Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial
by Alison Bass
listed in drugs
I have grown accustomed over the years to reading about the excesses of pharmaceutical companies and have, over the years, reviewed and published reviews with titles such as The Cholesterol Myths by Dr Uffe Ravnskov MD PhD which involved misrepresentation of clinical data on a massive scale over several decades, Overdo$ed America: The Broken Promise of American Medicine by Dr John Abramson MD and Food is Better Medicine Than Drugs: Your Prescription for Drug-Free Health by Patrick Holford & Jerome Burne.
Also, there have been recent scandals about clinical researchers being paid for their authorship in scientifically published papers in scholarly journals without having had full access to the clinical data and of researchers who have even invented the data for their publications.
However, even I have been shocked by Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass, which gives an account from several key players' perspectives about how the New York State Attorney General's office successfully brought a lawsuit against GlaxoSmithKline for consumer fraud for concealing, distorting and misrepresenting research clinical trial data about the antidepressant drug Paxil.
Award-winning journalist and University lecturer Alison Bass, who has worked as a mental health reporter for the Boston Globe and has covered medicine and technology stories for other publications, has compiled this narration through the stories of a number of personalities who played leading roles in this complicated and long-winded fight to expose the deception of clinical data by GlaxoSmithKline, the fraudulent use of research funds by clinical researcher Dr Martin Keller and the dreadful harm done to various young people prescribed antidepressant medication by their doctors.
The story is told through an almost chronological account of the major contributors to this victory, including Rose Firestein, Assistant Attorney General, diminutive, nearly-blind and workaholic who walked with a cane, and Donna Howard Assistant Administrator at Brown University's department of Psychiatry who proved that Dr Martin Keller, Chief of psychiatry at Brown had been receiving hundreds of thousands of dollars from the Massachusetts Department of Mental Health for research that wasn't being done.
Buried within corporate research files was data demonstrating that Paxil and other drugs including Prozac and Zoloft increased the incidence of suicides among adolescents widely prescribed these drugs. The narrative regarding the research deception, how the money trail was discovered, and the political shenanigans between the pharmaceutical giant and government departments was complex and highly person-centred upon several characters who played major roles in exposing the scandal.
As a former laboratory scientist myself, I found the description of how results which showed increased suicides could be transformed into either positive or neutral effects almost unbelievable. Recruited patients who exhibited suicidal thoughts or behaviour were dropped from the study, the reasons attributed to side effects or terms such as 'emotional lability'. The amounts of money being paid to clinical researchers, sometimes in the region of $20,000 per recruit to a clinical trial or half a million dollars to their research laboratory were astronomical; I have obviously been incredibly naïve regarding such sums.
Obtaining the documented proof was literally like getting blood from a stone, because the pharmaceutical companies were not at the time compelled to release their data to these attorneys. Even when the data was delivered, as mountains of paper which nearly blind Rose Firestein poured over at length, there was much drama in persuading her colleagues of the likelihood of succeeding in this approach, and much eleventh hour tactics adopted by the other [drug company] side's legal team. There are also fascinating insights into the medical establishment's reluctance to restrict a drug which a majority of doctors thought was effective for depression. Not surprising when all the negative information regarding these sometimes fatal side effects was completely suppressed.
This case was pivotal in spearheading the introduction of new standards for pharmaceutical companies and medical journals' reporting on drug research, including the registration and publication on an online database of clinical trial objectives and approaches. However the Epilogue eloquently catalogues the journey still to be travelled by politicians, doctors and drug companies to effectively protect public health and diminish corruption.
This book, although initially complex and somewhat detailed to follow, works its way to a crescendo of a thriller, certainly worth reading for the narrative as well as the facts. And, perhaps most importantly, it highlights how ordinary people of modest income but with high standards of integrity and motivation can overcome the Goliaths of the pharmaceutical industry.
Available from Amazon and from Workman Publishing.
- Sandra Goodman PhD
- Algonquin Books of Chapel Hill