Baba Ramdev sitting in front of a display of Patanjali products. Photo: Reuters/Adnan Abidi
- On July 10, Baba Ramdev’s companies ran half-page ads in many newspapers deriding ‘allopathy’ and touting impossible Ayurvedic cures for non-communicable diseases.
- While the ad tries to create an allopathy/Ayurveda binary (with Patanjali’s brand of Ayurveda, to be exact), it really creates an evidence/no-evidence binary.
- The ad is directly violative of the Drugs and Cosmetics Act 1940 and the Drugs and Magic Remedies Act 1954. The latter also pinpoints a government failure.
- This isn’t the first time Ramdev has taken potshots at ‘allopathy’ – nor is there a want of ads breaking the law to advertise unproven treatments to millions of Indians.
- But there is a want of law enforcement, prosecution and reprieve from the irony of the same entity being responsible for both evidence-based and evidenceless medicine.
On July 10, Patanjali Wellness and Divya Scientific Ayurved, the companies run by FMCG magnate Baba Ramdev, ran a half-page advertisement in many of India’s major English language newspapers. The ad accused allopathy of spreading “misconceptions” and levelled a raft of allegations with zero evidence against scientifically tested and validated medicine.
In turn, the ad claimed that Patanjali Wellness could treat many of India’s major non-communicable diseases – also with absolutely no evidence: high BP, diabetes, abnormal thyroid function, eye and ear diseases, high cholesterol, abnormal liver function, skin diseases, arthritis and asthma. The ad also bizarrely claimed a “permanent solution” for “genetic diseases”. Finally, it implied subtly that “heart blockage”, “infertility”, “urinary tract infection” and “stress” don’t have permanent cures, thus undermining the solutions that evidence-based medicine does have for most of these issues.
In effect, while the ad tries to create an allopathy/Ayurveda[footnote]Patanjali’s brand of Ayurveda, to be exact[/footnote] binary, it really creates an evidence/no-evidence binary.
Laws
In India, the ad directly falls afoul of two laws: The Drugs and Cosmetics Act 1940 and the Drugs and Magic Remedies Act 1954.
According to Part IX, Rule 106(1) of the Drugs and Cosmetics Act, “No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in Schedule J.” And Schedule J includes almost all of the ailments in the Patanjali Wellness ad.
Under the Drugs and Magic Remedies Act, the ad violates sections 3(d), 9, 14 and 15. Section 3(d) states that no one is allowed to advertise treatment or cures for any ailment listed in this Act’s Schedule. The Schedule includes most of the conditions that Patanjali Wellness has issued the ad for: high BP, diabetes, heart diseases, arteriosclerosis and some liver-related conditions. Section 9 extends the Act to apply to companies, not just individuals.
Sections 14 and 15 describe exceptions when the government has provided permission to advertise. But in this case, our government ought to have published a gazette notification before the ad was published, allowing it to be. Did it? Now that the ad has been published, the government needs to have Patanjali Wellness elaborate the reasons for drafting its ad and why it believes it should be exempt from sanctions, in writing. Will it?
Given the law, the ad is principally a reflection of a major flaw in its implementation: the persons that report bad advertisements – individuals, organisations, government bodies, etc. – are typically not empowered to prosecute violators. Instead, they can only report violators to higher bodies and recommend sanctions. The entities that can prosecute are the state governments.
But do they? According to a PTI report in March this year, the ‘Grievance Against Misleading Advertisement’ portal of the Department of Consumer Affairs registered 1,416 misleading advertisements of AYUSH products and services between April 2014 and July 2021. Between 2017 and 2019, the ASCI reported 1,229 misleading advertisements of AYUSH products to the Ministry of AYUSH. And the Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homeopathy Drugs recorded 18,812 objectionable advertisements from 2018 to 2021.
There is apparently no want of ads in India that are breaking the law to advertise unproven treatments to millions of Indians. Yet state governments have mostly chosen to keep quiet. And for want of prosecution, the malice continues unchecked.
Precedence
Six years ago, Patanjali Yogpeeth and Divya Pharmacy placed an ad in newspapers that said, among other things: “After an intense research of 25 years, and conducting tests on over 1 crore people, our Ayurveda Mission is to give a healthy lifestyle to the people of the country successfully.” The rest of the ad claimed remedies to control diabetes; a group of 200 scientists compiling a list of beneficial herbs (when in fact such lists already exist); and that a virus causes high BP!
The late Pushpa M. Bhargava, former vice-chairman of the National Knowledge Commission and founder-director of the Centre for Cellular and Molecular Biology, Hyderabad, tore into the claims. As he wrote for The Wire Science:
If “intense” research has been carried out for 25 years, it must have been done by research scientists in an institution and the results put in public domain – for example, by publishing them in respected periodicals as is the practice universally. No such publication is mentioned in the ad or is known to exist. In the absence of any such publication, one may legitimately ask: who were these scientists and what were their qualifications? What was the name and location of the institute? What was the research methodology used?
Even if you have all the test results of one individual recorded on one page, for one crore individuals you would need at least one crore pages of recorded data; with 300 pages per volume, the number of volumes of data would be well over thirty-thousand. Where are they? Will Ramdev answer these questions? In fact, should not answers to at least some of these questions have been provided in the ad to make it credible, especially when the claim that is being made would seem to be extremely unlikely to be correct on the face of it?
More recently, in July 2020, the Ministry of AYUSH itself had curtailed Patanjali Ayurved’s claim that a substance it had developed, dubbed ‘Coronil’, was a “cure” for COVID-19. Instead, the ministry forced Patanjali Ayurved to rechristen it as a ‘product’ to manage COVID-19.
Yet, in February 2021, Baba Ramdev announced at an event in New Delhi that ‘Coronil’ was the “first evidence-based medicine for coronavirus”. If it was a jab at the Indian government’s own policy of approving antiviral drugs with scant evidence of efficacy against COVID-19, no one noticed, not even the then Union health minister, Harsh Vardhan, who shared the stage with Ramdev at the event. (The ‘Coronil’ paper itself was practically meaningless.)
Then, in May 2021, when India was in the throes of the deadly second wave of the novel coronavirus outbreak, Ramdev and Vardhan put on a piece of political theatre: the former called allopathy “stupid”, and then was forced to withdraw his remark after a gentle rebuke from the latter. In the end, no one was punished.
So what exactly is going on?
One hypothesis that fits all the data is that Ramdev, with the tacit help of the BJP government, has been persistently trying to lower the evidence threshold for his company’s products – and raise the bar for his rivals. Which brings us back to the Patanjali advertisement in question.
Also read: Who Benefits When the Drug Regulator Is Opaque?
Evidence
The ad openly indicts evidence-based medicine itself. There are two components to this part of the discussion.
The first component is that claims of the sort Patanjali Wellness has made find traction with people at large in part because the ‘evidence’ of “evidence-based medicine” is seldom in the public domain. When it is, it is often communicated poorly. This is deeply unfortunate because evidence-based medicine is good at eliminating bias – including bias that arises from the allure of profits, as in Patanjali Wellness’s case.
There are two good examples of the way India in particular has helped to undermine evidence. The Government of India approved the use of ivermectin in 2020 in the treatment of COVID-19 without any evidence that it worked. Studies conducted later found in fact that it doesn’t work. The government removed it in September 2021. But between these two events, the Union health ministry and its attendant bodies retained ivermectin in the treatment regime and insisted that evidence of its efficacy against COVID-19 existed. The government’s love for hydroxychloroquine was even more inexplicable.
The government created a similar situation with Covaxin: to date, no study has found reason to doubt that the vaccine is safe, so its use per se is not a problem. However, the fact remains that the government chose to approve the vaccine for mass use after its large-scale safety test had barely begun (with the drug-controller claiming very scientifically that the vaccine was “110% safe”). Misguided actions like this only sow confusion about what constitutes evidence, who can create it and when and why it matters.
The second example has to do with the government’s general neglect of rural healthcare. This state of affairs came back to bite the government when rural communities became suspicious of healthcare workers who seemed to suddenly take the trouble to come to their village to vaccinate them – whereas all these years their plight had been neglected. (Of course, the poliovirus, BCG and smallpox vaccines beat this ‘trend’, but they are practically from another era at this point.)
Evidence-based medicine is useless if the evidence won’t be placed in the public domain and communicated accurately, authoritatively and sensitively, by journalists as well as scientists within and without the government. If we bungle the communication or hide evidence in scientific journals or in inaccessible language, evidence-based medicine offers zero advantages over traditions that trivialise the need for evidence. They both become oppressive – one in Ayurveda centres and homeopathy clinics, the other in hospitals and private clinics.
Consider the examples of 2-DG, favipiravir, itolizumab and Virafin. They were all approved based on evidence that certainly doesn’t exist in the public domain. If a doctor prescribes it, we’re forced to take their word, pay the bill and pray. If a friend or a relative dies anyway, and if it so happens because we invested in the wrong treatment, how can we ever know? More importantly, what stops the drugmaker from claiming the death was the result of some cause other than their drug?
The other component of this discussion has to do with evidence-based medicine in a more philosophical context. In a July 2020 article, Trisha Greenhalgh, a professor of primary care health sciences at the University of Oxford, dug into the assumptions that underlie evidence-based medicine, and explained the importance of questioning these assumptions before we decided evidence-based medicine is the best. These are, in her words:
“… a singular truth, ascertainable through empirical enquiry; a linear logic of causality in which interventions have particular effect sizes; rigour defined primarily in methodological terms; and a deconstructive approach to problem-solving.”
According to Greenhalgh, “The trouble with pandemics is that these assumptions rarely hold.” The point vis-à-vis the Patanjali Wellness ad is that our focus on evidence-based medicine could create unmeetable, even irrelevant, expectations that, when they go unmet, can poison our opinion of the importance of evidence.
This point matters when the time comes for us to demand appropriate alternatives from our government and from our health workers. It also matters that Ramdev, etc. may just be advancing alternatives to a red herring: allopathic medicine is (or can be) evidence-based but it is also tested and regulated medicine, whereas Patanjali Wellness’s medicine doesn’t seem to be.
Pleas
Enterprises like Patanjali Wellness have flourished because of cronyism but also because they have been able to take advantage of the consequences of the Indian government’s complacent, and at times even derisive, treatment of public health, especially in rural centres.
In the shadow of the state’s neglect, threatened by or already suffering poverty, and being unable to understand what terms like ‘clinical trial’, ‘phase-4 studies’ or ‘cold chain’ really imply, a newspaper advertisement purporting to ‘fix’ diabetes would sound very appealing – especially when burnished with claims to ancient wisdom.
To be clear, none of these issues let Patanjali Wellness and its terrible ad off the hook. In fact, wait long enough and the allopathic medicine that Ramdev & co. are so fond of deriding will have to answer for the people whose health would have worsened because they delayed the proper treatment.
The famous Tamil cinema comedian Goundamani made a pertinent comment in an old film about alcohol consumption in Tamil Nadu (YouTube clip): “Only eight companies make alcoholic drinks in the country. If our leaders made up their minds and asked these companies to stop production, we can eliminate alcoholism. But they won’t – instead, they will go to the people and plead with them, one by one, asking them not to drink.”
Goundamani’s worldview may not admit the value of behavioural changes or moderation, but in the case of the Patanjali Wellness ad, it applies perfectly. Both the people who drafted the ad and the people who published it are acting in bad faith. And scientists, journalists and activists are left to do the pleading.