DTC genomics

Gene and Tonic for June 5, 2015

What does genomics have to do with a hippie rock music event?  A few things.  Find out in today’s humorous preview of the Festival of Genomics, happening later this month in Boston.  

Yes, there are the sports genes everyone knows about.  But what about those less studied that might affect your career in sports?  Do you know what is written on the sports page of your genome?

And what has Ben Carson considering brain surgery?  Tune in to this week’s wrap of genomics news - it’s another Gene and Tonic from Mendelspod.

Pharma companies have always had their chief medical officers (CMOs). Now, as the diagnostics industry grows, many kinds of life science companies are filling this important position as well. Sequencing tool makers, direct-to-consumer firms, bioinformatics companies—they’re all appointing CMOs.

Paul Billings was the first and only CMO at Life Technologies before they got bought out by Thermo Fisher. Now he’s filling that role at Omicia, the genome interpretation company where he manages clinical cases and the transmission of information to doctors and patients. He also handles regulatory issues and clinical trial selection. And, as eloquently demonstrated in today's show, he represents his company externally, a vital and delicate function in a rapidly changing, heavily regulated industry.

This position gives Paul a clear window into some of the most important topics and debates we’ve discussed on the program: patient consent, direct-to-consumer testing, the use of arrays vs. sequencing, and the regulation of laboratory developed tests (LDTs).

Trailer for This Month in Biotech - A new monthly show from the producers of Mendelspod.

Coming January 30th.

Guest:

Misha Angrist, Author, Assoc. Professor, Duke Institute for Genomic Sciences

Listen (7:03) Presidential bioethics commissions do not have a good record

Listen (5:06) Questioning FDA priorities

Listen (4:31) Not the best arguments in FDA letter to 23andMe

Listen (3:26) Can we do DTC genomics right?

Listen (4:49) Thoughts on A Troublesome Inheritance

Listen (4:30) Self censorship

Today we continue with part two of our interview with Duke Assoc. Professor and author, Misha Angrist, mostly centered around the issue of regulating genomic medicine.

Misha questions recent FDA actions, such as the clamp down on 23andMe.

"I'm generally pretty hard on the FDA," he says.

Misha has a "complex view" about the FDA's letter last November to 23andMe. While he thinks 23andMe "dropped the ball" and went too far in interpreting consumers' genomic data, he also thinks the FDA used the wrong arguments in their letter ordering the DTC company to discontinue its health related testing.

He lauds 23andMe's hiring of Jill Hagenkord as CMO, saying that she "gets it."

We finish with Misha's response to Nick Wade's new book, A Troublesome Inheritance: Genes, Race, and Human History.

Editor's Note: Since this interview was recorded, the 23andMe blog put out an update saying that the FDA had accepted their submission for a new 510(k) application.

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Guest:

Hank Greely, Professor of Law, Stanford

Listen (5:00) What's the best argument for FDA regulation of genetic testing?

Listen (10:50) A health exceptionalist

Listen (7:06) What about a Consumer Reports for genetic testing?

Listen (5:05) A device or a report?

Listen (3:13) Tools in command

Listen (3:43) The genoscenti vs. the general public

Hank Greely is a law professor at Stanford who teaches a course on the FDA and keeps a close watch on the genomic revolution. Hank is concerned with the ethical, legal, and social implications of new biomedical technologies.

We're excited to have Hank join us as part of our series, Regulation and Genomic Medicine. He has developed one of the most clear voices on the question of whether the FDA should regulate genetic testing.

"The best argument for regulating 23andMe is that they're providing health information that is not very good," he starts out in today's interview.

We threw the best arguments against regulation that have come up in this series at Hank. For example, one researcher compared the state of bioinformatics and genome interpretation today with that of the early days of the computer. Was the computer good enough in the 80's, the researcher asked. No, but we still used it, he said.

Hank accepts this argument and agrees that the U.S. has been a more libertarian country than many countries around the world. But we make an exception for health, Hank says. Computers weren't used in the early days, he points out, for guiding cars through traffic.

But is the FDA being overly paternalistic? Are 23andMe's predictions really any different from using data from the Framingham studies?

"In health, I am much more paternalistic than I am with anything else," Hank says. When the information is of really weak power and dubious accuracy, I get still more paternalistic."

Hank is quick to point out that he's not for banning astrology, something that he calls "completely useless." He takes issue with the fact that 23andMe has sold itself as a health company.

"When something wraps itself in scientific and medical guise, and is presented as being scientifically correct, we have the right to demand that it actually is."

What about letting the market bring up the value of genetic testing on its own? Is a genetic test really a device or is it a report done by a professional? And are we doing too much sequencing for sequencing sake? Hank isn't one to avoid tough questions. At the same time, he doesn't deny that some truly impactful technology is here.

"I expect that within 10-15 years there's going to be whole genome sequences in the electronic medical records of most people in this country. If we learn to use them well, interpret them well, convey the information to the patients well, they hold real potential for improving public health. If we do it poorly, they could make things worse."

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

Guest:

Anne Wojcicki, CEO, 23andMe

Listen (5:39) What was your personal reaction to the FDA letter?

Listen (5:34) What is the appropriate level of regulation?

Listen (3:30) Results roulette?

Listen (1:06) What is the path forward with the FDA?

Listen (4:17) How do you go about deciding next steps?

Listen (3:48) Audience: What about international options?

Anne Wojcicki is a fighter. Seen by many in our industry as a leader in delivering genomics to the masses, she now has a more complicated job as CEO of 23andMe.

On November 22 of last year, the FDA sent a letter to Anne and her team in Mountain View telling them to stop marketing their popular genetic testing service. It's a day, Anne says, she'll remember well.

In one of the few interviews she has given since the letter, Anne shares her reaction to it.

"There was a lot of shock. And I think it took a while to settle in to really understand what the implications of the letter were," she says at the top of the interview.

Though some see her as standing strong for the right of the average person to see their genomic profile, yet others in the industry feel Anne and her company are undermining the potential of personalized medicine by delivering an inferior product. Today we ask Anne just what she thinks is the appropriate level of regulation and what is her response to those who say that the 23andMe test is merely genetic "results roulette."

Confirming that the company is working diligently to comply with the requests of the FDA, Anne says she leans on a team that has become used to a "whiplash culture." And while she admits that the company could do a better job of labeling the product, she nevertheless asserts that the "current regulatory process was not ready for us." She's of the opinion that the company can again offer the health related testing.

Today's show reveals a CEO who remains undeterred in her mission while acknowledging a more complex way forward.

"This is not the simple path. It's a fight. And I'm really honored to be part of that fight and driving a change. But I have more headaches than I used to," she says at the conclusion.

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

Guest:

Mya Thomae, Founder, CEO, Myraqa

Listen (3:10) This letter more specific than in the past

Listen (2:51) What did 23andMe file with the FDA in 2012?

Listen (4:57) Are genetic tests medical devices?

Listen (4:36) Going the regulatory route good for business and patients

Listen (6:02) What about freedom of information?

Listen (1:53) How are 23andMe results different from risk assessments using standard epidemiology?

Listen (5:34) Does the letter signal a more assertive FDA?

Listen (1:05) Why has 23andMe not stopped selling the product?

On Monday, November 25th, the FDA sent a letter to the direct-to-consumer genetic testing company, 23andMe. The letter has received a bit more attention than the average FDA correspondence. The letter was addressed to 23andMe CEO, Anne Wojcicki, and told her that the company’s Personal Genome Service was in violation of the Federal Food, Drug and Cosmetic Act. The FDA requested that the company “immediately discontinue marketing” the test until it receives authorization.

Since the letter came out, there has been much discussion in the life science industry and with the public at large. Some say the letter reveals an over reaching, paternalistic government agency trying to hold back the inevitable, while others see the opportunity for a turning point for a diagnostics industry.

Mya Thomae has been helping companies comply with FDA regulations for 20 years. Mya is intimate with how the FDA works and laments that the diagnostics industry, as opposed to the regulated therapeutics industry, has been on a "race to the bottom." She doesn't hesitate when asked whether the 23andMe test is a medical device.

"Genetic tests are certainly medical devices, and there's numerous examples of different types of genetic tests moving their way through FDA," she says.

The problem with 23andMe, Mya asserts, is that they "haven't done the hard core clinical trials to show that their algorithms do indeed work as they say." And she finds it unfair that 23andMe can keep selling their tests while at the same time some companies are doing the trials, are working with the FDA, and are putting in the time and effort to develop quality tests.

Speaking of the 23andMe website, Mya points out hat the results are constantly changing based on the latest research paper that has just come out.

"Some folks have referred to it as results roulette," she says.

Should 23andMe be treated different from her clients who are pursuing regulation?

"I think 23andMe is different, but I think it's different in the way that makes it a research project as opposed to a product that should be giving clinical results to patients," she says.

What about our right to obtain our own genetic information? And how are the 23andMe results different from checking your risk factor for heart disease against the Framingham studies at the NIH website?
Mya addresses these and other concerns which have risen in the media since the letter was published. She also explains that regulation will be good for business as well as patients.

Is the letter any different from previous FDA letters, and does it signal a more assertive FDA when it comes to LDTs? Mya says she's lost some bets already on when the FDA will regulate LDTs, but she does see a shift happening. At the end of the interview she refers to some final guidance the FDA issued on RUO (research use only) kits the same day the letter to 23andMe was posted. RUO kits and reagents are not allowed for use with diagnostic tests that are approved by the FDA.

We end with the question, why hasn't 23andMe stopped selling the product?

Editor's Note: On Dec 5, 2013 23andMe discontinued selling any health related reports in compliance with the FDA's request.

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