Japan’s Shionogi says COVID-19 pill shows rapid clearance of virus

Japan’s Shionogi says COVID-19 pill shows rapid clearance of virus

The company has global aspirations for the antiviral pill

https://www.foxbusiness.com/healthcare/japans-shionogi-says-covid-19-pill-shows-rapid-clearance-virus

An experimental treatment from Shionogi & Co. Ltd. has shown rapid clearance of the virus that causes COVID-19, according to new data, the Japanese drugmaker said Sunday.

The pill, S-217622, “demonstrated rapid clearance of the infectious SARS-CoV-2 virus,” Shionogi said in a statement, citing results from a clinical trial of the drug.

The company has global aspirations for the antiviral pill, which is now being evaluated by Japanese regulators.

The findings released Sunday also showed “there was no significant difference in total score of 12 COVID-19 symptoms between treatment arms,” although the drug showed improvement in a composite score of five “respiratory and feverish” symptoms, Shionogi said.

 A ground crew member moves pallets of a shipment of Pfizer’s antiviral COVID-19 pills, Paxlovid, as they arrive at an Incheon International Airport cargo terminal Jan. 13, 2022, in Incheon, South Korea. ( Jung Yeon-Je, Pool/Getty Images / Getty Images)

The drugmaker said in March it would launch a global trial for the drug with U.S. government support, and Chief Executive Isao Teshirogi has said production could reach 10 million doses a year.

Shionogi’s shares have been on a roller coaster on speculation about success of the treatment. The stock climbed Friday after a report the U.S. government is in talks to acquire supplies of the drug.

Biologics for JIA? Not So Fast, Say Insurers

Biologics for JIA? Not So Fast, Say Insurers

— Nearly all required prior authorization in a small study, and requests often rejected at first

https://www.medpagetoday.com/rheumatology/arthritis/98368

A photo of a young girl holding her painful hand.

It’s not a simple matter to prescribe tumor necrosis factor (TNF) inhibitors for patients with juvenile idiopathic arthritis (JIA), at least those with insurance, a single-center study found.

Among 54 patients seen at Boston Children’s Hospital for newly diagnosed JIA in 2018-2019, their insurers required prior authorization for all but one, according to researchers there led by Jordan E. Roberts, MD.

And for 14 of those, the initial requests were denied, the group reported in JAMA Network Open. Four of the patients ended up taking another type of medication because of the denials, although TNF inhibitors were eventually approved for all 54.

That latter finding indicates that insurers’ policies “present barriers to care despite appropriate specialty medication requests,” Roberts and colleagues argued — a situation also faced by adults with rheumatoid arthritis and similar conditions for which TNF inhibitors are a standard of care.

In many cases, insurers insisted on particular forms of “step therapy” with either (or both) nonsteroidal anti-inflammatory drugs (NSAIDs) or nonbiologic disease-modifying anti-rheumatic drugs (DMARDs) before they would authorize TNF inhibitors.

For some patients, insurers demanded that patients receive a different TNF inhibitor from that prescribed by clinicians. Four such patients, for example, were required to take adalimumab (Humira) instead of etanercept (Enbrel) or infliximab (Remicade). “Infliximab’s intravenous formulation allows for more precise weight-based dosing than subcutaneously administered [TNF inhibitors],” Roberts and colleagues pointed out.

In other cases the insurer simply decreed that TNF inhibitors were not a “medical necessity,” even though clinicians judged that their patients were not responding adequately to nonbiologic therapy. TNF inhibitors are “strongly recommended” in the most recently published guidelines, and were already central to treatment as far back as 2011.

In fact, 91% of the patients in the Boston Children’s study had previously received conventional DMARDs and 61% had taken NSAIDs. Mean patient age was 10 and just over half were girls; no particular JIA subtype was predominant.

Median active joint count was 2 (interquartile range 1-4) when TNF inhibitors were first recommended, and medians for patient/parent and clinician global assessments stood at 3 on a 10-point scale, with 10 representing the most burdensome disease.

Both figures suggest that most patients were experiencing some degree of difficulty that TNF inhibitor therapy could help relieve.

Public insurance (n=10) was no better than private in terms of the barriers erected, the admittedly limited data indicated. Denials of initial requests ensued in 30% of these cases, compared with 25% of patients covered by private insurance, and median times to approve prior authorization and to start TNF inhibitor treatment after the requests were made were similar (2.5 vs 3 days and 20 vs 24 days, respectively).

While a 3-week wait to begin recommended therapy may not seem long, Roberts and colleagues observed that early aggressive treatment has been tied to improved outcomes.

Limitations to the study were the small number of patients and its location in Massachusetts, where Medicaid is “relatively comprehensive”; formularies differ considerably among state Medicaid programs as well as among private insurers.

In this small study – mean aged of pt was 10 y/o – and bodily damage caused by juvenile idiopathic arthritis (JIA) is NON-REVERSIBLE so the denial by these insurance companies – per this survey … the time between first being prescribed and receiving the TNF inhibitor … Initially the joint damage on a 1-10 scale was a TWO and by the time that the insurance companies stopped playing around – THREE WEEKS – with prior authorizations… the joint damage had progress ONE WHOLE POINT.

ALL HAT AND NO CATTLE


Isn’t there someone in Rhode Island that professes to be a strong advocate for chronic pain pts ?  I know when people reach out to me, I try to get back with them the same day and no later than the next day. I have been watching the TV show YELLOWSTONE and they have a phrase they use that may be appropriate here ” “they” must be ALL HAT AND NO CATTLE”  To make sure that I was correct about the definition.  I found this on the web https://wordhistories.net/2020/12/07/all-hat-no-cattle/  to have or cultivate a particular image or reputation which has no basis in reality

Why employees of major pharmacy chains are quitting their jobs


It’s my last day at the WAG and this is my final (i think) draft of the email that I‘ll send to upper management as I end my shift. I held back many unprofessional words but also wanted them to hear my frustration for not just myself but all other pharmacists and techs.

This is a final “goodbye letter” to Walgreen after 7 yrs working up to being a pharmacy manager. All the things/tasks that this tech is referencing in this letter is in the industry as “metrics”.  Generally this is something that your local independent pharmacy doesn’t worry about. When I had my own independent pharmacy… the “metrics” that I looked at… was the number of prescriptions filled and $$ generated this month compared to the previous month or the same month one year ago..  Once a month that took – MAYBE – 10-15 minutes of my time.  If my pharmacy was filling more prescriptions and generated more revenue – it was easy to come to the conclusion that we were doing something right…  if those numbers did not increase, we were doing something wrong and we need to find out what it is and how we make adjustments.  These pharmacy chains seem to want to over analyzes even minute details. Often they waste all of these staff hours trying to figure out how they could cut staff hours and generate more profits for the corporation. When work feels more like a battlefield, it’s essential to take steps to cope and improve your experience.

If you patronize a chain pharmacy and you wonder why you have to wait too damn long to get your prescriptions filled… or the pharmacy doesn’t have your meds in stock or why the Rx dept staff looks like they are running on a tread mill all the time… or why you can’t get them to answer the phone when you call.

If you are tired of being treated just like another number when you are trying to get your necessary medication filled… here is a hyperlink to find a independent pharmacy by zip code https://ncpa.org/pharmacy-locator

APDF runs on donations – please use these apps to donate

I’m looking for someone from Michigan affected by the high costs of insulin for a reporter


I’m looking for someone from Michigan affected by the high costs of insulin for a reporter. Here’s the info. You can call. Today, I’m wrapping up a story on drug prices, and that includes the Afford Insulin Now Act that would cap insulin cost-sharing at $35 — at least for some people.
. Unfortunately, I’m on a tight deadline. Might you know anyone in Michigan who can help? The best way to reach me is 734-725-1155. Please feel free to share that number.
Many thanks for all the help. Unfortunately, I’m on a tight deadline. Might you know anyone in Michigan who can help? The best way to reach me is 734-725-1155. Please feel free to share that number.
Many thanks,
Robin Erb
Michigan Health Watch
Read my latest.
Bridge Michigan
(734) 725-1155

‘Euthanasia Pivots on Intent:’ Physician Witnesses in Husel Trial Speak Out

‘Euthanasia Pivots on Intent:’ Physician Witnesses in Husel Trial Speak Out

Physician expert witnesses on either side of the Husel trial dive into case’s gray areas

https://www.medpagetoday.com/special-reports/exclusives/98345

Joel Zivot, MD, of Emory University in Atlanta, was the only witness called by the defense. Wes Ely, MD, of Vanderbilt University and the Nashville VA, was one of 53 witnesses called by the prosecution.

In this exclusive MedPage Today video, Zivot and Ely discuss the finer points of the case, such as the lack of guidelines on end-of-life opioid dosing, plus the intent of relieving pain versus the intent of shortening the dying process.

A transcript of the conversation follows:

Zivot: I think that the issues around the Husel case — there was a lot of focus on dosage, and I understand where the concern around dosage would be relevant. In medicine, we spend a lot of time thinking about dosage. Many other kinds of medications that we administer, of course, have an associated dosage with them.

Now what’s tricky about opioids is that, with respect to specific dose, we understand that there’s a variety of responses that can occur as a consequence of things like prior exposure, or the intangible problem of how much pain a person is actually having. If I’m giving a medication, for example for high blood pressure, I’ve got a very nice sharp target and I know when I’ve achieved that dose. On the other hand, the intangible problem of pain, especially around the time of death, is very difficult to measure.

And so the only thing that we can know is by engaging our empathy. We have to look at a person and imagine, if we were them, what it might feel like as we dose them.

I think that the practice reflects this in that if one looks at the literature, people are very careful not to say that one must only give dose “X” in every case. The American Medical Association, for example, when it talks about this really just specifies a quantity necessary to achieve the desired goal

Ely: Standard doses of analgesics opiates — opioids for relieving pain — really center around, for fentanyl, in the 50 micrograms to 100/200 microgram ranges as starting doses. We have to talk explicit numbers, but those numbers are not hard and fast.

The key is that if our goal, if our intent is to relieve suffering, we have to balance the risk and the benefit of the drug. So that’s why with fentanyl, for example, we would start in the 50 microgram to 100 microgram range, and then we would go up if the patient, as Dr. Zivot said, still exhibited signs of pain.

What we don’t do with these drugs is immediately jump to doses 10 or 20 times higher — that 1,000 to 2,000 micrograms — without first going with the lower doses, because the lower doses could achieve pain relief without the main problem of completely suppressing the drive to breathe. Because these drugs will suppress the drive to breathe of the brain, and fentanyl will also create intense chest stiffness that prevents someone from breathing, too. We see that all the time in the operating room.

So, the standard doses aren’t hard and fast, but the general idea is if your intent is to relieve pain: start low, go high. Don’t start way high because of the potential downsides. And as you move to the way high doses, that’s where you shift from intent [to relieve] pain to something like — for example, in countries that have legalized euthanasia — an intentional shortening of the dying process.

Zivot: Well you know, Wes, you and I of course go back in our relationship. And what I think is interesting is that you and I share some important views. So, for example, we both have grave concerns about the practice of euthanasia. We both have said publicly that we are against euthanasia. And I would stand by that now.

When I think about the Husel case, I think that when I reviewed the records, I thought that Husel was not practicing euthanasia. When you reviewed the records, perhaps that’s what you thought — that he was practicing euthanasia. And it is further, perhaps, your position — and you can correct me if I’m wrong — that euthanasia here equates with murder. Maybe that’s the place where we found ourselves at odds.

You know, the court is very limited in terms of how it can manage these sorts of things. In the conversations between physicians and in the house of medicine, we’re capable of having a more nuanced conversation. But the court is very specific as to what it means to murder, and murder, I think, was what was at stake here and murder was the problem.

Ely: Yeah. I like your answer a lot, Joel. And I don’t know what Dr. Husel’s intent was, I never claimed to know Dr. Husel’s intent, and euthanasia does pivot on intent. So, if I intentionally am doing something to shorten your dying process, that is wrong and it’s against the law. If I am intending to relieve your suffering, that is not against the law even if by double effect I do shorten your life with the drug.

Somebody who’s in the ICU is voiceless when they are in critical care, on a ventilator, and unconscious. And so we have to protect them, because the mark of a society is how do we speak for people when they are vulnerable and don’t have a voice. And so in this case, I think we have to ask ourselves the difference between palliative care and euthanasia.

There was a beautiful paper published by Charlie Sprung in 2008 that involved 17 countries in Europe, over 30 ICUs, and they studied over 3,000 people. And the unique thing about this, Joel, was that doctors admitted in which patients they were intentionally trying to shorten the dying process. You couldn’t tell by dose, by the way, the doses were similar. But what the conclusions of the paper found were that there was a gray zone here which is very difficult to define, and we’ve got to talk about this more as a society and as medicine. As you went from palliative care to euthanasia on two different spectrums, what happened was palliative care is intent to relieve pain with doses that almost never could end a life, versus intent to shorten life with doses that almost always will shorten life.

The doses of 2,000 micrograms, 1,000 of fentanyl — that will almost always stop somebody from breathing. So those doses do fall into the category of almost always going to shorten somebody’s life.

Zivot: Look, I think that Thomas Aquinas, of course, spoke about the struggle of this in the doctrine of the double effect, and the distinction between what one intends and what one foresees. And I think to your point, what Dr. Husel intended, I suppose, cannot be known.

I can surmise his intent. I don’t think he had, you know, the history or the comportment of a murderer. Now, the issue of course for the court is the idea of how to gauge intent through action.

Normally as physicians, where we’re kind of engaged or interact with the law is through the concept of negligence, and negligence is something that we think of as a non-criminal wrong or a tort. What was unusual about Husel is that Husel was now charged with a criminal wrong, and a criminal wrong is constructed very differently than a non-criminal wrong.

In a criminal wrong, one needs two elements. It needs, first of all, the guilty act, which is referred to as actus reus. And then it also needs the guilty mind, which is mens rea. This is, I think, what you were alluding to, Wes, as to how to figure out what was his mind.

Now, where I think the court erred here is that they assumed that the act alone was where the guilty mind therefore must lie. It’s the same problem with this case in your state with the nurse, where an action alone was considered to be only the thing that a person with a guilty mind could possibly do. And that’s very troubling, that’s very troubling. I think the law here has really shown itself to be strikingly limited to navigate these very important end of life kinds of questions and practices that you and I are engaging in right now.

Ely: Excellent answer. And I’ll make a couple of comments. Actus reus and mens rea — I think in this case, there was actus reus. There was a dose given, as I said, which is almost certainly going to end up shortening someone’s life. A median time of death of 12 minutes is very unusual. Mens rea, I have no idea. I do not know what was in Husel’s mind, but I do know that the families were not informed that the patient was about to get a lethal dose of drug, and they did get what I absolutely consider a lethal dose of drug.

Again, I do not know his mind or his intent, but I will say this: in the circumstance of taking care of patients in the ICU, we have to always be aware that we do have the power to actus reus, to commit a harm against a person that can’t be reversed.

In this case, what was really striking, and this was a mind turner for me, was that the pain scores for many of these people were zero all throughout the day, meaning no indication of ongoing pain, until the moment that they received 1,000 or 2,000 mcgs of fentanyl and benzos. And then, all of a sudden they were at 10. That seems to me a very unusual thing, where somebody would out-of-the-blue go from zero to 10.

The most striking thing of all to me, and I didn’t even know this really until I reviewed these cases so in depth, was that — I’ve never seen this in 30 years of medicine — all 14 death notes were part of the DNR and the withdrawal of life support note.

Now, for the general public, usually as a doctor, I would write a note. I just conversed with the family and they believe the patient would want to not be resuscitated. Then hours later, we have now chosen to withdraw support, and then maybe hours or a day or two days later, the patient has now died. But in all 14 of these people, those three notes were in the same note. I’m making them DNR, I’m taking them off the vent, they’re dead.

That to me shows that these doses were part of an active shortening of the dying process. Whether he meant to do it or not, it happened. And that’s all I was speaking to. I never would want this guy to go to jail, but I do want us to protect society for vulnerable patients. We have to set the laws up and the rules within medicine so that we don’t take advantage of people who can’t speak for themselves.

Zivot: Well, I think that you and I agree on the importance of protecting vulnerable people. I think that’s the job of medicine. The people who are the majority need no protection. It’s always the minority and the vulnerable who require our protection.

Let me say a couple things. First of all, I think that actus reus — I would say that an act occurred, but whether that’s a guilty act, I think I would push back on. I just think that an act occurred. And I think that when we think about the conflict in bioethical practice, we can probably start with the very simple first two directives of secular ethics. The first being: do no harm. And the second one: do good. So non-maleficence and beneficence.

And I think, again, that was what Aquinas and others were kind of bumping up against — how can you do something that has two actions, where one action seems to be beneficial and one action seems to do harm? Around the bioethics table or at the bedside, we can discuss this. Where I think we got into trouble here is that the law decided it had something to say here in a way that I think was ultimately very problematic.

What I do know about these cases is that in every case a conversation took place. In every case, the family agreed that the patients would be made DNR, and most of the time, as we know in intensive care, patients die because we stop. That’s the normal way to die in intensive care. It’s an unusual action that people die in intensive care in the midst of chest compressions. That’s more uncommon than common.

So, now it might be claimed that the conversation was manipulated in some way, like in the Sprung paper that you referred to — are you talking about the Ethicus Trial? Is that what you’re talking about?

Ely: Yes.

Zivot: So in the Ethicus Trial, what was noteworthy is that if you look actually just from the physician’s perspective, they looked at three end endpoints — withdrawing, withholding, and active shortening — in that study. And what was noteworthy was that depending upon the geographic location within Europe and the religion of the particular physician, the practice varied.

Now, the thing about the ICU of course is that in a normal doctor-patient relationship, a patient can pick their doctor. In the ICU, the patient doesn’t pick their doctor. So, depending upon which week it happens to be, you’ll get one doctor or another. And what’s noteworthy too, is that doctors’ practices do vary. One doctor may practice one way and another doctor may practice another way. Patients, again, have no control over this. And it may in fact be that the week you happen to be in intensive care and, depending on which doctor you have, your outcomes could be quite different.

That’s a striking kind of problem. Now, none of that is murder. So, I want to keep coming back to that. You know, what Husel did I think is worthy of conversation, and it’ll be interesting to see if Husel returns to the practice of medicine and what he himself has learned from this. But I think that in terms of the variation of physician practice, our relationship with dosage, the way that we bring in our empathy, how we talk to patients and families — these are all very important subjects.

Ely: Sure. Let me close by saying that in no way do I know or surmise whether or not any conversations were manipulated by Dr. Husel. I have no idea. What I do think is that when people sign for their loved one to get DNR orders, they don’t sign on to get a dose of drug that will stop them from breathing. And that did happen, even though the families didn’t know it.

Now, importantly, you brought up the variation of physicians. We actually know from the New England Journal of Medicine, in Flanders, Belgium in the year 2013, a paper was published that showed that of times when people were given medicines to provide palliative care, 27% of the time (and this did not get brought up in the trial) doctors were deliberately giving a dose in Flanders, Belgium to end the patient’s life. The families were not told that they were getting that dose. The doctors did intend it, and that is considered a crime in Belgium. It’s considered murder in Belgium, but they weren’t criminally prosecuted.

And what I hope happens from the awareness that came about with Dr. Husel’s situation is that we all reconsider — and I know this actually is happening at the Society of Critical Care Medicine because people contacted me yesterday and said we’re going to review this for the upcoming guidelines of pain, anxiety, and delirium — that we’re going to address and what are reasonable doses. We can’t skip steps and jump to these high doses that cause chest restriction and lack of breathing without further first going through very low doses.

Also, let’s have a system of checks and balances so that we can calibrate one another and inform one another from within medicine, rather than having to go into the courtroom to do this, which I don’t even believe in. I’d rather this be done within the context of us within medicine.

Zivot: I think that the law struggles, and I think that the law here struggled greatly in trying to navigate an important subject that really should be under the purview of medicine. And it’s our job here, I think, to make sure that we are trying to engage this subject and do a better job of conveying to the public and to each other what we intend to be, so we can draw the distinction between the reduction of suffering, active euthanasia, and even in the most extreme, unusual example, the intentional killing of a person with malice.

Ely: I think we have to ask ourselves the question of where are we going and how are we gonna get there? And I think that the answer to the first question of where we’re going is that we should proceed in medicine to do a better job of relieving human suffering while staying within the boundaries of avoiding intentionally shortening someone’s life.

The way that I think we can do that is for doctors and nurses and bioethicists to have a system of checks and balances where when we deliver palliative care, we agree that the doses we’re giving are not likely to cause more harm than good, but rather to relieve pain, relieve anxiety, shortness of breath, et cetera. That we start at the lowest doses and then watch ourselves gradually increase so that we avoid this large jump towards doses, which are then on the spectrum of very likely to shorten somebody’s life, which then leaves us in an area that we don’t want to be in.

We don’t have the right to take someone’s life, but we absolutely have the intent and the vocational calling to relieve suffering.

Health Freedom Defense Fund: defending an individual’s bodily autonomy

Health Freedom Defense Fund

https://www.thethinkingconservative.com/health-freedom-defense-fund/

About the Health Freedom Defense Fund

Vision

At Health Freedom Defense Fund, we stand for freedom, we stand for choice, and we stand for the most basic of human rights, bodily autonomy.

HFDF asserts that no person, business, institution, organization, or government has the right to force a person to put something into their body against their will. If any of those entities have or claim that power, we are not free and we do not live in a decent, moral, or just society. As has been agreed by all free nations for decades, the practice of ethical medicine requires prior, voluntary and informed consent. Period.

HFDF leadership, staff and our members all dream of inhabiting a world where the individual and his or her rights are not only acknowledged but respected above all else. One of our guiding principles is that two wrongs do not make a right and any society that will sacrifice one of its members in service to the greater good is not a society we want to embrace or support.

We work to educate and advocate for these foundational principles to a free society and we defend them in the courts when necessary.

In this vein, we encourage everyone to stand up for their rights, and to do so peacefully and nonviolently.

We are living through unprecedented and challenging times but bear in mind Gandhi’s wise words, “Remember that all through history, there have been tyrants and murderers, and for a time, they seem invincible. But in the end, they always fall. Always.”

Visit the Health Freedom Defense Fund Website

Mission

Of all the basic rights that human beings possess, none is more sacred than that of bodily autonomy. Defense of this most fundamental of human rights is the primary mission of Health Freedom Defense Fund.

HFDF educates individuals about the primacy of the individual and ethical principles such as informed consent as a means of advancing society to a place where every individual is free to pursue education, employment, worship, or participate in society free of coercion, threat or pressure for his or her personal health care choices.

Health Freedom Defense Fund is a 501(c)(3) non-profit which seeks to protect and advance health freedom, educating Americans on informed consent, advocating for human rights and bodily autonomy for all people, and legally challenging unethical mandates, laws, and policies when necessary.

Visit the Health Freedom Defense Fund Website

President/Founder

Visit the Health Freedom Defense Fund Website

Leslie Manookian
Leslie Manookian

Leslie Manookian, MBA, M.L.C. Hom is president and founder of Health Freedom Defense Fund. She is a former successful Wall Street business executive. Her career in finance took her from New York to London with Goldman Sachs. She later became Director of Alliance Capital in London running their European Growth Portfolio Management and Research businesses.

Leslie is also an award-winning documentary filmmaker. In 2011 she released The Greater Good to rave reviews and awards; a documentary she wrote and produced, which explores the debate surrounding vaccines. This impactful film brings increased awareness to this issue and the importance of health freedom.

Protecting Americans medical and health freedoms inspired Leslie to found Health Freedom Defense Fund. After observing the trampling of our constitutionally protected, inalienable rights for the past two decades, she was filled with trepidation as 2020 unfolded, aware of various pieces of legislation in place which would facilitate further erosion of the rights of Americans. HFDF was the result.

Leslie’s and HFDF’s mission rests on the foundational principle that bodily autonomy is the most sacred and precious of human rights and must be fervently guarded. Leslie and HFDF endeavor each and every day to instill that notion in the public consciousness and codify it in law.

 

Bob Sheerin addressing when prescribers taking pts off pain meds

FDA: warns about tests may not be supported with “sound scientific evidence” BUT remains silent on the MME system use

https://www.pharmaciststeve.com/was-is-the-cdc-2016-guidelines-built-on-a-false-foundation-and-created-a-covert-genocide-on-a-protect-class-of-people/

FDA Issues Warning on Prenatal Genetic Tests

https://www.medpagetoday.com/obgyn/generalobgyn/98285

Relying on results could lead to inappropriate medical decisions, agency warns

The FDA warned in a safety communication that non-invasive prenatal tests (NIPT) are screening tests — not diagnostic tests — and patients and healthcare providers may make inappropriate healthcare decisions based on their results.

The agency said it’s aware of reports that people have made such decisions using the results of these tests without additional confirmatory testing.

“Pregnant people have ended pregnancies based on the results of genetic prenatal screening alone, without understanding the limitations of the screening test and that the fetus may not have the genetic abnormality identified by the screening tests,” the agency stated in a press release.

FDA’s warning follows recent media coverage of a Hastings Center report that found the marketing around the tests often included misleading information, which could lead parents to terminate a normal pregnancy. The New York Times had also reported on rates of false positives with the tests earlier this year.

The agency said in its statement that it is “concerned” that advertising claims on the tests, such as that they are “reliable” and “highly accurate,” may not be supported with “sound scientific evidence.”

The issue centers around the likelihood of a result being a false positive. For instance, with very rare conditions caused by a microdeletion — a small missing piece of a chromosome — a positive result is more likely to be false than it is that the fetus has the disease.

“In other cases,” the agency stated, “a positive screening result may accurately detect a chromosomal abnormality, but that abnormality is present in the placenta and not in the fetus, which may be healthy.”

FDA said additional testing of a genetic screening result, such as amniocentesis or chorionic villous sampling, may be needed to confirm whether the fetus indeed has the genetic disorder.

The agency also warned that none of the NIPT tests are authorized or approved by the FDA. Rather, they’re all classified as laboratory developed tests (LDTs), which means their accuracy and performance aren’t evaluated by FDA. The agency has had a general policy of “enforcement discretion” for most LDTs, which means it doesn’t generally enforce applicable regulatory requirements for these tests.

FDA stated in its press release that it is “continuing to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDTs.”

“While genetic non-invasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. We strongly urge patients to discuss the benefits and risks of these tests with a genetic counselor or other health care provider prior to making decisions based on the results of these tests.”

Josephine Johnston, director of research at The Hastings Center, told MedPage Today that the FDA’s safety communication “is a way of doing a little bit of regulation of an area they don’t regulate. … This is the only thing they can do.”

She noted that FDA’s review of its LDT regulatory policy has been ongoing for several years. “Tests are falling under this exemption they were never intended for, but it’s never changed,” she said. “There are probably strong and forceful arguments on both sides of the issue.”