All posts by CPTFeditor

Phthalates Q&A

Environmental Exposures, Other Cancers
By Paul Brown & Stephanie Fox-Rawlings, PhD
Updated 2016

Phthalates are synthetic chemicals found in everyday plastic products, including toys, children’s care products, medical tubes and saline or blood bags, and food packaging. They are used to make plastic flexible.  They are also used in many personal care products that smell good, such as shampoo and creams, as well as air fresheners. The use of some phthalates is being restricted in some products; however, they are still very common. Phthalates can leach out of the plastic to cause health problems, especially for young children.

Q: Animals exposed to phthalates are more likely to develop serious diseases and health problems, such as liver cancer, kidney cancer, and male reproductive organ damage1, but have any studies shown that phthalates cause health problems in humans?

A: Yes, studies by Harvard researchers have shown that phthalates may damage human sperm DNA, reduce sperm numbers, and reduce its mobility2, and another study from several major medical centers has found that phthalates may cause genital changes for boys.3 Mount Sinai researchers found that girls exposed to more phthalates were more likely to be overweight.[end Wolff MS. (2012, January).Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research 112:186-193] Other studies have shown that being exposed to phthalates increases the chance of developing asthma, allergies and bronchial obstruction.4

Q: Can phthalate exposure affect a child’s behavior?

A: Yes, prenatal exposure to phthalates and/or as a young child increases the chances of cognitive and behavior problems.5 Higher levels of phthalates have been associated with attention and memory problems, increased aggression and law-breaking behaviors, as well as poor social skills.

Q: Have scientists representing the European Union concluded that phthalates are safe?

A: No, in 2006, the European Union banned the use of 6 phthalates in toys that may be placed in the mouth by children younger than 3.6 The banned phthalates are DINP, DEHP, DBP, DIDP, DNOP, and BBzP. More recently the European Union banned the use of DEHP, BBP, DBP and BiBP in electronic equipment starting in 2019. The chemicals cause environmental and health hazards during recycling or disposal.7

Q: How are phthalates regulated in the US?

A: As of February 2009, U.S. law bans children’s toys and child care products related to sleep or feeding that contain the phthalates BBP, DBP, or DEHP. Toys or items that can be placed in a child’s mouth cannot contain DIDP, DINP, or DnOP.8 In 2014, the Chronic Hazard Advisory Panel recommended banning DIBP, DPENP, DHEXP, DCHP, and DIOP.9 The Consumer Protection and Safety Commission (CPSC) followed with a proposed a rule to ban DIBP, DPENP, DHEXP, and DCHP in children’s toys and care products.10 However a final rule (and thus the ban) has not been published. The Environmental Protection Agency (EPA) has planned to assess seven phthalates under the Toxic Substances Control Act, which could limit their use in all kinds of products.11 These are DBP, DIBP, BBP, DEHP, DnOP, DINP, and DIDP. However, it is unclear when assessment will occur.

Q: If phthalates are banned, will the toy industry start using unsafe alternatives?

A:  No, federal legislation requires that alternatives to the banned phthalates are not hazardous under the Federal Hazardous Substance Act.8 Manufactures are also required to sufficiently test their product to insure it will not cause injury through normal use or predictable misuse.

Q: Should the Consumer Product Safety Commission (CPSC) establish federal regulations for phthalates that preempt state laws?

A: That would be a bad idea because some States have better laws than the federal government. The CPSC is a small agency that has a hard time keeping up with reports of unsafe products that are sold in the U.S. In 2015, CPSC recalled more than 600 distinct products, including 52 for children and babies.11 The states of California and Washington have passed strong laws to protect adults and children from unsafe products, and it would be inappropriate for federal laws to interfere. California has listed six phthalates (DBP, DEHP, BBP, DINP, DIDP, and DNHP) on their Prop 65 lists of chemicals known to cause cancer, birth defects or reproductive harm.12 In Washington state, the definition of “children’s product” is broader that that used by the CPSC. Therefore, there are some children’s products that cannot be sold in the state of Washington but are not banned by the CPSC. Examples include children’s cosmetics or clothing that are not packaged as toys.13

For more information, contact Dr. Diana Zuckerman or Paul Brown at (202) 223-4000 or by e-mail at dz@center4research.org and pb@center4research.org

F.D.A. faulted for problems with drug tracking

News Stories & Editorials,
By Sabrina Tavernise, New York Times
January 14, 2016

WASHINGTON — Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer.

Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how the F.D.A. was doing with those tasks.

The answer was not very well.

“F.D.A.’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult,” the accountability office concluded in its report.

[…]

“We are shortcutting an important part of the approval process in the hope that we get the information later, but now we’re finding out that’s not happening,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit consumer research group.

[…]

To read the full article, click here.

FDA faulted for failure to track safety issues with drugs already on market

News Stories & Editorials
By Sheila Kaplan, STAT
January 14, 2016

WASHINGTON — Most Americans assume that drugs approved by the Food and Drug Administration are safe to take as directed. But safety concerns often arise only after the drugs go on the market, when companies or doctors tell the FDA about cases of patients who have fallen ill or died from their medications.

On Thursday, however, a federal watchdog agency said the FDA is failing to sufficiently track and publicly disclose instances in such cases.

The Government Accountability Office investigation, conducted at the request of Representative Rosa DeLauro (D-Conn.), raises deep concerns about the FDA’s oversight. It expresses particular concern about the lack of tracking of drugs cleared under two expedited approval programs, which account for about one-quarter of all medicines permitted to go on the market.

“FDA has acknowledged that expediting drug application approvals can pose risks for patients,” GAO investigators wrote, stressing that “postmarket” monitoring for those drugs was especially important.

The investigators also criticized the FDA for failing to post quarterly reports listing certain potential safety issues that it has identified. Despite a statutory requirement that it do so, last year FDA posted no reports at all in its tracking system.

[…]

Diana Zuckerman, president of the National Center for Health Research, agreed the FDA needs to do a better job of monitoring safety issues with drugs that received expedited approval.

“All the pressure now within the FDA, and from patients and Congress is, ‘Let’s get drugs on the market more quickly. Let’s get those cures available to the people who want them more quickly.’ And the FDA has been doing that,” Zuckerman said.

On other hand, she said, the agency also needs to “make sure that better studies are done to see exactly who is likely to benefit and who is likely to be harmed.”

To read the full article, click here.

Breast implants after mastectomy: Risks you need to know

Breast Cancer
Diana Zuckerman, Ph.D.
Updated 2016

The complication rate for getting breast implants after mastectomy has been described by experts as “alarmingly high and arguably unacceptable,”14 even though most of the information about complications is based on studies that were paid for by companies that make breast implants or silicone.

How safe are breast implants and how many women have complications after getting reconstruction with breast implants after a mastectomy? When the Food and Drug Administration (FDA) approved breast implants, they acknowledged that the complication rate is very high for all women, especially those undergoing reconstruction. What the FDA did not know, however, is that early-stage breast cancer patients that undergo mastectomy and reconstruction with breast implants are 10 times as likely to commit suicide as other early-stage breast cancer mastectomy patients. 

We do not know why the suicide rate is so high for mastectomy patients with breast implants, but we do know that complications are very common. For example, a study conducted by implant manufacturer Inamed (now called Allergan) found that 46% of reconstruction patients needed additional surgery within the first 2 to 3 years after getting silicone gel breast implants 15. Not surprisingly, the implant maker did not publish an article describing this high complication rate, which was more than twice as high as the 21% reported by Henriksen and his colleagues in their study funded by Dow Corning (which manufactures silicone).

Why was the complication rate lower in the Dow Corning study? One explanation is that the women in that study had breast implants for an average of only 23 months, compared to 2-3 years in the Inamed study. Even so, the Dow study found that 31% of the women developed at least one serious complication and 16% developed at least 2 serious complications in that short period of time. The Inamed study reported that 25% underwent implant removal, 16% experienced Baker III-IV capsular contracture (which is painful breast hardness), 6% experienced necrosis (death of breast tissue), 6% had other types of breast pain, and 6% had an implant that ruptured, and other women reported infections and other complications.2  This shows that both studies found very high complication rates despite a short follow-up of less than 3 years.

In their Dow-funded study, Henriksen concluded that “reconstruction failure (loss of implant) is rare.” Of course, it should be rare after less than 2 years. In contrast, when Inamed used Magnetic Resonance Imaging (MRIs) to detect rupture, they found that 20% of reconstruction patients had ruptured implants by the third year;16 while very few ruptures were detected without MRIs. Since Henriksen did not use MRIs to detect rupture, he probably undercounted the number of failed implants.  Moreover, FDA scientists concluded that the risk of rupture would likely increase exponentially every year.17

The lack of MRI use also helps explain the lower rate of additional surgery for the Henriksen study. If a woman underwent an MRI and learned that her implant was ruptured, she would probably have surgery to remove it.

Many plastic surgeons claim that the Institute of Medicine concludes that breast implants are safe. However, the Institute of Medicine report was completed in 1999, and most research on breast implant patients was published after 1999, making the report very outdated. Many of the studies reported higher levels of diseases or symptoms among women with breast implants, which would have reached statistical significance if the studies were larger and women were followed for a longer period of time. For example, the study by Schusterman et al, included only 250 women with implants, all of whom had implants for only 2 years.

In 2001, Food and Drug Administration scientists reported a significant increase in fibromyalgia and several other autoimmune diseases among women whose silicone gel breast implants were leaking, compared to women with silicone implants that were not leaking outside the scar tissue capsule.4 The National Cancer Institute (NCI) found a doubling of deaths from brain cancer, lung cancer, and suicides among women with breast implants compared to other plastic surgery patients.18 National Cancer Institute findings regarding autoimmune diseases were not definitive.19 National Cancer Institute scientists concluded that more research was needed to determine if implants increase the risk of cancer or autoimmune diseases. 5,6

The unanswered questions about diseases and the high complication rate for breast cancer patients with breast implants raise important safety issues. It is difficult for patients to receive informed consent when few studies of breast cancer reconstruction patients are available. 

An earlier version of the above article was based on Dr. Zuckerman’s article published in Archives of Surgery, Vol 141, July 2006, pages 714-715. The original article can be found here.

Ovarian cancer: who should be concerned and what can they do?

Ovarian Cancer, Uncategorized
Prianka Waghray and Laura Gottschalk, PhD

Ovarian cancer is the fifth leading cause of cancer death in women in the U.S. 20   Most women who are diagnosed with cancer of the ovaries are at least 55 years old.  When women are treated before the cancer has spread, 9 out of 10 will be alive five years later.  Unfortunately, ovarian cancer is usually not detected until it has spread, and then only about 1 in 4 women will still be alive five years later.21

Is there a way doctors could find it earlier and save more lives?  Screening is the key for several other cancers, but is less effective for ovarian cancer.

Is there a screening test for ovarian cancer?

There are ways of screening for ovarian cancer, but they are not very accurate. The current methods are:  the CA-125 blood test, ultrasound, and pelvic examinations.22

Since 2012, the U.S. Preventive Services Task Force has recommended against annual ovarian cancer screening tests for women who do not have symptoms.3 They concluded that women who have no signs or symptoms, no family history of breast or ovarian cancer, and no increased risk based on their genes do not benefit from screening and may even be harmed by it.

The Task Force reviewed all the studies conducted on women with no symptoms of ovarian cancer to see if using two screening methods—the CA 125 blood test and transvaginal ultrasound—would help detect ovarian cancer earlier and save lives.  They concluded that annual screenings using these two methods for women who have no symptoms did not reduce the number of women dying from ovarian cancer.  Moreover, screening resulted in many women being told they might have cancer when they didn’t (false-positive test results), which led to anxiety and potentially harmful unnecessary surgeries.

A 2015 study of over 200,000 British women also did not find that screening resulted in a significant decrease in ovarian cancer deaths compared to women who did not have any screening 23. These results further support the recommendation against screening in women with no symptoms.

The Task Force’s recommendation against screening does not apply to women who have a family history of breast or ovarian cancer or known genetic defects such as BRCA1 and BRCA2 gene mutations.

What are the signs and symptoms of ovarian cancer?

Women over 40 years of age who have any signs and symptoms associated with ovarian cancer should ask their doctor about getting screened. Since these symptoms are common to many other diseases as well, they should be reported to the doctor if they persist for two weeks or longer.1 According to the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), you should pay attention to the following signs and symptoms:What you need to know about: Ovarian cancer. 24

  •  Unusual vaginal bleeding, such as irregular periods, bleeding that is heavier than normal for you, or that occurs when you are past menopause
  • Discharge from your vagina that is not normal for you
  • Pain or pressure in the pelvic or abdominal area (the area below your stomach and between your hip bones)
  • A swollen abdomen
  • Bloating or feeling full quickly while eating
  • Feeling very tired all the time
  • Back pain
  • Change in bathroom habits, such as having to pass urine very often and with greater than usual urgency, constipation, or diarrhea

Screening Tests for Women with Symptoms or who are at Increased Risk:

CA-125 blood test:

The CA-125 blood test is a screening method that looks for a protein called CA-125, which is higher in women with ovarian cancer and some other conditions, such as   non-gynecological cancers, and endometriosis.25   Since CA-125 can be associated with many different health conditions, it is not useful for determining ovarian cancer.  For more information about CA-125 blood test go to http://dev.stopcancerfund.org/prevention/ovarian-cancer-ca-125-blood-test-does-it-work/   

Transvaginal ultrasonography:

This type of ultrasound (sound waves) makes a picture of the uterus, ovaries and cervix.26  It can be used to detect small masses.3 Unfortunately, by the time the tumor in the ovaries is big enough to be detected, the cancer has already progressed to the later stages.

Pelvic examination:

A pelvic exam is a physical exam a doctor does to check for problems or abnormalities in a woman’s female reproductive organs.  Sometimes the doctor will combine a pelvic exam, which involves touching and lightly pressing on the lower abdomen, with a rectovaginal exam, in which  the doctor inserts one finger into the vagina and another into the rectum while placing the other hand on top of the pelvis. This allows the doctor to feel for abnormal growths or lesions.  These exams help detect tumors and other abnormalities in later stages of the disease.

Who is at risk and what to do if you have a family history of breast or ovarian cancer

The risk for ovarian cancer increases with age. Most women with ovarian cancer are over 60 years old. 27  Other factors that the risk include:

Having family members such as a mother, sister, aunt, or grandmother on either your mother’s or father’s side with either breast or ovarian cancer.

  • Having already had uterine, breast or colorectal cancer.
  • Having never given birth or having had trouble getting pregnant
  • Coming from an Eastern European Jewish background (Ashkenazi)
  • Having endometriosis
  • Have tested positive for a genetic mutation called BRCA1 or BRCA2

The National Cancer Institute also warns that women who have taken menopausal hormone therapy—estrogen only or estrogen with progesterone—are at increased risk of ovarian cancer.  The risk is greatest for women who took it for 5 years or more.728

If you have one or more of these risk factors or you have any of the previously mentioned symptoms associated with ovarian cancer, you should talk with your doctor.  But remember, just because you have one or more of the risk factors above, doesn’t mean you have or will get ovarian cancer!

If several women in your family had ovarian or breast cancer at a young age or told you that they have the BRCA mutation, genetic counseling can help you find out if you have a higher risk as well.  BRCA1 and BRCA2 increase a woman’s risk of breast and ovarian cancer (For more information, click  http://www.center4research.org/2011/09/the-failed-promise-of-gene-based-tests-for-diagnosing-and-treating-cancer/).   Genetic testing is not recommended for all women, just those with a family history of cancer.

What should I do if I have the BRCA1 or BRCA2 genetic mutation?

If you have the BRCA mutation, it doesn’t mean you will definitely get ovarian cancer.  According to the National Cancer Institute, anywhere from 15% to 40% of women with BRCA1 or BRCA2 will develop ovarian cancer.29  However, you should talk to your doctor about the following strategies to prevent ovarian cancer or detect it early:

1)      Surveillance:  Patients should be screened regularly using currently available methods such as transvaginal ultrasound, CA-125 blood tests, and clinical exams to detect the presence of ovarian cancer.

2)      Prophylactic surgery:  This is surgery to prevent cancer by removing most of the “at-risk” tissues.  One option is the removal of healthy fallopian tubes and ovaries.  Although this type of surgery will reduce your chances of developing ovarian cancer, some women have developed ovarian cancer even after the prophylactic surgery.

3)      Non-surgical ways to reduce your risk:   Avoid hormone therapy (for more information, see http://dev.stopcancerfund.org/newsite/p-breast-cancer/menopause-and-the-ongoing-hormone-therapy-debate/); maintain a healthy weight; increase your physical activity; and reduce your alcohol intake to no more than 3 drinks a week.  While hormone therapy increases the risk, birth control pills —which also contain hormones—tend to reduce your chances of getting ovarian cancer, even if you have BRCA1 or BRCA2. 9

What about Medicines?

Medicines such as tamoxifen and raloxifene are taken by some women, including BRCA carriers, to lower their chances of getting breast cancer, but have not been show to protect against ovarian cancer.9

The Bottom Line:

The U.S Preventative Services Tasks Force recommends against annual screening methods for ovarian cancer in women who have no symptoms and are not known to be at increased risk for ovarian cancer.  Ovarian screening methods should only be used for women who have a family history of ovarian cancer, the BRCA1 or BRCA 2 gene mutation, or who have signs and symptoms of ovarian cancer.

Related Content:
Ovarian Cancer: What are the treatment options?

Why do mastectomy patients with breast implants commit suicide?

Breast Cancer, Breast Cancer, Cost
Diana Zuckerman, PhD

Breast cancer patients often describe having a new appreciation for life. It is important for women and their friends and family members to know that women who have breast cancer have an increased likelihood of committing suicide for up to 15 years after their cancer diagnosis [1].

Even more surprising, one study among women who got breast implants after mastectomy found that their suicide rate was 10 times higher compared to other mastectomy patients [2]. More research is needed, but this study has received little attention. No other studies were conducted to learn more.  However, it is important to note that all the women in the study had early-stage breast cancer – which experts agree does not require a mastectomy. In fact, the latest research on mastectomies indicates that women who undergo mastectomy do not live as long as women of the same age and diagnosis who undergo lumpectomy and radiation instead.

The Bottom Line

If mastectomy is not medically necessary, it is a bad choice since cancer patients who undergo mastectomy don’t live as long as lumpectomy patients and additionally, are more likely to commit suicide.

 

Sources

[1]  Misono, S., Weiss, N.S., Fann, J.R., Redman, M., & Yueh, B. (2008). Incidence of suicide in persons with cancer. Journal of Clinical Oncology,26, 4731-4738. doi: 10.1200/JCO.2007.13.8941] [end Riihimäki, M., Thomsen, H., Brandt, A., Sundquist, J., & Hemminki, K. (2012). Death causes in breast cancer patients.Annals of Oncology, 23, 604-601. doi: 10.1093/annonc/mdr160

[2] Le, G.M., O’Malley, C.D., Glaser, S.L., Lynch, C.F., Stanford, J.L., Keegan, T.H.M., & West, D.W. (2005). Breast implants following mastectomy in women with early-stage breast cancer: Prevalence and impact on survival. Breast Cancer Research, 7, R184-R193. doi: 10.1186/bcr974

Home sweet home? Flame retardants in your home can harm you

Environmental Exposures
By Abigail Fredenburg, PhD, Caitlin Kennedy, PhD, Anna Mazzucco, PhD
Updated 2016

Could your couch increase your chances of getting cancer? Possibly. Studies show that every day we are exposed to chemicals that were intended to protect us from household fires but are hazardous to our health.30 31 Toxic flame retardants are used in upholstered furniture such as couches, chairs, and mattresses, as well as in drapery and carpets. They are even in our televisions and plastic-cased electronics. Flame retardants have also been found in foam in baby products such as baby carriers, high chairs, strollers, and nursing pillows.32

Who invited cancer-causing chemicals into our homes?

At one time, It made sense to require flame retardants that would prevent or slow the spread of fire, but we now know those same chemicals can cause cancer. They also can affect children’s growth and brain development.

Dr. Linda Birnbaum, the director of the National Institute of Environmental Health Services, explains that new research used 3-D imaging to demonstrate how synthetic flame retardants “interfere with the body’s natural hormones.”33 When chemicals affect adult hormone levels, they can be very harmful, such as reducing fertility or harming a developing fetus.

Other research shows how this can affect children’s learning. University of Cincinnati’s Dr. Aimin Chen and colleagues studied pregnant women and their children to determine the effect of prenatal exposure on learning and behavior. The researchers measured the amount of common flame retardants in 301 pregnant women at 16 weeks of pregnancy and tested their children during their first 5 years of life. Pregnant women with higher levels of flame retardants had children who tended to have more learning problems at ages 2, 3, 4, and 5 years, and the children also were more likely to be hyperactive.34

Another important way that young children are exposed to flame retardant chemicals is through their crib mattresses. The volatile organic compounds (VOCs) in crib mattresses come from the foam stuffing, usually made of polyurethane or polyester. Studies from the last ten years suggest that exposure to these chemicals increases the risk of asthma and lung infections in young children.35 36 A study from 2014 revealed that infants may be at greater risk from the chemicals in crib mattresses than adults for several reasons: their small size means there is less distance between a baby’s body and the mattress, and babies generate more body heat while sleeping which causes more chemicals to be released into the air that they breathe. Also, babies sleep more hours a day than adults do, lengthening the time they are exposed to the mattress chemicals.37

These findings have important implications for children’s health and are why previous flame retardants, such as brominated “Tris,”were banned from use in children’s pajamas in the late 1970s and chemicals called PentaBDE and OctaBDE were phased out of commercial products, beginning in 2004.38 39 Despite these laws, we are still exposed to these and even more harmful chemicals. Why? Because banned chemicals are replaced by new chemicals that we don’t yet know much about. As shown in recent studies, these new chemicals can also be dangerous, and in some cases may be more dangerous. Researchers found higher-than-expected levels of one such chemical, organophosphate esters, in the outdoor air in 5 sites around the U.S. Great Lakes. This new chemical was found in amounts 100 to 1,000 times higher than older PBDE’s.40

Even after flame retardants are phased out, we keep getting exposed when we use old furniture passed on to family members, or sold at garage sales. Because there is no standard process to safely dispose of furniture containing flame retardants, these chemicals remain in our environment via discarded furniture, dust, and air.2 Flame retardant chemicals can even be measured in tree bark. Research shows the highest levels are in densely populated areas, such as Toronto, Canada, but high levels are also found in remote regions of Indonesia and Nepal.41

Researchers at Duke University led a national study to identify flame retardant chemicals in the polyurethane foam used in couches. TDCPP was the most commonly detected flame retardant, often used to replace PentaBDE and OctaBDE in couches manufactured after their 2004 phase out. TDCPPcan cause cancer and is very similar to the Tris that was banned decades ago. Of the 102 couches tested, researchers detected toxic flame retardants in 85% of them.42

In a second study conducted by the Silent Spring Institute, dust samples were collected from 16 homes in California. House dust is the primary way Americans are exposed to toxic flame retardants, by inhaling and ingesting them.1 Researchers found Tris in 75% of the homes despite its ban from children’s pajamas more than 30 years ago and its listing in California as a chemical known to cause cancer.

California has a higher furniture flammability standard than other states, known as Technical Bulletin 117 (TB117). Because of its large size, it is often easier for companies to follow California’s standards for all their products, not just those sold in California. Manufacturers also make their products comply with TB117 to protect themselves against law suits.43 But, as a result, they are risking consumers’ health by exposing Americans to higher levels of flame retardants in their homes than they would otherwise be.44

In general, California’s stricter standards (on organic foods and on air quality, for instance) have paved the way for protections across the country, but in the case of flame retardants, their standards have been harmful.

We all depend on government regulators to keep us as safe as possible, by making our homes, cars, airplanes, foods, and medicines as safe as possible. Unfortunately, current standards for flame retardant furniture are not based on solid research.45 Fortunately, California has responded to criticisms of their standards by adopting new guidelines in November 2013 based on the latest research. The new guidelines require upholstery and fabric covers to be smolder proof, a new test that simulates fires from a lit cigarette. The changes are meant to more accurately reflect the situations that usually lead to fires in homes, and make it possible for manufacturers to use lower amounts of less toxic chemicals. As a consequence, manufacturers will use different, and presumably safer, flame retardants for products sold in California and across the country. The changes went into effect in January 2015.46 47

Since many of us can’t buy all new furniture to help reduce exposure to these toxic chemicals, we need to try to keep our homes as dust free as possible. Remember, as these flame retardants are released or shed from upholstered furniture and other household products, they accumulate in house dust. Vacuum regularly, use a wet-mop, and wash your hands frequently. Have young children who spend a lot of time on the floor wash their hands regularly, too.

If you are thinking of buying a new mattress or furniture, the Green Science Policy Institute provides a reference guide for furniture made without added flame retardants.48 There are now also many “green” furniture companies that use all natural and non-toxic materials like wool and organic cotton that are not only better for you and your family, but also for the environment. In 2015, Ikea, Wal-Mart Stores Inc., Ashley Furniture industries Inc. and Macy’s Inc. stated they would ban flame retardants from all their furniture, although it is not clear when the bans would be in place.49 50 Keep in mind that not all furniture comes with a tag outlining what it is made from. You may want to check online to find out more before you buy furniture that could expose yourself and your loved one to chemicals for years to come.

The bottom line is that reducing dust in your home, maintaining or replacing old furniture and making careful decisions about new purchases are important steps for keeping a healthy home!

FDA to create early warning system for medical devices

In the News, News Stories & Editorials
By Robert Lowes, Medscape
December 31, 2015

Hammered for its regulation of medical device safety, the US Food and Drug Administration (FDA) today proposed telling the public about “emerging signals” of possible device risk before it determines whether the risk actually exists.

Such early warnings already are issued for drugs through the FDA Adverse Event Reporting System (FAERS), a database on adverse event and medication error reports submitted to the agency. A dramatic fall-off in the number of drugs flagged for potential risk signals in FAERS since 2012 prompts FDA critics to wonder whether a similar system for medical devices will benefit the public.

In today’s proposal, the FDA explained that it historically has alerted the public about safety concerns that crop up after a device goes on the market, and usually after it has determined what to do about them. Agency responses include recommendations for the “device user community” and possible regulatory action.

However, the FDA said there is a need to notify the public “about emerging signals that the agency is monitoring or analyzing, and for which the agency does not yet have specific recommendations.” […]

Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank focused on children and adults, said she does not believe that the downward trend line means that the FDA has been receiving fewer adverse event reports. Rather, the process of disseminating possible risk signals has become “moribund.”

“We think FAERS information is not being made public in a timely manner,” Dr Zuckerman toldMedscape Medical News. She cites lack of regulatory and political will as the reason. FDA user fees collected from drug manufacturers “are dependent on speed of review for drug approvals, not on timely FAERS information,” she said. “Similarly, Congress has complained about the speed of drug and device approvals, not on the speed of warning safety signals.

“Unfortunately, safety is not currently a priority at the FDA or Congress,” Dr Zuckerman said. […]

To see original article, click here.

Why the FDA wants to ban tanning beds for minors

News Stories & Editorials
By Emma Court, MarketWatch (WSJ)
December 22, 2015

The skin damage caused by tanning beds doesn’t disappear like a Snapchat…that’s why the Food and Drug Administration wants to ban minors from using them.

Exposure to ultraviolet light can build up over time. And research shows that UV exposure from artificial sources is more damaging and more likely to cause melanoma–the most dangerous skin cancer–when started at young ages.

To reduce the risk of skin cancer, the FDA proposed a ban that would prevent people from using them before their 18th birthday. On Monday, the proposal was opened for a 90-day public comment period.

“There haven’t been too many steps the FDA has taken that are probably as important as this one. This really has the potential for saving a lot of lives,” said Diana Zuckerman, president of the National Center for Health Research. “Of course, if it’s effective it’ll have a huge impact on the business.” […]

Read the full article here.

Politicians want to speed up drug approvals. That could backfire.

In the News, News Stories & Editorials
Carolyn Johnson, Washington Post
November 24, 2015

To patients grappling with incurable diseases, new therapies can’t come quickly enough. A bill that hopes to address this need sailed through the House in the summer with the goal of getting more “21st Century Cures” through the drug approval pipeline. But a pair of new studies found that speeding up this process could put drugs that are ineffective or harmful on the market.

At least for complex neurological diseases, such as Alzheimer’s, Parkinson’s and depression, recent history suggests that approving drugs faster based on biomarkers — early signs that a drug could be working — might make drugs that ultimately don’t work available to patients, two teams of researchers found.

These early biomarkers are one of several ways the House bill could speed up the drug approval process. A Senate version of the bill is expected to be presented soon, with many wondering how similar it will be to the House version. The Food and Drug Administration has said the House legislation wouldn’t override its ability to approve safe and effective drugs.

[…] A second study published in the British Medical Journal this week examined three Alzheimer’s drugs that progressed to late-stage trials based on positive data in earlier stage trials that suggested the drugs were working. In each case, the team found that the phase two trials suggested the drugs would work — two showed encouraging decreases in measurements of beta amyloid, a protein that builds up in the brains of Alzheimer’s patients. One drug, semagacestat, was then tested in 1,537 patients and was found to cause skin cancer and even worsen patients’ ability to perform activities of daily life. The other two drugs looked promising in intermediate trials, but also failed once tested in large numbers of patients.

The researchers projected that if the semagacestat had been approved based on its encouraging results in intermediate trials, the treatment would likely have cost thousands of dollars a year, treated 234,000 patients, and caused 19,000 cases of skin cancer.

“This is just yet another example where, if you look at these very reasonable surrogate endpoints …  you can get results that are completely different when you look at things you really care about, which, in this case, is memory loss and the ability to function, day-to-day,” said Diana Zuckerman, president of the National Center for Health Research.

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