O/T Absence of evidence

[Guest guest]

Pharmaceuticals

Absence of evidence

Nov 27th 2008 | NEW YORK

From The Economist print edition

http://www.economist.com/science/displaystory.cfm?story_id=12675892

Do drug firms suppress unfavourable information about new products?

RICHARD FEYNMAN, a Nobel-prize-winning physicist, declared in a

speech in 1974 that science requires " a kind of utter honesty " . He

insisted that researchers must publicise all the outcomes of their

work, and " not just the information that leads to judgment in one

particular direction or another " . To judge by the mounting evidence

of publication bias involving studies on new drugs, his words have

not yet reached the pharmaceuticals industry.

A study published this week in PLoS Medicine, an online journal,

confirms what many have suspected and what previous studies have

hinted at: drug companies try to spin the results of clinical

trials. If this were done merely in marketing materials, it might be

tolerable. What Bero of the University of California, San

Francisco, and her colleagues found, however, was troubling evidence

of suppression and manipulation of data in studies published in (or

often withheld from) peer-reviewed medical journals.

To see if firms massaged data from trials of new drugs, Dr Bero and

her team compared the information that companies share with

America's Food and Drug Administration (FDA) about those drugs with

what they eventually publish in medical journals. By law,

submissions to the FDA must be comprehensive, whereas decisions on

whether and how to publish those same data later in journals are

governed by self-interest, scientific convention and peer review.

In theory, there should be no difference between what the regulators

are told about a new drug's strengths and weaknesses and what

doctors and other researchers read in journals. But Dr Bero's study

found a yawning gap between the two. By looking at all the new-drug

applications approved by the FDA in 2001 and 2002, the researchers

got hold of a comprehensive set of data. They checked whether, five

years later, details on all of those trials had made it into print

intact.

The results are distressing. Only three-quarters of the original

trials were ever published, and it turned out that those with

positive outcomes were nearly five times as likely to be published

as those that were negative. Earlier investigations have shown that

the explanation is not editorial bias: well-designed studies in

which drugs fail have as good a chance of being published in leading

journals as those in which drugs succeed.

In the years studied by Dr Bero, 155 primary outcomes appeared in

both regulatory filings and in the medical literature. However, the

FDA knew about 41 others that never made it into a journal. On top

of that, 17 outcomes appeared in publications without having first

been discussed in regulatory filings. Fifteen of these 17 made the

drugs in question look better. And even when published studies had

been filed with the FDA, on several occasions the published

conclusions differed from those reported to the FDA in ways that

favoured the new drugs.

Industry experts insist there are benign reasons for some of these

discrepancies. For example, in the hope of making a name for

themselves, overworked researchers may choose to publish successful

studies rather than push to get a failed or problematic

investigation into print. Sometimes the trials as submitted to the

FDA are flawed, so researchers try to fix them before getting them

published (though that would not explain why so many of the " fixes "

seem to make the drug in question look better).

Dr Bero is unimpressed by such arguments. She points out that many

patients enter drug trials believing the results will be published,

so that researchers can develop new therapies. Others complain that

misleading presentations in journals may lead ill-informed doctors

to favour new drugs over cheaper, older ones even if they work no

better or have undesirable (but unadvertised) side effects.

Such grouses have resulted in a few changes. The main federal

sponsor of biomedical research in America, the National Institutes

of Health (NIH), runs a website, clinicaltrials.gov, on which all

drugs trials must be registered in addition to being reported to the

FDA. And since September the NIH and FDA have published brief

summaries of trial results. But critics would like to see more

action. An-Wen Chan of the Mayo Clinic, a large medical-research

centre in Minnesota, wants the public to have access to the full

details of the protocols used to study all new drugs. Dr Bero argues

that it is unethical not to publish the full results of medical

trials. Feynman would surely have agreed.

[Guest guest]

Yes, this is really important and this is also a VERY good argument on why the

ACOEM " position paper " is not worth the biased as can be " paper " its

" printed " on.

On Fri, Nov 28, 2008 at 8:39 PM, tigerpaw2c <tigerpaw2c@...> wrote:

> Pharmaceuticals

>

> Absence of evidence

> Nov 27th 2008 | NEW YORK

> From The Economist print edition

>

> http://www.economist.com/science/displaystory.cfm?story_id=12675892

>

> Do drug firms suppress unfavourable information about new products?

>

>