Pharmalot... Pharmalittle... Good Morning

Thank you for providing the link to the Telegraph's article, "Thalidomide Casts A Shadow 50 Years Later".

Thalidomide is still casting dark shadows 50 years on, but not because of the reasons posited by Prof. Lachmann. Thalidomide is casting dark shadows 50 years on because of the justified fear that another thalidomide will be approved. But first, let’s consider the inaccuracies in the article. The caption of the photograph states that thalidomide was launched as a drug for treating morning sickness. This is incorrect. According to the 1972 book Thalidomide and the Power of the Drug Companies, by Henning Sjöström and Robert Nilsson, thalidomide was first test-marketed by its German manufacturer, Chemie Grünenthal, in the Hamburg area in November 1956 as a drug supposedly active in the treatment of respiratory infections. (Yes, you read that correctly!) By the end of 1957, Chemie Grünenthal intensively marketed this “completely atoxic” sedative, which was available without a prescription in Germany, and licensed it to companies in other countries. When sales increased explosively in 1959, adverse event reports about nerve damage and other problems flooded in from all over Germany. No matter. Chemie Grünenthal’s reaction: deny; deflect; destroy; dissemble; distort: prevent thalidomide from being available only by prescription. In one instance of bullying among others, when a German neurologist planed to publish a report of 20 cases of nerve damage caused by thalidomide, Chemie Grünenthal representatives bullied editors of two journals to prevent them from publishing the report. The material that I mentioned is from the first 69 pages of the book. But “worse it yet to come”: The book’s first mention of thalidomide and birth defects is on page 93. Chemie Grünenthal’s sordid history with respect to thalidomide is about much more than about birth defects, as tragic as that was. Was Chemie Grünenthal’s handling of thalidomide an event of the distant past that just would not happen again? Read Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine, a 2001 book by Trent Stephens and, Rock Brynner. Then read about Merck’s sordid history handling Vioxx in the 2008 book, Poison Pills: The Untold Story of the Vioxx Drug Scandal, by Tom Nesi. I concluded that Merck’s handling of Vioxx was taken straight out of Chemie Grünenthal’s thalidomide playbook. Prof. Lachmann continues by asserting that it can now cost roughly $1 billion for a newly discovered drug to become available to patients. I point out that the cost of new drug discovery and development is the subject of controversy, with some estimates being $100 million, one-tenth of the oft-repeated $1 billion amount. Plus, Prof. Lachmann states that it takes 10 years to for a drug to become available to patients. I share his concern about the length of this delay, the “drug lag”. Prof. Lachmann’s suggested solution: Patients, having been given full information about effectiveness and safety, sign an indemnity that they will not sue if things accidently go wrong. But whom can one trust to provide full information? Chemie Grünenthal? Merck? A used-car salesman? Besides, as a practical matter, patients can sue to seek discovery to find out about who know what when. Prof. Lachmann concedes that there is no question that litigation is appropriate where there has been negligence, deceit, fraud, or incompetence. But then he states that in most cases litigation is based on statistical side effects in which there is no way to tell, for example, if a particular heart attack was caused by the drug. Therefore, pharmaceutical manufacturers will settle out of court, adding greatly to drug costs and encouraging more of the same type of litigation. Given the books that I have read about negligence, deceit, fraud, or incompetence that is uncovered during discovery, I am unconvinced by Prof. Lachmann’s assertion that most cases are based on statistical results rather than chicanery. Prof. Lachmann statement that medical regulation is itself driven less by the facts and more by the dread fear of litigation is astonishing. As explained in an article, “Big Pharma’s Crime Spree” (http://tinyurl.com/6sxvgmp), consider that in January 2004, Pfizer pled guilty to felony account of promoting a drug for uses not approved by the US Food and Drug Administration, was fined $430, and promised not to do it again. But then in 2009, Merck was fined $1.2 billion, “the largest criminal fine in U.S. history” for doing it again, plus $1 billion to settle civil cases. (Yes, you read that correctly!) Where was Pfizer’s fear of litigation, Prof. Lachmann? Prof. Lachmann’s solution to the drug lag is to curtail actions by patients and their attorneys to be compensated for damages. A better way would be for pharmaceutical company executives to be held responsible for their actions.