All posts by CPTFadmin

Testimony of Diana Zuckerman at the Meeting of EPA’s National Environmental Justice Advisory Council on September 28, 2022

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. We scrutinize the safety and effectiveness of medical and consumer products, and we don’t accept funding from companies that make those products.  Our largest program is focused on cancer prevention and treatment.  My expertise is based on post-doc training in epidemiology and public health, and my previous positions at HHS and as a faculty member and researcher at Harvard and Yale.

 Thank you all for the important work you’ve been doing and will be doing on this Advisory Council.  As a public health person, I’ve always been surprised at the lack of other public health advocates who are active on environmental issues and environmental justice issues, and I want to offer to be helpful in any way that would be useful to all of you.  We all know that lives are at stake.

I want to comment very briefly on the PFAS recommendations, since that’s an issue we’ve worked on for years.  Let me add that we are very concerned about all endocrine disrupting chemicals not just PFAS.

Everything I heard about PFAS this afternoon was inspiring and important.  I would just suggest that it’s a huge task, and I encourage you to start a little smaller in order to succeed in educating the public and especially environmental justice communities and at the same time focus on actions that are doable, that will inspire others, and that will make change happen.

Testimony of Dr. Diana Zuckerman About COPIKTRA FDA Advisory Committee Meeting on September 23, 2022

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. Our largest program is focused on cancer. My expertise is based on post-doc training in epidemiology and public health, and my previous positions at HHS and as a faculty member and researcher at Harvard and Yale.

In April this same Committee examined 6 randomized trials of Pi3K inhibitors used for hematologic malignancies and found that all reduced overall survival –despite potential benefit for PFS. FDA says that these consistent findings across multiple randomized trials within the same drug class is unprecedented in oncology.
That’s a shocking finding that we need to take seriously. And that’s the context for today’s meeting.

The sponsor did a 5-year randomized controlled post-market study – 3 years longer than the data that resulted in initial approval. They found the median OS was 11 months shorter than the comparison drug. In fact, 50% of the patients died during those 5 years, compared to 44% taking the other treatment – a treatment that is no longer considered effective and so is rarely used.

Then they analyzed patients with 2 or more prior therapies, since that was the indication. Those Copiktra patients lived about 3 months shorter – not as bad as the larger sample, but still worrisome. Especially since 56% died during the 5 years of the study, compared to 49% assigned to the other treatment.

Adverse events caused the deaths of 15% of the Copiktra patients compared to only 3% of the other treatment group. And the percentage of Grade 3 or greater AEs was 91%, and 78% had Serious AEs–about twice as high as the comparison group. This has clear implications for quality of life, in addition to the patients not living as long.

The FDA did the right thing by requesting this post-market study. And the sponsor did the right thing by completing the study. Now is the time to listen to the results. We urge this Advisory Committee and the FDA to make it clear that approvals will be rescinded when evidence indicates that promising short-term results are reversed based on longer term data from post-market studies.

Patients and oncologists want as many treatment options as possible, but we do patients no favors by maintaining approval for a drug that does more harm than good. As was true yesterday for other cancer treatments, the preponderance of evidence is clear today.

As a cancer survivor myself, I understand the need for treatment options. I thank this committee and the FDA for its objective, scientific analysis of the data presented yesterday and today. I hope it will help everyone understand that an individual patient may seem to do well on a specific treatment, but that treatment may not be the REASON the patient did well. There are other individual differences that cause some patients to do better than others, and to live longer than others. As FDA stated, these diseases are often indolent. That’s why large, long-term randomized controlled trials are so important – to help us understand which treatments are better for which patients.

There are so many problems with the data, including the very substantial changes in treatment standards that have occurred since this study was designed, the low number of US patients, and the dearth of nonwhite patients – all these support rescinding approval for this indication.

It takes years for FDA to rescind approval unless the sponsor does the right thing by voluntarily doing so. But your vote today will be very influential.

I hope that the sponsor will conduct new research to determine if a subgroup of patients can benefit from this drug under current treatment standards, and if a lower dose is safer as well as effective, and if so FDA should of course consider approval for a different indication. But that isn’t where we are today.

Testimony of Dr. Diana Zuckerman About PEPAXTO FDA Advisory Committee Meeting on September 22, 2022

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.  Our largest program is focused on cancer.  My expertise is based on post-doc training in epidemiology and public health, and previous positions at HHS and faculty member and researcher at Yale and Harvard.

All of us want more treatment options for refractory cancers, but we want patients to be able to have confidence that FDA approval means a product is proven safe and effective.  The OCEAN study of 495 multiple myeloma patients has important information that was not available when the drug received accelerated approval. Even if some patients taking Pepaxto do well, it is only with a randomized controlled trial that we can determine if Pepaxto is helpful or if the patients would do better without it.

Our Center’s analyses support the FDA findings that the data do not confirm the indication.  In the randomized trial comparing Pepaxto to another treatment option, median survival was 5.3 months shorter, and the death rate was slightly higher. 

The Sponsor says some patients do better but we agree with FDA that “Results from subgroup analyses cannot be used to conclude benefit in a subset of patients, when the overall patient population has shown a detrimental treatment effect.”

We also agree with the FDA that PFS is not improved and that “An anti-cancer therapy that prolongs PFS is not considered safe and effective if the therapy results in a detrimental effect on OS”

Public trust in the FDA has been weakened in recent years.  FDA standards matter to all of us.  Would you want your loved one to take Pepaxto rather than a superior treatment option?  Not all oncologists will be as knowledgeable about the data as those serving on this panel.

It concerns us that the sponsor continues to ignore FDA concerns, rely on shortcuts instead of better research, and that the company withdrew the drug in October but then rescinded the withdrawal.  Was this just a delaying tactic?  We agree with the FDA that the sponsor did not provide new data, and with Dr. Pazdur that FDA approval relies on solid information about appropriate dosage, which is lacking here.

Maybe Pepaxto would benefit some types of patients and better research is needed to prove that.  As FDA states, the preponderance of evidence from the prespecified analysis and in all other subgroups suggests an increased risk of death in patients and a potential for harm.”

We were pleased that the Committee voted 14-2 that the evidence does not support that the benefits outweigh the risks.

Joint Letter to Support FDA Proposed Rule Reducing Nicotine Levels in Cigarettes

September 12, 2022

Dr. Robert Califf
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Re: Nicotine Standard

Dear Dr. Califf:

The undersigned public health, medical and professional organizations write in strong support of your recent announcement that FDA will issue a proposed rule to reduce the nicotine level in cigarettes to non-addictive or minimally addictive levels. Such a standard would generate massive public health benefits, preventing millions of young people from smoking and dramatically reducing the number of people who die from tobacco-caused diseases. We urge you to move forward with this proposal as quickly as possible.

Despite great progress in curbing smoking prevalence in recent years, tobacco use – primarily smoking – remains the leading cause of preventable death and disease in the United States, killing more than 480,000 Americans every year.1 Sixteen million Americans are currently living with a tobacco-caused disease.2 Over 30 million Americans currently smoke, and every day over 1,600 kids try their first cigarette.3 Approximately half of people who smoke will die prematurely as a result of their addiction, losing at least a decade of life on average compared to those who do not smoke.4

We applaud the Administration for taking action to reduce tobacco use as part of its Cancer Moonshot initiative.5 Cigarette smoking causes about 30 percent of all cancer deaths in the U.S.6 Reductions in tobacco use have already had an impact on cancer rates. According to CDC, 60 percent of the decrease in cancer death rates among men and 40 percent of the decrease among women from their peak in 1990 to 1991 until 2014 were due to declines in tobacco-related cancer deaths.7 More progress can be made and reducing nicotine levels will have a profound impact.

Nicotine is the primary addictive agent in cigarettes and other tobacco products. According to the U.S. Surgeon General, “the addiction caused by the nicotine in tobacco smoke is critical in the transition of smokers from experimentation to sustained smoking and, subsequently, in the maintenance of smoking for the majority of smokers who want to quit.”8 Thus, reducing the nicotine content in cigarettes to non-addictive or minimally addictive levels will prevent experimentation by the young from becoming a lifetime of addiction and tobacco-caused disease. It also will reduce the level of nicotine dependence in adults who smoke, making it easier for them to quit.

Current evidence establishes the potentially historic lifesaving impact of reducing nicotine content in cigarettes to non-addictive or minimally addictive levels. As you know, FDA estimated in 2018 that approximately 5 million additional adults who smoke could quit smoking within one year of implementation and, by the year 2100, more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. Smoking rates could drop to as low as 1.4 percent, resulting in more than 8 million fewer tobacco-caused deaths through the end of the century.9 The dimensions of this public health benefit make timely implementation of this policy a moral imperative.

Reducing nicotine levels in cigarettes to achieve these enormous public health gains is technologically feasible. As FDA noted in its earlier Advance Notice of Proposed Rulemaking (ANPRM), there are a wide range of available technologies to reduce nicotine in cigarettes, including “through tobacco blending and cross-breeding plants, genetic engineering, and chemical extraction.”10 Indeed, the tobacco industry’s own documents show that the industry has a long history of manipulating nicotine levels in cigarettes to make them more addictive. As U.S. District Court Judge Gladys Kessler determined in her landmark opinion finding that the major cigarette companies had violated the federal anti-racketeering statute, “Defendants have designed their cigarettes to precisely control nicotine delivery levels and provide doses of nicotine sufficient to create and sustain addiction.”11 Surely the companies cannot now credibly maintain that they are unable to reduce nicotine levels to no longer sustain addiction. In addition, FDA has noted that recent scientific studies do not support concerns that nicotine reduction would cause people who smoke to compensate by increasing the number of cigarettes smoked or inhaling more deeply to increase nicotine intake. Studies of very low nicotine cigarettes have not found evidence of compensatory smoking but have found demonstrable reductions in cigarettes smoked per day and in exposure to harmful smoking constituents.12

To realize the full potential public health benefits of a nicotine product standard, FDA must extend that standard beyond cigarettes, to other combustible tobacco products. Exempting other combustible products would invite tobacco manufacturers to market existing, or develop new, non-cigarette substitutes, like the small, flavored cigars the industry introduced after flavored cigarettes (except menthol) were removed from the market. It also would make the exempted products a potential vehicle for youth initiation. Thus, we urge FDA to make any nicotine reduction product standard applicable to other combustible tobacco products.

Reducing nicotine in cigarettes and other combusted tobacco products will complement FDA’s proposed rules to prohibit menthol cigarettes and flavored cigars. By addressing flavors and nicotine levels, FDA will be able to target both what attracts youth to these products and what addicts them. FDA should continue its work to promptly finalize and implement the menthol cigarette and flavored cigar proposed rules. Moreover, FDA should continue to address high rates of e-cigarette use by youth by promptly completing statutorily required premarket reviews and removing from the market those products that are not “appropriate for the protection of the public health.”

Reducing the nicotine content in cigarettes and other combustible tobacco products will dramatically reduce addiction, disease, and premature death from tobacco. We applaud FDA for setting forth a bold plan to protect kids and public health and urge the agency to act quickly to complete the rulemaking process. Every day that passes means more kids moving from experimentation to addiction and more adults who want to quit, and try to quit, but remain addicted to a lethal product.

Respectfully submitted,

AASA, The School Superintendents Association
Academy of General Dentistry
Action on Smoking and Health
Allergy & Asthma Network
Alpha-1 Foundation
American Academy of Family Physicians
American Academy of Oral and Maxillofacial Pathology
American Association for Cancer Research
American Association for Dental, Oral, and Craniofacial Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Physicians
American Dental Association
American Heart Association
American Public Health Association
American Society of Addiction Medicine
Americans for Nonsmokers’ Rights
Association for Clinical Oncology
Association for the Treatment of Tobacco Use & Dependence
Association of Black Cardiologists
Association of State and Territorial Health Officials
Asthma and Allergy Foundation of America
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Catholic Health Association of the United States
Center For Black Equity
Children’s Health Fund
Commissioned Officers Association of the USPHS
Common Sense Media
Community Anti-Drug Coalitions of America (CADCA)
COPD Foundation
Counter Tools
Dana-Farber Cancer Institute
Emphysema Foundation of America
Family, Career and Community Leaders of America (FCCLA)
First Focus on Children
GLMA: Health Professionals Advancing
LGBTQ+ Equality
GO2 Foundation for Lung Cancer
HealthHIV
International Association for the Study of Lung Cancer
Kaiser Permanente
March of Dimes
National Alliance to Advance Adolescent Health
National Association of Hispanic Nurses
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Association of Secondary School Principals
National Black Church Initiative
National Black Nurses Association
National Education Association
National Hispanic Medical Association
National LGBT Cancer Network
National Medical Association
National Native Network
National Network of Public Health Institutes
National Tongan American Society
North American Quitline Consortium
Oncology Nursing Society
Parents Against Vaping e-cigarettes (PAVe)
Preventing Tobacco Addiction
Foundation/Tobacco 21
Preventive Cardiovascular Nurses Association
Respiratory Health Association
SADD
Society for Cardiovascular Angiography & Interventions
The Center for Black Health and Equity
The Society for State Leaders of Health
and Physical Education
The Society of Thoracic Surgeons
Trust for America’s Health
Truth Initiative
US COPD Coalition

CC: Dr. Brian King, Director of the Center for Tobacco Products

1. HHS, The Health Consequences of Smoking – 50 Years of Progress: A Report of the Surgeon General, 2014 (2014 SG Report).
2. Id.
3. CDC, “Tobacco Product Use Among Adults—United States, 2020,” MMWR Morb Mortal Wkly Rep
2022;71:397–405, March 18, 2022, https://www.cdc.gov/mmwr/volumes/71/wr/mm7111a1.htms_cid=mm7111a1_w. Substance Abuse and Mental Health Services Administration (SAMHSA), HHS, Results from the 2019 National Survey on Drug Use and Health, NSDUH: Detailed Tables, Table 4.9A https://www.samhsa.gov/data/report/2019-nsduh-detailed-tables
4. 2014 SG Report
5. The White House, “President Biden Reignites Cancer Moonshot to End Cancer as We Know It,” Fact Sheet. February, 2, 2022, https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-
biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/
6. American Cancer Society. Cancer Facts & Figures 2022. Atlanta: American Cancer Society, 2022.
https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html
7. CDC, “Vital Signs: Disparities in Tobacco-Related Cancer Incidence and Mortality—United States, 2004-2013,” MMWR 65(44): 1212-1218, https://www.cdc.gov/mmwr/volumes/65/wr/pdfs/mm6544a3.pdf/.
8. 2014 SG Report.
9. Apelberg, BJ, et al., “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” New England Journal of Medicine, published online March 15, 2018. See also, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 11818, 11820 (March 16, 2018)(ANPRM)
10. ANPRM, at 11820.
11. U.S. v. Philip Morris, Inc., 449 F.Supp. 2d, 1, 309 (D.D.C. 2006), aff’d in relevant part. 566 F.3d 1095 (D.C. Cir.2009).
12. ANPRM, at 11820.

Liver Cancer: What is it and how to prevent it


An estimated 100,000 people live with liver cancer in the U.S.[1] with about 41,000 new cases each year.2 Although less common than many other cancers in the U.S., the rate of newly diagnosed liver cancer has tripled since 1980 and death rates have doubled.[2]  It is often diagnosed in late stages and when it is, the average survival after diagnosis is less than 4 months at stage 4, compared to more than 3 years at the earliest stage.[3]

Early diagnosis and reducing the risks of developing liver cancer would save thousands of lives each year.  Research indicates that liver cancer disproportionality affects Asian American and Pacific Islander (AAPI) communities, which is the fasted growing racial and ethnic minority in the US.[4] Asian Americans are almost twice as likely to be diagnosed with liver cancer than Non-Hispanic White Americans, and in 2019, liver cancer was the sixth leading cause of death among 25-44 year old Asian Americans.[5] A better understanding of those disparities could save many lives.

This article will explain the signs and symptoms of liver cancer and the steps you can take to prevent it. 

Symptoms and Outcomes of Liver Cancer

Many symptoms of liver cancer are also symptoms of liver damage, [6]which can include:

  • Jaundice (yellowing of the skin or the whites of the eyes)
  • Pain in the right abdomen or shoulder blade
  • Lump in your right abdomen

However, liver cancer can also result in symptoms that are typical of other illnesses:[7]

  • Weight or appetite loss
  • Nausea or vomiting
  • General weakness or fatigue 

Primary liver cancer refers to cancer that originates in the liver, and is usually a single large tumor, whereas liver cancer that originates from another region of the body but spreads to the liver is called liver metastases and usually consists of several small tumors.[6] Liver metastases are more common than primary liver cancer and may spread throughout the liver before they are detected, while primary liver cancer can cause symptoms very early.[6,8]

How can you prevent it? 

There are several things you can do to reduce your chances of developing primary liver cancer.

Get tested for Hepatitis C: Approximately half of all primary liver cancer can be attributed to a single cause: the Hepatitis C virus.[9] The virus causes inflammation to the liver, which can lead to scarring (or ‘cirrhosis’) and then ultimately to liver cancer. You can contract Hepatitis C by being in contact with the blood of an infected person, so injecting drugs. is the most common way the virus is spread in the U.S.[10] The virus may silently damage the livers of infected people for decades before any symptoms appear. In fact, about half of people with Hepatitis C don’t even know they are infected.[11] Of the 3.5 million Americans estimated to be infected with Hepatitis C, 81% are baby boomers who were likely infected before Hepatitis C was discovered in 1989.[9]

Since Hepatitis C often has no symptoms, it’s crucial to get tested. The CDC recommends that all adults get tested for Hepatitis C at least once in their life, and all pregnant women get tested during every pregnancy.[12] Persons who inject drugs or share needles should get tested regularly.[12]

Get vaccinated for Hepatitis B: Hepatitis B is thought to cause about 15% of Liver cancer cases in the U.S. Like Hepatitis C, Hepatitis B attacks the liver, and most people who have been infected don’t realize it.[13] While about 1 million more Americans are living with Hepatitis C than B,[13] Hepatitis B is 5-10 times more infectious and is most commonly spread from mother to child during birth.[14] It is also more commonly transmitted through sexual activity than Hepatitis C.[15] Fortunately, Hepatitis B can be prevented with a vaccine, while Hepatitis C currently cannot. The Hepatitis B vaccine is usually given as a series of 3 shots shortly after birth, 1-2 months after birth, and 6-18 months after birth.[16] As of 2022, the CDC recommends all unvaccinated children and adults age 19-59 receive the Hepatitis B vaccine.[17] 

Asian American and Pacific Islanders make up approximately half of all Americans currently infected with Hepatitis B, despite making up only 6% of the U.S. population. That is likely because Hepatitis B has circulated around many countries in East Asia, Southeast Asia, and the Pacific for thousands of years, and also because these regions have very low rates of infant Hepatitis B vaccinations.[18]

Get treated for Hepatitis B or C: There are many treatment options for chronic Hepatitis C that can reduce its viral load to an undetectable level and help prevent cancer-causing liver damage. Antiviral medications are one of the most common ways treat the virus. FDA has approved several antiviral medications for the treatment of either Hepatitis B or C in the US, and there continue to be new advances in treatment options. These antiviral medications may vary in terms of safety or effectiveness. For example,  information about two of the most widely used Hepatitis B antivirals (Baraclude and Vemildy) and Hepatitis C antivirals (Mavyret and Epclusa) are shown in the table below.[19,20] FDA has approved all these drugs as having benefits that outweigh the risks in treating Hepatitis B or C, but your doctor may suggest specific medications based on your Hepatitis diagnosis, preexisting conditions, and other health factors.

Name of antiviral Description and usage Unique advantages Side Effects (including % of patients who experience them)
Baraclude (Entecavir) Pill usually taken once a day for many months and up to a year or more to treat Hepatitis B. Shown to be more effective for those with resistance to other Hepatitis B drugs such as lamivudine or adefovir.19 Common

  • Liver Cancer (10-12%)21 
  • Low albumin in the blood, which can cause swelling, weakness, fatigue, or cramps (10-30%)21,22
  • Increases the risk of dangerous bleeding by lowering the platelets in the blood (10-20%)21,23
  • Elevated lipase, which may indicate disease of the pancreas (10-18%)21,24
  • Swelling in your lower legs or hands (10-16%)21

Rare / Serious

  • Kidney failure (0.1-1%)21
  • Lactic acid buildup, which can be fatal ^ 25

Enlarged liver^ 25

Vemlidy (Tenofovir alafenamide) Pill usually taken once a day for many months and up to a year or more to treat Hepatitis B. Very similar advantages to Entecavir when compared to other drugs.19 Research is needed to directly compare this drug with Entecavir to see if one is more effective than the other.19 Common

  • Headache (1-12%)26
  • Abdominal pain (1-10%)26
  • Nausea (1-10%)26
  • Fatigue (1-10%)26        
  • Rash (1-10%)26

Rare / Serious

  • Lactic acid buildup, which can be fatal ^ 27
  • Enlarged liver^ 27
Mavyret (Glecaprevir and Pibrentasvir) Pill usually taken once a day for 8-16 weeks to treat Hepatitis C. Only drug approved by FDA for a shorter 8-week treatment period instead of the usual 12-week period for other drugs.28 Common

  • Headache (10-17%)29
  • Itchy skin (10-17%)29
  • Fatigue (10-16%)29
  • Nausea (10-12%)29

Rare / Serious

  • Reactivation of Hepatitis B (for those co-infected) ^ 30
  • Allergic reaction (which can cause swelling or difficulty breathing) ^ 30
Epclusa (Sofosbuvir and Velpatasvir) Pill usually taken once a day for 12 weeks to treat Hepatitis C. Only drug approved to treat Hepatitis C in children as young as 6 years old.31 It is also the first medication to treat all 6 Hepatitis C genotypes.20  Common

  • Fatigue (10-32%)32
  • Headache (10-29%)32
  • Anemia (10-26%)32
  • Nausea (10-15%)32

Rare / Serious

  • Reactivation of Hepatitis B (for those co-infected) ^ 33
  • Allergic reaction (which can cause swelling or difficulty breathing) ^ 33

^ frequency not reported

Avoid alcohol and smoking: Alcohol is well known to damage the liver; an analysis of 112 studies found that consuming an average of just one alcoholic drink a day was associated with a 10% greater chance of developing liver cancer.[34] The annual average is of 9.5 new cases and 6.6 deaths from liver cancer for every 100,000 adults in the U.S.,[1] but a review of 28 studies that analyzed almost 5,000 new cases of liver cancer and more than 10,000 liver cancer deaths found that moderate and heavy drinkers (at least 1 drink/day for females and at least 2 drinks/day for males) were 42% more likely to be diagnosed with liver cancer and 17% more likely to die from it.[35] 

Smoking also significantly increases the chance of developing liver cancer. A 2018 study of more than 1 million Americans found that current smokers were 86% more likely to be diagnosed with liver cancer than non-smokers. Fortunately, the study also found that individuals who quit smoking at least 30 years ago had the same risk of liver cancer as those who had never smoked, suggesting that younger smokers who decide to quit smoking now can significantly reduce their future risk of developing liver cancer.

Maintain a healthy weight: Studies consistently show that being overweight or obese increases the risk of developing liver cancer;[36] In one analysis of 11 different studies, even after most studies controlled for the effects of age, sex, smoking, and other health conditions, being overweight (BMI between 25-30) increased the risk of liver cancer by 17%, while being obese (BMI 30 or above) increased the risk by 89%.[37] For example, one of the studies, of more than 780,000 Korean men, found a rate of liver cancer of 43 out of every 100,000 for men with a healthy weight (BMI 18.5-25), compared to 66 for every 100,000 for men who were obese.[38] This may be because fat tissue that accumulates in the liver can cause damaging inflammation, which may then lead to liver cancer.[36]

Taking steps to maintain a healthy weight through diet and exercise can therefore reduce the chances of developing liver cancer. An important question is whether losing weight through bariatric surgery also reduces the chances of developing liver cancer.[36] For example, in a study of 190 morbidly obese individuals with non-alcoholic steatohepatitis (a type of fatty liver disease that increases the risk of liver cancer), 85% were rid of the disease one year after bariatric surgery.[39] However, more long-term research is needed to investigate whether bariatric surgery reduces the risk of liver cancer or whether other factors are influencing those better outcomes.[36] For example, in a 2022 study, more than 5,000 adults with obesity who received bariatric surgery and more than 25,000 patients who received nonsurgical care were followed for an average of 6 years. While bariatric surgery patients had a lower rate of liver cancer (9 versus 15 cases per 100,000 people per year), this difference was not statistically significant when adjusted for other factors such as age, sex, smoking status, and medication use.[40]  That means that the differences were probably due to those other traits, not to the bariatric surgery itself.

References:

  1. Cancer of the Liver and Intrahepatic Bile Duct – Cancer Stat Facts. SEER. Accessed August 4, 2022. https://seer.cancer.gov/statfacts/html/livibd.html
  2. Key Statistics About Liver Cancer. Accessed August 4, 2022. https://www.cancer.org/cancer/liver-cancer/about/what-is-key-statistics.html
  3. Survival | Liver cancer | Cancer Research UK. Accessed August 9, 2022. https://www.cancerresearchuk.org/about-cancer/liver-cancer/survival
  4. Budiman A, Ruiz NG. Key facts about Asian Americans, a diverse and growing population. Pew Research Center. Published 2021. Accessed December 16, 2021. https://www.pewresearch.org/fact-tank/2021/04/29/key-facts-about-asian-americans/
  5. Chronic Liver Disease and Asian Americans – The Office of Minority Health. Accessed August 4, 2022. https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=47
  6. The Warning Signs of Liver Cancer. Verywell Health. Accessed August 4, 2022. https://www.verywellhealth.com/liver-cancer-symptoms-514170
  7. Liver cancer – Symptoms and causes. Mayo Clinic. Accessed August 4, 2022. https://www.mayoclinic.org/diseases-conditions/liver-cancer/symptoms-causes/syc-20353659
  8. Lee S. Liver metastases. Canadian Cancer Society. Accessed August 4, 2022. https://cancer.ca/en/cancer-information/cancer-types/metastatic/liver-metastases
  9. Viral Hepatitis and Liver Cancer. Published online 2016:3.
  10. Policy (OIDP) O of ID and H. Hepatitis C Basic Information. HHS.gov. Published April 10, 2016. Accessed August 5, 2022. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/hepatitis-c-basics/index.html
  11. Hepatitis C – Symptoms and causes. Mayo Clinic. Accessed August 5, 2022. https://www.mayoclinic.org/diseases-conditions/hepatitis-c/symptoms-causes/syc-20354278
  12. Schillie S. CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020. MMWR Recomm Rep. 2020;69. doi:10.15585/mmwr.rr6902a1
  13. Policy (OIDP) O of ID and H. Viral Hepatitis in the United States: Data and Trends. HHS.gov. Published April 20, 2016. Accessed August 5, 2022. https://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/data-and-trends/index.html
  14. What’s the Difference: Hepatitis B vs Hepatitis C? Hepatitis B Foundation. Published January 9, 2019. Accessed August 5, 2022. https://www.hepb.org/blog/whats-the-difference-hepatitis-b-vs-hepatitis-c/
  15. Sexual Transmission and Viral Hepatitis | CDC. Published April 22, 2021. Accessed August 5, 2022. https://www.cdc.gov/hepatitis/populations/stds.htm
  16. CDC. Hepatitis B and the Vaccine (Shot). Centers for Disease Control and Prevention. Published August 2, 2019. Accessed August 5, 2022. https://www.cdc.gov/vaccines/parents/diseases/hepb.html
  17. CDC. Hepatitis B – Vaccination of Adults | CDC. Centers for Disease Control and Prevention. Published March 28, 2022. Accessed August 5, 2022. https://www.cdc.gov/hepatitis/hbv/vaccadults.htm
  18. hepbtalk. Hepatitis B in Asian Populations. Hepatitis B Foundation. Published December 23, 2020. Accessed August 5, 2022. https://www.hepb.org/blog/hepatitis-b-asian-populations/
  19. Chen LP, Zhao J, Du Y, et al. Antiviral treatment to prevent chronic hepatitis B or C-related hepatocellular carcinoma. World J Virol. 2012;1(6):174-183. doi:10.5501/wjv.v1.i6.174
  20. Hepatitis C Medications: A Full List. Healthline. Published May 4, 2022. Accessed August 10, 2022. https://www.healthline.com/health/hepatitis-c/full-medication-list
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Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?

Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022


As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent.  I recently wrote to the mayor, superintendent of schools and members of the Westfield Town Council and Board of Education to share scientific information about artificial turf and playground surfaces. I want to provide the same information to you, so you can determine what is best for Westfield.

As president of the National Center for Health Research, I have testified about these products to local, state and federal agencies and legislators; parents; and others who want to ensure that our children are not exposed to dangerous chemicals that can harm them now or as they grow up. Our nonprofit think tank includes scientists, physicians and health experts who conduct studies and scrutinize research conducted by others. We explain scientific and medical information that can be used to improve policies, programs, services and products.

Toxic Chemicals in Artificial Turf and Infill Materials

In recent years, scientists have learned about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that are available to replace tire crumb and that are used in rubber playground surfaces. Tire crumb and rubber have well-known risks, containing chemicals that increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.

PFAS are of particular concern because they enter the body and the environment as “forever chemicals.” They are not metabolized and do not deteriorate, accumulating over the years. PFAS can cause liver damage and other serious health problems.  PFAS from artificial turf can get into groundwater, streams, etc. and from there into drinking water. New Jersey has one of the most stringent standards for PFAS in drinking water.

Replacing tire waste with silica, zeolite and other infill materials also has substantial risks.  For example, it is well known that “particulate matter” can cause lung problems and eventually cause lung cancer.

Evidence of Harm vs. Evidence of Safety

Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals (found in artificial turf and plastic) can be dangerous at very low levels, and also when they combine with other exposures in our environment.  That is why the U.S. Consumer Product Safety Commission has banned these chemicals from toys, pacifiers, teething toys and other products used by young children.

Companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

It is true that there no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can tell you that for decades there was no evidence that smoking or 9/11 exposures caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf.

We know that the materials used in artificial turf and rubber playground surfaces contain carcinogens.  When children are exposed to those carcinogens day after day, week after week, and year after year, it increases the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community.

I grew up in New Jersey and know that when the weather is warm and/or sunny, it is usually quite pleasant to be outside. But when the temperature above the grass is 80 degrees Fahrenheit, artificial turf and rubber playground surfaces can reach 150 degrees or higher. A sunny 90-degree day could exceed 160 degrees on these surfaces. These temperatures can cause “heat poisoning” as well as burns.

Bottom Line

There have never been any safety tests required prior to sale that prove that any artificial turf products are safe for children who play on them regularly. In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields.

Officials in communities all over the country have been misled by artificial turf salespeople and scientists hired to lobby. They were erroneously told that these products are safe. On the contrary, there is clear scientific evidence that these materials are harmful. The only question is how much exposure is likely to be harmful to which children? We should not be willing to take such a risk. Our children deserve better.

I am not paid to write to you or to speak at meetings on this topic. I do so because I care about the health of my children and yours.

To read the entire op-ed on the Tap on Westfield website, click here.

Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass

Los Angeles Times and Yahoo News, September 7, 2022


To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story.

Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On a warm, sunny day, when grass fields are about 90 degrees, artificial turf fields are often 150 degrees or hotter; my organization has measured temperatures up to 180 degrees. Rubber playground surfaces are similarly hot.

Artificial turf is sometimes installed in an effort to save water, but unfortunately, artificial turf must be watered to prevent it from getting so hard that it can cause injuries when children fall.

Scientists have clearly documented the dangers of artificial turf, including heat and PFAS and other chemical exposures, but their concerns are regularly ignored by school boards and other community decision makers. The Times can contribute to the health and safety of children across the country by examining what these dangers are and why they are being ignored.

Diana Zuckerman, Washington

The writer is president of the National Center for Health Research.

This letter originally appeared in Los Angeles Times.

Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust

Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022


A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say.

The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a reminder of how allegations of behind-the-scenes political pressure can influence the public’s perception of federal health agencies’ independence.

“When things are happening behind closed doors, it’s easier for people to try to mess with the FDA,” said Joshua M. Sharfstein, who served as the FDA’s second-in-command during the first two years of the Obama administration.

“The more transparent FDA is, the harder it is for someone to come in and try to interfere with decisions,” he added.

The report comes as positive ratings of the US public health system dropped by nearly 10 percentage points over the past decade, according to a May 2021 joint study by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Former federal officials and policy watchers say the FDA must maintain transparency in decision making to prevent external influence, especially as the agency oversees several ongoing health priorities—including authorization requests for omicron-specific Covid-19 vaccines and responses to the growing monkeypox outbreak.

The latest findings have garnered mixed reactions, with some policy watchers saying it shows the FDA defended scientific evidence in the face of efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies.

FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority of his tenure. And “throughout the pandemic, the FDA career staff has worked around-the-clock to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” agency spokesman Michael Felberbaum said in an emailed statement.

Building Resiliency

The subcommittee’s document, which also alleges efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency pandemic responses.

Many of the Trump administration’s alleged attempts to interfere happened behind closed doors, though the report found the FDA stood up to pressure to keep hydroxychloriquine around after data showed it lacked efficacy as a Covid-19 treatment. The FDA authorized the drug in March 2020 as a treatment for certain hospitalized Covid-19 patients. It revoked the emergency use authorization in June 2020.

Meanwhile, the FDA muscled guidance past the White House that made clear the agency wouldn’t let politics tamper with its decisions, all while facing pressure to authorize vaccines before the 2020 election.

Former FDA Commissioner Stephen Hahn said in an interview with the subcommittee that chief of staff Mark Meadows and other White House officials had “objections” to vaccine guidance language requiring that manufacturers submit at least two months of follow-up safety data for late-stage clinical trials. Hahn said he resisted attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”

[….]

Fighting Misinformation

Califf’s efforts to highlight the dangers of the pandemic’s rise in health misinformation is one way to rebuild public trust in the FDA, although the overall effort will be a challenge, policy analysts say.

“There are some people for whom I think it will be difficult, if not impossible, to regain their trust,” Diana Zuckerman, president of the National Center for Health Research and a former senior policy adviser to the Clinton White House, said. “It’s not really that much the fault of anything that the FDA did; it’s the fault of the misinformation they’re getting from news sources or social media.”

Califf wrote in an Aug. 22 article in the Journal of the American Medical Association that “the global information environment has been contaminated by misinformation and disinformation.”

“The FDA must be more proactive in preempting and countering misinformation,” he said, adding that there’s also a need for “collaboration across sectors to create an information environment in which decisions” by “consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”

Zuckerman argued that “Commissioner Califf has made it clear that he will not let the FDA’s reputation be undermined by misinformation.”

“He’s not going to have a political hack telling him what to do or say, and he’s shown a commitment to focusing on the science and protecting the reputation of the FDA,” she said.

To read the entire article, click here.

Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine

July 26, 2022

Thank you for the opportunity to speak today on how current FDA policies contribute to health inequities.

The National Center for Health Research is a nonprofit think tank founded in 1999 that conducts research and scrutinizes research conducted by others to evaluate medical products, procedures, and policies. We do not accept funding from companies whose products we evaluate.

There are many reasons for health inequities in the U.S., but today I will focus on one that usually gets no attention: Federal laws regarding diversity in clinical trials.

The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. This is not always enforced, but the requirement is in the law and NIH, CDC, SAMHSA and other agencies make an effort to abide by this law.

The one exception among federal public health agencies is the FDA, which encourages but does not require diversity in clinical trials. They justify this because the agency doesn’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers do pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.

Our NCHR Study of Racial Diversity

To see the impact of the lack of a requirement for FDA, we examined 22 of the highest risk medical devices reviewed by the FDA Advisory Panels for 4 recent years. We found:

  • The number of nonwhite patients in key trials ranged from 4 (3%) to 6,788 (17%).
  • Of 19 treatment devices, only 7 had analyses for racial groups for effectiveness and only 3 for safety.
  • 69% to 99% of the patients in the studies were White. The number of nonwhites was as low as 4; 1 for Hispanics.
  • There were too few patients in most racial or ethnic groups to draw meaningful conclusions.
  • Even when subgroup analyses were conducted, their conclusions were often discredited by the FDA, blamed on chance differences due to small sample size. If there was a lack of diversity or even when racial or ethnic differences were significant, that information was were often not included on the label, which is the main source of information for physicians and patients.

    Recent Examples from the FDA

    When the FDA reviewed the data on Aduhelm for Alzheimer’s Disease, they focused on 2 studies comparing placebo to high and low dosage:

    Study 301: 8 Black patients (half of 1%) and 37 Hispanic patients (2%)
    Study 302: 11 Black patients (less than 1%) and 67 Hispanic patients (4%)

    When the FDA reviewed data on the Reducer circulatory system device for angina, they found that there were no Black or Hispanic patients, and more than 80% of the patients were White or male, or both. And yet, most patients with angina are not White males.

    Why is Diversity Important in Clinical Trials?

    Response to treatment can vary due to genetics, health habits, metabolism, body part size/shape and other factors. If you exclude certain groups, you don’t know what works best for them. Keep in mind that you need enough patients to study safety and effectiveness for patients in each group.

    Example – Lutonix drug-coated balloon catheter to open blocked arteries

    You can see on this graph that the device seemed effective compared to the control group when men and women were combined. However, you can also see that the device was only effective for men, not for women. In fact, women did better with placebo. This is an example of how evaluating safety and effectiveness for a specific demographic group can provide information that is completely different from an analysis of a diverse group as a whole.

    Shortcomings of Very Small Samples

    When the racial or ethnic group is very small, the results may not be generalizable to the larger population that those patients represent. A few outliers can have an outsized effect on the outcomes – resulting in significant differences where they do not exist. Or, real differences may be apparent but not be statistically significant because the sample lacks statistical power.

    If an analysis is conducted on a small number of patients of a particular ethnic group, any differences could easily be due to chance. For example, the graphic below shows that the new drug seems to be more effective than an older drug (40% effective compared to 30% effective) , but that difference is not statistically significant. However, if the same difference was based on a much larger sample, it would be statistically significant.

    In conclusion, when the FDA approves a medical product that has not been evaluated on a relatively large number of patients in a specific racial or ethnic group, it is not possible to conclude whether the product is safe or effective for members of that group. If the FDA does not require adequate diversity in clinical trials used as the basis for FDA approval, then the agency should only approve those products for the types of individuals studied. That precision in approval decisions would create the incentive needed for companies to improve diversity in their trials and conduct appropriate subgroup analyses.

    Reference
    1. Fox-Rawlings SR, Gottschalk LB, Doamekpor LA & Zuckerman DM. (2018) Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly, Vol 96 (3) 499-529.

    Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women

    August 23, 2022

    I’m pleased to have the opportunity to provide this statement on behalf of the National Center for Health Research. We are a nonprofit research center, and our largest program is focused on cancer prevention and treatment. I previously worked at the White House office of Science and Technology Policy, the U.S. Department of Health and Human Services, the U.S. House and Senate, Harvard, and Yale. I am also a breast cancer survivor.

    Today I want to mention an issue that hasn’t been talked about: fear. Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.

    Despite their fear, few women of any age know that diet and exercise help prevent breast cancer. You’ve heard today that alcohol increases the risk of breast cancer, but did you know that drinking more than 3 alcoholic beverages per week can raise the risk of breast cancer? We all know young women who drink much more than that. We should also educate young women about the link between cancer and ultra-processed foods – I’m not just talking about the usual culprits, I’m talking about sauces and many other prepared foods that we assume are healthy when we buy them at the supermarket. In addition, being overweight or obese also increases the risk of breast cancer and of recurrence, because fat cells make more estrogen. We should be educating young women about these strategies for reducing their risks, since these are changes they can control.

    Research shows that more women undergo mastectomies and bilateral mastectomies in the U.S. than most comparable countries. And yet, research shows that early-stage breast cancer patients who undergo lumpectomy (BCT) and radiation live longer with better quality of life than early-stage mastectomy patients, and a study of more than 23,000 young women with early-stage breast cancer found that the 10-year survival rate was at least as good for BCT plus radiation as for mastectomy. Research is needed to see how outcomes vary among women with specific demographic traits and risk factors, but the research available thus far is reassuring. On a personal note, as a professional in the field, I was shocked when my breast surgeon repeatedly urged me to consider a bilateral mastectomy for Stage 1 breast cancer. I had heard from many other women who had similar experiences. I am sure women who aren’t experts in the field, and especially young women, are being influenced by that kind of pressure.

    In addition to all the other important issues raised by this committee today, I want to add that we should make sure that young women understand the difference between lifetime risk of breast cancer and their annual risk of developing breast cancer. And the difference between DCIS and invasive breast cancer. Educating young women can help reduce their fear and help enable them to take the time they need to advocate for themselves based on the information needed to make the treatment decisions that are best for them.

    One last suggestion: We’ve heard many great ideas today about the information that primary care physicians, OB/GYNs, and the public need to know about young women and breast cancer, as well as prevention and treatment strategies. Wouldn’t it be great if CDC put together an education campaign on some of these key issues, to be shown on TV so it reaches a large audience?