Is the Research Enterprise in Decline? (Part 2)
This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
My maiden guest post for the Biotechblog last focused on the global impact of reduced funding for innovative bio-pharma development on clinical research and the threat to the global clinical research enterprise. At that point the clinical research sector in India looked like an outlier with year-on-year increases in clinical trials and revenues projected to grow from $450 million in 2011 to $1b by 2016. Now as we approach the end of 2013, that rosy scenario appears increasingly unrealistic. India’s clinical research sector faces an uncertain future, with allegations including lack of informed consent and poor treatment of illiterate Indian patients.
Responding to civil society allegations of corruption and fraud, the Indian Supreme Court has intervened directly in the conduct of clinical research in India, suspending or freezing hundreds of clinical trials. While it is tempting to put the blame for lax enforcement of standards on the recent influx to India of MNC clinical trials, India’s Parliamentary Standing Committee on Health and Family Welfare identified similar shortcomings in oversight of both domestic Indian companies and MNCs alike, going back several years in time.
Well ahead of the Indian Supreme Court decisions in 2013, the Parliamentary Standing Committee reported in May of 2012 that the Central Drugs Standards Control Organization (CDSC) – the primary watchdog responsible for drug safety and related clinical research – had long since been captured by the industry it was charged with regulating:
The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured. p. 9
The Parliamentary Standing Committee cited systematic fraud, for example, in the case of Cipla’s application for approval of cancer drug Pirfenidone. The Committee concludes that Cipla never undertook the required Phase III clinical trial in India, and yet the company received marketing approval nonetheless.
Not only the regulators, but Indian academics and specialist hospital physicians are also compromised in the process. The Committee’s report to the both chambers of Parliament continues, documenting that the company coordinated or otherwise controlled simultaneous submission 4 separate letters of recommendation of approval from institutions located in Delhi, Mumbai, Chandighargh and Secunderabad – “all received exactly on the same day 2-7 2010 and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880.” (p. 34)
(In October of 2010, Cipla issued a glowing press release announcing the launch of the “World’s First Generic Pirfenidone in India, Giving Hope to Suffers of IPF (Idiopathic Pulmonary Fibrosis)” Despite the strong documentation presented to both Houses of Parliament supporting the contention that the Cipla did not conduct any clinical trials at all prior to approval of this first generic copy of a serious cancer drug, it remains on the market in India and internationally via Canadian online pharmacies – caveat emptor.)
Now the India Supreme Court process has taken matters to the other extreme, creating onerous and unrealistic new clinical research requirements and freezing clinical research in India, far exceeding requirements under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, known as ICH. These include mandatory compensation requirements for patients, and use of audio and visual recordings of informed consent, among others. Paradoxically, by imposing more stringent obligations than exceed ICH standards, the Indian Supreme Court rulings further reduces the likelihood that India can build needed capacities for ethical clinical research in compliance with international compliance.
In this context, a clinical research advocacy group known as: People for the Advancement of Clinical Research – India, has lodged an online petition at Change.org and petitioning Supreme Court of India: “Allow the Review and Approval Process for Clinical Trial Applications to Resume.” The Change.org petition provides compelling reasons for the continuation of clinical trials in India – identifying the existing standards and the extraordinary new measures now required under the recent Indian Supreme Court decisions. Everything in the petition is both true and yet sadly irrelevant given what we know to be the unfortunate ground realities documented by the 2012 Parliamentary Standing Committee report.
The Change.org petition seeks to reinstate the status quo ante without any serious reflection on how things have gone wrong, or suggestions on how to change a drugs development culture that tolerates cutting of corners and even outright fraud. All good intentions aside, Indian academics, industry and government agencies together have shown remarkable effectiveness at evading and undermining India’s compliance with ICH standards.
The Indian Supreme Court may have got it wrong, but the Change.org petition does not get it right.
About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.