Are Your Genes Still Free?

It gets murkier and murkier. The day after the Supreme Court ruled that natural human genes could not be patented, Gene by Gene [and perhaps Ambry Genetics] started offering BRCA1 and BRCA2 testing for $999. Myriad Genomics had been offering it for  about $4,000. Great news for womankind. But now Myriad has sued.

“If [Ambry and Gene by Gene] are proved wrong, and I think they will be, it will be at the expense of women who want to be tested,” Gold said. “It’s legal, but not ethical.” For Professor Gold's comment in context read the full story in Wednesday's The Daily Pennsylvanian.

Dr. D agrees with Ambry Genetics' claim that our genes should be free to express their vital information:

Although that expression cannot be free (as in no cost); it should not be restricted from most women because of artificially high pricing. 

I at least partly agree with Professor Gold. I am not a patent lawyer. I am also not a geneticist. Therefore, I do not claim to understand all the legal and biological intricacies of this current law suit. I don't have an opinion as to whether of not patent law gives Myriad a legal leg to stand on. However, I strongly believe that Myriad's position is not ethical. Not many women can draw on the financial resources Angelina Jolie could draw on when she had to make a potentially life or death decision. However, they still need access to the most relevant information their body can give them before they make that decision.

Disclosure: I am an unpaid volunteer manager for two surname DNA projects hosted at Family Tree DNA (FTDNA). FTDNA is a subsidiary of Gene by Gene. FTDNA is one of four genetic genealogy labs through which I have tested my own DNA. I have no financial interest in any of these companies.

Supreme Court Gives Us Ownership Of Our Genes

By now you have probably heard about yesterday's US Supreme Court decision in the case of AMP v. Myriad Genetics. In that decision a unanimous court ruled that corporations could not patent a naturally occurring human gene even if they discovered its location in the human genome. The ACLU, which had brought the case to the court, used the following image to declare victory.

ACLU Facebook post

That was a huge victory for those of us who are optimistic about the promise of personalized genetic medicine in which our own particular genetic make up is used to both diagnose and tailor treatment of our human disorders.

After the decision was announced Myriad made a statement that other patents that it owned would maintain its position. These would include its proprietary database that allows Myriad to interpret the results of its BRCA testing. All of us who have taken genetic genealogy seriously have learned that that DNA results, taken by themselves, have little meaning. It is only when these results can be compared with a large number of other results can meaningful interpretations be made. 

Fortunately Myriad's statement, while perhaps technically correct, is somewhat misleading. Other labs are already stepping forward to offer alternatives to Myriad's monopoly supported pricing. What Myriad was charging about $4,000 for is now available at the drastically reduced price of $995 at a respected and accredited laboratory. Thanks to CeCe Moore, Your Genetic Genealogist for the heads up about the announcement of this breakthrough in affordability. 

In a press release picked up by the Wall Street Journal, the Houston based company Gene by Gene announced the availability of BRCA testing in the US that it had previously only been able to offer abroad. Many of you are already customers of Gene by Gene through its Family Tree DNA (FTDNA) tests for family history information.

The developments of the last two days make BRCA testing much more affordable and probably is only the beginning of what competition in the marketplace will do to make genetic testing a routine part of our medical care.

Thank you to the US Supreme Court for allowing us to own our own genes!


Disclaimer: Although Dr D coordinates two Y-chromosome surname DNA projects based on results from FTDNA, he has no financial interest in the company.

Angelina Jolie, the BRCA Genes and Myriad Genetics

Angelina’s Jolie’s announcement in today’s New York Times op-ed, “My Medical Choice”, that she has had a double mastectomy is so timely for me. I just finished Jeff Wheelwright’s, TheWandering Gene and the Indian Princess. The book traces the BRCA1 and BRCA2 genes through a large extended family in the Southwestern United States. Although the book wanders through many other historical social and religious threads, the main focus is how the BRCA genes are inherited and chronicles the decisions many women faced in dealing with the results.

Also, the AMP v. Myriad Genetics case now before the US Supreme Court will refocus attention to whether the tests for these genes can patented and thus create a monopoly which allows Myriad to profit handsomely from the test. Although I’ll not go into the legal intricacies here, you can read the plaintiff’s (ACLU’s) viewpoint for yourself. Additional background can be found at Judy Russell’s The Legal Genealogist blog. The bottom line for this post is that the price Myriad is able to charge discourages many women from seeking testing that may be critical to their informed health decisions and/or their peace of mind. Look for the Supreme Courts’ decision around the end of June.

   

Genetics provide cancer insight

Today's Tennessean carries an interesting article about medical screening through DNA testing:

Genetics provide cancer insight | The Tennessean | tennessean.com

In the article

Dr. Joann Boughman, executive vice president of the American Society of Human Genetics in Bethesda, Md., said genetic counselors can provide context and help with decision-making.

"It’s important for individuals to know their family medical history, which may require some detective work to gather, Boughman said.

“It’s an engagement process, and it isn’t always rapid, and it can be very uncomfortable,” she said. But “once you start talking to your family in a reasonable way about this and explain, ‘Everybody is at risk for something; let’s figure out if, as a group, we’re at risk for something special,’ that people will start to open up.”

Dr. Boughman advocates having your results sent to your physician for help in interpretation and context. If this is going to work, more physicians are going to have to become much more conversant in genomic medicine.

You may also wish to consult:
www.talkhealthhistory.org 
familyhistory.hhs.gov 
Whatever you to do be proactive and take charge of your medical treatment planning. Your medical providers may or may not be prepared to do so on your behalf. Hopefully, you can be equal partners in deciding what is best for you and your family.