US tracking of virus variants has improved after slow start - Associated Press

After a slow start, the United States has improved its surveillance system for tracking new coronavirus variants such as omicron, boosting its capacity by tens of thousands of samples per week since early this year.

Viruses mutate constantly. To find and track new versions of the coronavirus, scientists analyze the genetic makeup of a portion of samples that test positive.

They’re looking at the chemical letters of the virus’s genetic code to find new worrisome mutants, such as omicron, and to follow the spread of known variants, such as delta.

It’s a global effort, but until recently the U.S. was contributing very little. With uncoordinated and scattershot testing, the U.S. was sequencing fewer than 1% of positive specimens earlier this year. Now, it is running those tests on 5% to 10% of samples. That’s more in line with what other nations have sequenced and shared with global disease trackers over the course of the pandemic.

“Genomic surveillance is strong,” said Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories.

Contributing to the effort are nearly 70 state and local public health labs, which are sequencing 15,000 to 20,000 specimens each week. Other labs, including those run by the Centers for Disease Control and Prevention and its contractors, bring the total to 40,000 to 80,000 weekly.

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Nine months ago, about 12,000 samples each week were being analyzed in this way.

“We’re in a much, much better place than a year ago or even six or nine months ago,” said Kenny Beckman of the University of Minnesota, who credited federal dollars distributed to public and private labs. He directs the university’s genomics laboratory, which now sequences about 1,000 samples a week from states including Minnesota, Arkansas and South Dakota. A year ago, the lab did no sequencing.

Relying on $1.7 billion in President Joe Biden’s coronavirus relief bill, the U.S. has been setting up a national network to better track coronavirus mutations.

Still, about two dozen countries are sequencing a larger proportion of positive samples than the U.S., said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health. Omicron’s emergence could “stimulate the United States to do this better.”

“I think we still have a long way to go,” Moss said.

Some states are sequencing only about 1% of samples while others are in the range of 20%, noted Dr. Phil Febbo, chief medical officer for Illumina, a San Diego-based company that develops genomic sequencing technologies.

“We could be more systematic about it and more consistent so we ensure there are no genomic surveillance deserts where we could miss the emergence of a variant,” Febbo said.

Aiding the surveillance effort, standard PCR tests that use nasal swabs sent to laboratories can detect a sign that someone probably has the omicron variant. If a PCR test is positive for only two of the three target genes — a so-called S-dropout test result — it’s a marker for omicron even before the extra step of genetic sequencing to prove it.

“It’s fortuitous,” said Trevor Bedford, a biologist and genetics expert at Fred Hutchinson Cancer Research Center. “If you need to do sequencing to identify the variant you’re always going to be lagged a bit and it’s going to be more expensive. If you just rely on this S-dropout as identification then it’s easier.”

He said other variants also have sparked this quirk in PCR test results, but not the delta variant. With delta so dominant in the U.S. right now, an S-dropout result will get noticed, Bedford said. (Bedford receives funding from the Howard Hughes Medical Institute, which also supports The Associated Press Health and Science Department.)

Dr. Anthony Fauci, the nation’s top infectious disease expert, said it is “inevitable” that omicron will make its way into the United States.

Many experts said it’s probably already here and will be picked up by the surveillance system soon. But the question is, then what?

University of Wisconsin AIDS researcher David O’Connor noted: “We don’t have the sorts of interstate travel restrictions that would make it possible to contain the virus in any one place.”

Instead, genomic surveillance will tell officials if omicron is spreading unusually fast somewhere and whether more resources should be sent to those places, he said.

When omicron does surface, public health authorities will have to consider other variables in their triage efforts, such as the level of infection already present in that community and the vaccination rate. Serious outbreaks in highly vaccinated areas would be particularly concerning.

Still, the University of Minnesota’s Beckman sees little upside in vastly ramping up sequencing.

“You don’t need to sequence more than a few percent of positive cases to get a feel for how quickly it’s growing,” he said.

Unlike in some other countries, U.S. government officials haven’t exercised the authority to force people to quarantine if they test positive for worrisome variants. Given that, sequencing is mainly a surveillance tool for tracking mutations’ spread.

“I think it’s important to track variants, but I don’t think it’s practical to think that we’re going to be able to sequence quickly and broadly enough to stop a variant in its tracks,” Beckman said.

___

AP writers Lauran Neergaard, Matthew Perrone and Ricardo Alonso-Zaldivar contributed.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Monday Nov. 29 COVID-19 update: Douglas County hospitalizations, ICUs, ventilators hit another peak - WOWT

(WOWT) - Below are today’s vaccination updates as well as data reports on new cases and other COVID-19 stats reported by health officials across Nebraska and western Iowa.

Keep scrolling to find helpful links and other information, including phone numbers to call for help getting signed up for your vaccine.

Douglas County update

The Douglas County Health Department on Monday reported an additional COVID-19 death since its last report on Saturday: a vaccinated woman in her 70s with underlying conditions has died, bringing the local death toll to 855.

DCHD also confirmed 103 new positive COVID-19 cases since Saturday’s report, bringing the local case total to 92,986.

Local hospital capacity stats are updated daily according to staffing levels. As of Sunday afternoon, local hospitals were 78% full with 310 beds available, up from 297 reported Saturday. ICU beds were 85% full, with 45 beds available, up from 40 reported a day earlier.

While hospitals had a little more room than previous days, they were caring for more COVID-19 patients in more serious condition than they have since January.

Local hospitals were caring for 269 patients with COVID-19 as of Sunday afternoon, the most since Jan. 5. The number of ICU patients jumped to 98 — the highest number since January — up from 75 a week ago and 64 two weeks ago. Seven of those hospitalized with the virus are pediatric COVID-19 patients.

Of the current patients, 50 are on ventilators — the most reported since Dec. 7, 2020, according to the Douglas County COVID-19 dashboard.

Additionally, five adults are awaiting COVID-19 test results.

To date, 71.9% of residents ages 12 and older are vaccinated; that translates to 59.5% of the community. As of Monday, 21.2% of local children ages 5-11 have had their first pediatric COVID-19 vaccination, with 0.84% of local kids considered fully vaccinated.

Monitoring for omicron

DCHD is monitoring for the new omicron variant detected in South Africa, but no such cases have been confirmed in the U.S., Nebraska, or Douglas County so far.

Douglas County’s Health Director Dr. Lindsay Huse told 6 News on Monday that now is not the time to panic, but rather to remain vigilant.

“I would think over the next week we’re going to learn a lot more information about the omicron variant, you know there are a lot of researchers that are currently doing lab testing on the virus to see what they can find out there from its genetic sequencing to how it responds to vaccines, all those sorts of things.”

CHI Health doctors answer questions about omicron

CHI Health hosted a live Q&A about the newest COVID-19 variant on Monday afternoon with Dr. Renuga Vivekanandan and Dr. David Quimby, infectious disease experts with CHI Health-Creighton University.

Both doctors stressed that while masking and vaccinations might not be perfect, they are key to fighting COVID-19.

Lincoln-Lancaster County update

The Lincoln-Lancaster County Health Department on Monday reported two COVID-19 deaths: two unvaccinated men, one in his 50s and another in his 70s, bring that area’s pandemic death toll to 328.

LLCHD also confirmed 391 cases over the holiday weekend and another 126 on Monday, for a total of 517 newly confirmed cases since its last report. That brings the total number of cases for that county to 44,708.

Additionally, the health department said hospitals in the area were caring for 102 COVID-19 patients, including 14 on ventilators.

To date, 61.6% of Lancaster County residents are considered fully vaccinated.

Vaccination clinics

Nebraska DHHS

Federal Retail Pharmacy Program: Pharmacies in and near the Omaha-metro area currently participating in the program include:

• Medicine Man Pharmacy, 15615 Pacific St. Suite 8, Omaha NE 668118
• ViaRx, 825 N. 90th St., Omaha NE 68114
• Walmart, 3010 E. 23rd St., Fremont NE 68025

Retail pharmacy vaccine sign-ups: Baker’s | CVS | Hy-Vee | Kohll’s | Kubat | Sam’s Club | Walmart

Douglas County

Below is a list of the Douglas County COVID-19 vaccination clinics scheduled for this week, including child vaccination clinics at area schools. All clinics are open to the public for any approved shot in the vaccination series. Those planning to get a booster shot should bring their vaccination card.

DCHD has no clinics planned for the rest of the week due to the Thanksgiving holiday, but Health Director Dr. Lindsay Huse reminded residents Tuesday that they are also able to get vaccinated at area pharmacies.

MONDAY

• 4-7 p.m. at Beveridge Magnet Middle School, located at 1616 S. 120th St. – Pfizer for ages 5+
• 4-7 p.m. at McMillan Magnet Middle School, located at 3802 Redick. Ave. – Pfizer for ages 5+

TUESDAY

• Noon-4 p.m. at Douglas County Health Department, located at 1111 S. 41st St. – All vaccines available.
• 4-7 p.m. at R.M. Marrs Magnet Middle School, located at 56919 S. 19th St. – Pfizer for ages 5+
• 4-7 p.m. at Nathan Hale Magnet Middle School, located at 6143 Whitmore St. – Pfizer for ages 5+

WEDNESDAY

• 10 a.m.-1 p.m. at Heart Ministry Center, located at 2222 Binney St. – Pfizer for ages 5+
• 5-7 p.m. at Bryan Middle School, located at 8210 S. 42nd St. – Pfizer for ages 5+
• 5-7 p.m. at Benson High Magnet School, located at 5120 Maple St. – Pfizer for ages 5+

FRIDAY

• 9 a.m.-4 p.m. at Douglas County Health Department, located at 1111 S. 41st St. – All vaccines available.
• 4-7 p.m. at Millard North Middle School, located at 2828 S. 139th St. – Pfizer for ages 5+

SATURDAY

• Noon-5 p.m. at Christmas in the Village at Mount Moriah Missionary Baptist Church, located at 2602 N. 24th St. – All vaccines available.

MONDAY, DEC. 6

• 4-7 p.m. at Andersen Middle School, located at 15404 Adams St. – Pfizer for ages 5+

In-home appointments

DCHD is helping those homebound to get vaccinated, scheduling in-home appointments for all three adult vaccination varieties, for any shot in the series.

To arrange this, call the DCHD information helpline at 402-444-3400.

DCHD booster plan

All Douglas County Health Department pop-up clinics will offer only Pfizer COVID-19 booster vaccinations, but once Moderna and Johnson & Johnson boosters are authorized, the health department plans to have all three available at its in-house and drive-through clinics.

Booster shots are recommended for people who received the Pfizer or Moderna vaccine and are:

• ages 65 and older
• anyone age 18 and older who lives in a long-term care setting
• anyone age 18 and older who has underlying medical conditions
• anyone age 18 and older who lives or works in a high-risk setting

The CDC is recommending booster doses be administered six months after receiving your second dose, and has authorized brand crossover for booster shots. Anyone with questions is advised to contact their healthcare provider for further guidance.

Boosters are also recommended for those who received the J&J vaccine at least two months ago, according to the health department.

Those with questions about boosters, particularly those with questions about underlying medical conditions or being in a high-risk setting, are advised to contact their healthcare providers or call the DCHD Information Line at 402-444-3400.

Underlying medical conditions that qualify for boosters include: cancer; chronic kidney disease; chronic lung diseases like COPD, moderate to severe asthma, interstitial lung disease, damaged or scarred lung tissue, cystic fibrosis, pulmonary hypertension, etc.; certain neurological conditions like dementia, Alzheimer’s, etc.; diabetes; Down syndrome; certain heart conditions such as heart failure, coronary artery disease, cardiomyopathies, hypertension; HIV/AIDS or others in immunocompromised states; liver disease like cirrhosis, liver scarring, nonalcoholic fatty liver disease, etc.; those who are overweight or obese; pregnant and recently pregnant people who are 42 or more days past the end of their pregnancy; certain hemoglobin disorders like sickle cell disease, thalassemia, etc.; current or former smokers; recipients of organ, blood stem cell, or bone marrow transplants; cerebrovascular disease like stroke, etc.; and substance use disorders including alcohol, opioid, cocaine use disorders, etc.

Those “high-risk” occupations qualifying for boosters include: first-responders such as healthcare workers, firefighters, police, and congregate care staff; education staff such as teachers, support staff, daycare workers; food and agricultural workers; manufacturing workers; corrections workers; U.S. Postal workers; public transit workers; grocery store workers; and residents of homeless shelters or correctional facilities.

OneWorld child vaccination clinics

OneWorld is offering pediatric COVID-19 vaccinations, for children ages 5-11, at the following clinics:

• Livestock Building, located at 4920 S. 30th St. in south Omaha
• In Bellevue, at 2207 Georgia Ave.
• In northwest Omaha at 4229 N. 90th St.
• In Plattsmouth at 122 S. Sixth St.

OneWorld will also offer children’s COVID-19 vaccinations at school health centers:

• Bryan High School, located at 4700 Giles Road
• Indian Hill Elementary, located at 3121 U St.
• Liberty Elementary, located at 2021 St. Mary’s Ave.
• Spring Lake Elementary, located at 4215 S. 20th St.

Walk-ins are accepted on a first-come, first-serve basis; or you can call 402-734-4110 to make an appointment.

Children’s Hospital

Children’s Hospital is planning to offer dedicated COVID-19 vaccination clinics for about a month, starting by Thursday, Nov. 11 — or sooner, if they are supplied the doses before that.

• 5-7 p.m. Thursdays at West Village Pointe and Spring Valley offices
• 8 a.m.-noon Saturdays at West Village Pointe and Spring Valley offices

After Saturday, Dec. 11, pediatric COVID-19 vaccinations will be available by appointment at any Children’s Hospital location.

• Tuesday and Thursday appointments available at the Mission Village location, 16909 Q St. Call 402-955-7575 or 402-955-SHOT (7468) for available times.
• Thursday and Friday appointments available at the Dundee location, 4825 Dodge St. Call 402-955-7676 or 402-955-SHOT (7468) for available times.

Nebraska Medicine

Nebraska Medicine is offering COVID-19 vaccinations at clinics in several retail pharmacies and health centers around the Omaha-metro.

NebMed will provide Pfizer vaccinations by appointment at:

• Eagle Run Health Center, located at 132nd Street and West Maple Road
• Fontenelle Health Center, located at 50th Street and Ames Avenue
• Girls Inc. Health Center, located at 45th Street and West Maple Road
• Old Market Health Center, located at 13th and Leavenworth streets
• Village Pointe Health Center, located at 175th and Burke streets

For those looking for walk-in appointments, single-dose Johnson & Johnson vaccinations will be available at these pharmacies:

• Outpatient Pharmacy at Bellevue Health Center, located at 25th Street and Highway 370, will offer J&J vaccinations from 8 a.m. to 8 p.m. Monday through Friday; and from 8 a.m. to 1 p.m. Saturdays.
• Outpatient Pharmacy at Durham Outpatient Center, located at 45th and Emile streets, will offer J&J vaccinations from 7 a.m. to 9 p.m. weekdays; and from 8:30 a.m. to 4:30 p.m. on the weekends.

Around Omaha

SOUTH OMAHA: Testing and vaccinations available at OneWorld, located at 4920 S. 30th St. Call 402-734-4110 to make an appointment for vaccinating anyone age 12 and older.

CHARLES DREW HEALTH CENTER: Call 402-451-3553 to schedule an appointment.

CHURCH CLINIC: Metropolitan Community Chuch of Omaha will host a walk-in COVID-19 vaccination clinic from 9 a.m. to 2 p.m. Saturdays. No ID is required, but a parent or guardian must be present at the clinic with teens ages 12-18.

MCC FORT OMAHA: Vaccinations also will be distributed Mondays and Thursdays from 9 a.m. to 7 p.m. at Metropolitan Community College’s Fort Omaha campus, located at 5300 N. 30th St. Appointments will be made through the county’s vaccination registry.

TOTAL WELLNESS: DCHD has been working with Total Wellness, located at 9320 H Court, to establish a vaccination clinic from 10 a.m. to 3:30 p.m. Tuesdays and Thursdays.

VETERANS: Any eligible veterans can go to the Omaha VA Medical Center’s COVID-19 vaccination clinics’ walk-in hours from 9 a.m. to noon weekdays and 8 a.m. to noon on Saturdays at the new Ambulatory Care Center.

Sarpy/Cass health district

The Sarpy/Cass Health Department offers COVID-19 vaccinations at its offices, located at 701 Olson Drive in Papillion:

• Tuesdays: 9 a.m.-2 p.m.
• Wednesdays: 1-6 p.m.

The health department offers the first and second doses of Pfizer and Modern vaccines, Johnson & Johnson (Janssen) single doses, and booster doses of all three vaccines.

Sarpy/Cass vaccination clinics

The Sarpy/Cass Health Department has scheduled vaccination clinics for all COVID-19 vaccine doses, including pediatric doses:

TUESDAY

• 5-7 p.m. at Plattsmouth Middle School, located at 1724 Eighth Ave.

THURSDAY

• 4-6 p.m. at Weeping Water Public Schools, located 204 W. O St.

FRIDAY

• 4-7 p.m. at Gretna Middle School, 11705 S. 216th St.

MONDAY DEC. 6

• 3-5 p.m. at Springfield Community Center, 104 Main St.
• 4-6 p.m. at Bellevue Lied Activity Center, 2700 Arboretum Drive

TUESDAY DEC. 7

• 4-6 p.m. at Papillion-La Vista South High School, 10799 NE-370

THURSDAY DEC. 9

• 4:30-6:30 p.m. at Conestoga High School, 8404 42nd St., Murray, Neb.

MONDAY DEC. 13

• 1-3 p.m. at Louisville Public Schools, 202 W. Third St.

Appointments are recommended but not required. For scheduling assistance, call 833-998-2275 or 531-249-1873.

Three Rivers health district

Three Rivers Public Health Department is giving out boosters to those in certain risk categories who have had Pfizer vaccinations. It is also working with area businesses and schools to provide plan more COVID-19 vaccination clinics.

Three pediatric vaccination clinics have been set up for children ages 5-11:

• Wahoo: 9 a.m.-3:30 p.m. on the first and third Mondays of the month at 1320 E. 31st St.
• Fremont: 3-6:30 p.m. Tuesdays and noon-3:30 p.m. Fridays at 2400 N. Lincoln Ave.

The health department has the necessary forms posted on their website, for minors and adults, for those who would like to fill them out ahead of their visit.

3RPHD’s regular clinics will continue:

• In Dodge County, the Three Rivers clinic at 2400 N. Lincoln Ave. in Fremont, is open for walk-ins from 3 to 6:30 p.m. Tuesday; and noon to 3:30 p.m. Friday.
• In Saunders County, the Three Rivers clinic in Lake Wanahoo, located at 1320 E. 31st St., is open to walk-ins from 9 a.m. to 3:30 p.m. on the first and third Mondays of the month.

Those who are home-bound or require special accommodations but need a COVID-19 test or vaccine can contact the health district at 402-704-2245 to make arrangements.

Off-line help

CHI HEALTH VACCINE INFORMATION: The info line is available at 402-717-1255 from 7 a.m. to 10 p.m. daily in August.

NEBRASKA VACCINE HOTLINE: Nebraskans can call 531-249-1873 or toll-free at 833-998-2275 for more information on the state’s COVID-19 vaccination process.

DOUGLAS COUNTY HELPLINE: Local COVID-19 information, in Spanish and English, is available from 8:30 a.m. to 4 p.m. weekdays, except for holidays. Call 402-444-3400 for assistance.

IOWA VACCINE HOTLINE: Older or home-bound Iowans looking for help scheduling a COVID-19 vaccination appointment can call 1-866-468-7887 from 8 a.m. to 4:30 p.m. Monday-Friday; or contact Connections Area Agency on Aging at 712-328-2540 or 1-800-432-9209.

Resource links

Where to get a test: Douglas County

Vaccine sign-up: Douglas County | Sarpy/Cass | Three Rivers | Nebraska

Vaccinations at hospitals: Nebraska Medicine | Methodist Hospital | Children’s Hospital

Retail pharmacy vaccine sign-ups: Hy-Vee | Walmart | Sam’s Club | Baker’s | Kohll’s | CVS | Kubat

Vaccine information: Douglas County | Douglas County clinics | Nebraska || Iowa | Pottawattamie County | Mills County | Fremont County

COVID-19 dashboards: Douglas County | Sarpy County | Three Rivers Health District | Lancaster County | Nebraska | Iowa | Worldwide

School info: Omaha Public Schools | Millard Public Schools | Bellevue Public Schools | Westside Community Schools | Papillion-La Vista Community Schools | Gretna Public Schools | Elkhorn Public Schools | Council Bluffs Community Schools | Lincoln Public Schools | UNL | UNO | Midland University

COVID-19 risk dials: Lincoln-Lancaster County

WOWT.com quick search: COVID-19 | Coronavirus | Vaccine

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Severe COVID-19: 1 in 100 patients may have brain complications - Medical News Today

Vanderbilt disease expert calls omicron variant one of concern - NewsChannel5.com

NASHVILLE, Tenn. (WTVF) — Dr. William Schaffner is sitting at a place of concern with the latest COVID-19 variant.

The Vanderbilt University Medical Center infectious disease expert said the omicron variant — first discovered in South Africa — could easily arrive in the United States and Tennessee. He said it was a matter of time before the variant showed up locally after it has already been reported in North America.

"This omicron variant has accumulated a whole series of mutations that involve that critical aspect of the virus," Schaffner said. "The thing that we call the spike protein. Think of the virus as a little ball with spikes sticking out. That spike protein is what we're talking about. That's the key. When the virus hits our cells, it lets the key get into the lock. It lets the virus get into the cell, multiply and start producing the disease. What the vaccine does is glom onto that spike protein, so it can't get into our cells and therefore we're protected. Can this new spike protein, on the omicron variant, evade the protections of our vaccines?"

President Joe Biden said in an address to the nation earlier Monday that the nation should have a level of concern but not panic.

Dr. Anthony Fauci told Biden that it will take about two more weeks to have more definitive information on the transmissibility, severity and other characteristics of the omicron variant, but the Fauci continues to believe that existing vaccines are likely to provide a degree of protection against severe cases of COVID-19, according to the White House.

"There's a lot of people who have fatigue over COVID," Schaffner said. "They wish it would go away. They have not only fatigue but annoyance. I'm going to have to ask you to sit tight. When the going gets tough, the tough get going. We're going to be dealing with COVID in one form or another going forward. I'm afraid that's the sad reality."

He said that the best option for people is to start masking again and to get vaccinated and booster shots.

"Even with omicron, the boosters and the vaccines give us a lot of antibodies," he said. "That will provide, we trust, some protection against omicron and obviously, protection against delta which is right here, right now, in Nashville spreading and making people sick — particularly unvaccinated persons."

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FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions | FDA - FDA.gov

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Here's what Louisville doctors are saying about the new omicron COVID-19 variant - Courier Journal

Victories against AIDS have lessons for COVID-19 - Nature.com

Amid the COVID-19 pandemic, a milestone of another global scourge has largely escaped the spotlight. It has been 40 years since the earliest reports of what ultimately became known as AIDS, in 1981. I initially dismissed the first report as a curiosity and probably a fluke, but another a month later, from the US Centers for Disease Control and Prevention, changed my mind and the direction of my career. Against the advice of my mentors, I shifted my research focus to understanding why young, healthy men were being beset by unusual conditions. I remember anxiously awaiting results essential in the fight against a disease that brought on so many seemingly unrelated symptoms: pneumonia, blindness, skin lesions, dementia.

This year’s World AIDS Day, on 1 December, marks both incredible progress and the need for more. HIV was shown to be the cause of AIDS in 1983–84. Soon, there were blood tests for diagnosis, and for screening the supply of donated blood. These revealed the enormous scope of the pandemic: between 1984 and 1985, new cases of AIDS in the United States almost doubled. Eventually, progress in understanding — getting the sequence of the virus’s genome, and comprehending how it decimated the immune system and how disease progressed — paved the way for dozens of approved therapies.

In 1985, a 25-year-old in the United States diagnosed with AIDS had a life expectancy of less than two years. Today, a person with HIV can expect to die in old age, of other causes. Since the global peak in 2004, AIDS-related deaths are down by 64%. Overall, about 73% of people with HIV are accessing treatment. Still, in 2020, almost 700,000 people died from AIDS-related illnesses and 38 million were living with HIV.

Achilles heel spotted for promising HIV-prevention drug

Millions of people have also been killed and disabled in the COVID-19 pandemic. The fight against HIV reveals how important it is to make use of existing treatments and strategies for prevention, to strive for better ones, to reach vulnerable communities and to consider equity, education and outreach. There are many similarities that sadden me: how hard some patient groups need to fight for recognition; how misinformation and denialism can promote illness and death; how slowly interventions reach vulnerable populations; how easy it can be to overlook patient inputs when setting research priorities.

The 40 years of AIDS have been punctuated by periods of both darkness and hope. In the early, frustrating days of the pandemic, physicians had little to offer our patients. Glimmers of hope came with treatments for opportunistic infections and the first partially effective antiretroviral drugs. In the mid-1990s, multidrug antiretroviral regimens transformed the prognoses of many people infected with HIV from dire to excellent. Now, more potent, better-tolerated drug combinations are available as a single daily pill.

A crucial lesson was that antiretroviral therapy both helps the person living with HIV and reduces their risk of transmitting it: treatment cuts the level of the virus in their blood until it can neither be detected nor passed on. Understanding that ‘undetectable equals untransmittable’ was a triumph of research, as well as of HIV activism, which has been a driving influence throughout this journey. Also transformative is pre-exposure prophylaxis: giving people antiretrovirals before they are exposed to HIV can be more than 95% effective in preventing them from acquiring it. I suspect that drugs based on monoclonal antibodies will soon play an important part in treating and preventing HIV, as they do for SARS-CoV-2.

Medical advances mean that HIV/AIDS could, theoretically, now be taken off the table as a major health threat (in the United States and globally), particularly if programmes such as the President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria continue to get robust support. Sadly, things are never that simple. Uptake of treatment remains suboptimal, in rich and poor communities. Reasons include lack of transport, substandard housing, mental-health issues, substance abuse, pill fatigue, drug toxicity, stigma and discrimination.

And so, a top priority is to ensure that everyone has access to existing treatment and prevention options, while we develop better ones. Earlier this year the first long-acting injectable antiretroviral treatment regimen, cabotegravir + rilpivirine, delivered once a month, was approved by regulatory authorities. An injectable, long-acting form of cabotegravir might soon be approved for prophylactic use.

Exciting work is under way for further HIV treatment and prevention. This includes development of very long-acting drugs that could be taken every six months or even less frequently. And then there are strategies for achieving durable HIV remission. Some people are working on eradicating the replication-competent HIV reservoir (a concept frequently referred to as a cure).

A safe and effective HIV vaccine has been elusive so far, but even a moderately effective vaccine could, together with the rest of the toolkit, bring an end to AIDS as a major health concern. It’s likely that one could build on some of the tools and platforms used for COVID-19 vaccines, including messenger RNA and optimizing immunogens to prompt the most effective immune response.

Entering the fifth decade of AIDS, the challenge to researchers is to work with at-risk communities to deliver treatment and prevention to everyone in the world who needs them.

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New Mayo Clinic study finds more women are COVID 'long haulers' - KARE11.com

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3. New information from Mayo Clinic sheds more light on COVID 'long haulers'  KARE 11
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The Omicron Variant - kottke.org

Last week, a worrisome variant of SARS-CoV-2 burst into the public consciousness: the Omicron variant. The concern among scientists and the public at large is substantial, but it is unfortunately going to take a few weeks to figure out whether those concerns are warranted. For a measured take on what we know now and what we can expect, read these two posts by epidemiologist Dr. Katelyn Jetelina (as well as this one on vaccines).

B.1.1.529 has 32 mutations on the spike protein alone. This is an insane amount of change. As a comparison, Delta had 9 changes on the spike protein. We know that B.1.1.529 is not a “Delta plus” variant. The figure below shows a really long line, with no previous Delta ancestors. So this likely means it mutated over time in one, likely immunocompromised, individual.

Of these, some mutations have properties to escape antibody protection (i.e. outsmart our vaccines and vaccine-induced immunity). There are several mutations association with increased transmissibility. There is a mutation associated with increased infectivity.

That sounds bad but again, we presently do not have enough information to know for sure about any of this. As Jetelina concludes in one of the posts:

We still have more questions than answers. But we will get them soon. Do not take Omicron lightly, but don’t abandon hope either. Our immune systems are incredible.

None of this changes what you can to do right now: Ventilate spaces. Use masks. Test if you have symptoms. Isolate if positive. Get vaccinated. Get boosted.

This Science piece by Kai Kupferschmidt also provides a great overview about where we’re at with Omicron, without the sensationalism.

Whether or not Omicron turns out to be another pandemic gamechanger, the lesson we should take from it (but probably won’t) is that grave danger is lurking in that virus and we need to get *everyone* *everywhere* vaccinated, we need free and ubiquitous rapid testing *everywhere*, we need to focus on indoor ventilation, we need to continue to use measures like distancing and mask-wearing, and we need to keep doing all of the other things in the Swiss cheese model of pandemic defense. Anything else is just continuing our idiotic streak with this virus of fucking around and then finding out. (via jodi ettenberg & eric topol)

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A Harvard nutritionist and brain expert says she avoids these 5 foods that 'weaken memory and focus' - CNBC

No matter how old you are, it's never too late to start eating in a way that gives you the best possible chance of staving off dementia as you age and making sure that you feel focused and sharp every day.

As a nutritional psychiatrist, faculty member at Harvard Medical School and author of "This Is Your Brain on Food," I study how our gut bacteria can trigger metabolic processes and brain inflammation that impact memory. Existing studies point to the idea that we may be able to reduce the possibility of dementia by avoiding foods that can compromise our gut bacteria and weaken our memory and focus.

Here are the foods I try to avoid or cut back on to fight inflammation and promote brain health, sharp thinking and good decision-making:

1. Added sugars

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The brain uses energy in the form of glucose, a form of sugar, to fuel cellular activities. However, a high-sugar diet can lead to excess glucose in the brain, which studies have linked to memory impairments and less plasticity of the hippocampus — the part of the brain controlling memory.

Consuming unhealthy processed foods like baked goods and soda, which are often loaded with refined and added sugars — often in the form of high-fructose corn syrup — floods the brain with too much glucose.

Although each body has different needs, the American Heart Association recommends that women consume no more than 25 grams of added sugar per day, and men stay under 36 grams added sugar per day. (To figure out if a packaged food contains added sugars, and how much, check the "added sugars" line in the Nutrition Facts panel.)

2. Fried foods

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French fries, tempura, samosas, fish and chips and chicken-fried steak. Is your mouth watering? I get it.

Still, when it comes to brain health, it pays to reduce the amount of fried foods you eat. In fact, one study including 18,080 people found that a diet high in fried foods was linked to lower scores in learning and memory. The likely reason: These guilty pleasures cause inflammation, which can damage the blood vessels that supply the brain with blood.

Another study looked at 715 people and measured their levels of depression and mental resilience. It also documented their level of fried food consumption. Sure enough, researchers found that those who consumed more fried foods were more likely to develop depression in their lifetime.

If you're eating fried foods daily, switch to weekly. If it's a weekly habit, try enjoying them just once a month. If you don't eat fried foods, you're already on your way to happier times!

3. High-glycemic-load carbohydrates

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Even if high-carbohydrate foods — for example, bread, pasta, and anything else made from refined flour — don't taste sweet, your body still processes them in much the same way it does with sugar.

That means they can also raise your risk for depression. Don't panic, I'm not going to suggest eliminating carbs from your diet completely! But the quality of the carbs you eat matters.

In 2018, researchers sought to evaluate which particular carbohydrates, if any, had an association with depression. They administered a questionnaire called the "carbohydrate-quality index" to 15,546 participants.

"Better-quality" carbohydrates were defined as whole grains, foods high in fiber, and those ranked low on the glycemic index (GI). The GI is a measure of how quickly foods convert to glucose when broken down during digestion; the faster a food turns into glucose in the body, the higher its GI ranking.

Researchers discovered that people who had the highest score on the carbohydrate-quality index, meaning they were eating better-quality carbs, were 30% less likely to develop depression than those who were eating high-GI carbs.

High-GI carbs include potatoes, white bread and white rice. Honey, orange juice and whole-meal breads are medium-GI foods. Low-GI foods include green vegetables, most fruits, raw carrots, kidney beans, chickpeas and lentils.

4. Alcohol

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I often encounter people in my practice who live stressful lives. The "work hard, play hard" mindset often leads to heavy drinking on weekends as a way to relieve stress. While drinking might make them relax in the moment, they pay for it the next morning, when they wake up jittery with brain fog.

Archana Singh-Manoux, a research professor and director at the French Institute of Health and Medical Research, and her colleagues followed 9,087 people over 23 years to see how alcohol related to the incidence of dementia.

In 2018, in the British Medical Journal, they reported that people who had abstained from alcohol completely or who consumed more than 14 drinks per week had a higher risk of dementia compared to those who drank alcohol in moderation.

In general, men who consume more than 14 drinks per week or more than four drinks in a single day at least once a month are considered to be heavy drinkers, as are women who drink more than seven drinks per week or three drinks per day. But different people (and their brains) respond differently to alcohol abuse.

When I work with anxious patients who drink, I always ask them to consider the contexts in which they might be using alcohol in an unhealthy way — for instance, using drinking as a means of coping with something they are trying to avoid — and to consider moderating the amount they drink.

5. Nitrates

Photo: Loreke76 | Twenty20

Used as a preservative and to enhance color in deli slices and cured meats like bacon, salami and sausage, nitrates may be connected with depression.

One recent study even suggests that nitrates can alter gut bacteria in such a way as to tip the scales toward bipolar disorder.

If you simply can't live without salami and sausages, seek out those containing buckwheat flour, which is used as a filler. Buckwheat flour contains important antioxidants that can counter some of the negative health effects of these meats.

Dr. Uma Naidoo is a nutritional psychiatrist, brain expert, and faculty member at Harvard Medical School. She is also the Director of Nutritional & Lifestyle Psychiatry at Massachusetts General Hospital and author of the best-selling book "This Is Your Brain on Food: An Indispensible Guide to the Surprising Foods that Fight Depression, Anxiety, PTSD, OCD, ADHD, and More." Follow her on Twitter @DrUmaNaidoo.

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A cure for Type 1 diabetes? For one man, it seems to have worked - Times of India

Brian Shelton’s life was ruled by Type 1 diabetes. When his blood sugar plummeted, he would lose consciousness without warning. He crashed his motorcycle into a wall. He passed out in a customer’s yard while delivering mail. Following that episode, his boss told him to retire, after a quarter century in the Postal Service. He was 57.
Early this year, his ex-wife, Cindy Shelton, spotted a call for people with Type 1 diabetes to participate in a trial by Vertex Pharmaceuticals. The company was testing a treatment developed over decades by a scientist who vowed to find a cure after his kids got the disease. Shelton was the first patient. On June 29, he got an infusion of cells, grown from stem cells but just like the insulin-producing pancreas cells his body lacked. Now his body automatically controls its insulin and blood sugar levels. Shelton, now 64, may be the first person cured of the disease with a new treatment that has experts daring to hope that help may be coming for many of the 1.5 million Americans suffering from Type 1 diabetes. “It’s a whole new life,” Shelton said.
Diabetes experts were astonished but urged caution. The study is continuing and will take five years, involving 17 people with Type 1 diabetes. It is not intended as a treatment for the more common Type 2 diabetes. “We’ve been looking for something like this to happen for decades,” said Dr Irl Hirsch, a diabetes expert at the University of Washington who was not involved in the study. He wants to see the result, not yet published in a peer-reviewed journal, replicated in more people. He also wants to know if there’ll be adverse effects and if the cells will last for a lifetime or if the treatment would have to be repeated. But, he said, “bottom line, it’s an amazing result”.
It all started with the quest of a Harvard University biologist, Doug Melton. He had never thought about diabetes until 1991 when his 6-month-old son, Sam, got sick and was diagnosed with Type 1 diabetes. . Type 1 is lethal unless patients get injections of insulin.
Patients are at risk of going blind. People with Type 1 diabetes are at risk of having their legs amputated and of death in the night because their blood sugar plummets during sleep. In time, his daughter Emma, four years older than Sam, also developed the disease, when she was 14.
The only cure is a pancreas transplant or a transplant of the insulin-producing cell clusters of the pancreas, known as islet cells, from an organ donor’s pancreas. But a shortage of organs makes this approach an impossibility. Melton started studying diabetes, determined to find a cure. He turned to embryonic stem cells, which have the potential to become any cell in the body. His goal was to turn them into islet cells to treat patients.
The challenge was to figure out what sequence of chemical messages would turn stem cells into insulin-secreting islet cells. The work involved figuring out how islets are made in the pancreas and conducting experiments to steer embryonic stem cells to becoming islets. After years when nothing worked, a small team of researchers achieved a breakthrough in 2014. They put a dye into the liquid where the stem cells were growing. The liquid would turn blue if the cells made insulin. After hours of waiting, one researcher saw a faint blue tinge that got darker and darker. The team was ecstatic. For the first time, they had made functioning pancreatic islet cells from embryonic stem cells.

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Coronavirus pandemic overshadows another Maine crisis: Drug overdose deaths - Yahoo News

Nov. 27—A decade ago, five years ago even, many Mainers struggling with substance use disorder could relapse with far less risk of suffering a fatal overdose.

Those odds have diminished significantly.

Fueled by the powerful synthetic opioid fentanyl, which is showing up in nearly every illegal drug being sold, overdose deaths in 2021 are on pace to shatter the annual record set just one year ago.

From January through September, there were 455 fatal overdoses tracked by the Maine Attorney General's Office and the Office of Behavioral Health, an average of more than 50 every month. If that pace holds for the final three months of the year, there would be more than 600 deaths, easily eclipsing last year's total of 502 that was attributed in part to increased isolation, challenges with accessing treatment and a disruption of illegal drug supply during the pandemic.

"I think the stress on people and the isolation from the pandemic are certainly factors, but I think the biggest factor is the lethality of the drugs," said Leslie Clark, executive director of the Portland Recovery Community Center. "When we think about people who relapse or are at risk of relapse, the consequence is just so much greater. That experience didn't use to be as likely to kill you."

Nicole Proctor, who is program director for the recovery hub at the Portland center and in long-term recovery herself, said there is no question drugs are more deadly than ever.

"I've been grateful that I'm not living through the lethal drugs that are out on the street," she said. "And it's not just opioid users. Fentanyl is showing up in cocaine and methamphetamine, even marijuana. I don't think there are necessarily more people using, I think there are just more people dying."

In the last decade, the number of yearly overdose deaths has more than tripled, fueled overwhelmingly by opioids — largely diverted prescriptions like OxyContin at first, then heroin and now fentanyl.

Maine went over 200 deaths in a year for the first time in 2014. In 2017, the total was over 400. Now, eclipsing 600 four years after that seems all but certain.

Three of every four deaths this year have involved fentanyl or an analog. Cocaine and methamphetamine each show up in a quarter of all deaths, often in combination with fentanyl.

"We're certainly not hiding it. The data is out there. But the reason you're not hearing about it is because COVID is squeezing out everything else," Gordon Smith, director of Maine's opioid response, said in an interview.

Drug deaths outpaced COVID deaths last year, although that's not likely to be the case this year. In 2020, there were 422 deaths attributed to COVID-19 and so far this year there already have been more than twice that many. More than three times as many people in Maine died by overdose last year as died in motor vehicle crashes.

Drug enforcement officials say drug cartels in Mexico are mass producing fentanyl and methamphetamine with chemicals imported from China. Fentanyl is profitable for drug dealers because it's so potent that small amounts can be mixed with other substances.

Last week, more than 389 pounds of fentanyl — and 17,500 pounds of methamphetamine — were found hidden inside a tractor-trailer full of auto parts at a port in San Diego. The seizures were the largest for either drug in the U.S. for both 2020 and 2021, according to a statement from the U.S. Attorney's Office.

Maine is by no means alone in the recent trend. The U.S. Centers for Disease Control and Prevention released estimates last week that more than 100,000 Americans died of drug overdoses from May 2020 to April 2021. That's the highest 12-month period ever recorded, although it's not yet an official count.

All but four states saw increases over the previous 12-month period. Nearby New Hampshire was among the states that saw overdose deaths decrease. Vermont, on the other hand, saw the largest increase, 70 percent, although that state started from a much smaller number than most.

Maine's increase of 24 percent was slightly lower than the overall U.S. increase of 28.5 percent.

So far this year, overdose deaths have been reported in every Maine county, led by 82 deaths in Cumberland County. Of the 455 reported through September, 314 victims have been male (69 percent). Individuals between the ages of 40 and 59 account for just under half of all deaths.

As high as the total has been so far, it could have been higher still without the widespread availability of naloxone, a drug that can save lives by reversing the effects of an opioid overdose. Of the 6,892 overdoses reported from January through September, 7 percent have resulted in fatalities.

"It's incredibly sad how many people are overdosing," Smith said. "But it's remarkable that we're saving 15 people for every person who dies."

Still, naloxone only works when it is administered shortly after an overdose. If it's not on hand or if emergency medical providers can't respond in time, it doesn't do any good.

Oliver Bradeen, executive director of Milestone Recovery in Portland, said the increase in overdose deaths has come at a time when people have been desperate for access to limited resources. The detox unit at Milestone, for example, was forced to close for roughly three months this year because of staffing shortages. Another detox facility in Bangor also closed temporarily. That meant people who didn't have private insurance had nowhere to go outside of a hospital emergency room.

"I think the thing we hear from folks, aside from the added level of isolation brought on by the pandemic, is that everything, when it comes to treatment, takes longer or takes more effort," Bradeen said.

In recent weeks, members of the Alliance for Addiction and Mental Health Services of Maine have warned that the vaccine mandate for health care workers would exacerbate staffing shortages at agencies that provide crucial treatment, especially in rural areas.

"When I came into recovery, I lived in a rural area and had to move to Portland to find support and resources that I felt I needed," Proctor said. "A lot of people may not have that option, but people can get resources away from Portland more easily than before and we continue to be more creative with how we deliver those services."

In many ways, Maine has more tools now to fight substance use disorder, Smith said: Medicaid expansion and increased reimbursement rates for treatment; the introduction of medication-assisted treatment in jails and prisons; the widespread availability of naloxone.

But more work is clearly needed.

"With every overdose, there is something to be learned that might help us prevent them in the future," he said. "For instance, how many people died while trying to get into treatment? If they aren't trying, that's one thing. You focus on harm reduction. But if there are barriers to treatment, that's something else."

Smith said he has a recurring nightmare about some college kid trying to buy one pill of Adderall — a prescription stimulant — to help him get through an all-night study session. The pill contains fentanyl, unbeknownst to the student.

"That kid isn't going to wake up. He's going to die," he said.

The unprecedented number of overdose deaths, combined with the hundreds who have died from COVID-19, has been unnerving for behavioral health workers.

"The people dying from overdose, so many are in their 20s and 30s, so when you think of how much of their lives have been lost, it really brings it into perspective," Bradeen said. "And many of them have kids, so that's another generation that's affected by this crisis, too."

"The loss in our community, and the devastation to families, is just so continual," added Clark. "But it does give us a stronger sense of purpose to keep doing this work. Because we also do see many people doing well and getting better."

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Va. mom anxious after 1st death from rare COVID-linked condition: 'They can get really sick' - wtvr.com

RICHMOND, Va. -- A post-COVID complication impacting children is causing concern for some parents after the first Virginia child died from the condition, according to the Virginia Department of Health.

State health officials have reported 111 total cases of Multi-Inflammatory Syndrome in Children, or MIS-C, across Virginia.

That includes five cases in the Henrico Health District, five in the Chickahominy Health District, six in the Chesterfield Health District, and none in the Richmond City Health District, as of Sunday evening.

One death has been confirmed in the Prince William Health District in Northern Virginia.

RELATED: Richmond hospital sees recent uptick in rare COVID complication in children

A mother in the Tri-Cities was able to spend the Thanksgiving weekend enjoying family time and playing with her kids after they recovered from COVID-19.

She noticed her 4-month-old daughter started with red eyes and allergy symptoms around Halloween time. Shortly after, her son began feeling ill.

“He got a fever and started coughing," she said. "He was shaking in pain.”

The mother, who did not want to be identified, said the whole family, including herself and her husband, tested positive for Coronavirus. Her 2-year-old son experienced the worst symptoms.

“He felt so bad," she said. "You could see it in his face, but there was nothing I could do.”

The whole family is now healthy and well, but the mother has new worries about MIS-C after doing a little bit of reading about it.

It's a rare condition where a child's immune system attacks organs of the body, and it can appear between four to six weeks following a COVID infection.

“They can get really sick really, really fast," the mother said. "Now that I know it’s four to six weeks, I do have concerns.”

The Virginia Department of Health confirmed Friday a child between 10 and 19 years old died from MIS-C, but doctors have said the median age of those affected by the complication is nine.

Medical experts recommend parents look out for these symptoms of MIS-C:

• Fever
• Stomach pain
• Diarrhea
• Vomiting
• Skin rash
• Blood shot eyes
• Dizziness
  

Parents are also urged to take their child to an emergency room if these severe warning signs show up:

• Trouble breathing
• Confusion
• Inability to stay awake
• Pale or blue skin

“I get up throughout the night and still check to see if [my children are] breathing, so I definitely will be keeping a closer eye on them," the mother said. “It’s hard during the holiday season to keep them away from family, but I mean, I would definitely be more cautious,"

Health experts have said the best way to avoid MIS-C is by protecting little ones from COVID-19.

Mass COVID-19 vaccination clinic at Richmond Raceway.

Virginians age 5+ are eligible for COVID-19 vaccine. Pre-registration is no longer required, so go to Vaccine Finder to search for specific vaccines available near you or call 877-VAX-IN-VA (877-275-8343).

Depend on CBS 6 News and WTVR.com for the most complete coverage of the COVID-19 pandemic.

Have You Been Fully Vaccinated?

People are considered fully vaccinated:

• 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or
• 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine

Virginia Department of Health

What you can and should not do once you have been fully vaccinated.

How to Protect Yourself and Others When You’ve Been Fully Vaccinated

COVID-19 vaccines are effective at protecting you from getting sick. Based on what we know about COVID-19 vaccines, people who have been fully vaccinated can start to do some things that they had stopped doing because of the pandemic.

We’re still learning how vaccines will affect the spread of COVID-19. After you’ve been fully vaccinated against COVID-19, you should keep taking precautions—like wearing a mask, staying 6 feet apart from others, and avoiding crowds and poorly ventilated spaces—in public places until we know more.

These recommendations can help you make decisions about daily activities after you are fully vaccinated. They are not intended for healthcare settings.

Click here for more information from the Virginia Department of Health.

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Hopes and concerns over a new Alzheimer's drug - CBS News

Not long ago, Joe Montminy was a hard-charging market research executive, wowing audiences at conferences all over the world. "I loved the job," he said.

Correspondent Susan Spencer asked, "You were good at this job?"

"I'd like to think I did a good job at it, yes."

But gradually he felt that the job he'd mastered was somehow mastering him: "There was one situation that really stands out. We were on a call going through a number of topics, and I had a hard time following the conversation and connecting the points. And that had never, ever happened to me before. And that's when I knew something wasn't right, because It was now affecting my ability to do my job."

Joe Montminy. CBS News

So, in 2017 Joe saw a neurologist, whose diagnosis stunned him: Early onset-Alzheimer's.  He was 54.

Spencer asked, "What did the neurologist tell you the outlook was?"

Montminy replied, "She actually said, you know, 'Joe, over the next three to five years you are gonna start to experience some declines. And then, you're likely not going to recognize your family in five to seven years,' and that I had a life expectancy of around ten years."

His reaction was one of shock. Just a month later, he retired from the job he loved. Today, he makes the most of family time at home in Plymouth, Mass.

But he's haunted by what lies ahead. "I've had friends say, 'Oh, you've caught it early. Hopefully, they can help you and you'll get better.' People don't realize that with Alzheimer's, there is no cure. It can be a fatal disease."

Dr. Daniel Gibbs, a neurologist in Portland, Oregon for nearly 25 years, told Spencer, "Alzheimer's Disease is the most common form of dementia. The key is, it's a progressive loss of brain function."

And an astounding six million Americans suffer from it, says Gibbs.

Spencer asked, "As a physician, what was the most difficult aspect of treating Alzheimer's patients?"

"I just felt so hopeless," Gibbs replied, "and it was hard for me to give any hope to the patients. Because we all knew what was in store."

"The cause of Alzheimer's Disease, broadly speaking, is really a challenge still today," said Maria Carrillo, Ph.D., chief science officer at the Alzheimer's Association in Chicago … a challenge that so far has evaded answers.

Maria Carrillo, Ph.D. CBS News

But Carrillo is nonetheless optimistic: "We have hope on the horizon, and that hope is that there are new treatments, not only available today, but hopefully in the near future."

One approach goes after the abnormal deposit of protein found in the brains of Alzheimer's patients. They're called amyloid plaques, and they may show up decades before symptoms do.

Spencer asked, "So, it's possible that, in the future, we'll be treating it before it's even symptomatic?"

"That is really the goal," Carillo said, "to be able to stop this disease in its tracks, to stop it at the biological timepoint when proteins are starting to accumulate in the brain that ultimately will lead to those memory and behavior changes that today we know of as dementia."

That's the thinking behind Aduhelm, the first new FDA-approved Alzheimer's drug in almost two decades.

Biogen

When asked why new medications for Alzheimer's are so few and far between, Gibbs replied, "Well, it's not for want of trying. It's a very complicated disease, is the short answer."

The excitement over Aduhelm stemmed from its proven ability to clear those protein formations, the amyloid plaques.

When asked if he would take the drug if offered, Joe Montminy said, "If I was eligible and if I had the insurance coverage, I would absolutely take the drug. My challenge is the price tag. I cannot afford the $56,000 price tag."

And for now, insurance coverage is no guarantee, though drug maker Biogen says it does offer "programs to help patients … assess eligibility for financial assistance ..."

But beyond the staggering cost is a more urgent concern: does Aduhelm really do anything to stop symptoms?

Dr. Aaron Kesselheim, professor of medicine at Brigham and Women's Hospital in Boston, said, "The new drug that the FDA approved in June targets amyloid plaques very effectively. But unfortunately, the drug doesn't seem to have any clear effect on the progression of Alzheimer's Disease."

Dr. Aaron Kesselheim. CBS News

Kesselheim was on the FDA Advisory Panel on Aduhelm, until he quit in protest when the agency gave the drug a green light … a move he calls "probably the worst drug approval decision in recent U.S. history."

Spencer asked, "How can you say definitively that it doesn't work any more than the FDA could say definitively that it does?"

"You can't say definitively that it doesn't work; you can't say definitely that it does work, either," said Kesselheim. "And in that circumstance, you need to do some more testing of the drug. The system in our country is that in order for a drug to be approved by the FDA, it has to show substantial evidence that the drug actually does work. And in this case, there isn't good evidence that the drug works."

But the FDA made Aduhelm available while studies continue, citing the "unmet needs for patients [facing this] fatal disease," and concluding, " … it is reasonably likely that … reduction in amyloid plaque will result in meaningful clinical benefit …"

"Reasonably likely" sounds pretty good to patients like Joe Montminy: "It's a major, major breakthrough that has taken us from drugs that only deal with the symptoms, to a drug that now can deal with one of the root causes of the disease."

"Possibly?" said Spencer.

"Possibly."

Spencer asked, Gibbs, "Describe for me the pressure from patients and their families to find a cure."

Dr. Daniel Gibbs. CBS News

"There is pressure," he said. "The experience that we have with Alzheimer's Disease, most of us, is when we, a relative or an acquaintance is in the nursing home and dwindling away, doesn't recognize anybody, and it's just, you know, a terribly frightening thing to think, 'That's my future.' And it is devastating."

A devastating future Dr. Gibbs now sees through a very different lens. He no longer practices medicine, he said, because he has Alzheimer's. "And even though I'm still in the mild cognitive impairment stage of it, I stopped practicing neurology."

"Do you think that, being an expert in this field, does that at this point make it harder or easier for you to deal with it?"

"I mean, I know what to expect," Gibbs replied, "but I also know what I need to do to hold off the bad stuff at the end as long as possible."

Cambridge University Press

Gibbs enrolled in an early trial of Aduhelm, which landed him in the ICU. He is one of a small number of patients who suffered serious side effects. "My severe reaction doesn't affect my opinion on the FDA's approval," he said. "Because they're rare. And I fully recovered."

He said he is still optimistic about this class of drugs.

And as for Joe Montminy, he told Spencer, "I've really come to realize how precious time is. So, I'm much more focused on how I spend my time and who I spend it with."

He said he'd consider any new medication, controversy or not. "If you don't take chances, nothing good happens," Montminy said. 

     
READ A BOOK EXCERPT: "A Tattoo On My Brain: A Neurologist's Personal Battle Against Alzheimer's Disease" by Dr. Daniel Gibbs

     
For more info:

      
Story produced by Amiel Weisfogel. Editor: Carol Ross.

     
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From 2010: Jan's story - A love lost to Alzhe... 09:55

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