http://www.nytimes.com/2013/04/02/business/global/top-court-in-india-rejects-novartis-drug-patent.html?pagewanted=1&_r=0&nl=todaysheadlines&emc=edit_th_20130402

A few highlights from the article:

“The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines…

In Monday’s decision, India’s Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention…

Leena Menghaney, a patient advocate at Doctors Without Borders, said that the ruling was a reprieve from more expensive medicines, but only for a while…”

The pricing of drugs is probably one of the most contentious issues between developed and developing nations. Countries like India, Argentina, Brazil, and Thailand that manufacture generic drug, which go on sale at affordable prices, have passed laws ameliorating the deleterious effects of the decreased expiration date on phony patents.

Although profits are essential to innovation in science, why are there so many me-too drugs (i.e. Nexium, statins, etc.)? And why are there fewer phase I clinical trials and a surge in phase 2 and 3, which only test the effect of slight variations on old drugs?

If you are interested in this issue you should read “The Truth About Drug Companies” by Marcia Angell.

The UN has committed to developing a set of Sustainable Development Goals (SDGs) that will build upon the Millennium Development Goals (MDGs), which end in 2015, in order to link the eradication of poverty, maternal mortality, and infectious diseases to the protection of the atmosphere, oceans, and land. As one of the scientists spearheading this effort, Johan Rockstroem, stated, “we are now at the point that the stable functioning of Earth systems is a prerequisite for a thriving global society and future development.” The recent drought in Somalia, the rising water levels, the acidification of the ocean, the air pollution in China and the UK, and the deforestation in South America are harbingers of not only environmental, but also socioeconomic, disasters. In order to address broad environmental concerns, a group of international scientists propose six SDGs: ensure thriving lives and livelihoods; sustainable food security; sustainable water security; universal clean energy; healthy and productive ecosystems; and governance for sustainable societies. The classic model of sustainable development since 1987 has focused on economic, social, and environmental factors, but has failed to integrate these three issues to meet the needs of the present while protecting the environment on which the general health and well being of current and future generations depend.

Despite the urgency to address global environmental concerns, some developing countries fear that a new focus on SDGs will divert aid from MDGs that have not yet been achieved and overburden the already sprawling developmental aid agenda. The proponents of the SDGS, however, argue that the SDGs extend many of the targets of the MDGs and work towards more long-term goals. Thus, the SDGs and MDGs do not operate within a different framework, but are intertwined: the SDG on thriving lives and livelihoods, for example, seeks to “end poverty and improve well-being through access to education, employment and information, better health and housing, and reduced inequality,” which is the focus of the MDGs. Although several scientific initiatives, such as the UN Environment Programme, the IHDP, and Future Earth are collaborating to develop the SDGs, it will be difficult to generate the necessary shift in global development agenda from addressing the MDG’s short term goals focusing on the social determinants of health to the SDG’s long term goals emphasizing the broad issues of sustainable development, which will require a multi-sectorial approach and a shift from donor/beneficiary country relationships to meaningful international partnerships that encourage policy coherency and global collaboration.

Successful and Schizophrenic. This is an interesting op-ed by a self-proclaimed, successful schizophrenic who was granted the Genius Award by the MacArthur Foundation. The media has often either villainized the potential violence of those who are mentally ill or romanticized it in its depiction of mad scientists or musicians. This article reminds us to differentiate a diagnosis from a prognosis.

India’s Aravind Eye Care Center

Atul Gawande suggests that the Cheesecake Factory restaurant chain — with its size, central control and accountability for the customer experience — could be a model of sorts for health care. Interestingly the world’s largest provider of eye care in India has found success by directly adapting the management practices of another large enterprise, and one that is not often associated with good health: McDonald’s.

In India, 12 million people are blind, the vast majority of them from cataracts that tend to strike people in India before 60. Blindness not only robs these people of their ability to see, but of the possibility of joining the workforce, leaving them dependent or homeless. Dr. Govindappa Venkataswamy created the Aravind Eye Care System, which began as an 11-bed hospital, but has now become a large and successful network of hospitals, clinics, community outreach efforts, factories, and research and training institutes in south India that has treated more than 32 million patients and has performed 4 million surgeries.

Many health nonprofits in developing countries rely on government help or foreign aid, which was often the case when for many of the non-profits and NGOs in southern India, the poor provinces in Argentina, and in the townships of South Africa. Aravind’s main services, however, are sustainable because patient care and the construction of new hospitals are funded by fees from paying patients. Since Aravind works with the effiency of an assembly line at a factory, it allows paying patients to subsidize the ones who cannot afford to pay for treatment while still maintaining low prices. The high volume of patients is key because it allows fixed costs to spread among many people. Although Aravind’s model of care is not ideal for many diseases it can be applied to simple procedures like male circumcision, which decreases the rate of transmission of HIV.

What is best about Aravind’s model of care, as opposed to many foreign NGOs or non-profits, is how refreshingly noncolonial it is. Aravind is run by Indian doctors and is completely sustained by patient fees. This makes it feasible for clinics of this nature to treat people in even remote, rural villages that the government may hesitate to fund.

Click here to read the article, which discusses the nutritional components of human milk, mainly the human milk oligosacharides, that may prevent HIV transmission from mother to child while breast feeding. In developing countries where noncommunicable and infectious diseases threaten vulnerable children, formula milk, which is expensive, may not be the solution for mothers infected with HIV. Although there is a 15% transmission rate, breastfeeding is deemed worth the risk for these mothers because their child may be protected from other diseases by their mother’s nutritious breast milk. More research must be done to investigate what components of breast milk prevent HIV from being transmitted from mother to child.

“A recent court ruling that favored freedom of speech over the authority of the US Food and Drug Administration (FDA) to regulate off-label drug promotion may have profound implications for the way drugs are marketed and, ultimately, for patients’ interests.”

The off-label use of medication in the medical community is common practice. A doctor or even friends may recommend that you use a drug for ailments that may not be specifically associated with the drug in question and the drug’s efficacy to treat that particular ailment is clinically untested.

“Under the Food, Drug and Cosmetic Act (FDCA), which gives the FDA its regulatory authority, it is a crime to promote a drug for purposes not listed in its label.”

Alfred Caronia, a sales representative for Orphan Medical, recently promoted a drug, Xyrem, whose active ingredient is g-hydroxybutyrae or the date rape drug, for uses not approved by the FDA, such as for fibromyalgia, restless legs syndrome, chronic pain and Parkinson’s disease

What is astonishing is that In a 2-to-1 decision, the judges stated that banning off-label marketing violated the representative’s freedom of speech.

The decision may be appealed, but if it is not this will have serious repercussions. Researchers are currently supposed to test a drug’s efficacy in treating specific condition. Even if an FDA-approved drug may be useful in treating a condition if its efficacy in treating that specific condition is not clinically tested then it is illegal to promote it for a purpose not listed in its label.

Clinical trials have generated many “me too” drugs (new drugs which are slight variants of drugs that are already on the market), and have encouraged researchers to publish and make money off of drugs that are already on the market by testing their potential efficacy for other conditions, trends which do not encourage innovative, clinical trials for entirely new drugs. However, as this article shows, it is important to emphasize the need for drugs to undergo rigorous clinical trials for each specific purpose in order to ensure their safe consumption by patients.

nature1 (click to read the NatureMedicine editorial)

“Baselessly categorizing at least 130 million Americans — and hundreds of millions in the rest of the world — as people in need of “treatment” for their “condition” serves the economic interests of, among others, the multibillion-dollar weight-loss industry and large pharmaceutical companies, which have invested a great deal of money in winning the good will of those who will determine the regulatory fate of the next generation of diet drugs.” Click here to read the article.

This study led by the CDC and the NIH is stunning because it challenges the notion that thinness equals good health. However, this observational study does not control for variables; it only notes correlations, which do not indicate causality. Nonetheless, it will force scientists, doctors, and patients to reevaluate what they label as “healthy,” and think more critically about the ways non-diseases, such as being overweight, are “medicalized” as a useful marketing strategy that underpins the growing weight loss industry, which includes the countless documentaries, videos, pills, and other supplementary tools that help people lose weight.

“In November, social media erupted over the case of a 25-year-old man seeking treatment for lung cancer who was turned away from two Beijing hospitals because he was H.I.V.-positive.” Click here for the full article

This is just one example of the many in which men and women who are HIV positive are discriminated against. What is surprising is that even among educated professionals the stigma against HIV persists. A doctor with HIV was shunned by other doctors in China because they felt they were at risk of contracting the virus by merely shaking the doctor’s hands and being near his lab coat. The growth of civil societies that can not only cater to the medical needs of HIV infected individuals, but can also debunk many of the myths associated with this disease by going to schools or passing out pamphlets to people during educational events open to the public. As with many biomedical and public health issues, the problem is also political. The government needs to support civil societies and non profits that cater to HIV infected individuals and stop censoring matters concerning homosexuality and HIV.

It is important to emphasize that civil societies should be leading this effort with the help of the government because it would leave the matter at the hands of the community, empowering those affected by the disease to seek their own way of making a difference.

In Buenos Aires, Argentina, for example I met with the director of the Ministry of Health, as well as, with a civil society led by HIV infected individuals from different provinces in Argentina. Although the Ministry of Health is useful in handling large tasks, such as creating policies to improve the sexual education at schools, civil society leaders feel it is their job to point out the problems that are particular to each community, while empowering local leaders to take part in the movement to spread HIV/AIDS awareness.