Medical ethics

New government regulations water down clinical trial safety norms

Two circulars empower ethics panels to remove requirements on the size of trials facilities and the number of trials principal investigators can work on.

Crucial changes made in the regulation of clinical trials in India recently seem to have been made to align the industry to the favourite mantra of the Narendra Modi government – ease of doing business.

Experts say that two circulars that the government issued on August 2 has reversed advances for better regulation of such trials made previously through the intervention of the Supreme Court.

The circulars – issued by the Central Drugs Standard Control Organisation, the apex body of the Government of India to regulate clinical trials and quality of drugs – put immense powers in hands of ethics committees, which have been at the centre of controversies for not regulating clinical trials adequately.

The first circular has taken away the requirement that any hospital conducting clinical trials must have a minimum of 50 beds. Instead, an ethics committee can decide the trial site.

The second circular has removed a restriction on the number of trials a principal investigator can work on at any given time. The cap was set at three. The final authority for this decision will also be the ethics committee.

Role of the ethics committee

Ethics committees are supposed to be formed by qualified individuals – a medical speciality being a minimum qualification – who have been approached by scientists and companies seeking approval for trials of their medicines. These are private bodies which can operate within a health facility or independently.

Critics of this new policy say that for ethics committees to decide on principal investigators and clinical trial sites – the two most important components of trials apart from human subjects – they need capacity building. For instance, ethics committee members should be able to judge scientific standards of a trial site, an indicator of which is the number of beds at the facility.

“Number of beds signify how complex an organisation is with various facilities,” said Amar Jesani, editor of the Indian Journal of Medical Ethics. “It gives an idea about the number of departments, intensive care, blood bank, etc. These are important in case of an emergency.”

S Srinivasan, co-founder of Vadodara-based organisation Low Cost Standard Therapeutics said that it was a bad idea to allow one principal investigator to monitor several trials.

“Ideal is one trial at a time," he said. "But in some exceptional cases, where that person might be the only one with required expertise, more trials can be considered. But leaving it completely in the hands of the ethics committee is not good.”

Trials that went wrong

A widespread debate on clinical trials in India started in 2009 when seven girls between the ages of 10 and 14 from tribal belts in Gujarat and Andhra Pradesh died during clinical trials of the Human Papilloma Virus vaccine for cervical cancer. The Bill and Melinda Gates Foundation-funded Programme for Appropriate Technology in Health was conducting the vaccination trials. The HPV vaccines tried were products of companies GlaxoSmithKline and Merck Sharp & Dohme.

In 2013, a Parliamentary Standing Committee report indicted government officials for colluding with other stakeholders to conduct unethical clinical trials.

They were conducted on young girls before being tried on adults, a major violation of rules in India. The Programme for Appropriate Technology in Health described the project as an observational study rather than a clinical trial. The Parliamentary committee concluded that this was done to avoid lengthy procedures and hit the vaccination market at the earliest.

In 2014, the Supreme Court of India had asked the government to put proper regulation in place before permitting any pharmaceutical company to proceed with clinical trials. This was in response to a public interest litigation filed by the NGO Swasthya Adhikar Manch.

Citing government data, the NGO showed that there had been 3,458 deaths and 14,320 cases of serious side effects related to clinical trials in India between 2005 and 2012. The Supreme Court has been taking a tough stand against unethical practices in various other cases.

"The circulars go against the spirit of the Supreme Court orders," said Amulya Nidhi, of Swasthya Adhikar Manch. "SC has said that the problem lies with the existing law which has to be completely changed. Any new rules have to be within SC's framework."

Any new rule or circular has to abide by the three principles laid down by the court – that is testing for commercial benefit analysis, that the trial is for a new molecules and ones that have an established history, and the medical need of the country.

The loopholes

"Many trials are conducted in India for diseases which are not prevalent here," said Nidhi. "Thus, the country and patients do not benefit from them. SC has said such trials should not be conducted."

Nidhi also points out that the new circulars do not specify penalties on principal investigators who don't meet these Supreme Court mandated paremeters.

Just last month, the Indian Council of Medical Research came up with draft guidelines to conduct such trials in an ethical and fair manner so that poor patients don’t end up being guinea pigs for medicines that won’t even treat them.

“The recent circulars are a reversal of all this progress that has been made to regulate clinical trials in the country,” said Jesani. “So much power in the hands of the ethics committee, where we have more than 600 of them in India, goes against the principle of strict regulation.”

Ethics committees have come under fire by health experts and activists for not working independently and instead playing into the hands of organisations interested in conducting clinical trials. This results in slips in supervision and in the enforcement of rules and regulations.

After a hue and cry over the past few years, the government made it mandatory to register an ethics committee with the Central Drugs Standard Control Organisation before taking approval for the trials.

“There is a lot of paper work,” said Jesani. “But before putting so much power in the hands of the committee, the government should have generated evidence of substantial improvement in their functioning. There is no such evidence.”

Clinical researchers, however, have welcomed the circulars. “The earlier restrictions impacted a sponsor’s ability to choose the best qualified investigators and sites for a study,” said Suneeta Thatte, president of the Indian Society for Clinical Research. “The new announcements vest this decision with ethics committees who are best positioned to deliberate on this and take a well calculated decision.”

Srinivasan of Low Cost Standard Therapeutics disagreed. “This is a clear cut case of inviting pharmaceutical companies to conduct clinical trials in India and signal them for ‘ease of doing business’,” he said. “The decisions seem to have been taken under pressure from the pharma lobby to make it convenient to test their drugs in India.”

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Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

Play

This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.