Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Monday, September 20, 2021
Early Intervention Improves Autism Symptoms Before School Age
Infants who seemed headed for autism spectrum disorder (ASD) had milder symptoms as toddlers if their caregivers were subject to a social communication intervention when infants were just 1 year of age, a randomized clinical trial found.
Infants whose families participated in the intervention exhibited significantly milder ASD symptoms 12 months later compared to those in the control group. They also had lower odds of being diagnosed with ASD by an independent clinician at age 3 years (6.7% vs 20.5%, OR 0.18, 95% CI 0.00-0.68), according to the study group led by Andrew Whitehouse, PhD, of the University of Western Australia.
"To our knowledge, this randomized clinical trial is the first to demonstrate that a preemptive intervention for infants showing early signs of ASD led to a small but enduring reduction in ASD symptom severity and reduced odds of ASD diagnosis in early childhood," the researchers wrote in JAMA Pediatrics.
ASD can be detected at 18 months and reliably diagnosed at age 2, but is often not diagnosed until children are much older, according to the CDC.
"Interventions beginning during the first 2 years of life, when the first signs of atypical development are observed and the brain is rapidly developing, may lead to an even greater impact on developmental outcomes in later childhood," the researchers said.
Their intervention, iBASIS-Video Interaction to Promote Positive Parenting (iBASIS-VIPP), provided feedback on reinforcing positive infant behaviors and caregiver responses to adults who were videotaped interacting with the infants. iBASIS-VIPP was delivered across ten sessions over 5 months at home by a therapist.
Whitehouse and colleagues had previously reported that the intervention did not significantly improve ASD behaviors at 6 months post-intervention. Their present analysis found the intervention to have a small effect over 2 years of follow-up.
"Although modest in size, this consistent pattern of intervention effects observed across developmental domains likely contributed to the best-estimate clinical judgments of diagnosis and the reduced odds of the iBASIS-VIPP group meeting DSM-5 diagnostic criteria for ASD at age 3 years," they suggested.
The study was conducted at two sites (in Perth and Melbourne, Australia) and randomized 50 infants to the iBASIS-VIPP intervention as well as the usual community care, while 54 infants received only the usual community care. The two study arms had similar characteristics at baseline with a mean age of 12.4 months and the majority being boys.
To be eligible, the children must have displayed at least three of five specified behaviors indicating likelihood of ASD. Infants with comorbidities that impact neurodevelopment were excluded. In addition, the primary caregiver needed to be proficient in English to participate in the intervention. One infant was excluded after randomization because of this requirement.
Caregiver sensitive responsiveness, measured by the Manchester Assessment of Caregiver-Infant Interaction, had improved after the iBASIS-VIPP intervention but the effect began to dwindle at the 24-month mark. All other measurements of caregiver-infant interaction showed no significant change from baseline.
At the final infant assessment conducted after 24 months, data from the 89 available participating children suggested that those in the iBASIS-VIPP group had reduced odds of exhibiting three of the seven ASD behavior criteria used in the DSM-5:
- Deficits in social-emotional reciprocity: 20.0% vs 36.4% (OR 0.35, 95% CI 0.00-0.82)
- Stereotyped or repetitive movements: 15.6% vs 31.8% (OR 0.29, 95% CI 0.00-0.73)
- Hyperreactivity or hypo-reactivity sensory input or unusual sensory interests: 4.4% vs 18.2% (OR 0.13, 95% CI 0.00-0.53)
The researchers conceded that while an autism diagnosis is generally reliable at 3 years of age, it may change for some children later on if they are reassessed.
"Follow-up of these children in later childhood, when the behaviors for ASD and other neurodevelopmental conditions may be more apparent and distinguishable, will be important to determining the longer-term clinical significance of the intervention effects observed in the current study," according to Whitehouse's team.
Disclosures
The study was sponsored by the Telethon Kids Institute and supported by the National Health and Medical Research Council, and the Angela Wright Bennett Foundation, the Telethon-Perth Children's Hospital Research Fund, the La Trobe University Understanding Disease Research Focus Area, and the Cooperative Research Centre for Living with Autism.
Whitehouse had no disclosures.
Several coauthors reported roles in developing the iBASIS-VIPP intervention, with one in particular holding the patent for it.
Patients Can Get Medical Record Errors Amended, but It's Not Easy
Changing a medical record to correct an error is anything but an easy process.
Under federal HIPAA rules, patients have the right to request that doctors fix errors, but the provider has up to 60 days to respond, and can ask for a 30-day extension.
The provider also can refuse, but must specify the reason in writing.
If the fix moves forward, the doctor can't alter the original note, but the patient has the right to have an amendment with his or her version of the facts placed in their electronic medical record (EMR).
Most EMR program modules do not let the patient edit or question something in an electronic note, although software entrepreneurs are working on solutions that will enable that feature.
"There's not a smooth process for doing that in today's EMRs. They didn't really build that into the certification criteria," said Deven McGraw, an attorney and chief regulatory officer for Ciitizen, a consumer health technology startup.
Then there's the question of who is responsible for actually making the fix and whether there even is a process. The doctor might refer the patient to the office staff or the doctor's nurse, who might refer the patient to the practice's health information or medical records office, which may send the patient back to the doctor.
It's also unclear whether any federal rules require the doctor to post the patient's requested amendment in the patient's portal so other providers can see the change. In one case relayed to MedPage Today, a doctor told a patient that he accepted the amendment but did not download it into the portal.
When asked to amend a chart note that incorrectly diagnosed this reporter with osteoporosis, the physician replied that it was inserted only so that Medicare would cover bloodwork for a vitamin D level, for which the patient would otherwise have to pay. "I was trying to save you money," the physician said.
That's not just wrong, it's potentially harmful, said Heather Gantzer, MD, immediate past chair of the American College of Physicians' Board of Regents.
If the patient came to the ED with acute back pain and compression fracture on a plane x-ray, and the ED team sees osteoporosis in the patient's history, a treating physician might say, "this happens" in people with osteoporosis, and initially discount any idea of something more serious, Gantzer said.
If the patient's record didn't indicate osteoporosis, she said, "maybe you are worked up with an MRI sooner rather than later, to be sure it's not a tumor."
Click here for the main story, "Open Notes Shines Light on Errors in Patient Medical Records."
https://www.medpagetoday.com/special-reports/exclusives/94502
Would an 'Immunity' Mandate Instill More Public Confidence?
Institutional trust is critical for the healthy functioning of government and society. Its erosion is likely complicit in the decline and fall of many old and historic civilizations including the Greeks, Romans, and dynastic Chinese. A few hundred years ago, the breaches of trust brought about by the ancien régime in the form of French Bourbon Kings or by England's George III were major factors in inciting the French Revolution and the U.S. War of Independence. Benjamin Disraeli, the 19th century prime minister who presided over the apogee of the British Empire, understood the larger ramifications of trust when he stated, "All power is a trust; that we are accountable for its exercise." In the U.S., institutional trust has been waning since the inception of its measurement in 1958.
Fast forward to current times where recent Pew data underscore the fact that only 24% percent of Americans actually "trust" the government. Given that dismal level of trust, it is perplexing why the government has decided to move forward with rigid, far-reaching COVID-19 vaccine mandates that will only serve to further erode public confidence.
The Erosion of Trust
In the U.S., we can draw a line from the Vietnam war all the way to the COVID-19 pandemic and easily mark where institutional trust may have been compromised. Within this arc, events and themes like Watergate, the failure of globalization to sustain the middle class, the Iraq war, the 2008 financial crises, racial injustice, and the final culmination of a protracted Afghan war have all played a role. The juxtaposition of far greater institutional transparency and the destabilizing echo chamber of social media are also to blame.
The Organization for Economic Cooperation and Development (OECD) asserts that citizens' trust is derived from an assessment of competence and values within public institutions. The values serve to inform and guide institutional action and they are in part guided by the principles of fairness, openness, and integrity. It therefore seems that the old adage holds: trust is earned not given. The COVID-19 pandemic has laid bare the lack of trust within U.S. institutions. Yes, we are now naked and exposed. We have witnessed, at times, asymmetric and feckless COVID-19 policies lurch from one extreme to the next like a pierced vessel foundering at sea. Some of this is to be expected. It is not easy to make policy decisions based on limited information and especially with a pathogen that doesn't seem to follow the playbook of its predecessors. Or really any playbook at all. This particular virus, while deadly, doesn't seem to incite the same fear that say Ebola or avian H5N1 might. If case fatality rates of COVID-19 were indeed higher, perhaps there would less debate and behaviors would homogeneously fall in line. But this clearly has not been the case.
The Issue With Sweeping Mandates
The Biden administration's decision to mandate vaccination for federal workers and institute other vaccine or testing mandates covering broad swaths of society will only serve to further abrogate institutional trust within the U.S.
The policy lacks the precise language needed to adequately speak to those who understand something about this virus. There now exists the need to make distinctions between categories and eventually degrees of immunity. One can imagine that with continued scientific examination we may perhaps better understand correlates of protection and transmission as they relate to a variety of means of immune acquisition. There will be small differences in immunity imparted by severity of natural infection, vaccine constructs, vaccine dose, and other factors that may have real world impact. The simple classification of vaccinated versus unvaccinated lacks the nuance required to satisfy the scientific mind. With many of our top journals reporting COVID-19 publications in open-access format, scientific literacy is at an all-time high. Discourse on virology, epidemiology, and immunology is something that may just as easily be understood by a barista at Starbucks as one of our healthcare professionals.
The Biden policy unfortunately continues to ignore other means of acquiring immunity, which may include natural infection and single doses of mRNA vaccine. We cannot turn away from that which has been known all along: this is not a pandemic of the unvaccinated. Many of the unvaccinated have been previously exposed to SARS-CoV-2 or had COVID-19. They have some immunity. This is a pandemic caused by a highly infectious virus that mainly manifests in the immunologically naive. Recent data from Israel continues to build upon the notion that immunity in people who survived a prior SARS-CoV-2 infection is robust and durable -- perhaps even more so than in the unexposed but vaccinated. Ignoring these facts and blindly forging ahead with blunt policies will continue to unravel vital threads of trust that remain in the system.
There is no doubt that vaccination continues to be the single most important strategy to lift us out of this pandemic, and people should not seek out natural immunity. But we must be honest, fair, and open (according to the OECD) in order to maintain trust.
What Biden and others really should require is not proof of vaccination, but rather proof of immunity. This could mean showing a vaccine card, evidence of sufficient antibody levels, or past documented infection. A sufficient antibody level or standard would need to be set and antibody testing would need to be made more accessible.
This more capacious directive of an "immunity mandate" affords a release valve for those who do not subscribe to the orthodoxy of vaccination but have recovered from a infection. It reduces the pressure contained in the system, while conserving the safety a vaccine mandate affords. It also provides cover to those who have elected for partial vaccination. This may be a particularly important strategy for children, those previously infected with COVID-19, or those who simply want to watch and wait. There is also precedent. The EU, U.K., and Israel are countries making room to better accommodate natural infection. But most importantly, it signals that we are open to the idea that we are imperfect and don't always have the answers. That the possibility exists for evolving science to allot for more than one answer and that we are not enslaved to the inertia of dogmatism. It is precisely by showing that we are fallible that our policies become more believable and engender ... well, more trust.
Jesse Pelletier, MD, is a private practice ophthalmologist in Miami, and co-founder/chief medical officer of Veloce BioPharma.
U.S. Extends Travel Restrictions at Canada, Mexico Borders
The United States on Monday extended restrictions at its land borders with Canada and Mexico through Oct. 21 that bar nonessential travel such as tourism by foreigners despite Ottawa's decision to open its border to vaccinated Americans.
Canada on Aug. 9 began allowing fully vaccinated U.S. visitors for nonessential travel. The United States has continued to extend the extraordinary restrictions on Canada and Mexico on a monthly basis since March 2020, when they were imposed to address the spread of COVID-19.
The latest monthly extension goes through Oct. 21, White House COVID-19 coordinator Jeff Zients told reporters Monday.
Zients said nearly all foreign nationals traveling to the United States by air will need to show proof of COVID-19 vaccination starting in early November.
He said "we do not have any updates to the land border policies at this point."
U.S. lawmakers have been pushing the White House to lift restrictions that have barred non-essential travel by Canadians across the northern U.S. border since March 2020.
The U.S. land border restrictions do not bar U.S. citizens from returning home.
Republican Montana Senator Steve Daines said Monday the White House's "continued refusal to open the northern border is inexplicable and is devastating Montana border communities and our economy."
Regulators could OK Pfizer boosters for older Americans this week
U.S. regulators could authorize a booster shot of the Pfizer Inc/BioNTech SE COVID-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday.
The Food and Drug Administration is expected to give the nod to the third shots for at least this group before advisers to the U.S. Centers for Disease Control and Prevention are due to meet on Wednesday. The CDC panel will discuss more precise recommendations for how to administer the shots.
On Friday, an FDA advisory committee voted to recommend emergency authorization of the additional Pfizer shots for Americans 65 and older and those at high risk of severe illness. The initial Pfizer vaccinations consisted of two doses.
The panel decided against recommending broader approval, citing a lack of evidence to support broad use, and they wanted to see more safety data, especially about any risk of heart inflammation in younger people after vaccination.
President Joe Biden has pushed for the additional shots in the face of surging hospitalizations and deaths caused by the highly contagious Delta variant, mostly among the unvaccinated, and rising cases of breakthrough infections among fully vaccinated Americans.
The FDA is not bound to follow the panel's recommendation but usually does. The rollout of boosters can begin as soon as the FDA authorizes the shots and the head of the CDC signs off on how they will be administered.
The FDA could later widen access to the booster shots. Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency's top scientists arguing they are not needed yet.
Woodcock said on former Biden administration official Andy Slavitt's podcast on Monday that boosters could be an important tool to contain the pandemic in the United States by reducing transmission.
"If people are acquiring the virus and spreading it, you want to stop that as much as possible. Of course we're using mitigation measures like masking and so forth, but vaccination is important," she said.
Despite the narrow scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign and whose immunity may be waning.
Norman Baylor, chief executive of Biologics Consulting and former director of FDA’s Office of Vaccines Research and Review, said the decision gives the FDA additional time to understand what data is required to approve booster shots broadly.
"It does give them some space," Baylor said.
Health officials signaled they expect boosters will ultimately be recommended for a broad swath of the population, but advised Americans not to seek booster doses until they have the nod from the FDA.
Biden's chief medical adviser, Dr. Anthony Fauci, told CNN on Sunday that the data needed to determine the advisability of booster shots of the Moderna Inc and Johnson & Johnson COVID-19 vaccines is weeks away.
Some countries, including Israel and Britain, have begun COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and some 2 million people had already received a third shot, according to the CDC.
https://news.yahoo.com/regulators-expected-ok-pfizer-boosters-101455766.html
India set to get first J&J Covid vaccine doses in October
India expects to get its first Johnson & Johnson Covid-19 vaccine doses from next month, filled and finished in India by a partner of the US drugmaker, a source with knowledge of the matter told Reuters on Monday. It could receive as many as 43.5 million doses of the single-shot vaccine in October, said the source - a big step towards helping India meet its target of producing more than 300 million doses in the month. India is the world's biggest centre of vaccine manufacturing. Once it has met its own needs, it plans to resume exports, which it stopped in April.
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