Top 10 tips to navigate Whole30 without crashing and burning

Top 10 tips to navigate Whole30 without crashing and burning
Top 10 tips to navigate Whole30 without crashing and burning
Cavan Images/Getty Images

(NEW YORK) — Welcome to GMA’s New Year, Best You. As we ring in 2023, we are sharing everything you need to start the new year strong. From keeping your New Year’s resolutions going to Instagram-worthy meal prep to workout programs to eating plans to taking time for yourself, we have it all covered.

The Whole30 program, based on a bestselling book, eliminates food groups like sugar, grains, dairy and legumes from participants’ diets for a full 30 days. With many people starting Whole30 in January, after the holidays are over, GMA asked certified health coach Brooke Brennan to share her top tips.

Brennan, a mother of two from Florida, has done the Whole30 three times herself and supported countless clients, family and friends through it as well. She is doing Whole30 again this January alongside her husband.

Here, Brennan shares her 10 tips for making it through the Whole30 program with a smile on your face.

1. Focus on what you are adding, not eliminating

The food you eat fuels you to LIVE your life.

Focus on all the good things you are adding into your body during the 30 days, instead of the things you are taking out. The more good stuff you put in each day, the more good stuff you are going to get out each day.

2. Get to know the free resources available to you

There are incredible resources at your fingertips on the Whole30 website that make completing it easy to understand and prepare for. Here are some to get you started:

Whole 30 Program Rules

Whole 30 Shopping List for Omnivores

Whole 30 Shopping List for Vegetarians

Whole 30 Pantry Stocking List

Finding recipes online is easier than ever before with many incredible recipe developers who specialize in creating beautiful Whole30 compliant dishes. An Instagram poll asked for the best Whole30 recipe developers and here are some that were recommended:

Thedefineddish.com

Paleorunningmomma.com

Nomnompaleo.com

Oliveyouwhole.com

Nocrumbsleft.net

3. Do Whole30 with a friend

Grab a buddy to do the Whole 30 with you.

The support, camaraderie and accountability can make the process so much more fun! But, if you can’t find someone who wants to join you, lean on social media. The Whole 30 Instagram page has a strong community of supportive men and women who are a wealth of knowledge during the process.

4. Plan ahead

Plan, plan and plan some more.

Eating on the Whole30 requires you to think about what you are going to be putting into your body at each meal — which, we all should be doing every day on or off any specific diet. Write down what you want your meals to be each day of the week on the Whole30 and shop to that list.

If you plan to be successful, you absolutely will be. Don’t leave your food up to chance! See the end of this piece for a typical menu of what I eat in a day on the Whole30.

5. Focus on ingredients over calories

Shift your focus to the ingredient list on the foods you eat instead of the nutritional label.

Knowing exactly what ingredients are in the food you eat is so much more important than the number of calories the food contains.

Learn to be your own ingredient detective. Hidden sugars are in so many foods we eat. Here is a great resource on Whole 30 Sneaky Sugars to help you know what to look for.

6. Find Whole30 compliant products

We are so lucky because there are a number of wonderful companies that create Whole30 compliant plus delicious products that you can grab and use every day.

Having dressings, sauces and seasonings you can use help transform your favorite foods into brand new dishes from one day to the next.

7. Don’t become a hermit

Go out to eat and be with your family and friends. Ordering out doesn’t have to be hard. You just need to know how to ask for what you want. The quicker you get out and about, the easier it will be.

Here are some ideas for things you can order at a restaurant:
– Order a salad (just hold all the non-compliant ingredients like cheese, croutons, tortilla strips, etc) and ask for extra avocado, veggies, egg and a grilled protein. Bring your own dressing or ask for oil and vinegar or lemon to dress it yourself.
– Order burgers without buns, tacos in lettuce shells with extra salsa and avocado (hold the cheese!) or when in doubt choose a protein and steamed veggies (or ask for veggies prepared in just olive oil).

8. Keep snacks on hand

Keep a snack in your bag just in case you need it. Getting “hangry” can lead to some interesting food choices, so if you feel hungry and it isn’t quite meal time, eat a snack.

Never ignore your hunger cues. That is your body’s way of telling you it needs some more gas in the tank. Our go-to snacks are hard boiled eggs, cold apples, berries, raw walnuts, leftover roasted veggies or almond butter (just look at the ingredient list and look to make sure the only ingredient is almonds!) with a banana.

9. Don’t skip the reintroduction

Whatever you do, don’t skip the reintroduction. The big magic happens in the 10 days following your Whole30, when you reintroduce the food groups one at a time to notice how your body responds.

What you learn during this 10-day process helps you to shape how you can eat to feel your best long-term. Here is the Whole 30 outline of the reintroduction phase.

10. Be confident

You can do anything for 30 days. Feel confident and empowered by your decision to complete the Whole30.

It can make you feel even better than you ever knew possible. I know we can’t wait to complete our fourth this month!

What I eat in a typical day on Whole30

7 a.m. Whole30 fiber and protein coffee.

9 – 10 a.m. Superfood nut, seed and fruit granola with unsweetened almond milk and fresh berries (Get the granola recipe HERE).

12 – 1 p.m. Buffalo tuna stuffed bell pepper (can sub hard-boiled egg or chicken for the tuna in this recipe) with a salad or roasted sweet potato.

3 – 4 p.m. Snack, if needed, of hard-boiled pasture-raised egg, a handful of raw walnuts or a small piece of fruit/berries.

6 – 7 p.m. Spinach, artichoke and leek “uncrusted” quiche with roasted dutch gold potatoes and avocado.

Copyright © 2023, ABC Audio. All rights reserved.

Dry January: What is it and how beneficial can giving up alcohol be?

Dry January: What is it and how beneficial can giving up alcohol be?
Dry January: What is it and how beneficial can giving up alcohol be?
Makoto Honda / 500px/Getty Images

(NEW YORK) — If you’re feeling hungover from New Year’s Eve champagne or had one too many boozy eggnogs over the holidays, let this January be a fresh start.

Taking the challenge of going dry in January, or Dry January, i.e. having no alcohol for the entire month, is one resolution that might actually make you healthier.

The Dry January campaign was started in 2013 by Alcohol Change U.K., a charity focused on reducing alcohol harm. For the past several years, the initiative has proved popular in the United States and other countries too.

What are the health benefits of Dry January?

While research on how quitting alcohol for a month affects your body is still limited, several studies have shown psychological and health benefits.

Over one dozen staff members at the magazine New Scientist teamed up with researchers at the Institute for Liver and Digestive Health at the University College London Medical School in 2013 to investigate the benefits of Dry January.

The staff members, who all considered themselves “normal” drinkers, underwent baseline testing with blood samples, liver ultrasound scans and questionnaires. For the next five weeks, 10 of them stopped drinking and four drank their normal amounts.

The people who stopped drinking had lower levels of liver fat (which can be a precursor to liver damage), improved blood sugars and lower cholesterol than they did at the beginning of the month. They also reported improved sleep and concentration. In contrast, the four people who kept drinking saw no benefit.

Another study out of the U.K. had nearly 100 participants abstain from drinking alcohol for a month and another nearly 50 participants continue drinking alcohol as normal.

They found that moderate-heavy drinkers who took a break from alcohol had improved insulin resistance, weight, blood pressure, and cancer-related growth factors.

The researchers do warn, however, that the study does not show that a short-term ‘detox’ period is all that is required to ‘refresh’ the liver or achieve other health gains. Abstaining from alcohol for a month is only one part of addressing negative effects from longer-term alcohol consumption.

People who drink excessive amounts of alcohol are at higher risk of death and many medical conditions.

Excessive alcohol use is the third-leading cause of preventable death in the United States, according to the U.S. National Institute on Alcohol Abuse and Alcoholism.

People who drink unhealthy amounts of alcohol are more likely to have high blood pressure, heart disease, liver disease, nerve damage, infections including pneumonia and even certain cancers like breast cancer.

Drinking excessive amounts of alcohol may also have a negative impact on mental health, including memory loss, depression and anxiety, according to the American Psychological Association.

Who should try Dry January?

Dr. Fulton Crews, director of the Center for Alcohol Studies at the University of North Carolina at Chapel Hill, said attempting to stop drinking for Dry January is a good opportunity for people to see if they have an actual addiction to alcohol.

“Many people are in denial about their drinking and hazardous drinking, and if they try to stop and are not able to, it really points out to them their weakness,” Crews told ABC News. “If they can’t stop for a month, they would realize that they have a problem.

“Either that or they do it, and they realize it’s not that hard for them,” said Crews, who described Dry January as a “good idea.”

Experts say Dry January may be especially helpful to those who consistently drink over the recommended amount of two drinks per day for men and one drink per day for women.

Excessive drinking includes binge drinking, defined as consuming five or more drinks for men in a single occasion and four or more drinks for women, and heavy drinking, defined as consuming 15 or more drinks per week for men or eight drinks or more for women). A standard drink is 12 ounces of a regular beer, 8 ounces of a malt liquor, 5 ounces of a glass of wine, and 1.5 ounces of a spirit, according to the Centers for Disease Control and Prevention.

For those individuals who drink alcohol within the recommended limits, Crews said he is “not sure there would be any observable benefits.”

“I don’t see any clear potential for a moderate drinking person to stop drinking,” he said.

If you do choose to participate in Dry January, Crews shared his advice for sticking to the program.

“Try to avoid temptation by maybe putting all the alcohol out of the house,” he said.

Does Dry January prompt bigger change for some?

Staying dry for January may also help jump-start people to give up alcohol for longer.

Although most people who participate in Dry January return to drinking, up to 8% stay dry six months later, according to Public Health England and the British Medical Journal.

And those who go back to drinking drink less. A 2015 study conducted in the U.K. and published in the journal Health Psychology found that people who participated in Dry January drank less often, had fewer drinks when they did drink and were drunk less often six months after Dry January was completed.

Dry January participants were also better able to refuse alcoholic drinks. These benefits were even seen in people who did not complete the whole month of Dry January.

It might seem daunting to stop drinking alcohol for a whole month. Between cocktail hour after work, beers while watching the football game, and that relaxing glass of wine after a long day, our culture sometimes seems to revolve around alcohol.

But the 2015 Health Psychology study found that 65% of people successfully completed the month of abstinence.

Have more questions about Dry January? Find out more about the benefits of the challenge HERE; get three tips to make Dry January easier HERE; and read about Ashton’s 2019 Dry January experience HERE.

If you are concerned about yourself or a loved one, call the Substance Abuse and Mental Health Services Administration’s (SAMSA) confidential, free, 24-hour-a-day, 365-day-a-year helpline at 1-800-662-HELP (4357). For information and resources about alcohol-related problems and health, visit the website of the National Institute of Alcohol Abuse and Alcoholism (NIAAA) HERE.

Copyright © 2023, ABC Audio. All rights reserved.

Going ‘keto’? Here’s everything to know about the trendy ketogenic diet

Going ‘keto’? Here’s everything to know about the trendy ketogenic diet
Going ‘keto’? Here’s everything to know about the trendy ketogenic diet
lacaosa/Getty Images

(NEW YORK) — The ketogenic diet, described as “Atkins on steroids” for its focus on foods high in fat and low in carbohydrates, is an increasingly popular diet, with more than 25 million posts about it on Instagram alone.

If you’re looking to start the trendy diet in the New Year, here is what you need to know.

What is the ketogenic diet?

The ketogenic, keto for short, diet was developed in the 1920s after it was noticed that after fasting, epileptics would experience a marked reduction in their seizures. The diet is designed to get your body into a state called ketosis whereby your body is so low on carbohydrates it starts burning fat for fuel.

Ketosis is also what the body does when fasting.

The diet’s proponents say it is the best way to lose weight without feeling hungry and that it increases energy levels.

What do people eat on the keto diet?

Keto dieters drastically cut carbohydrates to about 10 percent of their daily diet, which in some cases can be just 20 grams of carbohydrates per day.

That amount of carbohydrates is equivalent to one slice of white bread per day, Maya Feller, a New York City-based registered dietitian, told ABC News last year.

The amount of fat someone following the keto diet may consume in one day could be more than five times the recommended intake for daily fat for the average American, Feller says.

But she stresses that those fats should come from healthy fat food sources, such as olive oil and nuts.

“When I see people who are living the keto lifestyle, it’s rarely people who are eating fatty foods and doing nothing,” she said. “They’re trying to keep themselves in ketosis and doing things like eating chicken and fish; they’re actually paying attention.”

Foods that are “keto-friendly” include items like eggs, butter, unprocessed cheese, avocados, meat, low-carb veggies and nuts and seeds.

What to know before starting a keto diet

While the keto diet is consistently one of the most-searched diets online, it has ranked low on U.S. News & World Report’s annual best diets rankings in recent years in large part because of its restrictions and focus on fat.

Some critics of the keto diet argue that it is nearly impossible to follow for a long period of time, and that it could lead to muscle loss or deprive the brain of its preferred fuel source: carbs.

Additionally, they argue that the majority of the research on the keto diet has not yet looked at the long-term effects it has on non-epileptic people over the course of 15 to 20 years.

Feller, who was not associated with the U.S. News and World report ranking, warns, “If we’re talking about the majority of the country, [the keto diet] is not indicated and it’s not going to be adhered to properly, and [it] is not sustainable. It’s not ever my first-line recommendation.”

People who want to make a change in their health should take a look at what they’re eating and their dietary patterns, and then make modifications that are sustainable, Feller said, noting that dietitians are there to help.

How to get started

If you are ready to commit to the keto diet, Feller recommends talking with a qualified healthcare practitioner first to make sure the keto diet is safe for you and that you are correctly adjusting your macronutrients — protein, carbs and fat.

“You have to have a real understanding of what that means in the context of your day and the context of what you have been eating,” she said.

Feller also recommends making sure you get blood work done regularly, particularly a lipid profile.

Copyright © 2022, ABC Audio. All rights reserved.

Will the US plan for testing travelers from China help stem the spread of COVID?

Will the US plan for testing travelers from China help stem the spread of COVID?
Will the US plan for testing travelers from China help stem the spread of COVID?
Anthony Kwan/Getty Images

(NEW YORK) — The Centers for Disease Control and Prevention announced this week it would require a negative COVID-19 test from all travelers arriving to the U.S. from China as well as those from Hong Kong and Macau.

It comes as China experiences a surge of COVID-19 cases and hospitalizations after dropping its so-called “zero COVID” policy.

“CDC is announcing this step to slow the spread of COVID-19 in the United States during the surge in COVID-19 cases in the People’s Republic of China given the lack of adequate and transparent epidemiological and viral genomic sequence data being reported from the PRC,” the CDC said in a statement.

What’s more, Italian officials said Wednesday that nearly half of passengers on two flights from China to Milan tested positive for the virus.

Public health experts told ABC News that while they understand why the U.S. announced the measure, it is not a viable long-term solution.

“Pre-departure testing is not a fool-proof method to limit the spread of COVID,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “It’s hard to see a significant public health value.”

“The people that pre-departure testing will catch are overall drops in the bucket,” he added.

Brownstein and others said passengers testing before traveling may help protect other people on the plane by making sure they don’t contract the virus, but it won’t help the general public.

“One can imagine that the plane — if people are traveling and they have COVID, and they don’t know it — would be safer,” Dr. Peter Chin-Hong told ABC News. “So, I guess the fear, and the rationale for having this kind of travel restriction, is to prevent scary variants from coming in, or at least to delay it.”

He continued, “But at this point, the United States has seen so many waves of infection that probably the scariest variant wouldn’t do as much damage as if it were a naive population, like in March of 2020.”

Chin-Hong explained that this means because most of the U.S. population has antibodies either through natural infection or through vaccination, a new variant will likely not cause as much damage as it would have earlier in the pandemic when most Americans didn’t have antibodies.

The experts said another reason the U.S. instituted the rule is because there is little information coming out of China about the true scale of its COVID situation.

China has not reported any evidence of new variants, but has also been accused of underreporting case counts, hospitalizations and deaths.

For example, China’s National Health Commission says the country has only seen 5,241 COVID-19 deaths since the pandemic began, while data from Johns Hopkins suggests China has had over 16,000 deaths since the pandemic started.

Brownstein said it may be more effective to test passengers upon arrival in the United States, which is a rule recently implemented in Italy.

“I can imagine a situation where someone tests negative [before flying], but is incubating the virus and boards the plane,” he said. “But pre-departure testing is especially not valuable in a world where we already have intense transmission.”

Chin-Hong said China had strict testing measures in place too, but COVID-19 was still able to spread rapidly within the country, and travelers from China could circumvent the U.S. rule by flying to another country first.

He said what the U.S. should focus on is administering the updated bivalent booster to seniors aged 65 and older, because they are at the highest risk of serious disease, hospitalization and death. According to the CDC, only 37.5% of elderly people have been boosted.

“The main thing the U.S. should be doing is independent of China, is continue to invest in vaccinating older individuals, particularly those over 65 because that’s where most of the deaths are and that’s where the booster rate is still abysmally low,” Chin-Hong said. “If you can divert those resources to building up the immune defenses of the people who could get sick, that will have more longevity.”

Copyright © 2022, ABC Audio. All rights reserved.

Some school districts bring back mask mandates to stem spread of COVID, flu and RSV

Some school districts bring back mask mandates to stem spread of COVID, flu and RSV
Some school districts bring back mask mandates to stem spread of COVID, flu and RSV
Catherine Delahaye/Getty Images

(NEW YORK) — Several schools are bringing back mask mandates to reduce the spread of COVID-19 and other respiratory illnesses.

In New Jersey, two school districts said students will be required to wear face coverings indoors upon returning from winter break.

Paterson Public Schools, which serves abut 25,000 students from pre-kindergarten through 12th grade, said the new rule will go into effect starting Jan. 3.

“I know this is a relief to some, and a frustration to others. No matter what your position may be, I ask for your cooperation,” Eileen Shafer, Paterson school district superintendent, wrote in a letter to parents and guardians. “Please continue to maintain universal masking throughout our buildings and we encourage you to take all other precautions against the spread of the COVID-19, RSV, flu virus including frequent hand washing, avoiding large gatherings, and staying home when sick.”

Meanwhile, Camden City School District, with about 7,500 students between kindergarten and 12th grade, will implement required indoor masking for at least two weeks, through Jan. 17.

“The New Jersey Department of Health has already reported an increase in COVID, flu, and RSV cases,” CCSD Superintendent Katrina McComb wrote in a letter to families. “Therefore, in an effort to be proactive and remain vigilant, all schools and offices will operate under a short mask mandate upon reopening.”

The moves come amid a rise in COVID-19 cases across the country. According to data from the Centers for Disease Control and Prevention, weekly cases have increased 309,272 to 402,525 over the last five weeks, although they have begun to decline recently.

Meanwhile, infections of respiratory syncytial virus, or RSV, and the flu are still high — but appear to have peaked in mid-November and mid-December, respectively, and are now declining, according to CDC data.

According to the CDC’s latest flu report, the cumulative hospitalization rate for influenza is more than four times higher at this point in the year thanx every season going back to 2010-2011, but the number of new admissions has declined for the third week in a row.

Schools in New Jersey are not the only ones bringing back masks. Earlier this month, the School District of Philadelphia announced students would be required to wear masks for the first 10 days after winter break.

“In an effort to be proactive in supporting healthy environments and maintaining in-person learning following students and staff returning from winter break, the District will implement mandatory masking from January 3 through January 13, 2023,” the district wrote in a release, according to local ABC affiliate WPVI.

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Sisters celebrate anniversary of kidney donation that’s lasted a remarkable 50 years

Sisters celebrate anniversary of kidney donation that’s lasted a remarkable 50 years
Sisters celebrate anniversary of kidney donation that’s lasted a remarkable 50 years
Courtesy of Carolyn Rogers and Patti Rogers Harris

(NEW YORK) — Two sisters are celebrating a very special anniversary this year: the 50th anniversary of one donating her kidney to the other.

Usually organ transplants, such as kidney transplants, last 15 to 20 years if the organ came from a living donor, according to the National Kidney Foundation.

The fact that the kidney that Patti Rogers Harris, 68, of Hendersonville, Tennessee, received from her sister, Carolyn Rogers, 72, has lasted 50 years is nothing short of astonishing.

At the time, kidney transplant operations had only been around for 20 years, making it a relatively new procedure.

However, the sisters say they are feeling great and hope to encourage others to become organ donors and help save a life.

‘I didn’t know how sick I was’

When Harris was 4 years old, she had an undiagnosed strep infection that led to post-streptococcal glomerulonephritis, or PSGN, which is a rare kidney disease that can develop after certain strep infections, according to the Centers for Disease Control and Prevention.

PSGN is an inflammatory disease in which the body mounts an immune response and mistakenly attacks healthy body parts — in this case, the kidneys — and causes damage.

This can lead to kidney disease and, in rare cases, kidney failure.

Harris said throughout the course of her childhood, she always felt like she was sick.

“I was sick,” she told ABC News. “I didn’t know how sick I was, but I do remember having a whole lot less energy than my siblings. I’m kind of sitting on the sidelines watching them having fun.”

Harris’ health deteriorated until eventually, at age 16, she ended up in the hospital and doctors said she was suffering from kidney failure, and she needed to be on dialysis.

Dialysis is a procedure by which a machine helps filter the blood of waste products, toxins and excess fluids — which is supposed to be done by the kidneys.

Towards the end of Harris’ first year on dialysis, doctors approached her family with the idea of a transplant and if anyone in the family could be a match.

“So, it was the end of her first year of dialysis that I went in and started having the test to see who would be a good match,” Rogers told ABC News. “And I was. And then she was on dialysis for another year before we could do the [transplant].”

Rogers said she was unwavering in her determination to give her sister a kidney and Harris remembers that resoluteness.

“I do know people were being tested and Carolyn was adamant she was gonna give me a kidney,” Harris said. “I said, ‘Well, we’ll see what the doctor says.’ [She said], ‘I’m giving you a kidney.’ And I took it thank you very much.”
Transplants then and now

However, organ transplants were much more complicated 50 years ago than they are today.

Dr. Keith Johnson, one of the medical leads on the team that operated on Rogers and Harris, said matching a donor and a recipient has become a much more streamlined process today.

“Each kidney that became available was really a challenge,” Johnson told ABC News. “And the difference today is that there’s now a framework within which everybody works to decide and to very quickly allocate organs from donors, so that the recipients are known very quickly because of the computer system.”

Between 1954, when the first successful organ transplant was performed, through the early 1970s, there was no national system so doctors of individual transplant hospitals were calling transplant programs to see if they could find a suitable recipient.

“They would call transplant programs that they knew or had relationships with, in various parts of the country to find that if they had a recipient that was suitable for the kidneys that were just removed — and that was a very laborious process to try to figure out where the kidneys were going to go,” Johnson said.

The actual surgery itself has become much safer with easier recovery time for patients.

Surgical incisions to remove and transplant kidneys could be six to 10 inches back then. Rogers says her scar goes from the sternum to below the belly button — which she says is about nine inches. Now, incisions can be three inches or less.

“When you take the kidney out, you’re removing the artery and the blood vein from the kidney, you have to be concerned about bleeding,” Dr. Robert Richie, another lead on the medical team that operated on the sisters and the head of Vanderbilt’s kidney transplant program at the time, said. “And so, in order to be exceedingly careful, we had to have maximum exposure and so then we were making long mid-line incisions so that we could get a good look.”

“Over the years, we are now making smaller incisions,” he continued.

Additionally, since then, several drugs have been introduced that suppress the immune system to prevent organ rejection, which lowers the risk of mortality.

Convincing others to be donors

Harris said she doesn’t remember much about the surgery, which took place in September 1972, but Rogers remembers being prepped. She even recently spoke to Johnson about it.

“I remember the operating room and they said, ‘Carolyn, you’ve got to stop talking for [the anesthesia] to take effect’ and that’s the last thing I remember because I finally did stop talking,” she said.

Harris said she does remember how much her physical and mental health improved following the transplant.

“Really now, at 68, I have a lot of energy,” she said. “I feel comfortable in my body. I can’t even find the right adjectives for this topic because there’s not one.”

The pair hopes that their story will convince others to consider registering to be organ donors. Right now, more than 60,000 people are actively waiting on a transplant list to be organ donors, according to UNOS.

Since 1954, more than one million organ transplants have been performed, UNOS data shows.

“It can be such an outstanding gift for someone else to give a bit of themselves,” Harris said.

Rogers added, “What other reason are we on Earth for than to care for each other? Is there any other reason?”

“You can make a huge difference” by being a donor, she said.

Copyright © 2022, ABC Audio. All rights reserved.

House investigation finds FDA, drug firm Biogen ignored internal concerns for Alzheimer’s drug

House investigation finds FDA, drug firm Biogen ignored internal concerns for Alzheimer’s drug
House investigation finds FDA, drug firm Biogen ignored internal concerns for Alzheimer’s drug
Sarah Silbiger/Getty Images, FILE

(WASHINGTON) — A congressional investigation into the Food and Drug Administration’s review process for an Alzheimer’s treatment found that the agency “deviated” from its standard procedures to approve the Aduhelm drug with inconsistent data.

Aduhelm is notable for being the first drug in recent years approved to treat the underlying cause of Alzheimer’s, a disease with no known cure that is characterized by progressive dementia that affects more than six million Americans, according to the Alzheimer’s Association.

The joint 18-month investigation between the House’s Oversight and Reform Committee and Energy and Commerce Committee, released on Thursday, criticizes the FDA for “atypical collaboration and interactions” with Biogen, the drug’s manufacturer.

In statements, Biogen and the FDA both said their interactions prior to Aduhelm’s green light were appropriate in the context of the approval process.

“One of my top priorities as Chair of the Committee on Oversight and Reform is ensuring that the American people have access to effective and affordable medications,” Rep. Carolyn Maloney, D-N.Y., chairwoman of the House Oversight and Reform Committee, said in a statement.

The FDA “remains committed to the integrity of our drug approval process, which includes ensuring that safe and effective new treatment options are available to the millions of people with Alzheimer’s disease living in the U.S.,” the agency said in a statement to ABC News.

“The FDA’s decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials. … That said, the agency has already started implementing changes consistent with the Committee’s recommendations,” the statement said, in part.

The report also blasts Biogen for “an unjustifiably high price for Aduhelm” that it says was meant “to make history.” One year of the Aduhelm treatment originally cost $56,000 for a person of average weight, the report says.

“Biogen stands by the integrity of the actions we have taken,” the company said in a statement to ABC News. “As stated in the congressional report, an FDA review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation.'”

“Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm. That process is continuing to inform our work as Biogen introduces new innovative treatments to the market,” the statement read, in part.

Aduhelm was considered for FDA approval under the agency’s traditional pathway before the agency switched to consider the drug under its Accelerated Approval Program, according to the report.

The change in course — which the congressional investigation says occurred “abruptly” — came after the FDA internally found Aduhelm lacked “demonstrated clinical benefit necessary for traditional approval,” House investigators found.

Under the accelerated program, the FDA can approve some drugs that meet both “an unmet medical need” and “treat serious conditions,” according to the agency’s website. Aduhelm is not the only drug to be approved under this pathway, which the FDA carved out specifically to give more options to patients with diseases for which virtually no treatments exist. Accelerated approval is typically contingent upon the pharmaceutical company completing larger, longer-term studies.

During the monthslong approval process, the FDA and Biogen collaborated closely. FDA and Biogen officials met, spoke or otherwise had substantial email exchanges at least 115 times, according to the congressional investigation.

Although it is typical for drug companies to work closely with the FDA during the approval process, such collaboration between Biogen and its federal regulators “exceeded the norm in some respects,” according to the FDA’s own internal review, the report says.

The cooperation came after an independent review of Aduhelm’s effects on people with Alzheimer’s cast doubt on its ability “to effectively slow cognitive and functional impairment” in patients.

And when the FDA initially approved the drug for all Alzheimer’s patients, the congressional investigation found that the move concerned some Biogen advisers who were wary of such broad approval. The advisers did not communicate such reservations to regulators, the report says.

The FDA later walked back its broad approval of the drug, eventually recommending the drug’s use in only a narrower subset of patients with early-stage disease, which more closely mirrored the group included in Aduhelm’s clinical trials.

Following the FDA’s accelerated approval of Aduhelm, the Centers for Medicare & Medicaid Services established that Medicare would only pay for the drug under limited circumstances in which patients are part of approved studies.

That move severely limits the availability and practical implications of Aduhelm, essentially making it available only to people who can pay out of pocket for treatment.

And as part of the stipulations associated with accelerated approval, Biogen has more than six years to complete the final trial, per the report. Aduhelm remains available in the meantime.

Thursday’s report comes as the FDA evaluates two additional Alzheimer’s-related drugs, with a green light from the agency possible in the coming months. Biogen helped develop one of those drugs.

“FDA must take swift action to ensure that its processes for reviewing future Alzheimer’s disease treatments do not lead to the same doubts about the integrity of FDA’s review,” the congressional report says.

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How a stranger helped three Buffalo nurses get to work during the historic storm

How a stranger helped three Buffalo nurses get to work during the historic storm
How a stranger helped three Buffalo nurses get to work during the historic storm
Courtesy of Ally Maderer

(BUFFALO, N.Y.) — When the historic Buffalo, New York, storm stranded nurses at home, they turned to a stranger in a snowmobile club to give them an unconventional ride to work.

Ally Mederer, an ICU nurse at Buffalo General Medical Center, spent days trapped in her house during the deadly storm.

“I’ve lived in Buffalo my whole life,” she told ABC News. “I have never seen anything to this extent.”

But while Mederer was at home, some of her coworkers were stuck at the hospital.

“They had worked anywhere from 50 to 60 hours straight with minimal relief in the hospital, so we just felt awful for them,” she said.

Mederer’s colleague turned to social media, asking if someone had a way to help three nurses get to work.

She said they found a man who was a friend of one of the nurse’s dads. He was in a snowmobile club and had a “snow groomer” machine, which can shape trails for snowmobiles.

The nurses agreed to the unusual ride.

“We were like, ‘Whatever it takes, let’s get there,'” Mederer said.

“We obviously were a little nervous,” she added. “Until we actually physically got there, I didn’t think that there was any way it was going to happen. Even by the time we got picked up in the snow groomer, we weren’t sure what we were going to see on the streets — none of us had been out.”

Once they arrived at the hospital, she said “our coworkers were just ecstatic” to have the chance to go home.

“They had been working so many hours painlessly with no break, and they needed people to come relieve them, and they needed to try and get home to their loved ones,” Mederer said.

Mederer said she’s grateful for her Buffalo neighbors who are coming to one another’s aid.

“There are so many people out there right now like Rich McNamara, the one who drove the snow groomer. They’re literally putting their lives at stake for random strangers like me,” she said.

Buffalo “really is the city of good neighbors,” Mederer said.

ABC News’ Caroline Rotante contributed to this report.

Copyright © 2022, ABC Audio. All rights reserved.

Reporter shares husband’s journey from terminal brain cancer to remission

Reporter shares husband’s journey from terminal brain cancer to remission
Reporter shares husband’s journey from terminal brain cancer to remission
ABC News

(NEW YORK) — One reporter decided to get personal on air in order to give hope to others who may need it.

Diane Pathieu said she was told her husband Nick Adamski only had a year to live. That was two years ago.

Pathieu, who is a reporter with Chicago ABC affiliate WLS-TV, shared her family’s journey from a terminal brain cancer diagnosis to remission for others who might be facing a “hopeless diagnosis.”

In December 2020, unbeknownst to Pathieu, who was anchoring the morning news, her husband suffered a seizure due to a sudden brain bleed while at home alone.

They later received “the devastating news” that Adamski was diagnosed with a grade 4 glioblastoma, a cancerous and aggressive brain tumor.

“When a doctor says to you that your spouse has brain cancer, when he’s never had a single sign of anything before, it really just was so unbelievable to me,” Pathieu told ABC News’ Good Morning America.

Pathieu said her husband underwent emergency surgery to remove the glioblastoma, followed by over 40 days of chemotherapy and radiation. Despite the aggressive regimen, Pathieu said the cancer returned.

“That’s when he was given this expiration date and was told he only had 12 to 14 months to live,” said Pathieu, pointing to her husband beside her and adding, “I think that’s when for you, you said, ‘Oh heck no.'”

Pathieu and Adamski sought a second opinion at Northwestern Medicine, where they said doctors discovered Adamski’s tumor had specific gene mutations, one being FGFR-TAC3 fusion, which might respond to treatments that target those exact mutations.

The doctors performed methylation profiling as well as genetic testing, where they took the genetic fingerprint of Adamski’s tumor to better identify how to treat it precisely.

The tests revealed that Adamski may most likely respond best to a drug normally used to treat metastatic bladder cancer.

“In 17 hours, [the doctor] called me back and said, ‘We have a treatment for you,'” said Adamski. “It just felt like fate. It felt like a prank phone call. It was a good feeling, and it still is today.”

Adamski said that after just a few days of treatment, his tumor began to shrink.

Within a few months of treatment, Adamski was in remission.

Although some of the side effects of the treatment were rough, Pathieu and her husband said it was well worth it.

“To wake up every morning and say, ‘I’m still here,’ I’ll take all of it. That’s fine with me,” said Adamski. “I’ll take everything they throw at me as long as I’m still breathing.”

Pathieu said that the cutting-edge treatment and what she described as her husband’s “positive mental attitude” saved his life.

Copyright © 2022, ABC Audio. All rights reserved.

Expert tips to make New Year’s resolutions that last

Expert tips to make New Year’s resolutions that last
Expert tips to make New Year’s resolutions that last
Nora Carol Photography/Getty Images

(NEW YORK) — While most people can keep up with their New Year’s resolutions through the first days of January, it is those days and weeks throughout the rest of the year that can catch up with even the best of intentions.

So how do you make your New Year’s resolution stick?

Experts say it is important to remember it is a journey, not an overnight fix, especially when it comes to the most common of resolutions, weight loss and exercise.

“The reason why people make resolutions every year is because it’s really hard,” said Maya Feller, a New York-based registered dietitian nutritionist. “You first started eating when you were 6 months old, so that’s many years of learned food behavior.”

“Change is not going to happen overnight,” she said.

Feller and other experts shared their top tips for making sure your health and wellness resolutions become true lifestyle changes.

Solidify your intention

Even just a few days into January is the right time to remind yourself why you chose your resolution, according to Feller.

“Sometimes after just a few days of changing your diet you feel good and feel like you can let it go,” she said. “In the early part of January, reevaluate your motivation and say, ‘Why am I doing this again? I’m making this intentional choice again.'”

Rebecca Scritchfield, a Washington, D.C.-based dietitian and certified exercise physiologist, said it’s also important to remember your “why” multiple times daily.

“What’s going to help keep you motivated is continuing to think about the benefits you’re receiving, in both the short term and the long term,” she said. “The more you focus on the benefits every time you do it, you’ll see the good earlier. What you want to say is, ‘There’s too much good in this for me to stop.'”

‘Layer’ the changes

Feller advises her clients to pick the “low-hanging fruit” when they make a plan for their resolutions.

“If you’re eating two vegetables a day, make it four,” she said. “Once you’ve hit that, reevaluate again and ask yourself, ‘Why am I doing this and what do I have to add on?'”

Feller compares improving eating habits to building a house. You start by making sure you have a solid foundation and build up from there.

“You have to put the foundation down and solidify the behavior,” she said. “It is behavior change. That’s the thing about nutrition.”

Say no to the quick fix

Both Feller and Scritchfield stress that going for the quick solution, like a plan promising you’ll lose 15 pounds in January, will not be sustainable and may even leave you worse off.

“You might lose 15 [pounds] but you’re not going to continue it with that approach,” she said. “It’s better to have the small success so you can continue to step forward.”

Scritchfield said taking the more moderate, long-lasting approach to healthy eating and exercise demands that you let go of the shame or fear that comes from overindulging in the holiday season.

“You’re going to be so tempted in the new year to fall for an extreme plan because you’re feeling like you want to make a change and you’re also being told there is something wrong with where you are right now,” she said. “The more important value is feeling like you have a good life and feeling happy with your habits.”

“Go down the road of, ‘It’s OK to be where I am and what’s the next goal that I think is interesting to me and will also help me create a better life,'” she said. “Walk down that road of kindness as opposed to something that is short term.”

Live your values

Recognizing that the changes you are making are part of the person you want to be can help you sustain your resolutions over the long term, according to Scritchfield.

“A simple way of remembering your values is saying, for example, ‘I want to be the kind of person who enjoys healthy eating. I feel good when I eat at home and I’m saving money and that’s important to me so I’m going to keep doing this,'” she said.

Reflecting on your values in the moment, more specifically, will, according to Scritchfield, help you feel the benefits of your new habits faster and encourage you to stay on track.

“Growing your optimism really strengthens your mind’s commitment to continuing the steps,” Scritchfield said. “You want to look at three months down the road. If at the end of January if it feels sustainable, continue it for three more months and then, come springtime, you’ll see, ‘Oh, I don’t have to think about this so much anymore.'”

Don’t set a ‘dead person’s goal’

Scritchfield describes this type of goal as, “Any goal a dead person can do better than you, like, ‘I’ll never eat chocolate cake.'”

“Saying you’re going to eliminate it, unless you truly believe you’ll never have it again and you’ll live a good life without it, is a waste of time,” she said. “Instead, work on a better structure so you know that it will come but a structure that is manageable to you and doesn’t feel like deprivation but feels like a positive change.”

Scritchfield used an example of a person trying to quit drinking soda. Instead of saying you will never again drink soda, develop ways to cut back on soda while increasing a better habit, like drinking water.

“Say, ‘I’m going to carry water with me and I’m going to fill it up twice before I drink a soda,” she said. “Or, ‘I want to limit my soda to one a day after lunchtime and I want to make sure I have two full waters before I do that.'”

For those who would like to increase their water intake, Scritchfield gave a tip she uses in her own life.

“I put rubber bands on my water bottle,” she said. “I add one each time I finish a bottle.”

Write it down and be flexible

Writing down your New Year’s resolutions, your motivation and your plan for action help solidify your commitment, experts say.

“Make sure it’s written down, not just in your head,” said Dr. Marcelo Campos, a practicing physician and lecturer at Harvard Medical School. “Post it on your fridge or your wall to remind yourself about the commitment you made.”

“With anything that we do in life, it’s a good idea to have things written down that we can track over time,” he said, adding that goals should be specific and measurable.

Writing down your resolutions and action plan can also help you share it with others, which experts say is another key for long-term success.

“Make sure you have that support system in place so there is someone in the beginning who can help you hold you accountable while giving you sound advice, and that may be the help of dietitian or doctor,” Feller said. “Choose who you’re going to listen to.”

After making a plan and implementing it, also be flexible if the plan is not working for you.

“If someone is doing it on their own and struggling they may need to say, ‘I need to look at a different modality,” Feller said. “If it’s not working, there’s no reason to beat a dead horse.”

Bonus tip: Know that you are worth it

“People need to remember that they’re not defined by their weight or their health status. That doesn’t determine their value or worth,” Feller said. “[New Year’s resolutions] are not improve to your self worth because you are worth it to begin with.”

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