HHS gives; FDA takes away

On Monday the Department of Health and Human Services released a rule that permits lab results to be shared directly with patients without first sending to a doctor.  This rule gives patients more control over interpreting their medical results and increases the accountability of medical providers to patients.  It also raises confusion over the FDA’s recent letter to 23andMe, a genomic tech company, which compelled the company to stop providing medical analysis directly to patients.

I personally purchased a genomic testing kit from 23andMe in October, a few weeks before the FDA’s letter.  Within four weeks I received a detailed genetic and health risk analysis.  Under each category of health risk that my profile identified, 23andMe explicitly recommended that I discuss the result with my physician.  Armed with the knowledge of my personalized health risks, together with my doctor I developed a plan to counteract several genetic markers that increase my risk for developing chronic conditions later in life.

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In November the FDA compelled the company 23andMe to stop providing consumers with itemized health risks based on a personalized genetic analysis.  Ostensibly, the FDA’s actions were meant to protect consumers from making hasty decisions about their health based on the itemized health risks the company provided.

23andMe’s personalized genetic analysis is conducted by providing individuals with a vial that a consumer fills with saliva, which is then analyzed to provide personalized genetic indicators for 240 diseases and inherited conditions.  The kit and analysis cost $99 and results take 3-5 weeks.

In its letter the FDA cited a hypothetical scenario in which the analysis returned a false positive for breast cancer and would cause a consumer to immediately, without consulting a doctor, undergo a mastectomy as a preventative measure.  The example is both improbable and extreme.  It is unlikely that a surgeon would perform a mastectomy without a recommendation from a referring physician.  Further, there are few doctors who would recommend such a procedure without first performing a blood test on the patient to confirm her results.

An individual who elects to spend discretionary dollars on this type of medical analysis is the exact type of individual most likely to seek a second opinion from a physician or a medical expert.  These consumers, simply by purchasing and sending in their test kits, have already shown themselves to be proactive on using all available resources to manage their health risks.  It is unlikely that such a person would react to a health risk assessment by taking extreme measures without getting a professional opinion.

Additionally, if one follows the same logic as the FDA’s letter, the laboratory results that the DHHS on Monday permitted to be released to patients can result in patients neglecting to consult a physician on their lab results and taking similar actions.

The FDA plays a vital role in our society by ensuring that drugs, food, and medical devices do not cause harm to the American public.  Admittedly, the regulatory body often errs on the side of caution, and certainly the agency’s job jurisdiction merits this level of caution.  The safety of the American public is not a job at which one is permitted to occasionally fail. 

The FDA often balances the risks and benefits of new procedures and drugs by permitting drug trials for willing participants.  These participants are made aware of the unapproved nature of the drugs or devices before the trial and waive their right to hold the drug manufacturer liable. 

23andMe acknowledges that the medical reliability of their product will improve over time as they evaluate more samples and build their library of knowledge.  It seems that a fair solution to the current impasse is for 23andMe to be granted the ability to provide medical results to customers under a program similar to the one used to test new drugs, where consumers are made more explicitly aware of the untested nature of the results.  This helps protect consumers while granting them access to the available information about their own genetic code they seek.

Colangelo is the executive director of Consumers’ Research.  Consumers’ Research was founded in 1929 as a product testing and consumer advocacy organization and publishes a bi-monthly magazine on consumer topics.