15 March 2007

Drug Wars; the new AK-47


OK, So I understand that it takes science, technology, research, etc to develop a medicine. Of course, for every medicine that makes past the various stages of clinical trials, there are hundreds that fail in their infancy. When these compounds are seen to have beneficial effects, whose responsibility is it to get it to the appropriate populations and at what cost?

There are many issues to consider. Who are the appropriate populations are how are they defined? What medicines fall into this category to have a great impact? Are they "essential medicines" and who defines this? What about the laws in place to protect this property and their proprietors? What are the repercussions and implications to acting within the limits and outside the limits of the law? And of course lastly, how do we as a population of public health advocates, walk the tightrope by ensuring populations obtain the medicines without disrupting the balance of current donation schemes?

Let me ask you this: if you had in your hands the cure to a disease, or even a medicine that could alleviate the suffering of a child, a mother, a worker whose bones rattle with poverty at night when he sleeps, would you let it churn through the cycles of Intellectual Property and patent rights to eventually disseminate into the population? Are you confident that the population who truly needs it, or better yet deserves it will be able to access it?

How do we decide who is deserving of a medicine? Is it because you are born in a certain country; under a certain star; to certain parents? Is it because your discomfort is more than another? Is it because your silent pain is not heard by the those who need to hear it or that those who need to hear it have their i-pods plugged in too tight to be bothered by it.
Is someone labeled as "deserving" if they have less opportunity in a land of milk and honey versus someone who has more opportunity in the barren land of hope. How relative is it?

Let's look again and the definition of essential medicines:

The term "essential medicines" is defined by WHO as the medicines "that satisfy the needs of the majority of the population and therefore should be available at all times, in adequate amounts in appropriate dosage forms and at a price the individual and community can afford". Are these medicines defined by the people who live in these countries? This is do not know.

For example, recently Thailand declared Kaletra, an AIDS medicine, a lawful compulsory license allowing it to be reproduced. According to TRIP's, Article 31 permits countries to violate the patents to "be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use". Thailand has declared the AIDS epidemic a national emergency with various people demonstrating resistance to the current medicines out there and it is being used non-commercially.

What implications does this have? Well, a government declaring a national emergency should be at the discretion of the government. If for example, the U.S.A. had 10 reported cases of Ebola on a New York subway, I think that would warrant an emergency given the air borne transmission of the virus.

Even though Thailand was well within the limitations and completely legal by my understanding-a storm cloud looms over them. Abbott, the pharmaceutical company who produces this drug, engaged in negotiations with the Thai government.


The results:
Abbott has unilaterally offered to sell Thailand Kaletra at its fixed middle-income tiered company price,$2200/patient/year, a price that is 440% higher than the cost price Abbott offers to African countries and more than five times as much as what will be charged by generic producers once there are sufficient economies of
scale and competitive generic markets-(
Brook K. Baker, A New Low in the Pharma Drug Wars - Abbott Withdraws Seven Medicines in Thailand)


The whiplash is alarming. Abbott retracted applications for registration of 7 drugs including Kaletra
(The six other drugs are the painkiller Brufen; an antibiotic, Abbotic; a blood clot drug, Clivarine;the arthritis drug Humira; the high-blood pressure drug Tarka; and the Kidney disease drug, Zemplar.) The power of pharmaceutical companies in this day and age is as powerful as a medieval sword in the hands of a skilled swordsman.

As public health advocates, a great challenge lies ahead. Certain pharmaceutical companies have well established pharmaceutical donation programs that extend to corner of the earth that the average population deems extreme. However, these are few and far between.

We must first look at the disease and the population. From a Public Health point of view-will this population continue to spread the disease? However, with doing this, we create artificial subjective boundaries. Do we want to save the most people as possible, or everyone? What about the 1 in a million patient with a rare auto-immune disease? Is this patient left out due to sheer prevalence and transmission of the disease?

Ask the family what they think; if your mom/dad, daughter/son had one of these diseases, would you step back and say, forget about it-its too rare to care and cure. At what length is going "too far"? This ties back to societal altruism.

Altruism is not biologically favorable. The deer who comes out and sacrifices himself in front of the herd will never pass on these altruistic genes. Have we evolved past the biological contexts of our ancestors? Does this society we live in create an artificial "survival of the fittest" measuring fitness by convoluted political and economic mean. Ooops, sorry for the digression.......

This leads me to believe we should try to help as many people as possible. The case in Thailand serves as a brilliant case study to demonstrate the power of the Pharmaceutical world and how quickly it can go from a sheep to a wolf. I know feel with this power, the wars that are now waged with pharmas and people is more dangerous than the AK-47. In a global society where many developing countries, like Mozambique, have more AK-47s than people, I ask how is it that they do not have medicines or the right to access them.