HIV positive babies?

Sounds like an oxymoron, right? Well, sadly, it’s not. HIV transmission from mom to baby (affectionately referred to as Prevention of Mother-to-Child Transmission of HIV) has almost been eliminated in wealthy countries due to effective prevention strategies but the same can’t be said for many poor regions. While the reasons for this are complex, one factor remains: there is very little market incentive for pharmaceutical companies to develop paediatric HIV drugs that are appropriate and safe.

Thankfully, the Drugs for Neglected Diseases initiative (DNDi)—a not-for-profit organization that uses an alternative model to develop medicine for neglected diseases–is doing something about it. On July 18th at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, DNDi announced the launch of a new program that aims to address this unmet need. More details can be found here. According to Dr. Bernard Pécoul, the Executive Director of  DNDi:

“There are millions of children with HIV/AIDS in low- and middle-income countries, but their needs are absent from the HIV research and development agenda, and this is largely because they are poor and voiceless and do not represent a lucrative market. Working with partners, we hope to help fill this terrible gap and offer improved treatment options for children with HIV/AIDS.”

I can imagine a world where more people are able to live a healthy and fruitful life. Ideally, this begins with a healthy childhood. Props to DNDi for refusing to accept such a grim global reality.

Roche Wins as High Court Limits University Patent Rights

The United States Supreme Court recently announced their decision on a landmark case revolving around university patent rights on life-saving medical technologies. The technology in question, quantitative polymerase chain reaction (real-time PCR), is a highly effective tool in diagnosing infectious diseases and detecting new and emerging threats.

Originally developed by Stanford scientist Mark Holodniy, advancements in real-time PCR were claimed to be owned by the university, under the conditions of the 1980 Bayh-Dole Act that outlines universities’ legal rights for research funded by the federal government. Holodniy later signed agreements that transferred ownership of his PCR work to Cetus Corp, now owned by Roche Pharmaceuticals. Stanford argued that the Bayh-Dole Act superseded any agreement made afterwards by Holodniy and Cetus.

However, in the ruling led by Chief Justice John Roberts, it’s said that the 1980 law doesn’t displace the historical principle that inventors are allowed to have first claim on their work. This decision will certainly affect future cases of patent ownership and potentially all technologies that were jointly developed through federal funding, university research and industry collaboration.

The patent for real-time PCR will be held by Roche until 2021.

For more coverage on this case, the full article by Bloomberg News is available here.

A press release by Roche on the court’s ruling can be read here.

CIHR Reverses Drug Trial Policy

Canada’s national funding agency for health sciences, CIHR, made a controversial move to cancel a policy that required full public disclosure on results from drug trials. Without full disclosure of study results, the public may not be privy to important early details about drugs that may be ineffective or worse, significantly toxic. Transparency, a necessity for gathering evidence and truth in making healthcare related decisions, is believed to have been further undermined by the lobbying efforts of Canada’s pharmaceutical corporations. CIHR has increasingly drawn fire for its closeness with industry, having appointed last year an executive from Pfizer to their national board. Quoting Sir Iain Chalmers, co-founder of the U.K.’s respected Cochrane Collaboration research body: “It seems to me that CIHR has decided that it’s going to put my interests and the interests of other patients behind those of industry…. I think that’s tragic.”

The full article by the National Post is available here.

Drugs and Profits: NYT Op-Ed on Avastin

Dr. Frederick C. Tucker recently wrote an opinion on the state of Avastin–a very expensive anti-cancer drug designed to suppress the growth of breast cancer tumors when used jointly with primary chemotherapy drugs such as Taxol. Avastin received accelerated approval by the American Food and Drug Administration (FDA), but is now known for having significantly toxic side effects that outweigh quality of life, does not lengthen patient lives and whose approval is likely to be revoked.

Avastin itself is part of a new class of modern drugs generally referred to as biologics–medicines derived from an organic source. Akin in the way that vaccines are derived from pathogenic bacteria or viruses, many new biologic drugs are derived from recombinant DNA. The value of biologics has largely been contested and in cases like Avastin, where it costs an additional $90,000 to treat one cancer patient a year, we might ask why we are willing to spend so much on a drug that neither improves the quality of life nor extends it?

Now that Avastin’s effectiveness as an anti-cancer drug is questioned, Genentech, Avastin’s manufacturer, is frantically trying to find a way to hold its market share by commissioning more studies to demonstrate improved quality of life or prove it’s value for treating another unrelated illness–macular degeneration. As Dr. Tucker writes, drug companies are better off spending their money on discovering a genuinely innovative medicine instead of marketing a failed one.

Dr. Tucker’s full op-ed on the case of Avastin can be read here.

Guardian article on challenges with HIV drugs for children.

Here’s a quick news piece by Sarah Boseley at the Guardian:

The first major study of [HIV} drug resistance in young people, which looked at 1,000 European children born with HIV, raises questions about the suitability of anti-retroviral drugs for the young.

Drugs fail because the virus becomes resistant to them. This can happen if people take them erratically or stop taking them. Resistance sets in with adults, but more slowly.

But part of the problem, say Nathan Ford and Alexandra Calmy, is that the drugs available are not tested on children or turned into formulations that are easy for children to take. The doctors work for Médecins sans Frontières, which treats some of the 2 million children living with HIV, who were infected during childbirth – most of them in the developing world. Half of the children born with HIV die before their second birthday, they point out.

LINK: HIV study claims one in eight children resistant to drugs. (Thanks for link, Richard!)
LINK: Risk of triple-class virological failure in children with HIV: a retrospective cohort study (Lancet paper)

Driving a decade of change: HIV/AIDS, patents and access to medicines for all [Review paper]

(Full text of article available via open access at the link below.)

http://www.jiasociety.org/content/14/1/15

Journal of the International AIDS Society 2011, 14:15doi:10.1186/1758-2652-14-15

Abstract (provisional)
Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization’s Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a “treatment timebomb” awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.

 

Expanded access to ART has the potential to avert millions of AIDS orphans in Africa

(From Michael Carter, Aidsmap.com, Published: 28 March 2011) – link

Universal adult access to antiretroviral therapy compared to current roll-out could prevent over 4 million more children being orphaned because of HIV in the sub-Saharan African countries hardest hit by AIDS, according to published in the online journal AIDS Research and Therapy.

“Results from this study highlight the positive impact that expanded ART [antiretroviral therapy] may have in sub-Saharan countries already burdened with high numbers of AIDS orphans,” comment the investigators. They add, “we found that achieving universal ART uptake among adults may avert over 4 million maternal, paternal and double AIDS orphans over the next 10 years.”

It is estimated that 11.6 million children in sub-Saharan Africa have already lost one or both parents because of HIV.