Category Archives: Health

What kind of patent protection does India want?

In today’s Wall Street Journal Ronald A. Cass asks “does India want drug innovation or not?” That question, which he answers himself in the appearent negative, is in response to a recent Indian High Court decision rejecting Bayer’s case against Cipla to market a generic version of the Bayer anti-cancer drug Nexavar. The article concludes with the ominous warning that India is wasting away its future by diluting patent protection from anything but the absolute:

Activists, generic producers and their allies will applaud trading future gains for access to cheaper drugs now. India’s government, however, should look at the nation’s longer-term interests. Apart from living up to the country’s international commitments, decisions like the High Court’s Nexavar ruling will deter investments in innovations that will help secure India’s future—doing more for the nation’s health and economy than copying can. After all, access to copies isn’t worth much when there’s nothing to copy.

Breaking down the argument

Mr. Cass’s conclusion is based on a series of arguments that must first be recognized and that go something like this – national health is heavily influenced by the availability of new drugs, drug innovation is driven by investments in R&D, R&D investment is tied to patent protection, and patent protection must be absolute for it to encourage R&D investment. Since the HC decision weakens (in Mr. Cass’s interpretation) patent protection, it results in reduced drug innovation and hence puts at risk the country’s state of healthcare.

There are four arguments in this causal chain and each of them is at least partly wrong. Let us take them in turn.

What was the HC decision about?

First, does the HC decision weaken patent protection? No. In fact, the case was not about patent protection and the court did not even consider whether Cipla had a patent for its generic copy of the drug. Rather, the question being addressed was whether a company needs to have a patent to receive marketing approval from the drug regulator (the DGCI). As BNET reported, “The high court’s ruling suggests that the DCGI should look only at safety and efficacy in granting approvals, and leave patents to the courts.”

Bayer, in its case, had tried to prevent the DGCI from granting a license to Cipla on the grounds that the drug may be “spurious.” But as the court pointed out not all drugs made in India are spurious nor does a patent guarantee safety. It is the DGCI’s job to ensure a drug is safe. Patents, however, are to be enforced in court.

Therefore, this decision does not weaken existing patent protections. What it does do is prevent multinationals from raising patent protections beyond what has been provided for in existing law – which according to the WTO is very much within the provisions of the TRIPS agreement.

Does patent protection increase R&D investments, which increases drug innovation?

The next two causal steps in Mr. Cass’s thinking are that patent protection would lead to increased R&D, which in turn would lead to increased innovation. Yet, this is clearly wrong. It has been known for quite some time that drug R&D investment by big pharma is driven not by patent protection, but by expected returns. While patent protection does help ensure expected returns, the primary variable is the size of the market. This was known as the 10/90 gap. Today it is visible in the lack of investment by big pharma into TB, malaria, Chagas’ disease and other tropical or developing world diseases. In other words, no amount of patent protection will get big pharma to invest in the diseases that inflict billions of India’s poor – simply because they do not constitute a viable market.

Nor does increased R&D investment and protection lead to drug innovation. A study from Thailand “found no increase in technology transfer and foreign investment as a result of increased patent protection.” On the contrary, increased patent protection can lead to perverse incentives that actually reduce drug innovation, encouraging companies to invest not in R&D but in protecting their patents.

What improves national health?

The last argument Mr. Cass makes is that national health is tied to drug innovation and availability. On this he is certainly partly right. National health will improve as drugs become available to tackle diseases prevalent in the local context. However, he overlooks two critical aspects of his argument.

First, healthcare delivery issues aside, drugs for many diseases will never be available in India till people are rich enough to afford them. And second, that drug availability is not simply a matter of innovation but of price. In other words, national health will improve not only if a drug has been created for a disease, but if it is also affordable for the local population.

How much patent protection?

It would appear each of the four assumptions Mr Cass makes are partly or entirely wrong, rendering the article invalid. Mr. Cass also ignores a growing body of evidence, including scientific studies, that suggest that the patent system is reducing innovation in general and drug R&D in particular.

In view of this, the HC judgement seems to be a good balancing act. It retains the letter of the law and does nothing to reduce patent protections. But it does clarify the division of labor between the courts, the DGCI, and the Intellectual Property Appellate Board. Most important, it prevents multinationals from trying to raise patent protections through judicial action, rather than by legislation.

Mr. Cass, who is Chairman of the Center for the Rule of Law, should have been elated at the judgement. Instead, he is content to condemn India’s poor to death for the benefit of a future not yet certain (and for Bayer’s profit). This may be an easy tradeoff to make ensconsed in Boston. But I would go with the judge’s interpretation of the case.

Introducing Global Health

Global health policy and practice continue to be key issues on the development agenda. Since the Doha Declaration of 2001, developing countries have been extremely vocal on framing this agenda. Simultaneously, a host of innovations in the development of new drugs and the delivery of public health have transformed the public health landscape. Where health systems in the developing world were once all operated by public authorities, we now have a fragmented system funded by governments, aid agencies, MNCs, and large non-profits (most notably the Robert Woods Johnson and Gates Foundations).

To track this changing landscape, the THD (Technology, Health, and Development) Blog has reinvented itself as Global Health Ideas. Aman, the blog’s co-founder, gave this reasoning for the shift:

Because of increased attention and scope we decided it was time for a more permanent home that would also allow us to do more. We are still going to be blogging about global health solutions, innovative projects and the use of technology.

I’ve been following (disclosure: and occassionally blogging) on the THD Blog for a few years. It is an excellent resource that takes a practical perspective on health issues – looking at innovations that have the potential for real impact in developed and developing countries. If it relates to health, it likely will be discussed on this blog. And this week Aman and his co-conspirators will also be live blogging from the Global Health Council‘s annual meeting in Washington, D.C.

Head over to get your dose of health ideas.

Swine Flu Exposes Limits of Google Trends

Update: See this new NYTimes story that talks about where Google Flu Trends works and how. It validates the problem of “noise,” while providing new information on how the Flu Trends algorithm works.

Swine flu is in. In the rush to cover this latest possible pandemic, newswires are alive with activity, blogs and social networking sites are buzzing, and the CDC and WHO are back in the limelight. This despite the fact that the number of cases are limited (only 40 confirmed infections have occurred in the US).

The rush of news has been accompanied by a rush to track that news. The WSJ, amongst others, has a tracking website, including a map of infections in North America. Best of all, Google has a map showing how the infection is traveling.

This rush was started by Google Flu Trends, a website that tracks flu-related search queries to estimate influenza levels in different US states. Further studies suggested the same approach might work for other diseases as well.

Analyzing Google Trends

So how has Google Trends, the broader application of the Flu Trends concept, performed in the current scenario? A quick analysis shows that Google search results did in fact increase over the past few days (see chart – source: Google Trends).

Google Trends for swine flu (April 26, 2009)

A quick analysis shows three items worth mentioning:

  • First, while Google Trends does show an increase in search activity on “swine flu,” the first uptick in activity only occurred on April 23. By contrast, the first news stories appeared on April 21 when two cases were confirmed in California.
  • Second, Google Trends reports that the majority of search queries were from New Zealand, USA, UK, Canada, and Australia. Only a very small minority were from Mexico. Yet, Mexico is the country supposedly at the heart of the pandemic.

Explaining the Discrepencies

I had used a Google Trends like methodology two years ago to track the evolution of climate change as an issue in news coverage. Having worked on that, I can propose a few general reasons that explain why Google Trends is limited in this case.

First, it appears that Google Trends follows with some time lag, actual infections. This should not be surprising, as people are not likely to search for a disease before having had some exposure to it. This does not mean that it is not a useful tool for tracking diseases over the long term. At the very least, the response time of a system based on GT might be lower.

Second, the current scenario shows that Google Trends is highly susceptible to “noise.” Prior to this outbreak, swine flu was probably not a commonly known disease, and queries on it were extremely rare (if not non-existent). Thus, even the slightest uptick in search activity would show up as a major change. That uptick was provided by the highly charged media coverage of the subject. Given this, one wonders if the search results are more “noise” and less people with a genuine interest in the subject. So, Google Trends is likely to be more accurate where general knowledge of a subject (the baseline) is high, and media coverage (noise) is low.

Finally, and most interestingly, why is it that most of the search results came from the US, while Mexico is more exposed to it? Not surprisingly, this methodology only works where both a large number of the population and media are on the internet.

What Next for Google Trends?

When discussing why most search queries occurred in the US, it is worth noting another fact about the swine flu outbreak – that it has traveled extremely fast. Originating in Mexico, it has been carried to the USA, Spain, and New Zealand. This brings into question the validity of using the geographic source of search queries as a reliable indicator of where the disease actually is.

Still, it may also offer a way to enhance Google Trends. What if Google Trends data was combined with travel data on the number of people traveling from a “hotspot” of an infectious disease. It would be logical to assume that popular destinations, or ones which receive travel groups, would be the most likely next locations for further infections. Thus, a map could potentially be created of not only where the disease is generating interest, but where it might be headed.

Of course, Google does not have access to such data – though at some point it may decide to acquire a travel operator. But the general lesson is simply that to make Google Trends more useful, search query data needs to be looked at together with real-world data (such as travel data or hospital records).

It is still early days for the swine flu outbreak, but some commentators are already suggesting the “social web” has actually created hysteria rather than help track the disease. That may be true, but it is hardly a problem of the “social web.” As a reader on the FP pointed out, “Twitter is only a natural extension of a typical neighborhood.”

So, in this “typical neighborhood,” what the swine flu outbreak has done is illustrate where Google Trends does well – in tracking general interest amongst heavy Internet users. But it also exposes limitations – the methodology is (not surprisingly) susceptibility to “noise” from media coverage and is biased towards countries and issues that are online. This does not mean that the idea itself is flawed. Just that it must be taken with a pinch of salt, and that it needs work – especially interfacing it with real-world data streams – to make it really useful.

Bargaining Through Compulsory Licensing: ARV Treatment in Brazil

The peer-reviewed PLoS Journal is carrying a study by Amy Nunn of the Harvard School of Public Health, on the “Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment” (PDF here). This is a fascinating study on how Brazil has used aggressive negotiations with big pharma, combined with the credible threat of issuing compulsory licenses for generic manufacture, to bring down the prices of patented drugs. It concludes:

We estimate that the total cost savings resulting from price reductions for patented drugs was approximately US$1.2 billion from 2001 to 2005.

Continue reading Bargaining Through Compulsory Licensing: ARV Treatment in Brazil

How Health Aid Undermines Health Systems

The FT is carrying a full page analysis on the impact that “vertically integrated” healthcare aid programs, such as for HIV/AIDS, have on public health systems in the developing world.

There are some startling statistics on just how much is being pumped into these fashionable diseases – HIV, malaria, and into vaccine research. For instance, in Rawanda, a third of all IDA for health (about USD 47m) went to HIV/AIDS. In comparison, malaria received USD 18million, and only USD 1 million was spent on integrated management of child illnesses – though both were judged more serious priorities by the authorities.

Continue reading How Health Aid Undermines Health Systems

Tropical Virus Moves North as Europe Warms

BBC News reports that a “debilitating tropical virus carried by mosquitoes” is manifesting itself in the norther Italian town of Ravenna. The extent of the disease, is minor – only 160 cases thus far, and 1 death. The disease is known as chikungunya, is relatively rare, and usually found in the tropics. However, it seems to have mutated, and moved north.

An interesting factor in the migration of the disease may also be changing temperatures:

Professor Antoine Flahault, who coordinates French research on chikungunya, said the Italian outbreak was a “world first” outside the tropics. 

“The mosquito vectors (carriers) of this disease have been in Italy for several years. All we know is that increased temperatures and humidity make the climate more tropical and favour the proliferation of mosquitoes,” he said.

We all know of the bird flu virus, which has been a headache for authorities in Europe and the rest of the developed world. Bird flu migrates with people, a natural corollary of globalization. Globalization increases the likelihood that a disease will be able to move.

This migration of a virus suggests that worse may yet be on its way. As the planet and Europe warm, the likelihood that a disease will be able to stay also goes up, by homogenizing the climate across regions.

There is a silver lining though. If the rich world is afflicted by the same diseases as the poor, maybe we will no longer have such things as “neglected diseases” and the 10/90 global health gap.

Income Inequality in Asia Growing

The ADB has just released a report titled “Key Indicators 2007: Inequality in Asia” (covered in IHT and BBC). The report concludes that the gini index, a measure of relative inequality had grown in all 15 countries studied, since the 1990s. More alarmingly, absolute inequality had grown even more. The bank identified the trend as “the rich getting richer faster than the poor”:

Indeed, underlying many of the cases of increasing Gini coefficients is a growth process in which those at the top of the distribution (top 20% here) have seen their expenditures/incomes grow considerably faster than those at the bottom (bottom 20% here).

This report is follows on my previous post on the IEB on income inequality in India. In that I made some fairly basic points that a) income inequality was increasing in India (as measured by the Gini index), b) this was undesirable because income inequality reinforced social exclusion, (as a case I showed that inequality negatively impacted access to healthcare), and c) insofar as growth had not reduced, and possibly contributed to, inequality, India should revisit the kind of growth it engendered.

Continue reading Income Inequality in Asia Growing

Indian Court Rejects Novartis’ Legal Challenge

The Chennai High Court has just announced its decision on the case brought by Novartis against the Indian Patent Act. The Court rejected Novartis’ challenge saying that it has no jurisdiction on the matter.

The news has received near blanket coverage (covered in IHT, Forbes, as well as SciDev, MSF). Interestingly, Novartis has suggested it will not appeal the decision.

“We disagree with this ruling however we likely will not appeal to the Supreme Court,” a Novartis spokeswoman said by phone from Basel in Switzerland.

This decision is significant both for what it does and for what it does not do.

Continue reading Indian Court Rejects Novartis’ Legal Challenge