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Tag: Genetic testing

One Libertarian’s Dilemma: Genetic Testing or the FDA

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By Saurabh Jha, MD

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 out to be remarkably accurate.

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 lung cancer how would one know that the chances were indeed 12.5 %, not 6.25 % or 25 %?

We die only once. Whether one ends up with lung cancer or doesn’t, the veracity of the claim can be made only empirically. Meaning we need to see how many develop lung cancer out of 10, 000 people just like us.

Yet there is an element of scientific precision in the number, augmented by the decimal point. And it is precisely because genetic testing tends towards science not metaphysics that it falls within the dominion of the Food and Drug Administration (FDA). FDA does not regulate palm readers.

FDA has asked 23andMe to stop sales of its genomic testing.

As a libertarian seeped in the Austrian school of Economics, I am generally disposed against regulations. I also share the sentiments of the monetarist Milton Friedman that the true costs of the FDA must also include the treatment opportunities foregone in their lengthy review process.

So it hurts me to be somewhat sympathetic of FDA’s stance on 23andMe, even as I think an outright ban was a tad harsh.

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Can Personalized Care Survive ObamaCare’s Assembly Line Medicine?

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By John Goodman

Previously, I wrote about some wondrous developments that are taking place in medical science. Implantable or attachable devices already exist — or soon will exist — that can monitor the conditions of diabetics, asthmatics, heart patients and patients with numerous other chronic conditions. These devices will allow patients and doctors to modify therapeutic regimes and tailor treatments to individual needs and responses. Genetic testing is reaching the point where patients can be directed to take certain drugs or avoid other drugs, based solely on the patient’s own genes.

Almost all HIV treatment these days involves therapy cocktails tailored for each individual patient. The FDA has approved a breast cancer drug only for women with a particular genetic makeup. Patients are being advised to steer clear of an ADHD drug and certain blood thinners if they have particular genetic variations.

We are entering the age of personalized medicine, where the therapy that’s best for you will be based on your physiology and genetic makeup — and may not be right for any other patient.

Yet standing in the way of this boundless potential is an Obama administration whose entire approach to health reform revolves around the idea that patients are not unique and that bureaucrats can develop standardized treatments that will apply to almost everybody with a given condition. When former White House health adviser Ezekiel Emanuel told CNN recently that “personalized medicine is a myth,” he was fully reflecting the worldview of the authors of health reform.

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Genetic Testing and Insurance: One Datum

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By DAVID FRIEDMAN

Reductions in the cost of genetic testing and improvements in what we know about what it tells us produce obvious benefits; if you know you are  likely to have some particular medical problem, you may be able to take precautions against it. But they also have at least one potential downside.

The more is known about the chance of bad things happening to us, the less able we will be to insure against them.

A solution to this problem that is sometimes proposed is to permit individuals to have their genes tested but forbid insurance companies to require testing as a condition of insurance or to use the information it produces. The problem with that is adverse selection. If the customer knows his risk and the insurance company doesn’t, high risk and low risk customers are charged the same price, making insurance a good deal for the former and a bad deal for the latter. Insurance companies, realizing that most of those who choose to buy their insurance are bad risks, will charge accordingly, driving more of the low or average risk customers out of the market. In the limiting case, insurance is bought only by high risk customers, at a high risk price. A famous description of the problem is Akerlof’s article “The Market for Lemons.”

If we allow both insurance companies and their customers to make use of genetic information, then both high risk and low risk customers can buy insurance, but at different prices. The risk of having genetic variants that make you more likely to suffer some expensive medical problem is uninsurable, although you can still insure against the risk that, given those genes, the problem will actually appear.

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It’s My Life, It’s Now or Never

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By LISA SUENNEN
Lisa Suennen

You can walk into a pharmacy any day and buy a test kit to find out if you are ovulating so that you can undertake family planning activities. You can buy home testing kits to screen for high cholesterol, presence of the HIV virus, even illicit drug use. You can also pony up $500 and buy yourself a genetic test kit from 23andMe, a retail DNA testing service, to find out what might be in your genetic blueprint. Hey, you can even visit a fortune teller if you feel that is how you want to make pre-emptive healthcare decisions.

While some might look askew at how you get information to make choices about your life, it is rare that someone steps in and tries to stop you from doing so. In general, the American way is to say, “Hey, you’re an adult and it’s your life. If you want to engage in self-actualization, whether or not it has a scientific basis, that’s your beeswax.”

As medicine has evolved to a point where over-the-counter testing has become more and more accessible, many consumers have responded to the perceived advantages of privacy, convenience and the heightened ability to make health decisions early. In fact, these are part of the key principles espoused by those who believe that consumers have a right to their own healthcare information. The idea is that the information is about you, the healthcare consumer, and thus should be both readily available to you and yours to do with what you wish. And yet, that is not always the case. Often it’s not even close. Continue reading…

Should We Fear Genetic Testing?

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By THOMAS GOETZ
Thomas Goetz

Though the prospect of learning about our DNA might seem wrapped in mystery and intrigue, genetic information is not so different from any other metrics we know about ourselves: Our age, our weight, our blood pressure. With a little scrutiny, any of these numbers can tell us something about our health and ourselves. It’s the same with a genetic scan – it gives us some perspective on our health, though far from the complete picture. It is, in other words, a place to start thinking about how we’re living our lives.

It’s important to remember, though, that genetics is a very new science, and that getting a scan today is the equivalent of buying the first generation iPod – it’s a work in progress, and will get much better as time goes on. There’s a lot that science doesn’t know yet about the exact influence of DNA on our health, and the journey is part of the ride. But it’s a rare opportunity, unprecedented, perhaps, in history, that the general public might be granted unfettered access to experience science as it happens. It’s not something that everyone will be comfortable with, but we shouldn’t underestimate how profound this opportunity is.Continue reading…

Direct to Consumer Genetic Testing — The Need for Early Filtering of Genetic Information

By GAIA BERNSTEIN, JD
Gaia Bernstein

Genetic testing for adult onset diseases used to be mainly a medical service. In most cases a person who had a certain genetic disease that was prevalent in her family would go to test to see if she carries the genetic mutation. For example, a woman who had several cases of breast cancer in her family would test for the breast cancer genetic mutation BRCA1/BRCA2 to see if she carries the mutation and has a high probability of getting the disease. But, the proliferation of direct to consumer genetic testing changes the nature of the service to a consumer service. Companies like 23andme and Pathway Genomics (who was planning to start selling its kits in Walgreens) offer consumers the option to buy packages of tests (ranging from 25 to over a 100 conditions). Consumers often buy the tests to satisfy their curiosity or they may even receive them as a gift. People purchasing the testing packages usually do not consult a medical professional when deciding to undergo the tests and receive the results alone by accessing a website.

Yesterday I spoke before the FDA, which is considering regulating direct to consumer genetic testing. My presentation was based on a symposium piece I am working on. I argued for the need for a medical professional to guide people throughout the process and advise them not just on the interpretation of the results but also earlier in the process to determine what genetic information they actually want to have.

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Genetic Testing, Fact or Fiction: You Be the Judge

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By MICHAEL MILLENSON

Which of these two events is fact and which is fiction?

  • Organizations representing employers and health plans call for a moratorium on implementation of the Genetic Information Nondiscrimination Act, asserting that the new rules could have a “significant and adverse impact…on wellness and prevention efforts” in the workplace.

  • One of the largest companies in America begins matchmaking its employees based on their genetic compatability, hoping to save on the health insurance bills associated with imperfectly bred children.

Answer: No. 1 is a Dec. 2 press release from the Disease Management Association of America. No. 2 is a description of the Dec. 8 episode of the ABC-TV comedy, “Better Off Ted.”

Coincidence? You be the judge.

Ethics of the genetic testing marketplace

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By Hsien-Hsien Lei

Dna

Fresh on the heels of the launch of the deCODE BreastCancer genetic test last week, Dr. Arthur Caplan, renowned director of the University of Pennsylvania Center for Bioethics, said in an article for MSNBC.com that breast cancer gene tests are not worth the price.

If you are worried about your risk of getting the disease, or are thinking about getting a genetic test done for any other reason, talk with your doctor or a genetic counselor who can determine whether your family history justifies the expense. You may be surprised to find that you can make changes in lifestyle and monitoring your own health that can reduce your risk without testing.

Dr. Caplan even goes so far as to accuse genetic testing companies of corporate greed which, given the current economic environment in the U.S., is bound to send shivers down their spine.

With respect to deCODE’s breast cancer genetic test, it examines seven single nucleotide polymorphisms* (SNPs) that are purportedly involved in 60 percent of all breast cancers. Results from the test are given as personal lifetime relatively risk compared to the general population (specifically people of European descent). Other risk factors such as family history, pregnancy history, etc. are not taken into consideration when calculating a deCODE BreastCancer genetic test taker’s risk.

deCODE’s Chief Scientific Officer, Dr. Jeff Gulcher, responded to Dr. Caplan on its blog, deCODE You (a member of the DNA Network) and drew analogies between the BreastCancer genetic test and LDL-cholesterol tests. Anyone who is identified to be at higher risk of breast cancer (or in the analogy, high cholesterol leading to cardiovascular disease) would benefit from greater vigilance, more intensive screening, and possibly, preventive therapy.

Another DNA Network member, Dr. Steve Murphy at Gene Sherpas calls the deCODE BreastCancer test “hype.” Cancer Research UK also believes that “it’s too early for a test of this kind to be released to the general public.” Dr. Len Lichtenfeld of the American Cancer Society does not believe the test will “advance our cause in the fight to reduce deaths from cancer in a meaningful, evidence-based and scientifically accurate way.”

Speaking of cost, though,it seems that 23andMe customers get the better deal because six of the seven SNPs (rs4415084 was on the v1 chip but not on the v2 chip) examined in the deCODE BreastCancer genetic test are included on version 2 of the 23andMe gene chip (I checked using SNPedia) not to mention the other nearly 600,000 SNPs included in the 23andMe report. A 23andMe DNA test costs $399 while a deCODE BreastCancer genetic test costs $1,625.

deCODE’s test offers other bits and fancy algorithms for calculating risk to justify the price. But customers should be aware that there is more than one way to get the genetic data they desire. And that data’s worth can be hard to price.

*See the list of SNPs in this sample report (pdf).

Hsien-Hsien Lei (pron. shen-shen lay) is a PhD-trained epidemiologist and biotech consultant. She blogs regularly at Eye on DNA, where this post first appeared. She is a consultant to DNA Direct, a genetic testing company.