Great News, but Innovative, Really?

Byoliveridley

The “innovation” in this approach is not scientific, but economic.

Cheap drugs for poor nations | Guardian Weekly | Guardian Unlimited

Improvements they devise to the molecular structure of an existing, expensive drug turn it technically into a new medicine that is no longer under a 20-year patent to a multinational drug company and can be made and sold cheaply. The process has the potential to undermine the monopoly of the big drug companies and bring cheaper drugs not only to poor countries but back to the UK.

Okay, I may be missing something here, but this is not a scientifically innovative strategy. They are called Me-Too drugs. Pharma has been doing this for years. Read this article in the Stanford Medicine Magazine about exactly how this is done.

Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.

Is Nexium better? So far,

there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.

This is a well known and well used strategy. The Government Accounting Office (GAO) recently released a study which concluded that 68% of all drugs developed in the US between 1993 and 2004 were Me-Toos.

So, what is “innovative” and “revolutionary” about this approach is that non-profits are driving the drug development. By outsourcing the entire clinical trial to India, substantial savings are to be had. By not having to fund the US shareholders’ need for huge profits, enormous company overhead, high salaries, multi million dollar executive bonuses and marketing expenses that US/European pharma require, cost savings are potentially huge.

The downside? Well, unless the studies are run according to US/EU GLP/GMP guidelines, data quality, and therefore, drug safety can be suspect. The pedigree of the people involved in this effort makes it unlikely that the data is going to be suspect. If their ultimate aim is to sell these drugs in England, then they will have to meet the most stringent standards available.

Of course, these drugs will never hit the US of A. I can already hear the fear mongering, the safety doubts being raised, the “terrorists may get their hands on your pill” bogey, etc. But, Americans can afford to pay for their drugs more than your average Indian suffering from Hepatitis C can. Once the already teetering (by first world standards, of course!) healthcare system in the US gets closer to collapse (by first world standards, of course!), some of these “innovations” will become more viable in this most reactionary of countries.

I hope this model is proven to be viable.

Similar Posts

  • |

    Environmental Racism, Global Warming Edition

    Byoliveridley

    As armchair critics debate endlessly on the virtues and vices of carbon trading versus carbon taxes, they are in no danger of losing their armchairs (or their homes, or their money, or their livelihood). Africa and Asia, not so lucky.

    Poor Nations to Bear Brunt as World Warms – New York Times

    Two-thirds of the atmospheric buildup of carbon dioxide, a heat-trapping greenhouse gas that can persist in the air for centuries, has come in nearly equal proportions from the United States and Western European countries. Those and other wealthy nations are investing in windmill-powered plants that turn seawater to drinking water, in flood barriers and floatable homes, and in grains and soybeans genetically altered to flourish even in a drought. In contrast, Africa accounts for less than 3 percent of the global emissions of carbon dioxide from fuel burning since 1900, yet its 840 million people face some of the biggest risks from drought and disrupted water supplies, according to new scientific assessments. As the oceans swell with water from melting ice sheets, it is the crowded river deltas in southern Asia and Egypt, along with small island nations, that are most at risk.

    I read another story about Bangladesh recently, apparently in Bangladesh, there will be both flooding and drought due to cimate change!

    We are fighting climate change on the front line,” Professor Nishat
    told The Independent earlier this year. “But the battle has to be
    integrated across all countries.”

    Bangladesh has good reason to feel aggrieved at global warming. Its
    annual carbon emissions only 0.172 tons per capita, compared to 21 tons
    in the US.

    If the rivers dry up, it would leave Bangladesh completely at the mercy of the rains.

    What is to be done? There are no simple answers, but this is a global issue that requires a global solution. There needs to be a relentless push for efficiency and conservation, with technologies being made available sans intellectual property and patent protection to help India and China control emissions. Efficiency is where the low hanging fruit are. This wikipedia article is a decent compendium of options.

    Europe has started on the control path already. The U.S has to act, will it do anything this year? Or do we have to wait for this? I am very cynical about the West’s ability and willingness to act in this regard. When the prime contributors and benefiters of a harmful action are not the same as the ones who will face the worst consequences, where’s the will? As life in the third world becomes more miserable, the rich countries can always build more walls.

    No fun and games here!

  • | |

    Indian Parliament Discusses Climate Change

    Byoliveridley

    India stresses on Kyoto standards-India-The Times of India

    The discussion on global warming in Parliament will end with the statement of environment minister A Raja, possibly on Monday. He is bound to restate the country’s position on climate change in the international arena — that countries must bear “a common but differentiated responsibility” for climate change, a phrase that is the central pin of the Kyoto Protocol.

    De-jargonised, it means, while every country is adding to the problem, there are some that are more responsible than others, and should, therefore, bear the burden and costs of cleaning up more than the smaller culprits

    More highlights…

    The US, between 1950-2003, emitted 10 times more carbon dioxide than India did. Europe emitted 8.5 times more. Yet US and Australia, two of the biggest emitters of greenhouse gases, have refused to ratify the Kyoto Protocol (which asks developed countries to reduce their emissions) on the pretext that developing countries like India and China are not undertaking emission cuts.

    Worse still, if one looks at per capita emissions from different countries, which is a more equitable way of calculating emissions if one was to go by the principle that each person has as much right to the atmosphere as another, then India ranks a mere 120 compared to US which ranks 6 and Australia 10 on the culprits’ list. This is taking the emission levels of 2003.

    Well, they are right, and they are wrong too. The developed world has a lot to more to cut back on and should make the bulk of the cuts. But India and China also need to grow using current state of the art knowledge, not using the 1950s coal intensive, energy inefficient model of increasing supply without paying attention to demand. We have also come to realize that IPCC reports, due to their consensual nature, are conservative. So, they will tend to understate the effects of climate change and overstate the costs. It may not be as expensive in India and China as long as attention is being paid to hw the infrastructure is being developed.

  • | | |

    The real terrorist: Pollution

    Byoliveridley

    It is true. A staggering number of people die every year due to lack of access to clean water, air or food. Aggregate statistics like these are a good way to summarize the humongous nature of the problem. While reams and reams of coverage and attention are focused on “terrorists”, people all around the world die of much more mundane causes such as bacteria in water, smog, poverty, starvation, malnourishment, etc.

    ScienceDaily: Pollution Causes 40 Percent Of Deaths Worldwide, Study Finds

    About 40 percent of deaths worldwide are caused by water, air and soil pollution, concludes a Cornell researcher. Such environmental degradation, coupled with the growth in world population, are major causes behind the rapid increase in human diseases, which the World Health Organization has recently reported. Both factors contribute to the malnourishment and disease susceptibility of 3.7 billion people, he says.

  • |

    India, The Emerging (polio stricken?) Tiger

    Byoliveridley

    States on alert against polio – NDTV.com – News on States on alert against polio

    India appears to be in a grip of a polio outbreak with 352 cases reported so far this year, many of them from areas that were free of the virus, and officials fear the number may increase further. Uttar Pradesh alone has reported 312 cases, the highest of all the states, and World Health Organisation officials have described it as an “exporter” of the disease.

    In Uttar Pradesh, officials said 90 percent of the cases were due to ignorance in the minority Muslim community, who believed the polio vaccine could make children impotent.

    From wikipedia

    Only four countries in the world (Nigeria, India, Pakistan, and Afghanistan) are reported to have endemic polio.

    I remember reading about a Nigerian Province issue with Clerics claiming “that vaccines supplied by Western donors were adulterated to reduce fertility and spread AIDS as part of a general war on Islam”, which the Wikipedia Polio article verifies. But we have never seen this in India before, and I find it hard to believe. I will remain sceptical about the Muslim clerical influence on India’s polio debacle unless I hear better. News from India sometimes builds its own “truth momentum”, with speculation and hearsay morphing into bulletproof truth in a matter of hours. It is also easy in India to start rumors to deflect blame.Here’s a contrarian take from a Reuter’s Article

    “Tens of thousands of children were missed by state health workers over the past year during rounds of immunization, leading to a resurgence of the virus, they said.

    “We are very concerned. It raises the threat to India and is also threatening other countries,” said Jay Wenger, head of the National Polio Surveillance Project, a collaboration between the WHO and the Indian government.

    One federal official said around 10 percent of children in several western districts of Uttar Pradesh, known for its ramshackle state health care and sluggish bureaucracy, could have missed immunization between late 2005 and early 2006.

    “These (vaccination) rounds were of poor quality,” said the official, who did not want to be named.”

    Well, sounds more logical, does it not? But why let the depressing truth of inadequacy get in the way of a juicy and self-perpetuating tale of Muslim backwardness.

    India, the emerging tiger.

  • |

    Eastern United States vulnerable to climate change

    Byoliveridley

    http://www.eurekalert.org/pub_releases/2007-12/pu-sdn121007.php
    6157_rel.jpg
    Time to get out of the Eastern United States? A study to be published in the Proceedings of the National Academies of Science tries to quantify the relative risk of climate change using something called a “socioclimatic” risk factor. As always, the redder the worse. A look at the paper would no doubt be more illuminating, but for some reason, press releases about PNAS papers come out way before the papers actually become public. China is in bright red all the way, India in a rather bright orange. Where I live, the Eastern United States, is a nice beet red. No doubt, the unprecedented drought the South is experiencing right now is a nice big red signal.

    Interesting stuff, though the actual paper will tell the story. Any technique that tries to integrate all the complex scientific, social and economic variables of climate change into one number is bound to have a flaw or two. But such a metric is useful for estimating relative risk, as the authors themselves say.

    He added that the study does not address the absolute degree of impact or risk.

    “This study illustrates exposure of one nation relative to another,” Diffenbaugh said. “Thus, it is important to note that a country low on the relative scale could still face substantial risk.”

    Blogged with Flock

    Tags: ,

  • |

    "Eminent Domain" Police Firing Update

    Byoliveridley

    I had written recently about police firing deaths in West Bengal. It appears that there is a lot more to this story than a case of police overreaction.
    BBC NEWS | South Asia | Ten held over India police firing

    But there are suspicions that outsiders may have joined the police force to attack the villagers in Nandigram, protesting against the planned acquisition of farmland for an industrial complex.

    The West Bengal government has now said it is abandoning the project.

    “Outsiders”? That’s informative! Who might these “outsiders” be? More from an Indian source:

    The Central Bureau of Investigation -, probing last Wednesday’s Nandigram deaths in police firing, Saturday recovered a huge cache of arms and ammunition from Khejuri, a base of the Communist Party of India-Marxist -.

    Ten people, presumed to be members of the CPI-M, were arrested by the probe agency during the operation.

    The CPI-M is West Bengal’s ruling party, having been in power for more than thirty years. So the emerging hypothesis is that some “operatives” (read goons) from the ruling party decided to “help” the police clear out the protesting villagers. The tragedy has gone national because the CPI(M) is a supporter of the ruling coalition in India.

    It’s a complex issue, one that I want to learn a lot more about. But the gist of the story is that the ruling Communist party in Bengal is trying to kick start industrial development that has been stagnant for many years. The Haldia Development Authority has been tasked with this rather difficult task, and has been going about its merry business trying to acquire land and setup industrial parks and so called special economic zones.

    The issue here is not the idea, which is sound, but the process, which has been top-down, and designed and implemented with no input from the people who will be affected. Some level of increased industrialization will provide more infrastructure, jobs and money eventually. But the process needed to be planned so that the farmers affected could transition a little more easily from their generations of farm employment. Medinipur, the district where Nandigram is located is predominantly agricultural with 65% of the rural population working as farmers (source Indian Census 2001). There are nearly 6 million people involved in agriculture in this district alone. That’s an arkload of people who will be affected by a major change in the occupational profile, they need to be considered and consulted.

    So when the people affected protested and took the site over, the Chief Minister of West Bengal,  Budhaddeb Bhattacharya, asked the police to clear them out, and I guess they took that literally.

    These protests are spreading, with unrest in Orissa as well. The good news is that there’s been a lot of outcry, and the whole program has been put on hold pending a national policy on acquisition of land for industries. India is not China, people know how to organize, protest and generally make themselves heard. More importantly, the press will cover stories like these (at least for a few weeks, or until India loses to Bangladesh in the Cricket World Cup! – This happened on Saturday!), so development necessarily takes a slower and more tortuous path. That is not always a bad thing. Will they get the process right the next time they do it, I am not sure, but hopefully, these deaths will not have been in vain.

One Comment

Comments are closed.