Dinesh Thakur’s expose on Ranbaxy is not the first in the history of the pharmaceutical industry nor will it be the last. Probably the most infamous case in the pharma industry’s list of whistle-blowers is Peter Buxtun’s struggle to end the Tuskegee trial in 1972. After numerous internal attempts to stop the trial failed, he went to the media and the resulting public and political outcry finally had the desired result.
Buxtun’s testimony against his then employer, (the United States Public Health Service, no less) and subsequent investigations led to a major reform of clinical study protocols, with an emphasis on protection of participants and concepts such as informed consent. In fact, clinical trial protocols continue to evolve to this day: check out our story in this issue: Playing by protocol, page 37.
Reviewing some of the more prominent examples, we see a similar pattern. In 1996, Dr David Franklin’s disclosures on how Parke Davis (now owned by Pfizer) illegally promoted an epilepsy drug, Neurontin, for unapproved uses while withholding evidence that it was not effective for these conditions, eventually led to the establishment of higher standards.
And more recently, in November 2004, Dr David Graham, a veteran drug safety researcher at the US FDA, blew the whistle on the increased risk of cardiovascular problems associated with Merck’s anti-inflammatory blockbuster, Vioxx. After first attempting to discredit Graham, the US FDA had to ultimately mandate large warning labels on the drug’s packaging. After Vioxx, the US FDA has reportedly reviewed and upgraded its evaluation of drug safety standards.
The Ranbaxy saga seems to have already set in motion a review at India’s national regulator of drug safety standards, the Central Drugs Standard Control Organization and various Ministries associated with the industry. The Drug Controller General of India (DCGI) is due to submit a preliminary report on the implications of Ranbaxy’s guilty plea within a month’s time. The Commerce Ministry has issued a strong statement alleging ‘vested interests’ are out to malign the image of India’s generics industry, in a bid to move in on what has so far been India’s acknowledged forte.
In contrast to the Commerce Ministry’s damage control stance, the Health Ministry seems to have decided to be more circumspect. It is keenly waiting for the DCGI’s report so that they can take action on the quality aspect if necessary.
Threatened by a backlash from the medical community Ranbaxy issued a statement assuring consumers of the safety of their products. Simultaneously, stung by the allegations that Daiichi Sankyo was misled during the buyout process, Ranbaxy’s original promoters, the Singh brothers, refuted all charges alleging that the current owners were ‘trying to desperately shift the blame … away from itself’.
This war of words looks set to continue but what’s clear is that Ranbaxy’s peers in India now have to work harder if they want to remain among the global generic top guns. They will face tougher scrutiny, never mind that import alerts are part of any exporter’s business risks. The news that another major player from India, Wockhardt, was issued an import alert just days after Ranbaxy’s settlement merely added to this perception.
Beyond the corridors of India’s FDA Bhavan, this episode is hopefully a loud wake up call for other generic companies. Many industry leaders source from players in the unorganised sector, often referred to as the soft underbelly of the Indian pharma, and it is quite possible that while there are many ethical SMEs, there will also be those who crimp corners on cGMP.
The US FDA is better placed today to conduct more in-depth and surprise inspections on Indian drug manufacturing sites, with two offices in India and more staff on the ground. So the industry would do well to expect and prepare for more frequent and stringent inspections. The message for the industry would seem to be: ‘Document what you do’ and its corollary, ‘Do what you document.’
Viveka Roychowdhury
Editor
