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2018 Foremother and Health Policy Hero Awards Luncheon

National Center for Health Research, May 4, 2018

Friday May 4 is our Annual Awards luncheon at the Mayflower Hotel!

Every year, we take time off from our research and public education to thank women and men who have improved our lives.

The Foremother Lifetime Achievement Award recognizes women who expanded women’s horizons, improved our communities, and made remarkable contributions to our country.  We let them know what an honor it is to follow in their formidable footsteps.

We also recognize Health Policy Heroes. This award honors men and women (and perhaps boys and girls) who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide.


Please join our wonderful Emcee Maureen Bunyan as we celebrate
the National Center for Health Research’s
2018 Foremothers Lifetime Achievement and Health Policy Heroes Awards Luncheon
Friday, May 4, 2018 at Noon
The Mayflower Hotel
1127 Connecticut Ave NW
Washington, DC 20036
Please join us at the elegant Mayflower Hotel in Washington, D.C. as we celebrate these inspiring honorees.
Help us celebrate the amazing women who are our 2018 Foremother Lifetime Achievement honorees for careers that made all our lives better and broke down barriers for other women:
Dr. Rita Colwell is an extraordinary scientist whose work has successfully fought cholera and created safer water supplies around the world, saving lives while breaking down many barriers for women in science. She was the first woman to serve as Director of the National Science Foundation (NSF), presiding over a doubling of the NSF budget. She has won numerous other scientific awards over more than 40 years, including the National Medal of Science presented by then-President George W. Bush, and the Medal of Distinction from Columbia University. She previously served as the President of the American Association for the Advancement of Science (AAAS) and is a member of the prestigious National Academy of Sciences (NAS).
Lynn Povich is an award-winning journalist who began her career as a secretary atNewsweek magazine. She was one of 46 women who filed sex discrimination charges against the magazine in 1970, an experience that 40+ years later inspired her book THE GOOD GIRLS REVOLT, and the Amazon TV series that was soon followed by #MeToo. The law suit was groundbreaking, and she subsequently became the first woman appointed Senior Editor at Newsweek. Ms. Povich later became Editor-in-Chief of Working Womanmagazine and then joined as East Coast Managing Editor. She also edited a book of columns by her father, famous sports writer Shirley Povich.  She serves on the Advisory Boards of the International Women’s Media Foundation, the Women’s Rights Division of Human Rights Watch, and the CUNY Graduate Center Foundation Board.
Our Health Policy Heroes are the students, teachers, and parents of Parkland, Florida; Washington, D.C. metro area; and across the country who are successfully fighting for effective policies to prevent gun violence. Parkland teacher Susan Rioux will be one of the heroes accepting the award on their behalf. Ms. Rioux is credited with having taught Parkland students how to find safety in violent situations, thus saving their lives during the February 14 shooting. She is now one of those helping the children cope with PTSD and fear in the aftermath and supporting their efforts to reduce gun violence.
We hope you will take advantage of this great opportunity to meet these inspiring women, previous honorees, and many of D.C.’s other movers and shakers. Lunch is from noon to 1:30, preceded by a 11:30 champagne reception for honorees, patron guests, and sponsors only.

Prices below are valid through April 21.

Seats are limited and tickets are not available at the door.

Regular lunch tickets are available for a donation of $110 each. Patron Tickets ($175 per ticket) include a champagne reception with honorees at 11:30, priority seating, and a listing in the program. A Patron table for 10 is $1,750. Sponsorships are also available, from $1,800-$6,000.

The National Center for Health Research is the leading national organization dedicated to improving the health and safety of all adults and children. Donations for this event support our Cancer Prevention and Treatment Fund helpline.

To reserve a ticket, you may donate online here. Or, send a check payable to “NCHR,” to 1001 Connecticut Ave, Suite 1100, Washington, DC 20036.

Be sure to indicate it is for the Awards Luncheon.

For more info, contact Alex Pew at or (202)223-4000.

US Regulators Float Ideas for Boosting Medical Device Safety

Matthew Perrone, The Associated Press: April 17, 2018

U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.

Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

“We want to have better tools for detecting issues that occur post-approval,” FDA Commissioner Scott Gottlieb said Tuesday. “But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening.”

An agency critic said the report contains few concrete changes and “many sections that will please the device industry.”

“FDA’s safety strategies for medical devices are still years away from effective implementation,” said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. “Overall, the report indicates that the FDA’s approval standards for medical devices remain completely inadequate.” […]

Among other proposals laid out in the FDA’s “Medical Device Safety Action Plan,” the FDA will consider:

— How to quickly require additional safety requirements for certain devices, including training for doctors who work with the complex devices.

— Extra scrutiny of devices for women, following recent problems with vaginal mesh, the birth control implant Essure and surgical tools.

— New ways to encourage manufacturers to improve safety, including quicker approval for devices that appear safer than what’s available.

— Requiring cybersecurity features for electronic devices like implantable heart pacemakers and defibrillators.

The agency will also ask Congress for more money for a public-private system intended to monitor insurance claims, electronic health records and other data sources for early signs of device problems. The project is estimated to cost $250 million over five years to become operational; it is now slated to receive $30 million from device manufacturers.

Read the original article here.

Comments by Diana Zuckerman, Ph.D. on the U.S. Consumer Product Safety Commission Agenda and Priorities for FY2019/2020

Diana Zuckerman, PhD, National Center for Health Research,April 11, 2018

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues. We conduct studies, we scrutinize research done by others, and we try to make sense of conflicting research findings.  Our goal is to explain that information so it can be used to improve policies, programs, services, and products.  Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal year 2019 and 2020. We respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

I’m trained as an epidemiologist at Yale Medical School, and I was on the faculty at Yale and Vassar and a researcher at Harvard before moving to Washington, D.C. as a Congressional Fellow in the program sponsored by the American Association of the Advancement of Science (AAAS).  While our Center’s mission overlaps with much of the work of the CPSC, today I will talk as a scientist about safety risks that you don’t hear as much about – the ones that we can’t see.

We are surrounded by chemicals in the air we breathe, the table in front of me, and the dust in the room.  Today I will focus on three issues involving chemicals in products that affect our health and our children’s health. These issues are clearly consistent with the CPSC priorities. We are very concerned about flame retardants and phthalates, both of which migrate out of products and into the dust we breathe and touch. We’re also very concerned about artificial turf fields and playgrounds, which contain a range of endocrine-disrupting chemicals and other toxic materials that can harm children’s development and possibly increase risk for cancer as these children grow up.

Organohalogen Flame Retardants

Thank you for voting to initiate rulemaking on non-polymeric organohalogen flame retardants (OFRs) and to provide guidance for manufacturers, distributors, and retailers to avoid OFRs.1 We urge you to convene a Chronic Hazard Advisory Panel (CHAP) as soon as possible and develop regulations to address OFRs in children’s products, upholstered residential furniture, mattresses/mattress pads, and the plastic casing of electronic devices. In addition, it is essential to consider current flammability standards to determine if there are changes that would improve their safety from both chemical exposures and potential fire.

Since OFRs are not bound to products, they migrate out of products and into dust, and thus get onto our skin and food as well as into the air we breathe. Because so many products are made with these chemicals and because they are so long-lasting, consumers are repeatedly exposed day after day.2,3 In addition, many OFRs bioaccumulate in our food supply.4,5,6,7 As a result, nearly all people in the U.S. have OFRs in their bodies. 8

OFRs have been associated with various health problems, including disrupting hormones, altering brain development, and harming reproductive health, such as reduced ability to get and stay pregnant and the timing of puberty.5,9,10,11 While not all OFRs have been sufficiently studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

While we recognize that the Commission must be concerned about fire hazards as well, it seems that these flame retardants may not be effective at preventing deaths in real world situations.12,13 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Artificial Turf and Playground Surfaces

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. This requires your immediate attention, because artificial turf fields are becoming increasingly popular surfaces for fields and playgrounds where children are exposed day after day, year after year. And yet, the materials used are often treated as “trade secrets” making it impossible to know exactly what they are, which ones are safer, and which ones are more dangerous. We encourage you to closely evaluate the research that has been done, focusing on independently funded research rather than industry claims. We also urge you to carefully examine the EPA/CDCs studies when they are completed, and to develop rules that will protect our children from harm. We urge you to convene a Chronic Hazard Advisory Panel (CHAP) to examine the short-term and long-term risks of different types of artificial turf used in playing fields and children’s playgrounds.

Crumb rubber contains chemicals with known health concerns, which are released into the air and onto skin and clothing and even into children’s ears and noses. This is inevitable for a product that is outdoors and in constant use. The chemicals include endocrine disruptors such as phthalates, heavy metals such as lead and zinc, as well as other carcinogens and skin irritants such as some polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs).14,15,16,17,18,19 While one time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures over the years, especially during critical developmental periods, raise the likelihood of serious harm.

These fields can also cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.20,21 Fields heat up to temperatures far higher than ambient temperature, reaching temperatures that are more than 70 degrees warmer than nearby grass; for example, 180 degrees when the temperature is in the high 90’s and 150-170 degrees on a sunny day when the air temperature is only in the 70’s. 22,23,24 This can cause heat stress and burns.

Fields made of crumb rubber have been marketed as reducing injuries compared to grass. However, research has shown that this is not the case. We have spoken to students harmed by turf burn, and some studies have indicated increased risk for joint injuries and brain injury.25,26

We need to know more about the risks of “virgin rubber” compared to “recycled tires.” However, we already know that “virgin” rubber is made from many of the same chemicals that have these health concerns.27,28

Phthalates in Children’s and Household Products

CPSC has helped millions of American children by finalizing the phthalate rule to ban five additional phthalates (DINP, DPENP DHEXP, DCHP, DIBP) in children’s toys and care products.

The next priority should be for CPSC to expand its work on phthalates to include other household products. Children are exposed to many products with the same phthalates as those that are banned in toys and products specifically for children. Restricting the use of phthalates in common household products would reduce exposure for young children and also older children, pregnant women and other adults. Phthalates in household dust can be harmful regardless of what products it comes from and prenatal exposure is of particular concern.

Phthalate exposure has been associated with an increased risk for early puberty and reproductive problems.29,30,31 In utero exposure or exposure through breast milk puts the developing fetus, neonate, or infant at serious risk of abnormal neurological and reproductive development.32

In conclusion, endocrine disruptors and chemicals in common consumer products that do not stay bound to those products get into the air and dust and thus into our bodies. These chemicals tend to pose greater risks to fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market. Ideally, all of these chemicals would be evaluated in the final product for health concerns before it was sold. Since that is not happening, we must constantly play catch-up as health concerns are identified. Too often this leads to cases of false claims regarding the safety of new products that we later learn are as harmful or even more harmful that the ones they are replacing. While research is lacking regarding the exact extent of the dangers of many of these products, there is already sufficient evidence to cause concern. We need CPSC to address those as soon as possible.


  1. Consumer Product Safety Commission. (2017) Guidance document on hazardous additive, non-polymeric organohalogen flame retardants in certain consumer products.
  2. Gramatica P, Cassani S, Sangion A. (2016) Are some “safer alternatives” hazardous as PBTs? The case study of new flame retardants. J Hazard Mater. 306:237-246.
  3. Allgood JM, Vahid KS, Jeeva K, Tang IW, Ogunseitan OA. (2017) Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Sci Total Environ. 609:272-276.
  4. Lupton SJ, Hakk H. (2017) Polybrominated diphenyl ethers (PBDEs) in US meat and poultry: 2012-13 levels, trends and estimated consumer exposures. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 34(9):1584-1595.
  5. Lyche JL, Rosseland C, Berge G, Polder A. (2014) Human health risk associated with brominated flame-retardants (BFRs). Environ Int. 74:170-180.
  6. Schecter A, Colacino J, Patel K, Kannan K, Yun SH, Haffner D, Harris TR, Birnbaum L. (2010) Polybrominated diphenyl ether levels in foodstuffs collected from three locations from the United States. Toxicol Appl Pharmacol. 243(2):217-24.
  7. Widelka M, Lydy MJ, Wu Y, Chen D. (2016) Statewide surveillance of halogenated flame retardants in fish in Illinois, USA. Environ Pollut. 214:627-634.
  8. Centers for Disease Control and Prevention (2015) Fourth national report on human exposure to environmental chemicals, updated tables. http:/
  9. Dishaw L, Macaulay L, Roberts SC, Stapleton HM. (2014) Exposures, mechanisms, and impacts of endocrine-active flame retardants. Curr Opin Pharmacol. 0:125-133.
  10. Hendriks HS, Westerink RHS. (2015) Neurotoxicity and risk assessment of brominated and alternative flame retardants. Neurotoxicol Teratol. 52:248-269.
  11. Kim YR, Harden FA, Toms LM, Norman RE. (2014) Health consequences of exposure to brominated flame retardants: A systematic review. Chemosphere 106:1-19.
  12. McKenna S, Birtles R, Dickens K, Walker R, Spearpoint M, Stec AA, Hull TR. (2018) Flame retardants in UK furniture increase smoke toxicity more than they reduce fire growth rate. Chemosphere. 196:429-439.
  13. Shaw SD, Blum A, Weber R, Kannan K, Rich D, Lucas D, Koshland CP, Dobraca D, Hanson S, Birnbaum LS. (2010) Halogenated flame retardants: Do the fire safety benefits justify the risks? Rev Environ Health 25:261-305.
  14. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, et al. (2013) Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 90(2):423-431.
  15. Marsili L, Coppola D, Bianchi N, Maltese S, Bianchi M, Fossi MC. (2014) Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 5:(2).
  16. California Office of Environmental Health Hazard Assessment (OEHHA). (2007) Evaluation of health effects of recycled waste wires in playground and track products. Prepared for the California Integrated Waste Management Board.
  17. Kim S, Yang J-Y, Kim H-H, Yeo I-Y, Shin D-C, and Lim Y-W. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 27, e2012005.
  18. S. National Library of Medicine, National Institutes of Health. (2017) Tox Town (Environmental health concerns and toxic chemicals where you live, work, and play): Polycyclic aromatic hydrocarbons (PAHs).
  19. Armstrong B, Hutchinson E, Unwin J, and Fletcher T. (2004) Lung cancer risk after exposure to polycyclic aromatic hydrocarbons: a review and meta-analysis. Environmental Health Perspectives, 112(9), 970.
  20. Shalat SL. (2011) An evaluation of potential exposures to lead and other metals as the result of aerosolized particulate matter from artificial turf playing fields. Submitted to the New Jersey Department of Environmental Protection.
  21. Mount Sinai Children’s Environmental Health Center. (2017) Artificial turf: A health-based consumer guide.
  22. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. (2014) Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 72:895-900.
  23. Penn State’s Center for Sports Surface Research. (2012) Synthetic turf heat evaluation- progress report.
  24. Serensits TJ, McNitt AS, Petrunak DM. (2011) Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 225(3), 139-146.
  25. Balazs GC, Pavey GJ, Brelin AM, Pickett A, Keblish DJ, Rue JP. (2015) Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 43(7):1798-804.
  26. Theobald P, Whitelegg L, Nokes LD, Jones MD. (2010) The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: a comparative biomechanical analysis. Sports Biomechanics. 9(1):29-37.
  27. Canepari S, Castellano P, Astolfi ML, Materazzi S, Ferrante R, Fiorini D, Curini R. (2018) Release of particles, organic compounds, and metals from crumb rubber used in synthetic turf under chemical and physical stress. Environ Sci Pollut Res Int. 25(2):1448-1459.
  28. Kim S, Yang JY, Kim HH, Yeo IY, Shin DC, Lim YW. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environ Health Toxicol. 27:e2012005.
  29. Chen Q, Yang H, Zhou N, Sun L, et al. (2017) Phthalate exposure, even below US EPA reference doses, was associated with semen quality and reproductive hormones: Prospective MARHCS study in general population. Environ Int. 104:58-68.
  30. Mariana M, Feiteiro J, Verde I, Cairrao E. (2016) The effects of phthalates in the cardiovascular and reproductive systems: A review. Environ Int. 94:758-776.
  31. Yi Wen, Shu-Dan Liu, Xun Lei, Yu-Shuang Ling, Yan Luo, and Qin Liu.(2015) Association of PAEs with precocious puberty in children: A systematic review and meta-analysis. Int J Environ Res Public Health. 12(12): 15254–15268.
  32. Consumer Product Safety Commission. (2014) Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives.

CMS Payment Rule Seen as Bad for Some Patients

Joyce Frieden, MedPage Today, April 10, 2018

New final regulations on the Affordable Care Act (ACA) health insurance exchanges issued by the Centers for Medicare & Medicaid Services (CMS) have drawn mixed reactions from health policy experts and others.

The rule makes a number of changes to the exchanges, including:

  • Expanding the number of “benchmark” plans from which states can choose to model their coverage of the 10 “essential health benefit” (EHB) categories included in the ACA, potentially allowing states to choose plans with more generous or skimpier coverage than is currently offered on their exchanges.
  • Adding several new “hardship exemptions” to allow consumers to avoid paying a penalty for not buying health insurance. One exemption is for consumers who live in an area in which there are no health plans offered for them on the exchange, or only a single plan offered which is unaffordable. Another exemption is for consumers who live in an area in which the only health plans offered provide coverage of abortions, in cases where that conflicts with the consumer’s personal beliefs.
  • Allowing states to adjust the “medical loss ratio,” which determines what percentage of a health insurer’s revenue must be used for paying healthcare costs. Currently, according to the ACA, health insurers must spend at least 80% of their revenue on healthcare claims and quality improvement, with the rest going toward overhead and profit.
  • Increasing the percentage premium increase which requires review by insurance regulators. Under current ACA rules, review is triggered if an insurer requests to increase rates by an average of 10% or more; the new regulations increase that threshold to 15%.

“The final rule will mitigate the harmful impacts of Obamacare and empower states to regulate their insurance market,” CMS said Monday in a press release on the regulations. “The rule will do this by advancing the Administration’s goals to increase state flexibility, improve affordability, strengthen program integrity, empower consumers, promote stability, and reduce unnecessary regulatory burdens imposed by the Patient Protection and Affordable Care Act.” The release also asserted that the ACA “has led to higher premiums and fewer choices” and that the ACA “has priced many consumers out of the insurance market.”

Premium Increases for Comprehensive Plans

“The plan to allow the sale of policies with skimpier essential health benefits will inevitably cause premiums for good health insurance policies (the kind currently available through the ACA) to increase,” Diana Zuckerman, PhD, president of the National Center for Health Research, an organization that conducts, analyzes, and explains health-related research, wrote in an email.

“If very healthy people can buy skimpy health insurance policies, then people who know that they have health problems will be the only ones buying the better policies — resulting in an increase in costs. In other words, people with pre-existing health conditions such as cancer, heart disease, diabetes, and rare diseases, will be paying much more than anyone else — an outcome that most Americans do not want. The bottom line is that the result of these regulations will be exactly the opposite of the stated goal: rather than making healthcare more affordable, this would make health care much less affordable for the people who need it most.” […]

Read the original article here.

Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?

Emily Kopp, Sydney Lupkin, and Elizabeth Lucas, Kaiser Health News: April 6, 2018

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.” […]

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said. […]

Read the original article here.

NCHR Letter to the Senate on Right To Try

National Center for Health Research, March 23, 2018

Dear Senators,

We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. We agree with the idea that terminally ill patients should have access to potentially life-saving medical treatments, and understand that some terminally ill patients are willing to take big risks to have a chance to live longer. If they want access to experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.

That is supposed to be the goal of the federal Right to Try bill, but it fails. That is why four previous FDA Commissioners as well as the American Cancer Society; American Lung Association; National Physicians Alliance; American Society of Clinical Oncology (ASCO); Cystic Fibrosis Foundation; International Society for Stem Cell Research; National Consumers League; National Health Council; National Organization for Rare Disorders (NORD); Vietnam Veterans of America; and dozens of other patient and public health organizations oppose the bill, as we do.

We have spoken to families whose efforts to “try anything” made their loved ones’ remaining days miserable and left their families even more devastated. The House bill has a very loose definition of which patients would be eligible (since many patients with diabetes and heart disease have conditions that can cause irreversible damage that will cause premature death). In addition, it provides access to any drug that has passed Phase I clinical trials, which often don’t include even one patient. Instead Phase I trials can include healthy volunteers, such as college students, who are much less likely to be harmed by an experimental drug than a terminally ill patient.

Another problem is that these very preliminary (Phase I) clinical trials usually include very small numbers of people, and do not study whether or not a medical product has any benefit at all. They are designed to determine the immediate risks on just a few healthy volunteers or patients. That is why 85% of drugs that pass Phase I clinical trials are never proven safe and effective and never approved by the FDA.

Fortunately, the FDA’s current Expanded Access program requires at least some evidence that an experimental treatment could potentially be helpful. The FDA uses compassionate waivers when doctors request them for very ill patients, and FDA agrees to such requests 99% of the time.

The GAO’s July 2017 report on the FDA’s current Compassionate Use/Expanded Access program pointed out that most experimental drugs that pharmaceutical companies distribute under that program eventually obtain FDA approval. That shows that the program is working: It gives patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available. In other words, even if a drug was found to be extremely dangerous when used by patients through the Right to Try program, that information might not be available to FDA, patients, or physicians.

We have included our Center’s Right to Try Fact Sheet below, which we hope you will find useful.


Jack Mitchell, Director of Health Policy

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

  • FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
  • Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
  • When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
  • FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
  • Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
  • State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
  • Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
  • The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

Right To Try Fact Sheet

Cancer Prevention and Treatment Fund

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

  • FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
  • Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
  • When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
  • FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
  • Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
  • State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
  • Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
  • The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

NCHR, NWHN, and OBOS Comments to USPSTF on Behavioral Weight Loss Interventions

National Center for Health Research: March 19, 2018

Public Comment of National Center for Health Research, National Women’s Health Network, and Our Bodies Ourselves for
USPSTF Draft Recommendation Statement: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions

Thank you for the opportunity to share our views regarding the U.S. Preventive Services Task Force (USPSTF) draft recommendation statement concerning behavioral interventions for weight loss in adults.

The National Center for Health Research, National Women’s Health Network, and Our Bodies Ourselves are all nonprofit organizations that strongly support the role of USPSTF in reviewing and assessing scientific evidence about the harms and benefits of specific preventive care services to provide science-based recommendations for the public. In 2012, USPSTF made the same recommendation for behavior-based weight loss interventions with a “B” grade.[1] Since then, researchers have published additional studies on this topic, and changes in science or medical practice could alter the benefit risk ratio. Thus, we support the USPSTF’s current efforts to re-evaluate their 2012 based on updated evidence.

Based on the draft evidence review, we concur with the Task Force that there is sufficient evidence that behavior-based weight-loss interventions for adults with obesity (BMI ≥ 30) can help patients reduce weight and decrease incidence of type 2 diabetes and elevated plasma glucose levels.[2]

Prevention of obesity-related morbidity and mortality is an important public health issue, and providers need the most current information to help their patients. More than 35% of men and 40% of women living in the United States are obese.3 Obesity is associated with increased risk of numerous health issues, including: heart disease, type 2 diabetes, cancer, stroke, renal disease, dementia, sleep apnea, osteoarthritis, and premature death.

Primary care screenings identify many patients with obesity who could benefit from behavioral weight loss interventions. As discussed in the review prepared for USPSTF, research indicates that intensive behavior-based weight loss and maintenance interventions can be effective in helping individuals lose weight and prevent weight regain.[3] Although weight reduction was moderate, interventions were associated with meaningful health improvements, such as reduced incidence of type 2 diabetes. Importantly, the review did not identify any long-term or serious harms, so that even moderate benefits outweigh the risks.

Given the differences in BMI cutoffs and disparities between racial/ethnic subgroups and older adults, we strongly agree with the USPSTF that future research on important subpopulations should be a high priority.[2] This information could provide insight into how different populations will benefit from behavior-based weight loss interventions.

In conclusion, we support the USPSTF draft recommendation for behavior-based interventions for weight loss to prevent obesity-related health problems and death. We further support USPSTF’s efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more information becomes available, we encourage the re-evaluation and potential development of additional recommendation to improve the health of individuals with weight-related health concerns.

If you have questions about these comments please contact NCHR through Stephanie Fox-Rawlings at


National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves


  1. Moyer VA, U.S. Preventive Services Task Force. Screening for and Management of Obesity in Adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2012;157:373–378. doi: 10.7326/0003-4819-157-5-201209040-00475.
  2. Draft Recommendation Statement: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions. U.S. Preventive Services Task Force. February 2018.
  3. Draft Evidence Review: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions. U.S. Preventive Services Task Force. February 2018.

Statement on Failure of “Right to Try” Bill

Diana Zuckerman, PhD, National Center for Health Research, March 13, 2018

We thank the Members of the House of Representatives who voted against the misleadingly named Right to Try bill yesterday, because they understood that the bill would have done so much more harm than good for desperate patients.  The bill would not improve access to experimental treatments for which there is any real hope of benefit to seriously ill patients.  Instead, it would set up a new, untested program that would enable desperate patients to purchase drugs for which there is no evidence that they would help patients live longer or even temporarily feel  better.  Worse, these drugs could cause painful, debilitating deaths, with virtually no protections in place for patients.

We know that some patients are willing to try anything.  Unfortunately, 85% of the drugs that would become available through the Right to Try legislation are expected to be later proven to be not safe and not effective.

An effective program is already in place for patients who don’t qualify for clinical trials but want to try experimental drugs for which there is at least some small evidence of possible benefit.  That program is called “Expanded Access” or “compassionate use.”  It has been in existence for years and it works.  We urge all Members of Congress to learn more about that program and consider how to strengthen it, instead of being persuaded by false promises of false hope.

And be sure to also listen to the loved ones of patients who have been harmed by experimental drugs.  There are many more of them  than there are of patients helped by Right to Try legislation that has already passed in most states.

A copy of our Fact Sheet on the most recent House and Senate Right to Try bills is available here.

NCHR Letter to Maryland on State Funding for Artificial Turf and Playgrounds

Diana Zuckerman, PhD, National Center for Health Research, March 5, 2018

To: The Honorable Governor Larry Hogan
The Honorable Mike Busch, Speaker, Maryland House of Delegates
The Honorable Thomas V. Mike Miller, President, Maryland Senate
The Honorable Maggie McIntosh, Chair, House Appropriations Committee
The Honorable Edward Kasemeyer, Chair, Senate Budget and Taxation Committee

cc: Members of the House Appropriations and Senate Budget and Taxation Committees
Delegate Aruna Miller
Senator Roger Manno

Subject: State funding for synthetic (artificial) turf and playgrounds (HB 505, SB 763)

As president of the National Center for Health Research (NCHR) a resident of Montgomery
County for more than 25 years, and the former Chair of the Governor’s Women’s Health
Promotion Council, I strongly support HB 505 and SB 763 to prohibit the use of state funds for artificial turf fields and similarly dangerous playground materials. NCHR conducts research and helps consumers and policy makers understand scientific evidence that can be used to improve programs and policies that affect the health of adults and children. We do not accept any funds from drug or medical device industry sources. And, as a public health expert and parent of two children raised in Maryland, my focus is how we can keep our children safe and healthy.

Artificial turf is made from synthetic rubber, plastic, and other materials with known health risks. For example, the widely used material known as crumb rubber includes cancer-causing agents as well as chemicals that disrupt our bodies’ hormones. These are called endocrine-disrupting chemicals, and studies show that they contribute to early puberty, obesity, and attention deficit disorder. Since endocrine-disrupting chemicals have been banned from rubber duckies, teething toys, and other products children use for a relatively short period of time, it makes no sense for the State of Maryland to spend millions of dollars on playing fields and playgrounds that will expose our children to those same types of banned chemicals day after day, year after year.

The artificial turf industry and those that have financial and personal ties to them tell us that there is no clear evidence that their fields caused any child to develop cancer or any other disease. They also state that the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA) have declared these materials as safe for use in
playgrounds or athletic fields. Those statements are misleading. CPSC has conducted recent workshops on the topic attended by invited scientific and public health experts, but neither CPSC nor EPA have concluded that these products are safe.

In February 2016, the U.S. government announced a new action plan to better understand the likely health risk of recycled tire crumb and similar artificial surfaces. This initiative involves the Center for Disease Prevention and Control (CDC); the Agency for Toxic Substances and Disease registry (ATSDR); and CPSC. No results are yet available and given the anti-regulatory focus of the current federal administration, we do not expect any new restrictions in the near future. That makes the actions of Maryland even more important.

Meanwhile, various reliable science-based studies from the California Office of Environmental Health and Yale University, among others, have found dozens of harmful chemical in tire crumb used in these playing surfaces. In addition to the impact of those chemicals on children’s hormones and development, as mentioned above, tests have shown that artificial turf and playground materials can cause skin and eye irritation as well as asthma. The surface temperature can rise above 140 degrees even when the temperature of the air and grass is between 65 and 95 degrees. Recent testimony before the Maryland House Appropriations Committee provided striking examples of children suffering serious burns and MRSA-infected abrasions from artificial turf. In fact, players’ preferences and concerns about injuries helped convince the Ravens to switch back from artificial turf to natural grass several years ago.

In summary, those who manufacture or install artificial turf, and scientists and others with
financial and personal connections to those industries, have made safety claims that are not supported by any unbiased research. Even when they admit problems with tire crumb, they claim that newer types of artificial turf are safer. Unfortunately, some of the materials used in the newer types of artificial turf are not publicly disclosed, making safety claims meaningless and safety research all but impossible.

The State of Maryland has many spending priorities and should not be spending millions of
dollars for artificial turf fields and playgrounds that can exacerbate our children’s health
problems now, and potentially cause them to develop cancer in the years to come. Let’s instead invest in safe, natural playing fields, unless any synthetic alternatives are proven in unbiased research to be as safe and as cost-effective as grass for fields and engineered wood fiber for playgrounds.

Thank you for considering our views. We would be glad to supply additional information upon request.


Diana Zuckerman, PhD
National Center for Health Research