La publicación (autor anónimo) en BMJ de esta nota mueve a Jack a titular en PharmaGossip:
Wolf or Sheep?
Escribe:
Drug companies occasionally conduct post-marketing studies to collect data on the safety and efficacy of drugs in the real world, after they’ve been approved by the US Food and Drug Administration (FDA). “However,” writes the anonymous author in the British Medical Journal, “some of the [post-marketing] studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.”
Promotion enters into the picture as the company recruits doctors to enroll their patients into the study – a job for which they’re paid. The company tells doctors about the qualities of their drug, and the doctor relays that information to their patients. (Ver)
Y nos remite al post que Amy Maxmen publica en NATURE (Nature News Blog):
Advertising masked as science?
De él...
Some post-marketing studies fall into the category of so-called ‘switch campaigns,’ writes Edwin Gale, emeritus professor of diabetic medicine at the University of Bristol in the UK. Although these campaigns, which persuade prescribers to substitute a new drug for an established treatment, were denounced by the US Office of the Inspector General in 2003 and by the European Medical Agency more recently, they continue today.
“There isn’t a stringent definition of what a post-marketing study is, and so regulators turn a blind eye to what is going on,” Gale says. “But when studies involve half-a-million people, you have to start asking questions.”
Gale’s case in point is the largest insulin study to date: a 67,000-person trial called A1CHIEVE, sponsored by Novo Nordisk and completed in 2011. With diabetes patients enrolled in 28 countries, Novo Nordisk’s explicit goal was to look at the world-wide profile of their drug, a genetically engineered insulin analogue. Gale finds that aim questionable, given that the drug had already been tested in clinical trials, pre-approval, in 21 of those nations.
In the end, the study found few benefits of the drug over competitors, and risks, like low blood glucose levels, weren’t measured in a way that was meaningful, writes Gale. “This study is just not science at all,” he says.
What the study might have achieved is a larger market, says Gale, especially if patients remained on the drug after the study ended. He says, “I don’t have proof that this is a marketing study, but if it wasn’t a marketing study, what was it?”
The third editorial takes issue with the fact that A1CHIEVE study sites were not in Europe or North America, but rather in developing nations like India and China, where the market for insulin is skyrocketing along with rates of type 2 diabetes. The ethics of convincing doctors to switch from human insulin to analogues that cost at least twice as much in countries where people make a dollar per day, are questionable, says JohnYudkin, emeritus professor of medicine at the University College London. (Más)
Ver también:
InPharm/BMJ: diabetes post-marketing studies used to boost sales
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