All posts by CPTFadmin

The Problem with Medical Device Approvals

Suzanne Robotti, MedShadow: January 16, 2018

MedShadow doesn’t often cover medical devices, but I’ll make an exception to point out this article about Stephen Tower’s experience with an artificial hip. This is a must-read for anyone who has or anticipates getting an artificial hip or knee — or any other body part.

Stephen Tower, MD, is an orthopedic surgeon experienced in performing artificial hip replacements. Yet he found out firsthand that the hip he requested to be put in his body was defective in its design. He then worked for years to bring attention to the harm that the metal-on-metal hip from Johnson & Johnson was causing.

The interesting part of the story is how that device — and almost all medical devices — got approved by the FDA. Essentially, a device manufacturer can file a form claiming that its product is “substantially equivalent” to an existing device. If the FDA agrees, that’s it. There’s no need for testing and no follow-up studies.

In some cases the “substantially equivalent” claim makes logical sense, but doesn’t work in real life — that’s why the clinical trial process exists. The author of the op-ed, Jeanne Lenzer, explored many examples and the history of the FDA in her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Save It. […]

I’ll give the last word to Diana Zuckerman, the president of National Center for Health Research (NCHR), an independent nonprofit that scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. NCHR does not accept funding from device or pharmaceutical companies.

I asked Zuckerman for an example of a substantially equivalent approval that had particularly bothered her. She told me that the da Vinci Surgical System was “cleared for market” as substantially equivalent to the surgical tools it uses, such as a scalpel. But a robotic surgery system is more than just the tools it uses. The da Vinci robot was described by then-FDA Commissioner Jane Henney as the first of its kind and a product that “could change the practice of surgery.”

Although based on the 510(k) review process that rarely requires a clinical trial, the FDA required the first version of the da Vinci system to be studied in one clinical trial comparing the results to traditional surgery for gallbladder and reflux disease surgery. However, it and all future da Vinci robotic systems for all other surgeries were cleared for market by the FDA as substantially equivalent to the scalpel and other tools, and those later reviews didn’t require any clinical trials at all.

“How can a device be revolutionizing the practice of surgery and yet be substantially equivalent to tools that scientists tell us have been in use for more than 2,000 years? Does that make sense to any logical person?” […]

Read the original article here.

Which Breast Implants are Safest for Mastectomy Patients?

Diana Zuckerman, PhD, Madris Tomes, and Amelia Murphy, National Center for Health Research and Device Events

Based on the summary of book chapter in Breast Implants, Rene Simon (ed.), Nova Science Publishers, 2017.

Our new book chapter on breast implants explains that the 55-year history of breast implants reflects repeated efforts to improve their safety and effectiveness by reducing the cosmetic problems and health complications that develop during the years while they are in the human body. The most recent effort is the type of highly cohesive breast implants known as “gummy bear implants” because of the thick gel that is described as similar to gummy bear candies. The goal of the more cohesive gel is to make implants last longer and be less likely to leak. First approved in the United States in 2012, adverse event reports indicate that this newest generation of implants causes complications similar to older generations of silicone gel breast implants.

The first breast implants, made in the 1960’s, were for cosmetic enhancement. When women’s augmented breasts became hard over time, implant manufacturers responded by making the silicone gel thinner. One manufacturer, Surgitek, added polyurethane foam to the outside to make the breasts feel softer. Those design changes caused other problems, however: the thinner gel had a tendency to “bleed” through the silicone elastomer shell, which contributed to the most common complication, capsular contracture. Breast implants made with thinner gel also ruptured and leaked more easily, and the gel broke down into silicone oil which could migrate to other organs or cause silicone granulomas inside their bodies. The polyurethane foam caused other problems: implant removal was very difficult and women lost their breast tissue during explant surgery, and the foam was found to break down to a known carcinogen.

The Food and Drug Administration (FDA) did not require breast implant manufacturers to submit data to prove the implants were safe and effective until 1992. By that time, the manufacturers had developed implants with a thicker shell and a more cohesive silicone gel. However, the studies revealed that, like the earlier implants, the more cohesive implants did not “last a lifetime” as had been claimed. As a result, manufacturers continued to modify the silicone gel to make it less likely to rupture and leak.

Despite claims that gummy bear implants are safer than other breast implants, a 5-year study found that the rupture rate was more than 4% for first-time augmentation patients.  The percentage of women needing additional surgery within 5 years ranged from 17% to 48%, depending on whether the patients were augmentation patients or reconstruction patients, and whether the gummy bear implants replaced previous implants. Our analysis found that from January 1, 2008 through June 30, 2017, 1298 adverse event reports for silicone gel breast implants were made to the FDA, 252 (19%) of which were for gummy bear implants. This is very high when you keep in mind that gummy bear implants were relatively rare in the U.S. prior to FDA approval in 2012. This chapter puts these statistics in the context of what is known about the safety of silicone breast implants and how that has changed over time.

Copies of the entire book chapter are available upon request at info@center4research.org

Can the FDA Help Reduce Drug Prices or the Cost of Medical Care?

Diana Zuckerman, PhD, American Journal of Public Health: November 2017

The new US Food and Drug Administration (FDA) commissioner Scott Gottlieb has worked for pharmaceutical companies for most of his career, so it may have surprised some public health advocates when he responded to congressional pressure by taking on the hot issue of drug pricing as one of his first priorities.

In his blog written for the FDA Web site, Commissioner Gottlieb echoes the view of many public health advocates when he says: “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. […]

I agree with Commissioner Gottlieb that these sound like useful strategies, because generic drugs have been estimated to have saved $1.2 trillion between 2003 and 2012. However, I question how much these strategies can accomplish. Is this a Band-Aid approach to a much more complex problem—and if so, is the FDA part of the problem?

Generic Drugs, Competition, and Drug Prices

The Government Accountability Office (GAO) reported in 2016 that the price of 50-milligram capsules of the antidepressant clomipramine HCL, which is used to treat obsessive-–compulsive disorder, increased by more than 2000% in one year: from 34 cents per capsule in 2013 to $8.43 per capsule in 2014.  The 20-milligram capsules of piroxicam, to treat arthritis, increased by more than 2000% from 2010 to 2015: from 9 cents to $1.82 per capsule. The price of digoxin, a commonly prescribed heart medication, increased by 2800% in a single year.  Despite these increases, the GAO found that from 2010 to 2015 the cost of generics decreased by 59%. Nevertheless, the GAO reported that the price of 315 generic drugs went up by 100% or more during those years, causing financial difficulty for many patients. […]

When a large number of generic manufacturers are making the same product, the average price usually falls to 20% of the branded price, or even lower. There are exceptions, however. For example, eight companies make ursodiol, a treatment for gallstones.  In 2013, the cost was 45 cents per capsule, but in May 2014, Lannett increased its price to $5.10 per capsule, and its competitors soon followed.

Is the FDA Part of the Problem?

The contribution of the FDA to high drug prices was noted recently when the FDA approved an old, commonly used drug for a type of Duchenne muscular dystrophy. Deflazacort had not previously been approved in the United States, but many patients imported generic versions from Europe or Canada for $1000 to $2000 for a year’s supply. When the FDA approved it, a US company gave it a new name, Emflaza, and a new price tag, $89 000 per year (more than a 6000% increase).

Another glaring example of the unpredictable impact of competition involved brand-name drugs for hepatitis C. When Gilead put Sovaldi on the market in late 2013, it cost $1000 per pill: $84 000 for a 12-week course of treatment. The public and policymakers were incensed at what was considered an outrageous cost, but experts assumed the price would soon drop because other similar drugs were in the pipeline. Instead, the official price increased, despite two competing drugs….

FDA Drug Approval

Clearly, when the FDA approves new drugs that create competition, it does not necessarily lower prices. Congress has passed laws to require the FDA to approve drugs and devices more quickly, which Commissioner Gottlieb also supports. This has resulted in lower standards over the last two decades5 and has contributed to the high cost of medical care.

Read the original article here.

Question: My Silicone Gel Breast Implant May Be Leaking. How Do I Find out If It Is Leaking, and What Should I Do If It Is?


Q. My silicone gel breast implant may be leaking. How do I find out if it is leaking, and what should I do if it is?

A. We’re not doctors and we don’t provide medical advice, but I can tell you what we know based on research and from speaking with many experts and with women who have had breast implants.

The best way to tell if a silicone breast implant has ruptured or is leaking is to have an MRI with a breast coil. Unfortunately MRIs are expensive, but necessary because a mammogram can not accurately detect a rupture or leak. And, the squeezing from a mammogram can cause a broken implant to leak. A sonogram can be useful but only if the radiologist is specially trained to detect implant ruptures and leaks — and very few are. That’s why an MRI is the best strategy, although that also needs to be read by someone who has experience looking for a rupture or leak in a silicone breast implant.

FDA scientists found that by the time women have implants for at least 10 years, at least one of them has usually ruptured. However, implants often break sooner, sometimes even within the first year. For women with saline breast implants, a broken implant is obvious because it usually deflates quickly. However, when silicone gel breast implants break, there are often no symptoms at all for a year or more. Years later, there are several symptoms that many women report: the breast changes shape or gets smaller, lumps or bumps may appear on the breast or nearby, some women complain of a burning pain, and some women experience symptoms of autoimmune disease, such as joint pain, memory loss, confusion, or chronic fatigue.

Many plastic surgeons believe that silicone is “perfectly safe.” However, experts who have read the research agree that a ruptured silicone gel breast implant should be removed as soon as possible, especially if it is leaking. The MRI can help the plastic surgeon know where the problem areas are so he or she can avoid leakage during removal. Removing broken implants soon means there is less chance that the silicone will leak outside the scar tissue that surrounds the implant. It is important to have the procedure performed by a plastic surgeon who is very experienced in removing leaking silicone implants. Old or broken silicone gel breast implants should be removed “en bloc,” also called an “en bloc capsulectomy.”  This means that the entire intact scar tissue capsule with the implant still inside it are all removed together. This makes it easier to remove any silicone that may have leaked from the broken gel implant and also helps remove silicone or other chemicals that may have seeped out from the silicone envelope into the scar capsule.

A study conducted by Dr Noreen Aziz from the National Cancer Institute and Dr Frank Vasey from University of South Florida found that most women who had rheumatological symptoms (such as joint pain) felt significantly better after getting their breast implants removed and not replaced. Those who didn’t get their implants removed usually got worse. Those who had them removed and replaced (with silicone implants or saline) implants did not get better.

For examples of women who had less pain and other symptoms after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

Question: Should I Get Silicone or Saline Implants? Is There a Price Difference?


Q. Should I get silicone or saline implants? Is there a price difference?

A. We believe that saline breast implants are safer than silicone gel implants.

All breast implants have risks. The most common is when the breast gets hard and painful, known as capsular contracture. Many women with implants have that problem after a few years, but it appears to be more common with silicone gel breast implants than saline implants.

Implant surgery usually costs between $5,000-8,000, including the implants and one follow-up visit. Silicone gel breast implants cost about $1,000 more than saline implants.

However, there are a lot of extra expenses that you need to be aware of.

For example, saline implants and silicone implants both have a high complication rate, and almost half the women will need additional surgery to fix implant problems within 3-4 years. That additional surgery often costs $5,000 or more. That is why we suggest that women considering breast implants make sure they have at least $5,000 in their savings that they will save and not spend until they need it for their next implant surgery.

All breast implants will eventually break, but when saline implants break it is obvious (they deflate quickly) and when silicone gel breast implants break, there are often no symptoms at first. Having no symptoms might seem like an advantage, but it is really a disadvantage because silicone can leak out of the tear in the implant, and get to parts of the body where surgeons can’t remove it. Leaking silicone can cause pain and allergic or auto-immune reactions. When it is removed, the breast may be deformed.

Because of concerns about leaking silicone, the FDA warns that women with silicone gel breast implants need to get an MRI to check for leakage after 3 years, and then every other year after that. Unfortunately, breast MRIs cost about $2,000 each, sometimes more. That may seem very expensive, but it is the only accurate way to know if your implants are broken or leaking. If they are leaking, it is important to have them removed immediately.

Given the expense and the risks, why would any woman get silicone gel breast implants? There is one advantage: they feel more like a real breast. Saline implants may not feel as warm as the rest of the body in cold weather. (A figure skater told us they were painfully cold!) And, women with saline implants sometimes say that they make swooshing water noises. Most plastic surgeons prefer silicone gel implants because they tend to look and feel more natural. However, many women tell us that does not make up for the added risks and added costs.

The bottom line: all breast implants will break, all breast implants are likely to cause complications that require additional surgery, and some women will have a bad reaction within a few weeks or months of getting their breast implants. But some implants are safer than others, and since all silicone gel breast implants are more likely to leak as they get older, we believe that saline implants are safer.

For examples of women who had less pain and other symptoms after their implants were removed, see the personal stories on our website at http://www.breastimplantinfo.org/personal-stories/. You also might want to check out www.explantation.com to hear from women who have had their implants removed and not replaced. Many felt healthier, happier, and more attractive afterwards.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org/breast-reconstruction/surgical-alternatives/ or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

Are Processed Meats More Dangerous than Other Red Meats?

Megan Cole, Claire Karlsson, and Sage Wylie, Cancer Prevention & Treatment Fund

You have probably heard it many times already: don’t eat too much red meat or processed foods. But research shows processed red meats, like bacon, hot dogs, and salami are the biggest problem. Here’s why.

Red Meats vs. Processed Red Meats

In 2015, the International Agency for Research on Cancer (IARC) of the World Health Organization concluded that processed meats are a Group one carcinogen, which means it causes cancer.  Other Group one carcinogens include tobacco and asbestos. Based upon a review of over 800 studies, 22 scientists from ten countries determined that processed meats can cause colorectal cancer and probably stomach cancer. [1] Although people who eat more red meat are more likely to develop pancreatic and prostate cancer, nobody knows whether people who eat more red meat tend to have other poor health habits that are the real causes of these cancers, rather than the red meat itself.

Are processed meats more dangerous than other red meats? Yes!Bacon, hot dogs, bologna, and other processed meats are now blamed for causing cancer, and they also increase your chances of developing heart disease and diabetes. A 2010 study led by Dr. Renata Micha from the Harvard School of Public Health analyzed 20 previous studies and concluded that while eating more red meat didn’t predict whether a person developed heart disease or diabetes, eating processed meat did. [2]  A person who ate one portion (about one hot dog or two slices of deli meat) of processed meat every day was 42% more likely to develop coronary heart disease and 19% more likely to develop diabetes than if that person did not eat processed meat every day.  That risk was the same if the person ate 2 portions of processed meat every day instead of one, and doubled if the person ate 2 portions a day instead of none.  In other words, even if you like the taste or convenience of processed meat, eating less processed meat is always better for your health than eating more.

Why the Difference?

When comparing red meats with processed meats, there are some key nutritional differences. While levels of saturated fats and cholesterol are usually similar in processed and unprocessed meats, processed meats generally have four times the amount of sodium and 50% more preservatives than red meats.[3] Researchers suggest that these increased levels of sodium and preservatives may explain the increase in health risk. To determine if that is true, further research is needed. What is known, however, is that sodium increases blood pressure and preservatives have been shown to reduce tolerance to sugars. High blood pressure contributes to heart disease and reduced tolerance to sugars increases the risk of diabetes. Other studies have found that processed meats that have been cured, smoked and barbequed at high temperatures are more likely to cause colon cancer than other red meats.[4] Cured meats like salami may pose particular risks for cancers because the nitrate and nitrite salts used in the curing process can promote cancer cell growth. Yet much more research is needed to clarify how processed meats can lead to cancer.

In addition, a study found an increase in breast cancer for Hispanic women with the highest consumption of processed meat, although that was not found in non-Hispanic white women. [5]

…But Don’t Pick up That Steak so Fast.

Does this mean that you are now free to eat all the red meat you want as long as it isn’t processed? Well, no.  Studies have shown that red meat raises the level of “bad cholesterol,” because it is high in saturated fat. Chicken and fish are much lower in saturated fat.  While processed meat is labeled as a definite carcinogen, red meat is categorized as probably carcinogenic to humans (called Group 2A by IARC). Plus, eating less red meat may help reduce climate change, because cows emits harmful greenhouse gases.[6] Additionally, a study of 150,000 women, published in a major medical journal in 2016, found that eating red meat for protein instead of eating plants increases the chances of developing heart disease and dying at a younger age.[7]

What Meats Should I Eat and What Meats Should I Avoid?

As outlined by the US Department of Agriculture (USDA), consider the following when selecting meats for you or your family:
• Choose lean or low-fat meat and poultry. Avoid ground beef that is less than 80% lean (the leaner, the better), and choose skinless chicken.
• If you do buy processed meats, be sure to read the ingredients and Nutrition Facts label to avoid foods high in salt. Look for products labeled “low sodium,” “reduced sodium,” or “no salt added.” To be considered “healthy,” products must not have more than 600 mg of sodium per serving.
• Consider eating fish rich in omega-3 fatty acids, such as salmon, trout, and herring, or getting protein from other non-meat sources, such as beans, legumes, almonds, sunflower seeds, and egg whites.[8]

Is All Processed Meat Worse than Red Meat?

All processed meats are not necessarily worse than all other red meats, as the “healthiness” of a meat depends upon the number of calories per serving as well as its sodium and fat content. For instance, lean deli meat may be healthier than a fatty unprocessed hamburger or steak. However, in general, bacon, sausage, hot dogs, pastrami, and many other processed meats are fattier, saltier, higher in calories, and contain more additives than unprocessed red meats such as beef, pork, and lamb. Lean and low-sodium varieties of processed meat are less unhealthy, but still not as healthy as most non-processed meats.

The Bottom Line

Foods that are higher in calories, saturated fat, and sodium tend to increase weight, fat, and blood pressure, which in turn, may lead to the development of heart disease and/or diabetes. So? Eat a balanced diet with plenty of whole grains, fruits, vegetables, low-fat dairy, and lean proteins. Enjoy red meat in moderation and remember: if you have to choose between a hot dog or a hamburger, the unprocessed meat of the hamburger is the safer bet when it comes to avoiding cancer, coronary heart disease and diabetes. However, try to avoid topping your burger with high-salt processed condiments such as ketchup, salt, and pickles.

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

References

  1. Bouvard, Véronique; Loomis, Dana; Guyton, Kathryn Z; Grosse, Yann; El Ghissassi, Fatiha; Benbrahim-Tallaa, Lamia; Guha, Neela; Mattock, Heidi; Straif, Kurt. (October 2015). “Carcinogenicity of consumption of red and processed meat”. The Lancet. DOI: http://dx.doi.org/10.1016/S1470-2045(15)00444-1.
  2. Micha, R., Wallace, S.K., Mozaffarian, D. (June 2010).“Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes: A systematic review and meta-analysis”. Circulation. 121(21): 2271–2283. doi: 10.1161/CIRCULATIONAHA.109.924977.
  3. Sinha R, Cross AJ, Graubard BI, Leitzmann MF, & Schatzkin A (2009 March 23) Meat intake and mortality: a prospective study over half a million people. Archives of Internal Medicine 169(6):562-571.
  4. Santarelli, R.L., Pierre, F., Corpet, D.E., (2008). “Processed meat and colorectal cancer: a review of epidemiologic and experimental evidence”. Nutrition and Cancer. 60(2):131-44. doi: 10.1080/01635580701684872.
  5. Kim, A.E., Lundgreen, A., Wolff, R.K., et al. (2016). “Red meat, poultry, and fish intake and breast cancer risk among Hispanic and Non-Hispanic white women: The Breast Cancer Health Disparities Study.” Cancer Causes Control.  doi: 10.1007/s10552-016-0727-4. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26898200. Accessed on November 13, 2017.
  6. Powell R (2008) Eat less meat to help the environment, UN climate expert says. Telegraph.
  7. Song M, Fung TT, et al. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Internal Medicine; 2016.
  8. United States Department of Agriculture (USDA) (2010). Inside the Pyramid (Meat).

Health Insurance: It’s Open Enrollment Season – Now What?

Alex Pew, Cancer Prevention and Treatment Fund

If you don’t have health insurance, or want a new plan, you can use the Obamacare Health Insurance Marketplace to get coverage. If your employer doesn’t provide affordable health insurance, the prices are likely to be better through Obamacare (also called the Affordable Care Act).

Each year, health insurance companies make changes to their benefits, premiums, deductibles, and copayments. During open enrollment, you can enroll in a health insurance plan that fits your needs.

Open enrollment for Obamacare is from November 1 – December 15. Only 5 states (California, Colorado, Minnesota, Washington, Massachusetts, and the District of Columbia) have slightly longer open enrollment. However, many other insurance plans, including workplace plans, individual plans, and Medicare, also have open enrollment at the same time of year.

If you already have health insurance, it’s important to use open enrollment to review your plan’s coverage. You can check that it still meets your needs and change it if needed.

Why is the Open Enrollment Period so Important?

Open enrollment is when you can look around to make sure you aren’t paying more than necessary for good health insurance. Make sure you will be getting the services and benefits you need.

If you were enrolled in a plan in 2017, you will be automatically re-enrolled in 2018 for the same or similar plan. But, that plan could be more expensive or may not cover the services you need. You will not be able to change this plan once the open enrollment period ends, so don’t let yourself be automatically re-enrolled unless you are sure that the policy is what you want.

You can also use open enrollment to get health insurance for the first time. The law requires you to have health insurance, and the penalty goes up every year. In 2018, you can face a fine between $695 and $2,085, or up to 2.5% of your income (whichever is higher) if you don’t have health insurance.

You can get your insurance through the Affordable Care Act (“Obamacare”) on healthcare.gov (sometimes called the marketplace or the exchange).

Health insurance might also be offered through your job or your spouse’s job. Most employers will send out reminders about open enrollment and set aside a two-week period for reviewing the available health plans.

Whether you already had a health plan this year or not, here are some basic tips you should think about for 2018:

  • Do your homework. Reviewing your options could save you hundreds or thousands of dollars. Even if you liked your plan this year, it might not be the best choice for next year. And, it might be cheaper for your children to be on your spouse’s insurance plan instead of yours.
  • Double-check that the medications you are taking and the doctors you see are covered by the plan you choose. Choosing a cheaper plan could cost you more in the long run if your doctor is out-of-network or if your plan doesn’t cover something you need, such as a smoking cessation drug. Most insurance companies have a website where you can check which doctors and medications are covered.
  • Check that the services you need are covered. Are you going to need specific services that some insurance plans exclude, such as bariatric surgery, certain types of counseling or smoking cessation programs, or surgery to fix complications from cosmetic surgery? These exclusions are often hard to find – and you may not know they aren’t covered until you need them and get denied. Before signing up, you should call the insurance company to find out what is covered and what isn’t.
  • Don’t forget about vision and dental plans. These plans cover preventive services like eye exams and teeth cleaning. Some plans include dental benefits. You can also buy these plans separately through the exchange. Some plans on the exchange include vision benefits. If your insurance is covering anyone under the age of 18, they must offer dental and vision coverage. Routinely getting your teeth and eyes checked could help prevent more serious medical problems down the road. On the other hand, these plans might cost more than they are worth to you, so consider your own needs before deciding.

If you’re buying an insurance plan through healthcare.gov or state exchange websites:

  • Update your household and income information. You might be able to save money compared to last year.
  • Check that the plan covers what you need. Even if you were automatically enrolled, the plan might be different than last year.

Open Enrollment for 2018 Health Insurance

If you’re buying health insurance for 2018 through healthcare.gov, here are the important dates:

November 1, 2017: The first day you can enroll in a 2018 insurance plan.

December 15, 2017: The last date to enroll for coverage that starts January 1, 2018*. If you miss this deadline, you can’t sign up for a health plan for the rest of 2017. The only exception is if you qualify for a Special Enrollment Period, if you lose your health insurance, get married, or have a baby. Click here to learn more about the Special Enrollment Period. If you don’t change or re-enroll in a plan, you will automatically be enrolled into the same or a similar plan as you were this year. You will not be able to change this plan after the open enrollment period ends, even if it costs more or includes different coverage, so be sure to decide what you want to do before Dec 15.

If you live in California, Colorado, Minnesota, Washington, Massachusetts, or the District of Columbia, you have a little extra time to sign up.

January 1, 2018: The date your 2018 coverage starts if you enrolled or changed plans by December 15. If you live in one of the 5 states listed above, or Washington, D.C., you should check to see when your coverage would start.

Remember:

  • Coverage is affordable: The tax credit through healthcare.gov reduces most people’s premiums to be between $50 and $100 per month. Last year, 8 out of 10 people qualified for this reduction. Make sure to check your options to see how much the co-payments and deductibles are.
  • Cost-sharing reductions (CSR) are still available: Subsidies are available for people who have an income of 100%-250% of the federal poverty level. CSR are only available in Silver plans. Insurers raised monthly premiums because the Trump Administration stopped reimbursing them, but insurance companies are still required to discount those costs for many consumers.
  • Signing up for coverage is easy: It takes about 10 minutes to submit an application. You can even sign up on your smartphone! Out-of-pocket cost estimators like this one can help you estimate your total healthcare costs for the year including premiums, deductibles, and co-pays. There are tools to help you look up doctors and prescription drugs, so you can figure out which plans will cover your needs
  • Start early: The healthcare.gov website will be closed for 5 out of the 6 Sundays from midnight to noon EST during the open enrollment period, and there will be surges in the number of people trying to sign up on some days, especially in December.
  • Free, expert help is available: Free, anonymous help is available 24/7 if you want to talk to someone about your options or if you have questions about signing up. You can call 1-800-318-2596 or you can find local help by searching on HealthCare.gov.
  • If you don’t sign up by December 15th, you may have to pay a penalty: The minimum penalty for not having health insurance is $695-$2,085, but the fine can be up to 2.5% of your income.

To learn more about how healthcare.gov works, check out https://www.healthcare.gov/quick-guide/

Want to know how much health insurance will cost you? Use this calculator to find out!

Definitions:

  • Premium: the amount you pay for your health insurance every month.
  • Deductible: the amount you pay for covered health care services before your insurance plan starts to pay.
  • Copay: a fixed amount you pay for a covered health care service after you pay your deductible.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

NCHR Comments on the USPSTF’s Evidence Review and Draft Recommendation Statement for Behavioral Counseling for Skin Cancer Prevention

National Center for Health Research: November 6, 2017

Thank you for the opportunity to express our views about the USPSTF’s evidence review and draft recommendation statement on behavioral counseling interventions for skin cancer prevention. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Skin cancer prevention is a very important public health issue, and the public needs better information. The USPSTF previously cited evidence linking UV radiation exposure to an increased risk for melanoma later in life for children, and to a lesser extent, adults. Encouraging healthy sun-related behaviors that prevent UV exposure, and ultimately skin cancer, would save lives.

We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its recommendations in light of new research regarding behavioral counseling interventions to prevent skin cancer. We have a few comments regarding the draft recommendations:

#1: Based on new studies of children younger than 10 years old, we agree that there is sufficient evidence for USPSTF to expand their “B” grade recommendation for fair-skinned individuals from 10-24 years to 6 months-24 years.

#2: We agree with a “C” grade recommendation for fair-skinned adults older than 24 instead of an “I” grade. This means that discussion about behavioral counseling will be left to doctors and patients to decide based on doctors’ professional judgment and patients’ preferences. Some studies indicated that adults benefited from behavioral counseling interventions, particularly for interventions that were longer and more involved (e.g. sun protection-focused text messages over 12 months vs. single behavioral counseling session).

#3: We concur with maintaining an “I” grade for skin self-examination as the review team did not find any eligible studies to evaluate.

#4: Available data present challenges to making recommendations. For example, studies were not sufficiently long-term to study the incidence of skin cancer outcomes. Two adult studies followed patients for 24 months, but most studies only followed patients for 3-13 months. We agree that, ideally, additional studies are needed to assess skin cancer outcomes over a much longer period of time. We also recognize that it is not feasible to study the impact of these interventions long-term and agree with the USPSTF’s focus on reviewing behavioral counseling interventions aimed at promoting sun-protective behaviors that prevent individuals’ exposure to UV radiation in the short-term.

#5: Future reviews and recommendations should expand the recommendations to include people who do not have fair skin and light-colored hair and eyes. Although white people have the highest risk of melanoma and were overwhelmingly represented in this review, researchers noted that it is unknown whether these findings also apply to people of color, who die at higher rates from skin cancer. In addition, it would be beneficial to know if the benefits and risks were similar between men and women and for those who have family members who developed skin cancer.

#6: Studies are needed to determine which, if any, primary care-related interventions are effective for which demographic subgroups. Researchers concluded that successful behavioral counseling interventions were typically multi-component, including varying combinations of intervention components such as in-person counseling, print media, and sun protection aids like sunscreen.

In conclusion, we support USPSTF’s draft recommendations for behavioral counseling interventions to prevent skin cancer as well as their broader 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 provision of additional recommendations about more specific behavioral interventions to prevent skin cancer for individuals in various subgroups.

For questions or more information, please contact Megan Polanin, PhD, at mp@center4research.org.

Safety Checks at DC Playgrounds Under Question After Boy Injured on Crumb Rubber Floor

Q McCray, ABC 7 News: October 27, 2017

There’s no hiding 5-year-old Sam loves playing at Washington D.C. parks, but his mother can’t help but think what if.

“He fell about two and a half feet and broke his leg,” Eliza Graham explained.

Sam fell on one of D.C.’s older poured-in-place (PIP) crumb rubber floor playgrounds.

“No one in the District can speak to whether these playgrounds meet fall safety standards,” the mother of three added.

PIP and crumb rubber were D.C.’s flooring of choice for parks until a moratorium last year for health and safety reasons. One of them being attenuation.

Dr. Diana Zuckerman is President of National Center for Health Research.

“As they get older they get harder,” she said. “It can be extremely dangerous even deadly if a child falls.”

Manufacturers push “Gmax” testing to evaluate if PIP playgrounds are soft enough. Seven On Your Side found out D.C.’s Department of General Services (DGS) has never tested its rubber playground floors.

“Playgrounds do not fall under the Gmax testing for us,” DGS Director Greer Gillis said during a public hearing recently. “That’s one of the things we want to do in regards to playgrounds.” […]

Read the original article here.

NCHR Letter to the DC City Council on Artificial Turf

National Center for Health Research: October 26, 2017

Dear Council Members,

I am writing to respond to the request for additional information from Councilwoman Cheh as follow-up to my statement and the written materials I provided at the October 13 roundtable on artificial turf.

As the president of the National Center for Health Research, I expressed my strong concerns about the safety of the synthetic turf that the city has used and is continuing to use.  As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, the fact that school athletic fields and playgrounds are exposing D.C. children on a daily basis to chemicals and materials that are known to increase obesity; contribute to early puberty; cause attention problems such as ADD; harbor deadly bacteria; and exacerbate asthma is very disturbing.  Surely these are exactly the types of health problems that the D.C. government should be doing its best to reduce, not increase.

Federal agencies were investigating the safety of these products during the Obama Administration and were close to completion when the Trump Administration took over the two federal agencies involved, the Environmental Protection Agency and the Consumer Product Safety Commission.  Despite claims to the contrary at the October roundtable, neither agency has concluded that artificial turf is safe.  However, it is clear that we can’t depend on the Trump Administration to scrutinize the science regarding these products in a way that will be credible, and that means more work for the rest of us who care about children’s safety.

Envirofill and Other Hot Artificial Turf

As noted at the roundtable, all types of turf have risks and benefits, including natural grass.  However, some materials are well known to have substantial risks.  For example, DCPS is installed synthetic turf with Envirofill at Janney Elementary.  Although it is advertised as “cooler” and safer than older types of artificial turf, on a recent 64 degree afternoon, the temperature at the new Janney Envirofill field was 136 degrees, compared to 89 degrees on the grass.  And Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside.  Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica is contained inside the plastic coating.  However, sunlight and the grinding force from playing on the field breaks down the plastic coating.   For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated.  The other 30% can be very harmful as children are exposed to it in the air; here’s a screen grab from a November 2016 Patriots vs. Seahawks game, which shows how the silica sand infill is kicked up when players dive on a synthetic surface with silica sand infill.

In addition, the Envirofill pellets are coated with an antibacterial called Microban, which is a trade name for triclosan.  Triclosan is registered as a pesticide with the EPA and last year the FDA banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use, since research shows a link to liver and inhalation toxicity and hormone disruption.  Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

I recently gave a guest lecture at a local college and when I asked if anyone had experience with artificial turf, two young women had stories to share.  They described playing on an artificial turf field on a sunny day, where they could actually see the heat waves rising off the field that had a strong chemical odor.

Councilwoman Cheh asked me to provide scientific evidence to back up my statements.  In addition to the links provided above regarding triclosan and silica, I want to describe the data regarding carcinogens and hormone disrupting chemicals that can cause obesity, early puberty, and attention deficits.

Scientific Evidence of Cancer and Other Systemic Harm

First, it is important to distinguish between evidence of harm and evidence of safety.  Companies that sell and install artificial turf often claim that there is “no evidence that children are harmed” or “no evidence that the fields cause cancer.”  That is often misunderstood as meaning that the products are safe or are proven to not cause harm. Neither is true.

It took decades to prove that smoking can cause cancer, a fact that everyone now agrees is true.  As each type of artificial turf is replaced by a new type of artificial turf, it will be equally difficult to prove that these different types of fields cause specific children to develop cancer, obesity, early puberty, or ADD.  For that reason, we need to focus on what is known about the materials the fields are made of and what the implications are for children’s health.

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals as well as carcinogens.  There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).  The latter conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from recycled tires. One study evaluated the level of chemicals released and the other two studies looked at the risk of injury from falls.

The OEHHA studies showed that the children would be exposed to five chemicals, including four PAHs, one of which, chrysene,” was high enough to possibly increase the chances of a child developing cancer.[1]

Out of the 32 playgrounds studied, only 10 met that state’s standard for “head impact safety” to reduce brain injury and other serious harm in children who fall while playing. All five surfaces made of wood chips met the safety standard.[1]

A 2015 report by Yale scientists detected 96 chemicals in samples from 5 different artificial turf companies, including unused bags of tire crumb. Unfortunately, the health risks of most of these chemicals had never been studied.  However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes. [2]

Less is known about the materials that are used in PIP and other rubber products; some are recycled tire materials and some are “virgin rubber” but all are made from synthetic rubber, which is a petroleum based product.  This week I visited a playground at Chevy Chase Recreation Center.  Although the playground seems to be a relatively new solid rubber surface, there are several areas that are already broken, with dark crumb rubber and other very small colorful particles clearly showing. Some of the particles look like they could be from plants, but you can’t crush or tear them as you can with plant material.  Children can pick up those particles intentionally or unintentionally; little children are likely to eat it or get it in their mouths, shoes, or clothes, and children of any age will certainly get it on their skin.  As noted above, the evidence is clear that these rubber particles are dangerous.

Rather than provide a lengthy description of all the studies showing the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), I will assume you know that the evidence is clear about those chemicals being in rubber and plastic and causing health problems.  Scientists at the NIH environmental institute, which is called the National Institute of Environmental Health Sciences, have concluded that unlike most other chemicals,  hormone-disrupting chemicals can be dangerous at very low levels as well as at higher levels, and the exposures can be even more dangerous when they combine with other exposures in our environment.  That is why the Consumer Product Safety Commission has banned numerous endocrine disrupting chemicals from toys and products used by children ages 3 and younger.  Like playgrounds and artificial turf fields, these products were sold in the U.S. for many years prior to the ban, because the companies were not required to prove that the products were safe.

Instead of focusing on those studies, here is just one recent scientific study on the health risks of synthetic rubber.  A report warning about possible harm to people who are exposed to rubber and other hormone disrupting chemicals at work explains that these chemicals “can mimic or block hormones and disrupt the body’s normal function, resulting in the potential for numerous health effects…. Similar to hormones, EDC can function at very low doses in a tissue-specific manner and may exert non-traditional dose–response because of the complicated dynamics of hormone receptor occupancy and saturation.”[3]

That article lists numerous EDCs found in rubber products and warns that “studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.”

Dangers of Hard Fields and Playgrounds

I want to briefly mention safety issues pertaining to Gmax scores.  As you know, a Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  The synthetic turf industry and ASTM suggest that scores should be below 165 to ensure safety comparable to a grass field.  At the roundtable it was mentioned that grass fields can also get extremely hard, which is true.  However, the hardness of natural grass fields is substantially  influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again.  In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder.  Moreover, averaging Gmax scores for a field is an inappropriate way to determine safety.  If a child (or adult) falls, it can be at the hardest part of the field, which is why that is the way safety is determined.

Conclusions

I have appreciated the opportunity to meet with several Councilmembers’ staff and I commend the Council for banning crumb rubber during FY 2018.  Unfortunately, however, Envirofill, “poured in place” rubber (PIP), EPDM, and all the other synthetic materials currently on the market all have petroleum based materials and therefore share some of the same health risks.  While the companies that sell these products claim they are safe and meet federal safety standards, there are currently no federal safety tests required to prove that these products are safe.  In many cases, the materials used are not public, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields such as the Maryland Soccerplex. Although a well-respected grass expert offered a free consultation on how to install well-engineered grass designed to withstand rain and play, DGS did not respond to his offer.

I have also attached an annotated bibliography of numerous relevant scientific articles on artificial turf that will help you see that there is growing evidence of the harm of these synthetic materials on fields and playgrounds.  This is just a sample of studies, and there are many more, so let me know if you’d like additional information.

I am one of many parents and scientists in D.C. that are very concerned about the impact of these artificial fields and playgrounds on our children.  It is clear that city officials have assumed these products are safe because the salespeople told them they were safe.  Unfortunately, there is clear scientific evidence that these materials are potentially harmful, and the only question is how harmful are they and how much exposure is likely to be harmful?  Our children deserve better.

Sincerely,

Diana Zuckerman, PhD

President

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf 
  2. Yale Study Reveals Carcinogens and Skin Irritants in Synthetic Turf. http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/
  3. Anderson SE and Meade BJ, Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals, Environ Health Insights. 2014; 8(Suppl 1): pgs 51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/