Fw: Science for Sale ~ In a world of retail research, who can trustthe results?

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Science for Sale

By Tinker Ready, Boston Phoenix

On a frigid January morning, a group of young scientists gathered in a

small meeting room at Massachusetts General Hospital to share their latest

findings. Every year, the Massachusetts Alzheimer's Disease Research

Center, a network of Harvard Medical School faculty members, holds this

" poster session, " a time-honored form of scientific show-and-tell. At the

1999 meeting, scientist Dennis Selkoe moved through the room like a

celebrity, looking very Brothers in a sea of rumpled L.L. Bean. In

this small community of national researchers, Selkoe is a star, the man

responsible for shedding light on the biochemical breakdowns that destroy

the brains of Alzheimer's patients.

Selkoe is also one of a new breed of university-based entrepreneurs who

have found ways to move their work out of the lab and onto Wall Street. As

a founder of California-based Athena Neurosciences, he's earned millions

by linking his scientific fortunes with the pharmaceutical industry.

This spring, a Harvard review panel investigated whether Selkoe let his

corporate interests interfere with his scientific judgment. Last year, he

added his name to a National Institutes of Health (NIH) report endorsing a

controversial blood test for Alzheimer's. What he neglected to mention in

the report is that Athena manufactures the test and stands to profit from

NIH endorsement.

An anonymous complaint filed last December with the Harvard Medical School

dean's office charged Selkoe and another Harvard neurologist with conflict

of interest and suggested that the report played down research critical of

Athena's test. Last May, a Harvard panel decided that Selkoe did not

violate the university's conflict-of-interest rules. But the university

didn't completely let Selkoe off the hook. He agreed to publish an unusual

after-the-fact disclosure statement in The Neurobiology of Aging, the

journal that published the original report in April 1998. In addition, the

university said it plans to clarify its conflict-of-interest regulations

to ensure that researchers disclose their industry links whenever they

report on related research, said medical school spokesman Don Gibbons.

Selkoe regrets not noting his relationship with Athena Neurosciences in

the NIH report. " Otherwise, " he says, " I stand by the accuracy and

validity of the statements in the report. "

But not everyone agrees that this is a simple case of poor judgment.

de la Monte, a Harvard pathologist who helped develop a competing

Alzheimer's test, says " it's about time " Harvard dealt with Selkoe's dual

roles as academic scientist and drug-company consultant. " I have conflicts

too, " she says. " But I don't sit on a committee telling people to use the

test. "

It's not just a Harvard problem. Increasingly, academic science overlaps

with pharmaceutical marketing. Scientists are not required to disclose

their corporate ties; individual schools have rules for dealing with the

issue, but even if a scientist's work turns out to be compromised, there's

no guarantee that doctors or patients will ever know.

If you think science is neatly split between research in independent

university labs and in companies that produce products for profit, you're

about 20 years behind. In the past, most campus scientists paid their

bills with grants from the federally funded NIH, but a growing percentage

of campus labs are now linked to pharmaceutical or biotech companies. Some

fund a single study, while others fund an entire lab in exchange for

access to its findings. Scientists often sell the rights to their

discoveries--from disease-linked genes to potential new drugs--and share

the spoils with the university. And, increasingly, university-based

scientists are starting their own companies to cash in on their findings.

Some of these links have allowed key discoveries to move off the lab shelf

and into the medicine chest: The technology for the CAT scan was

discovered at Stanford University and licensed to General Electric.

Harvard's artificial skin for burn victims is now made by Cambridge-based

Genzyme. But consumer groups and health ethicists worry that without

proper safeguards, bias may creep into the work of scientists who stand to

profit, or that scientists concerned about patent rights may be less

willing to share findings with others who could challenge or build on

their work.

Bias happens. The University of California at Irvine shut down a

cancer-research lab in 1997 after finding that scientists there had

invested in a company that hoped to sell the drugs they were testing--and

then had failed to report side effects and used experimental drugs without

Food and Drug Administration approval. Researchers at the University of

Toronto looked at a series of heart-drug studies in 1998 and found that

researchers funded by companies that make the drugs were far more likely

than independent scientists to produce studies supporting their use.

Sheldon Krimsky, a Tufts University urban studies professor and research

watchdog, is disgusted by a recent $25 million deal struck between the

University of California and a Swiss drug company that now has first dibs

on Berkeley's plant genetics discoveries. " An entire department at

Berkeley is being bought off by Novartis, " he says.

Krimsky predicts that a private company will probably buy an entire

university some day; in the meantime, it's one professor at a time.

" There's no question in any reasonable person's mind that who you get the

funding from affects your work, " he says. He sees a pressing need for a

system that would require scientists to acknowledge their corporate

affiliations whenever they publish a study, speak at a conference, or sit

on a review panel.

" Readers should have the opportunity to form their own opinions on whether

conflict of interest exists, " he adds. But they rarely do. In 1997 Krimsky

found that in 272 of 800 scientific papers, the authors owned stock,

served as consultants, or had some other financial stake in the findings.

Only one-half of 1 percent of the 62,000 articles he checked included

disclosure statements.

The Athena Alzheimer's test is a classic case of how the pharmaceutical

industry can dress up marketing and call it academic research. Alzheimer's

affects about 4 million people in the United States; they and their

families are desperate for a cure. Testing at least offers hope to

patients suffering from memory loss, whose symptoms could be due to drug

interactions or minor strokes. But so far there is no blood test or brain

scan to diagnose Alzheimer's; doctors rely instead on a combination of

MRIs, memory tests, and gut instinct.

In 1993, Duke University scientists discovered an Alzheimer's-related

gene. Two years later, Athena bought the right to use the discovery to

develop ADmark, a promising but imperfect diagnostic test that hit the

market in 1996. In 1997, Quebec-based Nymox Corporation began marketing a

different test based on Harvard pathologist de la Monte's discovery

of a protein found in high levels in the blood of Alzheimer's patients.

Since both tests are new and imprecise (both claim 80 to 90 percent

accuracy), insurance companies won't pay for them. Athena thus found

itself with a hard sale, new competition, and skepticism among doctors.

So--following the " nine-out-of-ten-doctors-recommend " approach--it

elicited expert endorsements by granting the nonprofit Alzheimer's

Association $100,000 to explore the usefulness of Alzheimer's tests. The

nonprofit group then asked the highly respected NIH to host a panel and

endorse the final report. Athena's role was thus veiled behind two layers

of nonprofit credibility. The Alzheimer's Association rounded up experts

to conduct the research; among them were Harvard's Dennis Selkoe and Alan

Roses, the Duke scientist who discovered the gene.

The final report, published in the April 1998 issue of The Neurobiology of

Aging, endorsed the Athena test. The article noted Athena Neurosciences'

" sponsorship, " but nowhere did it mention that Selkoe co-founded Athena,

or that Roses held the patent.

The endorsement was subtle. The scientists evaluated not products but the

relevance of " biomarkers " --physical signs that the tests look for. But it

did call the technology behind the Athena test the only one that " can add

confidence " to conventional diagnostic techniques. They called de la

Monte's protein test " promising " but said it would " require further

study. "

Then, in December 1998, The Wall Street Journal pointed out both Selkoe's

and Roses' links to Athena. A week later, an anonymous complaint charged

Selkoe and another Harvard Alzheimer's researcher-- Growdon, who

chaired the panel--with violating the university's conflict-of-interest

rules.

Selkoe offered a written statement saying he suggested disclosing his

corporate affiliation, but Growdon had thought it unnecessary. " However, "

Selkoe wrote, " it should be considered that my affiliation with Athena was

already very widely known in the Alzheimer's disease field and was

included in published articles in the past. "

Well, not always. Science magazine reported in 1992 that Selkoe routinely

wrote about Alzheimer's without mentioning his corporate affiliation. And

a random check of eight studies Selkoe authored and published in 1996 and

1997 found no mention of his relationship with Athena--a relationship that

has paid off richly. When Athena went public in 1993, Selkoe owned 255,000

shares worth $3 million, according to Science. When Elan Corp PLC, an

Irish biotech company, bought Athena in 1996, Selkoe had a

$50,000-per-year consulting contract and sat on the company's board,

according to Securities and Exchange Commission documents. He now sits on

Elan's board of directors.

So who's minding the store? With so much money at stake, the scientific

community has been unable to reach a consensus. Congress paved the way by

passing a law in 1980 that made it easier for federally funded scientists

to patent and profit from their findings; many became stockholders, board

members, and consultants. The NIH, which dispenses $15 billion annually in

research grants, tried cracking down in 1989 by asking researchers to

report their corporate links when applying for funding, but angry

respondents called the plan an attack on academic freedom.

Instead, the NIH asked universities to set their own rules. Unfortunately,

the process remains secret, which defeats the purpose, says Mildred K.

Cho, a professor at Stanford University's Center for Biomedical Ethics:

" The disclosure is not a true disclosure if it is not public, " she says.

Because schools collect a share of royalties, they have their own

conflicts, she adds. These days, universities encourage " technology

transfer " : research that is sold or licensed to private companies. MIT

earned $21.2 million in royalties and from the sale of stock in startup

companies in 1997--up from $10.2 million in 1996. Harvard filed 61 patent

applications, signed 67 licensing agreements, and collected $16.5 million

from existing licensing contracts in 1997, up from $7.6 million in 1996.

The Dennis Selkoe case is interesting because Harvard created a

particularly strict conflict-of-interest policy in 1990, when it was still

smarting from the case of a Massachusetts Eye and Ear Hospital doctor who

tested a questionable eye drug on hundreds of patients. The drug turned

out to be useless, but not before the doctor earned $1 million by selling

stock in the manufacturer. So Harvard forbids faculty members to test

their own companies' drugs. But publishing rules are vague: a faculty

committee must grant researchers permission to present results without

disclosing relevant financial interests.

On a national level, this sort of policy means that neither patients nor

their doctors find out about potential conflicts of interest unless

someone blows the whistle.

Drummond Rennie, West Coast editor for the Journal of the American Medical

Association, is demanding change. In a recent speech at MIT, Rennie asked

scientists and universities to support efforts to make disclosure of

corporate financing routine and public. Meanwhile, in July, scientists for

what was once Athena Neurosciences and is now part of Elan Corporation,

announced that they had discovered a substance that seems to break down

fatty substances, or amyloid plaques, in the brains of mice. The company's

president said they plan to file an application with the Food and Drug

Administration by the end of the year for permission to begin human tests.

When Selkoe's team published results in the April 8, 1999, issue of

Nature, there was no disclosure. The journal doesn't require it, says

Krimsky. " My guess is, if the drug does not pan out--that's when people

will begin looking at the conflicts of interest. If it's successful, the

attitude will be that the scientists deserve the windfall. "

Still, the drug is unlikely to be perfect. And even if Athena is first, at

least 20 other Alzheimer's drugs are currently under study. Once they hit

the market, scientists will be asked to help patients decide whether

they're any good. And unless those researchers disclose their industry

links, no one will know whether they speak for the science or for the

company.

" The patient in me, " says JAMA's Rennie, " sees that as a real threat. "

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