May 2024 Digest

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~~~~~~~~~~~We're In the News ~~~~~~~~~~ ________________________________________

Numerous cancer drugs and other treatments that the FDA approved were found not to work

Bloomberg News shed light on a troubling trend: some FDA-approved cancer drugs and treatments have been found to be ineffective, resulting in billions of dollars wasted on products that do not work. Dr. Zuckerman and former AIDS activist and current Yale faculty member Gregg Gonsalves were both quoted discussing how FDA approval used to be too slow, but now the pendulum has swung too far in the opposite direction. This shift has allowed extremely expensive drugs that do not work to burden patients and strain Medicare, Medicaid, and our overall healthcare system beyond sustainable limits. Read more here. 

EPA released its 2024 report on artificial turf

EPA's 2024 report on artificial turf states that artificial turf contains toxic chemicals but concludes that most exposures can be considered 'generally safe,' a finding questioned by NCHR president Dr. Zuckerman. She told Politico's Energy & Environment News that "generally safe" implies that playing on artificial turf will be harmful to some players but not others, without specifying who. Dr. Zuckerman also pointed out that the adults and children playing on artificial turf vary in terms of frequency of that exposure, and some people are more vulnerable to these exposures than others. Many experts agree with us that the report is not credible because the conclusions are not supported by research on children or adults and because it did not evaluate the impact of PFAS and other chemicals in the plastic grass itself. Read more here. 

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~~~~~~~We're Speaking Out For You~~~~~~~~ ________________________________________

We testified at the House Small Business Committee

CPTF President Dr. Diana Zuckerman testified at the House of Representatives Small Business Committee hearing on May 8. The focus of the hearing was the ways that federal regulations could interfere with small businesses to develop innovative medical products and provide health care, a perspective that we challenged. As is customary in the House, the Ranking Democrat on the committee, Congresswoman Nydia Velazquez (D-NY), was able to invite only one speaker, and we were proud that she chose us. Dr. Zuckerman gave two examples where FDA granted approval to new drugs submitted by small businesses despite lacking evidence that they were effective. In both cases, patients, health insurance, and Medicaid paid millions of dollars for years but there is still no evidence that they work. She also described research showing that many new cancer drugs are sold for years without any evidence that they increase survival or improve quality of life. She was quoted in the media outlet Medical Economics, explaining that "If the FDA reduces the burden on companies by not requiring them to provide clear evidence that a new product is safe and effective, that increases the burden on patients, families, and physicians because we must make life-changing and life-saving medical decisions without the facts we need to make the decisions that are best for us and our patients." Read the entire article here. Read the full testimony here.

Dr. Zuckerman also testified before the Consumer Product Safety Commission on the same day, at their hearing requesting suggestions for priorities for 2025 and 2026. Our testimony focused on the need to protect children and adults from the chemicals and heavy metals in products made from "recycled" tire waste. These products can cause serious health problems, including cancer. In addition to playgrounds and artificial turf, Dr. Zuckerman pointed out that the greatest risk could be its use in rubber flooring in homes, in playrooms and exercise rooms, and in swing sets and other play equipment in backyards as well as landscaping options. To read her testimony, click here.

We commented on race and ethnicity data in clinical trials and studies

We voiced our support for the FDA’s draft guidance aimed at updating the way race and ethnicity data are included in clinical trials for medical products. We agree that current race and ethnicity questions can be confusing and we also recommended adding a new category for people from the Middle East or North Africa (MENA). The guidance is designed to ensure consistency in data collection with the ultimate goal of providing useful information about the safety and effectiveness of cancer treatments and other medical products for people belonging to different races and ethnicities. We urge the FDA to make these categories mandatory and provide incentives for companies and researchers to achieve greater diversity in clinical trials in order to collect the information needed to reduce disparities in medical outcomes. If you'd like to learn more, click here.

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~~~~~~~~~~News You Can Use~~~~~~~~~~ ________________________________________

Lung cancer treatment dosage is 4x too high

Senator Dick Durbin (D-IL) is accusing Amgen of “putting profits before patients” because it continues to market a high dose of Lumakras, a very expensive cancer treatment, instead of a lower dose that is equally effective, less toxic to patients, and would cost 75% less. FDA approved Lumakras 3 years ago to treat non-small cell lung cancer, under the condition that Amgen conducts a study to check its effectiveness at the high dose (8 pills per day) that was approved and a much lower dose (2 pills per day). The resulting study showed that the lower dose was equally effective and less toxic, but the study was poorly designed, resulting in questions about how effective the drug is at either dose. FDA and CMS say they do not have the authority to change the recommended dosage, and Amgen is apparently not interested in helping patients by changing the dosage.  We thank Sen. Durbin for his efforts and hope he can persuade the company and the agencies to protect patients from the higher dose. To learn more, click here.

EPA limits toxic air pollution from chemical plants

The Environmental Protection Agency (EPA) recently implemented stricter regulations on toxic air pollution from chemical plants, the most substantial change in two decades. Aimed at preventing cancer in low-income and minority communities near these facilities, the rule particularly targets ethylene oxide and chloroprene. The EPA's move responds to mounting concerns over the health risks posed by long-term exposure to these chemicals, which have been linked to several different types of cancer. By curbing emissions from roughly 200 chemical plants across the country, the regulation aims to significantly reduce toxic air pollution and improve air quality for affected communities. Read more here. 

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~~~~~~~~~~Info You Can Use~~~~~~~~~~~~ ________________________________________

Liver Cancer: what is it and how to prevent it

Liver cancer is an often deadly disease because it is frequently diagnosed when it is advanced. Our article describes the signs and symptoms of liver cancer and explains how you can prevent it. The best ways to lower your risk include getting tested for Hepatitis C, getting vaccinated for Hepatitis B, and treating these conditions if you have them. Cutting back on smoking and drinking alcohol can also help keep your liver healthy and cancer-free. Following these tips can make a big difference in protecting your liver from cancer. Read more here.

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Did you know that artificial turf and rubber playground surfaces contain carcinogens? Are your children or grandchildren getting exposed when they play? Follow us @safe.to.play

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