Brave New Drugs

By Sarah Greene Brave New Drugs Intoxicating ideas for saving a billion lives A call to indie innovators to come up with affordable alternatives David Nutt was no stranger to controversy by the time he was fired as chair of the UK’s Advisory Council on the Misuse of Drugs in October 2009, after claiming that alcohol is more harmful to health, and to society as a whole, than many illegal drugs—including cannabis, LSD, and ecstasy. Though no

By | January 1, 2011

Brave New Drugs

Intoxicating ideas for saving a billion lives

A call to indie innovators to come up with affordable alternatives

David Nutt was no stranger to controversy by the time he was fired as chair of the UK’s Advisory Council on the Misuse of Drugs in October 2009, after claiming that alcohol is more harmful to health, and to society as a whole, than many illegal drugs—including cannabis, LSD, and ecstasy. Though not offering absolute legitimacy to reggae singer Bob Marley’s claim that “herb is the healing of a nation, alcohol is the destruction,” Nutt called for the use of scientific evidence to inform policy and ran up against a government that didn’t “want facts to get in the way of prejudice.”

Two months after being sacked he launched the Independent Scientific Committee on Drugs, with a mission to “investigate and review the scientific evidence relating to drugs, free from political concerns.” The indie group’s first major study was recently published in The Lancet (Nov. 6) expanding on Nutt’s earlier ranking of harmful drugs, with particular emphasis on the harms of alcohol. For revelers picking up this magazine after multiple toasts to welcome in 2011, an essay presents his thought experiment on developing a safer, synthetic alternative to alcohol, whose effects could be reversed by antidotes. A revelation! As many revelers can attest, along with George Bernard Shaw, “alcohol [substitute] is the anesthesia by which we endure the operation of life.”

The quest for independence from politics, profits, and influence peddling by megacorporations also underlies the surprising emergence of nonprofit pharmas, as reported in this issue. Chemist Victoria Hale established two nonprofit companies because she wanted to create affordable drugs for people suffering from disease in developing countries. Funded partially by the Bill & Melinda Gates Foundation, Hale’s Institute for OneWorld Health (iOWH) has succeeded in bringing drugs to market by partnering with for-profit manufacturing facilities. The article’s sidebar describes a “brave new world of creative structures and mechanisms”—other hybrid ventures encouraged by government initiatives, such as community interest companies (CICs) in the UK and low-profit, limited liability companies (L3Cs) in the US. These are stirring examples of governments rising above lobbyist influence to develop smart and novel policies.

Continuing on the indie theme, bioengineer, entrepreneur, and author Rob Carlson writes about “biohackers in the garage” who are tinkering with genomes to develop innovative approaches to making drugs and other products. This he puts in the context of the “prudent vigilance” recommendation issued in December by the Presidential Commission for the Study of Bioethical Issues, regarding how synthetic biology should be regulated in the US. Carlson warns that restricting access to these tools, in the name of public safety, could actually drive a dangerous black market, as did government efforts to regulate illegal drugs such as methamphetamine. While there is a need for oversight in this brave new world of genomic architecting, achieving sound policy while reaping the benefits of rapid innovation will require a public that can grasp the nuances of modern biomedicine and its methodologies. Hmmm, how and when is that transformation going to take place?

Andrzej Krauze

Yet the results are rolling in, leaving no doubt that small is beautiful. Examples of faster-better-cheaper? Yeast cells engineered to produce artemisinic acid, the precursor of a major antimalarial drug. Antibiotic treatment for visceral leishmaniasis, a parasite infection that kills 300,000 people annually, bringing treatment costs from $300 to $10–15. Flu vaccines developed in days to weeks rather than 12 months or more.

In the November 15 issue of The New Yorker, Michael Specter presents a disturbing narrative about epidemic tuberculosis, which claims a thousand deaths per day in India alone, and ten million new cases worldwide in 2010. Detection is key to curing infection, but there is no reliable, affordable diagnostic test. The GeneXpert device can diagnose TB almost without error in two hours, but costs an astronomical $25,000, and $20 per test. The article is basically a call to indie innovators to come up with affordable alternatives, with the nearly certain outcome of saving millions of lives.

And, if that isn’t a sobering task, how about garage-hacking synthetic alcohol? Just don’t forget the antidote.

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Comments

Avatar of: anonymous poster

anonymous poster

Posts: 1

January 13, 2011

Come on, give scientists some leeway and stop reaching for pie in the sky. $25,000 is not an astronomical price to pay for an instrument, it is actually quite cheap compared to most instruments that have the ability to help save lives. If we want a healthier society that uses the latest technology to do so, then we have to stop regarding capital purchases as the devil in disguise. Don't people know that companies make most of their profits from recurring reagent costs, and not initial instrument costs? If we continue to live in the world of grant funded research on the cheap, and using cheap human labor, then we just will have to accept that the health status of the world will not improve because those people will have a cost bias. Governments can come up with the money if they truly desire to improve the health of their citizenry.
Avatar of: HERBERT BINCH

HERBERT BINCH

Posts: 15

January 13, 2011

While reading this article and the previous article on Dr. Nutt and the synthetic, reversible effect alcohol, I was left wondering who was doing or what happen to all the safety and efficacy work necessary to validate those pharmacological targets. While I sit here (doing this) unemployed from my pharma research career thinking; ?Gee I could have had a V8?, then I read the last paragraph of the article:\n\n?The article is basically a call to indie innovators to come up with affordable alternatives, with the nearly certain outcome of saving millions of lives. And, if that isn?t a sobering task, how about garage-hacking synthetic alcohol? Just don?t forget the antidote.?\n\nEr? ?Indie innovators?; weren?t they those ?Rave? folks who brought the world ?Ecstasy? and ?date rape drugs?. And for the guy/gal commenting on the cost of instrumentation, well, just look at what Fisher or VWR charges for a standard roll of aluminum foil, or see how long it takes to get reimbursed from petty cash. I remember when I used to carry (and leave) a 10ml. bottle of ketamine, for veterinary anesthesia, in my lab coat. Now, every micro liter has to be logged and the bottle stored in a locked box in a locked drawer or cabinet. Is this what you mean by indie innovation?\n
Avatar of: anonymous poster

anonymous poster

Posts: 1

January 13, 2011

I have to agree. $25,000 is quite cheap for a piece of modern lab equipment, especially one that can play a direct role in saving so many lives.\nI took a look at The New Yorker article and I was left with the impression that the GeneXpert machine is considered to be a major breakthrough for diagnosing TB. In fact, one of India's chief TB consultants is quoted as saying: "The machine is so powerful that it could help end tuberculosis,"..."I don?t think that is an exaggeration."\nThe article seemed to be saying the technology is now here, but there are regulatory, bureaucratic, and educational hurdles in India which are yet to be overcome.\n
Avatar of: HERBERT BINCH

HERBERT BINCH

Posts: 15

January 14, 2011

?Governments can come up with the money if they truly desire to improve the health of their citizenry.?\n\n?Improve the health of their citizenry?? How about just attempting to decrease the population of the ones that do. I wonder if they use 12 year olds in the labs like they do in the steel mills (refer to National geographic a couple of years ago) or in their foundries and frock shops. I?d just be happy with being able to afford to use our (U.S.) healthcare system. It costs me nearly $450 a month (since my unemployment from the pharma industry) for my family?s private health insurance and there?s nothing left to pay for that which it doesn?t cover. Heaven forbid should I fall seriously ill as did an elderly family member who lives with me.\n

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