Medtronic, the world’s largest medical device maker, hit the motherlode with a bioengineered bone growth protein widely used since 2002 in spinal fusion surgery. Known as INFUSE® Bone Graft, it’s a genetically engineered version of a protein that’s naturally released by the body and used during surgery to stimulate bone growth – for example, in order to strengthen the lower spine by fusing two adjacent vertebrae together.
But Medtronic forgot to mention that many of its favourable studies published about INFUSE had been drafted and edited by its own employees (including marketing department staff, in a practice called medical ghostwriting) while 13 physicians claiming to be the study authors had been paid $210 million by Medtronic over a 15-year period, according to a U.S. Senate investigation. Continue reading
As merely a dull-witted heart attack survivor with a relatively recent interest in scientific research (and only because it can influence how my doctor and yours practice medicine), I like to think that university researchers are a noble lot. But in an essay called The Dawn of McScience, Dr. Richard Horton delivers a surprising indictment of academic research.
In his New York Review of Books column about the book called Science in the Private Interest, he cites its author Dr. Sheldon Krimsky of Tufts University School of Medicine, who lumps universities in with industry like so:
“Universities have become little more than instruments of wealth.
“This shift in the mission of academia works against the public interest. Universities have sacrificed their larger social responsibilities to accommodate a new purpose – the privatization of knowledge – by engaging in multimillion-dollar contracts with industries that demand the rights to negotiate licenses from any subsequent discovery.” Continue reading
Every prescription drug (or over-the-counter medication) in your bathroom cabinet is there because it’s been evaluated in research called a clinical trial. For a basic introduction to clinical trials, let’s turn to former editor-in-chief of the prestigious New England Journal of Medicine, Dr. Marcia Angell, who wrote the following in her frightening landmark piece called “Drug Companies & Doctors: A Story of Corruption” (New York Review of Books, 1/15/2009):
“Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill.
“The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive – that is, they show effectiveness without serious risk – the drug is usually approved, even if all the other trials are negative.”