By Divya Rajagopal, The Economic Times | May 23, 2017
MUMBAI: Remember Ron the rodeo cowboy from the Oscar-winning film Dallas Buyers Club? The biopic portrayed the story of Ron Woodroof, an AIDS patient in the mid-1980s who signed up for an experimental AIDS treatment movement. He smuggled unapproved drugs into Texas for treating his symptoms and distributed them to fellow patients at a time when the disease was highly stigmatised. There’s now an Australian parallel, of sorts, with an Indian twist.
Australian Greg Jefferys, 62, is the unlikely protagonist of this story. Himself a Hepatitis C survivor, Jefferys has become a Ron for several who suffer from the potentially fatal viral infection. And just like Ron, who didn’t back off in the face of resistance from US regulators, Jefferys’ crusade has been equally relentless.
Together with fellow Australian, Dr James Freeman, Jefferys seeks to provide Hep C patients affordable versions of newly discovered drugs Sofosbuvir and Daclatasvir, which have a 100% cure rate in treating the liver disease. By doing so, the duo’s global coalition has become an unlikely ambassador for India’s generic drug industry, even when as it’s facing unprecedented flak across developed western markets for failing quality standards.
That’s where Freeman and Jefferys come in. They are reaching out to patients in Europe and beyond, trying to convince them to use generic versions. Their endeavour has turned out to be an underground startup of sorts that connects patients and doctors to generic drug suppliers in India, this gaining access to low-cost versions.
“There is very little mainstream coverage of the success of Indian generics in the US and other parts of the world, because of which you still have doctors who refuse treating their patients with generic drugs,” Jefferys told ET during his latest trip to Mumbai. “There is ignorance on part of patients, and prejudice on part of doctors about generic drugs.”
At full price, the medicines can cost as much as $80,000 for a full course. Generic versions are available for a fraction of that in India. Of course, these cheaper versions are meant for sale locally and in poor and developing markets. But even in the developed world, there are many who can’t afford these drugs.
This has far-reaching implications since doctors are refusing to prescribe or monitor patients, “even telling patients not to come back if they have taken generics,” he said.
Jefferys visits India at least thrice a year to buy drugs for needy patients. He’s aware of the international laws on such unofficial “imports” but knows enough about the rules to keep from breaking them as his services are “not for profit”.
“This is an indirect response to the exorbitant prices put on life-saving drugs,” said Leena Menghaney a lawyer working on the issue of access to medicines. “The buyers club is one of the responses to this issue.”
Governments across the world need to ensure access to affordable treatment so that patients do not have to travel long distances to get cheaper drugs, she said.
Tasmania-based physician Freeman started the FixHepC blog when he realised the cost of treatment was beyond the reach of patients even in a wealthy country like Australia.
He realised that generics was the only option to make these drugs accessible. His blog is a source of invaluable guidance for patients who discuss not just how to get medicines, but tips on monitoring the disease and recovery stories.
Freeman is doing what the Indian companies aren’t. At the European Association for the Study of Liver (a global conference on liver diseases) in April, Freeman and his researchers presented a paper on the effectiveness of generic drugs in treating Hep C patients. His study had looked at 1,000 trial patients who were cured using generic Sofosbuvir.
“India has ‘the scientist’s problem’. Scientists believe that the facts speak for themselves. Businesses understand that the facts do not speak for themselves, they must be advocated for,” he told ET in a Skype call from Tasmania.
“India, where the margins are much smaller than the US, must be far more creative with the use of marketing dollars. It does a poor job, not even doing simple things,” Freeman added.
He said he’s frustrated with what he regards as the fundamental mistakes that Indian companies make, from poor packaging to not publishing bio-equivalence (BE) data even when they exist. A BE study determines whether two medicines have the same effect on patients and is irrefutable proof of quality.
His second criticism is that Indian generic makers do not publish trial results of their generic drugs at international conferences, which are also huge marketing opportunities. Sensing a vacuum, a new generation of drug makers in Egypt and Bangladesh are seeking to move in on India’s role as “pharmacy to the world”
SURVIVING A SCARE
In 2014, Jefferys discovered he was infected with the Hep C virus. Luckily, US drug maker Gilead had announced that it had found a cure for the disease.
But it was priced at $80,000 for a course of treatment, making it impossible for patients like Jefferys to afford. That is when he heard about the licensing agreement between Gilead and Indian generic drug makers allowing them to sell the drug for $1,000 in nearly 90 low-income countries, including India.
What started as “medical tourism” to India turned into a social mission for him as he became the go-to person for patients who wanted cheaper Hep C drugs. Before he knew it, Jefferys had created a buyers club, helping patients buy generic versions of Sofosbuvir. In his personal blog, Jefferys documents the entire process of accessing the generic version to generating a prescription from doctors, to reaching out to a trusted supplier in India to buy the drugs in great detail.
Jefferys might not have the panache of a Matthew McConaughey but says he’s sincere about his “business model”, which involves even helping out ‘competitors’ or others who want to do the same thing. As one of the most publicised Hep C patients, his next challenge is to create greater awareness of generic options to those looking for affordable treatment. “There are still people who don’t know that such an option exists, and there are still patients who do not want to go for Indian companies,” he said.
ET View: Overhaul Regulation
India does have the potential to be the pharmacy of the world. But we do need to overhaul our hugely fragmented regulatory framework. With as many as 36 state and Union territory licensing authorities, a pharma manufacturer can well garner a licence in one state and distribute its product nationally. But any laxity, say, a batch that is Not of Standard Quality (NSQ) drug can have national and even international repercussions. Yet we have no mechanism to ensure nationwide withdrawal of a bad batch once it is established as being NSQ in a state, as per a report by Dinesh Thakur, Ranbaxy whistleblower and activist.