

are so nancially invested in their professors’ research through patents,

equity, and other nancial holdings that their disinterested pursuit of

knowledge has been gravely compromised. For instance, when the Harvard

Center for Risk Analysis’ longtime director, Professor John D. Graham, was

nominated by President George W. Bush to become the government’s

“regulatory czar” at the Of ce of Information and Regulatory Affairs (part

of the Of ce of Management and Budget), it helped to expose just how

extensive Harvard’s nancial con icts really were. Congressional hearings

revealed that Graham’s center solicited tobacco money and worked with the

tobacco industry to disparage the risks of secondhand smoke. (Harvey

Fineberg, a dean at the Harvard School of Public Health, demanded that one

check from Philip Morris be returned. In response, Graham wrote to the

company asking if it might send the $25,000 back to the Harvard center via

the Philip Morris subsidiary Kraft Foods instead.) Graham’s center also

argued that cell-phone use by drivers should not be restricted, even though

its own research, which was funded by AT & T Wireless Communications, showed

that such use could lead to a thousand additional highway deaths a year. As

a member of the Environmental Protection Agency’s scienti c advisory board

subcommittee on dioxin, a known human carcinogen, Graham argued that

reducing dioxin levels might “do more harm … than good.” His Harvard

center, meanwhile, was heavily funded by dioxin producers.

 

Worse yet, the universities’ loyalties are now so con icted that schools

are increasingly willing to cave in to narrow commercial demands rather

than defend their own professors’ academic freedom or the public interest.

When researchers at the University of Utah discovered an important human

gene responsible for hereditary breast cancer, for example, they didn’t

make it freely available to other scientists, even though we -- the U.S.

taxpayers -- paid $4.6 million to nance the research. The university raced

to patent it, then granted the monopoly rights to Myriad Genetics Inc., a

startup company founded by a University of Utah professor, which proceeded

to hoard the gene and prevent other academic scientists from using it.

 

Professors, too, are increasingly driven by the bottom line. More and more,

they not only accept industry grants to support their research but also

hold stock in or have other nancial ties to the companies funding them.

Many experts fear this skewing of professors’ research toward short-term

commercial goals will impede long-term scienti c and technological

innovation. Financial entanglements between researchers and corporations

have grown so common that the Securities and Exchange Commission (SEC) has

investigated numerous academic researchers suspected of engaging in insider

trading. In a case led in Pennsylvania, the SEC charged Dale J. Lange, a

Columbia University neurologist, with pocketing $26,000 in pro ts after

Lange bought stock in a company that was about to release promising new

ndings concerning a drug to treat Lou Gehrig’s disease. Lange had good

reason to expect the stock to soar because he had conducted the con dential

clinical trials himself. In 2000, an investigation by USA Today found that

more than half the experts hired to advise the U.S. government on the

safety and effectiveness of drugs -- a large number of whom are academics

-- now have nancial links to companies that will be affected by their

conclusions.

 

When Wyeth-Ayerst was trying to get its diet drug, Redux, approved for sale

in the United States, for example, it faced a serious hurdle: Patients in

Europe who had taken a drug virtually identical to Redux had an increased

chance of getting a rare, life-threatening lung ailment known as pulmonary

hypertension. To combat this negative health pro le, the company packed an

FDA hearing room with a who’s who list of the nation’s top academic obesity

experts, all of whom were also paid consultants to Wyeth-Ayerst or other

companies involved in the sale of Redux. In addition, the company recruited

expert “opinion leaders,” such as George Blackburn, a renowned obesity

expert at Harvard, to testify before the Medical Society of Massachusetts

for approval of the drug. Blackburn and other academic luminaries further

participated in the company’s “Visiting Important Professors Program” and

were paid thousands of dollars in honoraria to y to fancy resorts and

promote Redux at medical conferences. Not surprisingly, the drug handily

won market approval, and prescriptions in the United States began to soar.

 

Soon, however, evidence of the drug’s association with lung damage surfaced

once again, and the company turned to leading university scientists to do

damage control. In the summer of 1996, an internal company memo revealed

that the company was planning to spend $5.8 million to pay for more

university-based studies, noting that that money was needed to “establish

and maintain relationships with opinion leaders at the local and national

level to communicate to their colleagues the bene ts of Redux and to

encourage its use.” Among the many doctors willing to heed the company’s

call was Atkinson, the obesity expert at the University of Wisconsin, whose

name appeared on a company-authored article. “Let me congratulate you and

your writer,” wrote Atkinson in a thank-you letter to the ghostwriting rm

that was one of numerous company documents that became public during

subsequent legal proceedings. “Perhaps I can get you to write all my papers

for me!”

 

* * *

 

So how does this growing web of academic-industry ties affect research

outcomes? A vast body of work suggests that industry-funded research is far

from impartial. In 1996, Stanford researcher Mildred Cho co-authored a

study in the Annals of Internal Medicine that found that 98 percent of

papers based on industry-sponsored research re ected favorably on the drugs

being examined, compared with 79 percent of papers based on research not

funded by industry. An analysis published in The Journal of the American

Medical Association in 1999 found that studies of cancer drugs funded by

the pharmaceutical industry were nearly eight times less likely to reach

unfavorable conclusions than similar studies funded by nonpro t

organizations. More recently, a systematic review of 1,140 clinical trial

studies, published by researchers at Yale in 2003, concluded that, from

cancer to arthritis to cholesterol, the evidence is overwhelming that when

research is industry-sponsored, it is “signi cantly more likely to reach

conclusions that [are] favorable to the sponsor” than non–industry-funded

research.

 

In the area of health and drug research, of course, the results of such

manipulation can be deadly. Running down the list of drugs recently pulled

from the market or subject to increased health warnings -- Rezulin, the

diabetes drug; Redux (or fen-phen), the diet drug; Retin-A, the

anti-wrinkle cream; Neurontin, the epilepsy drug; Paxil, Zoloft, and the

many other antidepressants now deemed ineffective for children -- one nds

that a remarkable number of prominent university professors with close

nancial ties to the manufacturers played a central role in lobbying for

these drugs to be approved, recommending them to other doctors, and, in

many cases, urging that they remain on the market long after the problems

or lack of effectiveness became known. Not infrequently, the university

scientists who shill for the drug companies most aggressively are also the

biggest-name professors in their elds.

 

Universities have gone out of their way to assure the public that their

clinical trials meet the highest standards of “scienti c excellence” and

“academic rigor.” But over the last 20 years, public dismay over the

growing nancial entanglements in clinical research has prompted the federal

government to impose tougher con ict-of-interest regulations, only to

encounter erce university opposition. In 1995, the federal government nally

succeeded in pushing through rules that would apply to all academic

researchers funded by the Department of Health and Human Services (HHS) or

the National Science Foundation (NSF). But the rules, which remain in place

today, were not tough enough to be effective. Although they mandate that

serious con icts of interest must be managed and/or eliminated, they leave

the determination of what action is to be taken, if any, entirely up to the

university. The policy also doesn’t provide any guidance on which con icts

warrant serious attention, nor does it impose any prohibitions, such as

banning nancial con icts outright in the area of human-subject research.

Signi cantly, the policy also says nothing about institutional con icts of

interest.

 

The result, not surprisingly, is that university con ict-of-interest rules

vary widely. One comprehensive 2000 survey of the written policies at 100

academic institutions found that only 55 percent of schools required

disclosure of con icts of interest from all faculty, and only 19 percent

speci ed any limits on researchers’ nancial ties to corporate sponsors.

Worse yet, under this fragmented system, there is enormous pressure on

universities to keep their policies lax. Schools with tighter restrictions

run the risk of losing talented faculty to competing schools with more

permissive policies, where the nancial rewards and commercial prospects are

likely to be greater.

 

Another conspicuous problem with the HHS/NSF policy is that it does not

require universities to make any of the information they compile on faculty

nancial con icts available to the public. Many academic journals do require

their authors to disclose corporate nancial ties. But in practice,

reporting is astonishingly poor. In a 2001 study, Tufts’ Krimsky found that

a mere 0.5 percent of the 61,134 papers appearing in 181 peer-reviewed

journals contained statements about the authors’ nancial ties. More recent

studies have found similarly low levels of reporting.

 

In some respects, the whole debate re ects how far the academic world

remains from dealing seriously with the issue; disclosure of potential con

icts of interest is, after all, a far cry from eliminating them outright,

as many professions not only recommend but also require. In the legal

profession, for example, attorneys are prohibited from taking on cases in

which they have a nancial interest or other explicit con icts that might be

seen to compromise their professional integrity. The same is true of

judges. But when it comes to academia, neither the medical community nor

the government (whether through Congress or the regulatory agencies) has

taken up the task, instead proceeding under the assumption that

universities can be trusted to manage these commercial interactions

themselves. It’s a nice idea. But are academic institutions really capable

of performing this function? There is good reason to be skeptical: Far from

being independent watchdogs capable of dispassionate inquiry, universities

are increasingly joined at the hip to the very market forces the public has

entrusted them to check, creating problems that extend far beyond the

research lab.

 

Adapted from the book University, Inc.: The Corporate Corruption of Higher

Education, by Jennifer Washburn. Copyright 2005. Reprinted by arrangement

with Basic Books, a member of the Perseus Books Group. All rights reserved.

2005 by The American Prospect, Inc. Preferred Citation:

Jennifer Washburn, " Hired Education " , The American Prospect Online, Jan 14,

2005. This article may not be resold, reprinted, or redistributed for

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