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Who gets to decide who receives experimental medical treatments?

In the News, News Stories & Editorials, We're In the News

Jessica Hamzelou, MIT Technology Review, August 10, 2023

Max was only a toddler when his parents noticed there was “something different” about the way he moved. He was slower than other kids his age, and he struggled to jump. He couldn’t run.

Blood tests suggested he might have a genetic disease— one that affected a key muscle protein. Max’s dad, Tao Wang, a researcher for a climate philanthropy organization, says he and his wife were initially in denial. It took them a few months to take Max for the genetic test that confirmed their fears: he had Duchenne muscular dystrophy.

Duchenne is a rare disease that tends to affect young boys. It’s progressive—those affected lose muscle function as they get older. There is no cure. Many people with the disorder require wheelchairs well before they reach their 20s. Most do not survive beyond their 30s.

Max’s diagnosis hit Wang and his wife “like a tornado,” he says. But eventually one of his doctors mentioned a clinical trial that he was eligible for. The trial was for an experimental gene therapy designed to replace the missing muscle protein with a shortened, engineered version that might help slow his decline or even reverse it. Enrolling Max in the trial was a no-brainer for Wang. “We were willing to try anything that could change the course [of the disease] and give us some hope,” he says.

That was more than two years ago. Today, Max is an active eight-year-old, says Wang. He runs, jumps, climbs stairs without difficulty, and even enjoys hiking. “He’s a totally different kid,” says Wang.

The gene therapy he received was recently considered for accelerated approval by the US Food and Drug Administration. Such approvals, reserved for therapies targeting serious conditions that lack existing treatments, require less clinical trial data than standard approvals.

While the process can work well, it doesn’t always. And in this case, the data is not particularly compelling. The drug failed a randomized clinical trial—it was found to be no better than a placebo.

Still, many affected by Duchenne are clamoring for access to the treatment. At an FDA advisory committee meeting in May set up to evaluate its merits, multiple parents of children with Duchenne pleaded with the organization to approve the drug immediately—months before the results of another clinical trial were due. On June 22, the FDA granted conditional approval for the drug for four- and five-year-old boys.

Between 2009 and 2022, 48 cancer drugs received accelerated approval to treat 66 conditions—and 15 of those approvals have since been withdrawn.

This drug isn’t the only one to have been approved on weak evidence. There has been a trend toward lowering the bar for new medicines, and it is becoming easier for people to access treatments that might not help them—and could harm them. Anecdotes appear to be overpowering evidence in decisions on drug approval. As a result, we’re ending up with some drugs that don’t work.

[….]

Expanding access

There’s a difficult balance to be reached between protecting people from the unknown effects of a new treatment and enabling access to something potentially life-saving. Trying an experimental drug could cure a person’s disease. It could also end up making no difference, or even doing harm. And if companies struggle to get funding following a bad outcome, it could delay progress in an entire research field—perhaps slowing future drug approvals.

In the US, most experimental treatments are accessed through the FDA. Starting in the 1960s and ’70s, drug manufacturers had to prove to the agency that their products actually worked, and that the benefits of taking them would outweigh any risks. “That really closed the door on patients’ being able to access drugs on a speculative basis,” says Christopher Robertson, a specialist in health law at Boston University.

It makes sense to set a high bar of evidence for new medicines. But the way you weigh risks and benefits can change when you receive a devastating diagnosis. And it wasn’t long before people with terminal illnesses started asking for access to unapproved, experimental drugs.

[….]

Today, there are lots of ways people might access experimental drugs on an individual basis. Perhaps the most obvious way is by taking part in a clinical trial. Early-stage trials typically offer low doses to healthy volunteers to make sure new drugs are safe before they are offered to people with the condition the drugs are ultimately meant to treat. Some trials are “open label,” where everyone knows who is getting what. The gold standard is trials that are randomized, placebo controlled, and blinded: some volunteers get the drug, some get the placebo, and no one—not even the doctors administering the drugs—knows who is getting what until after the results have been collected. These are the kinds of studies you need to do to tell if a drug is really going to help people.

But clinical trials aren’t an option for everyone who might want to try an unproven treatment. Trials tend to have strict criteria about who is eligible depending on their age and health status, for example. Geography and timing matter, too—a person who wants to try a certain drug might live too far from where the trial is being conducted, or might have missed the enrollment window.

Instead, such people can apply to the FDA under the organization’s expanded access program, also known as “compassionate use.” The FDA approves almost all such requests. It then comes down to the drug manufacturer to decide whether to sell the person the drug at cost (it is not allowed to make a profit), offer it for free, or deny the request altogether.

Another option is to make a request under the Right to Try Act. The law, passed in 2018, establishes a new route for people with life-threatening conditions to access experimental drugs—one that bypasses the FDA. Its introduction was viewed by many as a political stunt, given that the FDA has rarely been the barrier to getting hold of such medicines. Under Right to Try, companies still have the choice of whether or not to provide the drug to a patient.

When a patient is denied access through one of these pathways, it can make headlines. “It’s almost always the same story,” says Alison Bateman-House, an ethicist who researches access to investigational medical products at New York University’s Grossman School of Medicine. In this story, someone is fighting for access to a drug and being denied it by “cold and heartless” pharma or the FDA, she says. The story is always about “patients valiantly struggling for something that would undoubtedly help them if they could just get to it.”

But in reality, things aren’t quite so simple. When companies decide not to offer someone a drug, you can’t really blame them for making that decision, says Bateman-House. After all, the people making such requests are usually incredibly ill. If someone were to die after taking that drug, not only would it look bad, but it could also put off investors from funding further development. “If you have a case in the media where somebody gets compassionate use and then something bad happens to them, investors run away,” says Bateman-House. “It’s a business risk.”

FDA approval of a drug means it can be sold and prescribed—crucially, it’s no longer experimental. Which is why many see approval as the best way to get hold of a promising new treatment.

As part of a standard approval process, which should take 10 months or less, the FDA will ask to see clinical trial evidence that the drug is both safe and effective. Collecting this kind of evidence can be a long and expensive process. But there are shortcuts for desperate situations, such as the outbreak of covid-19 or rare and fatal diseases—and for serious diseases with few treatment options, like Duchenne.

Anecdotes vs. evidence 

Max accessed his drug through a clinical trial. The treatment, then called SRP-9001, was developed by the pharmaceutical company Sarepta and is designed to replace dystrophin, the protein missing in children with Duchenne muscular dystrophy. The protein is thought to protect muscle cells from damage when the muscles contract. Without it, muscles become damaged and start to degenerate.

The dystrophin protein has a huge genetic sequence—it’s too long for the entire thing to fit into a virus, the usual means of delivering new genetic material into a person’s body. So the team at Sarepta designed a shorter version, which they call micro-dystrophin. The code for the protein is delivered by means of a single intravenous infusion.

The company planned to develop the therapy to treat patients with Duchenne who could still walk. And it had a way to potentially fast-track the approval process.

Usually, before a drug can be approved, it will go through several clinical trials. But accelerated approval offers a shortcut for companies that can show that their drug is desperately needed, safe, and supported by compelling preliminary evidence.

For this kind of approval, drug companies don’t need to show that a treatment has improved anyone’s health—they just need to show improvement in some biomarker related to the disease (in Sarepta’s case, the levels of the micro-dystrophin protein in people’s muscle).

There’s an important proviso: the company must promise to continue studying the drug, and to provide “confirmatory trial evidence.”

This process can work well. But in recent years, it has been a “disaster,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit that assesses research on health issues. Zuckerman believes the bar of evidence for accelerated approval has been dropping. 

Many drugs approved via this process are later found ineffective. Some have even been shown to leave people worse off. For example, between 2009 and 2022, 48 cancer drugs received accelerated approval to treat 66 conditions—and 15 of those approvals have since been withdrawn.

Melfulfen was one of these. The drug was granted accelerated approval for multiple myeloma in February 2021. Just five months later, the FDA issued an alert following the release of trial results suggesting that people taking the drug had a higher risk of death. In October 2021, the company that made the drug announced it was to be taken off the market.

There are other examples. Take Makena, a treatment meant to reduce the risk of preterm birth. The drug was granted accelerated approval in 2011 on the basis of results from a small trial. Larger, later studies suggested it didn’t work after all. Earlier this year, the FDA withdrew approval for the drug. But it had already been prescribed to hundreds of thousands of people—nearly 310,000 women were given the drug between 2011 and 2020 alone.

And then there’s Aduhelm. The drug was developed as a treatment for Alzheimer’s disease. When trial data was presented to an FDA advisory committee, 10 of 11 panel members voted against approval. The 11th was uncertain. There was no convincing evidence that the drug slowed cognitive decline, the majority of the members found. “There was not any real evidence that this drug was going to help patients,” says Zuckerman.

Despite that, the FDA gave Aduhelm accelerated approval in 2021. The drug went on the market at a price of $56,000 a year. Three of the committee members resigned in response to the FDA’s approval. And in April 2022, the Centers for Medicare & Medicaid Services announced that Medicare would only cover treatment that was administered as part of a clinical trial. The case demonstrates that accelerated approval is no guarantee a drug will become easier to access.

The other important issue is cost. Before a drug is approved, people might be able to get it through expanded access—usually for free. But once the drug is approved, many people who want it will have to pay. And new treatments—especially gene therapies—don’t tend to be cheap. We’re talking hundreds of thousands, or even millions, of dollars. “No patient or families should have to pay for a drug that’s not proven to work,” says Zuckerman.

What about SRP-9001? On May 12, the FDA held an advisory committee meeting to assess whether the data supported accelerated approval. During the nine-hour virtual meeting, scientists, doctors, statisticians, ethicists, and patient advocates presented the data collected so far, and shared their opinions.

Sarepta had results from three clinical trials of the drug in boys with Duchenne. Only one of the three—involving 41 volunteers aged four to seven—was randomized, blinded, and placebo controlled.

Scientists will tell you that’s the only study you can draw conclusions from. And unfortunately, that trial did not go particularly well—by the end of 48 weeks, the children who got the drug were not doing any better than those who got a placebo.

But videos presented by parents whose children had taken the drug told a different story.

[….]

But the difference is not statistically significant for the results the trial was designed to collect. And there are some safety concerns. While most of the boys developed only “mild” side effects, like vomiting, nausea, and fever, a few experienced more serious, although temporary, problems. There were a total of nine serious complications among the 85 volunteers. One boy had heart inflammation. Another developed an immune disease that damages muscle fibers.

On top of all that, as things currently stand, receiving one gene therapy limits future gene therapy options. That’s because the virus used to deliver the therapy causes the body to mount an immune response. Many gene therapies rely on a type called adeno-associated virus, or AAV. If a more effective gene therapy that uses the same virus comes along in the coming years, those who have taken this drug won’t be able to take the newer treatment.

Despite all this, the committee voted 8–6 in favor of granting the drug an accelerated approval. Many committee members highlighted the impact of the stories and videos shared by parents like Brent Furbee.

“Now, I don’t know whether those boys got placebo or whether they got the drug, but I suspect that they got the drug,” a neurologist named Anthony Amato told the audience.

“Those videos, anecdotal as they are … are substantial evidence of effectiveness,” said committee member Donald B. Kohn, a stem-cell biologist.

The drugs don’t work?

Powerful as they are, individual experiences are just that. “If you look at the evidentiary hierarchy, anecdote is considered the lowest level of evidence,” says Bateman-House. “It’s certainly nowhere near clinical-trial-level evidence.”

This is not the way we should be approving drugs, says Zuckerman. And it’s not the first time Sarepta has had a drug approved on the basis of weak evidence, either. 

The company has already received FDA approval to sell three other drugs for Duchenne, all of them designed to skip over faulty exons—bits of DNA that code for a protein. Such drugs should allow cells to make a longer form of a protein that more closely resembles dystrophin.

The first of these “exon-skipping” drugs, Exondys 51, was granted accelerated approval in 2016—despite the fact that the clinical trial was not placebo controlled and included only 12 boys. “I’ve never seen anything like it,” says Zuckerman. She points out that the study was far too small to be able to prove the drug worked. In her view, 2016 was “a turning point” for FDA approvals based on low-quality evidence—“It was so extreme,” she says.

[….]

But for many in the scientific community, that data still needs to be confirmed. “The clinical benefit still has not been confirmed for any of the four,” Mike Singer, a clinical reviewer in the FDA’s Office of Therapeutic Products, told the advisory committee in May.

“All of them are wanted by the families, but none of them have ever been proven to work,” says Zuckerman.  

[….]

Selling hope

On June 22, just over a month after the committee meeting, the FDA approved SRP-9001, now called Elevidys. It will cost $3.2 million for the one-off treatment, before any potential discounts. For the time being, the approval is restricted to four- and five-year-olds. It was granted with a reminder to the company to complete the ongoing trials and report back on the results.

[….]

Doctors may end up agreeing that a drug—even one that is unlikely to work—is better than nothing. “In the American psyche, that is the approach that [doctors and] patients are pushed toward,” says Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania. “We have all this language that you’re ‘fighting against the disease,’ and that you should try everything.”

“I can’t tell you how many FDA advisory committee meetings I’ve been to where the public-comment patients are saying something like ‘This is giving me hope,’” says Zuckerman. “Sometimes hope helps people do better. It certainly helps them feel better. And we all want hope. But in medicine, isn’t it better to have hope based on evidence rather than hope based on hype?”

A desperate decision

A drug approved on weak data might offer nothing more than false hope at a high price, Zuckerman says: “It is not fair for patients and their families to [potentially] have to go into bankruptcy for a drug that isn’t even proven to work.” 

The best way for people to access experimental treatments is still through clinical trials, says Bateman-House. Robertson, the health law expert, agrees, and adds that trials should be “bigger, faster, and more inclusive.” If a drug looks as if it’s working, perhaps companies could allow more volunteers to join the trial, for example.

Their reasoning is that people affected by devastating diseases should be protected from ineffective and possibly harmful treatments—even if they want them. Review boards assess how ethical clinical trials are before signing off on them. Participants can’t be charged for drugs they take in clinical trials. And they are carefully monitored by medical professionals during their participation.

That doesn’t mean people who are desperate for treatments are incapable of making good decisions. “They are stuck with bad choices,” says Fernandez Lynch.

To read the entire article, see here 

 

Biden’s Crackdown on ‘Junk’ Plans: Minimal Impact on Payers

In the News, Policy, We're In the News

Jesus Mesal, Health Payer Specialist, July 14, 2023

The Biden administration’s proposed restrictions on short-term private health plans aim to protect consumers, but they raise questions about the future value potential of a thriving market segment and do little to quell the controversy about insurance criticized by some as “junk.”

Short-term plans offer flexible coverage periods, such as 30 days or three years, and cost 50% to 80% less than individual market coverage. They are not regulated to the same extent as plans offered in the Affordable Care Act insurance marketplaces and can, for example, exclude pre-existing conditions or limit the number of visits or coverage amounts.

The proposal from the Department of Health and Human Services, the Labor Department’s Employee Benefits Security Administration, and the Internal Revenue Service would restrict them to three months, or to four months at a maximum.

These “misleading insurance products” can “trick consumers into buying products that provide little or no coverage when they need it most,” says a joint statement from the agencies.

[….]

The plans, devised as a way for consumers to plug short-term gaps in coverage, have remained a source of political contention since the ACA was enacted in 2010. In 2016, the Obama administration limited their coverage period to three months to address concerns that consumers might choose these plans over comprehensive coverage under the ACA.

Two years later, former President Donald Trump reversed the rule, arguing that consumers should have choice. He extended the allowable duration of short-term plans to a year, with option for consumers to renew them for up to three years. Unlike the ACA’s once-a-year open-enrollment period, these plans are accessible at any time during the year.

Growing market

Since the policy swing, the short-term health insurance market has emerged as a thriving segment experiencing significant growth. The firm Persistence Market Research reports that its value reached $41.1billion in 2022, with the Trump administration rule change playing a substantial role in this expansion.

Mixed opinions

Democratic lawmakers have long advocated for measures to limit the impact of short-term plans. They argue that these lower-cost plans provide minimal coverage and have the potential to lure Americans away from more-comprehensive ACA plans.

The proposed rule could increase ACA marketplace enrollment by an estimated 60,000 individuals in the years2026, 2027, and 2028. Enrollment in ACA plans hit 16.3 million people this year, according to HHS.

“They are called ‘junk’ plans for a reason,” said Diana Zuckerman, president of the National Center for Health Research. Zuckerman questioned why the Biden administration took so long to take this step and does not agree with the argument that having one of these plans is better than having no coverage at all. Short-term plans end up being more expensive for Americans because many people cannot afford the bills they receive when they do not have coverage for emergencies, she said.

“When more people have high-quality health insurance, we are all better protected. These plans do not provide the 10 essential health benefits required by the ACA,” she told Health Payer Specialist. “People claim they have a choice, but what we have observed is that due to misleading marketing, many customers do not fully understand what they are purchasing, and it ends up costing millions of dollars for all Americans.”

[….]

Artificial Sweeteners: Do They Help You Lose Weight or Gain it? Are they Safe?

Diet, Habits, & Other Behaviors

Danielle Pavliv, Laura Gottschalk, PhD, and Amanda Chu

When people want to treat themselves to something sweet without having to treat themselves to a larger pants size too, they often reach for low-calorie, artificial sweeteners. But do artificial sweeteners actually help you lose weight? The answer is not necessarily. As for their safety, the answer becomes more complex.

What are Artificial Sweeteners?

The most popular types of sugar substitutes in the US and many other countries are artificial sweeteners. Artificial sweeteners are typically made in a laboratory and don’t contain calories or supply your body with energy, vitamins, or anything else nutritious. These sweeteners are many times sweeter than sugar, so less is needed to reach the same level of sweetness as something containing sugar. Sweeteners can be used in the home for baking and cooking, and they can also be found in soft drinks, candy, and canned foods that are not necessarily sweet. These artificial sweeteners are considered to be “ultra-processed” and in addition to being used as sweeteners in foods that are marketed as “low-sugar” or “sugar-free” are also used to mask the taste of preservatives or other ingredients in foods that are not sweet.[10]

There are six types of artificial sweeteners currently approved by the FDA.

TTwo “natural” sugar substitutes have also been approved by the FDA. Brand names such as Truvia, PureVia, Enliten (Steviol glycosides), Nectresse, Monk Fruit in the Raw, PureLo (monk fruit extract) are all made from plants. But before being sold in the store, they must first be highly processed in a laboratory. So don’t be fooled into thinking that the word “natural” means that it comes straight from nature to your table.

Do Artificial Sweeteners Help You Lose Weight?

It makes sense that eating and drinking fewer calories by switching to sugar substitutes should lead to weight loss. However, there are several studies that found that people who drink diet drinks weigh more than those who don’t.[1] However, that does not mean that the sugar substitutes cause weight gain, since people who are overweight may choose diet drinks in an effort to lose weight.

Researchers are questioning whether these products may actually make it more difficult to lose weight, perhaps because sweet drinks and foods make people crave more sweets.  For example, research published in 2021 found that drinking beverages sweetened with the artificial sweetener sucralose, led women and people with obesity to eat larger amounts of food at their next meal.[11] That would definitely stand in the way of people trying to lose weight.

The best way to study if artificial sweeteners help people lose weight is known as a randomized controlled trial. People in the trial would be randomly put into groups—one group uses artificial sweeteners while the other group uses sugar. Then, the two groups can be compared to see if using artificial sweeteners had a different impact than sugar. However, randomized clinical trials would be very difficult to conduct on artificial sweeteners because they are in so many different types of food, not just diet drinks.

In 2023, the World Health Organization (WHO) scrutinized scientific reviews of the effect of artificial sweeteners on weight control and concluded that artificial sweeteners do not help people lose weight.[2]

Are Artificial Sweeteners Safe?

A 2020 study published in the journal Cell Metabolism by a group of Yale researchers found that the consumption of the common artificial sweetener sucralose (found in Splenda, Zerocal, Sukrana, SucraPlus) in combination with carbohydrates can turn a healthy person into one with high blood sugar.[3]

You may have heard claims that artificial sweeteners could change hormone levels [4], increase the risk of heart problems [5], and cause higher rates of type II diabetes.[6] An important 2022 French study of more than 100,000 adults followed for a median of 9 years found that consuming artificial sweeteners was associated with a very slight increased likelihood of experiencing newly diagnosed cardiovascular conditions such as heart attacks and stroke. The study identified three artificial sweeteners that seem to cause the greatest increases. People taking aspartame (NutraSweet, Equal) were more likely to have a stroke, while people taking acesulfame potassium (Sunnett, Sweet One) or sucralose (Splenda) were more likely to develop coronary artery disease.[7]

The reasons why artificial sweeteners might harm cardiovascular health are unclear. However, experts suggest that these sweeteners could increase inflammation, metabolic disruptions, and alterations in the gut microbiome and blood vessels. That may increase the chances of developing conditions such as type 2 diabetes, unhealthy cholesterol levels, and high blood pressure.

Artificial sweeteners also increase the chances of being depressed, according to a study published in 2023 on 31,712 women aged 40-62. After statistically controlling for other traits such as age, smoking, and BMI, women who consumed larger quantities of artificial sweeteners and artificially sweetened beverages were more likely to be depressed. While the reasons are not fully understood, the use of these artificial sweeteners can lead to changes in the brain that could contribute to the development of depression.[8]

For many years, there were concerns about whether artificial sweeteners cause cancer. A recent study by the WHO’s International Agency for Research on Cancer (IARC) has found a possible link between aspartame and liver cancer. While the risk of cancer from aspartame is considered low for most consumers, those who consume large quantities could be harmed. In addition, children may reach the daily recommended limit more easily due to their lower body weight. In fact, a 44-pound child would only need to drink approximately four cans of Diet Coke per day to exceed the maximum recommended limit. That is why it is so important to be very careful to consume as little aspartame as possible, especially for children, to reduce the chances of developing cancer.[9]

Should You Use Artificial Sweeteners?

Does the increased risks of obesity, diabetes, and heart disease from consuming large amounts of sugary drinks may outweigh the risks posed by artificial sweeteners?  That is still now clear, but based on the research so far, it makes sense to avoid the largest drink sizes, whether sugary or artificially sweetened. There is growing evidence that consuming even small amounts of artificially sweetened beverages may result in similar health risks to sugary drinks, and they apparently do not help with weight loss. Finding healthier alternatives, such as making your own coffee or tea, or flavoring water with slices of lemon, lime, watermelon, or apple, is a good strategy for your health. And, keep in mind that you should never consume more calories in other food because you “saved” some by drinking a non-caloric drink![7]

All NCHR articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff. 

The National Center for Health Research is a nonprofit, nonpartisan research, education and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.

References

  1. Anderson GH, Foreyt J. Sigman-Grant M, Allison DB, The use of low-calorie sweeteners by adults: impact on weight management. J Nutr. 2012 Jun;142(6):1163S-9S.
  2. The World Health Organization. WHO advises not to use non-sugar sweeteners for weight control in newly released guideline. May 2023. Retrieved from https://www.who.int/news/item/15-05-2023-who-advises-not-to-use-non-sugar-sweeteners-for-weight-control-in-newly-released-guideline
  3. Dalenberg JR, Patel BP, Denis R, Vinke PC, Luquet S, Small DM. Short-Term Consumption of Sucralose with, but Not without, Carbohydrate Impairs Neural and Metabolic Sensitivity to Sugar in Humans. Cell Metabolism. Clinical and Translational Report, Volume 31, Issue 3, P493-502E7. March 03, 2020. https://www.cell.com/cell-metabolism/fulltext/S1550-41312030057-7
  4. Brown RJ, Walter M, Rother KI. Effects of diet soda on gut hormones in youths with diabetes. Diabetes Care. 2012 Mat;35(5):959-64.
  5. Vyas A, Rubenstein L, Robinson J. et al. Diet drink consumption and the risk of cardiovascular events: a report from the Women’s Health Initiative. J Gen Intern Med. 2015 apr;30(4):462-8.
  6. Suez J, Korem T, Zeevi D, et al. Artificial sweeteners induce glucose intolerance by altering the gut microbiota. Nature. 2014 Oct 9;514(75210:181-6.
  7. Corliss, Julie. Sugar substitutes: New cardiovascular concerns? Harvard Medical School. January 1, 2023. https://www.health.harvard.edu/heart-health/sugar-substitutes-new-cardiovascular-concerns
  8. Florko, Nicholas. WHO says aspartame might cause cancer–but that most adult consumers don’t need to worry. STAT. July 13, 2023. https://www.statnews.com/2023/07/13/who-says-aspartame-might-cause-cancer-but-that-most-adult-consumers-dont-need-to-worry
  9. Florko, Nicholas. WHO says aspartame might cause cancer–but that most adult consumers don’t need to worry. STAT. July 13, 2023. https://www.statnews.com/2023/07/13/who-says-aspartame-might-cause-cancer-but-that-most-adult-consumers-dont-need-to-worry
  10. Look for these 9 red flags to identify food that is ultra-processed. (2024, January 2). Washington Post. https://www.washingtonpost.com/wellness/2024/01/02/ultra-processed-foods-identification/
  11. O’Connor, A., Steckelberg, A., & Reiley, L. (n.d.). How fake sugars sneak into foods and disrupt metabolic health. Washington Post. Retrieved January 11, 2024, from https://www.washingtonpost.com/wellness/interactive/2023/sugar-substitutes-health-effects/

Our Public Comment on HHS Draft Framework to Support and Accelerate Smoking Cessation

Policy

We appreciate the opportunity to submit public comments to the Department of Health and Human Services (HHS) regarding their Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation.

This is an incredibly important issue and we understand that this framework, and its goals, will guide HHS cessation efforts moving forward. We are a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest. Below are recommendations for HHS to consider as the smoking cessation framework is developed.

BACKGROUND INFORMATION

Cigarette smoking is the leading cause of preventable death and illness in the United States. More than 480,000 die annually from smoke-related illnesses and approximately $240 billion was spent on healthcare for smokers in 2018.[1] Safe and effective cessation treatments and techniques are needed to improve the health and longevity of individuals living in the United States. A 2015 study from the Centers for Disease Control and Prevention (CDC) found that 68% of people want to quit smoking, but that desire alone is not enough to maintain a change in the behavior. Research has shown it can take 30 or more tries before a smoker quits successfully.[2],[3] The most common method of quitting for people in the United States is to set a quit deadline and attempt to stop cold turkey on that day. Evidence-based interventions that help assist in quitting have been developed, with some being more successful than others.

It is crucial for HHS to invest in cessation strategies that are safe and effective, including behavioral therapies and nicotine replacement therapies (NRT). Behavioral therapies and nicotine replacement therapies (NRTs) are common, with hundreds of studies looking at which of them are most effective. A 2021 meta-analysis of behavioral therapies found that any form of counseling (e.g., in-person, telephone, self-help, etc.), as well as guaranteed financial incentives, were the most successful forms of therapy.[4] The same study analyzed the economic benefits of behavioral therapies and found that different behavioral therapies were equally cost effective. A 2023 meta-analysis of NRTs looked at 68 studies and found a combination of NRT, such as nicotine gum alongside a nicotine patch, was more effective than using any method individually.[5] The same study also found that higher-dose products are more effective than their lower-dose counterparts and that using NRT prior to quitting smoking can be more effective than starting the NRT after quitting. However, higher-dose products may also have greater risks, and smoking cessation products can have serious psychiatric side effects.[6] Therefore, studies of the efficacy of NRTs compared to each other or to behavioral/counseling treatments need to also consider data on unpleasant or serious side effects.

Some claim that e-cigarettes can be used as a cessation therapy.  This claim has been described as “negligent and misinformed.”[7]  Research in this area needs to be carefully reviewed because despite conflicting findings, there is growing evidence that e-cigarettes are not safe and not effective to aid in smoking cessation.[8],[9] Most of the studies that support e-cigarettes for smoking cessation have flaws making the results questionable (e.g., short term follow up or not randomly assigning participants.) Since vaping is often promoted as a tool to quit smoking, it is essential to have better data to determine whether this is supported by evidence.

ACCESS AND COVERAGE

Increasing access and coverage of cessation treatments is a key step in decreasing the number of deaths related to smoking. A 2018 study examined patients who were offered smoking cessation treatments by their primary care doctor. The results showed fewer than 20% of smokers accepted any type of therapy.[10] This same study found that White patients were more likely to be offered a prescription for a cessation medication whereas Black patients were more likely to be offered cessation counseling. We recommend HHS determine effective strategies to help primary care providers increase patients’ knowledge about effective cessation therapies and willingness to try them. These key providers can give information to patients about how they can stop smoking and what resources are best at helping them to do so. Providing patients with several effective options, will allow them to find which strategy, or perhaps strategies, work best for aiding their smoking cessation.

SURVEILLANCE EXPANSION

Expanding surveillance regarding smoking and cessation behaviors is vital to understand the patterns and trends of the behaviors. Regularly evaluating data from point of sales and compliance with advertising requirements will allow HHS to act on the most up-to-date information and enforce decisions by the court. For example, the FDA banned flavored e-cigarettes after data showed that teenagers used preferred them to traditional tobacco flavors, and that they potentially served as a gateway to nicotine addiction.[11] Similarly, it is important to ensure that advertising restrictions banning the promotion and sales of e-cigarettes aimed at children and teenagers are enforced. We also recommend collecting information about trends in popular cessation therapies such as purchasing trends for NRTs. This will enable HHS to encourage safe and effective cessation methods.

PROMOTING RESEARCH

Promoting well-designed research to support and accelerate smoking cessation will help achieve the Cancer Moonshot’s goal to reduce the cancer death rate by 50% over the next 25 years. Better research is needed comparing the effects of different cessation therapies for different demographic groups.  Across races, people who quit smoking, particularly early in their life, have reduced risk of all-cause mortality.[12] However, there is not enough research on the most effective cessation therapies for specific populations. A small study conducted by researchers at the University of Miami found there were greater decreases in perceived stress for African Americans and Hispanics after receiving behavioral therapy for smoking cessation, but the study did not look at the effectiveness of other cessation therapies.[13]

 

[1] Centers for Disease Control and Prevention. (2022, July 28). Costs and expenditures. Centers for Disease Control and Prevention. https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/cost-and-expenditures.html

[2] Babb, S., Malarcher, A., Schauer, G., Asman, K., & Jamal, A. (2017). Quitting Smoking Among Adults – United States, 2000-2015. MMWR. Morbidity and mortality weekly report, 65(52), 1457–1464. https://doi.org/10.15585/mmwr.mm6552a1

[3] Chaiton, M., Diemert, L., Cohen, J. E… & Schwartz, R. (2016). Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ open, 6(6), e011045. https://doi.org/10.1136/bmjopen-2016-011045

[4] Hartmann-Boyce, J., Livingstone-Banks, J., Ordóñez-Mena, J. M… & Aveyard, P. (2021). Behavioural interventions for smoking cessation: an overview and network meta-analysis. The Cochrane database of systematic reviews, 1, CD013229. https://doi.org/10.1002/14651858.CD013229.pub2

[5] Theodoulou, A., Chepkin, S. C., Ye, W… & Lindson, N. (2023). Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. The Cochrane database of systematic reviews, 6(6), CD013308. https://doi.org/10.1002/14651858.CD013308.pub2

[6] Campbell, A. R., & Anderson, K. D. (2010). Mental health stability in veterans with posttraumatic stress disorder receiving varenicline. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 67(21), 1832–1837. https://doi.org/10.2146/ajhp100196

[7] McAlinden, K. D., Eapen, M. S., Lu, W., Sharma, P., & Sohal, S. S. (2020). The rise of electronic nicotine delivery systems and the emergence of electronic-cigarette-driven disease. American journal of physiology. Lung cellular and molecular physiology, 319(4), L585–L595. https://doi.org/10.1152/ajplung.00160.2020

[8] Laucks, P., & Salzman, G. A. (2020). The Dangers of Vaping. Missouri medicine, 117(2), 159–164.

[9] Venkata, A. N., Palagiri, R. D. R., & Vaithilingam, S. (2021). Vaping epidemic in US teens: problem and solutions. Current opinion in pulmonary medicine, 27(2), 88–94. https://doi.org/10.1097/MCP.0000000000000757

[10] Hooks-Anderson, D. R., Salas, J., Secrest, S., Skiöld-Hanlin, S., & Scherrer, J. F. (2018). Association between race and receipt of counselling or medication for smoking cessation in primary care. Family practice, 35(2), 160–165. https://doi.org/10.1093/fampra/cmx099

[11] Leventhal, A. M., Goldenson, N. I., Cho, J., Kirkpatrick, M. G., McConnell, R. S., Stone, M. D., Pang, R. D., Audrain-McGovern, J., & Barrington-Trimis, J. L. (2019). Flavored E-cigarette Use and Progression of Vaping in Adolescents. Pediatrics, 144(5), e20190789. https://doi.org/10.1542/peds.2019-0789

[12] Thomson, B., Emberson, J., Lacey, B… & Islami, F. (2022). Association Between Smoking, Smoking Cessation, and Mortality by Race, Ethnicity, and Sex Among US Adults. JAMA network open, 5(10), e2231480. https://doi.org/10.1001/jamanetworkopen.2022.31480

[13] Webb Hooper, M., & Kolar, S. K. (2015). Distress, race/ethnicity and smoking cessation in treatment-seekers: implications for disparity elimination. Addiction (Abingdon, England), 110(9), 1495–1504. https://doi.org/10.1111/add.12990

Fast Food Calorie Count Cheat Sheet

Diet, Habits, & Other Behaviors
Andrea Sun, Avery Nork, Jenny Niwa

Fast Food Facts (download pdf)

Let’s face it:  With so much to do, it’s hard to eat right. And even though you know that fast food tends to be more fattening and less healthy, fast food chains are convenient and avoiding them may not be the most realistic. However, obesity is linked to a wide range of health problems, including breast cancer, endometrial cancer, colon cancer, and liver cancer, and knowing your healthiest options can go a long way for your overall health.

There is good news. The FDA implemented the new menu labeling rule in 2018 after facing delays and challenges since it was finalized in December 2014.[1]

As a result, chain restaurants with 2 or more locations under the same name have to provide accurate information about calories and other nutritional information. Many changed their ingredients or made portions smaller to reduce calories. Customers can now consume fewer calories without dramatically changing their eating habits.[2] Consumers now are empowered to make more informed choices about their food and it is easier to choose healthier eating habits.

How Many Calories Should I be Consuming a Day?

The United States Department of Agriculture (USDA) has recommended dietary guidelines that include the number of calories you should consume a day, depending on your age, level of activity, and whether you are a man or woman.[3] The chart below will help you find out how many calories you should be getting.[3] If you regularly consume more than the recommended amount, you will probably gain weight.

Recommended Daily Calorie Intake by Gender and Age Based on Activity Level

Activity Level
Gender Age (years) Sedentary Moderately Active Active
Female Child

 2-3

 1,000

 1,000-1,200

 1,000-1,400
Male Child 2-3 1,000 1,000-1,400 1,000-1,400
Females 4-8

9-13

14-18

19-25

26-30

31-50

51+

 1,200-1,400

1,400-1,600

1,800

2,000

1,800

1,800

1,600

 1,400-1,600

1,600-2,000

2,000

2,200

2,000

2,000

1,800

 1,400-1,800

1,800-2,200

2,400

2,400

2,400

2,200

2,200
Males 4-8

9-13

14-18

19-20

21-25

26-30

31-35

36-40

41-45

46-50

51-55

56-60

 1,200-1,400

1,600-2,000

2,000-2,400

2,600

2,400

2,400

2,400

2,400

2,200

2,200

2,200

2,200

 1,400-1,600

1,800-2,200

2,400-2,800

2,800

2,800

2,600

2,600

2,600

2,600

2,400

2,400

2,400

 1,600-2,000

2,000-2,600

2,800-3,200

3,000

3,000

3,000

3,000

2,800

2,800

2,800

2,800

2,600

Source: HHS/USDA Dietary Guidelines for Americans, 2005 [3]

Sedentary means a lifestyle that includes only the light physical activity associated with typical day-to-day life. Moderately active means physical activity equal to walking about 1.5 to 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity typical of day-to-day life. Active means physical activity equal to walking more than 3 miles per day at 3 to 4 miles per hour, in addition to the light physical activity typical of day-to-day life. The calorie ranges are different for different age groups. For children and adolescents, more calories are needed at older ages. For adults, fewer calories are needed at older ages. [3] The National Center for Health Research wants to give you examples of menu choices offered by some of the most popular fast food chains. Take a look — you may be surprised!

Fast Foods by Category:

Pizza per slice: Calories
California Pizza Kitchen Original BBQ Chicken 190
Domino’s Medium Ultimate Deep Dish EXtravaganZZa Feast 350
Domino’s Medium Cheese 190
Domino’s Medium Cheese and Pepperoni 220
Papa John’s Medium Garden Fresh on Original Crust 200
Papa John’s Medium Spinach & Tomato Alfredo on Original Crust 200
Pizza Hut’s Medium Thin n’ Crispy, Pepperoni 200
Pizza Hut’s Medium Original Pan Meat Lover’s Pizza 310
Pizza Hut’s Medium Original Pan Hawaiin Chicken Pizza 240
Cheeseburges and Hamburgers Calories
Burger King Whopper (with cheese) 790
Five Guys (with cheese) 980
McDonald’s Quarter Pounder (with cheese) 520
Wendy’s ¼ Pound Single burger (with Cheese) 610
Hamburgers without cheese are ~100-150 calories less
Chicken: Calories
Burger King 8 Piece Chicken Nuggets 390
Burger King Original Chicken Sandwich 680
McDonalds McNuggets (10 piece) 410
McDonald’s McChicken 400
Wendy’s 10 Piece Chicken Nuggets 491
Wendy’s Spicy Chicken Sandwich 500
Popeyes Chicken Sandwich 700
Kentucky Fried Chicken Original Recipe Chicken Breast 390
French Fries: Calories
Burger King Medium Fries 387
Five Guys, Regular 953
McDonald’s Medium Fries 320
Wendy’s Medium Fries 427
Burritos: Calories
Baja Burrito with Chicken 988
Chipotle Chicken Burrito (with rice, black beans, pico, sour cream, and cheese) 1115
Taco Bell Beefy 5-layer Burrito 490
Taco Bell Grilled Cheese Burrito, Ground Beef 720
Sandwiches: Calories
Panera Smoky Buffalo Chicken Melt – Toasted Baguette 830
Panera Roasted Turkey & Avocado BLT (whole) 860
Quiznos Honey Mustard Chicken Sub, 8” 830
Quiznos Tuna Melt, 8” 660
Subway Turkey, 6 inch (no mayo no cheese) 280
Subway Sweet Onion Chicken Teriyaki, 6 inch (no mayo no cheese) 330
Salads (no dressing): Calories
McDonald’s Bacon Ranch Grilled Chicken Salad 440
Panera Greek Salad 400
Panera Strawberry and Poppyseed Chicken Salad 350
Quiznos Honey Mustard Chicken, Full 550
Subway Oven Roasted Chicken salad with MVP parmesan vinaigrette dressing 200
Wendy’s Apple Pecan Salad 450
Muffins: Calories Sugar
Au Bon Pain Cranberry Walnut 520 29 g
Dunkin Donuts Blueberry 460 44 g
Dunkin Donuts Honey Bran Raisin 440 39 g
Starbuck’s Blueberry 424 36 g
Starbuck’s Skinny Blueberry 264 29 g
Donuts: Calories Sugar
Dunkin Donuts Glazed Donut 260 12 g
Krispy Kreme Original Glazed Donut 190 10 g
Starbuck’s Old-fashioned Glazed Donut 480 30 g
Bagels: Calories
Dunkin Donuts Everything 350
Einstein’s Asiago Cheese Bagel 300
Einstein Everything 280
Starbuck’s Plain 280
Other Breakfast options: Calories
Burger King Sausage, Egg, and Cheese Biscuit 526
Dunkin Donuts Egg and Cheese Bagel 460
McDonald’s Sausage McMuffin with Egg 480
Taco Bell’s Breakfast Crunchwrap with Sausage 730
Starbuck’s Cheese Danish 290
Starbuck’s Banana Walnut & Pecan Loaf 410
Coffee: Calories Sugar
Dunkin Donuts Mocha Swirl Latte (10 oz) 220 32 g
Dunkin Donuts Coolatta with Skim Milk (16 oz) 140 29 g
Dunkin Donuts Latte (10oz) 120 9 g
Dunkin Donuts Coffee (14oz), (no milk or sugar) 10 0 g
Starbuck’s Caramel Frappuccino, Grande Nonfat with Whip 390 66 g
Starbuck’s Caffè Mocha, Grande Nonfat Milk, no Whip 250 34 g
Starbuck’s Caffè Latte, Grande 2% Milk 190 17 g
Starbuck’s Coffee Frappuccino Light 110 23 g
Starbuck’s Caramel Macchiato, Grande 250 33 g

Where to Find This Information?

Don’t fall for the “health halo” effect by assuming that all foods at restaurants marketed as “healthy” or salads and other foods you assume are healthy are actually better for you. Several fast food chains and restaurants have their nutrition information on their websites. If your favorite foods are not listed above, go to the chain’s website and look for the calorie information. You may be shocked…or pleasantly surprised! Remember: knowledge is power. Knowing how many calories are in your favorite snack or meal-on-the-go can help you watch your weight and stay healthy.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

References:

1. Federal Register. Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. National Archives. 2014. Access from https://www.federalregister.gov/documents/2014/12/01/2014-27833/food-labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-and-similar-retail-food

2. Evich, Helena. Obama’s calorie rule kicks in thanks to Trump. Politico. 2018. Access from https://www.politico.com/story/2018/05/07/fdacalories-food-labels-obama-trump-517191

3. U.S. Department of Agriculture. Dietary Guidelines for Americans 2020-2025. Access from https://www.dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf

NCHR Comments on FDA’s Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

Legislation, Policy

 

June 26, 2023

The National Center for Health Research (NCHR) appreciates the opportunity to submit public comments on the notice by the Food and Drug Administration regarding their Survey on Quantitative Claims in Direct-to-Consumer (DTC) Prescription Drug Advertising.

NCHR is a non-profit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We strongly support the efforts of the Office of Prescription Drug Promotion (OPDP) to protect public health by conducting research to evaluate patients’ understanding of quantitative information provided in prescription drug advertising. We work closely with patients and consumers and are well aware that many people do not understand quantitative claims made in drug advertisements.1 The information collected in this survey is essential to ensure the public is able to comprehend drug information in order to make informed medical decisions.

We appreciate the clear example provided in the notice regarding the type of information FDA is seeking to collect (i.e. claims describing medians). Some of the statements included were clear and direct (e.g., “People treated with Drug X lived for a median of 8 months” in combination with the explanation that “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months”). Research to evaluate patients’ understanding of such explanations will provide crucial information about individuals’ level of comprehension regarding quantitative information.  

We strongly recommend that determining patients’ and consumers’ comprehension of information regarding relative risk, absolute risk, relative benefit, and absolute benefit should also be evaluated by the FDA in this survey. For example, how does the public understand a statement that a drug reduces the relative risk of recurrence by 37% or increases the absolute chances of 5-year survival by 3%? Information about relative risk or relative benefit is often used in advertising because those numbers are inevitably larger and seem more impressive than the absolute difference in risk or benefit. According to the FDA’s own research, 65% of physicians believe DTC ads confuse patients about the relative risks and benefits of prescription drugs.2 Unfortunately, patients are not the only ones confused by these statistics.

The FDA notice states that survey questions will be informed by consumer feedback elicited in one-on-one interviews. We support this method of data collection but request that the FDA be more specific about how many interviews OPDP plans to conduct to compile this information, and what type of demographic diversity they will require when selecting people to be interviewed. A relatively small or homogeneous selection of individuals to interview one-on-one could result in unintentional bias in the survey, which in turn would have implications for the results of the estimated 1,100 completed surveys.

We urge you to consider our recommendations, which are intended to enhance the quality of the survey. We would be happy to help recruit patients for your survey or interviews.

 

REFERENCES

1. Sullivan, H. W., O’Donoghue, A. C., Lynch, M., Johnson, M., Davis, C., & Rupert, D. J. (2019). The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements. Medical decision making : an international journal of the Society for Medical Decision Making, 39(8), 975–985. https://doi.org/10.1177/0272989X19875946

2. Food & Drug Administration. (2015). The Impact of Direct-to-Consumer Advertising. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/impact-direct-consumer-advertising 

Plastic Wrap and Plastic Food Containers: Are They Safe?

Other Cancers
Avery Nork, Kiren Chauhan, Brandel France de Bravo, MPH, National Center for Health Research

Is it safe to warm up food in plastic containers or using plastic wrap in the microwave or the oven?  In 2016, President Obama signed a law that strengthened the Toxic Substances Control Act that requires testing of chemicals to make sure they are safe. Prior to that law, more than 60,000 chemicals on the market had gone untested. With that enormous backlog, it may be decades before the EPA has tested the thousands of chemicals that are widely used today. So, let’s look into this issue more carefully.

What harmful chemicals, if any, does plastic have? Two major chemicals to watch out for are phthalates (used to soften plastics) and bisphenol A (BPA), which is used to make very hard, shatterproof plastic (it usually has #7 on the bottom) and is also found in the lining of canned foods and beverages. When phthalates and BPA get into our bodies, they affect estrogen or testosterone. BPA, phthalates, and other chemicals known as endocrine disruptors act like hormones in our body and affect our natural hormone production.  These types of chemicals have been linked to cancer, problems in the reproductive organs, and several other health problems.1 In addition, a 2023 study found that children exposed to phthalates in the womb or during their first year of life were more likely to develop behavioral, attention, and learning disorders. That’s why six phthalates are banned by law from children’s products, and why the FDA is studying BPA to determine if it should be banned from baby bottles and the lining of food and beverage cans.

Plastic wrap has been ‘phthalate free’ since 2006, but in the United States it is made of polyvinyl chloride or PVC and contains a “plasticizer” called di(2-ethylhexyl)adipate or DEHA. DEHA is not a phthalate but is chemically very similar to the phthalate called DEHP.

Studies in the 1990s showed that DEHA can cause liver tumors in mice, and other studies showed that DEHA migrates from plastic wrap into food—particularly high fat foods such as cheese. A 1998 study by Consumers Union tested plastic-wrapped foods and found DEHA levels higher than what is recommended and even permitted by European advisory committees and regulatory agencies.2 A 2014 study found DEHA in various cheeses as well as beef, chicken, and pork that was sold in clinging plastic wrap at grocery stores.3 A 2021 study found that DEHA triggered brain and heart injuries in rats, but research is needed to better understand the risks for humans.4

Similarly, high density polyethylene (HDPE) plastic containers, which are typically used to store household cleaners and pesticides but are sometimes used for food storage, tested positive for PFAS. The results of a 2023 experiment showed that PFAS were capable of transferring into food, and that if there are PFAS in your food storage, it will transfer into your food over time. The researchers tested olive oil, ketchup, and mayonnaise and found that all of them had detectable levels of PFAS after being in contact with an HDPE for a week. While HDPEs are currently not intended for food storage, there is nothing stopping plastic companies from using them that way. This could be potentially harmful to thousands of people by exposing them to high levels of PFAS.

“I don’t eat a lot of canned food and I don’t drink soda. Are there other ways that chemicals found in plastic could be getting into my food?”

Many foods are sold in plastic containers and most of us keep leftovers in food storage containers made out of plastic, such as Tupperware, Rubbermaid, other brands, as well as carryout containers from restaurants. While none of these containers seem to be made with phthalates (since those are usually relatively soft), some may have BPA. As companies have become more aware of the dangers of the plastics they were using, they replaced some chemicals with others. When we checked Rubbermaid’s website in 2023, it states that it currently makes no products with BPA or phthalates (if you want to see if any of your older Rubbermaid products contain BPA, check here). Tupperware says all of its products are BPA free as of 2010, but any older products still might contain levels of BPA. If you want to check if your Tupperware is BPA-free, check the bottom of the container. Any number 1 through 6 means it is BPA-free, but a 7 means there might be BPA in that product. In addition, the company that makes Saran Wrap changed the chemicals in its product, making it less clingy but less dangerous to our planet.5

Regardless of whether a plastic food container contains phthalates or BPA, it may not be entirely safe. Plastics break down over time, which means they can potentially release trace amounts of whatever chemicals they are made of into the food. This is more likely to happen when the plastic has been heated or when it’s old and has been subjected to repeated use or washings. In fact, numerous studies show that most, if not all, humans have microplastics in our bodies, often from the food and drinks we consume every day.6 Perhaps these chemicals are harmless, but there isn’t any research on the cumulative effect of constantly eating food stored or heated in these plastic containers. It would not be surprising to find out that they may not be as safe as many of us assumed.

So what about all that food we buy that says to microwave it in the plastic container it’s sold in?

That type of plastic is said to be “microwave safe,”, but this means it won’t melt in the microwave—it doesn’t mean that it won’t release small amounts of chemicals into your food. Anything not marked “microwave safe,” will soften and lose its shape in the microwave. “Take out” food containers or other disposable plastic food containers (like the ones that refrigerated foods such as soft cream cheese or butter are sold in) are especially unsafe to use in the microwave. In their study, Good Housekeeping researchers microwaved food in a variety of plastic containers labeled microwave safe and found no detectable levels of BPA (or phthalates) in most.7 But if your favorite containers have these chemicals, in addition to all the other ways you can be exposed to endocrine-disrupting chemicals and microplastics, you could end up with unhealthy levels of these chemicals in your body. Two Canadian environmentalists experimented on themselves for four days by exposing themselves to various chemicals found in food and beverage containers and other household objects and wrote a book called Slow Death by Rubber Duckie!

We need more research to know what plastics are safe—under what conditions and for what use. Until we have that information, you can “play it safe” and reduce the amount of chemicals getting into your food from plastic by following these tips:

  • Avoid allowing plastic wrap to come into contact with food, especially when heating or if the food has a high fat content (like meat or cheese). If you want to prevent food from splattering in the microwave, cover it with a microwave-safe dish or a paper towel.

  • Use glass or ceramic containers to microwave food and beverages, and avoid microwaving in plastic or disposable containers.8

  • Although 96% of canned foods from major supermarkets that were tested in 2019 were BPA free, you might want to throw away older canned goods in your home that still might have BPA in the lining.9

  • Look for drinks sold in cartons or glass. Some of the glass bottles may have lids lined with BPA, but even so, the top is not usually in contact with the beverage. If you carry a reusable water bottle, switch to stainless steel or make sure your sports bottle is “BPA-free.” [Do NOT re-use the kind of plastic bottles that bottled water is sold in, because they are not safe for repeated use.] Plastics that contain BPA are usually hard and make a clicking noise if you hit them with your fingernail or a fork or other metal utensil, and may have the number seven on the bottom.

Remember that all plastics break down when exposed to heat—whether in the microwave or dishwasher—and when exposed to strong soaps. Cracks and cloudiness are signs that a clear, reusable plastic container has started to break down and may be releasing BPA or other chemicals into your beverage or food.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

References.

  1. National Institutes of Health. (n.d.). https://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf
  2. Report to the FDA regarding plastic packaging. CR Advocacy. (n.d.). https://advocacy.consumerreports.org/press_release/report-to-the-fda-regarding-plastic-packaging/
  3. Cao, X. L., Zhao, W., Churchill, R., & Hilts, C. (2014). Occurrence of Di-(2-ethylhexyl) adipate and phthalate plasticizers in samples of meat, fish, and cheese and their packaging films. Journal of food protection, 77(4), 610–620. https://doi.org/10.4315/0362-028X.JFP-13-380
  4. Behairy, A., Abd El-Rahman, G. I., Aly, S. S. H., Fahmy, E. M., & Abd-Elhakim, Y. M. (2021). Di(2-ethylhexyl) adipate plasticizer triggers hepatic, brain, and cardiac injury in rats: Mitigating effect of Peganum harmala oil. Ecotoxicology and environmental safety, 208, 111620. https://doi.org/10.1016/j.ecoenv.2020.111620
  5. Emma KumerUpdated: May 18, 2023. (2023, May 18). Is it just us, or is Saran wrap less sticky?. Taste of Home. https://www.tasteofhome.com/article/why-todays-saran-wrap-is-less-sticky/
  6. Pinto-Rodrigues, A. (2023a, April 10). Microplastics are in our bodies. here’s why we don’t know the Health Risks. Science News. https://www.sciencenews.org/article/microplastics-human-bodies-health-risks
  7. Is it safe to heat food in plastic?. Good Housekeeping. (2022, August 16). https://www.goodhousekeeping.com/institute/a17859/plastic-safety-heat-food/
  8. Food Safety and Inspection Service. Cooking with Microwave Ovens | Food Safety and Inspection Service. (n.d.). https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/cooking-microwave-ovens
  9. Canned Foods. Center for Environmental Health. (2020a, January 27). https://ceh.org/products/canned-foods/

US Mammogram Update Sparks Concern, Reignites Debates

Breast Cancer, Uncategorized

Kerry Dooley Young, Medcape, July 19, 2023

A recent update to the US recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.

The US Preventive Services Task Force (USPSTF) is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design (V-BID) at the University of Michigan, Ann Arbor, told Medscape.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screening mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs those with the highest.

[….]

The Ongoing Debates

Concerns over the costs of potential follow-up tests are not the only issues experts have highlighted since USPSTF released its updated draft guidance on screening mammography.

The task force’s proposed update has also reignited questions and uncertainties surrounding when to screen, how often, and what types are best.

When it comes to frequency, the major organizations that provide screening guidance don’t see eye to eye. The USPSTF recommends breast cancer screening every other year, while the American College of Radiology (ACR) recommends screening every year because that approach leads to saves “the most lives.”

At this time, the American College of Obstetricians and Gynecologists (ACOG) guidance currently teeters in the middle, suggesting either annual or biennial screening and highlighting the pros and cons of either approach. According to ACOG, “annual screening intervals appear to result in the least number of breast cancer deaths, particularly in younger women, but at the cost of additional callbacks and biopsies.”

When to begin screening represents another point of contention. While some experts, such as ACOG, agree with the task force’s decision to lower the screening start age to 40, others point to the need for greater nuance on setting the appropriate screening age. The main issue: the task force’s draft sets a uniform age to begin screening, but the risk for breast cancer and breast cancer mortality is not uniform across different racial and ethnic groups.

A recent study published in JAMA Network Open found that, among women aged 40 to 49, breast cancer mortality was highest among Black women (27 deaths per 100,000 person-years) followed by White women (15 deaths per 100,000 person-years). Based on a recommended screening age of 50, the authors suggested that Black women should start screening at age 42, whereas White women could start at 51.

“These findings suggest that health policy makers and clinicians could consider an alternative, race and ethnicity–adapted approach in which Black female patients start screening earlier,” write Tianhui Chen, PhD, of China’s Zhejiang Cancer Hospital and co-authors of the study.

Weighing in on the guidance, the nonprofit National Center for Health Research urged the task force to consider suggesting different screening schedules based on race and ethnicity data. That would mean the recommendation to start at age 40 should only apply to Black women and other groups with higher-than-average risk for breast cancer at a younger age.

“Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors,” the National Center for Health Research wrote in a comment to USPSTF, provided to Medscape by request. “What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation.”

While the ACR agreed with the task force’s recommendation to lower the screening age, the organization suggested starting risk assessments based on racial variations in breast cancer incidence and death even earlier. Specifically, the ACR recommended that high-risk groups, such as Black women, get risk assessments by age 25 to determine whether mammography before age 40 is needed.

  Screening options for women with dense breasts may be some of the most challenging to weigh. Having dense breasts increases an individual’s risk for breast cancer, and mammography alone is not as effective at identifying breast cancer among these women. However, the evidence on the benefits vs harms of additional screening beyond mammography remains mixed.

As a result, the task force decided to maintain its “I” grade on additional screening beyond mammography for these women — a grade that indicates insufficient evidence to determine the benefits and harms for a service.

The task force largely based its decision on the findings of two key reports. One report from the Cancer Intervention and Surveillance Modeling Network, which modeled potential outcomes of different screening strategies, indicated that extra screening might reduce breast cancer mortality in those with dense breasts, but at a cost of more false-positive reports.

The second report, a review from the Kaiser Permanente Evidence-based Practice Center, reaffirmed the benefits of routine mammography for reducing deaths from breast cancer, but found no solid evidence that different strategies — including supplemental screening in women with denser breasts — lowered breast cancer mortality or the risk of progression to advanced cancer. Further studies may show which approaches work best to reduce breast cancer deaths, the report said.

In this instance, ACOG agreed with USPSTF: “Based on the lack of data, ACOG does not recommend routine use of alternative or adjunctive tests to screening mammography in women with dense breasts who are asymptomatic and have no additional risk factors.”

Women with dense breasts should still be encouraged to receive regular screening mammography, even if the results they get may not be as accurate as those for women with less dense breasts, said Diana L. Miglioretti, PhD, of the University of California, Davis, who worked on a report for the USPSTF guidelines.

What’s Next?

Despite ongoing debate and uncertainties surrounding some breast screening guidance, support for ending copay requirements for follow-up tests after a positive mammogram finding is widespread.

[….]

When the USPSTF finalizes its breast screening guidelines, the recommendations will be woven into discussions between primary care physicians and patients about breast cancer screening.

To read the entire article, click here.

NCHR Comments on USPSTF Draft Recommendation on Breast Cancer Screening

Breast Cancer, Legislation, Policy, Uncategorized,

June 6, 2023

We are pleased to have the opportunity to express our views regarding the U.S. Preventive Services Task Force Draft Recommendation Statement regarding breast cancer screening.

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

While we support the task’s draft recommendation that women who are at average risk of breast cancer should undergo a screening every other year rather than annually, we are concerned that the task force’s recommendation of lowering the age of screening mammography from 50 years old to 40 years old is broadly applied to all women, rather than directed at groups most at risk. The guidelines are only supposed to be regarding women of average risk of breast cancer, and information is widely available to indicate some women are at higher risk because of genetic predispositions, smoking, obesity, family history, and other factors.  Dense breasts are also a risk factor, but unfortunately breast density also makes mammography less accurate[1] and tends to be especially high for women under the age of 50[2].

It is especially important to note that the most recent research, which may post-date the writing of these draft recommendations, had findings that suggested that Black females should start screening approximately 8 years earlier than White women, and that Hispanic and Asian and Pacific Islander females could start even later[3]. For that reason, we urge the USPSTF to consider whether the recommendation to start at age 40 should only apply to Black women and to other women who also have higher than average risk of breast cancer at a younger age, whereas starting at age 50 or even later is scientifically supported for other racial/ethnic groups that have been studied.

We agree with the USPSTF that there is not enough evidence to recommend screening mammography for women 75 years old or older.

We also agree that biennial mammogram screening has benefits that outweigh the risks for most women between the ages of 50-74 and for women at high risk between the ages of 40-50, there is currently insufficient evidence that using additional screening tools, such as using an MRI following a screening mammogram, is beneficial even for women with dense breasts, unless a diagnosis is needed when abnormalities are shown during the mammogram.

We understand that the USPSTF may be reluctant to suggest different screening schedules for Black women or for any specific group of women, but we urge the Task Force to focus on the scientific data. In this case, that includes different recommendations based on race and ethnicity data. Women are capable of understanding why the age to start mammography screening may be different for women with different risk factors. What is confusing is when some physician groups recommend annual mammograms for all women starting at age 40, even though the data do not support that recommendation. USPSTF should not compromise its standards to be more similar to those recommendations.

NCHR is grateful for the opportunity to comment on this USPSTF draft recommendation. The National Center for Health Research can be reached at info@center4research.org or (202) 223-4000.

 

REFERENCES

1) Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 2002 Oct;225(1):165-75. doi: 10.1148/radiol.2251011667. PMID: 12355001.

2) Barrette, Lori, Breast Density: What Women Should Know” University of Rochester Medical Center. 15 October 2015. <https://www.urmc.rochester.edu/news/publications/health-matters/breast-density-what-women-should-know>

3) Chen T, Kharazmi E, Fallah M. Race and Ethnicity–Adjusted Age Recommendation for Initiating Breast Cancer Screening. JAMA Netw Open. 2023;6(4):e238893. doi:10.1001/jamanetworkopen.2023.8893

Patient, Consumer, and Public Health Coalition Letter to FDA Commissioner Califf Regarding FDA Advisory Committee Meetings

Legislation, Policy

July 12, 2023

The Honorable Robert Califf, MD
Commissioner
Food and Drug Administration
10903 New Hampshire Ave.
Silver Springs, MD 20993

Dear Commissioner Califf,

As members of the Patient, Consumer, and Public Health Coalition, we appreciate your recent comments reaffirming your commitment to improving the format of Advisory Committees and look forward to working with you throughout these efforts. However, we also want to express our strong concerns when the Food and Drug Administration (FDA) Center Directors publicly undermine or privately overrule the recommendations of their own scientists’ and statisticians’ regarding applications for accelerated approval and full approval.

At our meeting with you on March 1, you expressed your view that some nonprofit leaders and academic researchers were inaccurately and unfairly assuming that FDA Advisory Committee members were more knowledgeable than the FDA scientific reviewers who had spent months reviewing the data and other information provided by sponsors. What we have seen for several years, particularly in recent months, is that the FDA Advisory Committee members often agree with scientific and statistical concerns and conclusions expressed in the FDA scientific memoranda provided to them to review, and it is the Center Directors or other officials that are overriding the views of FDA scientific reviewers.

Below we have summarized a few recent examples where the FDA decision conflicted with FDA scientists and statisticians summaries that were provided to FDA Advisory Committee members and the public.

FDA staff who presented the data at the FDA Advisory Committee meeting on May 12 regarding the accelerated approval application for Sarepta’s gene therapy Elevidys made it very clear that they did not feel remotely confident that the benefits outweighed the risks for boys ages 4-7. For example, they stated that the surrogate endpoint for the drug is not “reasonably likely to predict clinical benefit” in support of accelerated approval. They also stated that although the data appeared to be more promising for boys ages 4-5, the post-hoc analysis could not be trusted. However, in his remarks, Center Director Peter Marks told the Advisory Committee that the FDA should show flexibility by granting approval. We consider this flexibility especially problematic because FDA had previously granted accelerated approval to three other Sarepta drugs, none of which have completed their confirmatory trials. In fact, the confirmatory trial for Exondys 51, which was approved in 2016, were due in November 2020 but instead was not even started until July 2020.[1]

Despite Dr. Marks’ persuasive remarks at the Advisory Committee meeting, members only narrowly voted (8-6) in favor of the gene therapy, and even those who voted in favor expressed numerous concerns about the data. It has been reported that Dr. Marks overruled the recommendations of all FDA staff when he granted accelerated approval to Elevidys, consistent with what was clear for all to see at the Advisory Committee meeting.[2] Sarepta immediately announced that the treatment would cost $3.2 million per patient. Meanwhile, Sarepta is charging up to $1 million per patient per year for Exondys 51 – approximately four times the cost the company estimated in 2016. In fact, Sarepta has so far earned a total of $2.5 billion in sales from Exondys 51 and the two other Duchenne drugs granted accelerated approval.[3]

Unfortunately, the unilateral decision by CBER Director Peter Marks to overrule his own staff is troubling and harmful to the reputation of the FDA, as was the similar decision by CDER Director Janet Woodcock regarding Exondys 51 in 2016. These are just two of numerous examples where FDA Center Directors have gone against the recommendations of its own scientists and advisors to grant approval for a drug when the safety and effectiveness were not consistent with FDA requirements for approval. Two other recent examples include the controversial approval of Aduhelm (initially for all Alzheimer’s patients although it was only tested on patients with mild cognitive impairment) and Relyvrio for the treatment of patients with amyotrophic lateral sclerosis (ALS). These drugs will be marketed for years without confirmation of clinical benefit.

The June 28, 2023 Advisory Committee meeting regarding a drug for Fibrodysplasia ossificans progressive (FOP) is a somewhat different example. As was the case with Elevidys, the written memorandum by FDA staff expressed strong concerns about the scientific evidence: The primary end point was not met; the historical comparison sample was inappropriate; the data were manipulated post hoc in questionable ways; the nominal benefits were unreliable due to the wide confidence intervals; and there were increases in flare-ups – the very symptom that the drug was supposed to reduce. However, unlike the Elevidys meeting, the oral presentations by the FDA scientific and statistical staff were very obviously watered down versions of their written analyses. In fact, the main FDA presenter often seemed to be speaking on behalf of the sponsor, not the FDA. While still expressing concerns about whether the drug was safe and effective, the FDA speakers’ oral presentations contradicted the written FDA documents by stating that they were confident that the treatment probably had benefit and the risks of flare-ups were probably not so serious – an odd statement given that flare-ups were the outcome measure intended to be reduced by the treatment. Those statements were dramatically inconsistent with the written document summarizing the same analyses. This would have been worrisome but more justifiable for an accelerated approval, since the drug was intended to fulfill an unmet need for a terrible disease; however, the FDA meeting was considering full approval. FDA’s oral statements were so persuasive that several members of the Advisory Committee stated that the “FDA reassurances” convinced them that the benefits probably outweighed the risks, thus persuading them to vote in favor of the drug despite their strong reservations.

At an FDA Advisory Committee meeting in September 2022, FDA’s scientific summary of the confirmatory trials of PI3K inhibitor duvelisib (Copiktra) concluded that the risks outweigh the benefits for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).  However, despite decreases in survival, the product retains its accelerated approval and FDA has not announced whether it intends to support those conclusions.

It is our understanding that FDA Advisory Committees are supposed to provide independent experts to review the FDA analyses, and not be unduly influenced by FDA staff or officials’ urging members how they should vote. Moreover, we agreed with your remarks on March 1 that FDA scientists and statisticians are the experts with the greatest knowledge of the data and the issues involved. It undermines the integrity of the FDA, the morale of FDA staff, and the public’s faith in FDA decisions when FDA officials grant an approval that contradicts its own scientists and statisticians. Equally important, overriding the scientific staff harms patients and contributes to a healthcare system that is financially unsustainable.

You have made it clear in numerous public statements that you are concerned about the format of Advisory Committee meetings, and we are as well. We urge you to speak out about the importance of FDA decisions supporting the FDA’s own scientific and statistical analyses. Please consider the following recommendations as you work to improve the format of the Advisory Committees:

  1. Provide training to FDA Advisory Committee members to help them understand the statistical analyses that are an essential part of all Advisory Committee meetings, and ensure they respect the importance of understanding and considering scientific evidence as part of their advisory role;
  2. Require that the FDA scientific and statistical staff who write the FDA memoranda for Advisory Committee meetings have the scientific freedom to express their own views, and that those views are accurately presented in FDA oral presentations at the meeting;
  3. Encourage Center Directors and other FDA officials attending Advisory Committee meetings to refrain from making comments that can be interpreted as encouraging committee members to vote a particular way; when FDA officials attend these meetings, their remarks should make it clear that FDA wants to hear their views and not to influence their votes.
  4. Remind Center Directors and other FDA officials that overruling the views of their own scientific and statistical staff undermines the public trust, and should be avoided, especially when the scientific staff are in consensus.

Sincerely,

American Medical Student Association Wisconsin

Breast Cancer Action

Doctors for America

Government Information Watch

Jacobs Institute of Women’s Health

Medical Device Problems

MISSD

Mothers Against Medical Error

MRSA Survivors Network

National Center for Health Research

National Women’s Health Network

Patient Safety Action Network

TMJ Association

USA Patient Network

Washington Advocates for Patient Safety

Woodymatters

 

 

1. ClinicalTrials.gov. A Study to Compare Safety and Efficacy of a High Dose of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON). Available: https://clinicaltrials.gov/ct2/show/NCT03992430.

2. Becker, Z. (2023). In approving Sarepta’s DMD gene therapy, FDA’s Peter Marks overruled reviewer’s rejection. Fierce Pharma. Retrieved from https://www.fiercepharma.com/pharma/fda-biologics-director-peter-marks-spearheaded-sareptas-dmd-gene-therapy-approval-overruled. Accessed July. 5, 2023.

3. Langreth, R., Rutherford, F., Milton, I., & Campbell, M. (2023). Sarepta’s gene therapy gets FDA accelerated approval: Are fast-tracked drugs safe? Benefits Pro. https://www.benefitspro.com/2023/05/19/sareptas-gene-therapy-gets-accelerated-approval-are-fda-fast-tracked-drugs-safe/?slreturn=20230530114553. Accessed July. 5, 2023.