At Home DNA Tests: Marketing Scam or Medical Breakthrough?

For those who are into this sort of thing (like me), here's some interesting news: This Thursday, July 27th, there's going to be a Senate hearing on the lack of oversight of genetic testing. It comes at the end of a year-long investigation into the safety and reliability of genetic tests offered to consumers via the Internet. The hearing is called: “At Home DNA Tests: Marketing Scam or Medical Breakthrough?” It will be at 10 a.m., July 27, in 106 Dirksen Senate Office Building. I encourage all to go (especially you journalists out there -- this is a great story I'd be all over if I weren't on a writing retreat in the middle of nowhere).

Kathy Huson, director of The Genetics and Public Policy Center at Johns Hopkins, who's been a source for several of my stories, will be testifying that a lack of oversight of genetic testing has created a situation where, “there is no way for a consumer to distinguish between the dubious and the decent” when it comes to the tests, and the labs offering them. “At best," she says, "consumers may be wasting their money” At worst, “they may be foregoing medically appropriate treatment or undertaking medically dubious treatment.”

The event will also include testimony from the Centers for Medicare and Medicaid Services and the Food and Drug Administration. And the Government Accountability Office will be releasing the results of their year-long investigation at the hearing. Should be a good time. I'll post details when they're available.

Update on the Catalona Case

A quick update on the tissue ownership case of William Catalona v. Washington University, which I wrote about in detail for the New York Times Magazine, and in several posts on my blog:

Catalona and the patients, who lost the original suit, just filed their appeal. I got the documents late last night -- the patients' brief (68 pages), makes a very strong argument for overturning the ruling. I'll be posting on that in more detail -- and on Washington University's response when it comes -- very soon.

As I said in my Times article, regardless of the first ruling, this case is far from over ... I look forward to seeing what happens next.

A Bit of Teaching News

I'm very excited to report that I've just taken a position teaching in NYU's graduate Science, Health and Environmental Reporting Program, otherwise known as SHERP. So starting in January, I'll be teaching their Writing and Reporting Workshop, (it's one class that's offered every-other semester).

And speaking of teaching, I'll also be teaching and speaking at several conferences in the coming months: The Mid-Atlantic Creative Nonfiction Writers Conference at Goucher College in August, the Penn Writers Conference and the beautiful writers' house at Washington College in October, then the Nieman Narrative Nonfiction Conference in Boston and the 412 Creative Nonfiction Festival in Pittsburgh in November. I look forward to them all.

DNA Testing and Racial Profiling

A while ago, I posted about my wariness of using DNA testing for genealogy research --– specifically my frustration with the fact that these tests are over-hyped by the media and sold as being able to say things like, you are or aren't African-American, which simply isn't scientifically possible at this point. It's just not that simple.

Well, I just read an interesting article by Sheri Fink --a physician and journalist -- in the current issue of Discover: "“Reasonable Doubt: Questions about the forensic infallibility of DNA emerge even as police begin to use it to profile suspects by race."” Toward the end of the article, she mentions that police departments are now using the exact tests (and companies) I wrote about in my earlier post and my Popular Science article to predict the race of potential suspects based on DNA samples.

One company, DNAPrint, takes DNA samples from crime scenes and creates a hereditary profile: 60% sub-Saharan African, 37% European, and 3% Native American, for example, then sends photos of people with similar genetic makeups, so the police can have something to go by when it comes to, among other things, skin-color. Fink writes:

"DNAPrint's senior scientist Matthew Thomas rejects the charge that the company'’s test, known as DNAWitness, is itself a form of racial profiling. '‘DNAWitness will hold up to scientific scrutiny whereas personal feelings and biases won't,'’ he said."”

DNA stands up to scientific scrutiny when comparing a crime-scene sample to the DNA of an actual suspect, but using it to predict a suspect's skin color is a different story (the genetics of skin color, and the genetics of race, are far more complex than that). Apparently this doesn't matter:

"“The company has handled about 100 criminal and victim identification cases. '‘The technology can aid pretty much any case where you don'’t have a suspect but you have a biological sample,'’ Thomas says. DNAPrint has received a $50,000 subcontract to provide raw data to a National Institute of Justice grantee. "

Here's what I'm interested in (of course): When they send out those profiles of people with genetic makeups similar to the criminals, they'’re using information they've collected in a database from testing many people. I wonder if this includes the DNAPrint database, which houses genetic information from thousands of people who submitted their samples for genealogy testing. I'’d like to see the consent forms they're using for whatever databases are involved in DNAWitness: My bet is they don'’t say anything that resembles, "“Can we use your genetic information for racial profiling?"” Which is an important point: Many people wouldn't want their DNA contributing to this project, whether the science were questionable or not.

Imagine all the African Americans who've submitted DNA to the database: How would they feel about their samples being used to get black men into a line up?

A Blow to the Fight Against Biological Patents: Labcorp V. Metabolite Dismissed

The other day, the Supreme Court dismissed a case I’ve been watching closely, which could have set some limits on how far patenting of genes and other bodily products will go in the future.

Several years ago, a company now called Metabolite patented the fact that an increased level of the amino acid homocysteine in your blood means you have a deficiency of certain B vitamins. So they own that diagnosis. Technically, if you test for, treat, research, write about or (in theory) even think about this disorder without paying a (steep) licensing fee to Metabolite, you're guilty of patent infringement (which I'm now guilty of for writing this).

Metabolite enforces their patent aggressively: A company called LabCorp developed a test for this deficiency and began offering it to doctors. So Metabolite sued them (in LabCorp v. Metabolite Laboratories) and won $7.8 million. LabCorp appealed right up to the Supreme Court, and quickly had scientists, patient advocacy groups, lawyers and ethicists fighting on their behalf with a flood of briefs. Their argument: Naturally occurring phenomena aren’t patentable; the relationship between homocysteine and B vitamins is as much a natural phenomena as gravity, therefore the patent should be invalidated. Sounds like a no-brainer. But it’s not, because there’s too much at stake.

For LabCorp, this is clearly about money – they don’t want to pay the $7.8 million, and they want to offer the test without paying future royalties. But for many others who wrote court briefs, this was their first big shot at limiting body-related patents – patents on diagnoses, proteins, even genes. Historically speaking, they had good reason to think they might win: Nearly a decade ago, patents on surgical procedures were common and strictly enforced, which meant if you went to the hospital with, say, a certain type of appendicitis and your doctor hadn't licensed the surgical procedure to fix it, he couldn't operate without risking a lawsuit. The practice of restrictive surgical patents stopped in the 90s because of a lawsuit similar to LabCorp v. Metabolite, where a court ruled that doctors weren't required to license surgical patents for treating patients.

The implications of LabCorp v. Metabolite could have been huge: If the court invalidated the patent, it would have called thousands of patents on medical tests and genes (worth potential billions) into question, because if a diagnosis gets ruled a natural phenomena, genes couldn't be far behind.

The court's only comment on dismissing the case was to say it shouldn’t have agreed to hear it in the first place. Which is odd. Three justices dissented, saying the court should decide the case because biotechnology patents (and similar patents in other businesses) are being granted too liberally and should be rolled back. They also said they would have invalidated the Metabolite patent.

Dismissing the case, the dissenting judges said, "threatens to leave the medical profession subject to the restrictions imposed by this individual patent and others of its kind," which could "raise the cost of health care while inhibiting its effective delivery."

Given my obsession with tissue research and consent issues, I can't help but point out that research participants probably had no idea this might happen: Hundreds of people donated the samples used to uncover this connection between homosysteine and B vitamins. Many gave spinal fluid samples (an invasive, painful procedure that isn't without risk), because they wanted to help people with this disorder get treatment. Their consent forms, like most, surely didn't say that Metabolite could use their samples to file for a patent that could actually restrict research and treatment for the disorder they were trying to help.

On The Road Again

I’m back at my West Virginia writing retreat putting finishing touches on my book, so my blog will be a little quiet for a while: I can get email on my Blackberry, but I don’t have internet access unless I drive into the nearby town and go online at Baristas or the local library (which is the whole point of being here – distraction free writing time!). I won’t be back in New York and posting regularly again until mid-August. But I will be posting periodically until then.