Life-Saving Drugs - The Great Game

"Just as you cannot blame a dog for barking, companies cannot be blamed for seeking profits. The real villains here are governments and public servants who have betrayed public trust."

"Fire in the Blood" is one of the most thought-provoking documentaries I've seen in a long, long time.

It makes you question so many things that you always considered as self-evident truths: R&D costs big money; companies spend billions sifting through thousands of molecules to discover one that can be converted into a medicine or vaccine; Indian companies produce illegal, ineffective copies of patented drugs....and in 87 minutes you realize that all this while, you've been a naive, gullible idiot.

The award winning documentary is about the battle against the HIV-AIDS epidemic in Africa. It is about the role of small individuals and small third-world companies taking on the might of global pharma MNCs. Consider these timelines:

• The first anti-retro viral (ARV) drug, AZT came out in 1963. It was released 1985, with a patent cover up to 2005. Just as the patent was expiring, Glaxo claimed that the drug was effective only in combination with another drug, and had the patent cover extended patent till 2017. In effect, patent protection for the same drug was stretched and "ever-greened" to 54 years!
• 1996 - discovery of the triple ARV combo against HIV-AIDS. The drug cost $15,000 /patient/ year.
• 2000 - Yusuf Hamied of Cipla offered to sell a generic of the triple-combo ARV for $800/year/patient; He offered free know-how to manufacturers in Third World Countries and offered the drug offered free to infected mothers. In response the pharma MNCs launched a massive publicity campaign maligning drugs from developing countries in general, and Cipla in particular.
• In 2004, Cipla brought down the cost to $360/p/y and finally once country - Uganda - decided to take up the offer to save its people. By then over 10 million more people had died of AIDS.

 Fire in the Blood is also quite instructive about USA's amazing hypocrisy and double-standards when it comes to public access to life-saving drugs..

Biotech Meets Nanotech

In India, Nano is the name adopted for a little car which was meant to be the most affordable car in the world.

On the other side of the globe, in USA, a scientist-entrepreneur of Indian origin is ready with something on a completely different scale. Dr. Anita Goel of Nanobiosym, has created a portable device called Gene-RADAR which, for the first time, can detect deadly diseases such as HIV/AIDS and tuberculosis in less than an hour, using just a drop of saliva or blood.

Incredible as this may sound, it is one of the many strides that being made with 'devices' that are no bigger than some molecules. In this case, Gene-RADAR uses nano-machines to detect specific DNA and RNA bio-markers in real time.

What are these nano-machines? A nano refers to a billionth measure (1/10^9). So a nanometer is a meter divided by 1000,000,000. It is a scale on which you can describe the size of molecules, parts of a living cell and the wavelength of visible light-spectrum.

Such devices are beginning to be used to detect the presence of viruses. As of now, the most accurate form of HIV viral load testing is  based on polymerase chain reaction technology,  a technique which amplifies a few copies of a piece of DNA to generate thousands or millions of a particular sequence for testing. In the U.S., the test costs about $200, and takes at least two weeks to get results, since the equipment used is large and not found in most hospitals.

At AIIMS in India, the premier, government-subsidized tertiary hospital in New Delhi, the same test costs about Rs.6000 (~ USD 100). Even then, it is way beyond the reach of regular patients.The is some hope that Nanobiosym's innovations will help bring down the cost of these tests.

Dr. Goel is  a pioneer in the emerging field of nanobiophysics, a new science at the convergence of physics, nanotechnology, and biomedicine. Her company aims to drastically cut the time and cost involved in diagnosing diseases, especially in parts of the world where it is difficult to install cumbersome lab equipment. Gene-RADARs are going to be field-tested in Rwanda next year, and possibly in India, later.

Under the current set of laws and regulations covering clinical trials, it is difficult to test the technology in India. It would be interesting to see how the device fares in Rwanda.

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REFERENCES & LINKS

* What to consider before a DNA test -- http://online.wsj.com/news/articles/SB10001424127887323308504579087103446161772

* Beikimpis, Victoria (2013) - Heal Thyself - http://mag.newsweek.com/2013/12/06/heal-thyself.html

* http://www.nanobiosym.com/our-team.html
- science & tech in society forum - http://www.stsforum.org/

* 23andMe - http://www.newsweek.com/fda-doesnt-want-you-unzip-your-genes-207358
- 23andMe - DIY genetic screening device - uses just a saliva swab
- Promised “health reports on 254 disease and conditions,” “carrier status,” “health risks” and “drug response” as a “first step in prevention…"

* http://venturebeat.com/2013/11/26/warning-letter-to-23andme-could-be-a-landmark-case-for-health-care/
- The FDA recently clamped down on a mobile medical app called uChek, pointing out that the company’s marketing was misleading.
-  Navigenics (a 23andMe rival that was acquired by Life Technologies for an unspecified sum)

* http://venturebeat.com/2012/08/13/using-a-few-drops-of-saliva-23andme-creates-a-song-out-of-your-dna/

* http://www.businessweek.com/articles/2013-11-25/a-portable-hiv-test-that-provides-results-in-minutes
- Gene-Radar uses nano-machines to detect specific DNA and RNA bio-markers in real time
- other lab-on-a-chip project - Theranos, for example, recently made its instant diagnosis technology available in some Walgreens (WAG) stores

* http://www.bizjournals.com/boston/blog/bioflash/2013/12/still-in-stealth-nanobiosym-sheds.html

* http://mag.newsweek.com/2013/10/18/cervical-cancer.html