Verinata’s Prenatal Testing Flow Chart: Unethical?

As I’ve mentioned before, on the home page there is a scroll of my twitter feed. Like this blog, I typically tweet about news related to Down syndrome and/or prenatal testing. But, sometimes Twitter’s 140-character limit is not enough to provide a thorough analysis of ethical issues.

Verinata is a laboratory that developed its version of non-invasive prenatal testing (NIPT), which has the brand name “verifi.” Featured on its website is the following decision-making flow chart for prenatal testing:

Recently, I tweeted the following about Verinata’s flow chart:

Some questioned why I termed the flow-chart “unethical.” Well, because it is.

As I’ve been covering in the series on the informed consent process, the current administration of prenatal testing is premised on informed consent. This means that out of respect for a woman’s right to exercise her autonomy, it has been argued that it is a moral obligation to offer an expectant mother prenatal testing so she may elect whether she (1) wants the information provided by prenatal testing or (2) wishes not to know, and (3) so she may make reproductive decisions based on prenatal testing results.

In ACOG’s most recent statement on prenatal testing advances, ACOG repeatedly stated the requirement that NIPT be offered only after prenatal counseling and as a result of an independent, non-routine, informed decision by the expectant mother. Perhaps this emphasis on offering NIPT is informed by ACOG’s prior experience in announcing new guidelines on prenatal testing.

In 2007, ACOG issued two practice bulletins, numbers 77 and 88. Practice Bulletin No. 77, issued in January, changed the standard of care. Previously, only mothers over the age of 35 were offered prenatal testing for Down syndrome. The rationale for that age cut off that for mothers 35 or older, the chance of having a child with Down syndrome was approximate to the chance of having a miscarriage from diagnostic testing to find out if their child had Down syndrome. Practice Bulletin No. 77 changed all that, recommending that all women be offered both prenatal screening testing and diagnostic testing.

Down syndrome advocates condemned the new ACOG guidelines. In response, ACOG issued a press release. In it, Deborah Driscoll, the vice-chair of ACOG’s practice bulletin committee and chair of OB-Gyn at the University of Pennsylvania, sought to highlight the key distinction between what ACOG actually recommended from the public perception:

We are not recommending that all pregnant women be screened, but rather we are recommending that all pregnant women be offered screening. Physicians are ethically obligated to fully inform our patients of their health care options, including prenatal testing. It is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities without judgment from the physician.

(emphasis in original). In December, ACOG issued Practice Bulletin No. 88, reiterating that all women were to be offered prenatal diagnostic testing as well as screening testing—but again, the recommendation was only to offer both types of testing.

This background then informs my criticism of Verinata’s decision-making flow chart. The flow chart appears on Verinata’s website under the tab for “providers,” so it is meant to instruct OBs and other medical professionals on how they should administer prenatal testing for their patients. It should be noted that at the bottom of the flow chart, Verinata states that, “Patient can choose/decline options based on clinical discussions with her provider.” However, my criticism is that the flow-chart does not present certain stages in the prenatal testing process as “options.”

Note that the steps following an NIPT result indicative of Down syndrome are not presented as “options” or, more particularly, as “offers” of diagnostic testing. Instead, Verinata advises providers that following an NIPT result suggestive of Down syndrome that diagnostic testing is then “recommended.” Diagnostic testing is never “recommended,” only the offering of diagnostic testing.

Even worse, the step following an NIPT result where Down syndrome is “detected” is simply “confirm with diagnostic testing.” Following this flow chart would mean diagnostic testing is not even offered, or that the patient should exercise an independent, voluntary choice to accept the risk of miscarriage associated with diagnostic testing. Instead, per Verinata’s flow chart, diagnostic testing should routinely follow an NIPT result that detected Down syndrome. This is contrary to ACOG’s admonition that NIPT should not be part of “routine” prenatal testing and that diagnostic testing should only be offered.

No doubt there is much to quibble with my criticism: the flow chart is just that, a flow chart, not a substitute for the professional counseling expected in a prenatal testing; space is limited and so words were chosen to note the distinction following each step; and, others. But, how much more space would it take to just list at each step, “offer diagnostic testing”? Not much at all, and the reasons for the language that is used instead of the language that should be used is why the flow chart is unethical: it fails to respect that each decision about each form of prenatal testing is supposed to be a voluntary, informed choice.

Postscript: By basing this criticism on the current ACOG professional guidelines, this post should not be taken as an endorsement of the ethics of those same guidelines. ACOG’s guidelines have their own ethical failings—and Verinata’s inconsistency with those guidelines in one respect  arguably provides more ethical care—but that analysis will be detailed in subsequent posts.

Question(s): What do you think of Verinata’s flow chart? Do you expect it will empower informed choice?