Showing posts with label Legal and Regulatory Issues. Show all posts
Showing posts with label Legal and Regulatory Issues. Show all posts

08 May 2024

Is It Time to Treat Sugar Like Cigarettes?

 

In 1964, Surgeon General Luther Terry issued a report on smoking and health saying that tobacco causes lung cancer and is a main contributor to bronchitis, emphysema and other lung ailments. Members of the Federal Trade Commission read the report the day it was released and quickly proposed a mandatory cigarette label that warned, "CAUTION: cigarette smoking is dangerous to your health and may cause death from cancer and other diseases." The legislation ultimately passed by Congress required a warning label with less dire language: "CAUTION: CIGARETTE SMOKING MAY BE HAZARDOUS TO YOUR HEALTH." In 1965, Congress passed the Federal Cigarette Labeling and Advertising Act (FCLAA), which required a health warning on all cigarette packs. In 1970, President Nixon signed the Public Health Cigarette Smoking Act, which banned cigarettes ads on the radio or television. It also required an updated warning on the cigarette packages which read: "Warning: The Surgeon General has determined that cigarette smoking is dangerous to your health." 

In the six decades since the release of the Surgeon General's report on health and smoking the percentage of Americans who smoke has continuously fallen from a rate of 42% in 1965 to an all-time low of 11% in 2021. The results of a February 2023 Centers for Disease Control and Prevention survey found that 57% of U.S. adults now support policies that ban the sale of all tobacco products.

People still smoke of course, and smoking still kills far too many people. Cigarette smoking remains the leading cause of preventable death in the U.S., with tobacco killing more than 480,000 Americans annually and costing more than $240 billion a year in related health care expenses. But the relentless campaign against cigarette smoking ranks as one of the most successful public health campaigns in history.

In comparison, sugar added to sweetened beverages alone kills about 184,000 people every year now. Forty nine percent of the US population is now either diabetic or pre-diabetic and the numbers keep rising. From 2000 through 2020, the US obesity rate increased from 30.5% to 41.9%. During the same time, the prevalence of severe obesity increased from 4.7% to 9.2%. That's right. Nearly 1 American in 10 is severely obese. Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer. These are among the leading causes of preventable, premature death. The estimated annual medical cost of in the United States was nearly $173 billion in 2019 dollars.

The average intake of added sugar in Americans' daily diet is about 19 teaspoons for men and 15 teaspoons for women, vs a recommended intake of 12 teaspoons or less.

There is some data to suggest that since added sugar content was required on nutrition lables in 2016 (after a years long fight with sugar producers) Americans have begun cutting back. Maybe it is time to also require a clear, visible warning lable on food just as we successfully did on cigarettes. We will never get everyone to stop smoking or stop drinking sugary beverages. But if we can reduce consumption as successfully as we have with smoking the benefits in the cost of healthcare, lives saved and the quality of those lives might just be enormous.


27 March 2024

We Should Have Higher Taxes!

 


Don't get me wrong here. I don't like paying taxes any more than anyone else does. Especially when I see how the government spends my money for me. But I am starting to warm to the idea of targeted consumption taxes intended to place the burden of societal costs on those who create those burdens.

Let's consider cigarette smoking as one example. In the United States, cigarettes are taxed at both the federal and state levels, in addition to any state and local sales taxes and local cigarette-specific taxes. There is no doubt that this is burdensome upon and unpopular among smokers. In New York State for example, a pack of cigarettes costs about $10 and roughly half of that cost is taxes. 

But here is the thing. Smoking imposes a very high cost on society, and I am expected to pay that cost through my own taxes, even though I don't smoke. Cigarette smoking cost the United States more than $600 billion in 2018 alone, including:

  • More than $240 billion in healthcare spending
  • Nearly $185 billion in lost productivity from smoking-related illnesses and health conditions
  • Nearly $180 billion in lost productivity from smoking-related premature death
  • $7 billion in lost productivity from premature death from secondhand smoke exposure.

As high as cigarette taxes may seem to smokers, in fact they raise less than $12 billion a year, leaving the other $588 billion for you and I to pay.

A consumption tax like that on cigarettes shifts at least some of the tax burden from society to those who create the costs through their consumption. No one is forced to pay this tax; no one is forced to smoke. Nor are they forbidden from doing so. They are just asked to contribute more to the costs their choice imposes on me.

This brings me around to my point (at last!). While tobacco use indeed imposes a steep cost on society, it pales in comparison to the costs imposed by over-consumption of sugar. A 2013 report estimated those costs as "in excess" of $1 trillion annually. Now, unlike cigarettes, I do consume sugar so taxing it would affect me directly. But I DO have control over how much of it I choose to consume. And in any case, if I think smokers should be financially responsible for the damage caused by their consumption of tobacco then I should also be help to account for the cost of my sugar habit.

Over 100 countries impose taxes on sugar already and have seen reductions in consumption as high as 30%. Such a reduction in the US would have huge and favorable impacts on rates of diabetes, obesity, heart disease and some cancers with concurrent reductions in healthcare spending. No one would be forced to stop consuming sugar and sugary products, only to pay more for the costs they are imposing on others.

When it comes to sugar, we should have higher taxes.

26 March 2024

The Ozempic Craze

 

Ozempic is a brand of the generic drug semaglutide that is currently FDA-approved to treat patients with Type-2 Diabetes by controlling their blood sugar levels. It also curbs appetite, making it an effective weight-loss drug for people with obesity-related illnesses. Unfortunately, this has made it very much in demand for people looking to lose a little weight for cosmetic reasons. 

So what is the problem with that? 

As various celebrities endorse its off-label use for weight loss, demand has soared to the point of creating artificial shortages of the drug for the people who actually need it. The ethical issue of consuming a drug you do not need at the expense of those who do aside, there are other problematic issues with using Ozempic this way.

Like any hot new “miracle drug,” it’s worth considering the risks—whether that’s “Ozempic face,” the term for someone becoming especially gaunt, or the fact that one recent study of semaglutide found that one third of the weight loss came from muscle, bone mass and lean tissue and not fat. As is often the case for drugs that cause weight loss, the effects regulating diet and portion control generally last only as long as people actively take it. In other words, as soon as you stop taking it, you start regaining the weight you lost. At $935 a dose, that is no small consideration.

Anytime you see the word "craze" popping up regularly, its time to take a closer look. You can do that here.

If you want to lose weight, just do it the safe, healthy and sustainable way - the same way you gained it - slow and steady. If I can lose weight and keep it off anyone can. Its not complicated. Its just not always quick and easy. And for some people that seems to be a deal breaker. 


19 February 2024

Yes, It CAN Happen to You

In 2023, American consumers lost $10 billion to fraud, and by far the most common swindles were internet imposter schemes. According to a CNBC report, nearly 854,000 people filed complaints to the FTC about imposter scams in 2023, representing about a third the total consumer fraud reports that the agency received. Consumers lost $2.7 billion to such scams and the average loss was $800. How many such scams went unreported is anyone's guess.

An imposter scam is when someone pretends to be someone you trust to persuade you to send them money, or to give them information that they can use to steal your identity (any your money) later. A scammer may falsely claim to be a romantic interest, the government, the IRS, a relative in distress, a well-known business (Amazon is especially popular with scammers), or a customer or technical support expert. A particularly popular scam is to claim to be the "security department" at a company you do business with claiming that there is suspicious activity on your account and asking for you help to get to the bottom if it.

Surprisingly, Millennials, Gen X, GenY are about 30% more likely to fall for such schemes than are people over 60. But older people are much more likely to get in deeply and lose more money than younger ones. For example, victims age 80 and older had a median loss of $1,450. By comparison, the typical loss didn’t exceed $500 for those younger than 70.

Right about now you are congratulating yourself for being too skeptical, to well informed or just too smart to fall for any such nonsense. And yet hundreds of people just as skeptical, informed and smart as you are do fall for them every day.

Internet scams are carefully designed by scammers and criminals to manipulate your emotions and tap into your unconscious biases, so you are practically hardwired to fall for them, says cybersecurity expert and computer scientist Daniela Oliveira, an associate professor at the University of Florida in Gainesville. In one study a group of people who ranging in age from 18 to 89 were sent a variety of  so-called “spear-phishing emails,” that is, phishing emails that are somewhat tailored to the individual and targeting different approaches such as finances, health, ideological issues, legal issues, security and social issues. If the user took the bait and clicked on the link in the phishing email, they were sent to a fake, innocuous webpage, and the researchers recorded a hit. 

At the end of the study, the participants were asked to read a set of 21 phishing emails and rate how likely they would be to click on each one. People indicated a very low likelihood that they’d fall for them even though 43 percent of them took the bait during the study and clicked on the links at least once and 11.9 percent clicked more than once when they were not told in advance that the email was a scam.

So yes, even you can fall for it. 

Here is the rest of the CNBC report, including suggestions for how you can reduce the odds of getting caught up in an internet scam yourself.


 

28 February 2023

Aging is Society's Problem Too

 

 

For many of us, growing older is a personal issue. An issue for us and our families to sort through and deal with. But the fact is that, globally, aging populations are a demographic time bomb that is mostly being ignored by nations and societies. The world is experiencing a seismic demographic shift—and no country is immune to the consequences

By 2050, there will be 10 billion people on earth, compared to 7.7 billion today—and many of them will be living longer. Much longer. As a result, the number of elderly people per 100 working-age people will nearly triple—from 20 in 1980, to 58 in 2060. That's right. There will be nearly 3 times more elderly people for those young, working age people to support as there are now. Globally, the working-age population will see a 10% decrease by 2060. It will fall the most drastically, by 35% or more, in Greece, Japan, Korea, Latvia, Lithuania, and Poland.

There are many other social and economic changes that we can come to expect as the global population continues to age, including:

  • With more people claiming pension benefits but less people paying income taxes, the shrinking workforce may be forced to pay higher and higher taxes. How long will they be willing to do so?
  • As we have discussed before, longer lives do not necessarily mean healthier lives, with those over 65 more likely to have at least one chronic disease and require expensive, long-term care. Where will that money come from?
  • Changing workforces may lead capital to flow away from rapidly aging countries to younger countries, shifting the global distribution of economic power. Standards of living will rise in a few places, such as India, but decline in many others.
  • The strain on pension systems is perhaps the most evident sign of a drastically aging population. Although the average retirement age is gradually increasing in many countries, people are saving insufficiently for their increased life span—resulting in an estimated $400 trillion deficit by 2050. Who will pay for that?
  • A pension is promised, but not necessarily guaranteed. Any changes made to existing government programs can alter the lives of future retirees entirely—but effective pension reforms that lessen the growing deficit are politically risky and so mostly ignored. How long can it be ignored?

Societies will have to divert a larger and larger share of national income to support a growing population of retirees. Many are already far along this path. Figures released by the United Nations Population Division show that Asia is at the forefront of this trend with Hong Kong, South Korea, and Japan expected to have the highest share at roughly 40 percent of their populations aged 65 and older by 2050. But Western Europe and North America are not far behind.

What does a world with billions of elderly people look like? Here is a preview.




 


18 August 2022

Safer Supplements

 

What do Magnum XXL 9800, Jaguar Power and Kangaroo Intense Alpha all have in common? They are all dietary supplements that supposedly enhance male sexual performance. But they have something else in common too. Despite the fact that they were all sold as supplements on various websites, such as Walmart.com, and retail stores, the FDA has issued public warnings they they illegally contained sildenafil, the active ingredient in viagra. By law, supplements cannot contain drugs, so how could this happen?

Unfortunately it happens often for two main reasons. 

First, supplement products are not strictly regulated like drugs are. The FDA regulates dietary supplements under a completely different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that the firms manufacturers are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations. In other words, it is on the honor system. The FDA has the authority to take action against any adulterated or misbranded dietary supplement product but only after after it reaches the market and has caused harm. 

Second, many supplement products are manufactured in countries like China or India with even less oversight and regulation than in the USA. Since companies buy these foreign-made supplements and then "rebrand" them as their own products it can be difficult or impossible to learn where they originated.

So what can you do to protect yourself?

1. Take a look at your diet before adding supplements. As their name indicates, they are meant to “supplement” a healthy diet. If you are looking to decrease inflammation in the body that may be leading to pain while eating a diet high in fried foods and processed sugar, which both cause inflammation, you should start with your food choices. Often times food and drink changes can give the results that are expected from a supplement. 

2. Look for domestically produced products. Buy from companies that manufacture their own products in the US or buy from companies that do. These will almost never be your cheapest choice.

3. Have realistic expectations. Supplements can be a part of a healthy diet and lifestyle but don't expect miracles from them, despite what their marketing may claim. If it sounds too good to be true, it almost certainly is.

A number of consumer advocacy organizations are pressing Congress to update the law and allow better regulation of supplement products. Until they succeed, you are on your own.

 

29 June 2022

Antibiotic Free? Really?

 

US raised livestock are often treated with antibiotics not only to treat infections but to prevent them. At the same time, antibiotic resistant infections are on the rise, with about 25% of them attributable to meat. Resistant bacteria may not respond to antibiotics, prolonging infections and making them more serious, preventing needed surgeries and causing severe illness and even death.

For this reason, if you eat meat, you are urged to buy only meat and poultry that has been raised without antibiotics. (The drugs may still be used to treat an actual infection, but not used as a preventive measure - there are less risky ways to do that.) The United States Department of Agriculture (USDA) approves meat labels with claims such as "No Antibiotics Ever," "No Added Antibiotics" and "Raised without Antibiotics." But are these claims reliable?

Not very, according to a new study published in Science that found that a substantial portion of cattle destined for the ‘Raised without Antibiotics’ market have been given antibiotics.

The study tested 670 cattle from designated "raised without antibiotics" feed lots for traces of the drugs. They found that about 15% of the animals tested positive for "at least" one antibiotic. How can this be?

Because the USDA runs the label program on the honor system. (Seriously, they do.) To use "no antibiotic" claims on their labels, producers must submit documentation to the USDA. Once. After that, there are no inspections to verify compliance. Not ever. What could possibly go wrong, right?

What can you do? To be certain that the meat you buy is indeed raised without antibiotics first ignore any label claims. Instead, buy meat labeled "USDA Organic". Organic farms and processing facilities are inspected at least annually and are subject to unannounced "surprise" inspections at any time. Organic livestock must, by definition, be antibiotic-free.


07 April 2022

Supplement Labels

 

We have talked a lot about food nutrition labels, what they contain and how to decode all the misleading ways manufacturers try to trick you. Supplement labels, while very similar, have their own little tricks. Here is what to look for.

Before you even get to the details, understand that the FDA regulates dietary supplements under a different set of regulations than those covering foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • 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 but are not required to submit any sort of proof to the FDA.

  • The FDA has the authority to take action against any adulterated or misbranded dietary supplement product but only after it reaches the market and some harm has been caused.

Also, supplement manufacturers are prohibited from claiming that their product will treat or cure any condition or disease. Never-the-less they do not shy away from vague claims about their product's ability to "support", "boost" or "strengthen" things like memory, immunity or even slow ageing. This is perfectly legal but take such claims with a healthy dose of skepticism. Another favorite supplement claim is that is is "natural". This has no meaning and can be ignored.

Another claim you will often see on supplement labels is that the facility where they were produced is an "FDA Registered Facility".  This does mean that the facility has registered with the FDA and may occasionally be subject to an inspection. It does not mean that is is "approved" in any way by the FDA. As with food products, "USDA Organic" means that the product is free from certain ingredients and most pesticides and that only non-GMO ingredients are used.

Finally, there is the Supplement Facts panel. This corresponds to the Nutrition Facts label on food products. The FDA requires that serving size, ingredients and percent of the recommended daily value per serving for each ingredient be listed. But the agency does nothing to confirm that what is listed is what is actually in the package. So look for a certification seal from an independent testing laboratory such as ConsumerLab, UL, USP or NSF International.

It is common practice for companies to manufacture their products outside the USA where even the weak regulation of the FDA does not apply. Your best bet is to purchase only from a company that you have researched and, ideally, that manufactures its products in the US or Europe. Clearly this is not a case where shopping for the lowest price is a good strategy.






23 March 2022

Aloe-free Aloe Vera

 


Aloe vera has a variety of benefits when used on your skin. You may have used it as a soothing sunburn treatment but the plant is rich in antioxidants and has proven antibacterial properties. It’s used in a great many skin care products for its healing, soothing, and hydrating effects. There is a good chance that you have used it yourself.

But Dr. Tod Cooperman, MD, president and founder of Consumer Lab, warns that many "aloe vera" gels actually contain no aloe at all. Instead, they are made with artificial thickening agents that replicate the feel of aloe fairly well but lack any of its soothing, moisturizing and anti-inflammatory qualities. What a surprise, huh?

Consumer Lab recommends carefully reading packaging and labels. Choose products that list aloe as the first ingredient and promise "no artificial thickeners".

It is sad that companies are so ready and willing to mislead and lie to us about what is in their products. But as long as laws and regulations allow it, it is not going to stop. Caveat emptor.


11 March 2022

GMO or No GMO?

 

According to the FDA and the National Academy of Sciences, genetically modified organisms (GMO) are safe to eat and there have been no reported cases of an illness attributed to eating them. Still, many people prefer to avoid GMO foods as much as possible and there are now Federally mandated disclosure requirements. Unfortunately, as is usual with such rules, they are full of loopholes and (intentionally?) confusing.

If a food contains DNA from a modified organism it is required to disclose that. But while this can be disclosed on the package by displaying a "Bioengineered" statement or symbol, it doesn't have to be. The regulations allow companies to disclose this on their web sites if they prefer. Instead of clearly stating that the food is GMO, they can instead provide a web address or phone number for you to use to ask them. So not seeing the "Bioengineered" label does not mean the food is non-GMO.

Then there is "derived from". If one or more of a food's ingredients comes from a GMO plant but the food itself contains no DNA from the plant, the packaging may (it is not required) carry a label saying the food is "derived from" GMO ingredients. Confused? You're supposed to be. "Derived from" typically means that the ingredients are made from a GMO plant that has been so highly processed that none of the plant's DNA remains. These kinds of foods are typically oils, sugars, syrups and such.

And there is a loophole for meat big enough to herd a cow through. Foods that list meat, poultry or eggs as their first (main) ingredient are exempt from the disclosure rules entirely.

There is one bit of good news in all this. If a food is labeled as being "organic" it can not have any GMO ingredients. Other than that, the labeling is mostly misleading and you are on your own. Also, remember that words such as "natural" and "healthy" are meaningless on a food package.


04 February 2022

More than 70% of Imported Olive Oil Isn't

 

Thanks to the genuine and well known health benefits of olive oil, worldwide demand has skyrocketed in recent years. Genuine, 100% pure extra virgin olive oil is expensive, so sadly, but not surprisingly, scammers and actual criminal organizations have seized on this as an opportunity. 

Criminals in Italy and Greece have been raking in fortunes by selling massive amounts of counterfeit olive oils, mostly to North America. 60 Minutes recently cautioned that you face a "sea of fakes" when you shop for olive oil in the grocery store. Food journalist Alicia Upton reported that even in Italy up to 50% of the olive oils in supermarkets are fakes and the percentage is closer to 75% in the US market. The New Yorker Magazine reported that profits from counterfeiting olive oil are "comparable to cocaine trafficking with none of the risks."

The problem is not confined to generic brands. Colavita, Star, Bertolli, Filippo Berio, Pompeian and other name brands failed International Olive Council testing 73% of the time. Thirty-three people were recently arrested in Italy for fraudulently exporting olive oil. Investigators allege that the Calabrian mafia is a major player in agromafia, including an elaborate olive oil scheme. Per The Olive Oil Times, investigators report that the Piromalli clan has been, "labeling low-quality, adulterated oil products as extra virgin olive oil and exporting it to the U.S."

So what can you do to protect yourself from paying top prices for inferior oils? The North American Olive Oil Association's Olive Oil Quality Seal program conducts random testing and certifies oils shown to be genuine. You can find a list of them here. Generally, olive oils produced in California are reliable.

Such is the world in which we live.

 

27 December 2021

Poultry Safety

 

 

Who really knows why chickens cross the road? Who really cares? In any case this post is not about poultry making it safely to the other side of the street.

The CDC estimates 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States. Of course that is from all sources, but nearly 2 million people are sickened annually just from poultry contaminated by bacteria (principally salmonella and campylobacter). 28,000 of them end up in the hospital and nearly 500 die, but it is an experience that nobody wants to have. Reducing the incidence of these bacterial illnesses has been a stated national public health goal in the US for over a decade, yet the same number of people get ill from eating contaminated poultry today as in 2010.

Maybe this is at least partly because the US Department of Agriculture, who is responsible for regulating food safety, allows contaminated chicken to go from slaughterhouse to market legally. The USDA, in fact, allows 9.8 percent of the whole chickens it tests to be contaminated with salmonella. The percentages are even higher for chicken parts (15.4 percent) and ground chicken (25 percent). Campylobacter, too, is allowed in poultry—15.7 percent of samples for whole chickens, 7.7 percent for parts, and 1.9 percent for ground.

As if that is not bad enough, the USDA applies the limit to all bacterial strains in total. "What this means," says Brian Ronholm, director of food policy at Consumer Reports,"is that a manufacturer can meet the USDA's target by reducing strains that rarely make people sick without targeting the strains that tend to cause more severe illnesses."

But wait! No one eats raw poultry, right? Doesn't cooking kill salmonella and other bacteria?

“The short answer is yes, cooking will kill salmonella, but it has to be the right type of cooking,” says Trevor Craig, corporate director of technical consulting for Microbac Laboratories. As a general rule of thumb, cook all poultry to an internal temperature 165℉. The only way to ensure that you have hit the right temperature is using a meat thermometer to check. If you don’t cook your food to a certain temperature you’re not actually going to kill off that bacteria.

It is also very easy to spread the contamination from poultry to other foods by using, say, the same utensils or cutting board to prepare them. Always clean your tools and prep area after working with poultry. Better yet, use different ones.

You can read more about the issue of bacteria contamination here and here.

Enjoy those holiday turkeys!



23 November 2021

The Food Labeling Wars Continue

 

 

One has to wonder why every time food labels are enhanced to include more accurate and complete information about what is in it, the food industry shrieks as though bitten in a tender place by a very angry dog. You might almost think they oppose pretty much any change in labeling regulations because they are hiding something.

The Food Labeling Modernization Act (HR4917) was recently introduced by Congressman Frank Pallone, Jr. of New Jersey and is presently in the House Energy and Commerce Committee. The proposed bill would mandate several changes to required food labels including nutrition summary labels on the front of food packages and warnings of excessive amounts of substances such as added sugar and sodium. If a food package highlights a specific ingredient, say, "whole grains", "fiber" or "real" fruits or vegetables, it would be required to list how much of it the product actually contains. Finally, food manufacturers would be required to list complete nutrition and ingredient information for their products on their web sites.

Food manufacturers are not amused and are fighting hard to spare us the "confusion" that the new labeling requirements would cause.

Meanwhile, Brian Ronholm, Director of Food Policy for Consumer Reports, points out that under present rules "claims about healthy ingredients are sometimes used even if the product has only a very small amount." For example, in a recent Consumer Reports review of 56 breads touting "whole grain" and "multi grain" content nearly all contained little else than refined wheat flour. "The bill would make labels simpler, clearer and more informative," Ronholm says, "and reduce the chance that consumers will perceive food as being more nutritious than it really is." Sounds confusing to me!

This would be an excellent time to let your Representative know that you want his or her support on this bill.


17 November 2021

Is Obesity a Disease?

 

In June 2013, the American Medical Association (AMA) House of Delegates voted to recognize obesity as a disease requiring treatment and prevention efforts. A number of other medical societies had sponsored a resolution to support this idea, including the American Association of Clinical Endocrinologists, the Endocrine Society, the American College of Cardiology, the American College of Surgeons, and the American Heart Association. The National Institutes of Health had declared obesity a disease in 1998.

The AMA's decision remains controversial, since the AMA’s own Council on Science and Public Health in 2012 said that there was not sufficient data to support calling obesity a disease. So then is obesity a clinical condition or a behavioral problem?

Right now, 42% of the population of the USA are obese (a BMI of 30 or higher). Another 30% are overweight. And despite spending $3.7B on weight loss products and programs in 2020 more than 70% of us are overweight and the number keeps growing year after year. Being overweight is a risk factor for over 200 chronic diseases including cancers, hypertension, diabetes, arthritis and heart disease.

In designating obesity as a disease, the AMA recognized that it is not simply a matter of choice and willpower but of a complex set of factors that include genetics, socioeconomic status, education, medications that a person may be taking, sleep quality and more. This does not negate the timeless advice to "eat less and move more". But it suggests that it is a condition serious enough to merit the attention of doctors and other healthcare practitioners. 

The stigma associated with obesity is also an important factor. No one who is obese does not realize it. But, unlike a person hobbled by arthritis or insulin dependence, they are often shamed and told to "just stop eating so much". There is no shame in needing therapy to treat a cancer but many obese people are too ashamed of their condition to seek help.

Another mitigating factor is the lack of insurance coverage for weight loss support programs. Considering the the serious and widespread negative public health impact of obesity this may seem strange. But as long as it is seen as purely a matter of personal choice and willpower, insurance companies are reluctant to provide coverage.

No one is saying that a healthy lifestyle that includes whole, nutrient-dense foods, exercise, stress management and restful sleep is not the foundation of weight loss. But many people are not able to succeed at it. Failing to recognize it as a serious health condition, if not a disease, worthy of support and attention from insurers, doctors, the healthcare community and society at large seems likely to allow the alarming prevalence of obesity to continue to grow.

11 November 2021

The Aduhelm Fiasco

 

In June of last year, to great media fanfare, the FDA approved the new drug Aduhelm (aducanumab) to treat Alzheimer's disease. Six million Americans suffer from Alzheimer's, which is a horrific and ultimately fatal form of dementia, and available drugs typically delay cognitive decline by only a few months at best. So any new medication is eagerly welcome. If it works, that is. And if anyone can afford it.

Two clinical trials of Aduhelm had concluded that the drug was so unlikely to slow the progression of the disease that both trials should be stopped early. They were.

Six months later, Biogen, the manufacturer of the drug, announced that they had analyzed the data more carefully and that the study group receiving the highest dose had actually improved. Based on this new information the FDA convened an external advisory committee to examine the evidence. 

"The totality of the data does not seem to provide sufficient evidence to support the efficacy of the high does," the FDA's internal analysis concluded, noting that even the "favorable" results presented by Biogen produced only a 0.4 point improvement on an 18 point scale. The advisory committee voted 10 to 0 against approving Aduhelm.

Instead, the FDA approved the drug, justifying its decision by citing that it appears to reduce the amyloid plaques often seen in Alzheimer's patients - despite the fact that there is no proof that the plaques cause the disease, rather than just being a symptom of it. Three  committee members resigned in protest. Further, the drug was approved for all Alzheimer's patients, not just the early stage patients on whom it was tested. (Did I mention that the list price of Aduhelm is $56,000 a year?)

Fortunately, new leadership at the FDA is taking a new look. In July, 2021, the FDA changed its recommendation and said that only people with early stage Alzheimer's should use the drug. That same month, the FDA's Acting Director ordered in independent investigation of the agency's approval process, citing an "off the books" meeting between the head of the FDA's neuroscience division and Biogen executives.

So there you have it. An enormously expensive drug that is mostly ineffective and has side effects such as brain bleeds and swelling approved against the advice of the FDA's own annalists and independent advisors. Doesn't sound like anything is amiss here to me. How about you?


09 November 2021

Patently Ridiculous

 

Developing an effective new drug and then bringing it to market is an expensive process. A very expensive process. In an analysis of the drug development costs for 98 companies over a decade, the average cost per drug developed and approved by a single-drug company was $350 million. But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion, due mainly to geographic expansion for marketing and ongoing costs for Phase IV trials and continuous monitoring for safety. Any way you look at it, that is a lot of money.

Drug companies often cite these high costs as justification for the often astronomical prices of drugs on the market. Most people would agree that investing in the development of important new drugs is a social good and should be well rewarded. But according to Andrew Witty, the former CEO of GlaxoSmithKline, one of the largest pharmaceutical companies in the world, the R&D costs cited by drug manufacturers are "one of the great myths of the industry". Why? Because of the patent system.

Patent protection allows a company to sell the product that it developed for over a decade without any competition. Its no secret that brand name drugs are more expensive than essentially identical generic versions of the same drug, and the difference is growing rapidly. In 2013, brand name drugs were about 6 times more expensive than generics; by 2017 - just 4 years later - they are 18 times as expensive. The patent system prevents generic drugs from even being sold so long as the patent is valid (about 10 years in most cases). Ten years of charging 18 times what a competitor would charge for a product people urgently need.

But wait! There's more!

Drug companies are constantly gaming the system by making insignificant changes to a drug as it comes out of patent protection - making it a pill instead of a capsule or changing the dosage or targeting it at a different condition - and then patenting the same drug all over again. And when a drug does come off patent protection, it is not uncommon for a drug company to simply pay generic manufacturers to not produce a generic version of a profitable drug.

There is much more behind the high cost of drugs than just the patent protection system. But do we really want to tolerate a system that lets us pay $200 for a drug that we could buy for $10 in Toronto?

What can you do to protect yourself? Often nothing. But here are a few things you can do.

1. Drugs do not cost the same everywhere. Shop around. If you have a chronic condition be sure to investigate online sources.

2. Do not assume that your health insurance will get you the best price. If can often be cheaper to use a pharmacy discount card or, if you have hefty copays, to just pay for it yourself. (Truth.)

3. ALWAYS ask you doctor if there is a generic or cheaper brand name version of what you need. Doctors tend to prescribe what they are familiar with without regard to the cost.

4. ALWAYS ask your doctor or pharmacist if a combination drug would be cheaper to buy as individual components. In some unusual cases this can reduce the cost as much as 96%.

5. Review your medications at every doctor visit and make sure you still need to be taking them. Doctors will rarely suggest stopping a medication.

Better yet, make the diet and lifestyle changes that will minimize or eliminate the need to tale medication at all.




08 November 2021

Are You Confused?

 

The Department of Health and Human Services (HHS) recently proposed a new rule that drug manufacturers don't like. They don't like it a lot. In fact they are pulling out all the stops to prevent the rule from ever taking effect.

What is this controversial new rule? HHS wants drug companies to be required to reveal the "list price" of all medications they advertise on TV. The rule would apply to any drug costing more than $35 for a monthly dose. 

The $35 limit is laughable, but drug companies aren't laughing. Not when a monthly supply of Humira rheumatoid arthritis pens costs $5,684. Even that seems like a bargain compared to the common multiple sclerosis drug mavenclad, which will set you back over $60,000 a month. And many cancer drugs, while not usually advertised on TV and so not subject to the proposed rule, can cost over $100,000.

Why are the manufacturers so unwilling to share prices in their ads? Really, its all about protecting you! Because if they were to make their prices public, you, the consumer, might be "confused".

Or is it that with price information the consumer might decide to shop around for a better deal? Nah. That would be even more confusing.

Are you confused?


11 October 2021

Buyer BeAware

 

The global nutritional supplements market size was valued at over $310 billion in 2020 and is expected to expand by 6.2% annually from 2021 to 2028. Over 70% of Americans are regular users of dietary supplements. Some of these are useful, many of them are not. And many are not even what you think they are. If you use or plan to use supplements, here are some things you should keep in mind in order to be a savvy consumer.

If you buy or are shopping for supplements, know first that the US FDA does not verify in any way that a supplement actually contains what its label claims it does. Numerous store brand supplements aren't what their labels claim to be. An investigation led by New York Attorney General Eric Schneiderman determined that only 21 percent of the products on the shelves of retailers such as GNC, Target, Walmart and Walgreen actually contained what was advertised on the labels. Tests by Consumer Reports found that supplements are not uncommonly contaminated with lead and bacteria.

The best defense is to look for products that have been tested by a reputable third party - ConsumerLab, NSF International, Underwriters Laboratory (UL) and US Pharmacopeia are all reliable independent testers. Such a seal does not necessarily mean that a product is safe to use or that is does what it claims to do. But you at least have some assurance that what you are buying is what you are getting.

Remember that quality is not free. Shopping by price alone is generally not a good idea. That is not to say that the most expensive products are always the best but the cheapest products almost certainly are not. A little bit of on online research into the company producing a product is also a good idea.

Supplements can indeed be helpful in ensuring that you are getting the complete nutrition that you need. But they rarely "cure" anything and are "buyer beware" products. A good guideline is that if a product claim sounds too good to be true, it probably is.


23 September 2021

Let's Better Regulate the Supplement Industry

 

 

As someone who has been directly involved in both using and selling dietary supplements for over 15 years, I might seem to be an unusual advocate for stricter and more comprehensive government regulation of the industry. But that is exactly the reason that I am.

It is not true that supplements are "unregulated" in the US. The Dietary Supplement Health and Education Act of 1994 (DSHEA) establishes the legal framework under which the FDA has authority to regulate dietary supplements. Under DSHEA manufacturers and distributors of dietary supplements are prohibited from marketing products that are adulterated or misbranded. But there is a catch. These firms are responsible for self-evaluating the safety and labeling of their products before marketing them to ensure that they meet all the requirements of DSHEA and FDA regulations. If they do not, there is no mechanism for the FDA to discover this other than complaints and lawsuits from users of the products. 

Worse, while the FDA is responsible for taking action against any unsafe, adulterated or misbranded dietary supplement product after it reaches the market, manufacturers are not required to prove the safety or efficacy of their products to anyone prior to marketing them. They are required to report any safety issues to the FDA once they "become known".

Finally, the FDAs actual enforcement powers are limited and largely underfunded. The industry is regularly criticized for problems related to poor quality control, safety, misbranding, and adulteration by independent watchdog groups, the very things the Act is supposed to prevent.

Misleading or outright false claims, products that do not contain what their labeling says they do, dangerous ingredients and poor quality are so common they no longer produce surprise or outrage. If and when the FDA does manage to stop a producer from violating minimal safety or truthfulness standards, they simply close down and reopen under a new name.

Here is just one example.

Dr. Joseph Mercola, is an osteopathic physician who claims to want to inspire people to take control of their health. He markets a variety of vitamin and mineral supplements under his own name. Specifically, in the last 2 years, he has been marketing Vitamin C and D, selenium, zinc, melatonin, probiotics and more as preventatives or cures for Covid-19 infection. He has even advised people to purposely contract Covid after taking his supplements to "safely build their immunity" to the virus.

The FDA took no action until it received multiple complaints, after which it required him only to cease marketing his products as a cure for Covid-19. They are still available, and now he is claiming to be the victim of a massive conspiracy by Bill Gates and other millionaires to suppress his work. Sadly this is not an isolated+ example.

All of this creates an environment of suspicion and lack of trust that penalizes those manufacturers who do follow the rules, maintain high quality standards, guarantee their products and avoid making false, unsubstantiated claims. Quality is not cheap, so they may also find themselves at a disadvantage in a marketplace where uninformed people often shop by price alone.

Americans are entitled to know that what they buy is what they are getting, that it is safe to use and that it will do what they are told it will do. Better regulation and better enforcement would benefit not only consumers but reputable companies as well.


24 August 2021

5G - The Improvement Nobody Needs

Let's say your company has a new product. It is heavily invested in its development and so markets it heavily and, because people have become dependent upon earlier versions, it is in a position to force people to use. At the same time that your company is aggressively marketing the product to consumers, it is warning its shareholders to expect lawsuits over alleged negative health impacts and eventual regulatory restrictions. Even people who never use it will be affected by it, and perhaps not in a good way. Do you proceed with the rollout?

You do if you are a wireless company and your new product is 5G service.

The main concerns regarding 5G are a result of its use of much higher frequency radiation to transmit data at much higher speed. This will be the first time that such high-frequency waves would be used on such a large scale. Admittedly, 5G will enable more than just downloading movies to your phone faster. The technology will also lay the foundation for things like self-driving cars and myriad smart devices.

But while this allows for a faster transfer of data, the higher frequency waves can’t travel though buildings or bad weather very well. Therefore wireless providers need to put 5G emitter cell towers everywhere from utility poles to parking garages. The technology requires millions of small cell transmitters that emit non-ionizing radiation. Because of this doctors began raising concerns about health risks, including the possibility of cancer and the impact on brain development. Many groups pressed the Federal Communications Commission to reconsider its decision not to review its 1996 health and safety guidelines for wireless-based technologies, including 5G. The Children’s Health Defense Fund took the challenge to court.

You have no say about where these emitting towers will be placed. One could be right outside your home. These emitters, more than a million of them, will more than triple your exposure to microwave radiation. One of the ironies of all this is that 5G will do exactly nothing to improve the reception of voice calls. It simply allows for much faster data transfer speed. So if you mostly use your phone as a phone, you will be taking on much more risk for no benefit at all.

The Environmental Health Trust offers the following suggestions for reducing your radiation exposure somewhat (but you will not be able to avoid it).

Don't carry your 5G phone in your pocket if possible. When you are not using it, power it off.

When using it for calls, use an earpiece to keep the phone away from your head. Failing that, use the speaker.

Don't sleep with your phone close. Better, turn it off.

If you have a landline at home, keep it and use it. Hold on to your 4G phone as long as possible. (The wireless companies will force you to upgrade eventually, whether you want to or not. And even if you don't the emitter towers will still impact you.)

Engage with your community to try to keep 5G towers away from schools, hospitals and homes. (Wireless companies are pouring millions of dollars into local politics, so eventually you will lose this fight.)

If you want to educate yourself about this issue, a great book to start with is "Disconnect: The Truth About Cell Phone Radiation, What the Industry is Doing to Hide It, and How to Protect Your Family", by Devra Lee Davis.