Posted by Roger Bate
As I argue in a piece on RealClearPolicy.com today, the FDA is being far too aggressive in its condemnation of a small but important piece of research conducted by Harvard’s Preston Mason. At the root of the problem is the dirty little secret of the FDA. They don’t really test the approved medicines on the market in the US. FDA pays a great deal of attention to approving new products, and in conducting inspections of plants for existing products. But it probably only tests a few hundred samples of products on the US market every year. It relies on the honor system - once it has established that a company can produce a medicine properly, the assumption is that it always will. But anecdotal evidence from US doctors, and systematic evidence of fraud from some exporting companies to US, indicates that perhaps the system is broken. Rather than sober reflection and more random drug sampling to establish how bad the problem might be, the FDA is lashing out at anyone who dares to say the generic drug emperor might be missing some clothes. This could be the beginning of a very ugly fight.
Posted by Roger Bate.
The Indian Government’s Health Ministry is shooting the messenger, again. Over the past year evidence has mounted that India’s drug regulator is both corrupt and incompetent and that Indian drug companies have taken advantage of this to make substandard medicines.
The latest twist shows the Health Ministry praising India’s democratic system for publishing reports on its regulators many failings, and then attacking critics for echoing those same criticisms.
India sees this as a political spat with malign intent from America and others, rather than a massive problem of its own making.
US FDA has to realize that it is not dealing with a like-minded bureaucracy but a hugely politicized Drug Industrial complex. Don’t expect India to improve its regulatory environment anytime soon.
Posted by Amir Attaran.
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.
It is lamentably accurate to say that India's approach to drug safety is stuck in the last century, and like a vintage car, it is quaint but dangerous.
We are not alone in this point of view. A recent paper in The Lancet by Peter Roderick and colleagues is starkly entitled "India Should Introduce a new Drugs Act". These scholars also criticize India’s too-little-too-late approach to amending its ancient laws, and we can do no better than to quote them:
“When examining India's drug laws, several conclusions stand out. First, the current Drugs and Cosmetics Act is old and deficient. The core primary legislation presently regulating drugs was passed in 1940 and has been amended at least ten times. It contains no duty on the regulator to be satisfied about the safety and effectiveness of a drug before marketing. This duty was only introduced for new drugs in secondary rules in 2001… India has badly drafted and weak rules on clinical trials, which were weakened further in 2005… The Drugs and Cosmetics (Amendment) Bill 2013 fails to provide a rigorous foundation for putting effectiveness, safety, rationality, and need at the heart of India's drug regulatory system. Indeed, it does not even attempt it. Rather, it is another patch on the 74-year-old, pre-Independence Act whose structural design has arguably been stretched beyond breaking point.”
Yet despite these facts, partisan apologists for India's sub-par drug industry like Anne Roehmer-Mahler or DG Shah continue to perceive that anyone urging action on improving drug quality standards has an ulterior motive, be it to place barriers before India’s pharmaceutical industry, or to boost intellectual property protection. To such persons, it is as if honest criticism of deficient safety laws is impossible, and there must always be a hidden agenda somewhere. Perhaps if they won’t believe us, they will believe what people unconnected to us published in The Lancet.
Posted by Roger Bate
The Economist has joined the increasing number of publications covering the problems within India's pharmaceutical industry. Notably, the authors notably cite our research:
"India’s efficient manufacturing has made drugs available to millions who could not otherwise afford them. Many Indian medicines remain of the highest quality. But too many are not. Roger Bate, of the American Enterprise Institute and the author of “Phake: The Deadly World of Falsified and Substandard Medicines”, studied more than 6,000 drug samples across Asia and Africa. Of these, nearly half were made in India and many were either degraded or contained too little active ingredient. The best solution would be to improve oversight not just by American regulators, but Indian ones."
To this end, today my colleagues Dinesh Thakur, Amir Attaran and myself publish our sixth S4S working paper, on the interactions between India's drug industry, India's regulator and the US Food and Drug Administration and how these interactions could be improved.
Margaret Hamburg, the head of USFDA, has just finished a visit to India where she tried to negotiate improvements to the existing relationships between her agency and those of the Indian government, in order to increase safety of US patients. We discuss her proposals in our paper. Unfortunately she is not negotiating with like-minded regulatory colleagues. India does not treat regulatory standards seriously, and assumes any interference by FDA is an attempt to undermine Indian sovereignty and India's generics industry. As a result there seems little chance that India will entertain her honest attempts to improve safety.
Sooner or later, the US Government will realize it requires a better strategy to deal with India. Until that time, drug quality will not improve.
Why Congress should lead in protecting the safety of patients worldwide.
Time: February 26th, 2014 at 8:30am
Location: Capitol Visitor Center, Congressional Meeting Room North
In May of 2013, Ranbaxy – one of India’s largest drug makers – pleaded guilty to seven felonies related to its quality-control problems, yet the company continues to export billions of dollars of drugs worldwide. Last month, another one of its plants was deemed unfit to export medicine to the United States.
With the United States importing more drugs from India than anywhere else in the world, the quality of its pharmaceuticals is a pressing public health and safety concern for all Americans. Congress has a responsibility to investigate just how reliable are India's drugs.
Please join us for a briefing and discussion on the threat of substandard and falsified medicines with a focus on India’s quality control failures. Dr. Roger Bate, an expert on substandard and falsified medicines, will moderate an expert panel to provide first-hand knowledge of these threats and actionable recommendations for policymakers. Bate is a scholar at the well known Washington, D.C. think tank, the American Enterprise Institute.
Our expert panel includes:
· Dinesh Thakur, a former Ranbaxy executive and the whistleblower in the Ranbaxy case, will give his insights from that case, and more broadly explain the risks of unregulated drugs being traded globally.
· Dr. Amir Attaran, a Professor of Law and Medicine at the University of Ottawa, will discuss the risks of substandard and falsified medicines, especially those made in India. Dr. Attaran will also highlight India’s special role in preventing an international agreement to tackle such medicines.
· Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic, will discuss the problems he increasingly encounters with inferior quality medicines in the United States.
· Dr. Preston Mason, is a member of the Cardiovascular Division at Brigham and Women's Hospital and Harvard Medical School. He will discuss his extensive research into poor quality atorvastatin (generic Lipitor).
Statements made by Dinesh Thakur, Dr. Preston Mason, and Dr. Harry Lever are available here. The presentation given by Professor Amir Attaran is here.
SearchingForSafety Working Paper 05: Recommendations for NGOs Involved in Pharmaceutical Procurement, Donation and Distribution in Developing Countries
Posted by Paul Jensen
SearchingForSafety publishes its fifth working paper this week. The paper offers recommendations that NGOs procuring medicines for beneficiaries in developing countries can take to reduce the risk of providing substandard or even fake medicines to the very people they’re working to help.
Procuring and distributing medicines is an inherently high-risk business. It requires having adequate logistical infrastructure, systems of organization, and human resource capacity. Inadvertently distributing substandard or fake medicines can cause grave human harm and lead to devastating professional, legal and reputational consequences for organizations.
Our working paper offers NGOs involved in donating and/or distributing medicines—or thinking about getting involved—10 recommendations for helping to ensure the quality of those medicines. These recommendations aren’t meant to provide comprehensive, authoritative guidelines for NGOs. However, NGOs that find it challenging to meet any single recommendation should examine their role in donating and distributing pharmaceuticals and assess whether they’re adequately equipped to do it.
You can read the paper here.
Posted by Roger Bate
While the number of Americans who purchase medicines from online pharmacies is relatively small—4 to 6 percent of adults—the market is significant in dollar terms. While exact numbers are hard to come by, sales from Canadian (or seemingly Canadian) website alone are around half a billion Canadian dollars annually. Safety is the biggest issue involved in buying medicines online. Websites can sell fake medications while stealing consumers’ information for the purposes of identity theft. While the FDA doesn’t certify online pharmacies, several third-party organizations do.
My colleagues Ginger Zhe Jin from the University of Maryland College Park and Aparna Mathur from the American Enterprise Institute and I published an article that assesses the quality of medicines purchased from online pharmacies based on the type of certification those online pharmacies possess. Furthermore, to better understand the demand side of the online pharmacy market, we surveyed Americans who purchase medicines from online pharmacies to see if certification provides consumers with information they use to reduce the risk that they will buy fake medicines online. The study was published in the Berkeley Electronic Journal of Economic Analysis & Policy.
You can download the study here.
The FDA advises consumers to avoid foreign pharmacy websites and to only purchase websites in the US that have been approved by the National Association of Boards of Pharmacy. However, there are at least four certification agencies that verify the credentials and business practices of online pharmacies: the NABP, CIPA (the Canadian International Pharmacy Association), LegitScript.com and PharmacyChecker.com. By definition, NABP and LegitScript.com only approve US websites, CIPA only approves Canada-based websites, and PharmacyChecker.com covers websites operating in US, Canada, and other countries.
We classified websites approved by the NABP and LegitScript.com as Tier 1, websites certified by CIPA and PharmacyChecker.com as Tier 2, and other websites without these certifications as Tier 3. Most Tier 2 and Tier 3 websites were registered outside the U.S.
Of the 328 samples that we purchased online and were delivered, all passed a Raman spectrometry test that verified authenticity except for 8 samples of Viagra purchased from Tier 3 websites. Of all the samples we were able to test and authenticate, Tier 2 websites were 49.2% cheaper and Tier 3 websites were 54.8% cheaper than Tier 1 websites.
To better understand the demand side of the online pharmaceutical market, we designed a survey that was distributed by the group RxRights—a group concerned with the price of pharmaceuticals in the U.S. Among the 2,522 people who responded to the survey, 61.5% said that they purchase drugs online and mostly from foreign websites, citing cost savings as the primary reason. Of those that shop online, 41% said that they check with a credentialing agency when deciding where to make their purchases.
The study, then, shows that certification agencies do provide useful information for foreign websites and for consumers who purchase medicines online.
Furthermore, while the FDA is justified in warning consumers against the dangers of purchasing from rogue websites, our findings suggest that a blanket ban on all foreign websites—which currently exists but is enforced mostly for large purchases and for purchases of controlled substances—may deny consumers substantial savings from purchasing medicines from foreign websites that are certified by third parties.
Posted by Paul Jensen
December 12, 2013
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.
The headlines coming out of the meeting have mostly focused on the $12 billion in pledges raised, including President Obama’s commitment to contribute up to $5 billion as long as other donors match it with $10 billion (see here and here). The amount raised was short of the $15 billion the Global Fund has said it needs at a minimum to support programs for the next three years. The fund will of course keep working to raise an additional $3 billion, but the uncertain availability of these additional resources will make planning and execution more challenging for those responsible for implementing HIV/AIDS, TB and malaria control programs.
Regardless of the total funding ultimately raised, these new resources will be used to provide free HIV, malaria and tuberculosis treatment to millions of people across dozens of low- and middle-income countries.
But what about the quality of those medicines?
After the donors made their public pledge announcements, the Global Fund and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) made a slightly less reported but equally important announcement: that they have entered into an agreement to conduct advocacy and awareness raising, research, and capacity building to better protect patients from being exposed to fake medicines.
Details about the agreement will follow in the coming months, but the agreement builds on the work of a new campaign called Fight The Fakes (www.fightthefakes.org), of which the Global Fund and IFPMA are both members along with eight other organizational partners including the International Council of Nurses, the World Medical Association, the U.S. Pharmacopeia Convention and others.
With such influential organizations putting their brands behind the push against fake drugs, perhaps this new partnership will bring the goal of securing an international treaty against fake and substandard pharmaceuticals a little closer within reach.
Posted by Roger Bate
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.
Health ministers and officials from countries including Kenya, Ghana, South Africa, Vietnam, Egypt and the Philippines were hosted by India at the end of 2013. "The idea behind this programme is to promote Indian pharmaceutical exports, apart from improving confidence among the global community that India is a trusted source for quality generics at affordable prices," said PV Appaji, director-general of the Pharmaceuticals Export Promotion Council. "There has been propaganda by vested interests among the global community, particularly trying to project India as a country with poor regulatory standards," said Appaji, echoing remarks by Commerce Department staff.
In any commercial sector there are always vested interests which can benefit from a competitors misfortune, and hence even promote narratives about that misfortune. In that sense India is correct that western industry is probably making the most of India’s problems (although I have seen no public pronouncements to this effect), but that doesn’t mean the problems don’t exist, or even that western industry is misleading anyone about India’s problems.
As the author of the Economic Times piece wrote wrote, “The commerce ministry is of the view that "vested interests" are deliberately tarnishing the Indian drug industry and that some countries are not adequately aware of the stringent regulatory standards being enforced in the domestic market.”
But as we point out in our working paper with Ranbaxy whistleblower Dinesh Thakur, the idea that India enforces stringent regulatory standards is quite simply laughable.
Until India acknowledges its problems, solutions will not only not be found, but they won’t even be looked for.
By NARAYAN LAKSHMAN
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.
Speaking at a seminar organised by the American Enterprise Institute here Dr. Lever said that drugs made by Ranbaxy, which agreed to pay $500 million in fines for having sub-standard manufacturing processes and making false statements made to the Food and Drug Administration, came to his attention after the U.S. regulator found repeated violations of current Good Manufacturing Practices at multiple Ranbaxy facilities in India.
In one case, Dr. Lever noted, a patient with heart trouble, who was taking an 80mg dose of the Ranbaxy drug Furosemide, was suffering from shortness of breath even after the dose was doubled. Then Dr. Lever switched the patient to a drug made by another manufacturer and he lost 15 pounds of fluid in one week – a desirable result for this condition.
Commenting on the efficacy of Furosemide this case, Dr. Lever said, “Is it that their batch-to-batch consistency is a problem? Maybe some companies are more consistent at making consistent drugs, but some companies like Ranbaxy aren’t. They still put [in] the active ingredient but for some reason it’s not consistent.”
Speaking to The Hindu Ranbaxy USA spokesperson Charles Caprariello said that deducing the causes of certain health conditions and how they respond to medications was a complex matter, and sometimes the differences even came down to patients not taking the drugs per doctors’ advice.
He similarly outlined the case of a patient using Ranbaxy’s formulation of cholesterol-reducing drug atorvastatin, for which the company in 2012 announced a massive recall after glass particles were found in the tablets, where the cholesterol level was about 100 points above normal.
Dr. Lever said, “All I did was kept the dose the same, called the pharmacy and said ‘Give him the name brand drug, instead’. We checked within a month and [his cholesterol] was back to normal.” The comments mark one of the first few cases of physicians stepping forward to question the quality of drugs made by Ranbaxy.
Although Dr. Lever admitted that for heart failure patients the condition was relatively “multifactorial” and it could be harder to isolate the causes, in the cited cases other factors apart from the drug manufacturer were held constant, he noted
Responding to comments by former senior Ranbaxy officials Kathy Spreen and Dinesh Thakur, who disclosed details about forged drug testing data to CBS news channel last month, Ranbaxy said that there was “no evidence that patients were adversely harmed as a result of the manufacturing issues at these facilities.”
However Mr. Thakur, who is a whistleblower in the FDA case against Ranbaxy, said at the AEI event that Dr. Lever’s account was a testament that the quality-control process for new generic drug applications was not working as intended, and “we have no mechanism to follow that up and see exactly what is happening in the market when people are switched from the brand to the generic.”
Further, Mr. Thakur noted, this was exacerbated in the case of generics because “There are two different standards of drug manufacturing, one for drugs made in India and shipped to countries such as Ghana or Latin America, or consumed in India, and a second standard for drugs sold in places such as the U.S.”
The full article is available here.