When I was a young girl, I watched my mother use a small amount of carbonated cola to successfully remove a rusty stain from our kitchen sink. I was amazed -- and a bit worried -- that a beverage I regularly consumed could also serve as a powerful stain remover.
Inspired by my mother's wizardry, I wondered what else the cola might do. Let's just say that experimentation allowed me to discover that the cola could not remove freckles from my little sister's face. And it failed as fuel for my father's cigarette lighter.
Obviously, the cola manufacturer made no marketing claims about its beverage other than encouraging its use as a tasty thirst quencher. My mother and I had freely chosen to use the cola for wholly unapproved uses -- notably, with both success and failure.
After becoming a physician, I discovered that we doctors often prescribed medications for unproven and unapproved uses. We would speculate how a drug proven useful by research to treat a specific illness might work for other diseases as well. That ostensible leap of faith into "the art of medicine" usually entailed a dollop of scientific hypothesis and a dash of hope, and it was generally taken only when a known cure for a patient's disease did not exist. Notably, both remarkable successes and lamentable failures ensued.
There is much talk today about "evidence-based medicine" providing the great corrective to drug-prescribing and medical practice guided by
But in reality, we know that too much of "the evidence" fed into those calculations is skewed -- many "negative studies" demonstrating a treatment's inferiority are never published by the funding corporate sponsor; and some "positive studies" touting a treatment's benefits are overweighted by spin doctors. Evidence biased by financial or reputational conflicts of interest among researchers remains of great concern.
In addition, insufficient evidence exists for most of the medical conditions that we patients suffer and we doctors treat. Even if all the published medical research currently at our disposal were scientifically sound and trustworthy, not all diseases have been adequately studied, and not all unique subpopulations of patients with a particular disease have been tested for unique treatment responses.
For example, the majority of antipsychotic and antidepressant prescribing for pediatric patients is not backed by supporting evidence of safety and efficacy -- the requisite research involving this subpopulation has simply not been financed and conducted.
The point is that we patients and doctors must still take frequent leaps of faith in the clinic and hospital. Ideally, holding on to what evidence may exist, we take those leaps together as partners who are mutually aware of the uncertainties, mutually focused on the patient well-being and mutually invested in a safe landing.
That is precisely why it should seriously matter when yet another corporate behemoth shoves us down a risky path it has knowingly forged with falsehoods, distorting medical evidence and corrupting our ability to make realistic health care choices. That is precisely why we should be outraged when yet another profit-seeking pharmaceutical company lures us to jump into an unsound health care decision at our own peril.
This month, it was widely reported that Abbott Laboratories pleaded guilty to government allegations that it had illegally promoted its anti-seizure drug Depakote for uses that were not approved by the Federal Drug Administration (FDA). In other words, Abbott had encouraged doctors to prescribe Depakote "off-label" to patients who suffered illnesses for which there existed no accepted credible evidence of the drug's efficacy or safety.
For example, according to various reports, Abbott admitted to maintaining a specialized sales team that actively promoted off-label Depakote use for elderly, demented nursing-home residents. These extremely vulnerable people had meager defense against Abbott's marketing exuberance, meager ability to understand Depakote's potentially lethal or serious side effects, and meager opportunity to legitimately consent to the drug's experimental use.
As part of the settlement, Abbott agreed to pay $1.6 billion in civil and criminal penalties -- of note, a mere year's worth of Depakote sales for Abbott. And, unfortunately, much of the media attention focused exclusively on this hefty financial penalty, as well as relevant legal and regulatory infractions involved in Depakote's unlawful marketing.
But this story needs to be told in profoundly human terms. It needs to be visualized as a narrative involving patients and doctors who daily struggle to make life-altering treatment decisions with what information they are given.
It needs to include a voice that speaks for thousands of people who languish silently in nursing-home beds. It needs to be narrated as a cautionary tale about modern medical practice and the corrupting influences that undermine evidence-based care.
Kate Scannell is a Bay Area physician and the author most recently of "Flood Stage."