Myths, Misconceptions and Misunderstandings about the Clinical Research Industry
Inaccurate reports have tarnished the CR industry's once-glorious image, disregarding the fact that worldwide no drugs can be launched without human trials.
Mumbai, Maharashtra, April 9, 2012 /India PRwire/ -- Some years ago, Indians encountered a particularly motivational slogan: 'India Shining'. Although the slogan had a political genesis, it contained the right cues that imbued common persons with positive energy. 'India Shining' definitely sounded realistic, making every Indian proud. It enabled many players to place India on the global map in the areas of Innovation, Development, and Quality in the Healthcare sector.
Over the past few months, however, the Clinical Research Industry has been besieged by media reports and statements from various government quarters reflecting abject ignorance about the CR industry, inaccurate reporting as well as political twists and turns. All of this has created an extremely bad name for this vital industry, for healthcare, and the nation. The stream of reports published was so strong, it seemed like a procession of electoral result bulletins. Most articles cited factors such as lax laws and regulations, illegal trials, sudden deaths, inadequate compensation, and Indians being used as guinea pigs. Over-reporting by the media has led to participating subjects reporting at sites and clinical research organizations (CROs) with false adverse effects, attempting to extort money and blackmail trial organizers! Without doubt, blackmail and extortion are the last things anyone would have expected.
Society at large must realize that the drugs we consume have been tested not only in animals but humans too. If we claim to have become guinea pigs, let it be known that across the world millions of human subjects from different nationalities were guinea pigs for the development of the medicines that people use today.
In a recently developed medical treatment for strokes, a medical device called Solitaire has been tested in humans for clinical efficacy. Solitaire is a self-expanding stent-like design and, once inserted into a clot using a thin catheter tube, it compresses and traps the clot. The clot is then removed by withdrawing the device, thus reopening the blocked blood vessel. In the first US-based clinical trials, Solitaire opened blocked vessels without causing symptomatic bleeding in or around the brain in 61% of patients. It also led to better survival rates three months after a stroke. There was a 17.2% mortality rate with the new device, compared to the 38.2% mortality with an earlier device. If people want such treatments to be readily available, then Indian patients would also need to participate in such medical trials, despite the mortality rate. Ultimately, participation in these trials will lead to better treatments and better healthcare.
It's important to understand that without human trials one simply cannot have any medicines or modes of treatment that improve constantly. Any product that's introduced in any market goes through a battery of quality check points and complies with all the necessary regulations -right from development to manufacturing of the product. Regulations in India's pharmaceutical sector and in the field of clinical research are as stringent as in the aviation industry. India boasts of regulations that are on par with international gold standards and in no way inferior to those in the west.
Despite the best regulations in place in any industry, however, irregularities can happen. Planes do crash, don't they? Does this mean the entire industry is bad and should be banned or maligned? Despite rail accidents and air disasters, have we stopped travelling in trains or planes?
People have missed a critical point here. While irregularities should teach stakeholders how to tighten regulations and bring about better compliance, people have instead tarnished the industry's image via negative propaganda. The entire industry advocates adherence to the highest standards and that those guilty of contraventions should be punished under appropriate laws. In the eyes of the world, this has become a point of contention, with many contesting the idea that India should be considered a destination for drug development. There are assertions and reports that investments will now move to China primarily because of regulatory delays, subjective interpretation of laws, bureaucratic issues and other hurdles.
Unfortunately, regulatory authorities have reacted to the recent alleged irregularities by making drastic changes to guidelines or by claiming that these trials were illegal. New draft guidelines on compensation are completely lopsided and do not leave any scope but for compensating towards anything that happens to the participating subject. Such guidelines will only suit bureaucrats and not the industry. The nation seems to be reverting to the British Raj, where rules were made purely to suit the rulers!
Did people ever consider the context in which the word "illegal" has been bandied about? The very claim that the trials have been conducted 'illegally' casts doubts over the functioning of regulatory authorities. The DCGI (Drugs Controller General of India) office that has powers to approve or reject trials should be empowered with authority and resources to become more effective than it is at present.
Various industry-based associations such as ACRO (Association of Clinical Research Organizations), ISCR (Indian Society for Clinical Research), and ABLE (Association of Biotechnology-Led Enterprises) have come forward and reached out to the office of the DCGI and the Ministry of Health. The approach has been to collectively bring in compliance and regulations that will protect the interests of the participating subjects as well as promote the progress of science. This is the best and most prudent way to bring about improvements and ensure that Clinical Research is conducted in the appropriate manner.
At the same time, it would be a welcome change if other stakeholders - both government and the media - reiterate their trust in the CR industry, thereby creating a positive image for it, rather than merely sensationalizing any news on it. Robust support and focused efforts from these stakeholders is all that's required presently to regain the lost glory and pride of the Indian healthcare industry. The entire industry is open minded and ready to collaborate with other stakeholders to make this happen.
The author is Mr. Ashish Dasgupta is the Vice Chairman - ACRO India (Association of Clinical Research Organizations)