Most people think of pharmaceutical research as a highly technical activity that takes place in world-class medical centers. The reality is somewhat different.
Mr. Elliott visited homeless shelters where mentally ill homeless people are recruited to participate in research studies to test psychiatric drugs.
The main ethical issues here, of course, are the competence and judgment of the prospective subjects. “When you say ‘money,’ everything else goes out the window,” said Hanif Jackson, a former program supervisor at the Ridge Avenue shelter in Philadelphia, which recently closed down. I heard the same thing from Harvey Bass, a chaplain who has worked at the Sunday Breakfast Rescue Mission shelter for 15 years. He said drug study recruiters often park outside the shelter and approach residents on the sidewalk. Although Bass didn’t think it was his place to warn residents away from the studies, it was clear that he was not exactly a fan. “These guys have no job, no home, and a habit,” he said. “You have people at their lowest state, and they’ll say yes to anything.”Read more here.
Abilify was the best-selling drug in America in 2013, with sales of $6.5 billion. It is also the most visible representative of an extraordinarily profitable class of drugs. Antipsychotics have been around since the 1950s, but for the first 40 years of their existence they were reserved for patients with serious mental illnesses, such as schizophrenia. (Medical journals advertised them with slogans such as “Reduces need for shock therapy and lobotomy.”) There was good reason for this caution: Antipsychotics can cause potentially dangerous or disabling side effects, such as muscle stiffness, tremors, extreme restlessness, and tics. The most notorious is tardive dyskinesia, a writhing, twitching motion of the mouth and tongue that can be permanent.
About 20 years ago, pharmaceutical companies began rolling out new and improved, or “atypical,” antipsychotics—drugs like Risperdal, Zyprexa, Seroquel, and later Abilify. The atypicals were expensive, but the companies’ marketing materials described them as safer and more pleasant to take. By the mid-2000s, physicians were prescribing the new antipsychotics for a dizzyingly broad range of conditions, including insomnia, depression, anxiety, bipolar disorder, agitation, autism, ADHD, and post-traumatic stress disorder. Prescriptions of antipsychotics for conditions other than serious mental illness doubled, and the drugs found frequent use in nursing homes, juvenile care facilities, and prisons.
There are 10 different atypical antipsychotic drugs now available in the United States, each of which had to be tested in humans. Several are available in long-acting or injectable formulations, which require additional human testing. When the patent on a drug expires, rival companies often release a generic version, which requires yet more testing. Add to this all of the experimental antipsychotics that were tested on volunteers but never made it to market, and you begin to understand the economic forces behind what I saw in Philadelphia. Drug companies need mentally ill research subjects, and homeless shelters are full of them.
Many people assume that medical research studies are tightly regulated to ensure the safety of the subjects, but that’s not the case. In the 1970s, after a series of notorious research abuses, legislators pushed for a central federal agency with the power to protect human research subjects. The medical research establishment fought this idea, however, and when the National Research Act was passed in 1974 a very different alternative followed: a patchwork system of small ethics committees known as Institutional Review Boards. The boards were originally located in hospitals and medical schools, but clinical research has since moved into the private sector. Many are now for-profit companies that review studies in exchange for a fee.
Thanks to Conor Friedersdorf
No comments:
Post a Comment