Tag Archives: public health

Fake Drugs will not Cure Malaria

The latest assault on malaria is unprecedented. Last year an array of organisations, including the Roll Back Malaria Partnership, based at the WHO and founded in 1998, the Global Fund to Fight AIDS, Tuberculosis and Malaria, founded in 2002, and the President’s Malaria Initiative, founded under George Bush in 2005, spent a record $2 billion fighting it.  The Roll Back Malaria Partnership has set goals for 2015 that include the heroic aim of cutting malaria deaths to near zero. This would mean more than doubling spending, to $5 billion a year. Mr Chambers is trying to rally the troops. The report he is to present estimates the benefits of fighting malaria in sub-Saharan Africa, which is reckoned to have accounted for nine-tenths of worldwide deaths from the disease in 2010.

Universal deployment of good treatment, diagnostics and preventive measures, including bed nets, would—in theory—prevent 640m malaria cases and 3m deaths by 2015, the paper explains. This would cost at least $6.7 billion between 2012 and 2015, says the African Leaders Malaria Alliance, a regional lobby. But, says the report, it would be a brilliant investment, yielding an astonishing $231 billion-$311 billion, counted in lives saved and malaria cases averted, if you factor in productivity gains and savings in the cost of treatment.

That $6.7 billion is not likely to materialise in its entirety soon. Nor does it include the cost of training health workers and improving surveillance. Problems of counterfeit or substandard medicines are particularly worrying. Tanzanian regulators recently seized 155 containers of fake anti-malarials. Since 2010 the Global Fund has subsidised the private market for the best anti-malaria drugs, known as artemisinin-combination therapies (ACTs). But Roger Bate of the American Enterprise Institute, a think-tank, found that 8% of subsidised ACTs in his sample had too little of the active ingredient. Moreover, those mosquitoes are beginning to resist ACTs and popular insecticides. The battle is far from over.

Fighting Malaria: Net benefit, Economist July 14, 2012, at 42

See also Malaria’s Deaths

The Next Pandemic and the United States Military

U.S. military forces are the front line of U.S. national security, but as a globally deployed force they are also on the front line of any new pathogen-based health threat that may emerge [including also due to biological warfare]. As overall human activity pushes ever further into previously undeveloped territory, the likelihood of exposure to new pandemic diseases increases.  The 2009 Army Posture Statement, cites a World Health Organization estimate of between 20 and 50 percent of the world’s population being affected if a pandemic were to emerge. WHO forecasts “it may be six to nine months before a vaccine for a pandemic virus strain becomes available.” In a separate report on pandemic influenza, the WHO describes several challenges to producing sufficient volumes of vaccine using current, egg-based protein-production technology, including the likelihood that two doses per person could be required due to the absence of pre-existing immunity.

In short, the potential for a pandemic exists and current technological limitations on defensive measures put the health and readiness of U.S. military forces at risk. A technological solution to increase the speed and adaptability of vaccine production is urgently needed to match the broad biological threat.

DARPA’s Blue Angel program seeks to demonstrate a flexible and agile capability for the Department of Defense to rapidly react to and neutralize any natural or intentional pandemic disease. Building on a previous DARPA program, Accelerated Manufacture of Pharmaceuticals, Blue Angel targets new ways of producing large amounts of high-quality, vaccine-grade protein in less than three months in response to emerging and novel biological threats. One of the research avenues explores plant-made proteins for candidate vaccine production.“Vaccinating susceptible populations during the initial stage of a pandemic is critical to containment,” said Dr. Alan Magill, DARPA program manager. “We’re looking at plant-based solutions to vaccine production as a more rapid and efficient alternative to the standard egg-based technologies, and the research is very promising.”

In a recent milestone development under Blue Angel, researchers at Medicago Inc. produced more than 10 million doses (as defined in an animal model) of an H1N1 influenza vaccine candidate based on virus-like particles (VLP) in one month….“The results we’ve achieved here with plant-based production of vaccines represent both significant increase in scale and decrease in time-to-production over previous production capabilities in the same time period. The plant-made community is now better positioned to continue development and target FDA approval of candidate vaccines,” Magill said. “Once the FDA has approved a plant-made vaccine candidate, the shorter production times of plant-made pharmaceuticals should allow DoD to be much better prepared to face whatever pandemic next emerges.”

DARPA Makes 10 Million Strides in the Race to Contain a Hypothetical Pandemic, July 25, 2012 (from the website of DARPA)

Drug Markets, Patents and the Developing World; the HIV Virus

Sales of antiretroviral drugs in America and the five biggest European markets reached $13.3 billion in 2011, according to Datamonitor, a research outfit…. Publicly funded research has played a larger role in developing drugs for HIV than for other diseases. A study published last year in Health Affairs found that HIV drugs were three times as likely to involve a patent from the public sector. HIV also has special status among regulators. America’s Food and Drug Administration (FDA) created a faster way to review HIV drugs, allowing them on the market before the most expensive stage of clinical trials.

In total, public and private investment has yielded more than two dozen HIV drugs. In 1987 Burroughs-Wellcome (now part of GlaxoSmithKline) introduced the first one, tackling an enzyme that helps the virus progress inside human cells. In 1995 Hoffmann-La Roche, a Swiss drug firm, launched the first protease inhibitor, which interrupts the virus at a later stage of replication….One company stands out: Gilead, of California. A late entrant to the HIV race, Gilead quickly took the lead. Its strategy was simple: the more convenient the treatment, the better. In 2004 Gilead launched Truvada, a once-a-day, one-pill combination of two drugs. In 2006 it introduced Atripla, a once-a-day, one-pill combination of Truvada and another treatment. Atripla’s average wholesale price in America is nearly $25,000 per patient, per year. In 2011 its global sales reached $3.2 billion.  More good news for Gilead has come in recent weeks. An FDA panel recommended Truvada for preventive use: ie, to protect healthy people from contracting the virus. Another FDA panel endorsed Gilead’s new Quad pill, which is the simplest, most effective combination drug to date.

If the process for developing HIV drugs has been unusual, selling them has been even more so. America is the rich world’s biggest market, with 841,000 patients diagnosed—ten times as many as in Britain. More than 60% of HIV drugs in America are bought with public money. Insurers give HIV special treatment: patients are rarely pressed to buy the cheapest pills, as they might be if they had another disease.

Distributing drugs in poor countries is harder. A decade ago, hardly any poor people could afford them. At first, drugs firms handled this badly. In 1998, 39 big Western firms sued South Africa to protect their HIV patents. Global uproar ensued; the firms backed down in 2001.  Then two things changed. First, rich countries started donating vast sums to fight AIDS in poor ones. In 2000 there was less than $2 billion for HIV programmes each year; by 2010 there was $15 billion, thanks to the Global Fund to Fight AIDS, Tuberculosis and Malaria and George Bush junior’s President’s Emergency Plan for AIDS Relief (PEPFAR).

Second, the price of AIDS drugs plunged. In May 2000 a year’s “triple cocktail” therapy cost $10,000 or so. By 2011 the same pills sold for $62 in poor countries. PEPFAR cash buys generic versions of patented drugs, which may be supplied only to poor countries. Last year two drugmakers won most of PEPFAR’s contracts: Aurobindo, an Indian firm, and Matrix, an Indian firm acquired in 2007 by Mylan, an American one. PEPFAR’s bidding system keeps margins slim even by the standards of the generics industry, says Rajiv Malik, the president of Mylan. But volumes are huge.

Can treatment expand further? Despite the subsidies and the plunge in prices, less than half of those infected with HIV take HIV drugs. Those who do, however, live a long time, and they have to keep taking the pills. What’s more, new studies show that it helps to start treating patients early, so demand is sure to rise.  Alas, aid dipped in 2009 and 2010, thanks to the financial crisis. To make matters more complicated, there is a trade-off between more drugs and better ones. Most patients in poor countries get outdated pills, according to Médecins Sans Frontières. Allowing generics firms to copy yet more patented drugs might help. Since 2006 Gilead has licensed drugs to generics firms for 5% royalties. Last year it went further, agreeing to license drugs to a “patent pool” to centralise royalty deals for a range of firms. So far, however, Gilead is the only Western company to join….

There are two distinct HIV markets. In rich countries, many good treatments jostle for market share. The best will generate fat profits, since patients have to take their pills every day. But Datamonitor predicts that growth will slow after 2017, as many drugs lose patent protection and prices crash. In poor countries, by contrast, Big Pharma makes very little money but the most efficient copycats thrive. Meanwhile, the world still waits for a cure.

The business of HIV: Battling the virus, Economist, June 2, 2012,at 80

The UN Peacekeeping in Haiti: blind leading the blind

Today’s foreign do-gooders in Haiti are the 9,000 members of Minustah, the UN’s peacekeeping force. They are surely better-meaning than the interlopers of the past. But the Haitian government has little more influence over them than it did over America’s marines. And in recent years the force has inflicted great damage. Its troops have been blamed for starting a cholera epidemic that has claimed 7,000 lives, and have been accused in numerous cases of rape and sexual assault. Its missteps are leading to ever more strident calls for greater accountability for peacekeepers.

The latest public-relations volley was launched on April 21st at the Tribeca Film Festival in New York. “Baseball in the Time of Cholera”, directed by two foreign-aid workers living in Haiti, weaves together the stories of a teenage athlete who loses his mother to cholera and lawyers suing the UN for negligent sanitation at a Nepali peacekeeping base. The film features plenty of news footage of the base, including sewage pipes flowing into a tributary of Haiti’s largest river. The first cholera cases appeared near the base, and the bacteria—a South Asian strain—quickly spread along the river and its network of canals, which Haitians use for bathing, drinking, irrigating crops and washing clothes.

Since the outbreak began the UN has tried to dodge accusations of responsibility, saying that the source of the disease is unknowable or unimportant. But a series of epidemiological and genome studies have all but established Minustah’s role as fact.   Citing scientific evidence, in November the lawyers featured in the film filed 5,000 complaints to Minustah’s claims office on behalf of cholera victims, seeking at least $250m in damages. The UN’s peacekeeping department says it is studying them. Until now, the claims office has dealt with smaller matters, such as property damage.

Minustah’s reputation has been further tarnished by charges of sexual abuse. Two Pakistani soldiers were accused of raping a 14-year-old boy, and a group of Uruguayan peacekeepers allegedly sexually assaulted an 18-year-old boy and videoed the incident. The justice system has worked somewhat better in these cases—a Pakistani military tribunal convened in Haiti convicted its soldiers last month, and the Uruguayans seem likely to face trial in their home country. But the Pakistanis were sentenced to just one year in prison. A popular song at this year’s Haitian Carnival included a line cautioning young men nearby the peacekeepers to watch their rears.

Excerpts from,UN in Haiti: First, do no harm, Economist, April 28, 2012, at 41

Malaria’s Unnecessary Deaths in the Developing World

Worldwide malaria deaths may be almost twice as high as previously estimated, a study reports.The research, published in the British medical journal the Lancet, suggests 1.24 million people died from the mosquito-borne disease in 2010.This compares to a World Health Organisation (WHO) estimate for 2010 of 655,000 deaths.  But both the new study and the WHO indicate global death rates are now falling.  The research was funded by the Bill and Melinda Gates Foundation. It used new data and new computer modelling to build a historical database for malaria between 1980 and 2010.  The conclusion was that worldwide deaths had risen from 995,000 in 1980 to a peak of 1.82 million in 2004, before falling to 1.24 million in 2010.  The rise in malaria deaths up to 2004 is attributed to a growth in populations at risk of malaria, while the decline since 2004 is attributed to “a rapid scaling up of malaria control in Africa”, supported by international donors.  While most deaths were among young children and in Africa, the researchers noted a higher proportion of deaths among older children and adults than previously estimated. In total, 433,000 more deaths occurred among children over five and adults in 2010 than in the WHO estimate.

The researchers also concluded malaria eradication was not a possibility in the short-term.  “We estimated that if decreases from the peak year of 2004 continue, malaria mortality will decrease to less than 100,000 deaths only after 2020,” they write.  The Lancet’s editor, Richard Horton, told the BBC: “Right now we don’t actually have any reliable primary numbers for malaria deaths in some of the most malarious regions of the world, so what numbers we have come from estimate. “What this paper reports is a new way of estimating the number of malaria deaths, where they’ve used additional data sets and improved mathematical models from calculating mortality.”  But despite what he calls the “disturbing” number of deaths recorded, he believes the underlying message of the report is that the disease can and is being controlled.  “Since 2004, the number of malaria deaths has dropped by about a third, and that’s really been the time when the Global Fund to Fight Aids, Tuberculosis and Malaria has swung into action” he said.  “Over the past decade, 230 million cases of malaria have been treated and the same number of bed nets have been distributed to people at risk of malaria, and the result of that has been this huge downturn. So what we know is that we’re actually able to turn off malaria with our existing interventions.”

Commenting on the new study, Professor David Schellenberg of the London School of Hygiene and Tropical Medicine said the researchers had “gone to great lengths to assemble information from a range of sources and to make adjustments for the inadequate data quality”.”We can argue about the strengths and weaknesses of their approach but should not be distracted by the details of the methods: however you look at it, far too many people are dying from malaria.

By Neil Bowdler, Malaria deaths hugely underestimated – Lancet study, BBC News, Feb. 2, 2012