Thursday, July 5, 2007

Compromised medical information

A study hits the medical media--prime time television news, newspapers nationwide, the internet--talking of new advances in medicine: a new drug for cancer, for arthritis, for heart disease, for Alzheimer's. It's been published in the current issue of a presigious medical journal.

But is it true? Is it factual? Is it even honest? These aren't insignificant questions. There are such things in medicine as 'conflicts of interest' and unfortunately they frequently infect our medical studies. Even the ones published in respected medical journals.

Today the cost of clinical studies is generally very high. Hospitals, medical centers--even federal health agencies with large budgets--find it difficult to finance a study. Frequently it is the pharmaceutical industry, or medical equipment manufacturer, that finance a clinical study.

Here's how it works. Drs. Jones and Smith and their associates at XYZ University or Medical Center wish to test a new drug on patients manufactured by ABC Pharmaceuti-
cals. Or ABC Pharmaceuticals seek out Drs. Jones and Smith to test its new drug. If the test turns out positive, ABC will earn a lot of money. ABC therefore underwrites the cost of Jones' and Smith's study.

But, you see, there's a catch. Because ABC pays for the study, it 'owns' it. That means that in order to publish their findings, Jones and Smith must first have the 'approval' of ABC Pharmaceuticals. In other words, ABC has 'first crack' at the study. If there is anything about the study or its outcome that ABC doesn't like--usually concerning side effects or drug efficacy--frequently ABC can choose not to have the study published. Period. The data are suppressed. The public will never learn of the findings or find out what ABC is objecting to. Or ABC can suggest to Jones and Smith that they remove data unfavorable to the drug and then go ahead and publish.

But why would Jones and Smith agree to do that? Because they are "on the take" from the drug company. They actually receive financial remuneration from ABC for doing the study. How about the hospital, the medical center, the research facility in which the study is done? Wouldn't they be equally outraged by ABC's tactics? But frequently enough they, too, are "on the take." Part of the deal of the ABC study is that the medical research institution in which the study is done is itself financially compensated.

This is a "classic" conflict of interest. At first, medical journals required authors to state whether they had financial ties to the company whose drug they were testing. If so, the editors of the journal would either reject the paper for publication or require a statement in the published paper that the authors--and/or medical institutions--were receiving financial compensation. But,in recent years, because this kind of conflict of interest has become so common, many journals no longer reject such papers or require such a statement.

How does this affect you? In 2006 a scandal broke concerning the drug VIOXX. The authors of this pharmaceutically-sponsored drug study published their results in the prestigious New England Journal of Medicine but prior to publication removed data unfavorable to VIOXX which indicated this drug could produce fatal heart attacks in otherwise healthy patients. It is unknown how many patients suffered fatalities or heart-damaging effects, but lawsuits against the pharmaceutical sponsor still persist.

How many VIOXX's are there out there? How many clinical studies are there out there that are not quite what they say they are? How many patients are there out there who are taking drugs in good faith that are not doing them any good or are positively and unrecognizably dangerous--until such time as fatalities or serious side effects break out? We don't know.

Well-known syndicated columnist Paul Krugman suggests that clinical studies and their results are to be considered "suspect" because of the "deep financial links" between doctors, hospitals, research institutions and drug companies.

The basic question here is: How reliable are our published clinical studies? And the media bally-hoo behind them?

Whenever a clinical study is published or publicized without it being known whether the authors of the study or the medical institution in which the study was done were being financially compensated by the sponsoring drug company--whenever this possible conflict of interest is not spelled out in detail--the study must be considered
"phony." Unless proven otherwise.


On the evening network television news, every week there are stories of "ground-breaking" new clinical studies--new drugs or medical advancements. Where are they? Where are the results of these well-publicized and dramatic developments?

Needless to say, today there are a lot of "phony" studies...

Until we have a system in which no doctor, no research institution, no hospital, no medical center can receive incentives from sources that have a proprietary interest in the drug or equipment under test--until we can eliminate the conflicts of interest
that are choking the truthfulness of our clinical studies--they will always be subject to ethical compromise and we will never have an accurate impression of their true clinical value.

2 comments:

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