Marketing strategies and science OR when science becomes pseudo-science

I have written that modern science is not a classical science with the ambition to find facts of the matter, in nowadays it is merely an instrument in hands of Big Pharma. A couple of illustrations are described here.

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.

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.

Although it’s not the case for A1CHIEVE, the FDA sometimes asks drug companies to do post-marketing studies when the agency has lingering questions at the time of drug approval. “That’s a good idea if the drug is important enough to warrant approval before all of the safety studies are done,” says Sidney Wolfe, director of the health research group at Public Citizen, a consumer advocacy group inWashington,D.C.He says the new diabetes drugs, including insulin analogues, do not fall into this category because they don’t have significant benefits over their competitors and come with risks. He echoes the sentiment that many post-marketing studies are thinly veiled marketing ploys.

I like this issue about the ethics: “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”. I thought that everybody knows that Big Pharma is out there not in order of ethics but to make profits.