Abusing Kids for Money

Re Contracts Keep Drug Research Out of Reach, New York Times, November 29, 2004, by Barry Meier:

While witnesses described a bloody landscape covered as far as the eye could see with the severed limbs and heads of men, women and children, officers responsible for the pacification campaign pointed out that milder measures had formerly proven ineffective. "No one wants to be a quote savage butcher unquote," said one. "But let's face it -- gentle persuasion isn't going to get these folks to cooperate with us." Pentagon spokespersons confirmed that minimization of casualties was a priority and that no more force than necessary had been applied.

This passage didn't actually appear in the New York Times, but it illustrates the journalistic orthodoxy of "balanced coverage" which is so much in favor at the paper. This style is on display, most recently, in "Contracts Keep Drug Research Out of Reach."

The article addresses the perversion of scientific research on the effects of antidepressants in children and adolescents. In a nutshell:

• University professors do the research;

• Drug companies pay the money for the research;

• Doctors and parents are the dupes of the predictably skewed research;

• The huge and growing numbers of medicated children are the victims, getting dosed with drugs which in many cases are ineffective and in some lead to suicide.

While the story is undeniably important -- an evil is being perpetrated against children -- this Times story, like so many others, fails to achieve the basic goal of journalism: It does not adequately inform, it does not present the information needed to adequately understand and assess the issue.

The problem with a research system in which much of the funding comes from drug companies is childishly obvious. As the article states:

Several studies of academic research have ... found that investigators may overstate, unwittingly or not, test findings to please a study's sponsor or a medical journal editor. And university researchers ... are also sometimes paid significant amounts of money by a drug's manufacturer for work directly related to their study of that medication, creating a potential conflict of interest.

(Note that "potential" is just a Times weasel word. The situation described is obviously an actual, full-blooded conflict of interest. This conflict, moreover, is manifest through distortions noted in a separate passage of the article, where a professor is cited acknowledging that "academic researchers are frequently guilty of spinning test findings, either to please a test sponsor or a journal editor or to advance their own agenda.")

This conflict is so obvious, the problems of distorted science so predictable, one wonders how this system of research can be allowed to persist -- particularly since the solution is equally obvious: Drug companies' power to select researchers could easily be eliminated, while preserving their freedom to fund research on specific drugs they wish to market, by requiring that funding go through and be administered by an independent intermediary (perhaps the Food and Drug Administration).

Why isn't the public, not to mention scientific/medical/ethical bodies, demanding such a reform? Judging from the article, this simple solution to corrupt drug research has not occurred to anyone.

Besides distorting (or "spinning") their research findings, conflicted researchers can also serve their sponsors by selectively publishing drug trial results according to whether or not they are favorable. This problem too is obvious and predictable, and it's also happening:

[W]hile one study of the drug Paxil, which showed positive results in depressed children, was published, another study showing that it was ineffective was not submitted to a medical journal. In addition, studies involving other antidepressants, like the drugs Remeron and Serzone, were also not published.

But the article confuses the issue of selective publication by mingling legitimate and illegitimate cases of non-publication:

Of the 12 studies, all five of the reports claiming positive results, meaning the drug worked without worrisome side effects, that were submitted for possible regulatory approval were published. The seven other studies were inconclusive or negative, which can mean that the drug failed to work or that the test failed because of its design.

Because many of the antidepressant studies were unpublished, many doctors never heard about the results. Several researchers who worked on the pediatric antidepressant trials said that in many cases they had little incentive to submit ambiguous or failed trials to medical journals because they thought the papers would be rejected by journal editors.

One of those researchers, Dr. Neal Ryan, a professor of psychiatry at the University of Pittsburgh, said there has typically been little publishing interest in studies with inconclusive findings or those that failed to work because of study design, a type sometimes referred to as a negative study.

"No one gets famous from publishing negative studies," Dr. Ryan said.

It's standard practice for a guilty person to create ambiguity and confusion by diverting attention to an innocuous practice and defending that practice. A competent reporter is supposed to thwart such evasions, but this Times reporter fails. There's a big difference between non-publication of a study in which:

• "the drug failed to work,"

and one in which:

• "the test failed because of its design."

The former would clearly be a significant and publishable finding. Did the doctors interviewed here arrive at findings that drugs failed to work? And then choose not to seek publication of those results? The article fails to inform readers.

It's bad enough that research on the mind-altering drugs prescribed to many kids comes from conflicted researchers. But the problems go still further. Research contracts typically stipulate that test results are confidential and are owned by the corporate sponsors. The article reports:

[F]ew medical schools ... require that study findings be published or widely disseminated as a condition of taking part in a trial, according to a survey by Duke University researchers published two years ago in The New England Journal of Medicine.

One result is that even well-meaning researchers are barred from publishing negative findings. The article reports that in 2000, two academic researchers were sued after publishing unfavorable test results.

Another consequence of drug companies being permitted to own research results and keep them confidential is that it enables them to prevent even the researchers themselves from learning of negative results. They accomplish this by contracting with multiple academic institutions to conduct separate drug trials. Only the company can see the data from all the trials, since researchers from different institutions are legally barred from sharing information.

The article does not explain this adequately but apparently, while the results of individual trials may not be statistically significant, the combined results are statistically significant. So sponsors can get meaningful results while keeping researchers in the dark. The article reports:

Last December, medical school researchers went to a professional meeting in Puerto Rico with a sense of urgency. Federal drug regulators were reviewing unpublished data from their studies on the use of antidepressants in children and adolescents to see if the drugs increased suicide risks.

The group included many of the researchers whose published positive findings had helped persuade doctors to prescribe antidepressants like Paxil, Zoloft and Prozac to young patients. Now, faced with growing safety questions, the researchers had been trying for months to gather all the test data about those and similar drugs to see if they had missed a pattern not apparent in any single trial.

But they could get only pieces of that information.

Some drug companies refused to turn over data to the group, even though these researchers had helped come up with it, the researchers recalled. In other cases, they could not freely share their own data with colleagues who had not worked on a test. The reason, they said, was that medical schools, in agreeing to run the tests, had signed agreements with the drug makers that kept the data confidential....

In January, the [researchers] issued a report defending the effectiveness of the drugs and disputing evidence that their use increased suicidal behavior. Subsequently, the F.D.A., which had access to all the study data, determined that such a risk did exist for some depressed young patients.

Is there any justification for permitting drug companies to own research results and keep them secret? Or does their legal power to own and control research results serve only to promote their profits at the expense of public health?

Answering such questions is journalism's most basic mission in a democracy. Citizens need the information to assess their government -- since it's the government that writes the laws that determine whether companies may or may not own research results.

But the Times fails to resolve the question. The article reports the drug companies' stance on the issue impassively:

Drug companies say that because they pay for a trial they own the data it generates. They say that contract clauses - including ones for confidentiality - are not intended to suppress possibly negative trial findings but to make sure that data is properly analyzed before it is released.

Is there really a danger of improper analysis? Is corporate control needed to safeguard research results from incompetent handling by the scientific establishment? Is there a problem perhaps with the runaway popular press misleading the public with undigested findings?

Is there a legitimate concern here, in other words, or is the corporate position sheer nonsense?

But the drug companies' position is allowed to pass unquestioned.

The article reports:

In recent months, the outrage over the withheld antidepressant data has led calls for change and promises of some. Drug companies, faced with widespread criticism about their handling of test information, have promised to release more of it.... Legislation was recently introduced in Congress that would mandate reporting of test results. But its fate is not clear. [The industry's trade group, the Pharmaceutical Research and Manufacturers Association], has said it does not see the need for a reporting requirement.

Such legislation seems like an obviously, unequivocally correct measure. Is it?

Again, as if deliberately, the article muddies the waters by immediately following the above passage with extraneous issues:

Critics say, however, that academic institutions and their researchers need to examine their own practices because they share part of the blame.

A prolonged discussion about researchers' share of the blame ensues.

Again, the Times is failing its mission. The question of whether such legislation should be passed has not been confronted and settled. The recently introduced legislation's "fate is not clear." If elected representatives opposing it have no discernible motive other than to betray the public interest to curry corporate favor, then the Times should enable citizens to see it. Enabling citizens to understand their government is why America's press is protected by the First Amendment.

If there is no legitimate objection to legislation requiring all test results to be made public, then it is also foolish to dwell on alternative solutions which would obviously be far less effectual -- like urging people to voluntarily do the right thing (which would only drive the companies to deal with those still willing to do the wrong thing):

Advocates of greater trial disclosure say universities should be doing more to ensure that all test findings are published and data from those trials are publicly available. Universities, by recruiting patients for a trial, take on a moral obligation to them, they say.

"The obligation to the patients they recruit is to make the data they contribute available to other patients so that valid treatment decisions can be made," [said Lisa Bero, a professor of clinical pharmacology at the University of California, San Francisco, and the chairwoman of her campus's advisory committee on conflicts of interest].

The Times also cannot resist a colorful quotation, even if it contributes no insight whatsoever. So the article offers:

"People who are blaming this all on industry are missing the point," said Dr. Robert M. Califf, associate vice chancellor for clinical research at Duke University Medical Center. "I think that academia is part of the problem right now and not part of the solution."

And elsewhere:

"It takes two to tango, and academics are a part of this dance," said Dr. Drummond Rennie, an editor at The Journal of the American Medical Association and a longtime advocate of greater disclosure of the results of clinical trials.

The Times's focussing on ineffectual solutions and irrelevancies is also a breach of mission since it generates more confusion, rather than shedding light, and thus tends to perpetuate the ongoing pharmacological abuse of America's children.

We would not see such caution and neutrality if the child abusers were alleyway gropers and sexual deviants. But when the perpetrators are important, respected people, and there's money involved, then the Times is part of the problem.