Thousands of Indians have died in unethical clinical trials over the past decade. AFP
Thousands of Indians have died in unethical clinical trials over the past decade. AFP

Thousands of Indians die in unethical clinical trials



Thousands of Indians have died in unethical clinical trials over the past decade, even as a lawsuit to improve regulation of these trials has dragged unresolved through the Supreme Court for six years.

Between January 2005 and November 2017, 4,967 people died during the course of drug trials and research, according to government data obtained by a non-profit called Swasthya Adhikar Manch (SAM). Another 20,000-odd people have suffered adverse reactions in such trials.

Pharmaceutical companies have offered compensation to the families of the deceased only in 187 of these cases, said Amulya Nidhi, who founded SAM. At least 475 drugs have been tested in trials during this time, according to Sanjay Parikh, the lawyer representing SAM in the lawsuit it filed against the government in 2012.

The trials take advantage of loopholes in rules, loose oversight, and India’s large population of poor people who are often unaware of their rights as trial subjects, Mr Nidhi said. “We need a strong regulatory system, and we need action on violators.”

The number of clinical trials in India rose after 2005, when India relaxed its testing laws. Drug companies began to recruit clinical research outsourcing firms to conduct trials in India, where costs are drastically lower.

The annual revenue of these outsourcing firms has grown from $485 million in 2010-11 to over $1 billion today, according to research from Frost & Sullivan, a market consultancy.

India’s regulators have been unable to keep up with this explosion of testing. For instance, Mr Nidhi said, an ethics committee is supposed to oversee every trial. “At one point, in Chandigarh, there were 257 trials going on, but only one ethics committee overseeing them,” he said. “How is that even possible?”

Trials take place under the radar as well, Mr Parikh said, sometimes by simply paying poor subjects around 500 rupees a day and enlisting them. The details of the trials and the data harvested remain with the companies. “There’s no way to find this stuff out.”

In 2013, following an interim order from the Supreme Court, the government made it mandatory for companies to seek written informed consent from each subject before a trial, and for the process of seeking this consent to be recorded on video.

In reality, however, this rarely happens. What is more commonplace, Mr Nidhi said, is the kind of experience Pradeep Gehlot had. His story, as narrated to SAM, forms part of the non-profit’s case in court.

Mr Gehlot drives an auto rickshaw in the city of Indore, and when his father Srikrishna, a tailor, fell ill with breathlessness and chest pain, he admitted him to a government hospital.

In the hospital, Mr Gehlot was given a sheaf of papers to sign. They were in English, which he couldn’t read very well, but the doctors told him that his father would be treated, free of charge, with imported drugs, so Mr Gehlot went ahead and signed.

“Without his consent, Srikrishna was in a clinical trial for nearly two years,” Mr Nidhi said. “His health started deteriorating, and he died in 2012.”

When SAM heard about the case and sent a team to talk to Mr Gehlot, they confirmed from the documents that a trial had been conducted.

After Mr Gehlot complained, the doctor’s medical license was suspended for three months. SAM uncovered other cases of ethical violations in a different Indore hospital and filed further complaints.

The state government, after investigating the hospital, found that 81 “serious adverse events”—including 32 deaths—occurred during clinical trials on more than 3,000 people. These adverse events had not previously been reported to regulators. A third Indore hospital enlisted 1,833 children and 233 mentally ill individuals in trials without their consent, the investigators’ report found.

The report also suggested that doctors and clinicians running these trials had frequently been sent on trips overseas, or had been paid out of process, by pharmaceutical companies.

Punitive measures are weak, however. After its inquiry, the government imposed fines of $100 apiece on 12 doctors for not cooperating with its investigations. Two doctors were barred from conducting further trials for a period of six months.

_________

Read more:

Monsoon rains subside in India’s Kerala but disease fears rise

The end of an Indian summer tradition: evaporative coolers

India investigates Mother Teresa homes in baby-selling scandal

_________

But Chirag Trivedi, the president of the Indian Society for Clinical Research, a professional body representing pharmaceutical researchers, argued that the country’s rules are actually over-stringent, and that they have shrunk the number of ongoing trials.

One regulation, for example, calls for companies to also pay for management of all medical problems during trials, which is unfair, he said.

“There was a cardiovascular drug trial, which is for a heart ailment, where the company had to pay for tuberculosis treatment for nine months,” Mr Trivedi said. “We all know that tuberculosis is caused by a bacteria, not by any drug, and not by a clinical trial for a heart ailment.”

In every case that has warranted compensation, companies have paid out, he said.

Mr Trivedi admitted that, “as in any industry,” there were companies that indulged in unethical trials as well. “We cannot condone any irregularities,” he said. “Whatever protects the rights and safety of individuals, we will support such that. Every life is precious. We can’t treat Indians as guinea pigs.”

He also pointed out that clinical trials are vital to drug development. “The medicines that help you and me—they wouldn’t be available without trials.”

The next hearing of SAM’s lawsuit in the Supreme Court has been scheduled for December 4, but all parties to the suit have been asked to file their suggestions for an amended law next month, Mr Nidhi said.

But the regulations before 2005 were both sufficient and comprehensive, Mr Nidhi said. “Bring back the law that existed before 2005. That is what we are asking.”

Indoor Cricket World Cup

Venue Insportz, Dubai, September 16-23

UAE squad Saqib Nazir (captain), Aaqib Malik, Fahad Al Hashmi, Isuru Umesh, Nadir Hussain, Sachin Talwar, Nashwan Nasir, Prashath Kumara, Ramveer Rai, Sameer Nayyak, Umar Shah, Vikrant Shetty

In-demand jobs and monthly salaries
  • Technology expert in robotics and automation: Dh20,000 to Dh40,000 
  • Energy engineer: Dh25,000 to Dh30,000 
  • Production engineer: Dh30,000 to Dh40,000 
  • Data-driven supply chain management professional: Dh30,000 to Dh50,000 
  • HR leader: Dh40,000 to Dh60,000 
  • Engineering leader: Dh30,000 to Dh55,000 
  • Project manager: Dh55,000 to Dh65,000 
  • Senior reservoir engineer: Dh40,000 to Dh55,000 
  • Senior drilling engineer: Dh38,000 to Dh46,000 
  • Senior process engineer: Dh28,000 to Dh38,000 
  • Senior maintenance engineer: Dh22,000 to Dh34,000 
  • Field engineer: Dh6,500 to Dh7,500
  • Field supervisor: Dh9,000 to Dh12,000
  • Field operator: Dh5,000 to Dh7,000
JOKE'S%20ON%20YOU
%3Cp%3EGoogle%20wasn't%20new%20to%20busting%20out%20April%20Fool's%20jokes%3A%20before%20the%20Gmail%20%22prank%22%2C%20it%20tricked%20users%20with%20%3Ca%20href%3D%22https%3A%2F%2Farchive.google%2Fmentalplex%2F%22%20target%3D%22_blank%22%3Emind-reading%20MentalPlex%20responses%3C%2Fa%3E%20and%20said%3Ca%20href%3D%22https%3A%2F%2Farchive.google%2Fpigeonrank%2F%22%20target%3D%22_blank%22%3E%20well-fed%20pigeons%20were%20running%20its%20search%20engine%20operations%3C%2Fa%3E%20.%3C%2Fp%3E%0A%3Cp%3EIn%20subsequent%20years%2C%20they%20announced%20home%20internet%20services%20through%20your%20toilet%20with%20its%20%22%3Ca%20href%3D%22https%3A%2F%2Farchive.google%2Ftisp%2Finstall.html%22%20target%3D%22_blank%22%3Epatented%20GFlush%20system%3C%2Fa%3E%22%2C%20made%20us%20believe%20the%20Moon's%20surface%20was%20made%20of%20cheese%20and%20unveiled%20a%20dating%20service%20in%20which%20they%20called%20founders%20Sergey%20Brin%20and%20Larry%20Page%20%22%3Ca%20href%3D%22https%3A%2F%2Farchive.google%2Fromance%2Fpress.html%22%20target%3D%22_blank%22%3EStanford%20PhD%20wannabes%3C%2Fa%3E%20%22.%3C%2Fp%3E%0A%3Cp%3EBut%20Gmail%20was%20all%20too%20real%2C%20purportedly%20inspired%20by%20one%20%E2%80%93%20a%20single%20%E2%80%93%20Google%20user%20complaining%20about%20the%20%22poor%20quality%20of%20existing%20email%20services%22%20and%20born%20%22%3Ca%20href%3D%22https%3A%2F%2Fgooglepress.blogspot.com%2F2004%2F04%2Fgoogle-gets-message-launches-gmail.html%22%20target%3D%22_blank%22%3Emillions%20of%20M%26amp%3BMs%20later%3C%2Fa%3E%22.%3C%2Fp%3E%0A
COMPANY PROFILE
Name: Kumulus Water
 
Started: 2021
 
Founders: Iheb Triki and Mohamed Ali Abid
 
Based: Tunisia 
 
Sector: Water technology 
 
Number of staff: 22 
 
Investment raised: $4 million 
The specs
Engine: 4.0-litre flat-six
Power: 510hp at 9,000rpm
Torque: 450Nm at 6,100rpm
Transmission: 7-speed PDK auto or 6-speed manual
Fuel economy, combined: 13.8L/100km
On sale: Available to order now
Price: From Dh801,800
NO OTHER LAND

Director: Basel Adra, Yuval Abraham, Rachel Szor, Hamdan Ballal

Stars: Basel Adra, Yuval Abraham

Rating: 3.5/5

SPECS

Engine: Two-litre four-cylinder turbo
Power: 235hp
Torque: 350Nm
Transmission: Nine-speed automatic
Price: From Dh167,500 ($45,000)
On sale: Now

The 12 Syrian entities delisted by UK 

Ministry of Interior
Ministry of Defence
General Intelligence Directorate
Air Force Intelligence Agency
Political Security Directorate
Syrian National Security Bureau
Military Intelligence Directorate
Army Supply Bureau
General Organisation of Radio and TV
Al Watan newspaper
Cham Press TV
Sama TV

'HIJRAH%3A%20IN%20THE%20FOOTSTEPS%20OF%20THE%20PROPHET'
%3Cp%3E%3Cstrong%3EEdited%20by%3A%3C%2Fstrong%3E%20Idries%20Trevathan%3Cbr%3E%3Cstrong%3EPages%3A%3C%2Fstrong%3E%20240%3Cbr%3E%3Cstrong%3EPublisher%3A%3C%2Fstrong%3E%20Hirmer%20Publishers%3Cbr%3E%3Cstrong%3EAvailable%3A%3C%2Fstrong%3E%20Now%3C%2Fp%3E%0A
The%20specs
%3Cp%3E%3Cstrong%3EEngine%3A%3C%2Fstrong%3E%201.8-litre%204-cyl%20turbo%0D%3Cbr%3E%3Cstrong%3EPower%3A%20%3C%2Fstrong%3E190hp%20at%205%2C200rpm%0D%3Cbr%3E%3Cstrong%3ETorque%3A%3C%2Fstrong%3E%20320Nm%20from%201%2C800-5%2C000rpm%0D%3Cbr%3E%3Cstrong%3ETransmission%3A%20%3C%2Fstrong%3ESeven-speed%20dual-clutch%20auto%0D%3Cbr%3E%3Cstrong%3EFuel%20consumption%3A%3C%2Fstrong%3E%206.7L%2F100km%0D%3Cbr%3E%3Cstrong%3EPrice%3A%3C%2Fstrong%3E%20From%20Dh111%2C195%0D%3Cbr%3E%3Cstrong%3EOn%20sale%3A%20%3C%2Fstrong%3ENow%3C%2Fp%3E%0A
The%20specs
%3Cp%3E%3Cstrong%3EPowertrain%3A%20%3C%2Fstrong%3ESingle%20electric%20motor%0D%3Cbr%3E%3Cstrong%3EPower%3A%20%3C%2Fstrong%3E201hp%0D%3Cbr%3E%3Cstrong%3ETorque%3A%20%3C%2Fstrong%3E310Nm%0D%3Cbr%3E%3Cstrong%3ETransmission%3A%20%3C%2Fstrong%3ESingle-speed%20auto%0D%3Cbr%3E%3Cstrong%3EBattery%3A%20%3C%2Fstrong%3E53kWh%20lithium-ion%20battery%20pack%20(GS%20base%20model)%3B%2070kWh%20battery%20pack%20(GF)%0D%3Cbr%3E%3Cstrong%3ETouring%20range%3A%20%3C%2Fstrong%3E350km%20(GS)%3B%20480km%20(GF)%0D%3Cbr%3E%3Cstrong%3EPrice%3A%20%3C%2Fstrong%3EFrom%20Dh129%2C900%20(GS)%3B%20Dh149%2C000%20(GF)%0D%3Cbr%3E%3Cstrong%3EOn%20sale%3A%3C%2Fstrong%3E%20Now%3C%2Fp%3E%0A
At a glance

Global events: Much of the UK’s economic woes were blamed on “increased global uncertainty”, which can be interpreted as the economic impact of the Ukraine war and the uncertainty over Donald Trump’s tariffs.

 

Growth forecasts: Cut for 2025 from 2 per cent to 1 per cent. The OBR watchdog also estimated inflation will average 3.2 per cent this year

 

Welfare: Universal credit health element cut by 50 per cent and frozen for new claimants, building on cuts to the disability and incapacity bill set out earlier this month

 

Spending cuts: Overall day-to day-spending across government cut by £6.1bn in 2029-30 

 

Tax evasion: Steps to crack down on tax evasion to raise “£6.5bn per year” for the public purse

 

Defence: New high-tech weaponry, upgrading HM Naval Base in Portsmouth

 

Housing: Housebuilding to reach its highest in 40 years, with planning reforms helping generate an extra £3.4bn for public finances

The bio

Who inspires you?

I am in awe of the remarkable women in the Arab region, both big and small, pushing boundaries and becoming role models for generations. Emily Nasrallah was a writer, journalist, teacher and women’s rights activist

How do you relax?

Yoga relaxes me and helps me relieve tension, especially now when we’re practically chained to laptops and desks. I enjoy learning more about music and the history of famous music bands and genres.

What is favourite book?

The Perks of Being a Wallflower - I think I've read it more than 7 times

What is your favourite Arabic film?

Hala2 Lawen (Translation: Where Do We Go Now?) by Nadine Labaki

What is favourite English film?

Mamma Mia

Best piece of advice to someone looking for a career at Google?

If you’re interested in a career at Google, deep dive into the different career paths and pinpoint the space you want to join. When you know your space, you’re likely to identify the skills you need to develop.  

 

Specs
Engine: Electric motor generating 54.2kWh (Cooper SE and Aceman SE), 64.6kW (Countryman All4 SE)
Power: 218hp (Cooper and Aceman), 313hp (Countryman)
Torque: 330Nm (Cooper and Aceman), 494Nm (Countryman)
On sale: Now
Price: From Dh158,000 (Cooper), Dh168,000 (Aceman), Dh190,000 (Countryman)
Company%20profile
%3Cp%3E%3Cstrong%3ECompany%3A%20%3C%2Fstrong%3EWafeq%3Cbr%3E%3Cstrong%3EStarted%3A%20%3C%2Fstrong%3EJanuary%202019%3Cbr%3E%3Cstrong%3EFounder%3A%20%3C%2Fstrong%3ENadim%20Alameddine%3Cbr%3E%3Cstrong%3EBased%3A%20%3C%2Fstrong%3EDubai%2C%20UAE%3Cstrong%3E%3Cbr%3EIndustry%3A%20%3C%2Fstrong%3Esoftware%20as%20a%20service%3Cbr%3E%3Cstrong%3EFunds%20raised%3A%20%3C%2Fstrong%3E%243%20million%3Cbr%3E%3Cstrong%3EInvestors%3A%20%3C%2Fstrong%3ERaed%20Ventures%20and%20Wamda%2C%20among%20others%3C%2Fp%3E%0A