Patient Consent At Risk As Genome Sequencing Breakthroughs Divide Medical Community

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A forthcoming report in Science magazine argues that patient consent and confidentiality are under fire, after the American College of Medical Genetics and Genomics (ACMG) recently adjusted its formal recommendations to doctors that, for the most part, now leave the patient out of the decision-making process over how much data researchers can mine from their unique genetic codes.

According to a summary prepared in advance of the report:

Informed consent is the backbone of patient care. Genetic testing has long required patient consent and patients have had a “right not to know” the results. However, as 21st century medicine now begins to use the tools of genome sequencing, an enormous debate has erupted over whether patients’ rights will continue in an era of medical genomics.

Recent recommendations from the American College of Medical Genetics and Genomics (ACMG) suggest no. On March 22, the ACMG released recommendations stating that when clinical sequencing is undertaken for any medical reason, laboratories must examine 57 other specific genes to look for incidental findings. These findings must then be reported to the clinician and the patient. In an April 25 “clarification,” ACMG said that failure to report these findings would be considered “unethical.” The patient has no opportunity to opt-out of the testing of the 57 genes, except to decline all sequencing. The recommendations also apply to children.

The study, a joint effort by Susan M. Wolf of the University of Minnesota, George J. Annas of Boston University and Sherman Elias of Northwestern University, argues that the all-or-nothing sequencing of a patient’s genetic code would be beneficial, if only the patient could have a say over the “all-or-nothing” part.

“The ACMG’s ‘minimum list [of 57 genes]‘ includes mutations in genes that patients have long been able to refuse testing for, including cancer risk mutations (such as BRCA1) and cardiovascular risk mutations,” the authors argue. But, they add, there are myriad practical, medical reasons — as well as principled ones — why the control over the reach of genetic sequencing — and the information it yields — should rest solely in patients’ hands.

The patient may already be battling another disease, such as advanced cancer, or be late in life and see more burden than benefit in added genetic information. The patient may also fear that ‘extra’ results in their medical record will invite risk of discrimination.

Ominously, the “minimum list” of 57 genes currently on the table for data mining is expected to grow significantly, according to the ACMG. That, the report warns, places even greater urgency upon lawmakers to craft new legislation, or enforce existing law, if applicable, that strongly favors patients’ rights.

Ben Bullard

Reconciling the concept of individual sovereignty with conscientious participation in the modern American political process is a continuing preoccupation for staff writer Ben Bullard. A former community newspaper writer, Bullard has closely observed the manner in which well-meaning small-town politicians and policy makers often accept, unthinkingly, their increasingly marginal role in shaping the quality of their own lives, as well as those of the people whom they serve. He argues that American public policy is plagued by inscrutable and corrupt motives on a national scale, a fundamental problem which individuals, families and communities must strive to solve. This, he argues, can be achieved only as Americans rediscover the principal role each citizen plays in enriching the welfare of our Republic.

  • village idiot

    No problem here – the patients will be so bamboozled and petrified by all the medical terminology and the laws pertaining thereto, that they will just succumb anyway. Good move to alleviate the possibility of euthanasia.

  • 5live5

    Bob,
    Left you a question on another thread asking for an answer but none. I’ll try again. Is there any truth to the rumor that Obam or the government passed a bill holding chemical companies blameless even if their chemicals are later found to be harmful to humans? can you imagine if this had been law during Viet Nam? myself and a whole lot of other vets exposed to Dioxin (Agent Orange) would have had no recourse to their disabilities or their CHILDRENS disabilities brought about by this hazardous Chemical.
    also I was told that the government raided a lab and destroyed a bee colony that they were using to prove that a certain chemical company’s chemicals were killing off the honey bee hives. Have you heard of this and would you comment?