OT:Big Tobacco & An NIH-Funded Cancer Screening Study

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Big Tobacco & An NIH-Funded Cancer Screening Study

Posted October 8, 2007

Huffington Post - New York,NY*

http://www.huffingtonpost.com/merrill-goozner/big-tobacco-an-

nihfund_b_67610.html

The National Institutes of Health is in the midst of a $200 million

trial to determine if routine CT scans of smokers' and former

smokers' chests can identify lung cancer in its earliest stages and

save lives through early intervention. The Wall Street Journal

reports this morning (subscription required) that two of the

researchers involved in the study recently served as paid experts

for tobacco companies in civil suits brought by patients who want

the tobacco industry to pay for the screenings.

The issue was raised by the Washington-based Lung Cancer Alliance,

which supports screening. This patient advocacy group, the story

notes, has received $100,000 from General Electric, which would

profit from a massive expansion in cancer CT scans.

The House Energy and Commerce Committee has launched an

investigation into the conflicts of interest, and whether the

researchers who designed the NIH study tilted its design in ways

that would discourage mass screening. There are about 90 million

smokers and ex-smokers in the U.S.

Like all cancer screening tests, lung cancer screening would

inevitably turn up thousands -- perhaps millions -- of suspicious-

looking abnormalities. Biopsies would get done. Surgeons would

operate. Drugs would get taken. Costs would skyrocket. The cancer

rate, obviously, would rise, since more cancers would be found

earlier. And the survival rate -- defined as persons living at least

five years with the disease -- would probably improve.

But would it have done anything for overall lung cancer mortality?

Perhaps not. There is no evidence that earlier intervention for this

disease saves lives, and living longer with the knowledge that

you're going to die from lung cancer -- even if it goes over the

arbitrary five-year time frame -- isn't much of a benefit.

The two researchers with ties to Big Tobacco are University of

California Los Angeles radiologist Aberle, who testified in a

2003 case in Louisiana on behalf of American Tobacco Co., and

Dartmouth College radiologist Black, who testified in a New

York case for Philip . Aberle, one of the national leaders of

the NIH trial, said UCLA got the money from her testimony and Black

subsequently ended his relationship with tobacco companies.

NIH defended using scientists with previous ties to the tobacco

industry:

In a written response to the Lung Cancer Alliance, the NCI said the

expert witness work was appropriate. " Service as an expert witness,

presenting independent analyses based on published medical

literature, is a commonly accepted activity for physicians,

researchers, and other experts and in the instance of the specific

circumstances described did not violate the required disclosure

guidelines of the organizations involved, " NCI director

Niederhuber wrote.

Moreover,

In an interview, an NCI spokesman said the institute has no way of

knowing whether any other investigators in the 30-center study have

financial ties to tobacco or scanning companies because it does not

examine such potential conflicts.

So there you have it. Rival industrial interests are funding

researchers and patient advocacy groups who square off over the

utility of a wildly expensive technology of questionable benefit,

and NIH turns a blind eye to how conflicts of interest might

undermine its much-needed objective study of the issue. This is a

classic example of everything that ails the health care technology

assessment field, made more graphic by the presence of the tobacco

industry, everybody's favorite whipping boy and for good reason.

The steps forward are clear. Congress should create a new institute

to test new technologies and compare them to existing technologies,

a move that has been endorsed by leaders from both political

parties. The new agency must scrupulously avoid all conflicts of

interest, with industrial interests kept as far as possible away

from the decisions of what to study, how to design the trials, and

how to interpret the results. And, the researchers who conduct the

studies must follow a simple rule: You can't have had any financial

conflict of interest within the past five years to participate in

such a study.

Meanwhile, NIH must end its laissez-faire attitude toward monitoring

the conflicts of interest of the extramural researchers based at the

nation's universities, who absorb 80 percent of its annual $30

billion budget. Universities have proven that they're aren't up to

the task of monitoring their professors. Indeed, the

commercialization imperative that now dominates thinking at most

major universities (they earn revenue from licensing the patents

that come from NIH-funded research) has created a structural

conflict of interest that has blinded them to improprieties like

what just took place at UCLA in the CT study.

NIH catalogues every extramural research grant in a database that is

open and available to the public (it's called the CRISP database for

those who want to google it). One of the fields in that database

should include a complete disclosure by the grantee of all industry

affiliations and financial conflicts of interests over the past five

years. That will make it much harder to hide the kind of conflicts

of interest that now cloud this $200 million cancer screening trial.

The results of the trial are due in 2009. Should it show that

screening is not worth the candle, the trial will undoubtedly be

seen as fatally flawed by patient advocates, who have their own

conflicts of interest.

NIH insists the trial is well-designed. But when it comes to

conflicts of interest, appearances matter. The expenditure of $200

million in taxpayer money should have resulted in a definitive

answer. Now all we'll get is endless bickering over the meaning of

the results by self-interested parties whose first line of attack

will be the financial ties of the researchers or advocates on the

other side.

NIH has once again been caught with its pants down on the conflict-

of-interest issue. It should move quickly to change its rules.

Besides disclosure, it should not allow researchers to participate

in the major technology assessment trials that the agency funds if

those researchers have relevant conflicts of interest.

And the agency should set up an independent committee to review

whether all investigator-driven trials funded by the federal

government should have similar restrictions. The argument against

this radical step is that it will divide the world of research into

two camps: those who take money from industry and those who don't.

Maybe that isn't such a bad idea.