Delaying Aging Would Bring Trillions of Dollars in Economic Gains, Study Finds

People are living longer than ever, but there’s growing recognition that longer life expectancy is of little use unless we also delay the physical decline associated with old age. New research suggests doing so could be worth trillions of dollars in economic gains.

Over the last century, life expectancy has shot up across the world thanks to improvements in medicine, diet, and education. However, too often we are unable to make productive use of the extra years we have been blessed with due to the fact that old age is associated with a host of non-communicable diseases, general physical frailty, and disability.

This is driving a growing shift in focus from increasing lifespans to increasing “healthspans,” the number of years a person lives in good health. Key to this approach is a shift in focus from treating the individual diseases of old age to targeting the process of aging itself.

Besides allowing people to enjoy their advanced years, a strong argument for this approach is that boosting peoples’ healthspan will also allow them to remain economically productive for longer. That could be crucial for the future of countries across the developed world facing falling birth rates and graying populations.

Now researchers have used US economic, health, and demographic data to put a price on just how valuable such an intervention could be. In a paper in Nature Aging, they showed that treatments that slow down aging could be worth US$38 trillion for every extra year of life they give people.

This isn’t the first time someone has tried to pin a number on the benefits of slowing aging. The authors reference a 2013 study in Health Affairs, which estimated that a 2.2-year increase in life expectancy could be worth as much as $7.1 trillion over 50 years.

The new study uses a different methodology, though, known as value of statistical life. This is the measure used by various US agencies and represents how much people would be willing to pay to reduce their risk of dying. It incorporates concepts like health, consumption, and leisure, and therefore measures not just quantity but quality of life.

As a result, the approach achieves different results when applied to different scenarios. The researchers used it to assess the economic value of boosting lifespan but not healthspan, and healthspan but not lifespan. They found that increases in healthspan were more valued, but both of these scenarios were significantly less attractive than a scenario where healthspan and lifespan increased, which would be expected with successful anti-aging therapies.

To more precisely assess how powerful a general anti-aging therapy could be compared to simply treating specific diseases, the researchers then turned to the results of a recent study on patients taking metformin. The drug was designed to treat diabetes, but has recently received attention for its potential anti-aging effects.

A 2017 study in the Journal of Diabetes and its Complications on 40,000 older men with diabetes found that the drug reduced the incidence of a host of age-related conditions, like cardiovascular disease, dementia, and cancer. The researchers applied the proportional decrease found in this study to data on the number of deaths and years lost to illness due to each of these conditions in the US.

They found that the benefits of treatment with metformin in terms of increased life expectancy often matched or exceeded those from the complete eradication of cancer, dementia, or cardiovascular diseases.

Finally, to work out what the overall value would be of an anti-aging therapy that could extend both lifespan and healthspan, they applied the third scenario they investigated to current US Census Bureau data on the population, its age structure, and birth rates.

They found the value of a 1-year increase in life expectancy would be $37.6 trillion, and for a 10-year increase it would rise as high as $366.8 trillion. Most interestingly, they discovered that this anti-aging scenario would create a virtuous circle, because as delayed aging increases the average age of society and quality of life in later years, more people stand to benefit from further improvements in anti-aging therapies.

The authors note that the study does omit two crucial details that could have significant impacts on the value of such an intervention: health inequalities among the population being studied, and income inequality. The former is likely to further increase the value of anti-aging approaches, they note, but the latter could cause significant reductions in the value if the cost of therapies is high.

That means that while the potential for anti-aging therapies could be colossal, their true value will only become apparent if we can ensure widespread access to them.

How to Get Off Antidepressants the Safe Way

When you’re in the midst of depression, it can feel like you’re completely alone — but statistics-wise, that couldn’t be further from the truth. The National Institute of Mental Health reports that depression is one of the most common mental health disorders in the United States, with an estimated 17.3 million adults living with depression in 2017.

If you’ve been taking medication to manage your depression, there may come a time when you want to stop using it. But it’s vital that you do so carefully, with the help of a doctor, says psychiatrist Andrew Coulter, MD, MA. He shares considerations for going off your meds and what to be sure to communicate to your doctor.

Identify your reasoning

There’s no rule book for when to go off antidepressants, and the reasons to do so are as varied as the patients who use them in the first place. The first course of action, though, is to figure out why you want to stop. Then start a conversation with your doctor, who can work with you to determine the best course of action.

“As a doctor, if I don’t know why you’re coming off the medication, I’m not able to work around it,” Dr. Coulter says. “But if I have your rationale for quitting, I can provide the best treatment and work with you on how to stop your medication in a way that’s right for you.”

He explains some common reasons for getting off antidepressants.

You’re feeling better

Maybe you went on antidepressants after the death of a loved one, the loss of a job or the end of a relationship. Maybe you had situational depression brought on by the pandemic. Whatever the case, you’re feeling more emotionally stable and better equipped to face the world sans medication.

“If you were put on medication because of a stressful life event, and there’s been sufficient time and treatment that your symptoms have resolved, it may be time to try going without it,” Dr. Coulter says.

“If, after a year, you’ve clinically improved, and it’s your first episode of depression, it may be reasonable to try and come off the medication, especially if your symptoms are because of a specific stressor.”

You’re feeling worse

If you’ve experienced negative side effects since you started taking antidepressants, you may understandably feel inclined to stop using them. Instead, Dr. Coulter says it’s important that you communicate these issues to your doctor so they can work with you to figure out a switch.

“Unfortunately, patients don’t always tell their doctor when they don’t like the way antidepressants impact their lives,” he says. “But it’s important for them to tell us because we can help with that.”

You can’t afford them

You might think your doctor doesn’t care about your financial situation or that they can’t do anything to help. But if you’re unable to pay the high cost of your antidepressant subscription, let your doctor know. “Being upfront about cost lets us work around it,” Dr. Coulter says.

They may be able to switch you to a different antidepressant or to a generic version — one that’s covered by your health insurance or falls within your financial abilities if you’re paying out of pocket.

You want to try a different antidepressant

If you don’t like the antidepressant you’ve been taking, share those concerns with your doctor so you can work together to determine a better option.

“If you’re doing a medication switch, your doctor will want to go over all your medications with you, just to be safe,” Dr. Coulter says. 

Their goals are to minimize the side effects of transitioning from one medication to another and to minimize interactions between the two — along with anything else you’re taking.

You don’t want to be on medication

“Some people tell us that being on an antidepressant doesn’t fit with their treatment ethos, and others just don’t want to have to remember to take a pill every day,” Dr. Coulter says.

Whether you’re concerned about social stigma or want to try therapy as an alternative, you may prefer not to be on antidepressants — and that’s OK. Just be sure to communicate that preference to your doctor so they can help you make a safe transition to being medication-free. They may also ask about your openness to trying other methods of treatment for your depression, such as psychotherapy.

How your doctor will guide you

Once your doctor knows why you want to stop using your antidepressant, they can help you chart the best path forward. In most cases, the first step is to figure out a schedule for slowly tapering you off of the drug by reducing your dosage over time.

The average amount of taper time is two to four weeks, but it varies based on two important factors.

What you’re taking

The length of your tapering $will depend, in part, on what antidepressant you take (and its dosage), as various medications stay in the bloodstream for different lengths of time.

Fluoxetine, for example, stays in the bloodstream for a longer time than most, requiring a longer taper period.

What you want

You also get a say in how long your taper takes.

“It’s all about patient preference,” Dr. Coulter says. “If a patient is like, ‘Get me off of this now,’ we’ll figure out a rapid taper, even though it might be a bit uncomfortable. For people who really want to minimize side effects, we’ll do a very gradual, slow taper.”

What are the side effects of going off antidepressants?

One of the key reasons to set a taper schedule with your doctor is to avoid the side effects of going off antidepressants cold turkey. One of those is discontinuation syndrome.

“It’s well known when you come off an antidepressant that you can have what’s called discontinuation syndrome, which is a mild but very uncomfortable condition that occurs while your brain is adjusting,” Dr. Coulter says.

Discontinuation syndrome typically lasts one to two weeks and occurs in an estimated 20% of patients. Symptoms include:

• Anxiety.

• Agitation.

• Balance issues.

• Flu-like symptoms, including diarrhea, headache, lethargy, and loss of appetite.

• Insomnia.

• Nausea.

• Sensory changes, including blurred vision and feelings of electricity, known as brain shocks or brains zaps.

Beware a return of your depression

The other key reason to work closely with your doctor in stopping antidepressants is so they can continue to monitor your mental health.

“If a medication is treating illness, going off of it may lead that illness to come back,” Dr. Coulter says, “so your doctor will want to monitor you for a return of symptoms.”

Your doctor will likely want to set a time for a follow-up appointment so they can check in to see how you’re doing post-medication — particularly if you’ve tried unsuccessfully in the post to stop medication or if you have a history of serious depression or suicidality. Together, you’ll probably discuss a backup plan in case your depression returns, including whether you’ll try medication again or seek alternate treatment.

And even if you do successfully go off your medication, bear in mind that your doctor may recommend that you go back on it (or try another one) in the future if your mental health issues return — and they well may.

“Anxiety and depression are chronic illnesses, not necessarily acute illnesses,” Dr. Coulter says, “and when you stop treatment for a chronic illness, you expect that it could come back.”

7 Ways to Reset Your Relationship

Originally posted in The New York Times. Experts say couples can emerge from the pandemic stronger than ever by learning from the past and looking toward the future.

Credit...Bai Sun

By Jancee Dunn

June 16, 2021

As we emerge, blinking, from our pandemic seclusion, all of us have, in ways great and small, changed. So, too, have our relationships.

“During this time, couples may have been spending about as much time with each other as would normally be stretched across a two to three year period,” said Bryce Doehne, a clinical psychologist in Portland, Ore. “And they’ve had to occupy multiple roles that would have been previously filled by others, like friends, which is impossible.”

Now, as many couples plunge back into the hum of life, is a perfect opportunity for a relationship reset — to learn from our time hunkering down together and look toward the future.

Here is a seven-point plan to get started.

Do a relationship review.

First, have a sit-down together to assess what worked about your relationship — and didn’t — during quarantine, said Christiana Ibilola Awosan, a therapist in New York City. In order to make positive changes going forward, start by sharing with your partner what you learned about yourself during the pandemic, she recommended.

Then, Dr. Awosan said, consider using these prompts to continue the conversation: What did the pandemic show us about our relationship? What do we want to keep going forward? What do we want to discard? What has surprised you about me during this pandemic?

“Sometimes we tend to focus on what annoyed us about our partner, but there might be some good things that surprised you, like a strength you didn’t realize they had,” she said.

Voice your appreciation.

Perhaps over the past year, you haven’t felt like giving compliments to your partner — but positive feedback is important, according to a nearly three-decade study of marriage and divorce by Terri Orbuch, a research professor at the University of Michigan and a sociology professor at Oakland University. One of her divorced subjects’ biggest regrets was that they had not given their mate more “affective affirmation,” or encouragement and support in the form of words or thoughtful gestures. That includes compliments like: “You’re a great parent.” Dr. Orbuch has called the neglect of these simple acts “an overlooked relationship-killer.”

You know that fleeting moment when a burst of affection or attraction for your partner flits through your mind? “Don’t just think it,” said Don Cole, a licensed marriage therapist and clinical director of the Gottman Institute in Seattle. “It should not ‘go without saying.’”

“Many of us believe our partners should know that we love them, especially after being together for years,” he said. But research at the Gottman Institute, the renowned laboratory for the study of relationships, found that the most successful couples regularly “opened their mouths and actually spoke their words of love and respect and admiration.”

Those words are even more meaningful, Dr. Cole said, when you are specific. “My wife’s a trained soprano and I told her, ‘Yesterday you were walking around straightening up the house and singing, and I got a thrill down my back when I heard it,’” he said.

Why does specificity matter? Saying “you’re thoughtful” is nice, Dr. Cole said, “but when your partner tells a positive story where you demonstrated your thoughtfulness, that makes you more likely to hold that, to cherish it, to make you feel good about it.”

Build in time apart.

Make sure that each partner builds some alone time into their day, even if it’s a short walk. Liad Uziel, a senior lecturer in the psychology department at Bar-Ilan University in Israel, said that solo time and being with others “both shape our character from different perspectives.”

When we’re alone, Dr. Uziel said, “external pressure is reduced, we are often more in control of events and we can manage our time more freely.” Alone time, he said, is also important for what is called “identity consolidation,” in which one thinks of the past to process events, and the future to set goals.

In our relationships, taking time alone “offers a greater opportunity for each partner to develop their personal identity independently, which they can then bring to their relationship and strengthen it,” Dr. Uziel said.

Take time to connect.

Having less sex these days? It’s not just you. A recent online survey of 1,559 adults about their intimate lives by the Kinsey Institute at Indiana University revealed that over 43 percent of participants reported a decline in the quality of their sex lives since the pandemic began.

A sexual dry spell is no surprise, given that the pandemic’s stress and uncertainty were “libido killers,” said Shannon Chavez, a therapist in Los Angeles. If you need a nudge to get back in the game, she said, think of sexual connection “as a form of self-care, which is anything you do to take care of your overall health and wellbeing.” Prioritizing sex as health, she added, makes it easier to make time for intimacy.

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That includes putting it on the schedule. “Scheduling sex can be better for your sex life than it sounds,” Dr. Chavez said. “People fear it takes the excitement out of it, but if anything, it adds anticipation by planning, and isn’t rushed or put on the back burner.”

Why not aim for sex once a week? Not only is this an achievable goal, but according to one study of over 25,000 adults, it’s actually optimal. Research published in 2016 in the journal Social Psychology and Personality Science found that weekly sex was ideal for maximum wellbeing. If the respondents, who ranged from 18 to 89, had more than that, their self-reported happiness actually leveled off — and that finding held true for both men and women, and was consistent no matter how long they had been together.

Go to a party.

While we’ve seen plenty of our partners during the past year, what’s been missing, said Kendra Knight, an assistant professor of communication studies at DePaul University, is social gatherings in which you view your partner through the eyes of others. She said that seeing your significant other at an event — dressed up, being witty perhaps — can renew your own attraction.

Our estimation of our partner’s attractiveness, sometimes referred to as “mate value,” she said, “is partially a function of others’ appraisals.” That can range, Dr. Knight said, from physical attractiveness to social attractiveness (if, say, they’re the life of the party) to so-called “task attractiveness” — for example, making a batch of their famous margaritas or crushing a backyard horseshoe game.

Of course, if you or your mate is not ready for big events, or never liked neighborhood block parties in the first place, you might just shoot for dinner with close friends or family. Each of us has our own comfort level about heading out into the wider world after so much isolation. “Check in with each other regularly and share how you feel about stepping out,” Dr. Awosan said. “And work on being kind and patient wherever your partner is at.”

Rediscover your playful side.

The past year and half has been heavy. Now that we’re heading into a summer with far fewer restrictions than the last one, it’s OK to think about bringing some levity back. Being more playful in your relationship can revive that sparkle, according to a review from Martin Luther University Halle-Wittenberg in Germany.

The study’s lead author, Kay Brauer, a researcher in the psychology department, found that people who scored high in “other-directed playfulness,” or goofing around with others, “might be particularly important for reviving relationships after the long stretches of monotony during quarantine.”

Playful people, he said, tend to share inside jokes, surprise their partner, give them affectionate nicknames or re-enact joint experiences, like your first date or that disastrous time you tried karaoke. Look for opportunities to create inside jokes or act silly, like having your next date at an amusement park. “If there was ever a time to surprise ourselves and our partner with the new and unexpected, it’s now,” Brauer said.

Make plans.

Making plans together, such as for a vacation, a home renovation project, or even just swinging by a new restaurant, activates our brain’s craving for novel experiences, said Dr. Knight, “which in turn can amplify attraction to and interest in our partner.”

It also reinforces your bond, Dr. Awosan said: “Research has shown that when couples work together as a team, their relationship satisfaction and quality increases.”

In the past year and half, “people have lost jobs, lost loved ones, a sense of self,” Dr. Awosan said. “We’ve all lost something.” Planning something to look forward to, together, symbolizes hopefulness and optimism.

“It’s about the future,” she said. “It says, ‘We are moving forward.’”

Jancee Dunn is the author of “How Not To Hate Your Husband After Kids.”

What You Should Know About Breast Implants If You’re Over 40

Health Hub from Cleveland Clinic

As women enter a new stage of their life, more and more women over age 40 are choosing to have breast augmentations.

Plastic surgeon Risal Djohan, MD, says “We see both young women who have not yet had children and women who have already had their children come in for breast augmentation. But these two age groups often have different reasons for wanting the surgery and different goals.”

What women want from breast augmentation

Dr. Djohan says that the younger women, age 20 to 23, are more likely to have more severe breast hypoplasia. In other words, they usually have very small breasts when they come to see him at this age, and they hope to attain a fuller, more shapely look, while still appearing natural. And he says a small percentage of women come to him with congenital breast conditions.

The older women Dr. Djohan sees typically voice concerns about age-related changes to breast appearance. Aging causes a loss of volume and breast tissue begins to sag. This is typically related to postpartum deflation of breast tissue after pregnancy and nursing but also can be caused from gravity over time, he says.  

“Many women are waiting until later to start their families. Once they’ve had their children, they’re older than women in the past who finished having babies by their early 30s. This may contribute to this trend of older women choosing to have the procedure,” explains Dr. Djohan.

He says that while there’s nothing wrong with getting breast implants before you have children, breastfeeding can become a concern. Most women can breastfeed after having implants, but depending on a number of factors, a minority of women cannot successfully nurse after having the surgery. Women who have finished childbearing don’t have to consider this possibility.

Special concerns for breast implants over 40

“Many women over 40 worry if getting breast implants may interfere with having mammograms,” says Dr. Djohan. “In terms of mammograms and imaging over time, breast augmentation tends to be quite safe,” he says, adding that most of the time plastic surgeons place the implants under the muscle, which puts them in a separate space from the breast gland.

If you’re in the age bracket and considering breast implants, let your mammography technician know you have breast implants before the imaging process starts, Dr. Djohan suggests. The technician will then use special techniques when taking images of your breasts so the implants don’t interfere with the radiologist’s ability to detect any problems.

Sometimes women fear that the squeezing from the mammography device could rupture or displace their implants, causing a need for corrective surgery. But Dr. Djohan says that isn’t likely to happen. 

“Implants should not rupture or become displaced with a mammogram. I know that they’re squeezed in different shapes during the process, but an implant that is intact with sound placement or positioning should not have an issue,” says Dr. Djohan.

However, implants usually have a shelf life. But he says the likelihood for the need of replacement in 10 years is less than 10%. He says if you notice any changes during a self breast exam, you should check with your doctor for an exam.

“As an implant gets older, the outer shell can lose strength and leak,” Dr. Djohan says. “When the integrity of the outer shell deteriorates, the implant is more easily broken.”

For example, if a woman received her implants 25 years ago and now goes in for a mammogram, the possibility of rupture increases. He says implant material certainly has evolved with stronger outer shell material and implant fill with increased cohesivity.

Older women may need breast lift as well

Women older than 40 tend to have more realistic expectations about what breast augmentation can do for them and why they want the surgery in the first place. According to Dr. Djohan, the primary concern with this age group is a loss of volume with a lot of excess skin on the breast due to childbirth or weight loss. The surgeon needs to evaluate whether this excess skin will interfere with the aesthetics of the implant placement only without adjustment of the skin and breast tissue envelope covering it.

“If enough excess skin exists to detract from the look of the augmentation, you may need to have a breast lift at the same time as the breast augmentation procedure,” says Dr. Djohan. However, a breast lift will leave more noticeable scars than a breast augmentation. Women need to understand this before agreeing to the procedure, he says.

Despite any concerns, it’s really no big mystery as to why more women older than 40 are choosing to have breast augmentations. Older women are typically more self-assured about their place in life and are often more financially secure than many younger women, which likely contributes to this growing trend.

“Women past childbearing age have no intention of spending their later years feeling frustrated by their bodies and most report high levels of satisfaction after undergoing breast augmentation surgery,” he says.

Source: http://feedproxy.google.com/~r/ClevelandClinic/HealthHub/~3/QhfpYX0Tjxw/

Five Weight Loss Myths I am Constantly Fighting

The Health Care Blog

By HANS DUVEFELT

1) EXERCISE MORE

I talk to people almost every day who think they can lose weight by exercising. I tell them that is impossible. I explain that it takes almost an hour of brisk walking to burn 100 calories, which equals one apple or a ten second binge on junk food. To lose a pound a week, you need to reduce your calorie intake by about 500 per day – that would be the equivalent of five hours of moderate exercise every day. We’d have to quit our jobs to do that.

2) EAT MORE FRUITS AND VEGETABLES

The other fallacy I hear all the time is that, somehow, adding “healthy” fruits and vegetables can make a person lose weight. I tell them that adding anything to their daily calorie intake will have the opposite effect. I more or less patiently explain that our job is to figure out what to take away instead of what to add. Maybe substituting a fruit for a Whoopie pie is healthy in other ways, but it has almost nothing to do with weight loss.

3) EAT BREAKFAST

A third fallacy is that eating a healthy breakfast will ensure weight loss. To explore this one, I ask: “Are you often hungry?”

So many of my overweight patients deny ever feeling hungry – that gnawing feeling in the pit of your stomach and the low blood sugar onfusion and weakness I feel by 9 or 10 am after doing barn chores on an empty stomach (only coffee).

When I hear “I never feel hungry”, I don’t recommend starting a good breakfast habit because that would likely increase a person’s daily calorie intake. But when I hear that a breakfast skipper goes for the doughnuts mid morning due to hunger, I certainly recommend eating breakfast. When I do, I always point out that the typical American cereal and banana breakfast, along with soft drinks, is actually the major reason for our obesity and diabetes epidemics.

4) EAT 3-4 MEALS A DAY

The fourth myth is that you somehow have to eat a certain number of meals. That depends on how you feel. If you’re in the habit of eating, say breakfast and supper and have no symptoms if you were to skip lunch, then why eat it, unless you’re trying to put on weight? The problem, again, is when a meal-skipper gets the munchies. We need to avoid that trap.

5) DIABETICS NEED CARBS (AND SEVERAL MEALS PER DAY)

Number five is all the overweight diabetics who have been told by dieticians and diabetic educators that they must eat a certain amount of calories or carbs or number of meals just because they are diabetics. That is sometimes the case, because some diabetic medications can cause low blood sugar if you skip meals, but it is by no means a universal truth. If you want to lose weight and feel just fine not eating all the meals and snacks those people tell you to consume, why force yourself to do it? Why not listen to your body (instead of your desires or prior indoctrination)?

It is a sad state of affairs that almost everybody knows complicated things like operating their smartphone but are so lost when it comes to knowing what to eat. (We can thank the food/snack industry for that.)

Hans Duvefelt is a Swedish-born rural Family Physician in Maine. This post originally appeared on his blog, A Country Doctor Writes, here.

Source: https://thehealthcareblog.com/blog/2021/05/13/five-weight-loss-myths-i-am-constantly-fighting/

Audit reveals supplement regulation and oversight is lacking

A Canadian audit of dietary supplements shows serious problems with the quality and safety of the products you may be buying.

Scott Gavura on May 13, 2021
Credit: Science Based Medicine

Health regulations are generally established to protect patients and consumers. When it comes to dietary supplements, they have long favored the supplement industry at the expense of the consumer. When written and enforced appropriately, regulation can give consumers access to safe products that are labelled correctly and give reassurance that what is on the label is actually in the bottle. That is exactly what we have in countries with rigorous regulation of the pharmaceutical drug industry. But the natural products industry has consistently fought oversight in the United States, Canada, and other countries, in order to reduce the regulatory requirements and the burden to ensure their products are safe, effective, and manufactured to a high quality standard. While this undoubtedly is useful to manufacturers, the benefits to consumers have been less clear. Yes, there are a lot of products available to buy. But can you trust them? Most countries have chosen to take a “light touch” with these products, exempting them from most of the requirements placed on over-the-counter or prescription drugs. Now a new audit, from Canada, gives a sort of report card to consumers on the health consequences of a “hands off” regulatory approach.

American vs. Canadian regulations: Two approaches

In the United States, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established the regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA can only intervene to pull products off the market if they are adulterated or misbranded. It notes:

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

DSHEA draws a crude distinction between food and drugs meaning that many product can be considered “supplements” when they are more appropriately categorized as drugs. In addition, manufacturers can put virtually any claim on a supplement, without any requirement to provide evidence it works, as long as it’s accompanied by what’s called the Quack Miranda Warning: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease“. The regulation of marketing claims is effectively left to the Federal Trade Commission (FTC), which can prosecute manufacturers for fraud. There is also a lack of rigorous oversight of manufacturing practices, nor is there industry standardization of ingredients, or even purity guarantees. It is truly a manufacturer’s market.

Canada took a slightly different approach when regulating supplements. Like the American approach, the Natural Health Product Regulations were a compromise – not requiring pharmaceutical-level oversight and regulation, but establishing basic expectations and standards. Canada defines a “natural health product” as one of:

• vitamins, minerals, and probiotics

• herbal remedies

• homeopathic remedies

• traditional medicines e.g., (Chinese and Ayurvedic)

• amino acids and essential fatty acids

In contrast with the United States, natural health products must be licensed by Health Canada in order to be sold. To obtain a license, manufacturers must submit evidence of efficacy. While this sounds reasonable, the evidence standards are laughable. The TV show CBC Marketplace decided to test Health Canada’s standards several years ago. They applied for approval to market a homeopathic remedy they named “Nighton” (an anagram of “nothing”) to be used to treat fever and pain in infants and children. For evidence, they submitted a few pages photocopied from an old homeopathy textbook. No trials were conducted and no safety data was provided. Without any questions, their product was approved and licensed as a “natural health product”, and for a time, was listed in the national database of health products Health Canada declared were “safe, effective, and of high quality.” This isn’t exceptional. You will find hundreds homeopathic remedies on store shelves in Canada that have been approved for sale by Health Canada. Since 2004, 91,000 licenses have been granted for natural health products. Frustratingly, these products are sold alongside over-the-counter drugs, which are regulated to much stricter standards. Only a close inspection of the label can tell an informed consumer if a product was approved under this licensing framework.

The other major component of the Canadian regulations is site certification. Health Canada not only approves products, it approves the sites that manufacture them. Manufacturers must provide information demonstrating that it meets Good Manufacturing Practices (GMP). GMP are manufacturing standards to ensure accuracy, precision, and safety of products. GMP includes processes and people that are fully trained and qualified. Unlike drug manufacturers, Health Canada does not pre-inspect facilities that manufacture natural health products – it relies on attestations and documentation.

On paper, these requirement look to be modestly more rigorous than the American approach. But do they work? The Office of the Auditor General of Canada recently completed an audit of Health Canada’s approach to natural health products to determine if these products are safe and accurately represented to Canadians. The results give some clues to the consequences of light regulation, which may hint at what is occurring in other countries.

Safe? Effective? Health Canada can’t say

The Office of the Auditor General of Canada is independent of Health Canada (and the federal government) and is responsible for providing information and advice to the Canadian Parliament. This audit was intended to determine if natural health products available to Canadians are safe and properly labelled. To do so, they examined the licensing process for both products and manufacturing sites, verifying if Health Canada obtained sufficient information before a product was sold. It also examined if Health Canada took action after a product was licensed to manage any health risks related to these products.

Safety and efficacy assurances lacking

Health Canada requires supplement manufacturers provide a written attestation that they follow good manufacturing practices. They do not inspect facilities before products enter the market. Here is what the auditors found:

• The auditors pulled a sample of 25 site licenses. In 13/25 licenses, Health Canada relied on inspections from other countries. In 10/13, there was no assurance these inspections included natural health product manufacturing processes.

• For the remaining 12 sites, Health Canada failed to verify one or more components that would demonstrate GMP.

• The audit noted that good manufacturing practices cannot be verified until after production has started. However, when products are manufactured and sold is not disclosed to Health Canada, so it could not verify that health products sold were manufactured in sites that met GMP requirements.

Health Canada failed to respond to serious product issues after they entered the market

The auditors found that Health Canada would react to complaints about labeling and advertising, but did little to actively prevent misleading or inaccurate information from being given to consumers by manufacturers. Even when it took action, it was not always successful in addressing the issue.

88% of products were advertised with misleading information

Here I think I’ll just quote from the report:

We found that Health Canada did not sufficiently monitor whether product label information and advertisements met the product-licence conditions. We found that the department monitored product labels and advertisements in response to complaints instead of monitoring the market using a risk-based approach. To gain an understanding of the market, we examined a sample of 75 licensed products for sale on Canadian websites. We found that 88% of these products were advertised with misleading product information. Also, 56% of the products we examined were marketed with misleading label information—label information that included one or more of the following problems:

health claims not authorized by Health Canada because they might not have been proven, such as claims to relieve fatigue, enhance endurance, or burn fatan erroneous statement that the product was recommended for children of ages 3 and older when it was authorized only for adolescents and adultsan incomplete list of risks and authorized ingredientsthe wrong dosage of medicinal ingredientsproduct label information, such as safety warnings, printed very small (that is, in a 4-point font); on paper, font sizes under 8 points are difficult to read without magnification; according to Health Canada, poor readability of the printed label information contributes to incorrect product use

Limited monitoring of products and manufacturers

Regulators in Australia and Europe inspect all supplement/natural health product manufacturers on an established cycle (e.g., once every four years). Health Canada has no program for routine on-site inspections. Because of the sheer number of products approved (91,000 since 2004) it has been unable to monitor licensed products and their manufacturers. Many products have been approved by Health Canada but never sold (like the CBC’s product described above). This may be due in part to the fact that Health Canada does not charge licensing fees for these products, unlike any other health product it regulates. Consumers are bearing the entire cost of this ineffective regulatory framework, and manufacturers pay nothing.

Incredibly, Health Canada doesn’t know where approved products are actually manufactured: Fewer than 5% of licence holders actually disclosed this information to the regulator.

Health Canada started to inspect manufacturers in 2016. The audit found:

• Health Canada inspected 6% of active licensed companies between 2017 and 2019. Sites were chosen because of high-risk products (e.g., sterile products) or because they had a poor compliance history.

• In almost half of the sites it inspected, it took regulatory action because of significant health issues. Seven site licenses were cancelled, and five product licenses were cancelled.

• In some cases, site licenses were eventually renewed, but without verifying companies met other GMP requirements.

• In the case of license renewals, 22 of a sample of 25 were renewed without verifying sites were following GMP requirements.

Additional activities revealed poor patterns of compliance. This statement, buried in the audit report, was remarkable:

Health Canada conducted other activities to gather compliance information, which also exposed quality problems with certain manufacturers. For example, in 2019, the department reviewed 35 companies’ testing results for 2 products that each company had recently released for sale. The department found problems at all sites, including the use of expired raw materials, unacceptable amounts of contaminants, and product tests that did not confirm the product expiry date. For half of the 35 companies, Health Canada took regulatory action, such as issuing a notice of intent to suspend the site licence, because the problems were serious.

Limited monitoring of unlicensed products

Health Canada is expected to monitor regulators like the FDA to identify high-risk products that may be available in Canada. The auditors found no program to actively monitor this. Despite the ease of accessing products online, Health Canada did little monitoring of non-compliant products. Importantly, the auditors found dozens of products advertised to treat or prevent cancer, a claim which is forbidden for these products.

Regulation that favor manufacturers also hurt consumers

One of the most pervasive yet appealing health myths is the idea that “natural” equals “safe”. It’s a statement that has repeated constantly by manufacturers of supplements and “natural” health products. And this argument has been used successfully, in Canada and elsewhere, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. This Canadian audit reveals a sad consequence of weak regulation. Canadians can’t trust that what is on the label is actually in the bottle, and Health Canada isn’t ensuring that these products is safe and effective. Health Canada agrees with the audit findings. Time will tell if things change for the better. Until then, this is buyer-beware marketplace, and consumers are quite literally paying for it.

NEW Study Further Proves MDVIP as Leader in Cardiovascular Disease Prevention

ANDREA KLEMES, DO
MDVIP Chief Medical Officer

The measurable impact of MDVIP’s approach to reducing risk for cardiovascular disease is in the medical literature again. I am thrilled to announce our newest study (our 11th!) that appears online in the Journal of Community Medicine and Public Health. The chief finding of this research is that high-risk patients are less likely (11-12%) to suffer a heart attack or stroke in the MDVIP network as compared to non-members. Our expanding series of peer-reviewed papers published in respected journals have become a benchmark for patient outcomes in personalized, membership-based healthcare. 

STUDY OVERVIEW

Investigators examined the occurrence of acute myocardial infarction (AMI) or stroke/transient ischemic attack (TIA) in at-risk Medicare beneficiaries enrolled in MDVIP versus non-MDVIP beneficiaries in the same geographic area between 2005 and 2014. At-risk patients were defined as 65 and older with at least two of three risk-related chronic conditions: hypertension, hyperlipidemia and diabetes. Linear probability modeling estimated the differential change in vascular events from pre- to post-enrollment among a sample of 15,409 MDVIP patients and found a statistically significant decrease in the rates of AMI (12%) and stroke (11%) relative to the comparison population of 1,012,349 non-MDVIP patients. Considering more than 1.5 million heart attacks and strokes occur every year in the U.S., a 12% reduction equates to 180,000 fewer of these life-threatening incidents.

NUMBERS WORTH SHARING

We hope you feel as gratified as we do about the impressive results you are achieving in the fight against the #1 cause of death in our country. And this news is too great to keep to yourself. Feel free to forward the study link above. Whether you’re talking with current or potentially new members, physician colleagues or local business leaders, here’s the story you can proudly tell that elevates the value of a close doctor-patient partnership:

MDVIP’s Annual Wellness Program testing, clinical curriculum, education, lifestyle tools and overall model structure have been validated in multiple published studies demonstrating their effectiveness in cardiovascular disease prevention. Our first study showed our testing identified 40% more patients at risk of a cardiac event in the next 6 months to 2 years as compared to traditional testing. Another study supported that when MDVIP-affiliated physicians identify members at higher risk, they have the time, tools and technology to work closely with patients to decrease inflammation levels and reduce that risk. An economic model published by a third party looked at MDVIP’ s clinical data and predicted about a 10% decrease in cardiovascular events. And most recently, a review of Medicare claims confirmed that MDVIP patients at high risk for a heart attack or stroke had 12% less cardiovascular events than traditional Medicare patients.

As we continue to prove the medical relevancy and actionability of our program, we take every opportunity to increase awareness of the MDVIP difference. We issued a national press release to engender media interest in this latest article with upcoming interviews in the works, and we’ll be amplifying our outcomes data as we engage with employers, insurers and our friends on Capitol Hill.