ISSUE ISSUE 2433 TheTheVoice Voice FALL/WINTER 2018 FOR PREVENTION, TREATMENT, AND POLICY SPRING/SUMMER 2014 FOR PREVENTION, TREATMENT, AND POLICY National WHAT’S INSIDE We’re in the Headlines…2 Center Brain Stimulation as a Treatment for Depression?...3 What are the Implant Files?...4 for Health Is the Affordable Care Act Still at Risk?....4 What is Breast Implant Illness?...5 Research Honoring Foremothers….6 Dietary Supplements...7 We are dedicated to improving the health and safety of adults and children by Can Sleeping Pills Cause Cancer? Can Avoiding using research to develop more Them Improve Your Health? effective treatments and policies. The Cancer Americans spend more than $41 billion each year on prescription sleeping pills, and that doesn’t Prevention and Treatment count the popular over-the-counter sleep aids such Fund is our major program. as Tylenol PM and Benadryl. If you are one of the many Americans that needs help sleeping, you’ll want to know about a study showing that people who take these drugs are significantly more likely to be diagnosed with cancer or to die within the next The Cancer two and a half years than people who don’t take Even before this study, there were at least 18 other them. Published in the prestigious British Medical studies showing an increased risk of death for Prevention Journal, author Dr. Daniel Kripke estimates that people taking sleeping pills, and several also and Treatment sleep medications could be causing more than showed an increased risk of cancer. However, this Fund 300,000-500,000 deaths every year. study is especially well-designed and the only one that includes the newer, short-acting class of popular sleeping pills known as non- Our Cancer Prevention and The researchers studied more than 10,000 primary care patients in Pennsylvania who were prescribed benzodiazepines, such as Ambien, Lunesta, and Treatment Fund helps adults sleeping pills and compared their health to patients Sonata. and children reduce their risk without such prescriptions who were the same sex, ethnicity, marital status, smoking status, and had Among study participants, the most commonly pre- of getting cancer and helps similar health conditions, alcohol use, and BMI. scribed sleeping pills were Ambien (also known by everyone get the best possible other names) and Restoril. However, the higher Sleeping Pills, Death, and Cancer risk of death was true for those prescribed any sleep treatment. aid , including Lunesta, Sonata, barbiturates, as well as antihistamines such as diphenhydramine Patients who were prescribed sleeping pills were (the active ingredient in Benadryl), which is also more likely to have died during the 2.5 years of the used in many over-the-counter sleep aids. The study than were the patients not prescribed average age of patients in the study was 54, but the Cancer Helpline: sleeping pills. Even the patients who were study found harm associated with sleeping pill use prescribed fewer than 18 pills per year were more [email protected] in every age group. than 3 times as likely to die. Patients who were prescribed more than 132 pills a year were more Are Some Sleeping Pills Safer than Websites: than 5 times as likely to die. Others? www.center4research.org When the study started, none of the patients had All the sleeping pills studied increased the risk of www.stopcancerfund.org been diagnosed with cancer. Heavy users of sleep- ing pills (over 132 pills prescribed per year) had a death, but Lunesta showed a more than 500% in- 35% greater risk than those with fewer pills pre- creased risk compared to any of the other sleeping scribed. Among those with prescriptions for sleep- pills. However, Lunesta was a relatively new drug ing pills, the increased risk of their developing lym- at the time of this study, and relatively few people phoma, lung cancer, colon, and prostate cancer was took it. For that reason, it is not possible to say greater than the risk from being a current smoker. whether the risk of Lunesta is really that high. This CFC #11967 study did not evaluate cancer or death rates among patients taking Belsomra, a newer sleeping aid with numerous side effects. Continued on Page 4 We’re in the Headlines! Board of Directors US Goal to be “First” on Devices Worries Former Regulators Brandel France del Bravo, MPH Associated Press, Consultant November 11, 2018 Sarah Deutsch, JD -Implant Injuries Hidden: FDA’s Deal with Counsel, Mayer Brown Breast Companies Made Thousands of Cases Look Like New Drugs So Pricey They Need New PaymentPlans Dan Fox Just One President Emeritus, Milbank November 26, 2018 LA Times, Memorial Fund FDA Targets Vaping, Alarmed by Teenage Use August 13, 2018 Ben Gitterman, MD Politico, Devices? Associate Clinical Professor New York Times, Pediatrics and Public Health September 12, 2018 What Are the Unexpected Dangers of Medical George Washington University NPR, May 24, 2018 To Improve Treatments, Researchers Want to Hunt Mary G. Hager, MA Journalist (retired) for Clues in Medical Records Nancy Hardt, MD This Popular Implant Prevents Pregnancy Retired Professor and Associate NPR, July 16, 2018 for Years. It Could Also Go Missing in Dean University of Florida College Your Body. of Medicine October 8, 2018 Circa, Bayer to Stop Sales of Birth ControlLasik Surgery Can Have Little Known Judith L. Harris, JD Device Tied to Injuries Life-Changing Consequences Reed Smith Today Show, NBC, Legal Reader, June 19, 2018 Alan Mendelson, LLD November 26, 2018 Axion Venture Partners Omega Logan Silva, MD Former President, American Medical Women’s Association The FDA announced fines for companies Duchy Trachtenberg One in 10 Americans has some kind of medical selling e-cigarettes to children and teenagers, Former Councilmember device implanted in their body. In an NPR as well as guidances to the manufacturers. Montgomery County, MD podcast, NCHR’s president warns that the NCHR president Dr. Diana Zuckerman told FDA standards for approval of implants are Susanne Wilke, PhD, MBA the New York Times that the FDA's plan much less rigorous than for prescription drugs. Venture Capitalist will be much less effective than other Most medical devices do not even have to be strategies they should consider. Two months proven to be safe or effective. NCHR’s president Susan F. Wood, PhD later, FDA finally announced more effective urges listeners to ask doctors questions about Associate Professor strategies. the scientific evidence that the device is good George Washington University for them, and let Congress know you support better safety testing for new devices. Diana Zuckerman, PhD President The U.S. government keeps talking about Nat’l Center for Health Research streamlining the FDA approval process to get drugs and medical devices to patients faster. NCHR’s president explains to MedTech how Unfortunately, this is adding to the cost of the FDA never takes devices off the market, and medical care and results in many medical instead relies on the manufacturers to "volun- We can’t be bought. products that don't work. NCHR’s president tarily" withdraw them. FDA finds it hard to explained to Newsweek, ProPublica, find the science to justify taking them off the Medscape, and AP how patients are market due to the lack of solid scientific Our Center doesn’t harmed when drugs or medical devices are research. accept funding from approved too quickly. drug companies or device manufacturers, Nexplanon is an implanted contraceptive that lasts for 3 years. Though it's inserted into the so we rely on the NCHR’s president wrote an article for Spectrum News about how the new "Right upper arm, it can migrate and be difficult to re- generosity of to Try" law can result in the exploitation move if it causes dangerous side effects. Despite individual donors. You of people with autism and other conditions, deaths and serious harm reported to the FDA, including cancer. Vulnerable patients and no action has been taken. NCHR’s president can donate their families deserve better protections from tells The New York Post and Circa that FDA online at treatments that don't work and could be very often delays action when devices are shown to be risky or ineffective. stopcancerfund.org. harmful. Page 2 Health Matters Brain Stimulation as a Treatment for Depression? Thank you to our wonderful Transcranial magnetic stimulation (TMS) devices receiving a “sham treatment” – they were hooked up have stimulated the brains of tens of thousands of to a TMS machine but the magnetic pulses did not President’s patients in the United States, often as a treatment for reach their brains. The results of these studies were Circle Donors: depression that hasn’t responded to anti- surprising because in most cases depressant medication. Millions of neither the TMS patients nor the sham Most TMS patients Dianne & Rick Ammons Americans suffer from depression, and patients had much improvement in Holly Bilden-Stehling most try one of the dozens of antide- do not improve their symptoms of depression. In fact, Christopher Cooper pressant medications on the market – substantially, and the placebo patients in studies of Sarah Deutsch most of which are available as relatively any improvement of antidepressants often did as well as the inexpensive generic medications. TMS patients and improved much more Estate of Amanda Belfiore TMS treatment typically costs $300 per any patients tends to than the sham patients. We analyzed Benjamin Gitterman session, usually 5 days/week for four to disappear in the this further and concluded that the Judy Harris & Norm six weeks. That’s obviously inconvenient weeks or months sham treatment was often so obvious to Ornstein and expensive, but the important the doctors involved in the studies that after their TMS Janet Holt question is: Does it work? treatment ends.