Is Kerala’s LDF government sharing data with Canadian PHRI in rebranded health survey?
An ongoing health survey by the Kerala government is actually designed and steered by the Canada-based Population Health Research Institute, according to emails and letters exchanged by health officials and researchers involved in the project. Ironically, the Left Democratic Front government in the state, led by the Communist Party of India (Marxist), had strongly criticised the state’s previous Congress-led United Democratic Front government for partnering with the PHRI for an almost identical project, ultimately forcing them to shelve it. When media reports first broke news that the LDF had relaunched a similar project, the state government claimed that it was not sharing any data with PHRI. But the emails and letters, accessed by The Caravan, reveal that the government appears to have been lying.
The emails were exchanged by senior officials from the Kerala government, PHRI and other medical institutes involved in the project. The individuals include Rajeev Sadanandan, a top health bureaucrat who served under both LDF and UDF governments; Salim Yusuf, a professor at the McMaster University in Canada who heads the PHRI; K Vijaykumar, a professor at the Government Medical College in Thiruvananthapuram; and KR Thankappan, an emeritus professor at the Achutha Menon Centre for Health Science Studies, also in Thiruvananthapuram. Their communication, which was brought to The Caravan by a whistleblower, discloses the deliberations behind key decisions such as granting PHRI the access to data, addressing the media and political scrutiny over the project, and reveals the massive financial investment into the project.
Most pertinently, the communications reveal that Pinarayi Vijayan’s LDF government did little apart from rebrand and reintroduce the UDF’s Kerala Health Observatory and Baseline Survey, or KHOBS of 2013. In December 2018, two years after coming to power, the LDF government announced the launch of its survey called the Kerala Information of Residents - Aarogyam Network, or KIRAN. But within weeks of the new government coming to power, Vijayakumar had initiated the discussion to revive the previous government’s project. Vijayakumar is also a secretary of a non-profit called Health Action by People, which was involved in both surveys, sought to bring back the project.
Under the UDF government, Sadanandan had served as the principal secretary in the health department when the KHOBS project was underway. He was deputed to the central government in 2013 after KHOBS was shelved, and returned to the state government as the additional chief secretary in the health department in May 2016. On 3 June that year, Vijaykumar wrote to Sumathy Rangarajan, a programme coordinator with PHRI, “Mr rajeev sadanandan took charge. Coast is clear. Shall v plan a go?”
Health Survey Resumption (June 2016) by Tanvi Mishra on Scribd
In ten minutes, Rangarajan responded, “That great news VK. I will speak with Dr. Yusuf and get back to you.” The next day, Yusuf wrote to the two of them, “We need a new name for the same study (there are still antibodies to the Old study), we need to get the Minister on side, as well as the new CM and then develop a communications strategy ahead od starting to get the Press on side.” He added, “So, I am keen to go ahead but this time, we need to anticipate any potential political or logistic problems and then start after we have a good strategy.”
By all indications, the new chief minister Vijayan and his government were on Yusuf’s side and amenable to this plan of action—even aspects that it later categorically denied. In an October 2016 email about the logistics for initiating KIRAN, Yusuf expressly made data sharing a precondition for the project. He wrote, “If the govt will agree, we can use any approach that works—including what we had for the pilot—as long as we have data transferred to the PHRI every day—in fact few times a day!”
KIRAN Data Collection Emails (Oct 2016) by Tanvi Mishra on Scribd
In December 2018, the Kerala government formally launched the KIRAN health survey. The survey, according to the state government, was to identify prevalence and risk factors of non-communicable diseases. The government order announcing the survey stated that the data collected would include details about diet, exercise, life style, drinking and smoking habits, diseases and methods of treatment. The order further stated that the project would be implemented by the non-communicable disease division of the state’s department of health and family welfare. It noted, “This is a questionnaire-based survey targeting nearly 10 lakhs representative population of the state through the health staff in all 14 districts of the state.”
The government order noted that KIRAN would be conducted with the support of the Achutha Menon Centre for Health Science Studies, or AMCHSS, the State Health Systems Resources Centre, a technical support body in the health department, and the E-Health Kerala, a centralised digital healthcare database in the state. The AMCHSS is a research body of the Sree Chithiratirunal Institute of Medical Sciences and Technology, a central government institute under the ministry of science and technology. The order noted that the AMCHSS and the SHSRC would train data collectors, who comprise of district medical officers, and that the e-Health team was providing tablets for the survey.
The PHRI’s and McMaster University’s involvement is not mentioned in the government order. The research institute is funded by McMaster University, a public university in Canada and an affiliated organisation called the Hamilton Health Sciences, which is a network of hospitals that is known for its drug research and clinical trials. The PHRI is headed by Yusuf, a Canadian citizen who was born in Kerala. Yusuf is also the vice-president of research at the Hamilton Health Sciences and teaches at McMaster University.
Another organisation that was not named in the government order but played a central role in both iterations of the survey is the Health Action by People, an NGO of doctors based in Thiruvananthapuram. V Raman Kutty, a professor at AMCHSS is the chairman of HAP, and Vijayakumar is its secretary. HAP has been collaborating with McMaster University since 2003 for an international epidemiological study to identify factors behind cardiovascular diseases and the use of secondary preventive drugs. The principle investigator of this study, which is called the Perspective Urban Rural Epidemiological Study, or PURE, is Yusuf, and its lead investigators in India includes Vijaykumar and Raman Kutty. The study found that the use of preventive drugs such as aspirin and cholesterol and blood pressure-reducing medication were less in low-income countries like India and suggested improving “the long-term use of basic, inexpensive, and effective drugs.”
The PHRI, the HAP and the AMCHSS have been at the helm of both health surveys. The emails and documents accessed by The Caravan reveal the meticulous planning that preceded the launch of KHOBS, and at every hurdle they faced since then, till 2017. The communications expose the willingness of Kerala’s LDF government to implement a project that it had vociferously opposed just a few years prior when in the opposition. The exchanges between the individuals and organisations involved demonstrate that there was no practical difference between the two surveys. The corridors of power, it appears, are guided by considerations that lay bare the fickleness of political parties and their ideological positions.
Khobs Mou (July 2013) by Tanvi Mishra
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ON 14 DECEMBER 2011, the state government, the PHRI and the HAP held its first meeting on what was then identified as the “Kerala initiative.” The minutes of the meeting also clearly laid down the different roles of the involved parties. Yusuf proposed that the HAP could serve as “an interface between Health Department and PHRI/McMaster”—perhaps to account for the optics of a direct relation with a foreign, private organisation. The minutes further noted, “HAP and PHRI will design a format for data collection, cleaning and analysis.” Rangarajan, the project manager from PHRI, also appears to have been designated as the point person to “provide help/support to the program” during this meeting. They concluded the meeting deciding to hold monthly calls between Sadanandan, one person from HAP who may be Vijayakumar or Raman Kutty, and one person from PHRI who may be Rangarajan or Yusuf.
Minutes of First Meeting (D... by Tanvi Mishra
In May 2013, the Kerala government conducted the KHOBS pilot study. By August, the pilot was conducted and a supervising committee comprising Yusuf, Vijaykumar, Manu Raj, who formerly studied at McMaster and worked at PHRI as a clinical epidemiologist, and Bipin Gopal, the nodal officer of Kerala’s non-communicable disease control programme, had met to discuss their progress. Following the meeting, Vijaykumar wrote to Sadanandan that there was a “mismatch” in the data, which needed to be reviewed. “These checks can only be done by a team of statistician, data manager, epidemiologist and programmer, from PHRI, Canada,” he wrote. “Currently, they don’t have access to the pilot data base in the server. For these issues, we need to permit such a team from PHRI to access the pilot data and fix the errors.” That same day, on 15 August, Sadanandan wrote back granting PHRI access to the data collected.
KHOBS Data Sharing Emails (Aug 2013) by Tanvi Mishra on Scribd
The access to data, it appears, was one of the easy hurdles for the project. A second, more difficult one, was obtaining the clearance from the central government for collaborating with an international partner. According to the protocol issued by the Indian Council of Medical Research—the apex body for medical research in the country—any research project involving foreign assistance collaboration must be approved by a health ministry screening committee, or HMSC. Its members include representatives of the ministries of health, external affairs, finance, and science and technology. It is mandatory for all proposals for foreign collaborations to be submitted to the ICMR’s International Health Division, which acts as the secretariat of the HMSC.
In October 2013, Yusuf wrote to Vijayakumar and Raj, preparing for their application. He opened by saying that “it is important to be prepared to deal with any questions that come up with the HMSC clearance.” He identified the major concern that had to be addressed as “why Canada should access the data,” and proceeded to list seven detailed points that could be provided in response. Among them, he cited that Canada would not receive any “patient identifier, as all information will be anonymized,” and that the PHRI has been working with the government for two years already and has already invested over $500,000 in the project. Yusuf also claimed that the PHRI was one of few organisations in the world that is able to analyse the data.
HMSC Letter (Oct 2013) by Tanvi Mishra
But that clearance never came to be. By December that year, VS Achuthanandan, who was the leader of opposition from the CPI (M) at the time, began challenging the ruling UDF government on the policy. Achuthanandan accused the UDF government of gifting the Canadian state and PHRI with data about Kerala’s population, and soon after, the Kerala government was forced to shelve the project. In June 2014, the former health minister, VS Siva Kumar, stated in the assembly said that KHOBS had been cancelled because it was not approved by the central government.
As it turned out, the LDF’s opposition to the project appears to have been disingenuous. Within weeks of the new government coming to power and the swearing in of Pinarayi Vijayan as the new chief minister, Yusuf, Vijaykumar and Sadanandan had begun talks to revive the controversial project. The emails reveal that the same parties were involved, as well as the same procedures. In June 2016, Rangarajan wrote to Vijaykumar and Gopal seeking to “setup weekly calls with both of you” on Yusuf’s request. In a November 2016 email, Gopal wrote to Rangarajan, “E Health will provide us our required tablets by first week of September,” referring to the devices to be used for the new survey.
The media got wind of the proposed relaunch as early as December 2016. That month, the New Indian Express reported the move to revive the project, while noting that the LDF had previously opposed the survey “inside and outside Assembly accusing the UDF of collaboration with the Canadian government.” Gopal told the newspaper that the “PHRI was involved as expertise for developing the software for analysing the high volume of data is not available with the state or the country.” He further said that there was no need for a new agreement with PHRI because the agreement between the UDF government and the PHRI, signed in 2012, was still operational.
KIRAN Media Report Emails (December 2016) by Tanvi Mishra on Scribd
At 9.56 am on 13 December, the day the article was published, Yusuf received the piece on email from Veronica McGuire, a media-relations coordinator at McMaster University. Two hours later, he forwarded it to Sadanandan and Vijayakumar. “You are probably aware of this article,” he wrote. “It looks like some mischief makers are still active. I wonder who the “sources” are? I hope the govt will stand firm and support this program which is of obvious good for the state.”
Four days later, Yusuf wrote to Sadanandan expressing concerns about the implementation of the project. “I hope there will not be any serious obstacles and you along with the Health Minister and the CM can overcome any potential challenges,” he said. Sadanandan replied, “There are some objections raised in the party forum which is the final decision making body for the communists above minister and CM. Could go bad. They are beyond my reach. We are making efforts to influence the process.”
Within months, the project hit another obstacle with a vigilance committee inquiry into the survey. In an email dated 25 March 2017, Raman Kutty wrote to Vijayakumar that the vigilance department has started looking into HAP’s relationship with PHRI, PURE and KHOBS. Jacob Thomas, the former DGP who headed the vigilance and anti-corruption bureau during 2016–17, confirmed to me that the department was looking into the parties involved in KHOBS based on information and documents it had received. He said the investigation had been dropped, but upon being asked when and why this happened, Thomas declined to answer. He said he was no longer in the civil services and did not wish to discuss the issue further.
Meanwhile, the work to launch KIRAN appears to have continued unabated. On 15 May 2017, Rangarajan wrote to Yusuf, Vijayakumar, Kutty and others finalising the rebranded health study. She noted that the email included, among other attachments, the “Final KIRAN protocol” and an “Ethics Approval for PHRI/HHS.” Rangarajan added after the latter, “I have submitted an Amendment to our ethical committee for the Change in Name from KHOBS to KIRAN. As soon as I receive the approval, I will send this.”
Ultimately, the government overcame all the hurdles and relaunched KHOBS as KIRAN in December 2018. In what was likely a decision taken to avoid the questions raised by the media, the LDF government sought to minimise PHRI’s visibility in the project—at least to the public. Officially, the government maintained the position stated by Gopal to the New Indian Express. For instance, in May 2019, the opposition raised questions about the involvement of PHRI in the state assembly—a reversal of the exchange that happened six years prior.
KK Shailaja, the health minister, addressed the assembly and answered that the state government had sought the PHRI’s help to develop a software for conducting the survey. She said the AMCHSS had sought PHRI’s technical assistance to analyse the data, and that a request to collaborate with the PHRI was pending before the HMSC. “While the data collected by the health department is safe at the State Data Centre, the allegation of sharing data with the Canadian company is baseless,” Shailaja added. But the emails indicate that data-sharing was an essential component of the understanding between the Kerala government and the Canadian medical research organisation, and the state appears to have obliged.
The health department, too, has denied the involvement of PHRI and McMaster in replies to right-to-information requests on KIRAN filed by a non-profit called the State Human Rights Protection Centre. In a response from April 2020, the state’s directorate of health services said that no agencies outside India were associated with the project as per the government order on KIRAN. The RTI response continued, “Population Health Research Institute was mentioned in the proposal submitted by AMCHSS for big-data analysis. No communication was done between the Directorate of Health Services and the Population Health Research Institute.”
The health directorate’s response contradicted Shailaja’s statement about awaiting HMSC clearance for PHRI’s technical assistance. Pertinently, neither KIRAN nor KHOBS figure in the list of foreign-collaborated projects approved by the HMSC published on its website. Going by the list on the HMSC website, the committee has not approved the AMCHSS’s collaboration with PHRI, which would suggest that the PHRI’s involvement in data collection and analysis for these projects is illegal.
PHRI had disclosed its collaboration on KIRAN on its website, identifying it as one of its research projects. The project status was described as “Ongoing,” and the study period as 2013–18. The webpage noted that Yusuf and Philip Joseph, an investigator with PHRI, were the principal investigators of the project, and identified Rangarajan as the Program Manager. PHRI appears to have taken the webpage down after the Deccan Chronicle and television news reported it in April 2019. The Deccan Chronicle reported that PHRI had stated on its website that the ACHMSS was “carrying out the survey on their behalf.” Raman Kutty, the HAP chairman, told the Chronicle that the PHRI was involved in the survey from the beginning, and added, “There is no decision yet on sharing the data with the agency.”
Yet, the email communications seem to belie this claim. In the October 2016 emails, the PHRI representatives discussed the implementation of KIRAN, including the recruiting field staff, conducting the survey, setting up servers and sharing the data. In one email, Yusuf wrote to Vijayakumar, “If the govt will agree, we can use any approach that works ---including what we had for the pilot ---as long as we have data transferred to PHRI every day---in fact few times a day!” Yusuf was also being consulted on the number of staff, survey schedule, frequency of data collection and analysis for KIRAN, in this email thread.
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IT IS IMPORTANT TO UNDERSTAND this project in the context of the commercial interest behind medical data. The mining of medical data is a global multibillion-dollar industry. The technology market-research company BIS Research estimated that the value of big data in healthcare stood at $14 billion in 2017, and expected it to reach over $68.75 billion by the end of 2025. Adam Tanner is an investigative journalist and writer in residence at Harvard’s Institute for Quantitative Social Science, who wrote the book Our Bodies, Our Data: How Companies Make Billions Selling Our Medical Records. According to Tanner, companies generally insist that their data-mining practices are beneficent procedures for medical research and healthcare, but actually analyse it or sell it for profit. He has written that there is a great demand for pooled medical data as businesses are willing to pay for insights from its analysis to guide investments in the pharmaceutical industry or tailor advertising campaigns to promote drugs.
The PHRI is a private foreign institute that collaborates with pharmaceutical companies on clinical trials and drug research. Its website states that the organisation conducts research in “102 countries on six continents, with 1,500,000 people involved in up to 100 studies.” The commercial promise of medical data explains the vast amounts of money it has incurred in KHOBS and KIRAN. In the October 2013 letter that Yusuf sent to Vijayakumar and Raj to prepare for the HMSC, he noted that the PHRI had already spent over Rs 3 crore on KHOBS. Yusuf wrote, “PHRI has invested >$500,000 into the project and expects that it will cost us about $250,000 to $300,000 per year for the next five years.” It is unknown how specifically PHRI uses data from the health survey, and whether it is sold to any other party. Yusuf, PHRI and McMaster University did not respond to questions emailed to them. The story will be updated if and when they respond.
KHOBS Invoices (2013) by Tanvi Mishra
In an invoice dated 13 September 2013, HAP billed PHRI over Rs 6 lakh for the three-month period from September to December for expenses including salary of the staff, printing questionnaire for the survey, and collecting blood samples. The bill was signed by Vijayakumar on behalf of HAP. In another invoice, dated 10 October 2013, HAP raised a bill of $7,800, approximately Rs 5.7 lakh, for the “Kerala Health Surveillance Study.” The Kerala government did not appear to have accounted for these amounts in the expenditure it has cited before the state assembly. In June 2014, the former health minister, VS Siva Kumar, told the assembly that the government had spent just Rs 4.65 lakh for the project.
Another alarming fact revealed by the email correspondence is that the KHOBS project was designed not just as an observational survey, but as an intervention project to administer a drug and study its impact. In fact, the intervention appears to have been on the agenda since the very first meeting between the health officials and members of PHRI and HAP held in December 2011. Without identifying the speaker, the minutes stated, “I think it is best that for the intervention the lead comes from the K govt and HAPS and McMaster can add in information re the best approach for hypertension and diabetes control and secondary prevention.” It was decided during the meeting that “as an intervention, polypill has been considered” for the pilot study. A polypill is a tablet or capsule that combines multiple drugs within one. Since 2018, the Narendra Modi government has tightened its control on polypills, with over 400 such combination drugs banned as of January 2019. The Polycap combination does not appear to have been banned as per the lists available on government websites.
Yusuf had already approached Cadila Pharmaceuticals to procure Polycap, the polypill for cardiovascular disease manufactured by the company, free of cost for the KHOBS pilot study. He said in the meeting the pharmaceutical company had committed to providing “3 to 6 months of free supply for upto 500 to 1000 people as long as we can collect some key and simple data systematically, analyse and publish it.” Yusuf added, “It will help the Kerala Project and also Cadila.” Sadanandan, the minutes noted, was to explore the possibility of funding from philanthropists for the project. The documents accessed by The Caravan are unclear on whether this understanding with Cadila continued under KIRAN.
Cadila is an Ahmedabad-based pharmaceutical company headed by Rajiv Modi. Its founder, Indravadan Modi, was among a group of businessmen who supported Narendra Modi when he faced backlash for his inaction during the communal violence of 2002 in Gujarat. In 2003, Cadila joined business groups, including the Adani Group, to form the Resurgent Group of Gujarat in 2003 and threatened to leave the Confederation of Indian Industry when some of its members raised criticism against Modi.
The Polycap is a combination of five medications including aspirin, blood pressure and cholestrol reducers used for prevention of heart attack and stroke. The drug was rolled out in the market in April 2009.
According to the PHRI’s website, the institute has conducted three Polycap trials—called The Indian Polycap Study, or TIPS 1, 2 and 3—in around 20 countries, in the period from 2007–09, 2010–11 and 2012–20, respectively. The website also states that TIPS 1 and 3 were sponsored by PHRI itself, while TIPS 2 was sponsored by Cadila. The global trial registry of the US National Library of Medicine has published the details of the TIPS 1 study, in which it identifies Bengaluru’s St John’s Research Institute as the main sponsor, and PHRI and Cadila as additional sponsors and collaborators.
The registry lists four private institutions in Kerala among the 54 Indian organisations that participated in the TIPS trial. Among these is the Baby Memorial Hospital in Kozhikode, which is also listed as a participant in a different, Cadila-sponsored TIPS-K study, which began in 2010, published by the Clinical Trial Registry of India. The TIPS-K study tested the use of potassium supplements along with Polycap. The AMCHSS’s parent organisation, Sree Chitra Tirunal Institute of Medical Sciences, is also listed as a participant. Pertinently, the CTRI website does not list any institutional ethics committee of the Sree Chitra institute, and also notes that the Baby Memorial Hospital’s ethics committee has not yet approved the trial. The hospital is one of five hospitals for which the approval status reads “Submitted/ Under Review,” whereas the ethics committees of the 20 other participating institutes approved the trial.
The US National Library of Medicine does not specify whether all the participating institutes had gotten the approval of their respective ethics committees. The Baby Memorial Hospital did not respond to emails about whether the hospital had participated in the Polycap trials and if its ethics committee had approved them. Harikrishnan S, a professor of cardiology at the Sree Chitra institute, denied that the institute was ever part of any Polycap trial. Emails to the Sree Chitra institute, AMCHSS and HAP about the health surveys went unanswered.
The PHRI website lists Yusuf as a “key member” of the TIPS 1, 2 and 3 trials. The US library’s global registry identifies him as a study chair and investigator in the TIPS study. In effect, Yusuf was recommending the drug he was experimenting for the intervention phase of KHOBS.
In 2012, the Networks of Centres of Excellence—a Canadian government-led funding agency—rejected a proposal by a PHRI-led research group called the Canada India Research Innovation Health Network, or CIRIN. The PHRI’s letter of intent stated that “CIRIN health researchers have ongoing partnerships with Cadila Pharmaceuticals in India.” It further noted, “The Government of Kerala (Ministry of Health) is a new partner in CIRIN and we will develop a ‘health observatory’ in the whole state of Kerala.” Among the ways in which it proposed to do so, CIRIN claimed that it would be “incorporating the polypill into primary care.” One of five weaknesses of the proposal cited by the NCWE was that the “link between the poly pill and the diagnostics-related program was not evident.”
Sadanandan has also played an active role in promoting polypill treatment at global platforms, utilising his official position as the principal secretary in the state’s health department. In September 2012, Sadanandan participated in a global summit on “combination polypharmacy for cardio vascular diseases” organised by PHRI in Canada. Two months later, he wrote to an expert committee of the World Health Organisation, recommending the inclusion of polypill therapy to prevent cardiovascular diseases in WHO’s model list of essential medicines. Sadanandan wrote that he was recommending Polypill for its “relative affordability, availability and effectiveness.” The committee did not approve the proposal. It does not feature in the latest list released by the WHO.
In a booklet on Kerala’s health sector published by the Kerala government in May 2019, Gopal and Vijayakumar wrote that it was Sadanandan’s idea to conduct a health survey of a representative population in all districts. They wrote that in 2013, “Rajeev Sadanandan voiced the importance of developing a health observatory by doing a systematic surveillance of a representative population covering all districts.” Ultimately, they wrote, “an epidemiological study in the form of observatory was designed with the technical support of the renowned, global public health expert Dr. Salim Yusuf of McMaster University” along with experts in Kerala.
“Even though a successful pilot study was conducted the report remained unpublished as the project was abandoned due to some unfortunate controversies,” Gopal and Vijayakumar wrote. “The additional chief secretary shouldered the responsibility of getting through these issues and pitched back to proceed the study in 2018-19.” Sadanandan retired in May 2019 and is currently serving as the chief minister’s advisor in handling the COVID-19 pandemic. Yusuf wrote in the booklet that he and Sadandanan, “jointly came up with the idea of a state wide large representative survey that would serve the government needs to improve the health care of Kerala.”
The chief minister’s office, the health ministry and Sadanandan did not respond to emails either. The story will be updated as and when they respond.