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Early trial results released yesterday suggest a significant breakthrough for public health: a malaria vaccine that works. Scientists have been searching for a malaria vaccine for decades. The most infamous efforts resulted in scientific fraud and total failure. But today we may be on the cusp of having an effective vaccine.

Even a moderately successful vaccine would be a great advance in combating a disease that kills nearly 800,000 people, mainly children, and sickens hundreds of millions of others every year.

Preventative measures, like using bed nets and insecticide sprays (indoors and out), combined with widespread treatment, has lowered prevalence of the disease by perhaps 20 percent in the past decade. A successful vaccine would lower this further and faster.

But we cannot declare victory yet. Trial results suggests the vaccine works only 50 percent of the time, so the vaccine must be repeatedly deployed in conjunction with existing policies in order to continue to suppress the disease. Problems with the vaccine’s safety may emerge as clinical trials proceed. The eradication of malaria is still a long way off, but this vaccine could be a small but important step to that desired eventuality.

Last month I wrote about the dangers of substandard drugs, and particularly poor quality ingredients coming from China. One of my recommendations was that U.S. Food and Drug Administration increase its inspections of plants in China. So it is great news that this is now set to happen.

As a story in the New York Times explains, $299m in fees will be collected by the FDA from generic manufacturers to increase overseas inspections. The result of this is that foreign plants will be inspected every two years, rather than not at all or every decade or so, as currently.

This proposed legislation is likely to be approved by Congress before the end of September, and it will be a welcome change that should lower the chance of really poor production facilities still selling products in the United States. But problems still remain. Notably, inspectors will not have unfettered access to plants in China. The FDA will still have to provide notice to Chinese authorities of their intent to inspect, which means minor infractions, which can cause major safety problems, may still occur.

Combating poor-quality drugs requires all sorts of actions, especially in the poorer nations of the world. Without international agreement on how to define the criminal aspects of the counterfeit drug trade, extradition is largely impossible. Once agreement on definitions is achieved how should we pursue the counterfeiters who inflict mayhem and death across the planet? In the Journal of International Criminal Justice, my colleagues and I propose one possible solution: establishing a convention against fake drugs.

Over the past few days (and months), the Global Fund, which dispenses money to buy drugs for developing nations, has come under a lot of scrutiny for fraudulent activities. I’ve added to that with various papers and blog posts. A really thoughtful post from William Savedoff, with comments from April Harding and Nancy Birdsall, is here.

All this attention is warranted. Health aid has expanded enormously over the past decade and the oversight hasn’t matched it. Yet all the focus on the Global Fund is a shame—it has done far more than any other multilateral agency to be transparent and expose corruption. It may have come across that I am very hostile to the Fund; I am not, I just hate to see money wasted when it can do so much more good. I think that the work of the Fund’s inspector general and the Global Fund Observer, an independent watchdog magazine, is invaluable. If only the United Nations agencies took oversight as seriously, we’d have far more pressing problems of corruption to dwell upon.

Long may the discussion of Global Fund failures and successes continue, but as the inspector general of the Fund points out, it cannot investigate some donations because they go through the UN Development Program. The UNDP knows it is highly corrupt and will release no information. What this means is that it is very hard for researchers like me to investigate it, which means journalists, always on tight schedules, don’t have anything to report.

I suspect over coming months the Global Fund’s support in Congress will weaken; perhaps it should, given what we know. But the United States should lower its funding to the United Nations, not the Global Fund, until the UN actually becomes more transparent.

Image by Hugh Nelson.

The Global Fund Observer published the following piece about the many issues I raised on corruption at the Global Fund, but I hadn’t seen it ’til now because they got my name wrong. Is it any wonder that an organization that fails to pay enough attention to details, so that it loses millions of drugs, has an oversight magazine that can’t even get a name right?

According to Robert Bate of the American Enterprise Institute, as many as 30 million donated malaria treatments are stolen every year.

Bate said that most of these treatments are financed by the Global Fund, and that the Fund’s recent efforts to combat the problem amount to “too little, too late.” He added, “The Global Fund has always had the power to oversee the distribution of its funds, but it has chronically failed to act on that responsibility.”

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Image by e-Magine Art.

DDT is a remarkable insecticide, used effectively for 70 years in the battle against insect-borne disease, particularly malaria. But it is perhaps better known as a cause of environmental harm, even though most of the allegations made against it were false (for a detailed history of these issues, see here.)

DDT polarizes debate. Probably less miraculous than some of its conservative supporters would like to believe, and far less harmful than most liberal environmentalists and militant bloggers assert, debates around DDT are driven largely by other issues.

The problem is that it is not just at the fringes where DDT use is undermined. The center of the debate, where DDT’s use hangs by a thread, is dominated by vested interests opposed to DDT. But DDT still has considerable value for malaria control, and endemic countries are calling for continued freedom to use DDT.

Perhaps some bloggers think that these health ministers are idiots or tools of vested industries or have other financial reasons for asserting DDT’s importance. Of course, largely irrelevant commentators are one thing, but when the UN chooses to mislead the public about DDT and promote alternatives which are, frankly, useless, then making a reasonable case for DDT and other insecticides is harder. My colleagues, Don Roberts and Richard Tren, have just published a worrying paper and AEI has a Health Policy Outlook on the topic today. Both of these papers tell different aspects of the disgraceful story of the purposeful exclusion of data conflicting with an ideological goal, that of ridding the world of DDT. The results of carefully manipulated studies are promoted while other data are ignored or even suppressed, and all at taxpayer expense. The fraud is even more egregious when its objectives are to achieve political and administrative goals detrimental to the practice of public health.

Fraudulent claims are being made by officials at the highest levels of the United Nations Environment Program, the Secretariat of the Stockholm Convention on Persistent Organic Pollutants, the Global Environment Facility, and the environmental health units of the World Health Organization and Pan American Health Organization, to seize authority over what is done to control malaria, to promote anti-insecticide propaganda within malaria endemic countries, and to justify global DDT elimination by 2020.

Importantly, the fraudulent claims are not being publicized or promoted by legal entities or professionals with legitimate malaria control knowledge and expertise. Officials of global environmental agencies and organizations claim that there is no further need for DDT, asserting its global elimination can be completed by 2020. In line with these claims, the Secretariat’s 2007 plans proposed a budget of $150 million for stopping DDT production. The successful elimination of DDT through false propaganda will add to a long history of fraudulent claims causing harm to public health, and far into the future will cause irreversible harm to the health and welfare of many people.

Scientific methods to detect fake medicines are a small but essential part of the arsenal of weapons to fight counterfeiters. Until now, most really cheap tests (less than $1), such as rapid dye assays, could at most demonstrate if the desired compound was actually present, but not if its concentration was roughly correct. But a dye test developed by Harparkash Kaur and colleagues at the London School of Hygiene and Tropical Medicine is more sensitive than previous tests. In today’s bulletin for Africa Fighting Malaria, I went back to my own counterfeit drug data and assess that when only previous dye tests or other cheap tests were available, nearly 5 percent of all samples subsequently found to be substandard or fake would not have been caught. It seems likely that most of these would have been identified as substandard or fake by Kaur’s test. If deployed correctly, Kaur’s test could easily save hundreds of lives a year—all that’s needed now is for an entrepreneur to commercialize the test’s packaging for deployment in the field.

Image by Frank Battermann.

New research published today by Roger Bate and me addresses the issue of drug quality in developing and emerging markets by looking at the first point of drug regulation—registration systems—in a variety of countries, including India, Brazil, China, and many African nations.

Not only is drug quality important to the health of citizens of those countries, but—since as much as 80 percent of active ingredients in U.S. drugs are made overseas—Americans should also be concerned about drug regulation abroad.

Looking at 12 countries, our research provides an idea of how stringent authorities are in registering drug products. There are major differences in registration costs, pre-quality testing requirements, evaluation timelines (see chart), and other areas. Such differences are often important: For instance, just how thorough can the review of a new drug be when conducted in seven days, when the process takes at least three months elsewhere?

With a four-fold increase in U.S. drug recalls from 2008 to 2009, there is more pressure on the Food and Drug Administration (FDA) than ever to protect the pharmaceutical supply chain from unsafe or adulterated products. But the FDA only has the capacity to inspect foreign production plants once every 13 years.

Unable to do the job alone, the FDA should put more pressure on foreign regulatory authorities. While a general lack of human and financial resources impacts many foreign authorities’ ability to regulate, not all perform equally badly. Countries with stronger political commitment to regulation stand out from their counterparts. Recent efforts in Nigeria to tighten registration and clarify procedures are in stark contrast to efforts of countries like Uganda, where corruption continues to occur in the open, or Kenya, where huge gaps in product registration exist. But it’s India and China that Americans should watch, as most of our drug ingredients come from there, and in both countries the news is mixed—as we discuss in our report.

Ultimately, many nations may not have the capacity, or even the experience, necessary to adhere to Western regulatory standards. But with the global pharmaceutical supply chain expanding, it is important that regulatory authorities in emerging markets strengthen regulation where they can, and our research highlights an area where they can start that is manageable and makes sense.

Emily Putze is a research assistant at AEI.

The September edition of the Lancet conferred upon New Delhi the dubious distinction of having a bacterium named after it. The “Indian Superbug,” or New Delhi metallo-β-lactamase 1 (NDM-1), is a bacterium carrying a newly recognized gene that is extremely immune to antibiotics. The Lancet study identified 143 cases of NDM-1 isolates in India (and Pakistan and Bangladesh) and 37 in the United Kingdom. The study claimed that many of the UK cases involved people who had traveled to India or Pakistan within the past year, or “had links” with these countries. However, the broader message being drawn from the study—that Indian hospitals are unsafe for surgery and health tourists should beware—lacks any foundation and makes us suspicious that this hype is instead an attempt to stigmatize the nation’s burgeoning medical tourism industry.

In fact, within days of the publication of the report, the paper’s Chennai-based lead author, Karthikeyan Kumarasamy, dissociated himself from parts of it, claiming that while he did the scientific work, inferences were made and published by his British counterparts without his consent. He told the Hindustan Times:

It’s all hype and not as bad as it sounds. The threat of the NDM-1 is not that big as, say, H1N1 (swine flu). The conclusion that the bacterium was transmitted from India is hypothetical. Unless we analyze samples from across the globe to trace its origin, we can only speculate.

This statement, in addition to the fact that the Lancet report was funded in part by competing pharmaceutical company Wyeth, has Indian hospitals and doctors up in arms about associating the enzyme with New Delhi. They believe that the move had more to do with decelerating the “outsourcing” of healthcare services to India rather than well-founded concerns among the Western medical research community.

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Image by the Center for Disease Control and Prevention.

The World Health Organisation has granted Sanofi Aventis an increased shelf life from two to three years for its flagship antimalarial product ASAQ, a combination therapy of artesunate and amodiaquine. This is great news since drug distribution systems in the key markets in Africa are often woeful and the longer the shelf life the better chance that the drugs will get where they’re required. Some products were either being incinerated or were being allowed to be stolen from national drug stores because they were close to expiry.

Eighteen months ago I co-wrote a study on ASAQ’s main competitor, suggesting that its shelf life could probably be increased to three years. It will be interesting to see if manufacturers of that product now push harder to establish a longer shelf life for their product—after all, I suspect they’ll now lose market share to the longer lasting ASAQ.

Image by e-MagineArt.

Today the journal Research and Reports in Tropical Medicine published my study on diverted drugs and the problems they cause. There are a variety of definitions of drug diversion but the one used in the paper applies to stolen public-sector drugs being diverted into the private sector. Western taxpayers have been subsidizing anti-malarial drugs for Africans in large volumes (roughly 120 million treatments in 2009) for the past few years, and this practice has undoubtedly saved thousands of lives. But it has led to all sorts of unintended consequences, and in some places these may even undermine the good being done.

Essentially, some countries’ health departments unofficially encourage diversion of public-sector medicines, since there is a de facto acknowledgment that the government cannot distribute medicines to where they are required. Senegal does this more overtly than most; while other governments generally don’t practice this unofficial policy, some unwittingly let it happen.

Among older therapies and those not donated we found very few diverted products, no more than a few percentage points. But roughly 30 percent of the private market samplings of the most important new (and most donated) artemesinin combination therapy was in fact stolen and diverted public-sector product.

The most charitable interpretation of why this is happening is that managers of understaffed government stores know the entire distribution system is dysfunctional. They watch as the millions of treatments ready to be distributed are picked up too slowly and in too small an amount, with the clock ticking to drug expiration for those that remain. They turn a blind eye as the drugs close to expiration disappear from the stores. No doubt, they hope the drugs will be distributed amongst the poor, or at least will be sold before expiration in myriad informal drug markets.

It might sometimes happen that way, but a vast amount seems to be traded across Africa, and some—from our samplings maybe 10 to 15 percent—has already expired. I suspect that non-governmental organizations (NGOs) will point out that this is a further example that Africans need even more help, that Western taxpayers should be supporting the medical stores and FDA-equivalents in Africa further. This argument has some validity, and USAID and others are helping countries improve public-sector drug oversight. But it also ignores the importance of private-sector drug delivery in Africa, where maybe 60 percent of drugs are procured. Understanding private-sector drug distribution better, rather than decrying it as immoral as many NGOs do, is critically important.

While donors throw money at the public sector, they may unwittingly support the unacceptable face of the private sector—criminal distributors of the stolen drugs from government stores, a counterproductive and costly tragedy.

Image by kittenpuff1.

At long last, the Indian government has published the results of its survey of fake drugs. It confirms the headline it has been pushing for nearly a year, that almost none of the 24,136 samples collected were fake. Only 11 drugs were fake, according to the Report on Countrywide Survey For Spurious Drugs, published by the Central Drugs Standard Control Organization (CDSCO).

The report is remarkably detailed on the statistical modeling involved, and stresses that the “sample collection and its verification was a mammoth task and involved strenuous day and night work on part of NGOs, CDSCO officials, and laboratories over a period of 7 months.”

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Image by DraconianRain.