Ethics, Policy, and Synthetic Biology

Posted on November 19, 2010 by

By Jef Akst, writing for The Scientist: Q&A: Ethics chair on synthetic biology

The Scientist spoke with chair Amy Gutmann, president of the University of Pennsylvania, about the commission’s conclusions that, despite the potential risks of creating synthetic organisms, the research should be allowed to continue.

The interview provides a good primer on the ethical issues. I’ll just point out one interesting bit. Near the start, Gutmann says:

Given that it’s a very new field, there is an opportunity to ensure that as it develops, its benefits for the public are maximized and its risk, correspondingly, minimized.

Without the benefits, no risks are worth taking. So we have to begin with the benefits…. [emphasis added]

That sounds reasonable enough, except that — depending on how narrowly you read the word “benefits” — it seems to cut off the possibility of the pursuit of knowledge for its own sake.

Posted in ethics, regulation, risk, synthetic biology | Leave a comment

No Gene Patents, Please: US Dept of Justice

Posted on November 1, 2010 by

Needless to say, this story is rather a big deal.

By Andrew Pollack, for the NYT: U.S. Says Genes Should Not Be Eligible for Patents

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer….

In essence, the new position is based on the idea that genes are naturally-occurring, and hence not inventions in the sense required by patent law.

However, the government suggested such a change would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops or gene therapies, could still be patented. Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina, who headed a government advisory task force on gene patents, called the government’s brief “a bit of a landmark, kind of a line in the sand.”

Interestingly (or at least interestingly to philosophers and law professors), this is roughly in line with a Lockean theory of property, according to which something in nature can be claimed as property only once one has ‘mixed one’s labour’ with it.

Posted in genes, patents, policy | Leave a comment

Cloned Foods, Europe, and Scientific Literacy

Posted on October 26, 2010 by

By Henry Miller, for the WSJ: The Cloned Cow Has Left the Barn

Benighted European politicians seem determined to discourage certain innovations in food technology even when the rest of the world stands as living—and eating—proof of their safety.

The European Parliament called in July for a ban on marketing foods derived from cloned animals and their offspring, and on Oct. 18 the European Commission proposed sweeping, temporary bans on animal cloning for food production. The proposal encompasses the use of cloned farm animals and the marketing of food from clones, and also create a system to trace imported genetic material such as semen and cloned embryos.

These proposals conflict with the expert opinions of the European Food Safety Authority, which has said repeatedly that with respect to food safety, there is no difference between milk and meat from conventionally bred animals and those obtained from clones and their offspring….

I’ll only add that the vast majority of people simply have no idea what a clone really is. And that’s a shame. Because whether the topic is human cloning or cloning animals for food, a little misunderstanding goes a long way. And it really doesn’t take much understanding to correct quite a few ethical errors. I’m not a scientist, but every year in my Critical Thinking class I spend about 120 seconds teaching my students the basics of the laboratory cloning process. That’s all it takes.

If you think this topic is important, do yourself a favour and at least read up on the basics. To that end, here’s the Wikipedia page on cloning.

Posted in cloning, ethics, Europe | Leave a comment

Monsanto’s Business Troubles

Posted on October 5, 2010 by

The Twittersphere and anti-biotech blogosphere have recently seen a flurry of joyful announcements of financial trouble at biotech giant Monsanto. Rumours of the companies death are, as they say, greatly exaggerated, but it is true that the company has suffered a bit of a downturn.

For a journalistic take, see this story by Andrew Pollack, for the NYT: Monsanto’s Fortunes Turn Sour

As recently as late December, Monsanto was named “company of the year” by Forbes magazine. Last week, the company earned a different accolade from Jim Cramer, the television stock market commentator. “This may be the worst stock of 2010,” he proclaimed.

Monsanto, the giant of agricultural biotechnology, has been buffeted by setbacks this year that have prompted analysts to question whether its winning streak from creating ever more expensive genetically engineered crops is coming to an end.

The company’s stock, which rose steadily over several years to peak at around $145 a share in mid-2008, closed Monday at $47.77, having fallen about 42 percent since the beginning of the year….

The problem, very roughly, is that some of Monsanto’s (genetically-modified) seeds have underperformed, and failed to meet the expectations of their customers — i.e., farmers. According to a company VP cited in the NYT story:

“Farmers clearly gave us some feedback that we have made adjustments from.”

I’m no expert on the seed industry, but that quote — and the idea of a biotech company needing to make immediate adjustments based on customer feedback — really gave me pause. The time-lines for getting a new genetic manipulation to market are relatively long. (Can anyone give me a specific time-line?) In most industries, consumers give feedback and expect improvements soon. What are the consequences of that mismatch between the long time-lines of scientific research, the short-term expectations of customers, and the perhaps even shorter-term expectations of investors?

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(See also: Monsanto’s Business Model: Ethically Less than the Sum of its Parts)

Posted in agriculture, ethics, GMO | Leave a comment

Canada to Gene Testers: Come On In!

Posted on October 2, 2010 by

From the Canadian Medical Association Journal (CMAJ): Federal government says regulation of consumer genetic tests is unnecessary:

Industry forecasts indicate that Canadians will soon face a marketing avalanche to persuade them to purchase personal genetic test kits. But while American officials are moving to regulate do-it-yourself genetic testing kits because of concerns that results may be erroneous or may prompt patients to alter their medications or make other unhealthy choices, Health Canada says it is open season for companies hunting for Canadian sales.

Many have expressed worries about direct-to-consumer genetic testing. I’ve blogged about some of those worries, including here:

But it’s not at all clear that the permissive attitude of Health Canada is going to result in an avalanche of tests being made available in Canada. A lack of regulation can actually mean a lack of certainty for companies, and a lack of certainty makes for bad investments. I personally spoke to one American biotech executive a couple of years ago who cited Canada’s relative lack of regulations as one reason why her company was hesitant to invest here.

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Biotech, Innovation & Clinical Trials

Posted on October 1, 2010 by

Here’s a blog entry, over on the Research Ethics Blog, that ought to be of interest to people interested in biotech: A Tale of Two Cousins: Tragedy and the Clinical Trial

Recently the New York Times published a story about two cousins in the US, both with a lethal form of melanoma, who were also both enrolled into a Phase III Clinical Trial to test a new, breakthrough cancer drug. The drug, PLX4032, has been shown to radically reduce the size of solid tumours in specific kinds of cancers, including intractable melanoma, in recent previous trials….

This is of interest to the world of biotech because PLX4032 is aimed at cancers rooted in particular mutations. In fact, according to ThePharmaLetter, it is “the first in a new class of drugs specifically designed to target the abnormal molecular activity resulting from an individual genetic mutation…” (See also the Wikipedia page for PLX4032.)

So, the challenges presented by the PLX4032 clinical trial are ones the biotech industry — and regulators and ethics board — are only going to see more of.

Posted in clinical trials, ethics, genes, health, pharmaceuticals | Leave a comment

Genes, Height, and Complexity

Posted on September 30, 2010 by

A new study published in Nature suggests that, while height definitely has a strong genetic component, the contribution of genes to height is far from simple. See the report here, via Scientific American: Complex Genetic Trait Research Reaches New Heights

Height has a lot to do with genetics. If your parents don’t need a step stool to reach the top shelf, you’re probably right up there, too. About 80 percent of height is due to DNA. The rest depends on diet and other environmental factors.

In the new study, researchers analyzed DNA from more than 180,000 people, looking for genetic differences that dictate height. The scientists, part of a consortium called the Genetic Investigation of Anthropocentric Traits (or GIANT), found 180 gene regions that govern how tall we get….

Presumably this is informative to people who were either excited, or worried, about the prospect of gene therapy being used someday by parents who wanted to give their kids the advantage of a little extra height.

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