Web pharmacies: A field study of ciprofloxacin and atorvastatin

By Roger Bate

244 treatment packs of the broad spectrum antibiotic ciprofloxacin and 198 treatments of cholesterol controlling atorvastatin were sampled from a stratified sample of 61 web pharmacies. Each sample was analyzed for active pharmaceutical ingredient content (API) and 18 of 442 (4%) were found to be grossly (less than 80%) under content (11 cipro and 7 atorvastatin). Most of the 18 came from non-certified sites, but two came from certified sites. None of the failures appeared to be a falsified medicine (packaging appeared correct and contained over 50% API). All failures were made by Asian manufacturers (12 Indian and 6 Chinese). All the failures regardless of source are a risk to patient health. For Cipro they could also accelerate population level resistance to this crucial antibiotic. Read More…

New Paper: Assessment of Medicine Quality in Emerging Markets: The changing face of inferior medicines over time.

Roger Bate

In this analysis of all our previous data, a substantial minority of medicines to treat infectious diseases in emerging markets are of suspect quality, at least 13.5% of over 10,000 samples. This is a risk to patients and threatens to accelerate drug resistance. The two main types of inferior medicines are counterfeit or falsified medicines and substandards. As efforts against fake medicines have increased over the past decade, the rate of such products has fallen in our samplings. The international community and domestic regulators must improve efforts against substandards, just as they have against falsified medicines, if quality is to improve further. Read More…

New Study: ciprofloxacin

Roger Bate

244 treatment packs of the broad spectrum antibiotic ciprofloxacin were sampled from a stratified sample of 61 web pharmacies. Each sample was analyzed for active pharmaceutical ingredient content (API) and 11 (4.5%) were found to be grossly (less than 80%) under content. Most of the 11 came from non-certified sites, but two came from certified sites. None of the failures appeared to be a falsified medicine (packaging appeared correct and contained over 50% API). All failures were made by Asian manufacturers (7 Indian and 4 Chinese). All the failures regardless of source are a risk to patient health, and could accelerate population level resistance to this crucial antibiotic.  

Link Read More…

New Paper: Medicine Quality in Emerging Markets: Measuring the problem

Roger Bate

A new paper from the SMC team is published this week PDF and Link  in the peer review journal Internal Medicine Review.  It shows that when our previous research has underestimated the amount of substandard medicines on the market in emerging nations. We therefore hope that nations take the problem more seriously than previously.

Substandard heart medicines across Africa

Roger Bate
 
Most of the research on medicine quality in Africa has focused on antimicrobial medicines. We have looked into medicines to treat bacterial infections, malaria and tuberculosis in particular, however, a new PAPER across 10 francophone African nations looks at seven cardiovascular medicines and it makes for worrying reading.

One of the medicines (amlodipine) failed 28.5% of the time, others failed far less often, however, for four nations, including Benin, Niger, The Democratic Republic of the Congo and Congo-Brazzaville, over 20% of all medicines failed.

One wonders how many heart problems and deaths have been caused by these substandard medicines.

New Paper: The Risks and Benefits of the Online Pharmacy Market

Roger Bate

Summary
Perhaps five percent of American adults purchase medicines from online pharmacies. This amounts to millions of people who are looking for convenience and cheaper prices, spending well over a billion dollars a year.

Safety is probably the most important issue involved in buying medicines online. Websites can sell fake medications while stealing consumers’ identity.

Over the past decade my research team has purchased drugs from online pharmacies, each time evaluating the processes, products, sites and those who credential them.

While the US Food and Drug Administration does not certify online pharmacies, it funds one of several third-party organizations that do. We found that credentialing of sites was the single most important determinant of whether the site was likely to always sell good quality medicines. Credentialed sites, whether in US or overseas, sold us good quality medicines. Some non-credentialed sites sold us fake medicines.

From a policy standpoint these findings conflict with what the pharmaceutical and pharmacy industries would want. Both maintain that buying from outside the US is dangerous and that one can only be safe buying FDA-approved US-sourced medicines. The result is obfuscation and misleading statements from both industries and their respective front organizations. This is harmful to both patients and the reputations of both businesses.

The FDA overseas drug quality and tells consumers it is illegal to personally import medicines into US. But on its websites, it acknowledges what nearly everyone who buys online knows to be true, that if you import less than 90 days supply of medicine for personal use the law is not enforced.

FDA does not have jurisdiction of overseas sites and hence cannot actively support them, but it could at least discuss the evidence on credentialing that is in the peer review literature. To not do this is a detriment to its goal of helping US patients access good quality affordable medicine.

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Consumer understanding about dangers of inferior medicines

Roger Bate

Since we first worked with RxRights, a group to help underinsured Americans access cheaper medicines, we have undertaken occasional consumer surveys to understand where consumers get their information about medicines, where they buy those medicines and how they assess medicine quality. We use a mixture of surveymonkey online surveys and directly administered surveys. Read More…

Working Paper: Pilot Assessment of the Quality of Ciprofloxacin in selected Latin American Cities

Summary
Ciprofloxacin was sampled from pharmacies in ten Central and South American cities. At least six per cent of the medicines are substandard or falsified. Sao Paolo, Buenos Aires and Montevideo have very few substandard or falsified medicines, whereas Asuncion and Caracas had considerably more. There are possible explanations for this, such as the latter cities having more unregistered products sold in pharmacies, but this is only a pilot study, without detailed analysis of the possible socioeconomic and legal causes. The study also only assesses a few cities and one medicine, a more detailed assessment would be useful to guide policymakers as to how to respond to this public health menace.
Paper Link Read More…

New empirical study supports anecdotal reports that some Indian companies send inferior medicines to Africa

By Roger Bate

A new peer review study by SMC authors is available this week - Paper. The paper in the American Journal of Health Economics is officially published on 20th July, but the correct proofs are now available (link to attachment). For those without the time to read the entire paper, read my summary published on the RealClearHealth news site - Summary Read More…

Fact Sheets for Physicians

By Roger Bate

Since we started asking physicians about the quality of medicines their patients use, we have received numerous requests from many of those physicians to provide information on the quality of medicines, especially Indian-made medicines.
Here (link) you can see the fact sheet that we have started to distribute to physicians. We will update this with details from the surveys when they are completed in the fall. Read More…

Concerns about Biosimilars in India

By Roger Bate


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.

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Indian Drug Quality - the case of Ipca

By Roger Bate

By now readers of this site, and my writing in particular, will know that criticism of Indian pharmaceuticals and their makers is a regular occurrence. And this post is no different – well sort of. Ipca is a large Indian company that makes a wide variety of products. I know the company best for the antimalarial product it makes, a version of a fixed dose artemisinin combination therapy (ACT), the best antimalarial on the market. It is one of fewer than ten producers approved by WHO and stringent regulatory agencies. Over one hundred million treatments of this medicine are used every year, saving many tens of thousands of children’s lives and shortening the suffering of millions from this age old scourge.

But earlier this month Christopher Game of the Global Fund for AIDS TB and malaria, announced it would no longer buy Ipca’s ACT. The Global Fund is the largest purchaser of these medicines, and so the decision probably has significant short run costs for Ipca.

What is interesting is that the main reason Mr Game gave for not buying their product was the recent warning given to Ipca by US Food and Drug Administration about entirely different products sold into USA. Mr Game said the Fund would only procure from buyers with “no outstanding issues with regulators”.

It does appear that Ipca misled FDA about data integrity issues, and lying to regulatory agencies throws into question the trustworthiness of the company, and for this Mr Game’s response is both timely and fair. But this policy opens the Fund up to potential problems. After all many companies often have disputes with regulators. At any moment there are dozens of companies in dispute with FDA, will the Fund act so aggressively against other companies?

The other interesting thing to note is that Ipca’s ACT never failed any quality control tests as far as I know. The several dozen samples we tested in our routine assessments over the past few years all passed basic quality tests. And some of those that are still approved by Global Fund failed our tests - the sample sizes for some of these products was small. It is interesting conundrum; a valuable product that is often in short supply that has not failed any tests is withdrawn when perhaps inferior products remain.

As more information arises I will revisit this subject in later posts.

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Physician concerns about medicine quality - India

By Roger Bate

The Safe Medicines Coalition is undertaking surveys of physicians in different cities in the world to ascertain knowledge and concern about inferior medicine quality. The first survey results were from Africa and were reported here. Today we report the summary statistics for three Indian cities, Delhi, Chennai and Kolkata. Forty general physicians from these cities were surveyed. Some questions do not lend themselves to statistical compilation, so they are left blank in table 1 below.

Overall the results are “better” than for Africa. Fewer doctors have encountered as many problems with medicines and generally there is more trust in the systems in place. However less than half of the physicians in Chennai (45%) thought the regulators did a good job. Kolkata and Delhi had better results in this regard, perhaps the local regulators do a better job in those states than in Tamil Nadu. As in Africa, many physicians are still worried that the regulators are letting inferior products on to the market, which isn’t surprising given the poor quality of medicines we occasionally found in our surveys.

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Physician concerns about medicine quality

By Roger Bate

The Safe Medicines Coalition is undertaking surveys of physicians in different cities in the world to ascertain knowledge and concern about inferior medicine quality. The first survey results from Africa are in and the summary statistics are below. 40 general physicians from the cities of Nairobi in Kenya, Lagos in Nigeria and Dar Es Salaam in Tanzania were surveyed. Some questions do not lend themselves to statistical compilation, so they are left blank in table 1 below. Over the next few months, we will release data from the surveys in both summary and more detailed form.

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Antibiotic Resistance in India: Drivers and Opportunities for Action

Ramanan Laxminarayan and Ranjit Roy, Chaudhury have an interesting paper in PLOS Medicine this week about antibiotic resistance in India which can be found here


Summary Points
  • Antibiotic use is a major driver of resistance. In 2010, India was the world’s largest consumer of antibiotics for human health.
  • Access to antibiotics is rising, which portends well for the large proportion of India’s population that has thus far had poor access to these life-saving drugs.
  • The convergence of factors such as poor public health infrastructure, rising incomes, a high burden of disease, and cheap, unregulated sales of antibiotics has created ideal conditions for a rapid rise in resistant infections in India.
  • Over-the-counter, nonprescription sales of carbapenems in India are among the highest in the world and contribute to growing carbapenem resistance among Gram-negative organisms.
  • Improving regulation of drug production and sales, better managing physician compensation, and encouraging behavior change among doctors and patients are of immediate priority.
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FALSIFIED OR SUBSTANDARD? ASSESSING PRICE AND NON-PRICE SIGNALS OF DRUG QUALITY

The Journal of Economics and Management Strategy recently had a Q&A session with Roger Bate, Ginger Zhe Jin, Aparna Mathur on Falsified and Substandard Medicines. You can read the link here or click read more below. Read More…

Substandard drugs cheaper than generics they copy: peer review findings - Roger Bate

The Journal of Economics and Management Strategy has published our paper (Link), the first to statistically prove that substandard medicines are cheaper than the generics they copy. This is useful since it means that regulators (especially in emerging markets) can target more precisely the parts of the market likely to exhibit such problems. As predicted fake products are passed off at nearly identical pricing to the generics they copy, so market signals are not helpful in finding fakes.
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Substandard TB drugs probably accelerating resistance - Roger Bate

The World Health Organization released details today that tuberculosis now kills more than HIV/AIDS – approximately one and half million people every year. And the largest worry is that drug resistance versions of medicines to treat TB are becoming more common and deadly. This is a major risk for emerging nations and a costly one for richer nations, where quarantining patients is incredibly expensive.
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Government wants to grade drugmakers, but keep grades secret

In July, the FDA announced it intends to require four types of quality metrics from pharmaceutical manufacturers and three optional ones. It held a meeting to get industry feedback on the metrics on Monday. 

Roger Bate spoke to the virtue of revealing these metrics to doctors and consumers.
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Indian drug company recalls drugs from US market

Poor regulation has led to the recall of several major drugs distributed by Dr. Reddy's Laboratories used to treat hypertension and seizures. The Indian drug manufacturer has recalled these drugs due to their failure in several dissolution tests and their proximity to expiration. Read More…

Generic A.D.H.D. Drug, Not Equivalent to the Brand, Is in Use Anyway

When Dr. Louis Kraus, a chief of child psychiatry at a hospital in Chicago, writes prescriptions for patients who have attention-deficit hyperactivity disorder, he often chooses Concerta, an extended-release form of the drug Ritalin that gives patients relief from their symptoms for as long as 12 hours.

He was unconcerned when, a few years ago, pharmacies began substituting lower-cost generic alternatives for brand-name Concerta — after all, generic drugs are widely seen as effective and account for the overwhelming majority of prescriptions filled nationwide.

His feelings changed last November, however, when the
Food and Drug Administration announced that two of the three available Concerta generics, one made by Mallinckrodt Pharmaceuticals and the other by UCB, could no longer be considered the equivalent of the brand and, in most states, could not be automatically substituted by pharmacies for the brand name. Read More…

India’s Generic Drug Industry Has a Maggi Problem

India’s favorite comfort food, Maggi two-minute noodles, is mired in scandal. It all began in late May, when state-level regulators in Uttar Pradesh announced that they had found trace elements of lead — 17.2 parts per million, or at least seven times the allowable levels — in samples of the popular product from across the northern state. Other states, including Delhi, also claim to have found elevated levels of lead in Maggi noodles; samples in states such as Maharashtra and Kerala and Goa, meanwhile, came back clean. Singapore, which had initially asked importers to pull Maggi noodles, has now allowed sales to resume after its food regulator cleared it.

Nestlé India, which 
claims to have conducted its own tests on more than 1000 samples and found them safe, denies the claims of elevated lead levels. It asserts that all of its products are safe. What’s more, no one has fallen sick or died from consuming Maggi products. Still, on June 5, the company issued a nationwide recall. So far, neither Nestlé India nor Indian authorities have been especially forthcoming with details on their testing methodologies or information on the quality of the labs they used. Read More…

Stemming the Tide of Fake Medicines

OP-ED ON THE NEW YORK TIMES:

A flood of fraudulent medicines sold mostly in the developing world is threatening the health of hundreds of thousands, if not millions, of people in those nations and consumers in more advanced nations as well.

International organizations, national drug regulators and the drug industry itself have been struggling for years to curb sales of phony or poorly prepared medicines. But articles in a special issue of the American Journal of Tropical Medicine and Hygiene, published online last month, show that efforts to control this problem have had only modest success over the past decade.

The number of outright fakes — pills containing no active ingredients at all — may have declined. However, the problem of
substandard medicines that have some, but not all, of the active ingredient they are supposed to contain has worsened. Sometimes a medicine degrades because it has not been stored or handled properly. But often the manufacturer deliberately reduces the amount of active ingredients to save money while increasing inert ingredients to keep the weight and shape the same.
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Nick Basta's Review of FDA OIG Report

HHS OIG confirms better FDA inspection performance for generics manufacturers
May 08, 2015

But is bioavailability sufficiently monitored by FDA for generic products on the market?
 
Dating back to the FDA Safety and Administration Act of 2012 (FDASIA), Congress had taken a more critical look at FDA inspection practices generally, and the specific problem of fewer inspections of manufacturing sites outside the US than inside it. A 2010 GAO report had found that 40% of domestic manufacturers had been inspected, but only 11% had been during 2007-2009 (not all manufacturers have to inspected all the time; and since then FDA has instituted a risk-based evaluation process to target certain sites). Now, HHS’ Office of Inspector General has found that FDA is getting closer to parity in US/non-US “surveillance” (routine) inspections; in FY2013, 57% of inspections were of non-US facilities. However, the parity based on risk evaluation is still to be met, as well as comparable “depth and rigor” of the inspections.
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WHO to ignore powerful producers of substandard medicine

The World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began a few years ago. But the reality is that this interim report does not advance the effort far and instead of reporting to, and demanding action at, the World Health Assembly this coming May, it has postponed doing so until 2017.

Perhaps worst still one can see the hands of the usual suspects in this interim report – notably India. It should be remembered that India was the reason that the anti-counterfeit IMPACT initiative of WHO was scuppered a few years ago. It’s not that the Indian government wants the world flooded with inferior medicines, but it doesn’t want anything that will undermine the rapid growth of its generic drug industry, some of whom play fast and loose with the rules on drug manufacturing. Read More…

Not all generic drugs are created equal: Why FDA, NIH and Congress need to protect Americans

OP-ED Posted on Fox News

Blockbuster brand-name drugs may make the headlines, but generics rule our nation’s medicine cabinets. Over 80 percent of America’s drug supply is now generic. And the rapid rise of these treatments is partially attributable to the laws governing dispensation: pharmacies are legally allowed to swap in low cost generics for their relatively pricier brand name equivalents.

Such substitution rests on a simple assumption: brand names and their approved generic alternatives are chemically equivalent, operate the same way in the body, possess the same therapeutic powers and run the same health risks.

Read More…

FDA Should Follow Europe's Lead on Indian Drug Suspensions

OP-ED ON THEHILL.COM

Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between July 2008 and 2013."

U.S. Federal regulators should follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. In the past, when the US FDA discovered similar fraudulent behavior, it advised patients to continue to take drugs of questionable quality while restricting their further import into the country. This approach provides a fig leaf to the manufacturers in question; they use it to justify their business while the FDA gives them time to take corrective actions. Unfortunately, this approach hasn’t provided the results that the FDA had hoped for. A cursory review of the inspection results of manufacturing facilities in India continue to identify behavior that the FDA calls “data integrity”; in layman’s terms this means that the FDA found the manufacturers continue to try and cheat the agency to secure approvals to sell their products in the US.
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Capitol Hill Briefing - March 18th

Link to Paper

Can We Trust Our Medicines?

The authors of a new working paper will address the ongoing challenges of maintaining high quality standards for America’s drug supply. They will analyze how questionable standards of assessing bioequivalence has cast doubt on the efficacy of many medicines available in the U.S. marketplace, and how dangerous imports are even undermining our safety. They will expose these problems and explore possible solutions.

Wednesday, March 18th, 2015
9:00 - 10:00 A.M.
430 Dirksen Senate Office Building


Panelists
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 info@safemedicinescoalition.org

FDA should follow Europe’s lead on Indian drug suspensions

Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between
July 2008 and 2013."

U.S. Federal regulators should follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. In the past, when the US FDA discovered similar fraudulent behavior, it advised patients to continue to take drugs of questionable quality while restricting their further import into the country. This approach provides a fig leaf to the manufacturers in question; they use it to justify their business while the FDA gives them time to take corrective actions. Unfortunately, this approach hasn’t provided the results that the FDA had hoped for. A cursory review of the inspection results of manufacturing facilities in India continue to identify behavior that the FDA calls “data integrity”; in layman’s terms this means that the FDA found the manufacturers continue to try and cheat the agency to secure approvals to sell their products in the US.
Read More…

Canada: A Haven for Internet Pharmacies and Organized Crime

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.

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From Ebola to Medical Fraud: Ignorance is never bliss

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.

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UNODC Failing to Tackle Substandard Medicines

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.

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UN Draft Law Against Medicine Crime is Fatally Flawed

ARTICLE ON THECONVERSATION.COM

A new legal template for fighting medicine crimes around the world is being developed by the United Nations. The first 39-page draft of the document was unveiled at a meeting in Vienna last month.

The aim of the proposed “
model law” is to address the dangers of medicines that have been criminally falsified, often because they contain no active ingredient, and substandard medicines that have been recklessly made because drug manufacturers have cheated or cut corners.

Counterfeit medicine, which counts as brand or trademark theft, was originally excluded from the proposal on the recommendation of Amir Attaran, law professor and lead consultant to the UN Office on Drugs and Crime (UNODC), because it is widely seen as coming under intellectual property law – a matter usually dealt with by the World Trade Organization. Unfortunately, UNODC came up with
different draft provisions that criminalise all sorts of medicine fraud, including counterfeiting trademarks.
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Designing a Global Coalition of Medicines Regulators

COUNCIL ON FOREIGN RELATIONS: POLICY INNOVATION MEMORANDUM

Globalization has transformed the marketplace for medicines in recent decades, giving rise to new threats including the poor traceability of global supply chains, counterfeit and substandard medicines, and antibacterial resistance. Aware that public drug authorities must cooperate to meet the emerging challenges of modern medicines regulation, the U.S. Food and Drug Administration (FDA) has been discussing with counterpart agencies abroad creating a "global coalition of regulators." Yet a coalition alone is not enough; the devil, as always, will be in the details. In pursuit of this goal, the FDA and partner medicines regulatory agencies should design a coalition with five distinct features:
narrow scope, to promote realistic goals; flexibility, to adapt to future circumstances; selective membership, to maximize like­-mindedness, particularly in the early stages;nongovernmental (NGO) participation, to leverage the capacities of both NGOs and for-profit corporations; and institutional partnerships, to orchestrate the activities of other regulatory organizations. Read More…

Drug Pricing: The root cause of the internet pharmacy debacle

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.

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Another Voice: India's Drug Laws Are Obsolete

We have often noted on this blog and in a recent working paper that India's medicine safety laws are atrociously obsolete, and a menace to global public health (although principally a menace to Indians' own health).  This is hardly open to controversy: after all, India's Drugs and Cosmetics Act is a 1940 law, and the Drugs and Cosmetics Rules are dated 1945.  Both are colonial laws that precede India's independence in 1947.  Although Indian legislators have floated amendments over the years, none has truly brought the laws up to date, and all have been band-aid measures that were outdated even before they became law.   Read More…

Global Fund and IFPMA Announce Partnership Against Fake Medicines

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.

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India's Ostrich Drug Policy

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. 

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U.S. doctor questions effectiveness of Ranbaxy drugs

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.

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India's Dangerous Drug Problem

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.

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Large-scale Theft of Malaria Medicines Donated by President’s Malaria Initiative; Global Fund Inspector General Increasing Efforts to Battle Theft and Falsification of Medicines

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.

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Surveying Delhi Pharmacists and Customers on Attitudes Toward Medicine Quality

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. 

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Parsing counterfeit and substandard medicines with the experts

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.

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Time For a Global Treaty To Protect Patients Against Fake and Substandard Drugs

This post comes to us from Dr. Paul Orhii, Director General of Nigeria's National Agency for Food and Drug Administration and Control, and Roger Bate, Adjunct Scholar at the American Enterprise Institute.

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.

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VIDEO: Roger Bate - Phake

Roger Bate speaks at the American Enterprise Institute on the crisis of counterfeit drugs in the developing world.

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