Biotech Ethics

From the Boston Globe: Recession spurs egg and sperm donations

Charitable donations may be down because of the recession, but another type of donation is up for the very same reason: egg and sperm.

More women are trying to make money by offering their eggs to infertile couples, and men are doing the same with their sperm. Egg donor agencies in the Boston area report that their applications are up from between 25 and 100 percent over this time a year ago, and New England sperm banks have seen a similiar trend in the past six months.

Except, of course, they’re not donations.

…applications from women who want to offer their eggs have doubled in the past year, with the bulk coming in the past six months. If a woman meets the agency’s criteria, she earns $10,000 every time she donates. (Technically, the women are compensated for their time and inconvenience; it is illegal to sell one’s eggs.)

So what’s the role of money? What should it be? One fertility specialist weighs in:

“The money that’s given is limited; it’s not going to be something to create a yearly revenue to get them through life,” he said.

He believes in compensating women for their time and trouble but said there needs to be “some ethics to it” – both an altruistic motive and a monetary limit.

“When I see people who want to ‘sell’ their eggs for $20,000 or more it makes no sense, because then it becomes commercial, like selling any other thing,” he said. “There has to be a little bit of kindness, because these couples have had a lot of hardship and desire a child very strongly.”

(Not exactly from a neutral news source. But still…interesting.)

From the Natural News blog: South African GMO Crop Failure Highlights Dangers of Food Supply Domination

Farmers in South Africa have suffered millions of dollars in lost income due to the failure of their genetically modified (GMO) corn to produce kernels. The three varieties of plants look lush and healthy from the outside, but when the husks were pulled back there are no kernels. Monsanto’s GMO corn was planted on 82,000 hectares of farmland, an amount that equals over 202,000 acres. The loss is spread over three South African provinces, and 280 of the 1,000 farmers who planted the corn have reported the lack of kernel development.

Monsanto has blamed the failure on under fertilization processes in the laboratory and attempted to make light of the situation by claiming that only 25% of the Monsanto seeded farms are involved in the loss. But Marian Mayet, environmental activist and director of the Africa Centre for Biosecurity in Johannesburg is not buying it….

From the Journal of New England Technology: George Church creates building block for ‘artificial life’

he man who mapped the human genome is now doing a major follow up by creating the components of synthetic life, offering potential biotechnology breakthroughs but also creating worries over the related ethical, safety and religious consequences.

Harvard University molecular geneticist George Church, the founder of the Human Genome Project, has led a research team to create a self-replicating ribosome. While ribosomes were reconstituted 40 years ago, this appears to be the first time it has been done succesfully and synthetically. Exactly where the research will go isn’t certain, however.

And the ethics part?

…with this step forward comes a new set of ethical considerations, say experts. “We need to be critically aware of the profound implications of creating synthetic life,” said Karl Giberson, director of the Forum on Faith and Science at Gordon College in Wenham. “I don’t think this is something to be scared of. I don’t think Mother Nature is being violated in some egregious way. But this is an area of science with important ethical considerations, and religious sensibilities and higher priorities need to be on the table, under discussion.”

But having such a concern isn’t a matter of religious zealotry. “We are intruding into areas of nature that transcend us, and we need the ability to make informed and appropriate decisions,” he said.

Over on my Business Ethics Blog, I’ve blogged quite a bit about ethical issues in food biotechnology over the last 3 years. It thought it might be useful to gather some of those blog entries together, here, for the convenience of those of you with an interest in the topic:

Pioneer’s Business Model for Genetically Modified Foods for Africa (March 2006)

GM Foods, the Environment, and Corporate Obligations (Dec. 2006)

Trans-fats vs. Genetically Modified Foods (Dec. 2006)

Monsanto, Argentina, and Trade in GM Crops (May 2006)

The Not-So-Simple Ethics of Biotech (April 2007)

Biotech: An Industry in SEARCH of Regulation (July 2007)

Ethics, the FDA, and Cloned Meat (Jan. 2008)

(Lilly) Buying Controversy (from Monsanto) (Aug 2008)

PETA’s Prize for Artificial Meat (Sept. 2008)

Sugar is Sugar (or, the Ethics of Caving in to Silly Demands) (Jan 2009)

And finally: Ben & Jerry’s Behind “Cyclone Dairy” (Apr. 2009)

(Keep in mind that those entries are from my Business Ethics Blog, so they’re primarily about corporate obligations, rather than, say, about public policy.)

From the Milford Daily News: Biotech companies testify on data mining

Drug makers and health insurance officials challenged a proposed law that would limit information about which medicines are the most popular in Massachusetts, saying that a ban on “data mining” would cost both consumers and the state’s biotech industry.

Testimony yesterday before the Joint Healthcare Financing Committee chaired by state Sen. Richard T. Moore, D-Uxbridge, focused on bills that would ban transfers of prescription information containing patient-identifiable information for commercial purposes.

The process, known as “data mining,” is used to determine trends in prescription drug use. Generic drug companies, which use trend data to determine what brands to make, claim that without the use of data mining, patients would continue to use brand name medicines at a much higher cost….

It’s worth nothing that there are 2 distinct kinds of issues at play here. One is about harms & benefits. The other is about rights (in particular, the right to control information).

It’s also worth nothing that governments are likely to be thinking about balancing two competing goals, here. First, protecting the privacy of citizens in their jurisdiction. And second, catering to the needs of an industry that stands to bring wealth to that jurisdiction.

Check out this debate, from The Economist: The ethics of DNA databasing

The claim being debated: “People’s DNA sequences are their business, and nobody else’s.” The participants in the debate are one of the world’s leading bioethicists, and one of the world’s leading biotechnologists.

Bioethicist Arthur Caplan defends the claim. He begins like this:

There are, it is increasingly said, plenty of reasons why people you know and many you don’t ought to have access to your DNA or data that are derived from it. Have you ever had sexual relations outside a single, monogamous relationship? Well then, any children who resulted from your hanky-panky might legitimately want access to your DNA to establish paternity or maternity.

Biologist Craig Venter attackes the claim. He begins like this:

As we progress from the first human genome to sequence hundreds, then thousands and then millions of individual genomes, the value for medicine and humanity will only come from the availability and analysis of comprehensive, public databases containing all these genome sequences along with as complete as possible phenotype descriptions of the individuals.

From the Pittsburgh Tribune-Review: Pitt researcher again pursues cloning patent

A University of Pittsburgh stem cell researcher has renewed his efforts to win a patent on a process to clone human embryonic stem cells, despite lingering questions from his past efforts.

Patent Office records show an amended patent application filed by Gerald P. Schatten and two colleagues was published Jan. 1, the same day a rival application was published by Oregon researcher Shoukhrat M. Mitalipov.

“They are just going through the process,” Pitt spokeswoman Anita Srikameswaran said when asked about the filing. She noted the original application was filed several years ago.

Schatten did not respond to requests for comment. Under standard university policy, Schatten would share any royalties from the patent with his employer. Srikameswaran said Magee-Womens Research Institute has a financial interest in the patent.

His application refers to a stem cell cloning process developed by his one-time colleague, disgraced South Korean researcher Hwang Woo-suk. Patent reviewers challenged a number of claims in his earlier submission….

Check out this largely-reputation-based ranking of multinational health companies by Covalence: Covalence Ethical Ranking 2008 for the Health Care sector. (Released 2 months ago, in January.)

Rank | Company

1. GlaxoSmithKline
2. Johnson & Johnson
3. Abbott
4. Bristol Myers Squibb
5. Boehringer Ingelheim
6. Novartis
7. Roche
8. Astra Zeneca
9. Eli Lilly
10. Novo Nordisk
11. Aetna
12. Pfizer
13. Baxter International
14. Sanofi aventis
15. Takeda
16. Merck & Co Inc
17. CIGNA Corp
18. WellPoint
19. Medco Health Solutions Inc.
20. Becton-Dickinson
21. Amgen
22. Genentech
23. Boston Scientific
24. UnitedHealth
25. Zimmer Holding
26. Daiichi Sankyo
27. Medtronic
28. Astellas Pharma
29. Wyeth
30. Schering Plough
31. Gilead Sciences Inc

Acknowledging the limitations of such rankings, here’s some food for thought:
1) As an investor, which of these companies seems like a good risk?
2) As a potential employee, which of these companies would you be proud to work for?
3) If you were on an ethics board reviewing a research proposal funded by a drug company, which of these companies would make you want to be very, very careful?
4) Which of these companies have particularly good or bad reputations that might not be warranted?
5) What aspects of bio-pharma company ethics might not be well-captured by the kinds of methods groups like Covalence use to assess corporate ethics generally?

(These things are always imperfect. Make sure to take a look at Covalence’s methodology.)

From The Scientist: Biotech’s Baddies: More than 60 individuals have been blackballed by the FDA for criminal acts against the agency. Here are some of the worst offenders.

No matter how bad things seem for the United States Food and Drug Administration these days, 20 years ago they were arguably worse. In the late 1980s, the agency was embroiled in a generic-drug scandal, in which FDA administrators accepted bribes for quick drug approvals, and drug makers admitted to deliberately defrauding drug regulators. The days when the federal agency could rely solely on the trustworthiness of the industry it was supposed to be regulating were done.

But from the ashes of the generic-drug scandal, some positives did arise. One of the programs resulting from the scandal, and the subsequent Generic Drug Enforcement Act of 1992, was the FDA’s mission to “debar” people or whole companies from participation in agency activities, such as applying for drug approval, if found guilty of deliberate fraud.

David Read, who was the FDA’s first Debarment Task Force chair, says that when the agency first set out to ban investigators for fraudulent activities involved with the generic-drug scandal, the magnitude of dishonesty in the drug business was staggering. “[The Generic Drug Enforcement Act] resulted in a lot of investigations, which turned up a lot of surprises,” he says. “As people started investigations, they found things that weren’t expected….”

Ben & Jerry’s have owned up to it. They say they were aiming to raise awareness and they argue for a “national tracking system” for cloned animals. Bad idea. See the details @ my Business Ethics Blog: Ben & Jerry’s Behind “Cyclone Dairy”.