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Comments on USPSTF Draft Research Plan for BRCA-Related Cancer

Policy

February 14, 2024

We appreciate the opportunity to share our views on the United States Preventive Services Task Force (USPSTF) draft research plan regarding “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing.”

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.

The draft research plan is an excellent overview of the questions and issues that need to be addressed and we support those plans. However, we strongly urge the USPSTF’s research plan to also evaluate how to best communicate with patients who are considering testing or who are receiving their test results. In our interviews with patients, we have found that when information is given about the lifetime risks of breast and ovarian cancer for women with BRCA-1/BRCA-2 genetic mutations, most women become frightened.  However, they are relatively reassured when they are also given information about the risks of breast and ovarian cancer in the short-term, such as within next 5 to 10 years. Since the risk of developing breast and ovarian cancer is much lower in the short-term, women are less frightened and less likely to feel that they must urgently undergo surgery that will have major implications on their quality of life or life plans, such as the ability to bear children. All patients deserve information about the short-term, long-term, and lifetime risk of developing BRCA-associated cancers, but this is especially important for younger women.

In addition, communicating risks to patients should include statistics on absolute risks and risk reduction for different interventions compared to no interventions, as well as relative risks.  For example, if a patient with a BRCA mutation has a risk of developing breast cancer during the next X number of years that is twice as high as women without a BRCA mutation, many BRCA positive women will interpret that information differently than being told that their risk of developing breast cancer is 20% instead of a 10% risk for women without a BRCA mutation. Similarly, if the risk of ovarian cancer during the next Y number of years is reduced by 50%, that may be interpreted differently by a patient than being told that her risk of developing ovarian cancer within the next Y years would be 5% instead of 10%.

Therefore, as part of USPSFT’s research plan for BRCA-related cancers, we urge the USPSTF to evaluate the impact that different ways of communicating risk has on patients’ decisions, satisfaction with their decisions, and their quality of life.

The Evidence Behind Clinical and Self-Breast Exams

Breast Cancer

January 30th, 2024

For many women monthly self-breast exams have long been considered an essential part of their health routine, alongside maintaining a balanced diet and regular exercise. However, conflicting advice from healthcare professionals over the years has left women of all ages feeling uncertain about whether they should continue this practice.

In 2009, the U.S. Preventive Services Task Force recommended that women at average risk for breast cancer should not feel obligated to learn how to perform self-breast exams. This recommendation echoed the guidance provided by the American Cancer Society in 2003. The task force, an independent panel of national experts in disease prevention, reaffirmed this recommendation in their updated 2016 review of breast cancer screening.

These recommendations were based on extensive studies conducted in 2003, which revealed no significant benefits to self-exams. In fact, the studies highlighted potential harm caused by unnecessary biopsies and a false sense of security when small lumps go undetected, leading women to forgo mammograms. This comes from two population-based studies conducted in Russia and China, involving nearly 400,000 women found no evidence that self-exams reduce breast cancer deaths. In fact, the findings, suggested that self-examinations had no significant impact on survival rates and may even lead to unnecessary biopsies. The group that performed self-exams underwent 3,406 biopsies, compared to 1,856 in the group that did not perform exams. And, there was no significant differences in breast cancer deaths were observed between the two groups.

Breast self-exams have more benefits for women at higher risk for breast cancer, such as those with a strong family history of the disease, previous benign biopsy results, or genetic mutations such as BRCA 1 and BRCA 2.  Those women are encouraged to visually examine their breasts monthly and undergo annual breast imaging studies starting at age 30 or even earlier. Additionally, women at higher risk may choose to have clinical breast exams between their yearly mammograms, ultrasounds, or MRI screenings, depending on their individual cancer risk. Factors that put women at higher risk include hormone replacement therapy, being overweight or obese, leading a sedentary lifestyle, and consuming more than the recommended amount of alcohol.

Still it is important to note that even having a clinical breast exam should be part of a shared, informed decision with your doctor. While the American College of Obstetricians and National Comprehensive Cancer Care Network recommend that women at high risk for breast cancer receive a clinical breast exam yearly and women who are low risk receive a clinical breast exam every three years the American Cancer Society does not recommend patients receive clinical breast exams as they may lead to false reassurance or unnecessary testing.

For women who still prefer to conduct self-exams, it is recommended to learn the proper technique from a healthcare professional. Most physicians, keep synthetic breast models on hand to provide hands-on lessons to patients who request assistance. Regardless of your decision regarding self-exams, it is crucial to regularly visit your healthcare provider to discuss all cancer and health screenings.

Breast cancer prevention, screening, and management are becoming more individualized and it is important that informed decisions are being made through a shared decision model with your doctor. Thus, it is crucial to be aware how these lifestyle choices affect your risk of breast cancer and to talk to your doctor about the need and frequency of breast cancer screening. Physicians also recommend seeking guidance from a nutritionist, participating in exercise classes, and in some cases, consulting with a genetic counselor to determine breast cancer risk.

Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records

Uncategorized

Fred Schulte & Holly K. Hacker, KFF HEALTH NEWS, ON CBSNEWS.COM, December 20, 2023

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life-threatening or may result in death.”

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

  • Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.
  • Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
  • Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.
  • And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

“Too little, too late”

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

“Exciting features”

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

Legal barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

To read the original article with photos, click here.

Eating Habits That Improve Health and Reduce Cancer Risks While Helping with Weight Loss

Diet, Habits, & Other Behaviors

The latest research shows that measuring your waistline and keeping your BMI (body mass index) at a reasonable number will help keep you alive and healthy, while reducing your chances of developing cancer or cancer returning after treatment.[1] Research also shows that certain foods improve your health even if they don’t help you lose weight. This article will focus on eating habits that help you lose weight, but will also include information about the kinds of foods that are good for your health even if they don’t affect your weight.

Let’s start with the obvious: Sticking to a healthy diet in order to lose weight is hard for almost everyone. Keeping track of calories and fat can be confusing, and the nutrition labels on the foods we buy aren’t always that helpful. How are consumers supposed to figure out which diet advice is just hype – that ultimately doesn’t contribute to better health – and which advice offers good, medically sound information?

Here are some basic guidelines to keep in mind:

  • Calories matter
  • Serving size matters
  • Fats and cholesterol matter
  • Fruits, vegetables and whole grains matter
  • Exercise matters
  • Sticking to it matters

The Key to Losing Weight is to Eat Fewer Calories than You Burn in a Day- But There is More to it than That

Simply increasing your activity level might be enough if you only need to lose a few pounds to get your BMI into a healthy range. Most of the time, however, eating fewer calories is also going to be needed. Scientists have found that, in order to lose weight, a person must burn more calories than they consume.[2] Unfortunately, calories add up quickly!  For example, have you eaten at a fast food chain recently?  To work off the calories from a double cheeseburger, extra large fries and a 24 ounce soft drink – about 1500 calories – you would have to run for two and half hours at a ten minute mile pace! (For more information, see Fast Food Facts: Calories and Fats).  And some chain restaurants offer meals that have much more calories for lunch or dinner than an average person should eat in an entire day!

What happens if you exercise without lowering the calories you’re eating? A 2009 study found mixed results: some lost a significant amount of weight while others gained weight.[3] Although some weight loss strategies are effective for some people but not others, eating fewer calories and increasing exercise is most likely to help most people shed pounds.

Eating Fewer Calories Doesn’t Necessarily Mean Eating Less

The trick to dieting without being hungry is to choose foods that contain fewer calories and also fill you up. An example would be having a piece of fruit instead of fries with lunch.  It helps to remember that not all foods are created equal!  Some foods, such as nuts, are high in nutrients and essential vitamins, while others lack nutritional substance, such as products containing added sugars. “Nutrient-dense food” provides substantial amounts of vitamins and minerals and relatively few calories, but leaves you feeling fuller while also supplying valuable fuel for your body.  A person is more likely to stick to a diet if calories are nutrition-dense and offer variety.[4]

Empty calories from foods with processed and refined sugars, such as candy, pasta and bread made from white flour, and many energy drinks and soft drinks, leave you hungry again soon after, craving more food.  In contrast, the “complex carbohydrates” in vegetables, whole-grain breads and cereals, and low-fat yogurt and milk, provide long-lasting nutrients, improve digestion, help stabilize blood sugar, and keep your energy at an even level.  Although fruits are also considered simple carbohydrates, they contain vitamins and nutrients that occur naturally, unlike those found in processed and refined foods.

A 2011 study in the respected New England Journal of Medicine found that certain foods were linked to weight change more than others.[5] After following participants for an average of 17 years, researchers found that gaining weight was most strongly linked to foods such as potato chips, sugar-sweetened beverages, and red meat.  People who ate more vegetables, whole grains, nuts, fruits, and yogurts were less likely to gain weight over the years, even though some of those foods are quite high in calories.

What about low-carb diets versus low-fat diets? A 2014 study compared the effects of both diets on body weight and cardiovascular health. They found that the low-carb diet was much more effective than the low-fat diet for losing weight and reducing cardiovascular risks.[6] So hold back on the white bread, but don’t feel bad about eating some olive oil.  But if you want to maintain that weight loss, remember that variety in your diet as well as exercise are also important.

Don’t Assume that Foods Marketed as “Healthy” Really Are or Will Help You Lose Weight

Don’t fall for the “health halo” effect: assuming that all foods at restaurants marketed as “healthy” or all foods of a category labeled “healthy” (e.g., salads) are actually better for you.  Research shows that customers at fast food restaurants underestimate the calories in their meals [7] and most consumers underestimate the calorie content of foods that are labeled “low-fat.”[8] For example, if you look at a bag of potato chips, you will probably see that the “low fat” ones almost have the same number of calories as the regular chips made by the same company.

The choices that will keep your calories down are not always obvious.  For example, a 2013 study found that adolescents ordered about the same number of calories at Subway as they did at McDonald’s.[9] Try to check the nutritional contents of your meal options and make an informed decision. If nutritional information is not posted in the restaurant, it is probably available on the restaurant’s website.

Eating 5 Small Meals Is Not Better than Eating 3 Larger Ones

For several years, some experts have claimed that eating 5 or 6 times a day can be a better way to lose weight than eating only 3 times a day.  However, the latest research indicates that is not true.[10]

Studies have found that eating off of smaller plates or bowls helps people eat less, because most of us tend to fill our plate and then finish what is on it.[11],[12] Unfortunately, portion sizes for restaurant meals, baked goods, other prepared foods, and even homemade meals – everything from breakfast muffins to a plate of spaghetti – have grown to very unhealthy proportions in the last few decades. This is contributing to the obesity epidemic.

In addition to adjusting your portion size, limiting the hours when you eat can also help you maintain a healthy weight. In a study published in British Journal of Nutrition in 2013, researchers followed a group of healthy men for four weeks. They ate their normal diets during all four weeks, but for 2 of those weeks, they fasted for 11 hours at night (from 7 pm to 6 am). The study found that under the time-restricted conditions, the men consumed approximately 200 fewer calories per day and lost weight during the two weeks of nightly fasting compared to the two weeks when they did not fast at night. The researchers believe that it was the combination of few calories and night-time fasting that resulted in the weight loss.[13]

What About Fats?

Recent research has shown that eating foods high in cholesterol don’t necessarily contribute to a person’s cholesterol levels.  The past focus on fats is also being questioned, especially in light of an investigation indicating that the original reports that blamed fats were written by researchers paid by the sugar industry.[14]

Fats are high in calories, but some fats are more dangerous for you than others.  The least healthy ones include saturated fats and of trans fats. These tend to be the kinds of fat that are solid at room temperature – like the fat in meat products, butter, margarine, shortening and lard – and the fats that come from baked goods and fried foods.  The fats that are good (in moderation) are “unsaturated” or “polyunsaturated” fats. These tend to be liquid at room temperature, like canola oil, olive oil and some of the other vegetable oils. There are exceptions, however, such as coconut oil, which is high in saturated fats. Diets such as the Mediterranean diet, which includes more unsaturated fats and plant-based foods, can lower the chances of cardiovascular diseases. So, for people who find it difficult to stick with a low-fat diet, such as a vegan or vegetarian diet, there are other healthy alternatives.[15] Check the nutrition label before you buy, to be sure that you’re choosing the product with the lowest possible saturated fat content.

Eat More Fruits, Vegetables, Whole Grains, and Low- or No-Fat Dairy Products Every Day

There are many good resources to help you learn about healthy eating, such as the US Department of Agriculture website at My Plate. Nutritionists at the Harvard School of Public Health have similar (but not identical) healthy food guidelines. What these diets have in common includes recommendations to:

  • Aim for at least five servings of fruits and vegetables a day. Usually, the more colorful the fruit or vegetable, the more nutritious. For example, dark green spinach has more nutrients than light green iceberg lettuce. In 2023, an analysis of studies of 2372 adults with mean ages 20 to 67 reported that a vegan or vegetarian diet can help people reduce their risk of developing cardiovascular diseases.[15] However, research has also shown that any diet that replaces at least some fats, carbohydrates, and foods high in added sugar with fresh fruits and vegetables is likely to improve your health.[16]
  • Try and choose whole grain cereal, pasta, rice, and bread. Many foods that claim “whole wheat” or “whole grain” on the front of the package actually contain very little, but breads that are truly high in whole grains now give the exact amount in a very obvious place on the label.  Be sure to see if the amount listed is for one slice or two – in many cases, a “portion” is listed as 2 slices for the amount of grains but only one slice when listing calories per portion!  And don’t be fooled by bread color: dark brown breads are often colored with coffee or other dyes, not whole grains.
  • Avoid food that is high in sugar, such as pastries, sweetened cereal, and soda or fruit-flavored drinks.
  • Reduced-fat or no-fat (skim) milk, reduced-fat cheese, and low-fat or no-fat yogurt are good sources of the protein and calcium we need. Try to eat 2-4 servings of low-fat or no-fat dairy products each day.
  • Fruits and vegetables often cost less than unhealthy foods.[17],[18] By buying healthy food options, you’re doing both your body and your wallet a favor!

Exercise Does Burn More than Calories

Increasing the amount of exercise you do each day means you burn more calories to help you lose weight.  And it doesn’t take much; just 30 minutes of moderately strenuous daily exercise helps prevent heart disease, which is the #1 killer of women and men in the U.S..[17] The exercise you choose doesn’t need to be elaborate either, or even take place in a gym.  Walking, biking, swimming, or gardening can do the trick, and getting a friend or family member to exercise with you can turn this into a valued part of your daily routine.  Learn more about the health benefits of physical activity and how to get started from the CDC.

Staying Healthy is a Life-Long Proposition

Don’t think about dieting as a short-term weight loss goal.  Instead, ask yourself the question: How long do I want to live and how sick do I want to be?  Scientists have found that one of the keys to success is to think about these goals every day.[18] For example, people who get on a scale and check their weight daily are more successful at keeping their weight under control than people who don’t.[18]

Don’t Waste Your Time and Energy and Money on “Quick Fix” Solutions

For some people, there may be faster ways to lose weight than following the diet suggestions listed here.  But those quick solutions tend to be temporary; even bariatric surgeries don’t necessarily provide long-term solutions.  Learning to eat in a healthier way allows you to sometimes indulge in foods that aren’t so healthy, while still being healthier than you ever were before, and living longer.

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

  1. For more information about BMI and how it is calculated, see Obesity in America: Are You Part of the Problem?
  2. Thomas, D.M., Bouchard, C., Church, T. et al. Why do individuals not lose more weight from an exercise intervention at a defined dose? An energy balance analysis. Obes Rev. 2012; 13: 835–847
  3. Church, TS, Martin, CK, Thompson, AM et al. Changes in weight, waist circumference and compensatory responses with different doses of exercise among sedentary, overweight postmenopausal women. PLoS ONE. 2009; 4
  4. Vadiveloo M, Sacks, FM, Champagne, CM, et al. Greater Healthful Dietary Variety Is Associated with Greater 2-Year Changes in Weight and Adiposity in the Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) Trial. J Nutri. 2016, doi: 10.3945/jn.115.224683
  5. Mozaffarian D, Hao T, Rimm, EB, et al. Changes in Diet and Lifestyle and Long-Term Weight Gain in Women and Men. The New England Journal of Medicine. 2011;364:2392-404.
  6. Bazzano LA, Hu, T, Reynolds, K et al. Effects of Low-Carbohydrate and Low-Fat Diets: A Randomized Trial. Annals of Internal Medicine. 2014;161(5):309-310
  7. Block, JP, Condon, SK, Kleinman, K, et al. Consumers’ estimation of calorie content at fast food restaurants: cross sectional observational study. BMJ 2013; 346
  8. Ebneter, DS, Latner, JD, Nigg, CR. Is less always more? The effects of low-fat labeling and caloric information on food intake, calorie estimates, taste preference, and health attributions. Appetite 2013. 68(1): 92-97)
  9. Lesser LI, Kayekjian K, Velasquez P, et al. Adolescent purchasing behavior at McDonald’s and Subway. J Adolesc Health. 2013 Oct; 53(4):441-5.
  10. Varady KA. Meal frequency and timing: impact on metabolic disease risk. Curr Opin Endocrinol Obes. 2016 Jul 21.
  11. Hanks, A, Kaipainen, K, Wansink, B. The Syracuse Plate: Reducing BMI by Introducing Smaller Plates in Households. J of Nutrition Education and Behavior. 2013, 45 (4), Supplement, S41
  12. Wansink, B, Painter, JE, North, J. Bottomless Bowls: Why Visual Cues of Portion Size May Influence Intake. Obesity Research. 2005,13 (1)
  13. LeCheminant, JD, Christenson, E, Bailey, BW, Tucker, LA. Restricting night-time eating reduces daily energy intake in healthy young men: a short-term cross-over study. British Journal of Nutrition. 2013, 110 (11)
  14. Connor, Anahad. How the Sugar Industry Shifted Blame to Fat. The New York Times. 2016. http://www.nytimes.com/2016/09/13/well/eat/how-the-sugar-industry-shifted-blame-to-fat.html?_r=0
  15. Koch, C., Kjeldsen, E., Friikkle-Schmidt, R. Vegetarian or Vegan Diets and Blood Lipids: a Meta-Analysis of Randomized Trials. European Heart Journal. 2023, ehad211. https://doi.org/10.1093/eurheartj/ehad211
  16. National Institute of Diabetes and Digestive and Kidney Diseases. Take Charge of Your Health: A Guide for Teenagers. U.S. Department of Health and Human Services. Available https://www.niddk.nih.gov/health-information/weight-management/take-charge-health-guide-teenagers
  17. Bishop, K., Wootan, MG. Healthy bargains: Fruits and vegetables are nutritious and economical. A Center for Science in the Public Interest study. Available https://cspinet.org/healthybargains.pdf.
  18. Carlson A, Frazao E. Are Healthy Foods Really More Expensive? It Depends on How You Measure the Price. Washington, D.C.: United States Department of Agriculture. May, 2012. Report No. EIB-96.
  19. Pandey, A, Garg, S, Khunger, M, et al. Dose Response Relationship Between Physical Activity and Risk of Heart Failure: A Meta-Analysis. Circulation. 2015; http://dx.doi.org/10.1161/CIRCULATIONAHA.115.015853
  20. Bertz, F, Pacanowski, CR, Levitsky, DA. Frequent Self-Weighing with Electronic Graphic Feedback to Prevent Age-Related Weight Gain in Young Adults. Obesity. 2015; 23(10): 2009-2014

FDA Warned of Overstepping Authority With Lab Test Rule Proposal

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

Nyah Phengsitthy, Bloomberg Law, December 7, 2023

Federal efforts to bring laboratory tests to detect Covid-19, blood infections, cancers, and more under FDA authority received intense scrutiny from stakeholders that indicate significant legal hurdles for the final regulation.

The Food and Drug Administration this week faced heavy pushback on its proposed rule (RIN 0910-AI85) that would hand the agency explicit authority to regulate medical tests that come from a single laboratory, also known as lab-developed tests (LDTs). If finalized, the FDA could label LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, requiring the products to face additional rigorous review before being marketed.

The proposal follows concerns about risks associated with new tests that have entered the market in recent years, according to the FDA. The move also trails Congress’ failure to include provisions in a 2022 year-end spending bill that would have clarified the agency’s authority over LDTs.

Clinical lab groups, academic centers, and members of Congress question the FDA’s power to regulate LDTs. The agency, which received thousands of comments on the rule by the Dec. 4 deadline, seemingly faces a rocky path forward amid litigation threats in the early rulemaking stages.

“The litigation over the LDTs rule has the potential to be the most significant litigation FDA has seen since the legal fight over the regulation of tobacco products in the ‘90s,” said Stacy Cline Amin, a partner at Morrison Foerster and the FDA’s former chief counsel.

“[….]

The FDA’s rule would amend its regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and are devices under the FDCA, including when the manufacturer is a laboratory.

The rule also puts in place a four-year phase-out period on the agency’s general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

That power shouldn’t be handed to the FDA, the American Clinical Laboratory Association said in its comments.

The association, which represents the nation’s largest commercial reference laboratories such as LabCorp, Quest Diagnostics, and Mayo Clinic, argue the agency should be denied statutory authority and that any expansion of its role should be tailored by Congress.

[….]

The Association for Diagnostics & Laboratory Medicine said LDTs already face regulation under the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments of 1988, along with complementary state laws that interact with CLIA.

But those welcoming the FDA’s rule like the Center for Science in the Public Interest and the National Center for Health Research say that oversight isn’t enough.

“There’s nobody at CMS that’s saying what the sensitivity and specificity is in the test—how many false positives, how many false negatives,” said Diana Zuckerman, president of the National Center for Health Research.

That specific information will determine if a product does more harm than good, or vice versa, Zuckerman said.

“It’s not their job and that’s the kind of information that FDA needs,” she added.

Additional oversight would also ensure health-care providers and patients can rely on accurate tests, proponents say. According to the proposal, many laboratories fail to perform appropriate or adequate validation studies, which has shown data demonstrating their test doesn’t work as intended.

“The results of these mistakes will be people being told that they have diseases that they don’t have, and therefore getting treatments that they don’t need,” said Peter Lurie, president of the Center for Science in the Public Interest.

“If you don’t get the diagnosis, you won’t get the treatment,” said Lurie, who served as the FDA’s former associate commissioner for public health strategy and analysis.

‘Gauntlet’ to Congress

The FDA declining to extend the comment period on the proposal raises speculation that it’s trying to finalize certain rules in advance of the next election cycle, according to some attorneys and industry groups.

The agency’s push comes after its previous failed attempts to move forward with a successful framework to regulate LDTs. In 2014, the agency released a draft guidance that would have set the path forward, but a 2017 white paper from the FDA explained the numerous differences on the framework, which the agency declined to finalize.

[….]

To read the entire article, click here.

Testimony of Diana Zuckerman at FDA Advisory Panel on Blood Irradiators

Policy, Testimony & Briefings

November 7, 2023

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. So I have no conflicts of interest.

In addition to my current work, my perspective reflects my post-doctoral training in epidemiology and public health, my training in bioethics, previous policy positions at HHS and a Congressional Committee with oversight over FDA, and as a faculty member and researcher at Yale and Harvard. I am also a founding board member of the Alliance for a Stronger FDA, which is a coalition of industry and nonprofit organizations that work to ensure that the FDA has sufficient appropriations to fulfill its important mission.

Thanks for the opportunity to speak today. Since you have such impressive medical expertise on this panel, I will focus on policy issues that have important implications for patients – a goal that we all share.

The FDA has spelled out their concerns about these devices in their written summary and will talk about them today, so I will focus on the big picture.

  1. These devices have been treated as 510k devices since 1976 and that has resulted in limited scientific data — in fact, FDA found very few studies of either safety or effectiveness, none of which were randomized controlled trials and none that evaluated a specific device used to prevent cancer metastasis.
  2. Most importantly, no studies indicate that the use of blood irradiators improves patient outcomes.

So given the lack of evidence of benefits, what are the risks?

  • There are few adverse event (AE) reports to FDA’s Medical Device Reporting (MDR) system. But that may be because the devices aren’t used frequently and MDR reports are voluntary and everyone agrees that AEs are under-reported. We all know that surgeons are very busy and do not have strong incentives to report AEs, especially when it isn’t clear if a problem was caused by the device vs. human error.
  • Even so, the FDA has identified numerous potential serious risks, including incorrect or improper dose of radiation, damage to blood components caused by the radiation, and radiation causing an immune response that is harmful to cancer patients. Device malfunction or poor design could result in unintended radiation exposure of the operator or the public, or electrical shock or burn.
  • Several papers reported that blood irradiation took additional time, 15-20 minutes, and that can sometimes be harmful.
  • Perhaps most important, most patients and surgeons assume that these products are proven safe and effective. Would they choose to use them if they knew how little scientific evidence there is regarding safety or effectiveness?

THE BOTTOM LINE: These devices fit FDA’s definition of Class III

  1. “Insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness.”
  2. “The device is for a use which is of substantial importance in preventing impairment of human health.”

The FDA is asking if special controls would be sufficient instead of a PMA.  They don’t specify which special controls, but the problem here is we don’t know if the products have any benefits regardless of how they are used.

Would FDA impose special controls requiring evidence of effectiveness, and if so, why not require a PMA instead? We don’t know if either of the current products are safe and effective, and we don’t know if one is better than the other. That is why I encourage you to urge the FDA to categorize these as Class III and require a PMA, so that we will finally have well designed clinical trials to determine safety and effectiveness.

Would registries be as good as clinical trials to study blood irradiators that are already on the market? Registries can collect important information.  But registries do not provide a control group, and this is especially problematic for a device that is not widely used, since those who use blood irradiation to prevent metastasis may differ in important ways from those who do not.

Our Comments on the FDA Draft Guidance for Industry Concerning Dietary Guidance Statements in Food Labeling

Policy

September 25, 2023

We appreciate the opportunity to comment on the Food and Drug Administration (FDA) draft guidance for industry concerning questions and answers about Dietary Guidance Statements in food labeling.

We are 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.

We support the use of Dietary Guidance Statements to improve dietary patterns, reduce the burden of nutrition-related chronic diseases, and advance health equity. Dietary Guidance Statements provide important nutrition information to consumers, and are especially important to consumers with poor nutritional habits. They also encourage industry to reformulate products to improve nutritional standards.

We recommend the following to improve this guidance:

  • Revise the recommendation that manufacturers may use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar.

Manufacturers should not be allowed to use Dietary Guidance Statements on products that exceed recommended limits on saturated fat, sodium, or added sugar, even with an added disclosure statement explaining the nutrient levels the product may exceed. This would be confusing and potentially misleading to many consumers. If the FDA insists on this confusing strategy, the agency should clearly describe which recommended nutrient level is exceeded, and should be designed to grab the attention of consumers, similar to that of a black box warning on medical products.

  • Provide an explicit definition that includes examples of a “consensus report.”

In this draft guidance, FDA defines a “consensus report” as: “A report that represents the consensus produced by a group of qualified experts whose bias and conflicts of interest have been minimized and that are convened to study a specific issue. The consensus report conveys agreed-upon recommendations that reflect widely accepted, objective views of current scientific evidence.” This definition does not specify what FDA considers a “minimized” conflict of interest. This definition needs to be explicit to ensure that inappropriate sources are not included and that Dietary Guidance Statements do not conflict with recommendations in the Dietary Guidelines for Americans released every five years by HHS.[1]

We recommend that FDA provide a list of which published reports from U.S. Federal government agencies, U.S. scientific bodies, or U.S. health organizations outside the Federal government are appropriate to serve as the basis for Dietary Guidance Statements. The list should be updated at least every five years, and be in agreement with the release of updated Dietary Guidelines for Americans.

  • Amend the use of Dietary Guidance Statements related to juice and reduce misleading claims about fruit drinks.

The FDA guidance recommended that products should contain at least ½ cup equivalent of fruit per Reference Amount Customarily Consumed (RACC), which can also be ½ cup of fruit juice per RACC. However, a Dietary Guidance Statement on a product that contains fruit only in the form of juice would be misleading to consumers, because the Dietary Guidelines for Americans place an emphasis on the importance of whole fruits. FDA should amend the guidance to clarify that Dietary Guidance Statements involving fruit should emphasize the benefits of whole fruit over fruit juice, as well as the benefits of fruit juice compared to fruit drinks.

  • Amend the use of Guidance Statements regarding whole grains.

Consumers are often misled by claims of products that “contain whole grains” despite whole grains constituting a small amount or small proportion of the total grains. The Dietary Guidelines for Americans recommend a diet including “grains, at least half of which are whole grain.” As an example guidance statement, the FDA provides a label saying, “Make half your grains whole grain.” This should be amended to recommend that “at least half” your grains should be whole grain. Additionally, for products that contain high amounts of grain, the FDA should recommend at least 50% of the total grains be whole grains.

  • FDA should provide guidelines for Dietary Guidance Statements on alcohol.

Evidence regarding the harmful effects of alcohol, including moderate amounts of alcohol, is well documented and we therefore urge that the Dietary Guidance Statement should include that information.  That would require amending the definition of Dietary Guidance Statements to include those that “represent or suggest that a food or food group may or may not contribute to or help maintain a nutritious dietary pattern. ” Dietary Guidance Statements regarding alcohol should emphasize the recommended limits as well as established evidence about the impact of alcohol consumption on health.

[1] https://www.dietaryguidelines.gov/about-dietary-guidelines/purpose-dietary-guidelines

Our Comments On FDA’s Requirements for Tobacco Product Manufacturing Practices

Policy

October 6th, 2023

We appreciate the opportunity to comment on the FDA’s proposed guidance regarding tobacco product manufacturing practice requirements: “Requirements for Tobacco Product Manufacturing Practice.”

We are 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.

Overall, we support FDA’s proposed rule for regulating tobacco manufacturing practices. Prior evidence suggests that the absence of agency established tobacco regulations may expose consumers to unnecessary hazards, addictive products, and risks associated with tobacco products.1 While this proposal will not make tobacco products safe, it will help to limit health risks that are not normally associated with the use of tobacco products. Tobacco consumers will still remain at higher risk for cancer, stroke, heart and vascular disease, and chronic obstructive lung disease compared to non-tobacco users. Thus, NCHR urges the FDA to make it clear that this rule will not make tobacco products safe or protect consumer health, but rather is intended to reduce the risks.  We also strongly urge the FDA to put more emphasis on implementing explicit policies that protect the public health as much as possible, rather than emphasizing the agency’s willingness to be flexible in how companies implement this rule.

We agree with the FDA’s proposed requirement that each manufacturer maintain a master manufacturing record (MMR) so that the FDA is able to hold manufacturers accountable and is able to track whether the tobacco products conform to packaging and labeling specifications. Further, as part of the MMR, it is imperative to require tobacco manufacturers to make products that consistently and accurately reflect the nicotine concentration printed on the label. This is essential for e-liquids and e-cigarettes, as they have been shown to range from having anywhere from 35% less nicotine to 52% more nicotine than is printed on the label.2 Moreover, younger e-cigarette users frequently misinterpret the concentration and strength of nicotine in e-cigarettes and many are uncertain about whether some e-cigarettes even contain nicotine.3 When the amount of nicotine consumed is unclear, it has the potential to increase the chances of consumers becoming addicted. Therefore, in addition to requiring manufacturers to accurately and clearly specify the nicotine concentration contained in the product, we also recommend that the FDA require clear, user-friendly labeling to help consumers better understand and calculate their nicotine consumption.

We also strongly agree with the FDA’s proposed regulations to restrict flavor additives, reduce hazardous contamination, and impose maximum nicotine levels in order to mitigate unnecessary health risks. These standards are essential for everyone, but may be especially likely to decrease tobacco initiation among younger consumers, as well as reduce the duration of use and risk of tobacco addiction. E-cigarettes have been shown to contain hazardous contaminated substances such as volatile organic compounds, metals, glass, and plastics and so we support FDA’s proposal for a Quality Management System (QMS), to help reduce contamination, hasten recalls, and prompt regulatory action for contaminated or misbranded tobacco products.

While we agree with the FDA’s proposed approaches for measuring and imposing tobacco standards, we find the enforcement mechanisms and corrective actions against manufacturers who violate these proposed regulations to be inadequate. The incentive for compliance is low, the FDA’s responses to noncompliance have not been sufficiently rigorous, and prior corrective actions have not been commensurate with the gravity that violations pose to the public. For example, the civil monetary penalties that have been previously issued for past e-cigarette violations are relatively rare and not sufficient to improve compliance. As of August of this year, the FDA had sought injunctions against only six companies and filed monetary penalty complaints against only 21 companies for illegally selling e-cigarettes, which pales in comparison to the scope of the problem.4 Thousands of unauthorized and illegal e-cigarettes remain on the market, posing a major threat to public health. NCHR recommends that the FDA enforce more violations and implement more stringent and aggressive enforcement strategies for each violation. For example, when there are multiple violations, rather than charging manufacturers with a single violation in one proceeding, which results in a maximum fine of $19,192, we urge that the manufacturer be charged for each violation, since the FDA has the authority to charge a manufacturer with multiple violations up to $1.2 million in a single proceeding.5 Incentives for compliance would be much greater if the statutory maximum is issued for each violation of the Family Smoking Prevention and Tobacco Control Act. Charging manufacturers with a single violation is not having the desired impact; stiff monetary penalties are needed to increase compliance among manufacturers that repeatedly market flavored e-cigarette products, produce tobacco products with hazardous foreign material, or are non-adherent to regulatory and label requirements.

We are very concerned that in each of the injunctions filed by the FDA, there was a delay of over a year between the time the FDA sent a warning letter to the companies in violation and the commencement of injunction proceeding. Throughout this period, these companies continued to profit from the sale and distribution of illegal products, including menthol flavored cigarettes and all types of flavored e-liquids that are especially attractive to children and teenagers. This substantial delay between the FDA’s identification of violations and initiation of injunction proceedings has clear adverse effects on public health, making it especially likely that children and adolescents will try these products and become addicted to them. We strongly recommend that the FDA streamline the process, more quickly imposing corrective actions in order to reduce harm to individuals and to public health.

In conclusion, we appreciate the opportunity to comment on the proposed rule to regulate tobacco manufacturing practices. We strongly recommend requiring manufacturers to accurately reflect the nicotine concentration contained in the product on the label using clear, plain language in large font. Further, we support the proposed regulations to restrict flavor additives as required by law, reduce hazardous contamination, and impose maximum nicotine levels. Even more important, the FDA should exercise its full authority when imposing monetary penalties for violations to improve incentives for manufacturer compliance. Although tobacco products are inherently unsafe, these proposed regulations, if properly enforced, will be more effective at reducing health risks related to tobacco consumption. 

References:

  1. Lange, T et al. “Regulating Tobacco Product Advertising and Promotions in the Retail Environment: A Roadmap for States and Localities.” Journal of Law and Medical Ethics. 2015.
  2. Raymond et al. “The Nicotine Content of a Sample of E-cigarette Liquid Manufactured in the United States.” Journal of Addiction Medicine. 2018.
  3. Morean et al. “Adolescents’ awareness of the nicotine strength and e-cigarette status of JUUL e-cigarettes. Drug and Alcohol Dependency. 2019.
  4. FDA, Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products. August 10, 2023.
  5. Zuckerman Spaeder. “Effective Use of Civil Monetary Penalties to Control Illegal Marketing of E-Cigarette Products. 2023. Link: Federal Register :: Requirements for Tobacco Product Manufacturing Practice

Consumer and Public Health Groups Support FDA Proposal to Ensure Accuracy of Lab-Developed Medical Tests

Press Releases, We're In the News

September 29, 2023

A coalition of consumer advocacy groups is welcoming a proposed rule released today by the Food and Drug Administration to regulate laboratory-developed tests (LDTs), a category of diagnostic tests developed and used in a single lab. LDTs are a subset of In Vitro Diagnostics (IVDs) which are FDA regulated, despite the fact that they have been regulated differently for decades. The proposal clarifies that LDTs are medical devices, meaning FDA will ensure they are safe and effective before they are sold to consumers. The tests have long been under “enforcement discretion,” meaning FDA has not enforced premarket approval and other requirements, but stakeholders and regulators alike have been calling for increased scrutiny of these tests for years.

The proposed regulation will take effect 60 days after a final rule is published and contemplates a phase-in over the subsequent four years. As these tests have become more complex and more important to patient care, ensuring their accuracy has become more crucial, according to the coalition, which includes the Center for Science in the Public Interest, the National Center for Health Research, Strathmore Health Strategy, and U.S. PIRG.

False-positive test results could lead patients to believe they have a serious medical condition that they do not have, and false-negative results may cause a patient’s life-threatening condition to be missed. Some tests have falsely diagnosed people with cancer or inaccurately provided results that lead directly to chemotherapy selection. Many of the tests have been found to be inaccurate, including some COVID-19 diagnostic tests, genetic non-invasive prenatal screening tests, and blood tests manufactured by the biotech company Theranos.

The group applauds many provisions of the proposed rule. These include:

  • Including Academic Medical Centers in the regulatory scheme. There is no reason that people treated or tested at one facility should be more at risk for inaccurate results than those tested at another facility. All tests should be evaluated based on the benefits and risks of the tests, not the building in which the test is run. The proposed rule notes that “[r]eview of the underlying science behind an [in vitro diagnostic] is based on what the IVD does and is in no way related to where the IVD is made.” The FDA requests additional information on this topic, but the coalition hopes the agency sticks to its guns.
  • Including tests for rare diseases in the regulatory scheme. Patients with rare diseases should be equally protected from inaccurate tests.
  • Registration and listing requirements for all tests, which exist for all other medical devices. This will allow FDA and the public to know which tests are available. Further, manufacturers are required to publish performance data on IVDs, which will provide much-needed transparency about the clinical and analytical validity of these tests, according to the coalition.

“This rule is a critical step forward for clinical medicine,” said Dr. Peter G. Lurie, President of Center for Science in the Public Interest and a former Associate Commissioner at the Food and Drug Administration where he worked on LDTs, including on a report demonstrating their potential dangers. “It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health. This rule will close a gaping hole in FDA’s current regulatory reach.”

In the absence of FDA oversight, LDTs have been regulated only by the Centers for Medicare and Medicaid Services, which does not require documentation that the test results accurately inform the diagnosis of patients, a concept known as “clinical validity.” CMS only requires laboratories to document the “analytical validity” of their tests, or their ability to reliably detect a biomarker.

Oversight under FDA would be much more comprehensive and would ensure that healthcare providers and patients can rely on results to make medical decisions, particularly the riskiest medical decisions, where inaccurate test results can cause harm to patients. A modern regulatory framework for LDTs will improve patient access to accurate tests and promote innovation in the diagnostic testing industry.

“We strongly support the decision by the FDA to do what is necessary to rectify a situation that has been so harmful to patients,” said Dr. Diana Zuckerman, President of the National Center for Health Research.  “We understand the need for a transitional period but urge the FDA to address problems with existing high-risk LDTs as quickly as possible. We welcome the opportunity to work with FDA and other interested parties to ensure that FDA has the resources it needs to robustly regulate LDTs so that patients can make informed decisions based on test results.”

This comprehensive approach will require resources, including both user fees and Congressional appropriations. The coalition will continue working with all stakeholders, including Congress and the Agency, to ensure that the agency is adequately resourced to fulfill this critical function.

For more information, contact Dr. Zuckerman at dz@center4research.org

Do Heartburn Medications Cause Kidney Disease? Dementia?

Other Cancers, Other Cancers

Diana Zuckerman, PhD and Farzana Akkas, MSc,

In 2016, research was published indicating that people who take popular heartburn medications are more likely to develop serious kidney disease.[1] In 2023, research was published showing that people prescribed these popular medications are more likely to develop dementia. If you take any of these drugs, how worried should you be? And are there safer medications that work just as well?

Prilosec, Nexium Prevacid, Kapidex, Aciphex and Protonix are all a type of drugs called Proton Pump Inhibitors (PPI). There are several other drugs of this type as well.  They are all used to treat heartburn and acid reflux. In a 2016 study lead by Dr. Morgan Grams of Johns Hopkins University, people who use PPI are more likely to develop chronic kidney disease compared to those who take other types of heartburn medication.  The higher the dose or the more often they take these drugs, the more likely they are to develop kidney disease.[1] In the first of several expected settlements, in October 2023 AstraZeneca agreed to pay $425 million to settle about 11,000 lawsuits in the United States that claimed that Nexium and Prilosec caused chronic kidney disease. AstraZeneca did not admit wrongdoing under the settlement, part of broader litigation against makers of PPI that involve several major pharmaceutical companies.

Even more important, the researchers found that most of the 15 million Americans who were prescribed a PPI don’t really need them.  One in four of long-term users can stop taking them without suffering from more heartburn or acid reflux.[1]

Since the research on dementia is more recent, let’s focus on that first. The 2023 study of more than 5,000 people ages 45 and older who did not have dementia at the start of the study concluded that those who take PPI for 4.5 years or longer are more likely to develop dementia.[2] The study compared more than 4,000 people who did not take the drugs to 1,490 adults who took PPI for up to 2.8 years, between 2.8 to 4.4 years, or for more than 4.4 years. During the 30 years of the study, 585 people (10%) developed dementia. Of the people who did not take the drugs, 425 people developed dementia, which equals 1.9% per year. Of the 497 people who took the drugs for more than 4.4 years, 58 people developed dementia, which equals 2.4% per year. THESE numbers seem small but they add up over time (for example, 38 compared to 48 over 20 years). Researchers did not find a SIGNIFICANT increase in dementia for people who took the drugs for fewer than 4.4 years. This study does not prove that PPI causes dementia but it shows an association which could be caused by the drugs or could be caused by an unknown behavior or medical condition that causes both heartburn and dementia. More research is needed to determine whether long-term PPI use actually causes dementia.

The evidence regarding PPIs and kidney disease is more conclusive. Even before the 2016 study, research had shown that people who take these drugs are more likely to have painful kidney problems such as acute kidney injury and acute interstitial nephritis.[3, 4, 5, 6, 7] The 2016 study is important because the patients taking a PPI developed chronic kidney disease, which is more serious.  It means that their kidneys can no longer filter blood effectively, which can cause kidney failure. Those patients will need dialysis.

Do PPI cause these health problems or does overeating cause these problems? To address this question, the researchers compared results of PPI users to people taking a different type of heartburn medication called H2 blocker users (such as Pepcid, Tagamet and Zantac). After statistically controlling for heath factors such as obesity and hypertension, they found that people who used a PPI were still more likely to develop chronic kidney disease when compared to people using H2 blockers.  And, those who took the PPI medication twice a day were more likely to develop chronic kidney disease than those who took it once a day.

Another study, based on more than 190,000 veterans taking heartburn medication came to a similar conclusion. Regardless of their age and health, the PPI users in that study also were more likely to develop chronic kidney disease than the veterans taking H2 blockers.[8]

H2 blockers like Pepcid, Tagamet or Zantac are less expensive and seem to be safer than the PPI medications.  Many of them are available without a prescription.  And of course, a major cause of heartburn and acid reflux is our health habits. Maintaining a healthy weight and quitting smoking helps reduce the chances of heartburn or acid reflux.  If that doesn’t work, some people find it helpful to avoid spicy or greasy food, chocolate, mint, and coffee until the symptoms go away.[9]

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

  1. Lazarus, B., Chen, Y., Wilson, F. P., Sang, Y., Chang, A. R., Coresh, J., & Grams, M. E. (2016). Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. JAMA Internal Medicine JAMA Intern Med, 238.
  2. Northuis, C., Bell, E., Lutsey, Pm. George, K., Gottesman, R., Mosley, Tom., Whitsel, E., & Lakshminarayan K. (2023). Cumulative Use of Proton Pump Inhibitors and Risk of Dementia: The Atherosclerosis Risk in Communities Study. American Academy of Neurology.
  3. Blank ML, Parkin L, Paul C, Herbison P. (2014). A nationwide nested case-control study indicates an increased risk of acute interstitial nephritis with proton pump inhibitor use. Kidney Int., 86(4):837-844.
  4. Sierra F, Suarez M, Rey M, Vela MF. (2007) Systematic review: proton pump inhibitor–associated acute interstitial nephritis. Aliment Pharmacol Ther.,26(4):545-553.
  5. Antoniou T, Macdonald EM, Hollands S, et al. (2015) Proton pump inhibitors and the risk of acute kidney injury in older patients: a population-based cohort study. CMAJ Open, 3(2):E166-E171.
  6. Klepser DG, Collier DS, Cochran GL. (2013) Proton pump inhibitors and acute kidney injury: a nested case-control study.BMC Nephrol, 14:150.
  7. Leonard CE, Freeman CP, Newcomb CW, et al. (2012) Proton pump inhibitors and traditional nonsteroidal anti-inflammatory drugs and the risk of acute interstitial nephritis and acute kidney injury. Pharmacoepidemiol Drug Saf, 21(11):1155-1172.
  8. Xie, Y., Bowe, B., Li, T., Xian, H., Balasubramanian, S., Al-Aly, Z. (2016). Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD. Journal of The American Society of Nephrology, 27.
  9. Kang, J. H., & Kang, J. Y. (2015). Lifestyle measures in the management of gastro-oesophageal reflux disease: Clinical and pathophysiological considerations. Therapeutic Advances in Chronic Disease, 6(2), 51-64.