More than just a number: A call to improve adverse event reporting

Is it time to put in place a robust system to medically support and compensate people who are adversely affected by a medical product?

The answer appears to be yes. The need for it is being felt by patients and families adversely impacted by approved medical products. And their voice is finding support from public health experts, who feel that a robust adverse event reporting system and subsequent redressal and support are critical to keep the faith in the system from breaking down.

The hidden toll

The last few weeks have seen discussions on adverse events, triggered by AstraZeneca’s (AZ) reported Court admission in the United Kingdom that its Covid-19 vaccine could — “in very rare cases” — cause blood clotting and low platelet counts. The same vaccine was sold in India as Covishield by the Serum Institute. AZ faces a class action suit from a small group of families in the UK, reported to be affected by the vaccine.

In India, a group of parents brought together by the loss of their children (possibly linked to the Covid-19 vaccine) are also preparing to take legal recourse. The aggrieved families are seeking accountability to prevent this from happening again, says G Venugopalan, the father of 20-year-old Karunya, who passed about a month after she took the vaccine in June 2021.

Some aggrieved parents are working on setting up an online system where anyone, not just health practitioners, can report an adverse event, that can be investigated by experts and followed-up by patients, says Venugopalan. He expects it to be operational by mid-June — the month that marks three years since his daughter had taken the vaccine.

Former Commissioner with Maharashtra’s Food and Drug Administration, Mahesh Zagade, recalls a simple adverse event reporting system that he had proposed involving the nine lakh-odd chemists in the country. Since people buy medicines from chemists, they can report their side effects to the pharmacist who could then upload this onto a system for further investigation, says Zagade who had raised the issue of compensation for patients affected by J&J’s recalled faulty hip replacements. There needs to be an adverse event reporting system that is neutral, independent of doctors and drug companies, he says.

Affected by the faulty hip device recalled in 2010, Vijay Vojhala says, he has since undergone three surgeries. Others like him are seeing their quality of life affected, and their cases in court are seeing “tareek pe tareek” (repeated dates). “Compensation needs to be given to suffering patients,” he says, speaking for the “class of suffering patients”.

Risk analysis

When it comes to Covid-19 vaccines, global authorities have pointed to serious adverse events (side effects) being a rare occurrence. But it’s not just about a risk-benefit analysis of a product, says a public health expert, because at the end it’s more than just a number, a life has been impacted.

India’s AEFI (Adverse event following immunisation) website lists 254 serious incidents where causality had been assessed by the National AEFI Committee (May 3, 2022). The incidents are across all Covid-19 vaccine brands given in India and reactions range from anxiety and chest pain to Guillain Barre Syndrome and death. The causality ranges from links to the product to coincidental and unclassified, among others.

Public health system

Eminent virologist Dr T Jacob John calls for an over-arching public health system where healthcare practitioners are mandated to report any observations for diagnosis, without fear of outcome. This is further investigated by another team to map disease patterns and take action. Adverse event reporting and subsequent medical management and follow-up can be built into this over-arching system, John says.

Industry-watchers point to existing pharmaco-vigilance and post marketing surveillance programmes. However, there is little support for someone adversely impacted or dying from an approved product, they admit.

S Srinivasan of LOCOST (a producer of less expensive drugs) and representative of Aidan (All India Drug Action Network) calls for a “no fault compensation” system for people affected by approved medical products or during clinical trials. This should be stated by law, he says, so affected people are not struggling to establish the causal link between the adverse event and product.

Public health programmes should be transparent and risks communicated, so people can make informed decisions, says a public health expert. Individuals affected by adverse events should have access to quality medical treatment, with no strings attached. In the case of disability or death, there should be compensation, he adds, calling for a broader discussion involving stakeholders and patient groups — so a framework is in place for the future.