The Deputy Director for Safety at the FDA’s Division of Psychiatry Products answers my questions about how the risks of psychiatric drugs are evaluated by health regulators – and explains what you need to know to better protect yourself. Read the whole article or listen to an audio version of the interview at the Inner Compass Initiative website. (Note that while psychiatric drugs are the focus, much of our discussion generally applies to any other drugs as well.)
Many news articles about a study of influenza vaccine and miscarriages raised good questions—but for questionable reasons, reports Rob Wipond.
(This article appeared in The BMJ (British Medical Journal), January 5, 2018.)
When reporting on medical studies, the popular press has a habit of sensationalising. So the muted response to a recent research paper reporting increased risk of miscarriage with influenza vaccines was at first sight surprising.
The study, funded by the Centers for Disease Control and Prevention, found that women who had received an influenza vaccine containing the 2009 pandemic strain pH1N1 and who were also vaccinated in the next flu season had a statistically significant, 7.7-fold higher odds of spontaneous abortion within 28 days of the second vaccination. (Absolute risk increase could not be calculated because it was a case-control study.) The concerning odds ratio fostered extensive discussion in the paper. But the news media projected an air of calm, highlighting the observational study’s many limitations.
The headline on the health news website STAT read: “Study shows miscarriage risk may have increased after flu shots, puzzling researchers”2—as if the increased risk was in doubt. A widely syndicated Associated Press story ran with the headline, “Study prompts call to examine flu vaccine and miscarriage,” discounting the fact that this had been the purpose of the reported study. The Washington Post initially declared: “Researchers find hint of a link between flu vaccine and miscarriage”—but within hours that headline was softened to, “What to know about a study of flu vaccine and miscarriage.”
Read the rest at The BMJ.(subscription required)
Doctors’ relationships with drug company representatives have changed, say knowledgeable readers. But for better or worse?
A recently-unemployed friend of mine went into a Victoria walk-in clinic in June complaining about unease he couldn’t explain, and walked out with enough free packets of the antidepressant Cipralex and the stimulant Ritalin to last for weeks. If he liked these drugs, the doctor said, he should come back and get prescriptions for more. “It all happened so fast, in less than five minutes,” my friend said with both fascination and wariness.
I was working at the time on last issue’s article about the drug company sales representatives who fill our doctors’ shelves with free drug samples (“Meet Your Doctor’s Generous Friend,” Focus July/August 2013). My friend showed me his packets, each prominently stamped “Sample.” It seemed very coincidental. However, over the next several months coincidental encounters with Cipralex kept occurring, and I started to wonder how coincidental it really was.
Meanwhile, as damning as my article was of the relationships between drug companies, their sales representatives, and local medical doctors, Focus and I received only a few critical responses. That silence started making me feel like the reality was even worse than the article portrayed. Where were all the doctors declaring their independence from drug company money? Where were all the drug companies and reps declaring, “We’d never engage in those kinds of manipulative, corrupt activities”?
This month’s letter to the editor from a drug sales rep reflects one criticism we did hear: Bill’s and Sam’s stories of working as drug reps in Victoria and Vancouver from 1997-2009 were dated and things today are different. As some folks told it, today many local doctors know drug reps as responsible professionals who deliver samples and, if there’s any interaction, it’s a collaboration in patients’ best interests, period. However, my response was, even if practices in Victoria have changed, most doctors practising today will have been influenced by activities going on here as recently as four years ago, and going on elsewhere still today, and therefore Bill’s and Sam’s stories are still relevant.
This point would soon be even more robustly illustrated to me as I gradually learned about the corrupt international history of Cipralex and its enduring local legacy.
Pharmaceutical companies have paid billions of dollars in fines in the US for giving bribes and kickbacks to doctors. Are their drug sales representatives behaving any differently in Victoria?
“Dinner and Yankee game with family. Talked about Paxil studies in children.” That note, written by a drug sales representative about his evening with a doctor and his family, was one of many records that forced GlaxoSmithKline (GSK) to pay a $3 billion fine to the U.S. government in 2012.
According to Public Citizen, since 1991, there have been 239 legal settlements between U.S. regulators and pharmaceutical companies adding up to $30.2 billion in penalties—a third of those in the past two years. Over half related to the kinds of activities that drug sales reps were doing in the GSK case: Reps promoted drugs with misleading information or for unapproved uses (the antidepressant Paxil carries government warnings against use in children), and gave doctors “expensive meals, weekend boondoggles, and lavish entertainment,” “trips to Bermuda and Jamaica, spa treatments and hunting trips,” and “cash payments” disguised as administrative reimbursements or consulting fees, all “to induce physicians to prescribe GSK’s drugs.”
The sheer scale of these cases is overwhelming, collectively involving dozens of multinationals, thousands of drug reps, and seemingly tens of thousands of doctors (although doctors have rarely been charged). And it shows no signs of abating, when such fines seem to be just the cost of doing business in a sector where profits rank with those of the oil and financial industries.
Notably, these same multinational pharmaceutical companies spend billions of dollars promoting the same drugs to Canadian doctors. And surveys show many Canadian doctors meet with reps monthly, weekly, or more often, regularly attend their educational events, and regard them as a primary source for information about newer drugs. Yet there’s never been any similar lawsuits in Canada. Do drug companies play nicer here, or are we just bigger dupes?
There are over 200 drug reps registered to visit Vancouver Island Health Authority facilities, and more visiting private doctors’ offices, but there’s no central tracking of what they’re doing. However, two former sales representatives who worked in Victoria and Vancouver for four different pharmaceutical companies agreed to interviews with Focus, and they make the case that most Canadians are dangerously in the dark. (Both men requested anonymity, which required removing identifying details of companies, drugs, and doctors.)
Safety pronouncements for the waterway relate strictly to fecal coliform—but what about industrial chemicals?
My sense of place spins like I’m in a celebratory party version of Hitchcock’s Vertigo. Wow, I’m splashing in a Bermuda bay amidst California beach boys and Hawaiian dancing girls! No, my mind reminds me as I flutter about in warm ocean waters below a fervent August sun: This is downtown Victoria, British Columbia, and I just dove into the Gorge inlet.
It shouldn’t be so unexpected and disorienting. The Gorge’s shallow waters can take two months to turn over during dry summers, and so hover above a balmy 20 degrees celsius. But decades of unregulated pollution from industrial, sewage, boating, and urban sources transformed the once-popular swimming area into a liquid dump peppered with designated contaminated sites concentrated with lead, mercury, hydrocarbons, PCBs and more. Read the rest at Focus online.