Let my voice be heard, please?

Robert Goldberg is one of the authors for DrugWonks

Let my voice be heard, please?

The title of this feature is "Industry Voices." I do not represent industry. Over the 15 years I have written and been involved in healthcare issues and have advocated--at least from my perspective--the interests of patients and medical progress.  I believe commercialization is the fastest and most dependable way to translate and transfer innovation to humanity as a whole. I believe that medical progress has, more than any other human endeavor, added more to the longevity, well-being, and prosperity of humankind. I believe that as life expectancy increases and face the so-called problem of rising healthcare costs, we will no choice but to learn about the underlying mechanisms of the most troublesome diseases, apply our findings, and prevent disease onset. These preventive inventions will emerge from private companies, which should be encouraged and rewarded for their efforts by a robust patent system, a science-based regulatory system and a healthcare system that encourages the use of new technologies.

Further, the source of preventive medical technologies will most certainly emerge from the ability to precisely distinguish and predict differences among individuals and groups of people. We must understand their response to disease and treatments, as well as how certain types of medicines affect disease systems and humans as a whole. It is increasingly clear that a considerable amount of variation in health and longevity is a result of such differences--differences that were indecipherable less than ten years ago. Similarly, many of the high profile side effects of medicine that have made the headlines are the result of idiosyncratic responses to treatment that could be considerably reduced--and will be--with the use blood tests or whole genome sequence data to guide healthcare decisions. 

Unfortunately, little of the coverage of the pharmaceutical industry--particularly coverage of failed clinical trials and safety risks--takes this scientific perspective into account. To do so would suck much of the sensationalism out of the reporting and commentary, depriving journalists and bloggers of the opportunity to engage in conspiracy theories about the bad things happen to good people when the take pharmaceuticals.

The most recent case is the tragic story of Dennis Quaid's newborns twins, who were given 1000 times the dose of heparin. To Mr. Quaid, it wasn't enough to chalk it up to a horrible error. He said was the drug company's fault for putting varying doses in the same size bottle, and covering up other problems with the production of heparin. At least that was the strained assertion of the members of Congress who invited Quaid to testify.

Do journalists have a responsibility to put the relative risk of heparin use in the context of the benefits? How about reporting accurately and honestly about the source of the problems in heparin processing? Would a discussion about genetic variability and the challenge of titrating blood thinners in general be helpful in this regard? Or how about one of the more common mistakes the media makes in medical reporting: the relationship between SSRIs and suicide. Since a British researcher alleged that clinical trial data revealed a higher incidence of suicidal behavior and use of Paxil (Seroxat) nearly seven years ago, it has been all but assumed that all SSRIs were associated with a higher risk of suicide among children. (By the way, there is no correlation between suicidal thoughts or suicidal behavior and suicide.) 

How did this assertion, which has never been proven and is not even in the black box warning now required by the FDA as part of the package insert for all antidepressants, become conventional wisdom? The black box warning, based on clinical trials and not clinical use, says the following: "There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in these trials."

About a year ago there was wide coverage of genetic associations between SSRI's, genes and adverse responses to the drugs.  Note the wording of the reporting from Amanda Gardner of Healthday:

 "Variations in two genes may help spur suicidal thinking in individuals taking a commonly prescribed antidepressant, research suggests.

Although preliminary, the findings could pave the way for genetic testing to determine which patients with depression are likely to have this unusual but dangerous side effect.

"These findings, if replicated, would provide a way to have a genetic test that would tell us who is at a higher risk of developing suicidal ideation when taking antidepressants," said Dr. Gonzalo Laje, lead author of the study and associate clinical investigator at the U.S. National Institute of Mental Health. "Our long-term goal is to make sure that people with depression can take antidepressants, because treating depression is the best way to avoid suicide," he said. 

Notice the care distinction between "two genes may help spur suicidal thinking" and "treating depression is the best way to avoid suicide."

Now, at the risk of immediately wearing out my welcome at FiercePharma let me cite this publication as a repeat offender in confusing suicidality with suicide risk. (To its credit other Fierce publications have noted that a decline in SSRI scrips among kids has been associated with an increase in suicides.) Here is a post from the March 28, 2008 publication:

"These questions are arising in the wake of a British investigation into GlaxoSmithKline and its antidepressant Seroxat. The government concluded that GSK withheld information on the med's suicide risk for teens, but could not prosecute because withholding that data wasn't illegal under British law because Seroxat wasn't approved for use in kids, just adults. (GSK maintains that it didn't withhold info, anyway.) Officials say they intend to strengthen legislation governing clinical trial info by year's end.

And just the other day..."Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market."

Companies should be held accountable for the good that they do, the important research they conduct, the silly and stupid actions they engage in. This goes without saying. But we all need to be more careful in describing the risk and benefits of medicines particularly in an age when the genomic is likely to be the Rosetta Stone for explaining much that seems wrong or tragic. That's how I hope to express myself, if allowed to be heard. - Robert Goldberg

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