Diana Zuckerman, PhD

Updated February 2014

 

Avandia was a popular drug for diabetes, but is it safe? There is research evidence that patients taking Avandia are more likely to die compared to diabetic patients taking other drugs.  The FDA defends the use of Avandia, but many concerns remain.

Since 2007, the FDA required Avandia to include a black box warning for patients and doctors that it increases the risk of heart failure, which can be fatal.  A block box around a warning about risks is the strongest warning the FDA requires, similar to the black box warning on cigarette packages, warning that smoking causes lung cancer, heart disease, and is dangerous for pregnant women.

Nearly 20 million Americans have type 2 diabetes, also known as adult-onset diabetes, a condition where a person’s body does not produce enough glucose (sugar) orrespond well to the blood sugar that the body makes naturally. Diabetes can result in many very serious health problems, including kidney disease, blindness, limb amputation and, most notably, heart disease. It is these complications caused by the disease, not the diabetes itself, which cause serious long-term effects or death. Avandia is a prescription drug manufactured by GlaxoSmithKline that lowers the sugar levels in the blood. But, does it improve the health of diabetics?

Avandia was approved by the U.S. Food and Drug Administration (FDA) in March 1999 despite concerns from FDA scientists and other experts about the safety of the drug. As a condition of FDA approval, GlaxoSmithKline was required to continue to conduct clinical trials to assess the seriousness of heart complications related to the drug’s use.

On June 28, 2010, the Journal of the American Medical Association published two research studies that concluded that patients taking Avandia were more likely to die than patients taking other diabetes medication.

Previously, Dr. Steven Nissen and Kathy Wolski, MPH, published an article on the effects of Avandia and related drugs and cardiovascularrisks in the New England Journal of Medicine based on a meta-analysis of 42 small studies. They concluded that Avandia increases the risk of heart attack by 40%, compared to placebo. The FDA and GlaxoSmithKline criticized the study, saying that the data were short-term (six months or less) and that the studies differed widely, so that combining them in a meta-analysis was questionable.

The 2010 studies are harder to criticize.  One of them is also by Steve  Nissen and Kathy Wolski, and is based on a meta analysis of 56 studies of more than 35,000 patients.  The other is a 3-year comparison of Avandia and Actos, based on more than 220,000 patients and analyzed by FDA scientist Dr. David Graham and his colleagues.

The “black box” warning labels for Avandia (also called rosiglitazone) are also required for the other drugs in its class.  Other drugs in the same class as Avandia are called thiazolidinedione drugs.  In addition to Actos (pioglitazone), they include Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). The warning explains that these drugs can cause or increase heart failure. If FDA takes Avandia off the market, they may need to take the combination drugs listed above that include Avandia off the market as well (Avandaryl and Avandamet).

As a result of media attention and the black box warning, many doctors and patients have decided that the risks are too high. Prescriptions for Avandia decreased dramatically, but questions remained about the safety of other diabetes drugs, some of which had not been scrutinized as carefully as Avandia.

Dr. Nissen points out that the purpose of diabetes drugs is to lessen the possible danger of diabetes, “not improvement in a laboratory measure of glycemic [blood sugar] control.” Since heart disease is the #1 cause of death among diabetics, it is reasonable to ask why a diabetes drug that possibly increases rather than decreases the risk of heart disease should remain on the market. Are warnings enough to keep patients safe? After looking at the study results, many experts are urging that patients and doctors consider whether older drugs for diabetes may be safer and more effective – as well as much less expensive. They are asking: should Avandia remain on the market?

Starting in 2010, the FDA began requiring special certification for healthcare providers who prescribed Avandia.  Only specially certified pharmacies could dispense it, and only patients who were already taking it before the restrictions or new patients who could not use any other glucose-lowering medications were eligible to take it.

However, the company insisted that Avandia was safe and challenged the studies indicating it was not.  Dr. Nissen and other critics of the company’s research pointed out the flaws in the research design.  Despite the unanswered questions and continuing concerns of many experts, in November 2013, the FDA announced its conclusion that Avandia does not pose a greaterrisk of heart disease than the most commonly used Type 2 diabetes drugs and withdrew the stronger label warnings and otherrestrictions. Rather than proceeding with caution, the FDA told GlaxoSmithKline that they no longer need to conduct a previously required study comparing Avandia to Actos and other diabetes drugs.

The FDA’s decision leaves physicians and patients with limited information about which diabetes drugs are safer, and for which patients.  However, the law suits against Avandia have continued and the safety questions still concern many physicians and patients.

In January 2014, the FDA approved a new diabetes drug, Farxiga, that seems to be less effective than Avandia, Actos, and several other diabetes drugs; increases the risk of genital fungal infections and bladder infections, and may increase the risk of bladder cancer and breast cancer. Read here for more on Farxiga.

By Dana Casciotti, PhD

Updated January 2014

Animals play an important role in many people’s lives.  In addition to seeing-eye dogs and dogs that can be trained to detect seizures, animals can also be used in occupational therapy, speech therapy, or physical rehabilitation to help patients recover.1  Aside from these designated therapeutic roles, animals are also valued as companions, which can certainly affect the quality of our lives.  Is that companionship beneficial to our health?

The better we understand the human-animal bond, the more we can use it to improve people’s lives.  This article summarizes what is known and not known about how animals help improve the health and well-being of people, and what the implications might be for helping people who don’t have pets of their own.

Over 71 million American households (62%) have a pet,2 and most people think of their pets as members of the family.3  Some research studies have found that people who have a pet have healthier hearts, stay home sick less often, make fewer visits to the doctor, get more exercise, and are less depressed.  Pets may also have a significant impact on allergies, asthma, social support, and social interactions with other people.

Impact on Physical Health

Companion animals may improve heart health by lowering blood pressure and regulating the heart rate during stressful situations.  In a 2002 study, researchers measured changes in heart rate and blood pressure among people who had a dog or cat, compared to those who did not, when participants were under stress (performing a timed math task).  People with a dog or cat had lower resting heart rates and blood pressure measures at the beginning of the experiment than non-pet owners.  People with a dog or cat were also less likely to have spikes in heart rates and blood pressure while performing the math task, and their heart rates and blood pressure returned to normal more quickly. They also made fewer errors in their math when their pet was present in the room.4  All these findings indicated that having a dog or cat lowered the risk of heart disease, as well as lowering stress so that performance improved.

A similar study found that having your dog in the room lowered blood pressure better than taking a popular type of blood pressure medication (ACE inhibitor) when you are under stress.5

Children’s exposure to companion animals may also ease anxiety.  For example, one study measured blood pressure, heart rate, and behavioral distress in healthy children aged 3 to 6 at two different doctor visits for routine physicals.  At one visit a dog (unrelated to the child) was present in the room and at the other visit the dog was absent.  When the dog was present, children had lower blood pressure measures, lower heart rates, and less behavioral distress.6  Research on the health benefits of child and animal interaction is limited.  Further research is needed on how pets influence child development and specific health outcomes.

These findings suggest that the social support a pet provides can make a person feel more relaxed and decrease stress.7  Social support from friends and family can have similar benefits, but interpersonal relationships often cause stress as well, whereas pets may be less likely to cause stress.  The social support provided by a pet might also encourage more social interactions with people, reducing feelings of isolation or loneliness.  For example, walking with a dog has been found to increase social interaction, especially with strangers, compared to walking without a dog.8

Among elderly people, pet ownership might also be an important source of social support that enhances well-being.  In one study, elderly individuals that had a dog or cat were better able to perform certain physical activities deemed “activities of daily living,” such as the ability to climb stairs; bend, kneel, or stoop; take medication; prepare meals; and bathe and dress oneself.  There were not significant differences between dog and cat owners in their abilities to perform these activities.  Neither the length of time of having a dog or cat nor the level of attachment to the animal influenced performance abilities.    Companion animals did not seem to have an impact on psychological health but researchers suggested that a care-taking role may give older individuals a sense of responsibility and purpose that contributes to their overall well-being.9

A large German study collected pet information (dog, cat, horse, fish, bird or other pet ownership) from over 9,000 people at two different times (1996 and 2001).  The survey included a number of health, economic, and labor issues, so that respondents would not realize the researchers’ interest in a link between pets and health.  Researchers found that people who said they had a pet in both 1996 and 2001 had the fewest doctor visits, followed by people who had acquired a pet by 2001; the group of people who did not have a pet at either time had the highest number of doctor visits.10

Similarly, a study of women (men were not included in the study) in China found that dog owners had fewer doctor visits, took fewer days off sick from work, and exercised more often than non-dog owners.11

Research on allergies and asthma is mixed.  Some studies show that having a cat might increase allergen sensitivity, while others show it might protect against cat allergies.  Having a dog might not influence or might protect against specific dog allergies.12 A 2013 study found that mice were protected against allergies when they were exposed to dust that came from homes with dogs.13  The researchers discovered that the protective effect was due to a certain type of gut bacteria that is often present in people with dogs.  More research is needed on the connection between allergies, asthma, and pets, but it is possible that the impact of having pets on allergies may depend on the age of the person at the time they are exposed to an animal as well as the type of pet.  For example, 6 and 7 year old children who lived with a bird during their first year of life were more likely to have respiratory symptoms like wheezing compared to children who did not have a bird in the home as an infant.14

As is true with any relationship, some human-pet relationships are likely to be more rewarding than others. Some people are more attached to their pets than others and those feelings could influence the impact of the pet on the person’s health.  Other factors such as gender and marital status may play a role. For example, one study found that dog ownership was associated with lower rates of depression among women, but not men, and among single individuals but not married people.  So, while pet ownership might have a positive impact on well-being for some people, it doesn’t affect everyone the same way.15

The Challenges of Measuring the Positive Impact of Pets

The effect of human-animal interaction on health is not fully understood because it is difficult to study.  Most evidence on the benefits of having a pet comes from surveys of current health, but that means it is impossible to know if a person is in good health because she has a pet or if he is more likely to get a pet because he is in good health.  Someone whose health is poor may decide he does not have the time or energy to care for a pet.  The German study described above suggests that having a pet for a longer period of time is more beneficial to your health; but it is also possible that people with pets have less time to spare to go to the doctor or are less concerned about their own health, especially minor ailments.

In addition, people who love their pets are likely to want to let researchers know that their pets help improve their lives.  This could bias the study results.

Another issue is how the word “pet” is defined.  Does having a goldfish confer the same health benefits as having a golden retriever?  Most pet studies were of people who had a dog or a cat, making it difficult to draw conclusions about health benefits of birds, lizards, fish, or other pets.  How much time the person spends with his or her pet could be strongly influenced by the type of pet and in turn could influence the health benefits of having a pet.16

Temporary Companions

Researchers have also used animals to temporarily provide companionship to children with health or mental health problems, or elderly people who may not have the energy or resources for a live-in pet.  While these studies do not always have consistent results, some positive findings of interacting with a therapy dog include reduced levels of pain and anxiety among hospitalized children and adults, as well as increased focus and interaction among children with autism and other developmental disorders.  In nursing home settings, interaction with visiting dogs has led to more social behaviors, more interaction among residents, and less loneliness.17

While research on animal-assisted interaction and therapy is not always consistent and is often done with small groups of participants, there is some evidence that interaction with a companion animal even for a short time might have a range of benefits

The Bottom Line

The research findings are encouraging, so it makes sense to conduct more studies on how human-animal interaction influences our health.  We don’t yet know precisely what types of animals influence what types of health issues (physical, mental, and social well-being) and what characteristics about human-animal interaction are most important.  People who have pets know that there are many benefits to having a companion animal, but we do not yet know under what circumstances those benefits are most likely.  If research shows specific health benefits under specific circumstances, that information can be used to change policies in ways that benefit even more adults and children, by influencing rules and regulations for schools, health or assisted living facilities, residential treatment centers, and other places where people’s exposure to animals is sometimes discouraged but could potentially be encouraged.

For more scientific research about human-animal interaction, see How Animals Affect Us: Examining the Influence of Human-Animal Interaction of Child Development and Human Health by Peggy McCardel, Sandra McCune, James A. Griffin, and Valerie Maholmes.  The book is based in part on a workshop sponsored by the Waltham Centre for Pet Nutrition, a division of Mars, Incorporated, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

By Diana Zuckerman, Ph.D., Padma Ravichandran, and Elly Field
Updated September 2013

 

Although the minimum drinking age is 21 years old, teenagers and young adults between the ages of 12 and 20 consume about 11% of the country’s alcohol in a given year—mostly by “binge drinking.” 18 Binge drinking is defined for men as drinking 5 or more drinks in a row (in 2 hours or less), and 4 or more drinks for women. Young adults between the ages of 18 and 24 consume the most alcohol on average when they binge drink (about 9 drinks in a two-hour period), but high school kids are also very likely to binge when they drink.19

While binge-drinking seems to be declining among teens, extreme binge-drinking (15 or more drinks in a row) is not. In 2005, 22% of high school students admitted to drinking 5 or more drinks in a row during “the last two weeks,” which was reduced to 18% in 2011.20 However, about 1 In 20 high school students drank more than 15 drinks in a row in 2011, the same as 2005.

Is this harmless fun?  Or deadly?  Every few years, there are “hazing” deaths like that of David Bogenberger, a freshman pledging to a fraternity at Northern Illinois University. He died after answering questions for two hours from upper class fraternity brothers in exchange for vodka.21 But, those individual tragedies aren’t the entire story.

Physical and Mental Health Effects

Kids that drink tend to do poorly in school, and it can harm growth,  sexual development, and brain development. 22 Whether you drink too much alcohol or not, part of being young is not thinking about how what you do now can affect you later on. Unfortunately, excessive drinking in your teens and early adulthood can have an impact on your health many years later. Research shows that binge drinking while you’re young can worsen your memory and increase you risk for obesity and heart problems.

A 2008 study by researchers in Berkeley, California, found that young adults who started drinking alcohol early and heavily in adolescence were more likely to have more abdominal fat, to be overweight, and to have lower levels of the “good cholesterol,” all of which contribute to heart disease. 23

Long-term heavy drinking, which is defined for men as consuming more than 2 drinks per day every day, and more than one drink every day for women, weakens the heart muscle 24. This prevents the heart from effectively pumping blood to other organs. Binge drinking and long-term heavy drinking can also affect heart rhythms, causing the heart to beat irregularly or too fast. These strains on the heart can affect a person’s health in a number of ways. For instance, binge drinkers are almost 40% more likely to suffer from a stroke than people who don’t binge drink.25

Heavy drinking can also affect your abilities for the rest of your life.  Long-term, heavy drinking can affect our neurons and slow the communication between neurotransmitters in the brain 8, but binge drinking when you’re a teenager may actually change the structure of the brain, damaging the tissue that messages pass through when moving from one area of the brain to another.26 These brain changes may impair a teenager’s memory and ability to learn.

A study published in 2013 that tracked college students in Brazil and Spain for two years had similar findings: the researchers found that those who binge drank had greater difficulty recalling information on memory tests—both immediately and 30 minutes later 27.

Besides the potential effects on health and memory, excessive drinking early in life is often a red flag for other problems. A study that followed almost 1,000 adolescents from high school through age 24 found that those who were problem drinkers when they were young grew into adults with drinking problems. They were also more likely to be depressed, anxious, antisocial, and have problems with other types of substance abuse.28 A study that followed college students into adulthood discovered that those who binge drank were significantly more likely to experience alcohol-related problems during college and 10 years after college.29 The researcher also found that the students who binge drank in college were less likely to continue their education and, if they did finish, were more likely to work in less prestigious and lower paying jobs.

Community Consequences

Underage drinking not only affects the teenagers who do it, but everyone around them. One in three car crash deaths involve drivers with alcohol in their blood that is above the legal limit.30 A national survey found that 8% of high school students report they had driven a car after drinking alcohol, and 24% rode in a car with a driver who had been drinking alcohol. [2]

Underage drinking and binge drinking happen because we, as a society, allow it to. Adults may choose to look the other way, and teens and young adults often egg each other on. One study found that teenagers whose parents allowed them to drink engaged in riskier behavior than teenagers whose parents didn’t allow drinking. In addition, they generally experienced more negative consequences from their drinking.31 Even if their parents forbid drinking, teens have to contend with friends who drink and pressure them to join in. Research has shown that if you’re a young adult and your peers drink, you are more likely to drink as well.32

What should family members, teachers, and other adults do to help kids?

1)     Understand the impact of peer pressure. It’s easier to talk to teenagers about the negative effects and risks of drinking when it appears you are only talking about their friends. See if he or she feels pressure to drink, and if so, discuss the possibility of finding new friends to make it easier to spend less time with peers who drink or avoid them when they are drinking. Also, help a teen practice ways of saying “no” or removing himself or herself from situations where she is expected to drink, without losing face or appearing judgmental.

2)     Never ignore teenage drinking hoping it will go away. Often it is a symptom of more serious problems that the teen is experiencing now or will develop in the coming years.11

Bottom Line: What you need to know as a teen or parent

If you are a teen, pay close attention to your friends’ drinking and talk to them about the risks.  Avoid situations where you will be under pressure to drink or ride in a car with a driver who has been drinking. If you are worried that discussing your friends’ drinking with your parents will make them dislike your friends or limit your social time with them, find another adult you trust to discuss strategies for saying “no” and avoiding risky situations. You can also visit these websites for suggestions on how to deal with peer pressure and plan ahead to minimize risky situations:

For parents: Talk with your teens about how to approach various scenarios in which they might feel pressured to drink or ride in the car with a driver who has consumed alcohol. Tell your teen that you’ll pick him up or pay for his taxi, no questions asked, if he or his ride has made the mistake of drinking. The mistake and the decision to behave differently next time can be addressed the following day.  For more information on how to keep your teenager from drinking and driving, visit: http://m.cdc.gov/en/VitalSigns/teen-drinking-and-driving .

Lastly, if you need help for your son or daughter’s drinking, there is a toll-free number you can call: 1-800-662-HELP (4357). This is a service of the Substance Abuse and Mental Health Services Administration (SAMHSA), which is part of the U.S. Department of Health and Human Services (HHS). You will get a recorded message in English or Spanish giving you the option 1) to speak to someone about treatment or request educational materials, or 2) to get a referral to a treatment place in your state. If you don’t want to call and prefer to look for help online, visit this SAMHSA site: http://findtreatment.samhsa.gov/

By Brandel France de Bravo, MPH; Sarah Miller, RN;  and Jessica Becker

 

Updated JUNE 2014

 

Electronic cigarettes, or e-cigarettes, are being marketed as the “safe” new alternative to conventional cigarettes.  They can be used indoors, allowing smokers to get their fix wherever and whenever they want.  But are e-cigarettes safe?  What does the FDA think about them? Are e-cigarettes going to reverse the decline in smoking—giving new life to an old habit—or can they help people quit smoking?  Here is what you need to know before picking up an e-cigarette.

 

What are e-cigarettes?

E-cigarettes are battery-operated devices shaped like cigarettes that provide an alternative way to receive nicotine. Nicotine is an addictive drug (it stimulates and relaxes) that is naturally found in tobacco, but cigarette manufacturers have often added extra nicotine or engineered their cigarettes to maximize the amount of nicotine delivered to smokers in each puff. 33

E-cigarettes work by heating a liquid cartridge containing nicotine, flavors, and other chemicals into an inhalable vapor. Because e-cigarettes heat a liquid instead of tobacco, what is released is considered smokeless.34 However, studies show that exposure to the chemical used to create the vapor (propylene glycol mist) may cause respiratory inflammation and eye irritation.35 Propylene glycol is used in pet-friendly anti-freeze solutions (a safe alternative to ethylene glycol) and in smoke machines at dances or the theater.

Flavors, such as “gummy bear,” “cotton candy,” and “bubble gum” are not only encouraging teenagers to try e-cigarettes, they are resulting in accidental poisonings among children.  Over half of the 2,405 calls to poison centers between September 2010 and February 2014 concerned children 5 and under who had come into contact with e-cigarettes. 36 E-cigarettes are far easier for young children to smoke as they require no matches. Worse still, the liquid in the cartridges is highly concentrated so absorbing it through the skin or swallowing it is far more likely to require an emergency room visit than eating or swallowing regular cigarettes.

 

Are e-cigarettes safer than conventional cigarettes?

The key difference between conventional and e-cigarettes is that e-cigarettes don’t contain tobacco. But, it isn’t just the tobacco in cigarettes that causes cancer. Conventional cigarettes contain a laundry list of chemicals that are proven harmful, and e-cigarettes have some of these same chemicals.

Nicotine is one of the chemicals found in both conventional and e-cigarettes. It is highly addictive and has been shown to reduce bone health.37

An analysis of e-cigarettes by the FDA in 2009 found that they “contained detectable levels of known carcinogens and toxic chemicals to which users could be exposed.”38  For example, in e-cigarette cartridges marketed as “tobacco-free,” the FDA detected diethylene glycol (a toxic compound found in antifreeze), tobacco-specific nitrosamines which are carcinogenic to humans, and other toxic tobacco-specific impurities. The body’s reaction to many of the chemicals in conventional cigarette smoke causes chronic inflammation, which in turn leads to chronic diseases like bronchitis, emphysema, and heart disease.39 Since e-cigarettes also contain many of the same toxic chemicals, there is no reason to believe that they will significantly reduce the risks for these diseases.

You may have also heard that free radicals produced by the smoke from cigarettes can damage veins and arteries and lead to heart disease. It is possible that the vapor from e-cigarettes may contain fewer free radicals because it is not smoke. This does not mean, however, that smoking e-cigarettes is safe for your heart.

There are no long-term studies to back up claims that the vapor from e-cigarettes is less harmful than conventional smoke. Cancer takes years to develop, and e-cigarettes were only very recently introduced to the United States. It is almost impossible to determine if a product increases a person’s risk of cancer or not until the product has been around for at least 15-20 years. Despite positive reviews from e-cigarette users who enjoy being able to smoke them where regular cigarettes are prohibited, very little is known about their safety and long-term health effects.

 

Can e-cigarettes be used to cut down or quit smoking regular cigarettes?

If a company makes a claim that its product can be used to treat a disease or addiction, like nicotine addiction, it must present studies to the FDA showing that its product is safe and effective for that use. On the basis of those studies, the FDA approves or doesn’t approve the product. So far, there are no large, high-quality studies looking at whether e-cigarettes can be used to cut down or quit smoking long-term. Most of the studies have been either very short term (6 months or less) or the participants were not randomly assigned to different smoking cessation methods, including e-cigarettes. Many of the studies are based on self-reported use of e-cigarettes. For instance, a study done in 4 countries found that e-cigarette users were no more likely to quit than regular smokers even though 85% of them said they were using them to quit. 40. Another year-long study, this one in the U.S., had similar findings.41  People may believe they are smoking e-cigarettes to help them quit but 6-12 months after being first interviewed, nearly all of them are still smoking regular cigarettes.

The FDA has not approved e-cigarettes for use in cessation, or quitting smoking.42

In September 2010, the FDA sent a warning letter to five distributors of e-cigarettes who were marketing their product this way: E-CigaretteDirect LLC, Ruyan America INC., Gamucci America (Smokey Bayou INC.), E-Cig Technology INC. and Johnson’s Creek Enterprises LLC.  After this warning letter, four of the companies changed their position to say that their e-cigarettes are not intended to be used as a way to quit smoking. E-Cig Technology INC. hasn’t made any changes to their website in response to the warning letter.

 

Teenagers and e-cigarettes

The percentage of teenagers who have tried e-cigarettes has more than doubled in just a year, from 4.7% in 2011 to 10% in 2012. Over 1.78 million U.S. students in middle school and high school tried e-cigarettes in 2012, according to the National Youth Tobacco Survey. And this statistic greatly underestimates use because most teens don’t even know e-cigarettes as “e-cigarettes”; they call them “e-hookas” or “hookah pens” or “vape pipes.”  Furthermore, 1 in 5 middle schoolers who said they had tried e-cigarettes also said they had never smoked conventional cigarettes. 43

Experimentation with e-cigarettes by young people is worrisome for a couple of reasons: 1) the younger people are when they begin smoking, the more likely it is they will develop the habit: nearly 9 out of 10 smokers started before they were 18;44 2) e-cigarettes may  introduce many more young people to smoking who might otherwise never have tried it, and once they are addicted to nicotine, some may decide to get their “fix” from regular cigarettes. Whether e-cigarettes end up being a “gateway” to regular cigarettes or not, young people who use them risk becoming addicted to nicotine and exposing their lungs to harmful chemicals.

The sharp rise in young e-cigarette users highlights the need to stop manufacturers from targeting teenagers with candy-like flavors and advertising campaigns such as this one that appeal to young people’s natural desire to rebel.

 ecigad

How are e-cigarettes regulated?

On a national level

Originally, the FDA tried to block the sale of e-cigarettes on grounds that they were an untested drug-delivery device (nicotine is a drug), but in 2010 a federal appeals court ruled that the FDA could only regulate e-cigarettes as tobacco products.45 The FDA was given the authority to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 when President Obama signed into law the Family Smoking Prevention and Tobacco Control Act.  This Act also gave the FDA the authority to regulate “other tobacco products” (including products made from or derived from tobacco) by issuing a regulation “deeming” the additional products as subject to the same law.

In April 2014, the FDA issued its first proposal (a “deeming rule”) for regulating e-cigarettes. These proposed regulations are just that: a draft proposal, which the public, scientists, and e-cigarette companies have a chance to review and provide input on before it is finalized. The full text of the deeming rule can be found here but in short, the FDA is proposing:

  • To prohibit  the sale of e-cigarettes to children and teens (under 18)
  • To prohibit vending machine sales of e-cigarettes
  • People over 18 will be required to show photo i.d. to purchase e-cigarettes, including through the internet.
  • The addition of a warning label to all packaging and advertisements stating “This product contains nicotine derived from tobacco.  Nicotine is an addictive chemical”.
  • All manufacturers of e-cigarettes will have to register with the FDA, which involves providing the agency with a detailed list of all the products’ ingredients, including how much nicotine they have, and information on their manufacturing process.

Despite these positive steps, the proposed rule is not nearly as tough as the regulations governing regular cigarettes. For instance, the FDA is still not proposing to limit the marketing of e-cigarettes to children and teens—only their sale. Also, it isn’t putting any restrictions on the media e-cigarettes can be advertised in, whereas regular cigarettes can’t advertise on television or radio.  E-cigarette companies will continue to use celebrities to endorse their brands and market flavors such as “bubble gum” and “cookies and cream”.

jennylucycigB

When e-cigarette companies register their products with the FDA, they will have to apply for FDA approval of the products, but here’s the catch: they will have two years AFTER the deeming rule is finalized to apply for approval and will be able to keep selling their e-cigarettes during that time. While the FDA’s proposed rule leaves the door open for the agency to issue more regulations on the sale, advertisement and marketing of e-cigarettes down the road, issuing and finalizing additional regulations will take time. Moreover, companies have to be given time to comply. All of this means that omissions and loopholes can take years to fix. Lastly, the FDA rule proposal does not address the sale of liquid nicotine which is used to re-fill e-cigarettes and exists as an unregulated market.  Presently, there is no requirement for childproof lids or restrictions on quantity on internet and retail outlet sales of liquid nicotine. If you would like to comment on the FDA’s proposal for regulating e-cigarettes, click here. The FDA has extended the deadline for comments until August 8, 2014.

On a state level

Individual states have taken action to govern the sale and use of e-cigarettes, including restricting their use in public areas and banning their sale to minors. For example, in May 2013, the California state senate proposed a law making all e-cigarettes subject to the same regulations and restrictions as traditional cigarettes and tobacco products.46

 

Bottom line

E-cigarettes have not been around long enough to determine if they are harmful to users in the long run. Unfortunately, many people, including teenagers, are under the impression that e-cigarettes are safe or that they are effective in helping people quit smoking regular cigarettes. Neither of these assumptions has yet been proven. Studies by the FDA show that e-cigarettes contain some of the same toxic chemicals as regular cigarettes even though they don’t have tobacco. The big three tobacco companies—Lorillard, Reynolds American, and Altria Group—all have their own e-cigarette brands so it’s not surprising that e-cigarettes are being marketed and advertised much the way regular cigarettes used to be. Here are the 7 Ways E-Cigarette Companies Are Copying Big Tobacco’s Playbook.

Unless you want to be a guinea pig, hold off on e-cigarettes until more safety information is available. And if you want to quit smoking or reduce the number of cigarettes you are smoking, check out these Quit Smoking Resources compiled by the Centers for Disease Control (CDC).

Anne Gallo, M.S., Sarah Miller, R.N., Diana Zuckerman, Ph.D., and Monica Purmalek
Updated July 2013

Can stress make you sick?  The answer is a resounding yes.  If you want to know how to handle stress, it helps to know what stress is, how it affects your body, and what you can do about it.

What is Stress?

Anything that an individual perceives as a problem can cause stress.  When we perceive a problem and don’t have the resources (or believe we don’t) to cope with it, we can experience stress.  Stressors can be physical, such as an illness or injury, or emotional, such as family, job, or financial problems.  Stress is a reaction to a situation where a person feels threatened or anxious.47  According to Dr. Esther Sternberg, director of the Integrative Neural Immune Program at the National Institute of Mental Health, our body’s response to stress is natural and adaptive.48  Even if the body has a natural way to handle stress, chronic stress may be harmful to our health, resulting in both psychological and biological changes that increase our chances of becoming ill.

 

Stress Hormones

When faced with stress (for example a physical threat), your body reacts with a “fight or flight reaction” to enable you to fight back or run away from danger.  The adrenal glands release the hormone epinephrine (adrenaline) and the neurotransmitter norepinephrine into the blood stream.  The adrenal glands also release corticosteroid hormones that release fatty acids for energy, causing digestion to stop, blood sugar levels to rise, and the heart to pump more blood to the muscles.

At the same time, the pituitary gland releases a hormone that stimulates the release of cortisol.  In the short term, cortisol helps the body divert energy to muscles and organs that are needed to avoid danger.  However, the same hormones that help defend the body in the short-term can hurt it when produced for longer periods. Because one action of cortisol is to suppress the immune system, chronic stress causes wounds to heal more slowly than normal and leaves the body prone to infections.  This is why chronic stress is also associated with gastrointestinal conditions such as ulcers and irritable bowel syndrome. Since cortisol changes blood sugar and heart rate, cortisol is also associated with diseases of the cardiovascular system, including hypertension, stroke, and heart disease.

 

Telomeres

Telomeres are caps that we all have on the end of our DNA.  As we age, we slowly lose small bits of our telomeres and they become shorter.  Therefore, measuring the length of a telomere can tell us the “real age” of a person’s cells.  Several studies have found that people who are under chronic stress tend to lose length on their telomeres more rapidly.  For example, one study found that caregivers of people with Alzheimer’s disease not only had poorer immune function, but that their telomeres were shortening more rapidly.49  In other words, the stress of caring for an Alzheimer’s patient was permanently aging their cells.

Another study found that otherwise mentally and physically healthy adults who had a history of being mistreated as children had shorter telomeres.50  This suggests that it’s not always possible to “reverse” the damage stress causes to our cells and that stress at a young age may have life-long effects.

 

Women and Stress

Studies show that women and men cope with stress differently.51  The friendships and other social support systems that are more common in women may help them cope more effectively with stress, enhancing their immune response and resistance to diseases.52  Studies have shown that women with breast cancer who have strong social supports have significantly longer life spans than women who do not.53  Interestingly, researchers found that social support provided by women is more effective at lowering blood pressure responses to stress in both males and females than support from men.

On the negative side, scientists find that women are two times more likely to develop depression in reaction to the stress in their lives.54  Working women are often under considerable stress as they try to balance work, marriage, and children. Some experts have found that chronic stress can cause a chemical imbalance that can lead to depression.55  In addition, those who care for sick and elderly family members are usually women. Studies indicate that these caregivers have high cortisol levels and therefore weakened immune systems.56

 

What Causes Stress?

It is unclear how much of the stress response is determined genetically and how much can be controlled by the individual. Genetics play a part in determining someone’s stress response, as does an individual’s experience with stress and their learned perceptions of specific events or situations as stressful. So, the way we see ourselves and others, our methods of handling stress, and our genetic makeup all affect the immune system and therefore our health.Not everyone is the best judge of what reduces his or her own level of stress. For example, smokers depend on cigarettes to relax, but the nicotine in cigarettes does exactly the opposite. Watching TV may feel relaxing, but depending on the program and on how TV interferes with sleeping or other responsibilities, it may sometimes increase stress and decrease the ability to cope with stress.  Here are some tips you can try to help you deal with stress.

 

Tips to Reduce Stress

Experts indicate that there are many different ways to manage our levels of stress.  It is important to keep in mind that different strategies work for different people. You can try to manage stress levels by meditation, exercise, and doing things that you find relaxing.  The most effective stress-reduction measure for many people, however, is exercise. Physical exertion causes your body to release endorphins which can make you feel better while also boosting your immune system.

If you need something to help you reduce stress in the moment, try taking slow and deep breaths. Slow breathing has been shown to have a calming effect that can lower blood pressure, reduce muscle tension, and decrease heart rate.

Our eating habits can affect our immune systems’ response to stress. A balanced diet emphasizing fresh fruits, vegetables, legumes, raw nuts and seeds, and whole grains can help the body respond better to stress. Reducing caffeine can also help. Studies have found that blood pressure during stress is higher if caffeine has been consumed.57   This suggests that people who have a high intake of caffeine might experience more stress and produce more stress hormones.

Getting enough sleep is also important.  (To find out why you should get enough sleep, read here).  Many Americans get only 7 hours of sleep a night, but research indicates that most adults and children do better with 8-9 hours; in fact, most teens in a sleep lab sleep more than 9 hours each night if given the opportunity.  It can be a vicious cycle: lack of sleep can make an individual more susceptible to stress, and stress often interferes with the ability to sleep.

Researchers have also linked the inability to identify and express emotions to a number of health conditions.58  Expressing emotions to members of a support system or even writing down feelings can help.  Try talking to others, whether friends, family, a counselor, or a professional, if you are having trouble managing your stress.

 

Bottom Line

It’s worth making the effort to think through how stress affects your life.  If you’re aware of how physical and emotional stresses affect your body, you will be better prepared to cope with stressful situations, modify the way you react to them, feel better, and live longer. It is important to remember that often we can’t do it all on our own – in that case, try seeking help from a professional.

If you or someone you know needs immediate help, please contact the one of the following crisis hotlines:
-Disaster Distress Helpline: 1-800-985-5990
-National Suicide Prevention Lifeline: 1-800-273-TALK
-Youth Mental Health Line: 1-888-568-1112

For more information, we recommend Dr. Esther Sternberg’s book, The Balance Within: The Science Connecting Health and Emotions (Holt, Times Imprint).

Also, check out our Survival Guides for Working Moms for more tips and research based information about coping with stress.

Kids in Danger · Consumer Federation of America
Consumers Union · National Research Center for Women & Families

For Immediate Release
Friday, November 16, 2012

Chicago, IL — A coalition of consumer groups praised the Maryland Department of Health and Mental Hygiene and its Director Joshua Sharfstein for announcing a ban on the sale of crib bumper pads, effective June 21, 2013.

The decision followed a more than year-long investigation by the Maryland Department examining the safety of crib bumper pads. The department conducted its own review of evidence, convened a panel of health experts, held two public meetings, and reviewed public comment. The department concluded that the risks crib bumper pads pose towards infants far outweigh any potential benefits.

Maryland becomes the first state in the nation to ban the sale of crib bumper pads. Chicago, Illinois adopted a ban that became effective in April 2012. In addition, most states already prohibit the use of the product in licensed child care facilities.
The groups — Consumer Federation of America, Consumers Union, National Research Center for Women & Families and Kids in Danger — hailed the act as a major step forward in protecting infants.

“Our organization has been working with families whose children suffocated on this unnecessary crib decoration,” stated Nancy Cowles executive director of Kids In Danger. “We applaud Director Sharfstein and his department for their thorough study of the issue and courage in taking the lead on this safety issue.”

Consumer, safety and health care organizations all agree that a baby sleeps safest alone, on their back in a bare crib that meets current safety standards. Adding soft padding to that environment in the form of pillow, bumper pads or comforters increases the risk of suffocation or entrapment. The American Academy of Pediatrics recently updated their safe sleep guidelines to warn against the use of bumper pads.

“While standards might be appropriate to address the safety of many products, for this unnecessary decorative item which poses danger to infants, Maryland’s action to ban the product will be more effective,” stated Rachel Weintraub, Legislative Director and Senior Counsel of the Consumer Federation of America. “The regulation gives the department the ability to move to a standard if one is developed that is as protective of safety as the ban.”

The regulation defines baby bumper pads as “a pad or pads of non-mesh material resting directly above the mattress in a crib, running the circumference of the crib or along any of the interior sides of the crib, and intended to be used until the age that an infant pulls to stand.” The ban does not apply to vertical bumpers that wrap tightly around each individual crib rail or to mesh crib liners. The Department nonetheless does not recommend the use of these or other novel products.

“This ban will save lives and serve as a model for other states,” added Diana Zuckerman, President of the National Research Center for Women & Families. “As a Maryland resident, mother, and president of a nonprofit group that is dedicated to improving the health and safety of kids and adults, this decision makes me very happy.”

“Action on the state level has historically been effective in addressing emerging hazards and bringing them to the general public’s attention,” concluded Ami Gadhia, Senior Policy Counsel of Consumers Union, the policy arm of Consumer Reports. “We urge CPSC to consider national action against this suffocation hazard.”

Dr. Diana Zuckerman

November 14, 2012

The FDA law is supposed to make sure that all medical products sold in the U.S. are safe and effective.  Unfortunately, it doesn’t.

There are several giant loopholes in the law, including loopholes for compounding pharmacies, as well as companies that call themselves compounding pharmacies but aren’t.  That loophole is enormous, and that’s why hundreds of people are now sick with fungal meningitis and so many have died.

And that’s just the tip of the iceberg, because thousands of people got medications that are not proven safe and not proven effective.   And I’m not just talking about the injections that harmed Jerry, which we heard about today.  There have been many other examples of unsafe medical drugs sold through compounding pharmacies, including cancer drugs that were either weaker or stronger than they should have been.

There’s enough blame to go around, but I don’t want to play the blame game today.  Obviously, a major part of the blame is on the compounding pharmacies that didn’t care enough about patients to make sure the products they were making were safe.  This includes the specific pharmacies in Massachusetts that have been identified, but also includes many other compounding pharmacies.  We also have to wonder about the state and FDA inspectors and officials who knew that there were serious, life-threatening problems but didn’t do enough to fix them, and the doctors who ordered products from compounding pharmacies without considering safety issues.

The innocent victims are the patients who trusted their doctors and the FDA to make sure their medications are safe.  The costs to them are enormous, but the human costs and the financial costs.

This VALID Compounding Act is designed to close the loopholes that are so harmful to patients.  It is a well thought out, comprehensive, and balanced bill, and I congratulate Rep. Markey and his staff on the bill and on their excellent report.

The FDA will do a much better job of enforcement if the law is improved.  The FDA’s hands have been tied — they haven’t been able to get the information they needed to fully investigate.  FDA’s resources are very limited, so the agency tends to focus on the slam dunks, not the efforts that are less likely to be successful.

This law will save lives.  It will save a lot of lives if it isn’t watered down by those who care more about protecting companies than protecting people.  We heard a lot of opposition to safety regulations this past year in the House of Representatives, based on claims that safety regulations kill jobs.  Let’s remember that having more inspectors and requiring research evidence of safety will create jobs.  Personally, I’d rather make new jobs for inspectors and researchers, than jobs for people making unsafe medical products.  This law will make new jobs and it will save lives and healthcare dollars, a great combination.

In closing, I want to point out that the history of the FDA is a history of disasters followed by improvements in the law.  The Food, Drug, and Cosmetic Act passed in 1938 after 107 people died, mostly women and children, from taking an elixir made with an antifreeze that was added to improve the color.  That law was greatly strengthened in 1962, after the Thalidomide tragedy caused thousands of babies to be born without terribly deformed arms, legs, fingers, and toes, and in some cases no arms or legs. And, medical devices – even implanted ones – were not regulated until 1976, after many women died or became infertile from the Dalkon Shield IUD.

This is the latest tragedy, and it is an important opportunity to prevent similar tragedies in the future.  That’s why it is essential to act now.  It is not a partisan issue, and we look forward to working with Congress to act quickly.

By Morgan Wharton and Jessica Cote, BS

Updated February 2013

 

Most Americans drink coffee every day.[1] The most widely known benefits and risks have to do with caffeine, which helps us stay alert but also may cause jitteriness and interfere with sleeping. A few studies have suggested that decaffeinated coffee also has a positive impact on health, perhaps because of other ingredients in the coffee bean such as natural antioxidants (which fight cellular damage) and acids.[2]

What are the health benefits of drinking coffee?

For years medical experts advised people to drink less coffee, mostly because of research suggesting coffee might increase the risk of heart disease. However, numerous studies conducted recently have discovered coffee’s unexpected health benefits. Like all well-designed research, most of these studies took into account factors that could affect the results such as age, sex, body mass index (BMI), physical activity, smoking status, and family cancer history. By controlling for those factors, researchers made sure they could separate coffee’s impact on health from the effects of people’s lifestyle and previous health problems.

Colorectal cancer

Meta-analyses combine data from several comparable studies to make one very large study. These results are usually more accurate than any one study can be. Taken together, three meta-analyses suggest that drinking about four or more cups of coffee per day may reduce the chances of getting colorectal cancer by 11-24%.[3][4][5]

Endometrial (uterine) cancer

Using data from 67,470 women who participated in the Nurses’ Health Study, researchers found that women who drank four or more cups of coffee per day had a 25% lower risk of endometrial cancer than women who drank only one cup of coffee per day. Compared to women who did not drink any coffee, those who drank four cups or more per day were 30% less likely to develop endometrial cancer. Decaffeinated coffee was just as effective as caffeinated coffee, but caffeinated tea did not lower the risk of endometrial cancer.[6]

Liver cancer and cirrhosis (scarring of the liver/chronic liver disease)

One study found that the risk of the most common type of liver cancer was reduced by drinking coffee. People who drank only one or two cups of coffee per day had a slightly lower risk of getting the disease compared to non-drinkers, but people who drank three or four cups of coffee were about half as likely as non-drinkers to get this kind of liver cancer. Meanwhile, people who drank five or more cups per day had an even lower risk than that (about one-third the risk of non-drinkers).[1]

Similarly, a study in Japan found a 76% decrease in the risk of that type of liver cancer in people who drank at least five cups of coffee per day compared to those who did not drink coffee. The strongest benefit was seen in individuals with hepatitis C, a disease which increases a person’s risk of developing liver cancer, although the researchers were not sure why.[7]

A study of 120,000 Americans over an 8-year period found a 22% reduction in the risk of cirrhosis per cup of coffee per day.[2] In Norway, a 17-year study of 51,000 citizens found that those who drank two or more cups of coffee per day were 40% less likely to develop cirrhosis compared to those who did not consume coffee.[2]

Skin cancer

Using data from two enormous studies, the Nurses’ Health Study and the Health Professionals Follow-up Study, researchers found that men and women who drank more than three cups of caffeinated coffee per month had a 17% lower risk of getting basal cell carcinoma compared to people who drank less than one cup per month. Basal cell carcinoma is the most common and least dangerous type of skin cancer.

Decaffeinated coffee was not associated with higher or lower basal cell carcinoma.[8]

Type 2 diabetes mellitus

People in Finland consume more coffee than almost any other nation, and a study of 14,000 people over 12 years  found that men who drank 10 or more cups of coffee daily had a 55% lower risk of developing type 2 diabetes mellitus than men who drank 2 cups of coffee a day or fewer.  Even more dramatic, women who drank 10 or more cups per day had a 79% lower risk of developing type 2 diabetes than those who drank fewer than 2 cups daily.[9]

A different Finnish study of 5,000 sets of identical twins found that individuals who drank more than seven cups of coffee per day had a 35% lower risk of type 2 diabetes than their twins who drank two cups or fewer per day.[2] Because identical twins are so biologically similar, the difference in disease risk can more confidently be attributed to coffee consumption levels. Studies of fewer people in other countries have found less dramatic but similarly positive results.

Parkinson’s disease

A study of more than 8,000 Japanese-American men found that men who did not drink coffee at all were three to five times more likely to develop Parkinson’s disease within 30 years than men who drank four and a half cups or more of coffee per day.[2]

Suicide

Because suicide may be related to alcohol intake, medications, and stress levels, suicide studies took those factors into account.  A 10-year study of 128,000 people in California found that the risk of suicide decreased by 13% for every additional cup of coffee consumed per day. Even one cup of coffee per day seemed to reduce the risk of suicide.[2] A different 10-year study of 86,000 women found a 50% lower risk of suicide for those who drank two or more cups of coffee per day compared to women who did not drink coffee.[2]

Brain power and aging

A study of 676 healthy men born between 1900 and 1920 suggested that coffee helped with information processing and slowed the cognitive decline associated with aging. Cognitive functioning was measured by the Mini-Mental State Examination, a 30 point scale. Men who regularly consumed coffee experienced an average decline of 1.2 points over 10 years, whereas men who did not drink coffee saw a decline of 2.6 points over 10 years. The greatest benefit occurred in men who drank three cups of coffee per day-their cognitive decline was only 0.6 points over 10 years.[10]

Even old mice are sharper with caffeine: a study using a mouse model of Alzheimer’s disease showed that coffee actually reversed the cognitive decline and slow-down in processing that occurred with age. Mice given caffeine in their water showed signs of recovering their memory during testing.[11]

What about the risks?

 

Childbearing

Two separate studies found that 300 mg of caffeine (two to three cups of coffee) decreased a woman’s chances of getting pregnant by more than a third. This same amount of coffee also increased the risk of women having low birth-weight babies by 50%. These studies took into account additional factors such as contraception used in the past and infertility history.[2]

Hip fracture

According to data from the Nurses’ Health Study, women aged 65 and over who drank more than four cups of coffee per day experienced an increased risk of hip fracture over the next six years-approximately three times the risk of women who did not drink coffee. Researchers took important factors into consideration such as calcium intake.[2]

Parkinson’s disease among post-menopausal women taking estrogen-only hormone therapy

Other researchers used data from the Nurses’ Health Study to evaluate the risk of Parkinson’s disease among women who drank coffee while using estrogen after menopause. For women who were NOT using estrogen therapy, those who drank four or more cups of coffee per day were about half as likely to develop Parkinson’s disease as women who did not drink coffee. For women who DID use post-menopausal estrogen, however, those who drank four or more cups of coffee were about twice as likely as those who didn’t drink coffee to develop Parkinson’s.[12]

Heart disease

Two different meta-analyses found that people who drank five or more cups of coffee per day had a 40-60% increased risk of developing heart disease compared to those who did not drink coffee at all.[2] Other studies have also shown that high coffee use (five to ten cups per day) increases the risk of heart disease, while moderate consumption (three to four cups daily) was not associated with a higher risk. Only coffee drinkers who consumed more than nine cups a day had a greater risk of dying from heart disease.[2] It is important to consider that  people drinking close to 10 cups of coffee a day are likely to have other health problems, such as stress or sleep deprivation, and this could contribute to higher risk of heart disease and death regardless of coffee use.

 

 

The bottom line

For most people, drinking coffee seems to improve health more than harm it. Many of coffee’s health benefits increase with the number of cups per day, but even one cup a day lowers the risk of several diseases. However, women who want to get pregnant or already are pregnant and women over 65 should probably limit their coffee intake because, in their case, the risks may outweigh the health benefits.

Even though numerous studies show coffee to be beneficial, it’s still not clear why. How can one popular beverage help metabolism (for example, lowering the risk of type 2 diabetes) and also protect against a range of cancers? Until further research can solve that puzzle, most adults should continue to enjoy their cup (or two, or three) of Joe. Finally, remember that nearly all studies on coffee and health have been done on adults. Coffee may affect children and teens differently.


[1] Cadden ISH, Partovi N, Yoshida EM. Review article: possible beneficial effects of coffee on liver disease and function. Alim Pharmacol Therap 2007; 26(1): 1-8.

[2] Higdon JV, Frei B. Coffee and Health: A Review of Recent Human Research. Critical Reviews in Food Science and Nutrition 2006; 46(2): 101-123.

[3] Giovannucci E. Meta-analysis of Coffee Consumption and Risk of Colorectal Cancer. Am J Epidem 1998; 147(11): 1043-1052.

[4] Yu X, Bao Z, Zou J, Dong J. Coffee consumption and risk of cancers: a meta-analysis of cohort studies. BMC Cancer 2011; 11(96):1-11.

[5] Je Y, Liu W, Giovannucci. Coffee consumption and risk of colorectal cancer: A systematic review and meta-analysis of prospective cohort studies. Int J Cancer 2009; 124:1662-1668.

[6] Je Y, Hankinson SE, Tworoger SS et al. A Prospective Cohort Study of Coffee Consumption and Risk of Endometrial Cancer over a 26-Year Follow-Up. Cancer Epidemiology Biomarkers & Prevention 2011; 20(12): 2487-2495.

[7] Inoue M, Yoshimi I, Sobue T, Tsugane S. Influence of Coffee Drinking on Subsequent Risk of Hepatocellular Carcinoma: A Prospective Study in Japan. Journal of the National Cancer Institute 2005; 97(4):293-300.

[8] Song F, Qureshi AA, Han J. Increased Caffeine Intake is Associated with Reduced Risk of Basal Cell Carcinoma of the Skin. Cancer Research 2012; 72: 3282-3289.

[9] Tuomilehto J, Hu G, Bidel S et al. Coffee Consumption and Risk of Type 2 Diabetes Mellitus Among Middle-aged Finnish Men and Women. The Journal of the American Medical Association 2004; 291(10):1213-1219.

[10] Van Gelder BM, Buijsse B, Tijhuis M, et al. Coffee consumption is inversely associated with cognitive decline in elderly European men: the FINE Study. European Journal of Clinical Nutrition 2007; 61(2):226-32.

[11] Arendash W, Cao C. Caffeine and Coffee as Theraputics Against Alzheimer’s Disease. Journal of Alzheimer’s Disease 2010; 20: S117-S126.

[12] Ascherio A, Weisskopf MG, O’Reilly EJ, McCullough ML, Calle EE, Rodriguez C, Thun MJ. Coffee Consumption, Gender, and Parkinson’s Disease Mortality in the Cancer Prevention Study II Cohort: The Modifying Effects of Estrogen. American Journal of Epidemiology 2004; 160(10):977-984.

by Dr. Diana Zuckerman

Huffington Post

November 2012

Imagine that you took a medication on the advice of a doctor, it turned out to be contaminated, and you just found out it might kill you. Let’s take it a step further: What if this contamination was completely and utterly preventable, the result of carelessness, greed, and indifference?

More than 400 men and women have been diagnosed with meningitis contracted after receiving a contaminated pharmaceutical injection, and 31 have died. By the time you read this, the numbers are likely to be even higher. Thousands of apparently healthy men and women have been waiting to see if they will become ill, because there can be a delay of several months from the time of infection to the time that symptoms appear.

The tragic meningitis outbreak was absolutely preventable and, worse yet, follows a familiar pattern that has resulted in other tragedies in recent years. Here’s what needs to happen to prevent further human loss:

  • Close the giant loopholes in the law. Our laws, as they are now, allow many medical products on the market that are not tested for safety or effectiveness before they can be sold. (You might want to read that sentence again.) This past year we saw deaths and permanent harm caused from defective hip replacements and heart valve rings. In recent years, some compounding pharmacies were found to have sold diluted cancer drugs and other drugs that were either dangerously powerful or hopelessly weak, and to have killed patients with those formulations. Before that, the attention was on defective defibrillators, which were blamed for the deaths of dozens of men and women. Congress is well aware of these loopholes in our legal system, and when lawmakers had the chance to close them up with Food and Drug Administration (FDA) legislation that passed overwhelmingly a few months ago, they did nothing.
  • Educate doctors so they can educate patients. Doctors and patients don’t realize the risks of these products because they assume the FDA has required safety studies. All of the medical interventions listed in the above paragraph, for example, were presumed to have been tested and found safe and effective, but none had been.
  • Make noise to incentivize people to act. The FDA often waits until tragedy strikes to step up to the plate to prevent future problems. Many members of Congress suddenly express concerns–but not about the patients and consumers who are their constituents; they complain on behalf of the businesses (constituents and donors), and they couch it as a concern about job loss. Apparently, selling safe medical products is not conducive to creating jobs. Too many legislators seem to think it is more important to hire more factory workers than it is to hire more safety inspectors.

Sometimes tragedies happen because of unpredictable accidents, terrible weather, evil intent, or an unfortunate confluence of events. In contrast, a deadly outbreak due to contamination at a large compounding pharmacy is a preventable event. But when the pharmacy associations continue to oppose efforts year after year that are intended to prevent such outbreaks, when doctors and medical facilities aren’t paying attention to loopholes in the law, and when so many members of Congress side with industry instead of standing for patient safety, then they all share the blame.
Here’s the roadmap we need to follow to get out of this mess:

1. Make physicians sign an informed consent form that says they understand that a product hasn’t been proven safe or effective by the FDA, and then provide a copy of that form to patients. Of course, that won’t eliminate the problems with compounding pharmacies or untested medical devices, but it will discourage the use of untested products by doctors and might cause patients to ask a few more questions before agreeing to procedures.

2. Enforce the current laws regarding inspections. If a company fails an inspection, it should be shut down until it passes. Period.

3. Close the loopholes in the law. Require medical products to be proven safe and effective before they can be sold in the U.S., regardless of who makes them! Sounds logical, right?

In 2007, an unlikely trio–U.S. Sen. Ted Kennedy, a liberal Democrat, and two conservative Republican senators (Sens. Burr and Roberts)–considered legislation to help prevent tragedies like the meningitis outbreak. That bill died before it was introduced, but is getting new attention in the Senate this month. A few days ago, Rep. Ed Markey, a Democrat from Massachusetts who is active on health issues, introduced a similar bill in the House of Representatives. The goal is to try to pass a bipartisan bill on the matter when they return to Capitol Hill next week. Let’s do what we can to make sure they are successful, because we can’t afford to wait until the next tragedy.

For more information about FDA policies and unsafe medical products, and Rep. Markey’s proposed legislation, check out http://www.stopcancerfund.org/ and http://www.center4research.org/category/public-policy/testimony-briefings-statements/.

Stay informed, and please, spread the word.

The original post of this blog can be found here.

September 28, 2012

Joshua M. Sharfstein, M.D.
Secretary
Department of Health and Mental Hygiene
201 W. Preston St.
Room 512
Baltimore, MD 21201

Re: Request for Public Comment: ASTM International Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories.

Dear Dr. Sharfstein,

As members of the Patient, Consumer, and Public Health Coalition, we are writing to strongly oppose the use of ASTM International Standard (F1917-12) as a safety standard for baby bumper pads.  The standard is not a useful alternative to the Department of Health and Mental Hygiene’s (DHMH) proposed ban.  As we stated in our July 19, 2012 letter to DHMH, we agree with DHMH that “the pads pose a risk of suffocation, strangulations, and death.”[1]

We noted in our July letter that crib pads were originally developed to prevent an infant’s head from becoming entrapped between crib slats.  However, for many years cribs have been required to place their slats closer together, so that design problem has been solved without the use of risky crib bumper pads.[2] As a result, the pads are now purely decorative.

The Juvenile Products Manufacturers Association (JPMA) is attempting to use ASTM standards to distinguish between safe and unsafe baby bumper pads.  JPMA claims that bumper pads with a thickness of 2 inches (the ASTM standard) or less are safer than thicker bumper pads.  However, JPMA offers no scientific evidence to support this claim and it would be impossible to ethically conduct such research.  If a bumper pad (no matter how thick or thin) blocks an infant’s airway, the infant will suffocate.   And, although it may seem logical to conclude that thinner bumper pads are safer than thicker pads, that would not mean they are as safe as no pads at all.  Given that doctors on Maryland’s expert advisory panel reviewing crib baby bumpers concluded that there was no evidence for meaningful benefits of bumper pads to infants,[3] even a small risk is unacceptable.

The U.S. Consumer Product Safety Commission reviewed its databases from January 1, 1990 to May 6, 2010 and found “a total of 52 infant deaths where bumper pads were mentioned in the narrative.”   In ten of the reports, there were no other contributing factors to the deaths other than the infant sleeping face-down next to the bumpers.  The reports included statements such as “face obstructed by bumper pad” and “suffocated in corner against bumper pad.”[4] There is no evidence that a thinner bumper pad would not cause suffocation if the child is lying in a corner against the pad.  Any possible benefits from these new crib bumper pads would be wishful thinking and clearly eclipsed by the already established serious risks of suffocation and injury.[5]

ASTM F1917 waffles when it comes to safety. In section 1.4, ASTM issues a “safety hazards caveat” pertaining to the testing method. It states, “This standard does not purport to address the safety concerns, if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use” (emphasis in original).[6] However, in the Rationale section of the standard (Section X 1.1), it states that testing to limit “the overall thickness of bumpers [to 2 inches] has not been known to present a hazard.” ASTM provides no evidence to back up that statement, and it is inconsistent with the previously quoted statement.  Moreover, in section 8.2.1, it states: “Warning to reduce the risk of suffocation, keep top of bumper up and in position.” Obviously, the risk of suffocation still exists or they would not require a warning label about the risk.

Members of the Patient, Consumer, and Public Health coalition support DHMH’s proposed ban on the sale of baby bumper pads in the state of Maryland.  The ASTM standard is absolutely not a viable alternative.  F1917-12′s performance requirements will not mitigate the severe risks (suffocations, strangulations, and entrapment) associated with bumper pads. The risk of bumper pads in cribs are well established while the safety or benefits of “safer” bumpers are unproven and certainly do not outweigh those risks. The performance requirements address the thickness of the pads, not the fact that the pads-no matter how thin or thick-can block an infant’s airways.

In the ideal world, parents would understand the risks of crib bumpers and would decide not to use them.  However, in the real world, not all parents understand these risks, and it is not uncommon for crib bumpers to be given as baby gifts, especially by adults who are not new parents and therefore unaware of the risks.  The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security.   Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree.

American Medical Women’s Association
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Public Citizen
U.S. PIRG
WoodyMatters

For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

 


[1] Maryland Department of Health and Mental Hygiene (2012). Q & A – Proposed Regulations Banning Baby Bumper Pads.

[2] Pediatrics, SIDS and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment; Pediatrics 2011; 128; e1341; originally published online October 17, 2011.

[3] Maryland Department of Health and Mental Hygiene (2012). Background and Assessment for Proposal to Prohibit Safe of Baby Bumper Pads.

[4] Consumer Product Safety Commission (2010). White Paper – Unsafe Sleep Settings Hazards Associated with the Infant Sleep Environment and Unsafe Practices Used by Caregivers: A CPSC Staff Perspective.

[5] ASTM published new infant bedding standard (August 14, 2012). Kids Today. http://www.kidstodayonline.com/article/554341-ASTM_publishes_new_infant_bedding_standard.php

[6] ASTM F1917-12 (2012).  Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories.  http://www.astm.org/VIEWER_TEMP_PDFS/F1917_md_dhmh.8982.pdf