In January 2017, the Indian media reported on an exceptional legal battle playing out before the Delhi High Court regarding a young lady suffering from multi-drug resistant tuberculosis, suing the Indian government for access to a new TB drug called bedaquiline that was supposed to be effective on TB patients resistant to all forms of drugs.
One of the six government hospitals authorised to administer the drug at the time had reportedly denied access to it on the grounds that the patient did not meet certain domicile requirements.
At the time, most media outlets did not explain why the government was curbing access to this new drug through the domicile rule. The few that did venture forth to give an explanation gave conflicting versions.
Scroll quoted the Indian Council of Medical Research (ICMR) chief to explain that the drug was being rolled out slowly because it was yet to be tested on patients and that it had demonstrated some problems related to cardio-toxicity. The Hindu, however, carried a long interview with Dr Jennifer Furin sitting in America, claiming that the Indian government was not giving access to the drug because of fears of building drug resistance – patients who started treatment on the drug but did not finish treatment would become resistant to the drug and in the process pose the danger of transmitting a new version of the TB bacteria that was resistant to even the latest drugs.
This resistance argument was in line with previous reportage in both The Hindu and Scroll where health ministry officials were quoted as saying that access to the drug was being curbed because of fears of drug resistance and that they wanted to make sure that patients would complete treatment on the new drug – hence the insistence on the patient being domiciled in a city.
So, what was the reason for curbing access to the drug – was it because the government wasn’t sure that the drug was safe or was it because of concerns of drug resistance? Both are very different reasons with very different implications. If the fear was of future resistance it made no sense to curb access to patients who would otherwise die. However, if safety was an issue, it was necessary to question the government on why the drug was approved in the first place?
Intrigued by the legal implications of the government’s policy, I roped in a student at the law school I teach at and began researching the issue. We filed RTI applications with the ministry of health and the Drug Controller General of India (DCGI) requesting an explanation and legal basis as to why the drug was not being made widely available.
The responses from both authorities were very surprising. The ministry claimed that the safety profile of the drug was not yet established since Phase III trials had not been completed and hence the drug was being made available only through a conditional access programme.
The DCGI claimed to have approved the drug.
Both responses were conflicting because for a drug to be approved under regulatory law, it needs to go through three phases of clinical testing. Phase I and Phase II are relatively small trials and Phase III trials are the riskiest phase involving thousands of patients and are meant to conclusively establish both the safety and efficacy of the drug.
Under Indian law, there is no provision to waive off Phase III trials (the law only allows the government to waive off the requirement to carry out local trials on Indian patients provided there is Phase III data from global trials). If the government had followed the procedure under the law, it should have insisted that Janssen, the company that owns the patent for bedaquiline, conduct clinical trials in India before any kind of approval could be granted.
If the government had adopted this approach, the patients who have been administered the drug would have been entitled to certain rights under the law, such as compensation if the drug caused them harm and more importantly, it would have ensured that the trials were covered by a legal regime designed to reduce conflict of interest and possible harm to patients.
When we dug a little deeper and found the consent forms that patients had to sign before they got access to the drug, we discovered that the government was forcing the patients to give up their right to any compensation in case anything went wrong, and more worryingly failed to warn patients that bedaquiline was not yet fully tested and that earlier clinical trials had reported higher patient deaths in the cohort that was being administered bedaquiline.
These are shocking lapses from an ethical perspective because informed consent requires patients to be informed of all the dangers involved with a treatment. In other countries like the US, the drug has only conditional approval subject to a long list of conditions including a blackbox warning where the deaths in earlier trials had to be published on the packaging along with full disclosure that the safety and efficacy of the drug was yet to be established.
The government also gave us under the RTI Act the correspondence between Janssen and the ministry of health, which revealed that the entire idea for the conditional access programme had come from Janssen. The deal struck between the government and Janssen was as follows – Janssen would give the drug for free to the government provided the government signed a data-sharing agreement wherein the government would share with Janssen all the clinical data generated when it administered the drug on Indian patients at six government hospitals.
For Janssen, this data was highly valuable because it still needed final approval in the US and EU and here it was getting the data literally for free from the Indian government, without having to bear the risk of conducting expensive clinical trials.
We got all of this information either from the internet or under the RTI Act for a grand total of Rs 20 (the cost of the RTI applications) while sitting in a campus in semi-rural Telangana. While my student and I were wondering why none of the health reporters had reported on these aspects of the bedaquiline story, The Hindu published two reports under Vidya Krishnan’s byline.
In the first report published on March 3, 2018, Krishnan basically accused the Indian government of not doing enough to increase access of bedaquiline and another new drug called delaminid. Krishnan claimed the government was not issuing compulsory licences for the patents covering the drug despite a recommendation from the former ICMR chief.
Her report was entirely silent on the fact that the drug lacked enough safety data and that Janssen itself was still in the process of conducting Phase III clinical trials in other countries. If doctors aren’t sure of the workings of the drug and were waiting for clinical trials to conclude, why will any generic want a compulsory licence to manufacture the drug? How are they ever going to make any money?
More surprisingly, Krishnan seems to have missed out on reporting by her colleagues at The Hindu who had accurately reported earlier that the second drug called delaminid had disappointed in the clinical trials.
After her first report was published, a health ministry official, Arun Jha, had tweeted out that access to the drug was being curbed because the government did not have enough Phase III trial data. In the next report published by Krishnan, she proceeds to completely twist Jha’s claim that the government was curbing access to the drug because of fears of increased drug resistance.
She then quotes Dr Furin, an American doctor, to berate the government of India for this policy. But Jha’s comment was clear that safety and not resistance was the chief concern and he was correct, since even the ministry’s sworn affidavit in court had stated that Phase III trials of the drug had not been completed.
By this time, both my student and I were simply amazed at what was playing out at The Hindu and we published on SpicyIP our version of the story rebutting Krishnan’s reporting and making available the RTI replies and the correspondence between Janssen and the ministry. All four pieces can be accessed here,here, here and here.
A few days later, Krishnan published yet another report in The Hindu, finally acknowledging that bedaquiline was yet to complete Phase III trials but giving a spin to the issue by quoting a study published by MSF in Lancet, claiming that bedaquiline had shown a 74 per cent cure rate, and then cited Dr Furin as an independent medical expert to back the MSF study.
What her report does not mention is that the MSF study was an observational study on just 28 patients, of whom only seven were from India. Clinical trials on the other hand can involve more than 1,000 patients. Further, it turned out that Dr Furin was a co-author on the MSF study published in Lancet and not an independent expert.
I published another piece on SpicyIP pointing out these anomalies. Krishnan then took to Twitter to accuse SpicyIP of peddling “conspiracy theories”.
That such an accusation comes from Krishnan is problematic because there are several instances where Krishnan has published patently incorrect stories. A couple of years ago she published a story on the front page of The Hindu on a scandal at GVK Bio that led to the EU banning 700 drugs tested at the facility.
It took two pieces in the Wire to dismantle her reporting. In 2016, she published a speculative piece in The Hindu linking the Zika virus to a chemical on the basis of a report published by an NGO.
A few months later, the WHO made it clear that there was no evidence to substantiate the claim linking Zika to the chemical. Around the same time, Krishnan was among several Indian journalists to fall for a claim by an Indian company that it had a vaccine candidate ready to tackle the Zika virus.
It took a report by India’s finest science journalist, Killigudi Jayaraman, to dismantle the company’s claims. At the same time, Krishnan and another reporter published yet another incorrect report on changing US regulations that would have impacted pharmaceutical companies in India. In that case, her colleague was candid enough to publish under his byline another report quoting the USFDA terming The Hindu report as false. To therefore accuse my co-author and me of spreading conspiracy theories seems unfair.
Rather than get drawn into a Twitter battle, I waited to hear from the reader’s editor at The Hindu. I had written to him after publishing the four pieces on SpicyIP telling him that there were serious factual errors in the paper’s reporting.
I received an acknowledgment but till date the reader’s editor has not commented on the issue and The Hindu has not published a correction or retracted any of Krishnan’s reports.
I think this is problematic because for many patients and doctors in India, the newspaper is the first source of information and The Hindu’s reports usually pop up on the first page of a Google search when a user is querying about bedaquiline in India.
More tragically, not a single health reporter from the other newspapers thought it necessary to take up the larger issues we raised on SpicyIP despite being aware of our research.
Update
Newslaundry did not reach out to The Hindu’s reporter and editor for their response before publishing this piece. We regret the oversight. In the interest of fairness, we will publish a rebuttal should the newspaper issue it.
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