Genetics and genomics

77 articles · Since 2011

Articles, page 4

The FDA and 23andMe puts a libertarian in a dilemma

January 25, 2014Jan 25, 201430

An advantage astrologers have over genetic testing is that the prediction of astrologers are personally verifiable. An astrologer once emphatically stated that I had no chance of a career in international cricket or Bollywood. So far both claims have turned…

How does one personally verify a “12.5%” increased chance of lung cancer, the sort of number the vendor for genetic testing 23andMe produces? If one develops …

Medical education

It’s never too early to talk about cost-conscious care

Allan Joseph

January 22, 2014Jan 22, 20142

Pretty much every conversation I’ve ever had about working to change physician culture boils down to two words: “medical education.” That was especially true at the 2013 Lown Institute Conference, which focused on the issue of right care: eliminating harmful overuse and harmful underuse. This comes down to reforming the way today’s physicians practice — eliminating the ordering of expensive tests and treatments that provide little to no benefit to …

Conditions and diseases

How should personal genetic tests be regulated?

Ruth Macklin, PhD

December 26, 2013Dec 26, 2013

Many people have heard of the company 23andMe; hundreds of thousands throughout the world have used the company’s Personal Genome Service (PGS), which provides a report that offers detailed information about an individual’s DNA. For $99, a consumer receives a test-tube kit from the company, fills the tube with saliva and sends it back. The company then performs a DNA analysis and provides information about the person’s health risks, ancestry …

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Conditions and diseases

The problems with the BRCA test from 23andMe

Nitin Roper, MD

December 15, 2013Dec 15, 2013

It’s been very interesting to read the range of responses to the recent FDA recent crackdown on the personal genetic service company 23andMe. Some have decried the FDA as too paternalistic while others have said the FDA is rightfully protecting…

The evidence, I believe, shows the FDA is correct: 23andMe should not be doing genetic tests that have serious medical implications. Let’s look at …

Health technology

Genetic counseling: The missing piece for 23andMe

Joyce Ho, MD

December 13, 2013Dec 13, 20137

On November 22, the FDA sent Silicon Valley’s leading personalized genetics company 23andMe a warning letter after six months of radio silence and recent increased efforts in marketing. Excerpts from the chastising letter read: "As part of our interactions with…

On November 22, the FDA sent Silicon Valley’s leading personalized genetics company 23andMe a warning letter after six months of radio silence and recent increased efforts in marketing.

Excerpts from the chastising letter read: “As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements …

Conditions and diseases

23andMe is providing data that physicians don’t know how to manage

Jennifer Gunter, MD

December 10, 2013Dec 10, 20138

The FDA has ordered 23andMe, a company that does direct to consumer genomic testing, to halt sales. I can’t speak on the accuracy of the results with 23andMe, I think that’s what the FDA is interested in. And this isn’t a post about transparency, because I think everyone should have access to their medical data. This also isn’t a post about genomics being bad. On the contrary, I believe …

Conditions and diseases

23andMe and the FDA: Did the government overreach?

James Marroquin, MD

December 10, 2013Dec 10, 20134

23andMe is a personal genomics and biotechnology company which for $99 conducts a comprehensive analysis of your DNA. In recent days, the Food and Drug Administration (FDA) instructed 23andMe to halt sales of its main product. The FDA’s problem with…

The FDA’s concern is apparently that the company has not met all of the complex regulatory requirements demanded by the type …

Conditions and diseases

Let’s bring up family health history during the holidays

Rebecca Sutphen, MD

December 8, 2013Dec 8, 20132

As we plan for holidays with family and friends, many are reminded to avoid religion and politics as topics of conversation, and while it may be advisable to skip these, there is another potentially uncomfortable topic that I urge everyone to bring up: family health history. Though it may not seem palatable to discuss diabetes and heart disease over servings of pumpkin pie, these conversations can be critical in helping …

Physician voices

How to realize the promise of personalized medicine

J. Leonard Lichtenfeld, MD

October 29, 2013Oct 29, 2013

I attended a meeting recently that got me to thinking about the fact that as we revolutionize cancer research and treatment, we are also going to have to revolutionize cancer care. And that may prove to be an even more…

The meeting was sponsored by a collaboration called ” …

Medical education

Many physicians view retirement as a kind of failure

Robert Marion, MD

August 15, 2013Aug 15, 201311

In early December 2012, I experienced two life-altering events. First, on December 5, Sadie, my first grandchild, was born. Second, on December 8, I suffered a myocardial infarction. All things considered, I was extremely fortunate. Because I received outstanding care almost immediately, I survived the heart attack. But that night, as I lay in bed in the coronary care unit after undergoing an angioplasty and the placement of a drug-eluting …

Conditions and diseases

When is genetic testing appropriate for children?

Courtney Schmidt, PharmD

July 1, 2013Jul 1, 2013

Angelina Jolie shared publicly her decision to have a preventive double mastectomy after genetic testing revealed that, due to a mutation in the BRCA1 gene, she carried an 87% risk of developing breast cancer and a 50% risk of developing ovarian cancer. Jolie identifies her mother’s decade-long struggle with ovarian cancer and death from that disease six years ago as one of the primary influences behind her decision.

Angelina Jolie’s …

Drugs and prescribing

Genomics and personalized medicine: Is it really different this time?

J. Leonard Lichtenfeld, MD

June 24, 2013Jun 24, 20133

Another year and another annual meeting for the American Society of Clinical Oncology in Chicago. This is a meeting that regularly attracts many thousands of doctors, researchers, pharmaceutical folks and others interested in the science and business of cancer from…

Conditions and diseases

DTC genetic tests and the wilds of personal medical information

Tia Powell, MD

December 10, 2012Dec 10, 2012

The other day I landed on the website of 23andMe. To my surprise, I learned that if I wanted to send the company a sample of my DNA, I’d have to swear under penalty of law neither to collect my…

The other day I landed on the website of 23andMe. To my surprise, I learned that if I wanted to send the company a sample of my DNA, I’d have to swear under penalty of law neither to collect my sample nor mail it from New York State. That’s because New York State requires a laboratory license and direct interaction with a physician for mail order DNA testing.

New York, it …

Conditions and diseases

The need for evidence in genomic medicine

Michael P. Douglas & W. David Dotson, PhD

April 21, 2012Apr 21, 2012

An IOM report makes recommendations that aim to ensure that progress in omics-based test development is grounded in sound scientific evidence and is reproducible, resulting in improved health care and continued public trust in research. Another new IOM roundtable workshop report discussed the differences in evidence required for clinical use, regulatory oversight, guideline inclusion, coverage, and reimbursement of genomic diagnostic tests and focused …

Conditions and diseases

Should you consider genetic testing?

Karen Lu, MD

December 12, 2011Dec 12, 20116

Some of your relatives have had cancer. And, you’ve heard that people with a family history of the disease may be more likely to get cancer. So, should you consider genetic testing to find out if cancer runs in your…

Some of your relatives have had cancer. And, you’ve heard that people with a family history of the disease may be more likely to get cancer.

So, should you consider genetic testing to find out if cancer runs in your family?

Here’s what you need to know to make a more informed decision.

Most cancer cases aren’t related to family history.

Only about 5 to 10% of cancer cases are due to an …

Read more…

Should you consider genetic testing?

Genetics and genomics

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