A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Today, we celebrate the advent of a “Good Pharma Scorecard” from New York-based nonprofit Bioethics International – and for good reason:
A third of clinical trials that led to new drug approvals were never disclosed to regulators in 2012, according to a new study from Bioethics International that was published today in BMJ Open. On top of that, nearly half of all drugs reviewed didn’t disclose at least one Phase 2 or Phase 3 trial.
This lack of public disclosure of key clinical data falls well below established legal and ethical standards, the nonprofit argues. Its new scorecard will independently rank biopharmaceutical companies and new drugs based on ethics, human rights and public health criteria – starting off with R&D and clinical trial transparency.
“A critical issue facing the biopharmaceutical industry today is the loss of public trust,” Bioethics International President Jennifer E. Miller said in a statement. “Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12 percent of Americans believe that pharmaceutical companies are honest and ethical.”
The general idea behind the Good Pharma Scorecard enables the biopharmaceutical industry to evaluate its performance across key areas of ethical and legal concern and offers companies the ability to publicly demonstrate meaningful improvement in trustworthiness over time.”
The BMJ Open study evaluated clinical trial registration, reporting and publication rates for 15 new drugs that were approved by FDA in 2012. It found that three of 10 companies – GlaxoSmithKline, Johnson & Johnson and Pfizer – disclosed all clinical trial results for at least one of their reviewed drugs.
Gilead didn’t perform so well. Rather, it disclosed 21 percent of its trial results for HIV drug Stribild. Another low-performer is Sanofi with multiple sclerosis drug Aubagio, which only published 16 percent of its clinical trial data. Here’s a very telling chart from the study:
“As part of our validation strategy for the results of the study, we shared our final datasets for each drug with its sponsor to verify accuracy. Notably, all companies responded to our requests for input,” David Korn, a Harvard Medical School pathology professor and author on the paper, said in the statement. “Many companies scoring lower on our ranking scale were interested in ascertaining where and how they were not transparent with the intention of improving, and those who scored highly offered recommendations for maintaining best practices.”
[Images courtesy of BMJ Open, Flickr user hobvias sudoneighm]
