In our ongoing surveys of physicians around the world, we have spotted some concerns for several physicians within India about biosimilars (the numbers will be left for a later blog post/academic article). The most obvious complaint is a simple and dangerous one – the biosmilars often did not work.
While the first biosimilar was approved in US last year, India has far more experience with the products. Indeed, the first controversy over the regulation of biosimilars was in 2001 when Dr. Reddy’s introduced a biosimilar of Roche’s Neupogen (Filgrastim). After complaints by Roche and its Indian partner, Piramal, an expert committee was constituted to examine the approval given to Dr. Reddy’s and after a detailed examination the approval was considered acceptable.
It is still unclear to me whether India even had a regulatory pathway for approving bio-similars. More than a decade after the Filgrastim controversy, India is facing yet another bio-similars controversy in a case involving approvals granted to Biocon to launch a biosimilar of Roche’s Herceptin. This time around, India does have in place Guidelines which lays down the requirements for bio-similars to enter the market. However the legality of the guidelines is highly questionable and the standards laid therein have been brought into question in the Roche-Biocon litigation. Another pressing concern however, is whether the Indian Government has done enough to amend its laws and create the long term regulatory infrastructure that is required to safely regulate bio- similars.
And given physician concern this should probably be a high priority.
Wednesday, March 18th, 2015
9:00 - 10:00 A.M.
430 Dirksen Senate Office Building
Roger Bate, PhD, American Enterprise Institute Scholar, will chair the panel, present the paper’s findings, and introduce the Safe Medicines Coalition.
Harry Lever, MD, Cardiologist, Cleveland Clinic, will discuss the ongoing problems with medicines he encounters in his medical practice.
Tod Cooperman, MD, Founder of Consumerlab.com, will share his experiences assessing drug quality and bioequivalence.
Preston Mason, PhD Cardiological Expert, Brigham and Women’s Hospital and Harvard Medical School, will discuss his scientific assessments of statin quality.
Dinesh Thakur, Whistleblower in Ranbaxy case and CEO of Medassure Corporation, will discuss how developments between the U.S. and India are affecting drug quality.
To RSVP or request more information, please contact firstname.lastname@example.org
In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada. Worse, 32 of the drugs were found to be counterfeit. All of these pacakges were entering the US illegally, so it is interesting to ask, why is there a Canadian theme—both authentic and copied by others—to the internet pharmacy business?
We recently published an article with some answers to this question – read it (here) . Canada gained a reputation for internet pharmacy when it became big business around the turn of the century (yielding about $400 million annually by 2003) when Andrew Strempler, Kris Thorkelson, and others from the province of Manitoba discovered the wealth to be made from selling prescription drugs to Americans who could capitalize on favorable exchange rates and price controls north of the border.
Reports coming out of Liberia talk of Ebola patients being “rescued”, and materials looted, from a facility in the capital Monrovia. Some of these patients and items are likely to end up in the capitals largest slum, increasing the chances that Ebola will spread rapidly through the capital.
One local police officer told the BBC: "This is one of the stupidest things I have ever seen in my life". "All between the houses you could see people fleeing with items looted from the patients." The BBC also reported that the assault on the clinic, mostly by young men armed with clubs, shouted insults about President Ellen Johnson Sirleaf and yelled "there's no Ebola".
Unsurprisingly health workers fled, this being just the latest attack on their efforts to contain the lethal virus that has so far killed roughly 55% of the over two thousand patients who tested positive.
Dr. Stefano Bonino of Durham University has just published an interesting and worrying article about the state of legal progress in the fight against poor quality medicine. The United Nations Office on Drugs and Crime (UNODC) has taken a significant interest in helping emerging nations work out how to combat the scourge of falsified and substandard medicines. UNODCs draft model laws were written by renowned expert (and contributor to this site), Professor Amir Attaran. I edited the draft at the request of UNODC, as did other experts. I was however, not invited to attend the session deliberating the draft held in Vienna from 9-11 July. It is fortunate that Dr. Bonino did attend, because UNODC is repeating a mistake made by another UN body, the World Health Organization (WHO).
The WHO is largely failing in its mission to combat poor quality medications because of the intransigence of influential member states such as India and, to a lesser extent, Brazil. As is well known to reviewers of our work on this site, India spends far more effort promoting its drug exports than in ensuring that the quality of those exports are fit for use. Any criticism of Indian drugs is assumed to be done at the behest of Western interests.
Most Americans buy medicines from overseas online medicine sellers because they are cheaper. Some of these people just don’t want to pay a “fair” amount others are simply unable to afford what they require. Proper pricing of medicines is difficult. Developing effective medicines requires years of research and even longer amounts of testing, yet for most products the cost of production is low. So pricing on average has to be orders of magnitude above marginal cost in order to recoup research costs. In principle low production costs means companies should be able to tier their prices based on ability to pay, amongst other factors. This is both equitable and efficient. See here for more details.
The US is quite unusual in allowing the market to set some medicine prices. Most other nations, such as Canada, cap prices and hence average prices are cheaper than in US – this is inefficient and overall inequitable. The products are the same and so, quite naturally, some US patients, especially those paying out of pocket, would prefer to pay Canadian or other nations capped pricing. And before internet pharmacies existed busloads of Americans went over the border to buy their medicines. Today millions do it via the web.
The Global Fund to Fight AIDS, Tuberculosis and Malaria held its fourth fundraising meeting, or “voluntary replenishment,” in Washington, DC last week. Hosted by the United States government, the meeting convened world leaders, philanthropists, luminaries and heads of private-sector outfits to pledge financial contributions to the fund to support its work over the next three years.Read More…
Rather than address directly the problems within its industry, India’s Commerce Department and drug industry affiliate groups are claiming “vested interests” are at work to unfairly undermine its reputation. “India is showcasing its best pharmaceutical manufacturing facilities to regulators from emerging economies to counter adverse publicity the country's drug industry has endured in recent times”, reported the Economic Times.Read More…
A cardiologist from Cleveland, Ohio, has come forward to question the effectiveness of drugs made by Ranbaxy, the India-based pharmaceuticals company that pleaded guilty in May 2013 to seven felonies in a case brought by the U.S Department of Justice.
Citing several cases of health issues faced by patients of his who used Ranbaxy drugs, Harry Lever of the Cleveland Clinic said that those whose symptoms were either worsening or not improving with these drugs saw significant improvement after he switched them to drugs made by other manufacturers.
When it comes to purchasing medicines from certain Indian generics companies, buyer beware. As my colleague Dinesh Thakur and I lay out in a new op-ed in the International Business Times, Americans are ingesting a large—$4.2 billion last year—and increasing volume of generic medicines imported from India. But the government of India has proven complacent at ensuring the quality of those medicines, including commissioning but then ignoring reports on the regulatory failings of the country’s pharmaceutical industry.
Earlier this year, one of India’s largest pharmaceutical companies, Ranbaxy, pleaded guilty to seven criminal charges, including falsifying clinical data and distributing adulterated medicines to the United States. As an editorial last week in the leading Indian newspaper The Hindu stated, “Until a deeper, institutional change takes place to break the nexus between drug companies and India’s regulatory regime—a change that incorporates everything from surprise checks on manufacturing facilities to greater transparency in, and policing of, drug approvals processes and clinical trials—there is a strong likelihood that Indian consumers of drugs made by these companies have poison coursing through their veins.”
Read the full op-ed here.
The Wall Street Journal released details this week of an investigation into large quantities of stolen—aka “diverted”—malaria medicines that the US government had donated to African countries through the President’s Malaria Initiative.
According to the article, the President’s Malaria Initiative has had a huge hand in reducing Africa’s malaria rate by a third between 2000 and 2010.
Our third SearchingForSafety Working Paper is published today, analyzing surveys of attitudes on medicine quality among pharmacists and their customers in Delhi. Initially conducted in 2008, we repeated a set of surveys this year and found some interesting differences.
Having worked on the fake medicines issue for a number of years, it came as a surprise that the issue is reaching the mainstream, which is what happened at London’s Chatham House recently when the issue of poor quality medicines was presented to an audience of international affairs analysts.
Panel member Professor McKee gave an overview of ‘falsified’ medicines – suggesting the solution was to strengthen national regulation through advice and support, improve intelligence and enforcement of criminal activities, especially organised crime – but he fears that money will not be found to support public health.
A decade ago, half of Nigeria’s medicines were fake or substandard. Today, it’s less than 15 percent, based on a new study I’ve published today with Paul Orhii, Head of NAFDAC (Nigeria’s health regulator), and others.Read More…