Re: The “Saatchi bill” will allow responsible innovation in treatment
Saatchi law: Legal hurdles and Clinical irrelevance
The ‘Saatchi law’ is a wonderful legal initiative but it is unlikely to achieve its original aim of promoting innovative treatments. .
Firstly, on the legal front, it is likely to run afoul of the EU clinical trials directive, which in turn has been singularly responsible for the significant drop in number of academic clinical trials across Europe .
Secondly, there is a high failure rate in development of novel, innovative treatments. It has been estimated that only ‘’1 in 1,000 new compounds that enter preclinical testing ever make it to human testing and only 1 in 5 agents that enter human trials receive FDA approval’’. . The high failure rate is not due to any legal or financial hurdles. It is just a sad fact that most novel drugs are not good enough to be used clinically. So it is indeed extremely unlikely that the proposed Saatchi law would promote new treatments. Even worse, it could end up potentially harming lot of patients by promoting use of ineffective new medications. In fact, the law could even be used to promote quackery and unscrupulous people have certainly used the legal loopholes to enrich themselves in the past. .
Hence, unlicensed medications, however innovative they are, should be properly tested in clinical trials (phase1, 2, & 3) to ensure scientifically credible information is obtained regarding their safety and efficacy. Clinical trials, with their ethical oversight and peer review process, should remain the gold standard, at present, for assessing novel and innovative treatments.
Thirdly, there is an important distinction between licensed and unlicensed medications. Licensed treatments are likely to have good safety data and hence use of licensed treatments for unlicensed conditions is certainly less risky. Indeed most pediatricians and many oncologists would attest that there is no clinical impediment in using licensed medications for unlicensed conditions, although in practice there is a financial impediment.
Clinically, at best, the proposed Saatchi law is likely be irrelevant but, at worst, the well intentioned legal safe guards proposed in the law would paradoxically end up curtailing the current widespread use of licensed medications for unlicensed conditions.
1 Rawlins MD. The ‘Saatchi bill’ will allow responsible innovation in treatment. BMJ 2014;348:g2771–g2771. doi:10.1136/bmj.g2771
2 Sundar S. The law of unintended consequences. J R Soc Med 2013;106:303. doi:10.1177/0141076813496235
3 Gulland A. Number of global clinical trials done in UK fell by two thirds after EU directive. BMJ 2009;338:b1052.
4 Boklan J. Little patients, losing patience: pediatric cancer drug development. Mol Cancer Ther 2006;5:1905–8. doi:10.1158/1535-7163.MCT-06-0179
5 Holland JF. The krebiozen story. Is cancer quackery dead? Jama J Am Med Assoc 1967;200:213–8.
Competing interests: No competing interests