Comments of Sally Greenberg, Executive Director of National Consumers League, before the Food and Drug Administration panel on post-approval long-term breast implant studies – National Consumers League

August 31, 2011

 

Contact: NCL Communications, (202) 835-3323, media@nclnet.org

Good Morning. My name is Sally Greenberg and I am Executive Director of the National Consumers League, an organization founded in 1899 dedicated to protecting the rights of consumers and workers in the United States and abroad. NCL has throughout its history been concerned about the welfare of women and their health.

I am here today because of our commitment to patient safety and our concern that the FDA sometimes relies on post-market studies to ensure safety and effectiveness of new medical products, but then does not make sure those post-market studies are completed appropriately.

I am not an expert on breast implants, but as a consumer advocate, I know that comprehensive and well-conducted scientific research is essential to ensure the safety of all implanted medical devices. If a researcher loses track of half of the patients, those findings are not useful for determining safety.

The Mentor large study lost track of 79 percent of their patients within just 3 years. In addition, Allergan lost track of almost half their augmentation patients after only two years. The Adjunct studies were even worse, with less than one-quarter of their patients still in the studies after 5 years. In their Core study, Mentor followed only 58 percent of their patients for 8 years.

None of those studies met the very reasonable standards that the FDA has set for competent research.  I understand that yesterday, several panel members asked if the FDA has ever threatened to rescind approval if a company does not complete post-market study requirements.  I think that is a good question, because if these companies have a track record of poor research, study after study, what incentive do they have to improve their procedures and processes  the next time a study is commissioned?

We want consumers to have safe choices, and that means that well designed and well-conducted studies are needed to provide bona fide informed consent for patients.  Patients cannot make safe choices on a long-term implanted device if there are no studies of long-term risks.

I was also amazed to learn that the patients in the breast implant studies apparently paid full price for their implants and all their medical care.  One of the major incentives for keeping patients in studies is to provide free medical exams.  They should have provided free MRIs so that FDA would have good data on breast implant breakage and leakage.

American patients should expect better from those who are commissioned to conduct studies. The FDA should expect better.

Thank you for giving me the opportunity to speak.

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About the National Consumers League

The National Consumers League is America’s pioneering consumer organization, dedicated to promoting and protecting the rights of workers and consumers in American and abroad. To learn more, please visit www.nclnet.org

Exploited student workers at Hershey – National Consumers League

By Michell K. McIntyre, Project Director of NCL’s Special Project on Wage Theft

Chocolate, sweets and indulgence—these are the things that come to mind when the Hershey Company is mentioned.  But now some might add irresponsible, exploitative and negligent.

On August 17th, 2011, hundreds of international exchange student workers (J-1 visa program participates) staged a sit-in at a Hershey packing facility and broke their silence on the exploitation they suffered at the hands of a Hershey contractor.

According to the State Department’s website, the J-1 visa program is designed to “provide an extremely valuable opportunity to experience the U.S. and our way of life, thereby developing lasting and meaningful relationships.”  Unfortunately, hundreds of students assigned to the Hershey Company got a different kind of experience.

According to the students, they paid between $3,000 and $6,000 to enter the J-1 visa program, hoping to learn about American culture and experience life in the US.  They ended up working as cheap labor to a contractor at a Hershey packing facility where, after suspicious paycheck deductions, they were making well below minimum wage.  The contractor assumed that, as foreign nationals, the students would never realize that they were the victims of wage theft and wouldn’t know whom to turn to for help.  Instead, the students organized themselves, got in touch with local unions, and brought their plight to the media.

It didn’t have to be this way.  I love exchange students, but if the contractor needed to staff the packing facility why didn’t they employ the thousands of unemployed workers in the area who would have loved to have a job with a living wage and decent benefits?  Is it because the contractor thought they could use cheap, below minimum wage student labor without getting caught?

In this case, there is plenty of blame to go around.  The Council for Educational Travel, who is supposed to be monitoring the student workers in the J-1 program; Hershey, who hired an unethical and possibly criminal contractor to staff and oversee their packing facility; and the contractor all share blame for these exploited foreign students.  Who is most at fault is not the question we should be asking but rather, what does that this say about American life?

To hear more about these brave students and their fight, please click here.

National Consumers League Statement on the Reverend Dr. Martin Luther King, Jr. National Memorial – National Consumers League

August 24, 2011

Contact: NCL Communications, (202) 835-3323, media@nclnet.org

Washington, DC — The National Consumers League released the following statement from Executive Director Sally Greenberg and Chair Jane King on the dedication of the Reverend Dr. Martin Luther King Jr. National Memorial:

The National Consumers League staff and board of directors welcome the long-awaited, permanent tribute to the Reverend Dr. Martin Luther King, Jr. that now stands alongside other memorials honoring our nation’s greatest leaders, who have stood for liberty and justice for all Americans through the generations. The King National Memorial honors a man of great courage, conviction and strength, a visionary who maintained his commitment to nonviolence as he demanded human dignity and opportunity for all. Florence Kelley, who was NCL’s first leader from the time of its founding in 1899 until 1932, served on the founding board of the NAACP. Kelley set the tone for the League’s work: to defend the rights of workers and consumers of all races and creeds to be treated with dignity and respect. She would have surely celebrated the memorial to a great a leader like Dr. King.

This new memorial on the national mall will create a richer experience for every person who walks there, and provide an opportunity to draw deeper meaning from the American experience and Dr. King’s role in advancing our country’s progression as  a nation that judges its citizens by the content of their character and not the color of their skin.

For NCL, the memorial will serve as an important source of inspiration, right here in our midst, to carry on with our work in securing the fulfillment of Dr. King’s dream of justice under the law, greater opportunity for all and an America that truly lives up to its historic promise.

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About the National Consumers League

The National Consumers League is America’s pioneering consumer organization, dedicated to promoting and protecting the rights of workers and consumers in American and abroad. To learn more, please visit www.nclnet.org

From hurricanes to earthquakes: be prepared for anything – National Consumers League

By Mimi Johnson, NCL Director of Health Policy

Nearly the entire eastern seaboard felt the quake on Tuesday, and nearly the entire eastern seaboard will feel the effects of Hurricane Irene later this week.  This is a great time to get your emergency plan in place, assemble an emergency kit, and stay informed.

Every home and business should have a disaster kit in place. The Centers for Disease Control and Prevention recommends the following items be placed in an emergency kit in your home, office, car, and/or school:

  • Water—one gallon per person, per day (3­ day supply for evacuation, 2 ­week supply for home)
  • Food—non­perishable, easy-­to-­prepare items (again, 3­ day supply for evacuation, 2­ week supply for home)
  • Flashlight
  • Battery-powered or hand-­crank radio (NOAA Weather Radio, if possible)
  • Extra batteries
  • First aid kit
  • Medications (7­ day supply) and medical items
  • Multi­purpose tool
  • Sanitation and personal hygiene items
  • Copies of personal documents (medication list and pertinent medical information, proof of address, deed/lease to home, passports, birth certificates, insurance policies)
  • Cell phone with chargers
  • Family and emergency contact information
  • Extra cash
  • Emergency blanket
  • Map(s) of the area

Consider the needs of all family members and when gathering supplies for your kit. Suggested items to help meet additional needs include:

  • Medical supplies (hearing aids with extra batteries, glasses, contact lenses, syringes, cane)
  • Baby supplies (bottles, formula, baby food, diapers)
  • Games and activities for children
  • Pet supplies (collar, leash, ID, food, carrier, bowl)
  • Two­-way radios
  • Extra set of car keys and house keys
  • Manual can opener

Additional supplies to keep at home or in your kit based on the types of disasters common to your area:

  • Whistle
  • N95 or surgical masks
  • Matches
  • Rain gear
  • Towels
  • Work gloves
  • Tools/supplies for securing your home
  • Extra clothing, hat and sturdy shoes
  • Plastic sheeting
  • Duct tape
  • Scissors
  • Household liquid bleach
  • Entertainment items
  • Blankets or sleeping bags

It is especially important to keep your kit current, and if you have a chronic condition, PLEASE keep a supply of meds in the kit.  Dealing with a disaster and unknowns can be stressful and chaotic, which makes it all the more important to maintain your health and keep a clear head.  The CDC has great resources for specific chronic conditions and what kits should look like for different conditions. For more information on managing your chronic condition, visit www.scriptyourfuture.org

While the likelihood of another moderate earthquake hitting the East Coast anytime soon is slim, it was a good reminder that natural disasters and emergencies can strike at any time, and often without any warning.  If you would like to learn more about how to best to prepare for possible disasters in your community, contact your local public health department for more information.

Advice for parents: Manage children’s after-school use of technology – National Consumers League

August 24, 2011

Contact: NCL Communications, (202) 835-3323, media@nclnet.org

Washington, DC—As millions of children across the country kick off a new school year this month, family schedules will return once again to classes, homework, and busy after-school routines. Many working parents may be concerned with how their kids will be using the TV, the Internet, or one of the many wireless devices at kids’ disposal. Costs, appropriate content, and privacy protections are just a few issues on parents’ minds when it comes to these devices and services. The National Consumers League (NCL) has developed new tools to help parents understand the resources at their disposal for monitoring and – where desired – restricting their children’s activities, even when they can’t be there in person.

American teens and tweens are using technology independently from their parents more than ever before, with some 75 percent of 12-17 year-olds now owning cell phones, and 93 percent of American teens using the Internet, according to the Pew Internet and American Life Project. Research from the American Academy of Pediatrics, founds that kids between the ages of 3 and 5 are exposed to an average of 73 minutes of TV, video games, or DVD-watching every day. The AAP report also found that young children exposed to violent content are more likely to experience sleeping problems, and those with TVs in their rooms are even more at risk.

Too much screen-time and exposure to inappropriate content aren’t the only issues for parents. According to OTX and the Intelligence Group, 58 percent of teens make purchases online and the average teen spends $46 per month on such purchases. Given recession-strapped household budgets, it’s more important than ever for parents to help manage their children’s online shopping habits.

“Many parents are aware that there is plenty of adult content out there that they don’t want their children to get their hands on. What they may not know is that there are many tools available to monitor and restrict kids’ access to that content,” said Sally Greenberg, NCL Executive Director. “NCL has surveyed what is available for parents looking to put in place reasonable restrictions, and posted the information on our Web site in an easy-to-use format for parents to better understand their options – many of which are free.”

NCL’s new tools are available at www.nclnet.org, and focus on the places children are most likely to access objectionable content—television, cable and satellite, wireless communications, and the Internet—and include tips both on how to access existing parental controls features and how to talk to children about appropriate limits.

NCL acknowledges Verizon for an unrestricted educational grant that made the consumer content possible.

“Raising consumer awareness about the availability and utility of parental control technologies is essential given the ubiquity of communications technologies,” said Kathy Brown, Verizon’s Senior Vice President for Public Policy and Corporate Responsibility. “Empowering consumers to take control of their families’ technology use is an important goal in today’s always-on, interconnected world.”

NCL’s advice for parents includes tips ranging from how to talk to children about what is acceptable to where the best place is to set up a family computer. Parents are encouraged to find out where they’re spending their time online, have open and honest dialogue, and to not let concerns about invading their children’s privacy stop them from doing your job as a parent.

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Politicians, please take note: regulation works – National Consumers League

By Sally Greenberg, NCL Executive Director

Today’s New York Times featured a piece about conservatives attacking the Environmental Protection Agency. Never mind that a substantial majority of Americans are concerned about air and water pollution and largely trust the E.P.A.

Conservative presidential candidate and member of Congress Michelle Bachmann drew applause ten days ago at a rally in Iowa when she declared: “I guarantee you the EPA will have doors locked and lights turned off, and they will only be about conservation. It will be a new day and a new sheriff in Washington, DC.”

Sorry to upset your apple cart, Ms. Bachmann, but it just so happens that regulation works. One of my favorite examples is the dramatic reduction in highway deaths over the past decade. Have we become safer drivers? I don’t think so. Have cars become safer and have we been more successful in cracking down on drunk driving? Absolutely.

How’s this for a statement of fact: Americans are less likely to die on the highway today than at any time since the middle of the Truman Administration (that was 1948-1952, 59 years ago) The number of people killed in accidents dropped to 32,788 in 2010, the lowest since 1949, according to the National Highway Traffic Safety Administration.

In fact, the 3 percent decrease in traffic fatalities since 2009 occurred even as drivers put nearly 21 billion more miles on their cars than they had the year before. Imagine: the death rate has declined by 25 percent since a peak of 43,000 in 2005. The reason for this reduction: stronger drunk driving laws, mandatory safety standards on vehicle for both crash protection and crash avoidance, including head and side air bags, better seat belts, head rests and crush zones in cars. Add anti lock brakes and rollover prevention (known as “stability control”) have all contributed to safer cars and thousands of lives saved. And guess what – all of these safety features came about as a result of regulation. EPA prevents our cities from being engulfed by smog and keeps our water clean and safe to drink, especially for children.

This talk about closing the EPA or any other regulatory agency is reckless, ill-informed, and not supported by the American people. Politicians should look elsewhere in their quest to garner votes.

First lesson of the school year: planning healthy lunches – National Consumers League

As the first day of school looms closer and the school year routine begins to reassert itself, the age-old question returns: what to put in those school lunches?

Rather than sending your kids off with healthy items you hope they’ll eat, packing lunch with your child is a great way to ensure you include not only healthy items, but healthy items that get eaten. Whether you pack on a daily basis, or only occasionally send your child with a homemade lunch, keep these important points in mind:

  • Pack a safe lunch. Ensuring a safe lunch means keeping hot foods hot and cold foods cold, from the time your child leaves the house until he/she sits down to eat. Use a thermos for hot foods, such as soup, and include a cold pack with foods that need to stay chilled. If possible, pack your child’s lunch in an insulated bag.
  • Meet your child’s caloric needs. Children’s caloric needs vary greatly, depending on age, activity level, and other factors. Talk to your child’s pediatrician to get a general estimate of what his/her caloric needs are, and aim to provide one third of those calories at lunch time.
  • Pack foods your child will eat. The nutritional quality of the lunch you pack means nothing if your child refuses to eat it (or trades components away for more appealing options). Brainstorm with your child to come up with healthy options that he/she wants to eat. See if dinner leftovers, soups, or salads appeal to your child. If he/she is tired of sandwiches or more traditional lunches, think in terms of smaller “snacks” that together create a healthy meal.

If your child buys lunch at school, view it as an opportunity to talk about choosing healthy options when faced with a range of choices.

For a complete set of tips on planning healthy school lunches, click here.

Brand Yourself: Running your own personal public relations campaign – National Consumers League

By Alex Scheider, LifeSmarts and Public Policy Intern

It’s the Internet age. Who do you want to be?  As it turns out, you have choices.  Take a look at these tips on how to brand yourself in the age of social media.  Making a conscious, informed decision about what kind of Internet user you want to be will save you from potential embarrassment and disappointment down the road.

What goes in the cloud, stays in the cloud

It’s a truism of the digital world we live in: adding information to the ‘cloud’ is easier than removing it.

Automated archive robots at archive.org are hard at work every day keeping a record of what was online in the past, with the goal of never losing data.  Newspaper archives now stretch back to the early 1990s and most websites no longer delete old content, leaving it live for Google to retrieve at a moment’s notice.

As editor of my college newspaper, I often receive requests from alumni to remove certain information from our newspaper’s archives. Our ethics policy disallows such action in order to promote our newspaper as a community paper of record, but the onslaught of such requests acts as a reminder that what goes online really does not go away anytime soon.

Take a proactive approach

Taking a proactive approach to your online presence is crucial as employers increasingly Google first, interview later.

Google is the gateway to first impressions.  Ideally, you should be the only person who appears in the top ten results in that search, giving others a positive impression of your work.

There are many ways to do this.  The easiest is to own a website, although avoid vanity.  A clean website that tells a bit about you and some well written, researched and edited blog posts or articles would be great.

Avoid poor representations of your work.  Journalists should avoid professional or ethical quandaries such as mixing opinion and news writing, artists should only post their best work and employees should avoid negative comments about current and past employers.

Use social media responsibly

Opening a LinkedIn account and choosing a recognizable user name will help you gain visibility on the web.  On the other hand, Facebook and Twitter can work against you.  Never post anything you wouldn’t want your boss to see and always attend to privacy settings.

American resumes do not often include pictures, due to the possibility of discrimination.  But no one will know if an employer takes a look at your online photos. Keeping this in mind, avoid posting pictures on the Internet that give a negative impression of yourself or your work.

News stories and the press

On the off chance that the media comes knocking on your door, possibly because you won the Lifesmarts competition, speak as though every sentence you say could be a quote because every sentence could in fact be a quote.  This includes high school or college newspapers.  Even if you support an opinion that could be considered controversial, think to yourself, should I share such an opinion and if I do share it, am I ready to be defined by this opinion on an Internet search?

Avoid at all costs

Whatever you do, remember that when you publish something publicly, anyone can see it, so proofread everything and avoid spelling and grammatical mistakes.

Strengthening the American middle class – National Consumers League

By Michael Finch, NCL Public Policy Intern

Earlier this month, three of the NCL interns (me, Alex and Ben) attended a hearing held by the Senate Health, Education, Labor and Pensions (HELP) Committee called “Building the Ladder of Opportunity: What’s Working to Make the American Dream a Reality for Middle Class Families.” For the first part of the hearing, Secretary of Labor Hilda Solis spoke about the Department of Labor’s efforts to rebuild a strong middle class.

Secretary Solis emphasized the importance of education and training in the effort to rebuild the middle class. A company represented in the second part of the hearing was a perfect example of this. IceStone, a recycled glass and concrete surface manufacturer, provides their workers with a living wage (starting at $10 an hour), and stresses the importance of professional development. All workers are given opportunities to improve their job skills (whether relevant to their current position or not) and therefore earn an even higher wage shortly after joining the company. The wage gap between their lowest-earning employee and their CEO is only ten times, an impressively small difference in an economy where the gap is usually closer to 300 times. Although IceStone only has a small number of employees, hopefully this model can be refined and used by more businesses in the future, both small and large.

One issue that Secretary Solis stressed that was of particular interest to us was the high youth unemployment rate. Young people are entering the workforce at much lower rates, and those who do manage to find employment encounter a high turn over rate. She pointed out that the lack of jobs for young workers is most likely caused by older workers having to wait longer to retire. This is just one entry in a long list of reasons young people should support bolstering our country’s safety nets for older Americans, but that’s an issue I could write a whole separate blog post about.

Back on the topic of young workers: Secretary Solis highlighted a heartening story about the company Jamba Juice, which agreed to provide 2,500 jobs to young workers as a part of the Department of Labor’s Summer Jobs USA challenge. When Secretary Solis visited Jamba Juice, they informed her that they have actually provided 2,700 jobs to young workers so far and would be willing to participate in similar programs in the future. As Secretary Solis put it, “I think once we begin a discussion with businesses about what we’re faced with, people will give it some thought and open up to those opportunities.” The Department of Labor had hoped to facilitate opening up 100,000 summer jobs for young people, and they’ve so far reached 80,000.

Another dismaying effect of the decline of the middle class mentioned by several hearing participants is the increasing wage gap between white workers and their minority counterparts. According to a new Pew Research Center study, white workers make around 20 times more than African-American workers, and 18 times more than Hispanic workers. This gap is the largest it has been since the government started collecting this data 25 years ago.

Secretary Solis suggested that increased training and professional development could also be a solution to this specific problem. She also emphasized the importance of helping workers to pinpoint and develop important skills and credentials that could make them more valuable to employers. This way, workers will be able to obtain, and retain, stable employment.

As Committee Chairman Tom Harkin pointed out, politicians on both sides of the aisle understand that the middle class is a vital part of keeping America great, and they acknowledge that a lack of opportunity for the middle class is bad for everyone. While the parties may vary on the specifics of cause and solution, they need to work together to figure out the best way to solve this pressing problem.

Consumer concerns emerge with yet another food illness outbreak – National Consumers League

By Alex Schneider, NCL Public Policy Intern

Last Wednesday, at the request of the US Department of Agriculture (USDA), food manufacturer Cargill announced a massive recall of 36 million pounds of ground turkey due to possible contamination from Salmonella.  Already, a 65-year-old Northern Carolina woman died due to the outbreak, and 77 people have reported falling ill, with one-third ending up in the hospital.  The outbreak has highlighted two consumer concerns related to detection of Salmonella and the use of antibiotics in the food supply.

The need for new testing procedures for salmonella

As reported by CBS News, after the first illness was reported in March and the first signs of an outbreak appeared in May, investigators were able to determine a link between Cargill ground turkey and the outbreak in July.  Inevitably, consumers, industry observers and the media will question why the recall was announced five months after the first reported illness.

The Center for Science in the Public Interest (CSPI) sent a petition to the USDA in May that would have declared four strains of Salmonella to be ‘adulterants.’  The four are – Salmonella Newport, Salmonella Hadar, Salmonella Typhimurium and the strain present in the current outbreak, Salmonella Heidelberg –and  have all been the cause of serious food illness outbreaks.

Under this classification, testing before the product goes to market would be required to identify potential contaminants, as is currently required in testing meat for E. coli O157:H7.  The classification would also mean that selling products with these strains of Salmonella would be illegal, the goal being to stop contaminated meat from ever reaching the marketplace.

Concerns over livestock antibiotics

The second big concern is that Salmonella Heidelberg is resistant to several antibiotics, including ampicillin, streptomycin and tetracycline, as described in a report by NPR.  Today, farmers use 29 million pounds of antibiotics, or four times those prescribed to humans, to get animals to grow more efficiently before their entrance into the food market.

The side effect – antibiotic resistant strains of bacteria  – poses considerable risks, as evidenced by this most recent outbreak of Salmonella.  Although alternative antibiotics exist to treat people who do get sick, this problem has the potential to get worse.  As the Food and Drug Administration has stated, medically important antibiotics should be avoided in the food industry.

NCL strongly supports the CSPI petition calling for a “test and hold” program for the four strains of Salmonella before meats are shipped out to consumers and make people sick, or even worse, kill them. NCL also calls upon the FDA to prohibit the use of medically important antibiotics in animal feed because of the very problem we see with Salmonella Heidelberg,  it’s resistant to treatment by specific antibiotics.