Industry groups challenge FDA’s LASIK guidance, call for withdrawal

 Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on laser-assisted in situ keratomileusis (LASIK) patient labeling, arguing that the agency’s recommendations are based on faulty and outdated data and challenging its legal authority to issue the guidance.

 
The draft guidance, issued for comment in July, notes the FDA has become aware of more potential side effects of LASIK treatment and asks manufacturers to update their labeling so physicians can discuss those risks and alternative treatments with patients. (RELATED: FDA proposes checklist to inform patients of LASIK surgery risks, Regulatory Focus 28 July 2022)
 
FDA extended the comment period in response to requests from several stakeholders; so far the agency has received more than 600 comments to the docket.
 
In their public comments, industry groups AdvaMed and the Medical Device Manufacturers Association (MDMA) have asked FDA to withdraw the guidance, saying it amounts to interfering with clinical interactions between physicians and patients, and in effect would regulate the practice of medicine.
 
“The draft guidance intrudes on the patient informed consent process for the LASIK procedure – informed consent related to medical procedures is solely in the purview of clinicians and/or their associated health care facilities,” said AdvaMed. “Although it is unclear, it appears that FDA is aware that the proposed patient labeling in the draft guidance may, in effect, dictate medical practice but nevertheless chose to issue the draft guidance.”

AdvaMed also said the manufacturers should not have to make labeling that includes a checklist of alternative and competing treatments.
 
“This seems to be squarely within the surgeon’s responsibility, who can and should discuss the details of why certain treatments are appropriate or inappropriate based on the specific characteristics of a particular patient’s eye(s) or vision,” they added.
 
AdvaMed said that instead of issuing the guidance, FDA should collaborate with ophthalmic medical societies such as the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery to gather the latest data on LASIK treatments and develop preferred practice pattern (PPP) guidelines that can help with standard of care.
 
“If the FDA believes that an FDA guidance directed to industry, rather than a preferred practice pattern, is warranted, it should open a new docket, separate from the draft guidance, for public comment, or convene an Ophthalmic Devices Panel meeting, in order to obtain up-to-date input for the formal record,” the group added.
 
Several stakeholders, including MDMA note that the guidance relies on information from a 2008 panel FDA convened on the topic and additional data from 2009, which do not take into account improvements to LASIK technology since then.
 
“Moreover, the Draft Guidance oversteps the scope of the FDA’s regulatory authority and contradicts the agency’s long-established regulatory approach, by impermissibly regulating the practice of medicine,” said MDMA. “As the FDA has long acknowledged, the agency does not regulate the practice of medicine, including informed consent obtained by physicians prior to engaging in a procedure with a particular patient.”
 
While the group said they agree that patients should be appropriately informed in their best interest, they don’t think the guidance achieves that objective and should be withdrawn.
 
Daniel Cameron, the Republican attorney general for Kentucky, also wrote to FDA, arguing its guidance is an infringement on state authorities. He said the agency does not have authority to preempt a state’s informed consent laws unless Congress gives it that explicit ability.
 
“In the medical device context, Congress has said that no state may establish any requirement that is different from or in addition to any applicable federal requirement,” said Cameron. “In most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal
requirement.”
 
The Kentucky AG also raised concerns that FDA is creeping toward regulating medical practice under the guise of attempting to shape the informed consent process. He pointed to a September 2020 guidance entitled, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, in which the agency similarly recommended incorporating a boxed warning and establishing a patient decision checklist into the product label.

Cameron said that once the breast implant guidance was finalized, FDA issued an order that restricted sale of breast implants only to health care providers and facilities that provided information to patients using a patient decision checklist. That, in effect, converted a recommendary guidance into a mandate, he said.
 
“As the FDA repeatedly states, the draft guidance is not a requirement, and it is a non-binding recommendation even if made final,” said Cameron. “Therefore, the guidance cannot be treated as ‘specific federal requirements’ that would preempt state requirements. This would be true even if the FDA later issued an order restricting the sale or use of lasers to doctors who comply, because, as discussed above, such action would be an impermissible attempt at circumventing the limits on the FDA’s authority.”
 
The Society for Excellence in Eyecare (SEE) also asked FDA to withdraw the guidance stating it exceeds its authority and is based on outdated information. The group notes that FDA lists several contraindications in the guidance but since the data was acquired LASIK technology has gotten better and many of the side effects listed by the agency are temporary which fails to consider the potential long-term benefits compared to short-term issues such as dry eyes, discomfort and blurred vision.
 
“It is not unusual for patients to have some mild discomfort right after LASIK, but it usually goes away within a few weeks or months,” said SEE.
 
In the guidance, FDA noted that certain complications such as dry eye, inflammation or infection may cause severe, constant pain in some patients, preventing them from doing their normal activities. In some patients, it states the pain may never go away and may be resistant to therapy.
 
SEE argues the agency is conflating the normal healing process after LASIK surgery with neuropathic pain. The group argues that neuropathic pain resolves with treatment.
 
But not everyone was against FDA’s draft guidance. The American Optometric Association (AOA) said the guidance was “timely and beneficial” in providing patients with transparency around the risks and benefits of LASIK devices. The group asked for some changes to the guidance, including the inclusion of pregnancy as a contraindication and contact lenses as required devices that may result from LASIK surgery complications.
 
The AOA also asked FDA if it intends to publish a similar guidance on photorefractive keratectomy (PRK).

https://www.raps.org/news-and-articles/news-articles/2022/11/industry-groups-challenge-fdas-lasik-guidance-call

AstraZeneca ENHERTU Statistically Significant Overall Survival, Reducing Risk of Death 36% V. Roche Kadcyla

 AstraZeneca and Daiichi Sankyo’s ENHERTU also improved progression-free survival by 22 months vs. T-DM1 in patients previously treated with HER2-directed therapy in the DESTINY-Breast03 Phase III trial

ENHERTU showed significant progression-free and overall survival improvements vs. chemotherapy in later-line HER2-positive setting in the DESTINY-Breast02 Phase III trial

https://finance.yahoo.com/news/enhertu-fam-trastuzumab-deruxtecan-nxki-133000076.html

Forgetful Fauci’s Deposition: All Those Lies Are Hard to Keep Straight

 Anthony Fauci’s penchant for misleading the public about COVID-19 may be heading into a federal courtroom soon, owing to a lawsuit brought by the Attorneys General of Missouri, Louisiana, and the New Civil Liberties Alliance. On November 23, 2022, Fauci sat for a sworn deposition about his own actions in directing the United States’ pandemic response. Consistent with his past media appearances, Fauci displayed a penchant for bending the truth to fit his own narrative and, more specifically, denied his own involvement in suppressing the Great Barrington Declaration (GBD) in October 2020. Only this time, it was under oath.

Just about a year ago, on the anniversary date of October 5, 2021 to be exact, we took what we thought would be our retrospective and dispassionate look at the GBD, as lockdowns dissipated and mask mandates faded away. Two months later, AIER discovered a shocking revelation in emails received from a Freedom of Information Act (FOIA) request to Fauci’s office. In early October of 2020, Dr. Francis Collins, then Director of the National Institutes of Health, ordered Fauci and his trusted lieutenant Clifford Lane to wage “a quick and devastating published take down (sic)” of the Great Barrington Declaration’s premises.

Armed with a federal judge’s order, the Attorneys General in the Missouri et al lawsuit finally got a chance to question Fauci about his involvement in these attacks on the GBD. They were specifically investigating whether Collins and Fauci’s actions contributed to censorship of anti-lockdown arguments under the “COVID misinformation” policies of social media companies such as Twitter, Facebook, and Google. Fauci, the man who since 2020 has promoted himself as “America’s Doctor” and a walking embodiment of “the science,” responded by denying he ever meaningfully engaged with the GBD.

Fauci was asked about his own role in Collins’ “devastating take down” directive, which ended with the NIH Director’s question “I don’t see anything on line yet – is it underway?” Fauci answered the Attorneys General with a bluntly stated denial about his own involvement:

No. This is not something I would be involved in. As I told you, I have a very important day job that is running a $6.4 billion institute. I would not be involved in examining this and doing something that would quote counter it.

The Attorneys General pressed him further on what Collins’s email meant, if not a directive for Fauci and Lane to prepare an attack. Fauci pleaded innocence, suggesting that Collins was “likely talking about writing a scholarly article to contest some of the premises” of the GBD.

The problem with Fauci’s denials, and his speculation about an academic motive in Collins’ order, is that they are provably false. The original emails from AIER’s FOIA request show that Fauci and Collins jumped into action to smear and discredit the GBD in the media. They went directly to the national press, labeling its authors, Martin Kulldorff, Sunetra Gupta, and Jay Bhattacharya as “fringe epidemiologists” and branding the Declaration itself as “nonsense,” in Fauci’s words.

Fauci’s own answer to Collins came in an email sent a mere 10 minutes after he received the “devastating take down” order. Instead of examining the GBD’s scientific claims and making a scholarly counter-argument, Fauci enlisted the authority of a political writer with no scientific qualifications. He circulated an opinion piece from Wired Magazine, declaring the GBD false on the now-comical pretext that the lockdown phase of the pandemic was already behind us in October 2020. By then “three weeks to flatten the curve” had already become seven months, and there was no end in sight.

The email records show that Fauci and Collins quickly mobilized the national media against the GBD. Collins deployed the “fringe epidemiologists” line in an October 13, 2020 interview with the Washington Post. In a private email to Fauci, he boasted “my quotes are accurate, but will not be appreciated in the WH.” Fauci quipped in response that “they are too busy with other things to worry about this” – a possible reference to the fact that then-president Donald Trump tested positive for COVID a day earlier. But Fauci reiterated his agreement with Collins, stating “what you said was entirely correct.”

Fauci and Collins’ actions over the next several days show no signs of either man working on a scholarly article to answer the GBD in a scientific journal. They do, however, show the pair waging an aggressive campaign in the national news media to attack and discredit the GBD scientists. A day after Collins’s Washington Post interview, Fauci emailed his team in apparent response to a thread entitled “Quote re Barrington Declaration.” He likened the document to the “AIDS denialist days” of the 1980s – an ironic claim, given that Fauci himself spread egregious misinformation about the transmission of AIDS/HIV and sparked a panic that led to public discrimination against AIDS victims.

At this point, the correspondence between Fauci and Collins disappears behind the veil of redaction. The original set of emails contains a multi-page message between the pair containing the keywords “Great Barrington Declaration” and dated sometime between October 14 and 16, 2020 but it is completely blacked out. The NIH claimed that the email was exempt from FOIA because it contained material from unspecified private deliberations.

When the records resume on October 16, 2020, they contain a partially redacted email to Deborah Birx in which Fauci speculates that Scott Atlas, his anti-lockdown foil on the White House COVID Task Force, would attempt to sway the White House into endorsing the GBD. “Over the past week I have come out very strongly publicly against the “Great Barrington Declaration,” Fauci declared – an action that he conveniently has no memory of doing, according to his statements under oath from the Missouri lawsuit deposition.

The Fauci-Collins onslaught against the GBD continued. At some point in the next week, Fauci apparently directed his chief of staff Greg Folkers to round up a list of political op-eds against the GBD. Folkers responded on November 2, 2020 in an email entitled “As discussed.”

When the Attorneys General questioned Fauci about this request and its connection to the “devastating take down” order, his memory suddenly failed him. “I don’t recall,” Fauci answered. “Greg would probably send me something that I’ve asked for. So somehow, back then, a couple of years ago, I asked for articles concerning herd immunity and I believe he sent them.”

We will likely never know the full extent of the “take down” campaign due to the NIH’s heavy use of redactions and delay tactics to hide the contents of the requested emails. Their initial batch of FOIA documents stops in early November 2020. Just last week, AIER received a second batch of records from the agency covering Fauci and Collins’s correspondence in this same time period with their counterparts in the UK. A full 58 out of 61 requested pages of records were blacked out under specious invocations of FOIA exemption rules. The agency has yet to respond to our other FOIA requests, submitted almost a year ago.

That said, the email records we do possess contain ample evidence of Fauci’s involvement in the “take down” order, plainly contradicting his sworn deposition. In those emails we see Collins colluding with Anthony Fauci (while fantastically CCing Lawrence Tabak, Deputy Ethics Counselor at NIH) to craft talking points against the GBD in the media. Behind the scenes, we see them working with Deborah Birx to keep the GBD off of the White House COVID Task Force agenda. And we see Fauci’s instructions to Folkers to assemble a list of media op-eds attacking the GBD, with the apparent intent of parroting them back to the very same press as official talking points from the NIH. 

Think about that for a minute. The Director of the National Institutes of Health all but ordered the Director of the National Institute of Allergy and Infectious Diseases to put together a smear campaign aimed at three distinguished scientists, each from an elite institution (Harvard, Stanford, and Oxford if you are keeping track at home), who were simply going where the science took them.

But Anthony Fauci decided that he himself was the representative of science, and no other opinions would be welcome in the public sphere.

And it’s really not much of a surprise now that Fauci wants to forget about all of this. It’s unseemly after all, that the Representative of Science would target fellow scientists trying only to do their jobs. But he will not be able to brush this mess under the carpet in his retirement from the NIH. As his recent performance in the sworn deposition indicates, Fauci’s evasions leave us with more questions than answers – and more clues that he used his position as a top official at a powerful government agency to persecute and suppress dissenting scientific beliefs.

Phillip W. Magness is Senior Research Faculty and Director of Research and Education at the American Institute for Economic Research. He is also a Research Fellow at the Independent Institute. He holds a PhD and MPP from George Mason University’s School of Public Policy, and a BA from the University of St. Thomas (Houston). Prior to joining AIER, Dr. Magness spent over a decade teaching public policy, economics, and international trade at institutions including American University, George Mason University, and Berry College. 

James R. Harrigan is Senior Editor at AIER. He is also co-host of the Words & Numbers podcast. Dr. Harrigan was previously Dean of the American University of Iraq-Sulaimani, and later served as Director of Academic Programs at the Institute for Humane Studies and Strata, where he was also a Senior Research Fellow.

https://www.aier.org/article/forgetful-faucis-deposition-all-those-lies-are-hard-to-keep-straight/

Affirming Deception

 One of the main public relations strategies of “gender-affirming care” advocates is to deny that the model of treatment being used in American clinics differs in any significant way with the one now used in European clinics. Over the past two years, and following systematic reviews of evidence, health authorities in Sweden, Finland, and the U.K. have agreed that no evidence exists that the benefits of puberty blockers and cross-sex hormones outweigh the risks. All three countries have since imposed measures to reduce drastically the accessibility of these drugs to teenagers.

Just two weeks ago, the World Professional Association for Transgender Health (WPATH)—a U.S.-based promoter of “gender affirmation” that now recognizes “eunuch” as a valid childhood “gender identity”—was still insisting that Europe’s only change was a decision by health authorities to conduct “more studies” and gather data. But with evidence of the actual changes increasingly hard to deny, WPATH has now finally had to reckon with reality. On November 25, it chose to air its grievances—and tacitly concede its previous disinformation campaign—about Europe’s change of direction when it criticized England’s National Health Service.

Back in October, the NHS released draft guidance based on a February report by the former president of the Royal College of Paediatrics and Child Health. In that report, physician Hilary Cass noted the “affirmative” model, which “originated in the USA,” as likely responsible for insufficient child “safeguarding” at the now-discontinued Tavistock clinic gender service. Tavistock staff, Cass wrote, “have told us that they feel pressure to adopt an unquestioning affirmative approach and that this is at odds with the standard process of clinical assessment and diagnosis that they have been trained to undertake in all other clinical encounters.” The NHS’s draft guidance calls for a restoration of careful and lengthy mental-health assessments before prescribing drugs.

In its November 25 statement, WPATH condemned the NHS in terms that reveal the organization’s strong preference for the affirmative model. The NHS, it complained, is emphasizing “careful exploration of a child or young person’s co-existing mental health, neuro-developmental and/or family or social complexities,” which WPATH deemed an “alarming” practice of “outdated gatekeeping.”

You might think that every rational American would support “careful exploration” of a distressed teenager’s state of mind before prescribing powerful drugs. But public confusion about gender-affirming care arises from the slippery definition of this protocol and how it differs from the more cautious Dutch approach that European nations are now implementing. Both models assume that gender-identity discordance—that is, the experiencing of one’s gender as different from one’s sex—is a natural, normal, and healthy variation of human development. The main difference between them concerns their assumptions about when and how gender identity can be known and what to do about it. Three points of divergence are especially important.

The first concerns childhood social transition—the use of new names and pronouns, as well as access to restrooms and sports teams. According to the affirmative model, as clarified by the American Academy of Pediatrics in 2018, gender identity is knowable from a very early age, and once declared, a child’s gender identity calls for immediate and uncritical “affirmation” by parents, peers, clinicians, and teachers.

This contrasts starkly with the Dutch model, which, drawing on decades of research, acknowledges that gender dysphoria in children is very likely to desist by adolescence or early adulthood, in many cases resolving into homosexuality. Moreover, research published in recent years strongly suggests that if a child’s cross-gender feelings are affirmed as evidence of a wrongly “assigned” sex at birth, that child is far more likely to persist in his dysphoria and seek puberty suppression. It is in light of the high likelihood of desistance that the Dutch model recommends “watchful waiting,” not affirm-first. Indeed, the Dutch team did not even recommend social transition (“real life experience” in the felt gender) in the early stages of puberty, but only after the teenager tried living as his true sex and found it too distressing. Social transition was seen as something to be done cautiously and incrementally, in conjunction with pharmaceutical puberty suppression, which the Dutch team thought of as part of the diagnostic rather than treatment phase. In its new draft guidance, England’s NHS strongly advises against childhood social transition and recommends it for adolescents only, based on informed consent and with a diagnosis of gender dysphoria.

Behind these differing recommendations on social transition are diverging assumptions about the etiology of gender identity—the second point of disagreement. Proponents of the affirmative model tend to believe that it has a strong neurological component. No evidence supports this. Studies on brain structure and functioning are notoriously inconclusive, mainly because they cannot control for homosexuality or for the effects of synthetic hormone use and gender-role change on the brain.

Several reasons, however, require advocates of the affirmative approach to believe in the neurological explanation. First, it allows for a politically potent analogy to gay rights (“born that way”), which in turn helps facilitate the capture of mainstream gay rights institutions and their repurposing—without arousing public suspicion—toward transgender issues. Second, if gender identity is not innate and fixed at a young age, there would be no good reason to transition a minor medically. When Jack Turban, a leading pro-affirming psychiatrist, tweeted that gender is “fluid” and not “fixed,” one of his critics asked “then why the f**k we [sic] cutting up kids, Jack?” to which he promptly responded by deleting the tweet. Finally, in American jurisprudence, a trait’s supposed immutability has direct relevance for a court’s willingness to afford it higher judicial protection. In a lawsuit filed by the ACLU on behalf of a transgender-identifying student, the Court of Appeals for the Fourth Circuit based its judgment against a school district on the supposition, endorsed in an amicus brief by medical groups, that being transgender is “as natural and immutable as being cisgender.”

Those adhering to the Dutch model tend to be agnostic on the question of etiology. Consistent with the contemporary standard in psychiatry, they are content to focus on classification of symptoms and believe that the cause of mental pathology may be less important, clinically speaking, than the contours, tenacity, and severity of its presentation. As the Dutch researchers themselves put it just over a decade ago, “the (patho-) biological basis of [gender dysphoria] is still poorly understood, and its diagnosis relies totally on psychological methods.”

No new research has emerged to challenge this basic insight. Less willing to allow popular narratives to cloud their judgment, practitioners of the Dutch model have been more open to recognizing the importance of social influences on identity formation in youth. The likely possibility that many teens were identifying as transgender and seeking irreversible medical interventions because of social influences prompted European health authorities to conduct evidence reviews and scale back the administration of hormones. Among U.S. practitioners of gender-affirming care, however, social-influence-based explanations remain strictly verboten. In their amicus brief for Eknes-Tucker v. Marshall, the lawsuit challenging Alabama’s ban on affirmative drugs and surgeries, 18 American medical groups wrote that there is “no reliable evidence” supporting the social influence hypothesis. Oddly, however, in its updated standards of care, WPATH acknowledges “susceptibility to social influence” as potentially relevant to “a select subgroup of young people” in forming a sense of self, though it clarifies that this should not be a barrier to social or medical transition.

The third key point of divergence between the affirmative and Dutch protocols concerns how to understand and what to do about co-occurring mental-health problems in clinically referred adolescents. In recent years, Western countries have observed a change in the main cohort presenting at their gender clinics. In the Dutch study, most of the minors were boys. Candidates were eligible for puberty suppression only if they had early-onset “gender identity disorder,” supportive families, and no serious co-occurring mental-health problems. In contrast, most referrals to pediatric gender clinics over the past decade have been teenage girls with no prepubertal history of dysphoria and with high rates of such mental-health problems as anxiety, depression, ADHD, and autism.

The Cass report, for instance, found that about one-third of the adolescents referred to Tavistock’s gender identity service for treatment had autism or some other neuroatypical condition. Finland’s Council for Choices in Healthcare reported that “psychiatric disorders and developmental difficulties may predispose a young person to the onset of gender dysphoria.” One plausible explanation for why transgender-identified teenagers exhibit such high rates of suicidal ideation and behavior, then, is that minors—specifically teenage girls—with preexisting mental health problems including suicidality are more likely to identify as trans.

Affirmative-model proponents argue that co-occurring mental-health problems should always be presumed as secondary to—meaning, caused by—unaffirmed gender identity and lack of social acceptance for transgender people. This belief system is known as the “minority stress” model, and it is important to clarify that, as with many other claims made on behalf of gender identity and medicine, it is borrowed from research on homosexuality. Practitioners of the Dutch approach, by contrast, argue that the causes of mental-health problems should be investigated and treated prior to gender transition, on the view that these might be causing the gender issues rather than the other way around, and that a less invasive psychotherapeutic approach is likely to be less risky than drugs and surgeries.

Not only are co-occurring mental-health problems not a red flag for medication, according to the affirmative model, but if anything, their presence makes “gender-affirming” drugs even more urgent. As Diana Tordoff, lead author of a controversial study done earlier this year at Seattle Children’s Hospital, admitted in response to a critic, “the only instances when it would have been appropriate to delay initiation of [puberty blockers and cross-sex hormones] is if there was a concern that a patient did not have the capacity to provide informed consent (which is exceedingly rare in adolescence). Therefore, youth who reported moderate to severe depression, anxiety, or suicidal thoughts were not precluded access to [these drugs], especially since initiating [them] is known to improve or mitigate these symptoms.” This was a remarkable thing for Tordoff to say, considering that the point of her study was to discover whether “gender affirming” drugs are needed to “mitigate these symptoms.”

Back in August, in response to our criticism of its anti-scientific approach, the American Academy of Pediatrics assured the public that “the vast majority” of gender dysphoric minors need “the exact opposite” of drugs and surgeries. According to the data published in Tordoff’s study, however, two-thirds of the youth referred to Seattle Children’s for gender issues were put on hormones. While it is possible that this sample is non-representative of how local teenagers with gender issues are treated, it is potentially a sign that Seattle Children’s does not follow the advice of the AAP. Assuming it does not, this would not constitute a violation of gender-affirming care but a fulfillment of its promise: patients should be in the driving seat of their own medical “treatment.”

Why do advocates of the affirmative approach publicly deny that their assumptions and methods depart from those of the Dutch? One likely answer has to do with an all-too-familiar feature of American life. Like most policy debates, the one over gender-affirming care has been framed in the language of “rights” and litigated primarily in the courts. Organizations like the ACLU regularly tell federal judges that because Republican state bans on pediatric gender transition go farther than in Europe (which is true), striking them down means preserving a well-accepted model practiced in Europe (which is false). Because judges are nonexperts whose busy schedules and institutional constraints force them to rely on partisan witnesses appointed by winning-focused lawyers, they have proved amenable to the false dichotomy.

At a Florida medical boards hearing last month, Aron Janssen, a child psychiatrist, claimed that Dutch clinical data are “the best we have” and that American gender clinics follow the Dutch model. Yet a recent investigation found that not a single interviewed provider at 18 pediatric gender clinics nationwide “described anything like the months-long [psychiatric] assessment” the Dutch clinicians require before putting a minor on hormones. Thomas Steensma, one of the Dutch researchers, himself observed that “the rest of the world is blindly adopting our research,” warning that most patients seeking medical transition are significantly dissimilar to the original Dutch cohort. Annelou de Vries, who spearheaded youth medical transition, also stressed the potential inapplicability of the Dutch data in the American Academy of Pediatrics’ peer-reviewed journal.

Another star witness supporting the affirmative model at the Florida medical boards hearing, Meredith McNamara of the Yale School of Medicine, denied any meaningful change had taken place in Europe. “I disagree that international guidelines are more conservative” and don’t “see any substantive differences” between American and European pediatric gender medicine, she said. England’s National Health Service, she insisted, is merely “gather[ing] evidence moving forward.” As with Janssen, it is not clear whether McNamara is ignorant of the realities of pediatric gender medicine in the U.S. or being dishonest.

It should be emphasized that while the Dutch approach is more cautious than the affirmative one and allows for more safeguarding of vulnerable minors, it is far from clear that even the Dutch model is based on good evidence. The systematic reviews done by European health authorities concluded that the Dutch study was subject to significant bias and methodological limitations and that the certainty of evidence it yields is “very low.” We are likely to see more evidence emerge about this patient cohort’s long-term clinical outcomes. But whether the Dutch study withstands the increasing scrutiny it is now receiving (it seems that things were not as clearly beneficial for the youth treated in the Dutch clinic), it is clear that the U.S. is not following even this supposedly more cautious approach.

In the Wild West of U.S. gender medicine, and consistent with the affirmative model’s hostility to any questioning of a minor’s asserted identity, the only criteria for the “medical necessity” of drugs and surgeries for minors are the wishes of teenage patients. The stronger the wish, the greater the medical “necessity.” McNamara illustrated this thinking in her response to the Florida board doctors. When pressed to explain how she determines when a teenage girl “needs” a double mastectomy and why (as she claimed) she’s never referred a patient for this procedure, McNamara could only say: “I’ve never had a patient express that they desire top surgery.”

McNamara’s latest commentary, in the prestigious New England Journal of Medicine, calls for legal and medical “experts” to fight for unfettered access to hormones and surgeries for youth. She strongly implies that legal coercive power could be used to stop “science denialism,” by which she means efforts to get the U.S. to conduct systematic reviews of evidence and base medical care on the findings of those reviews. Virtually every sentence of her short NEJM article is false or misleading. But that is almost beside the point. The main purpose of articles such as these is to continue cluttering medical journals with pro-affirming pieces in the hope that unsuspecting judges and journalists will regard the sheer number of them as evidence of a substantive medical consensus. Coverage of studies by Tordoff and Turban this year alone show how much traction egregiously misinterpreted results can gain in the public debate, and how hard it is to correct the public record once misinformation spreads.

Sooner or later, though, this house of cards will collapse. McNamara’s ominous call for legal authorities to be concerned about “science denialism”—of which her own writings and testimonies offer a good example—suggests desperation. When a movement is unable to defend its position using good faith and rational, evidence-based arguments, its only recourse is force and fraud. Meantime, WPATH’s admission that England has in fact become more cautious is a welcome, if sadly belated, development.

Leor Sapir is a fellow at the Manhattan Institute.

https://www.city-journal.org/wpath-finally-acknowledges-europes-restrictions-on-gender-affirming-care

Youngkin moves toward reimbursements for ‘unjust’ COVID-19 fines in Virginia

 Virginia Gov. Glenn Youngkin (R) announced on Tuesday that he plans to reimburse individuals and businesses who paid fines for violating most state COVID-19 restrictions put in place by his Democratic predecessor.

Youngkin signed an executive order directing all state agencies to report all COVID-19 fines and disciplinary actions they imposed, and the governor said he plans to develop a reimbursement process in his upcoming budget proposal for the restrictions imposed by former Gov. Ralph Northam (D).

“The fact that businesses are still dealing with COVID-19 related penalties and fines is infuriating,” Youngkin said in a statement. 

“Livelihoods are on the line,” he added. “In the previous administration, we saw our government shut down businesses, close our schools and separate us from each other. While we can’t undo the damage done during the Northam administration, we are taking action going forward to end COVID-era draconian overreach.”

Youngkin added that the review and reimbursements will not apply to violations in nursing homes, assisted living facilities and hospitals.

But the Virginia Republican said he will direct agencies to halt collection and enforcement of the other pandemic restriction fines in the upcoming budget request.

“I look forward to working with the General Assembly to address this, forgive COVID fines and fees and restore licenses that were unjustly suspended,” Youngkin said.

Upon taking office in January, Youngkin quickly took aim at some of Virginia’s pandemic restrictions.

He signed an executive order in January making wearing masks optional in schools, and months later he called on the Defense Department to indefinitely postpone the coronavirus vaccine mandate for Army National Guard members.

The text of the annual defense policy bill, which was released on Tuesday night, includes a repeal of the military’s coronavirus vaccine mandate.

https://thehill.com/homenews/state-watch/3765166-youngkin-moves-toward-reimbursements-for-unjust-covid-19-fines-in-virginia/

Evoke Gets Patent for GIMOTI® To Treat Moderate to Severe Gastroparesis

  Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that the United States Patent and Trademark Office (USPTO) issued US patent No. 11,517,545 under the title “Treatment of Moderate and Severe Gastroparesis.”

This patent expires in 2038 and covers the methods for treating moderate-to-severe gastroparesis with metoclopramide via an intranasal route of administration. The patent expands Evoke’s patent portfolio, which includes U.S. Food and Drug Administration (FDA) Orange Book-listed patents and other patents in the EU, Japan, Canada, and Mexico.

https://finance.yahoo.com/news/uspto-grants-patent-evoke-pharma-133000344.html

Titan Medical Suspends Special Meeting of Shareholders Around Strategic Review

 Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical technology company focused on single access robotic-assisted surgery (RAS), today announced that in view of the commencement of the strategic review process announced on November 30, 2022, the special meeting of its shareholders scheduled for January 12, 2023 will be suspended and, if appropriate and necessary, rescheduled to a future date. If rescheduled to a future date, the business of the meeting may include, to the extent required by corporate or securities law and as determined by the Board of Directors of the company, the approval of a potential transaction should one result from the strategic review process announced on November 30, 2022 or, if appropriate, the approval of a consolidation of the company’s common shares. No future meeting dates have been scheduled and no decision on any specific business item for any future meeting of shareholders has been made at this time.

Cary G. Vance, Titan’s President and CEO, commented, “After consultation with our financial and legal advisors, we determined it was in the best interest of the company and its shareholders to suspend the special meeting. This action, in addition to resulting in a cost savings, allows the company to focus its attention on the strategic review process, completing tasks towards an IDE filing with the FDA and fulfilling certain other contractual development and supply obligations."

With the suspension of the special meeting of shareholders previously scheduled for January 12, 2023, the company will not at this time be relying on a share consolidation to regain compliance with the Nasdaq Rule 5550(a)(2). As previously disclosed, Nasdaq granted the company an extension to regain compliance with Nasdaq Rule 5550(a)(2), which requires an issuer to maintain a minimum bid price of at least US$1.00 for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s discretion). While the company continues to undertake initiatives directed at increasing shareholder value, should the company not be able to evidence compliance prior to December 26, 2022, the company expects Nasdaq to notify Titan that its shares are subject to delisting. At such time, the company may appeal the delisting and it is expected that the company’s shares would continue to be listed and available to trade on Nasdaq at least pending the completion of the appeal process. There can be no assurance that the appeal process would result in any satisfactory outcome for Titan such that its common shares would remain listed on Nasdaq or as to the timing of any subsequent delisting should the appeal process be unsuccessful.

https://finance.yahoo.com/news/titan-medical-suspends-special-meeting-123000793.html