Three days after at least 27 of 30 patients injected with the drug Avastin got an infection, which can potentially lead to vision loss, the Post-Graduate Institute of Medical Education and Research (PGIMER) suspects the local chemist who supplied it may be responsible for the infection. The institute’s medical superintendent (MS) will file a complaint to the Drug Controller General of India for inquiry, he said on Friday.
“Since 2007, we directly buy Avastin (popular brand name for bevacizumab) from the manufacturer (Swiss firm Roche). This was the first time (in nine years) that, due the delay in supply from Roche, the purchase committee bought the drug from a local chemist,” the MS, Dr AK Gupta, said. “A major issue is the availability of spurious drugs in the market,” said Dr Ramandeep Singh, eye specialist at the PGIMER.
An officer from the PGIMER administration said on the condition of anonymity, “Following the set process, we sent a request to the hospital dispensary, which purchased the drug from Kumar and Company with whom the institute has a rate contract. The purchase was made this month.” Later, stock from Roche too came.
The chemist in question is Kumar and Company, whose owner Vinod Singla argued, “We are traders, not the manufacturers of drugs. How can I comment if any batch of a drug has caused infection? My job is to sell drugs. The manufacturers or the dealers should be questioned.”
All the patients, meanwhile, are improving, said Dr Vishali Gupta at the Advanced Eye Centre, PGIMER. “We are observing them on an hourly basis, and there is progress. We are giving them antibiotics and 12 have undergone surgery to cure the inflammation. It will take 4-5 days for them to be fit to leave hospital,” she added, but said she could not comment on the possible damage.
Though a cancer drug, Avastin is used by eye doctors across the world to treat two problems — macular degeneration, due to which you can lose visual ability to an extent, or completely; and diabetic retinopathy, which can make you irreversibly blind.
At the PGIMER, more than 30 people are administered Avastin every day, it is learnt. It costs Rs 1,500 per injection. “Hardly two patients a day go for the more expensive Lucentis drug costing Rs 23,000 per injection,” said Dr Ramandeep Singh, another specialist of eye treatment at the institute. Before this week’s incident, no patient faced side-effects, said doctors.
What went wrong this time?
In all, 30 people were given the injection in their eyes on July 12. “The Avastin bottle (batch number B7034B02) had the bacterium stenotrophomonas maltofilia growing in it, which led to the infection,” said Dr Vishali Gupta. This is a multidrug-resistant bacterium, which if not timely treated can lead to blindness.
The next day, three patients reported with swelling. The doctors then called all 30 patients, of which 27 reported with redness, pain, swelling and blurry vision. They are now being treated and the other three are being traced since the institute believes they too would have got the infection.
What’s this drug? Docs call it magic, maker says not meant for eyes
Even after it caused infection to at least 27 eye patients at the PGIMER, doctors believe Avastin, a cancer drug also popularly used for two eye ailments, is “magic” and the best affordable drug for the purpose. But the maker, Switzerland-base firm Roche, disagrees. Its spokesperson replied to HT over email, saying: “The safety of patients is always our priority and we are treating the event in Chandigarh relating to the off-label use of Avastin (bevacizumab) in the eye very seriously. Avastin is an important cancer therapy... We would like to reiterate that [it] has not been approved for use in the eye by the US FDA (Federal Drug Administration), EMA (European Medicines Agency) or the Government of India.”
But former director of the PGIMER Advanced Eye Centre, Dr Amod Gupta said, “For the two diseases of eyes, there is no other affordable alternative. It’s Ram-baan (Lord’s weapon). If you believe in magic, this is it!” For instance, while Avastin costs Rs 1,500, an alternative Lucentis for the eye ailments costs Rs 23,000 per injection. “Countries will go bankrupt if they have to spend several hundred thousand crorers on each patient per month. No economy in the world can afford such expensive medicines,” he said.
“We will continue to use Avastin unless we have orders against it from higher authorities,” said Dr Ramandeep Singh, another specialist of eye treatment at the institute. Dr Vishali Gupta too said there is nothing wrong with the drug and “it was never banned”. “An alert was issued by the drug controller that it should be used with caution for eyes, but that was withdrawn.” For the two diseases of eyes, there is no other affordable alternative
But the Roche spokesperson further said, “Roche respects the right of physicians to make decisions... We will continue to make them aware of the known risks [of using Avantis in the eyes]... [It] has neither been developed nor manufactured according to the quality standards for drugs to be injected into the eye.”
From a stop to a withdrawal in 2 months
On January 21 this year, Drug Controller General of India issued an alert as precautionary measure asking states to ensure bevacizumab (medical name of Avantis), a cancer drug, is not used for eye treatment. The alert came after its use hampered vision of 15 patients in Gujarat. The next month, a committee was formed to examine the issue, and on its recommendations the drug regulator withdrew the alert on March 13.