Biotech Ethics

In the coming years, expect to see more and more countries (and states & provinces) enacting legislation to impose restrictions on genetic testing — what kinds of tests can be done, whether they require a physician’s involvement or can be ordered from the comfort of your own home, etc. One key issue to watch will be whether legislators opt to legislate narrowly & carefully, or broadly in a way that throws the baby out with the bathwater. Here’s a story that starts to hint at the range of tests up for consideration…

From the Associated Press: Germany limits genetic testing

The German parliament approved legislation Friday limiting the use of genetic testing in an effort to prevent the technology’s abuse.

The law, which was debated for more than seven years, must still go before the upper house of parliament, but it is not expected to meet any resistance.

Under the law, genetic tests can only be carried out by a doctor and require the full consent of all parties involved. That makes it illegal to conduct anonymous paternity tests and anyone found in violation could be fined up to euro5,000 ($6,525).

The law further limits the use of genetic testing on fetuses to purely medical purposes, meaning parents are prohibited from using it to determine the sex of their unborn children….

Interesting that they chose to limit paternity testing. My guess is that paternity testing is among the most dangerous uses of genetic testing — most fears about GT are pretty much speculative (Will knowing I’ve got the gene for X change how I perceive myself?), but there’s nothing speculative about the harms that can be done to families by paternity tests. That’s not to say that paternity tests are not sometimes justified. It’s just to say that it’s a type of testing that has the potential, at least, to cause serious trouble. Of course, gene-based paternity testing is just the modern, more accurate version of a test that’s actually been available for years, so it’s not clear (to me) whether restricting gene-based paternity testing can accomplish the legislators’ objective.

I’ve blogged about “personalized genomics” quite a lot, both here and on the Business Ethics Blog. (See, e.g., Advertising Ethics & Personalized Genomics and Personal Genomics: the Ethics of Shared Uncertainty.) These services have received a lot of media attention lately. And now, attention from a prominent UK think-tank.

From the Times Online: Ethics inquiry to judge challenges of genetic testing

The risks and social challenges posed by genetic tests and other health services sold directly to consumers have prompted Britain’s most influential ethical think-tank to begin an inquiry into personalised medicine.

While DNA screens, personal MRI scans and internet advice services that bypass GPs have the potential to empower patients and encourage people to take greater responsibility for their health, they also have drawbacks, according to the Nuffield Council on Bioethics.

Genetic profiling services, which screen DNA variations for links to disease and other traits, are marketed as a way of identifying health risks that might be reduced by lifestyle changes or medical treatment….

Here’s the consultation webpage: Medical profiling and online medicine: The ethics of ‘personalised’ health care in a consumer age

It’s about parents having their kids genetically tested for athletic aptitude. (A version of this story came out a couple of months ago, before I started this blog, but it’s still of interest.)
From ABC30, Fresno: Playing with Genetics: D.N.A. & Sports

Most expectant parents can’t wait to see what their child looks like, and what that child will become. But now, parents can choose to take the surprise out of finding out by determining eye color, hair color, gender and even physical talents.

Just like the game of baseball it’s hit or miss when it comes to a kid’s ability to play. But what if parents could find out if their child has the genetic make-up to excel in sports?

Some parents apparently think the idea is pretty nifty. But there are skeptics:

“My first reaction is that parents obviously might want to know this information but my second reaction is kind of horror,” said clinical geneticist Cynthia Curry, M.D. She believes D.N.A. tests that claim to predict athletic ability may be just money-making fads. “I think they prey on parents desire to know what’s in their kid’s future and it’s very unlikely that that’s the sole predictor of their child’s athletic ability. It’s likely to be just one of many factors.”

My advice to parents contemplating this:
1) Think twice. Is this merely a cute idea, or is it actually in the best interests of your child? Think hard.
2) Ask the genetic testing company about the predictive power of their test.
3) Ask the company about privacy protections, and about what they do with samples after they’re tested. If you can’t get a good answer in plain English, run.

This story is from 2007, but it’s new to me and I’m guessing it will be new to many of you. And it’s a great read.

By Marc Gunther, writing for Fortune: Attack of the mutant rice

America’s rice farmers didn’t want to grow a genetically engineered crop. Their customers in Europe did not want to buy it. So how did it end up in our food? Fortune’s Marc Gunther reports

—–

Back in the spring of 2001, a 64-year-old Texas rice farmer named Jacko Garrett watched a fleet of 18-wheelers haul away truckloads of rice that he had grown with great care. “It just bothers me so bad,” Garrett said. “I’m sitting here trying to find food to feed people, and I’ve got to bury five million pounds of rice.” No one likes to waste food, but for Garrett, who runs a charity that collects rice for the needy, the pain was especially acute.

Garrett’s rice was genetically modified, part of an experiment that was brought to an abrupt halt by its sponsor, a North Carolina-based biotechnology company called Aventis Crop Science. The company had contracted with a handful of farmers to grow the rice, which was known as Liberty Link because its genes had been altered to resist a weed killer called Liberty, also made by Aventis.

But by 2001, Aventis Crop Science was living a biotech nightmare….

This story is a great example of what, as a Poli-Sci undergrad many years ago, i was taught was Rule #1 of environmental policy: “everything leaks.”

My only quibble with Gunther’s excellent story is that it may leave some readers with the impression that there was an actual danger to consumers, here. No one, anywhere, has ever been harmed by GM food. The events chronicled here are bad for various reasons, none of them having directly to do with risk to human health.

There’s nothing quite like seeing pharma whining about the bad rap it gets.

Check out this editorial by Dr Richard Barker, Director General of the Association of the British Pharmaceutical Industry, published in BBC News: ‘What have drugs companies done for us?’

…People seem to take for granted the antibiotics that cure infection, the anti-ulcer pills that prevent the need for stomach operations and the wide range of medicines that reduce the risk of heart attacks.

Finding new medicines is painstaking work; investigation into 5,000 compounds is likely to yield just one successful medicine, and the journey from first discovery to bringing a medicine to market takes between 10 and 12 years, at an estimated cost of £500m.

At the core of our industry are the unsung heroes who carry out this work – the scientists and researchers who very strongly believe they are on a mission to address human disease.

I would be astonished if they do not go into work everyday being motivated by the desire to bring cures to mankind….

Not wanting to oversell his point, Dr. Barker admits the industry has not been without its troubles:

Yes, along with other industries we have done some things wrong, but we have also done some things spectacularly right.

They’ve “done some things wrong”? Can anyone think of an industry with a worse record of wrongdoing? Sleezy advertising. Ghostwriting. ‘Evergreening.’ Inventing diseases. Disregard for the safety of human research subjects. It’s not at all clear that that stuff just disappears, even when we acknowledge the industry’s admittedly-important contributions. Of course, not every company is guilty of all of those offenses. But then, they don’t all get credit for curing polio, either.

Here are a handful of books I’ve read & found useful. It’s not an exhaustive list. Just a few off the top of my head.

Food Biotechnology in Ethical Perspective, by Paul B. Thompson
(I wish I’d written this book. It’s smart, well thought-out. Thompson isn’t gullible about technology, but nor is he alarmist.)

Guiding Icarus: Merging Bioethics with Corporate Interests, by Rahul Dhanda
(Rahul is an industry guy, and a pal of mine. I’m writing my own book in part because his wasn’t quite the book I was looking for.)

BioIndustry Ethics, by David L. Finegold et al.
(I think the final, chapter which offers advice to biotech companies, is flawed. But the book consists mostly of a set of very useful case-studies of how real-life biotech firms, big and small, tackled ethical challenges).

One of the weirder food biotechnologies to make headlines in the last few years is ‘synthetic’ or ‘in vitro’ meat. Just as human skin cells are currently grown in laboratories in order to make skin grafts to treat burn victims, animal muscle cells can be grown in order to make pieces of meat for human consumption.

So far, no one has figured out how to produce synthetic meat in useful quantities, but many believe it’s just a matter of time. On one hand, the idea of lab-grown meat inspires a significant ‘yuck’ factor. But lab- or factory-grown meat may well be more energy efficient and environmentally friendly than factory farming, and anyone concerned with animal welfare should like the idea of producing meat in a way that doesn’t involve cruelty to animals.

Here are some basic resources:

From NPR Health & Science, May 20, 2008: Lab-Grown Meat a Reality, But Who Will Eat It?

Countless families are familiar with the domestic challenge of vegetarians and meat eaters living under one roof. Vegetarians often find the mere presence of meat repugnant; meat eaters prefer their wings and ribs seasoned without guilt. But these days, as “mixed” households explore their dietary options, a handful of scientists are cooking up what might be a possible alternative: meat grown in a lab.

From Discover, July 12, 2006: Blinded By Science: The Way of All Flesh

“It would look,” says Dr. Vladimir Mironov, a cell biologist at the Medical University of South Carolina in Charleston, “like a coffee machine. This is my dream.”
Yet here is the thing. The object of Dr. Mironov’s dreams may well look like a coffee machine, possibly even down to the satisfyingly hinged compartments and the Krups logo, but it will produce meat….

From The Business Ethics Blog, Sept 27 2008: PETA’s Prize for Artificial Meat

PETA (People for the Ethical Treatment of Animals) has offered a $1 million prize to the “first person to come up with a method to produce commercially viable quantities of in vitro meat at competitive prices….”

And finally, from Wikipedia: In Vitro Meat.

Yuck factor aside, if anyone knows any good ethical concerns about synthetic meat, I’d be interested to hear them. (Obviously food safety is an issue, but not a unique or insurmountable one.)

Everyone who knows anything about genetics know that clones are not copies. They’re genetic copies (and even then not perfect copies, since for example, the cloning process does not copy mitochondrial DNA). A lot of different aspects of our environment exert a huge influence on how we turn out. That’s especially true of humans, complicated as we are. But it’s also true for animals. This becomes important as pet cloning starts being offered as a service.

From ABC News: Cloned Pets: Looks Can Be Deceiving

For the first time on Tuesday — $155,000 and a disgraced Korean scientist later — the Ottos of Boca Raton, Fla., met what they hope is the yellow Labrador retriever they had lived with for 11 years.

The couple this week welcomed into their home a 10-week-old puppy aptly named Sir Lancelot Encore, a genetic clone created in South Korea by a California biotech company from the DNA of the couple’s beloved dog Sir Lancelot, who died last year.

“He was a wonderful dog,” said Nina Otto, 66. “Money wasn’t an object. We just wanted our wonderful, loving dog back….”

Wait, wait…cloning won’t bring your dog back! Luckily, the story goes on to reveal that Otto seems to realize that:

Otto said she wanted her old dog back but is prepared for the possibility that Encore might look like his donor, but not act like him.

“Nobody is exactly like anybody else,” she said. “There was a 99 percent chance that he would look like Lancy and he does. He’s got the same eyes and coat. There is a 50-50 chance that he will act like him. We’re still the same people, a lot of the other dogs are the same, so there is a real chance he will have a similar personality….”

I wonder how many customers of this sort of service will realize that? I wonder how many sellers of such services will make sure their customers realize it?

Old laws don’t always fit new technologies well. Intellectual property laws, for example, have been an awkward fit with modern discoveries in genetics (hence the debate over patenting genes). Similarly, privacy laws may run aground with regard to genetic testing: genes after all are deeply private — yet always shared with members of your (biological) family.

Now here’s an example of trying to apply product safety laws to modern assisted reproductive technologies.

From the New Scientist: Sperm bank sued under product liability law

Sperm should be subject to the same product liability laws as car brakes, according to a US judge who has given a teenager with severe learning disabilities the go-ahead to sue the sperm bank that provided her with a biological father.

Brittany Donovan, now 13 years old, was born with fragile X syndrome, a genetic disorder causing mental impairment and carried on the X chromosome. She is now suing the sperm bank, Idant Laboratories of New York, under a product liability law more commonly associated with manufacturing defects, such as faulty car brakes.

Donovan does not have to show that Idant was negligent, only that the sperm it provided was unsafe and caused injury….

Here’s some extra information, from the Wall Street Journal’s health blog: Girl With Genetic Disease Sues Sperm Bank.

From the Genetic Future blog: 23andMe targeting pregnant women using “mommy bloggers”

Personal genomics company 23andMe has just launched an online community of “mommy bloggers” – a move I can only describe as sheer marketing genius.

I’ll give you a moment to let the vision sink in. Imagine a group of women hungry for information about the best way to ensure the future health and wellbeing of their unborn children. Now imagine a website packed with sincere, caring mother-types – most of them well-established bloggers with a strong existing fan base – writing about the real day-to-day issues that mothers care about (in the words of one recruit: “momming, aging, and my twenty year quest to lose the same ten pounds”; no doubt there will also be photos of puppies). Now imagine that those same bloggers have all been given a 23andMe genome scan and are writing excitedly about their results and what they mean for their health and their family….

Here is the direct link to 23andMe’s Pregnancy Community.

(Also check out this posting about 23andMe, from the Research Ethics Blog, last October: Want to find out what makes you “stand out from the crowd”? Consider signing up for a research study!)