Wednesday, April 29, 2009

Cloned Beagles: Glowing Now, Helping Science Later

From the Associated Press: SKorean experts claim to have cloned glowing dogs
South Korean scientists say they have engineered four beagles that glow red using cloning techniques that could help develop cures for human diseases. The four dogs, all named "Ruppy" — a combination of the words "ruby" and "puppy" — look like typical beagles by daylight.
But they glow red under ultraviolet light, and the dogs' nails and abdomens, which have thin skins, look red even to the naked eye.
Seoul National University professor Lee Byeong-chun, head of the research team, called them the world's first transgenic dogs carrying fluorescent genes, an achievement that goes beyond just the glowing novelty.
"What's significant in this work is not the dogs expressing red colors but that we planted genes into them," Lee told The Associated Press on Tuesday.


Now if they could only do this to reindeer. And get the gene to express itself mainly in the nose area.

OK, but seriously: it really is crucial to see that this achievement is not about making puppies (or any other animals) that glow in the dark. The fact that the dogs glow is just a convenient way to determine that the inserted gene (which happens to be a gene for flourescence in this case) is showing up everywhere in the dog's body, which is what you would normally want when you're doing genetic engineering. So, the technique works. Next step (as the scientists in the story note) is to insert a more useful gene.

-----
p.s. The photo accompanying the AP story is great evidence of the limits of genetics. Notice the dogs are not identical in appearance. (Look at the vertical white stripes on their respective foreheads.)

Tuesday, April 28, 2009

GM Corn Multi-Vitamin: Opponents Still Not Happy

From Discover: New Biotech Corn Gives Triple Vitamin Boost; Protestors Unmoved
A new genetically modified (GM) corn that produces beta carotene and precursors of vitamin C and folic acid is the first crop to be engineered to make more than one vitamin. Says lead researcher Paul Christou: “The major message of the paper is that it’s possible to engineer crops with multiple nutrients…. If you look at other nutritionally enhanced GM crops, up until now people have only been able to increase levels of one nutrient or vitamin” [Wired]. But anti-GM campaigners have not been won over by the scientific feat, even though the research behind it was not funded by agricultural corporations....

I'm generally optimistic about this sort of technology. However...
But key questions include:
1) Are the increases in vitamin levels enough to make a significant difference in the health of people who consume this corn? (And how much corn do they need to eat?)
2) Theoretical benefits aside, will such corn make it into the hands of the malnourished folks who need it the most? Why or why not?
3) A key market for most new technologies is made up by the affluent folks who can most easily afford nifty new products. Will affluent North Americans and Europeans be keen on this new corn? If so, it's much easier to see the product getting off the ground.

Monday, April 27, 2009

Germany Limits Genetic Testing

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.

Saturday, April 25, 2009

Nuffield Council Inquiry on DTC Genetic Testing

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

Kids, Sports, and DNA: Ethical Questions

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.

Friday, April 24, 2009

The Case of the Unwanted GM Rice

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.

Wednesday, April 22, 2009

Pharma Co's Don't All Get Credit for Curing Polio!

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.

Tuesday, April 14, 2009

Biotech Ethics Book Recommendations

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).

Monday, April 13, 2009

Synthetic Meat

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.)

Sunday, April 12, 2009

Cloned Pets: Buyer Beware

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?

Saturday, April 11, 2009

Old Laws & New Technologies: Suing Sperm Bank for Genetic Disease

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.

Thursday, April 9, 2009

23andMe's "Mommy Bloggers"

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!)

Wednesday, April 8, 2009

Recession & Eggs & Sperm Donors

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."

Tuesday, April 7, 2009

Are GM Crops Failing in Africa?

(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....

Ethics & Artificial Life

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.

Monday, April 6, 2009

Ethics of Biotech Foods — Genetically Modified, Synthetic, and Cloned

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.)

Saturday, April 4, 2009

Biotech Companies & Datamining

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.

Ethics of DNA databasing

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.

Patent Application for Cloning Stem Cells

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....

Ethics Rankings for Bio-Pharma Companies

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.)

Friday, April 3, 2009

Biotech's Villains

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...."

Wednesday, April 1, 2009

"Cyclone Dairy": A Spoof by Ben & Jerry's

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".