WSJ opinion – Africa’s Health Crisis

An interesting opinion from the Wall Street Journal about challenges and barriers to improving public health in Africa.

How to Worsen Africa’s Health Crisis: Killing off drug patents will kill off innovation and patients.

By ALEC VAN GELDER

Faced with Africa’s devastation by HIV/AIDS, people are looking for scapegoats. Global pressure groups and now the World Health Organization are targeting “Big Pharma.” The drug companies do make easy targets but that doesn’t make them villains. The life-saving treatments they create remain Africa’s best hope. The misguided battle against pharmaceutical companies’ patent rights will only make Africa’s health crisis worse.

Intellectual property rights for AIDS drugs are “the biggest public health challenge” as they make them too costly for most Africans, Hans Hogerzeil, head of the WHO’s Essential Medicines program, recently said. They are “a barrier to access,” he previously claimed, but the real barriers are the lack of infrastructure and the diversion of aid money. Fewer than 5% of WHO’s 423 Essential Medicines are currently protected by patents; mostly advanced “second-line” anti-AIDS medicines.

Brazil expands access to cancer treatments

Under a massive expansion of its oncology services, Brazil’s national health care system (SUS) will offer cancer patients access to nine new treatments and expand coverage for 66 already-covered procedures, including 46 chemotherapy treatments.  (source:  PharmaTimes)

The nine treatments which are to be made available for the first time through the SUS include three for liver cancer plus five for breast cancer, leukemia and lymphoma and one new radiotherapy treatment.

Investments in the SUS oncology services, which provide treatment for around 300,000 cancer patients, will increase 25% to 412.7 million reals this year, rising to 2 billion reals in 2011. The widening of value coverage for already-provided treatments will see investments in chemotherapy services increasing from 1.25 billion reals last year to 1.5 billion in 2011, with particularly large increases in spending on treatments for conditions such as chronic lymphocytic leukemia, set to rise 765%.

Cancer is Brazil’s second-biggest killer after cardiovascular disease, and the fact that the SUS guarantees virtually all diagnosed patients have access to treatment makes it an attractive market for drugmakers. For example, last year the country’s breast cancer drug market was worth  $424 million, rivaling some major markets such as the UK and Japan and greatly exceeding the other BRIC (Russia, India and China) nations, says market research firm Decision Resources, which forecasts that breast cancer drug sales in Brazil will rise to $611 million by 2014.

The analysts forecast that the SUS oncology services will continue to give priority to the introduction of new technologies, and that the government will maintain its support for local production facilities, such as the development, in partnership with Argentina, of two reactors for the production of oncology drugs, announced in June.

Decision Resources is also forecasting good growth for Brazil’s non-small-cell lung (NSCL) cancer drug market, driven by increased uptake of higher-priced brands of chemotherapy, around 21% annual growth for targeted regimens and maintenance treatment (all in the advanced setting) and modest uptake of novel targeted agents. Drugs produced by western manufacturers will increase their share of the market from around 60% last year to 70% in 2014, when the total NSCL cancer drug market will be worth $240 million, it says.

- With annual drug sales of just over $17 billion, Brazil is the world’s 11^th-largest pharmaceutical market and is once again the biggest in Latin America. Having fallen behind Mexico in the earlier part of the decade, it has produced consistent double-digit growth in the last five years, reaching a peak of 33% in 2005 and rising 13% in 2009, reports IMS Health.

9 tons of counterfeit medicines seized: East Africa

Authorities have seized 9,072 kilograms (20,000 pounds) of counterfeit medicine and arrested 80 people suspected of illegal trafficking in six East African nations, Interpol said Thursday.  (source: CNN)

More than 300 premises were checked or raided in the two-month operation across Uganda, Burundi, Kenya, Rwanda, Tanzania and Zanzibar, according to a news release from the international police agency.

The confiscated loot included anti-malaria drugs, vaccines and antibiotics. There was also a significant quantity of government medicines diverted to illegal resale markets.

It was the third such seizure operation in as many years in East Africa, intended to curb the manufacture and distribution of counterfeit medical products.

The World Health Organization defines counterfeit drugs as “medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source.”  Counterfeiting can apply to both brand-name and generic products, and forged products may include those with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging, WHO says.

The United Nations agency created a global task force in 2006 to deal with the problem, which has been growing as international markets expand and become globalized and internet commerce has taken off.

The fake products can prove detrimental to public health efforts in disease-ridden countries and in worst-case scenarios can cause death, according to the WHO task force.

The “D” Word – Economist blog

From the Economist’s Babbage blog…

LIFESAVER

FOR those in rich countries, diarrhoea is a nuisance. For those in the poor, though, it is a killer. About 1.3m children a year die from the dehydration it causes, and even those who survive may have their development stunted by the loss of nutrients it entails. One of the main causes of diarrhoea is rotavirus, so the development, four years ago, of a vaccine against this virus might have been thought good news for the poor world. It was not, though, because the trials were carried out only in rich countries and aid agencies were unwilling to subsidise the distribution in the poor world of a vaccine whose efficacy was unproven there.

That has just changed with the publication in the Lancet of clinical trials that tested the efficacy of rotavirus vaccine in Bangladesh, Ghana, Kenya, Mali and Vietnam. These trials, organised by Merck (the vaccine’s manufacturer) and the Programme for Appropriate Technology in Health (a medical charity based in Seattle), showed that although the new vaccine is not as efficacious in the poor world as it is in the rich, it is good enough to make a difference. In the wake of these studies another medical charity, the GAVI Alliance, has agreed to subsidise the vaccine. That will allow countries in Asia and sub-Saharan Africa to purchase the product at 10-30 cents a dose, compared with a market price of around $10. According to the trials’ organisers, injecting the vaccine into the immunisation programmes of the world’s poorest countries could save 2m children’s lives over the next decade.

New drug-resistant superbug spreading from India

A new superbug could spread around the world after reaching Britain from India and scientists say there are almost no drugs to treat it. (source: Reuters)

The new superbug – New Delhi metallo-beta-lactamase, or NDM-1 – makes bacteria highly resistant to almost all antibiotics.

Almost as soon as the first antibiotic penicillin was introduced in the 1940s, bacteria began to develop resistance to its effects, prompting researchers to develop many new generations of antibiotics.

But their overuse and misuse have helped fuel the rise of drug-resistant “superbug” infections like methicillin-resistant Staphyloccus aureus (MRSA).

In a study published in The Lancet Infectious Diseases journal on Wednesday, Walsh’s team found that NDM-1 is becoming more common in Bangladesh, India, and Pakistan and is also being imported back to Britain in patients returning after treatment.

For many years, antibiotic research has been a “Cinderella” sector of the pharmaceuticals industry, reflecting a mismatch between the scientific difficulty of finding treatments and the modest sales such products are likely to generate, since new drugs are typically saved only for the sickest patients.

But the increasing threat from superbugs is encouraging a rethink at the few large drugmakers still actively hunting for new antibiotics, including Pfizer, Merck, AstraZeneca, GlaxoSmithKline and Novartis.

New US legislation seeks R&D incentives for rare childhood diseases

New bipartisan legislation was introduced in the US Senate last week which seeks to encourage innovative R&D by drugmakers aimed at treating rare and neglected pediatric diseases. (source PharmaTimes)

The Creating Hope Act of 2010 builds on existing law to increase incentives for the development of treatments for disabling and deadly diseases, with a focus on rare conditions that may otherwise fail to attract sufficient R&D funding.

“Seven thousand known rare or orphan diseases afflict nearly 30 million Americans – approximately 50% of whom are children,” said Democrat Senator Sherrod Brown, who is co-sponsoring the bill with Republican Sam Brownback and Democrat Al Franken.

Under this law, companies which develop new drugs and biologics for neglected tropical diseases are eligible for a “priority review voucher” entitling them to expedited review of another drug produced by that manufacturer. Because this voucher can be used to expedite the marketing of a “blockbuster” or “me-too” drug, it provides a strong financial incentive for the development of treatments for otherwise neglected diseases.

The proposed new legislation would improve upon this incentive not only by increasing the commercial value of the priority review voucher by making it transferable, but by expanding priority review voucher eligibility to include rare pediatric diseases.

WHO launches stakeholder consultation on global HIV/AIDS Strategy

The World Health Organization has recently released a draft of their Global Health Sector Strategy for HIV/AIDS (2011-2015) for stakeholder review and commentary.  The WHO is hosting an online consultation to solicit feedback on key issues as well as general commentary on the strategy.

The Global Health Sector Strategy for HIV/AIDS 2011‐2015 aims to:

1. Set global goals for the health sector response to HIV/AIDS;

2. Guide national HIV responses; and

3. Provide a framework for concerted WHO action at global, regional and country levels.

The strategy builds on the achievements and experiences of the ”3 by 5″ initiative and the WHO HIV/AIDS Universal Access Plan 2006‐2010 and aims to align with broader strategic frameworks, including the Millennium Development Goals, primary health care renewal, Universal Access commitments and the UNAIDS Strategy for 2011‐2015.

A selection of submitted comments will be made available on the WHO web site. Official comments submitted by Member States will not be posted on the web site.

The submission form for comments on the WHO Global Health Sector Strategy on HIV/AIDS 2011-2015 is online at:  http://www.who.int/hiv/aboutdept/strategy_form/en/index.html.