House and Senate hearings begin to shed light on compounding pharmacies and meningitis outbreak – National Consumers League

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By Sally Greenberg, NCL Executive Director, and Ayanna Johnson, NCL Health Policy Associate

This past week, the House and Senate held hearings on the fungal meningitis outbreak and the state of compounding pharmacies in the US. Both the current FDA Commissioner, Dr. Margaret A. Hamburg, and the Massachusetts Department of Health Interim Commissioner, Dr. Lauren Smith, testified at the hearings, offering accounts of the roles their respective agencies played in the issue. The hearings highlighted the slipshod practices of drug compounding by the New England Compounding Center (NECC) in Massachusetts, which at times reached a scale of production resembling drug manufacturing. The co-owner of NECC, Barry Cadden, was subpoenaed and present at the House committee hearing, but invoked his 5th amendment right. The hearings are a part of the ongoing investigation into the outbreak and what can be done to prevent future threats to public health, like this, from happening again.

To date, the outbreak has left 34 patients dead, over 400 sickened and more than 14,000 patients who received injections wondering what is next. At the House hearing, the wife of a deceased victim gave a compelling account of her husband’s unexpected and rapid demise due to receiving a contaminated injection to relieve pain, stemming from a car accident. One thing was clear from her account: she and her family “have lived a nightmare” and had no idea what was happening to her husband. Unexplained headaches and periodic numbness were the only symptoms that signaled something was going terribly wrong. Stories like these put a name and face to the tally of victims. Our thoughts and condolences go out to all those who have lost loved ones or had loved ones sickened by this outbreak. Patients and consumers should be able to rest assured that their medicines are safe; the House committee members pledged to provide bipartisan support to finding a solution.

Since its opening in 1998, NECC has come under fire for numerous violations at both the state and federal levels. The hearings often focused on a timeline of events where NECC was inspected, was cited for violations and unlawful interstate commerce, or even risked closure for copying a manufactured prescription drug. NECC’s consistent interaction with government begs the question why was something not done earlier, but—as pointed out by numerous testimonies—the authority with which FDA can act in these situations is unclear. In fact, Dr. Hamburg brought a map of FDA jurisdiction over compounding pharmacies across the US, describing it as a patchwork of laws lacking clear lines of regulatory oversight.

Neither Dr. Hamburg nor Dr. Smith were heading their respective agencies when the state board of pharmacy or FDA interacted with NECC, each described her role, potential next steps, and why FDA’s jurisdiction over compounding pharmacies needs to be clarified through legislation. As we sat in the hearing room, we were startled at the questions directed at Dr. Hamburg by certain Committee members. They struck us as disrespectful and offensive. Committee members demanded a yes or no answer for complicated issues. There is a difference between compounding and drug manufacturing, which lawmakers must recognize in order to make substantive headway in creating an effective law. Additionally, the compounding industry has evolved substantially and new laws are required to reflect that. We appreciate the close regulatory attention that Dr. Hamburg and Dr. Smith are advocating for, to ensure that tainted drugs never get into the marketplace.

One congressman asked the FDA what it would need to prevent this from happening again, which we thought this was constructive. While it is important to determine what went wrong, pointing fingers and playing the blame game will not protect consumers and patients in the end. Finding out how to increase our public health agencies’ power to protect is important.

Dr. Hamburg agreed that FDA was in need of increased funding if all compounding pharmacies are to fall under FDA jurisdiction. The 7,500+ compounding pharmacies need to be registered with the FDA, and currently they are not. Dr. Hamburg also proposed a tiered system of management for compounding pharmacies that leaves traditional compounding under the jurisdiction of the state, and non-traditional compounding becomes FDA regulated. The Senate committee commended the work of the Centers for Disease Control (CDC) in investigating and reporting on the outbreak. It was encouraging to see Congress recognize the importance of public health, and the need for continued funding to support its efforts in the broader health care arena.

As the events surrounding the meningitis outbreak continue to unfold and more holes in regulation are exposed, it is important that efforts are directed to closing these gaps in the law. FDA’s commitment to bring those compounding pharmacies that are actually making drugs under its regulatory umbrella is laudable and the appropriate next step. The president of the International Association of Compounding Pharmacies also testified at the Senate hearing that legislators would have his organization’s support and commitment to collaborate on a bill to protect the public’s health. We hope he makes good on that promise.

Finally, the National Consumers League also calls on all members of Congress to support legislation introduced by Congressman Ed Markey (D-MA) —whose district includes NECC headquarters—to clarify FDA’s regulatory role and that of the state health departments and require registration of these pharmacies and labeling of all products they make.

Poultry ‘modernization’ bad news for consumers and workers – National Consumers League

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By Michell K. McIntyre, Director of NCL’s Special Project on Wage Theft and Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

What do you call a proposed federal regulatory rule that looks to help make hundreds of millions of dollars for industry at the expense of worker and the public’s safety? Irresponsible? Reckless?

In a nutshell, that’s what’s happening with the Department of Agriculture’s (USDA) proposed changes to the poultry inspection process. It sounds like a lot of legal mumbo jumbo, but what is boils down to is that it allows the fox to guard the hen house – almost literally. The changes allow the government to layoff federally trained and experienced poultry inspectors, who are tasked with keeping American poultry safe, and allows the poultry plants to hire private employees to carry out those duties. These private employees do not have mandatory training nor would have the same level of experience. The workers would also be at the mercy of their employers of when they could blow the whistle and stop an unfit carcass from getting mixed in with poultry sent to consumers’ tables. Poultry plants would also be permitted to speed up the inspection lines in order to make more profits. But at the cost of what?  Increased risk of worker injuries? Increase in foodborne diseases like salmonella and campylobacter?
A retired federal poultry inspector has been blowing the lid about what she’s seen at a pilot plant and calling into question the wisdom of the proposed change.  Phyllis McKelvey, grandmother of 8 and the whistle blowing retired poultry inspector with over 40 years of experience, took her concerns public through a Change.org petition that more than 177,000 people signed.  Last week, she delivered the petitions to USDA and called on them to stop this new inspection process from spreading to a majority of poultry plants.
The proposed rule would allow the poultry plants to speed up the lines of inspection to 175 birds per minute – that’s 3 birds per second and 1 bird per 1/3 of a second.  You can’t even wink that fast!
What makes USDA think untrained private inspectors can inspect a bird in that time? Can they find the puss, scabs, tumors and fecal contamination in that time?  Can even trained and experienced federal inspectors catch defects in that short period of time? And should we put public’s safety on the line in order for the poultry industry to make more profits?
That’s a gamble we’re not willing to take.
For more information on the USDA’s proposed changes to the poultry inspection process and what you can do, please visit UFCW and National Council of La Raza.

Black Friday lurking for shoppers, workers – National Consumers League

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

Thanksgiving – a day set aside to spend with family and friends and give thanks for one’s blessings. However, more and more often, shopping and the rush for the almighty deal has changed the meaning of the holiday. Stores in search of a new gimmick have decided that opening at midnight on Black Friday is no longer early enough and have moved up the opening time to Thanksgiving evening. This year, four major retailers: Walmart, Toy-R-Us, Kmart, and Sears will open at 8pm, with Target following at 9pm. While the new opening times give the public additional time to shop for deals, what does it mean for the workers forced to give up their precious time with their friends and family?
Are corporations and executives thinking about their employees when deciding to open so early on a national holiday? Do the workers’ lives and well-being factor into the decision? Or is the pursuit of profits all that’s considered? Time after time, companies put their well-being ahead of their employees’. These policies do not take into consideration the lives of the workers and are particularly disrespectful when one understands that most workers will have to be at work well before 8pm to open the stores. What happened to the workers’ Thanksgiving dinner and their time to spend with friends and family?
Workers across the country have been trying to stand up and fight for their well-being and challenge the corporate dogma of profits before anything else.  Last week, Hostess Brand workers went on strike to protest the company’s lowering of wages, slashing benefits, and halted contributions to pension plans. Instead of working with their employees, Hostess decided to blame their workers for Hostess’s financial problems and shut down the company. Walmart workers from Chicago to Dallas and Miami to Los Angeles have threaten to walk out on Black Friday if the company does not address the longstanding workplace issues including low wages, spiking health care premiums, and management retaliation for attempting to organize or even talk about joining a union. OUR Walmart and Making Change at Walmart, a coalition of labor organizations, civil rights groups, and religious institutions, have come together to support the workers of Walmart including the warehouse workers who have been going on rolling strikes from port to port. Besides walking out, Walmart workers may stage protests and rallies outside the stores and consumers should be aware of what happens behind the scenes at their retailers. What goes into those low prices and Black Friday deals? Management threats, closed-door mandatory lectures on the evils of collective bargaining, retaliation in the forms of decreased work hours, and unjustified terminations coupled with low wages and increasing health care premiums have left Walmart workers at the end of their ropes.
Do consumers take into account the working conditions at their favorite retailers? According to NCL’s spring 2012 survey, 94 percent of Americans say the way workers are treated is “very important,” “important,” or “somewhat important” to them personally in that the products they buy are not made under unfair, overly harsh, and dangerous working conditions. Instead of shopping at retailers that cut corners when it comes to their employees, we should reward companies who treat their workers with respect, livable wages, and benefits with our consumer dollars.

Shedding tears for workers — not Twinkies – National Consumers League

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We are saddened by the closing of Hostess Brand plants in cities throughout the country and have issued several statements to the press in support of the Bakery workers. The Bakery workers had gone on strike because they, in the past, had provided many wage and benefit concessions, which the company promised to use toward rebuilding the brand and improving the capital structure. Hostess did none of this, according to a report by a nonpartisan bankruptcy analyst and was terribly managed. Now the company is blaming the striking workers instead of taking responsibility for abysmal management and giveaways to six CEOs in 10 years who have failed to turn the company around and squandered the savings provided to the company by the workers. Now, 18,000 workers will lose their jobs. It’s shameful.

NCL symposium examines consumer issues and the next Congress – National Consumers League

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By John Breyault, NCL Vice President of Public Policy, Telecommunications and Fraud

The freshman class of the 113th Congress will feature 12 new Senators and 67 new Representatives. For consumer advocates, this is an opportunity to introduce ourselves to these new lawmakers and develop relationships that can help promote our economic and social justice mission on the Hill. Freshman like Senator-elect Elizabeth Warren have long been heroes to the consumer movement, but others such as Senator-elect Heidi Heitkamp and Members-elect Kevin Cramer, Joseph Kennedy III, and George Holding all have experience in regulatory agencies and in the legal system where consumer issues arise.

The incoming members of the 113th Congress will have a full agenda when it comes to consumer issues. Even before the next Congress, the Lame Duck session of the current 112th Congress is tackling the so-called “fiscal cliff” of tax increases and spending cuts mandated by the Budget Control Act of 2011.

It is in this context that NCL convened our inaugural Consumer Issues Symposium on Wednesday, November 14 to examine the future of three important consumer issues in the lame duck session and the coming 113th Congress. We chose to focus the event on three issues near and dear to NCL’s heart – food safety, sequestration and privacy. The goal of the event was to examine not only the future prospects for consumer-focused legislation in Congress, but also to highlight the real-world impact of these policy areas on consumers.

For example, the sequestration cuts envisioned as part of the “fiscal cliff” will require numerous federal agencies to significantly scale back their activities. When the USDA’s Food Safety and Inspection Service is projected to take an $86 million haircut, what does that mean for the safety of America’s food supply? Likewise, in a scenario where the federal Low-Income Home Energy Assistance Program is on track to take a $285 million budget hit, how will consumers living through the cold winter months adjust?

The event, organized in partnership with the law firm of Kelley Drye, was a great success. (Historical note: One of Kelley Drye’s name partners was Nicholas Kelley, son of Florence Kelley, the first General Secretary of NCL). It featured more than a dozen expert speakers from Executive Branch, Congress and advocacy organizations, including FTC Commissioner Julie Brill, FDA Deputy Commissioner Michael Taylor and former Congresswoman and CPSC Commissioner Anne Northup. Photos from the event are currently viewable on NCL’s Facebook page.

Good night for low-wage workers – National Consumers League

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

Last week’s election was the culmination of a long and often grueling campaign season that saw voters in three cities give low-wage workers a much-needed raise. San Jose, California and Albuquerque, New Mexico passed increases to the city’s minimum wage while Long Beach, California passed a living wage law for hotel workers.

San Jose’s increase to the city’s minimum wage was born out of a sociology class at San Jose State University. Low-wage workers in San Jose will enjoy a two-dollar increase that takes the minimum wage from $8 an hour to $10 an hour. Albuquerque not only increased their minimum wage by a dollar making it $8.50 but tied it to inflation and increased the tipped minimum wage to 60 percent of the regular minimum wage – making it $5.10 an hour.

In Long Beach, hotels with more than 100 rooms now have to choose between paying workers a livable wage – pay workers $13 an hour, give full-time employees five paid sick days a year and give employees an annual automatic 2 percent raise – or agree to enter into a collective bargaining agreement with employees. Either way you slice it, low-wage workers came out ahead in three cities.

Thanks to Hurricane Sandy rescue workers – National Consumers League

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

Politicians, and in some cases the public, too often take potshots at public employees especially union members, we are once again reminded of the incredibly important work they do for our health and safety. Hurricane Sandy has highlighted the significant role that union members play in our lives.

Many union members are also first responders – police officers, firefighters, and EMTs. Along with their everyday heroics of keeping our cities, families, and friends safe, disasters such as Hurricane Sandy show them once again marching into danger and risking their lives to rescue those stranded and in need of help. Firefighters battle fire after fire from broken gas lines that have destroyed entire blocks and conduct search and rescue operations to find victims of the hurricane.

Besides the police officers, firefighters, and EMTs who make up the first responders, other union members such as the International Brotherhood of Electrical Workers (IBEW) are working to restore power and fix infrastructure up and down the Eastern Seaboard. Teamster members are clearing trees, repairing rail tracks and cleaning flood damage from the streets. Sanitation workers are working long hours removing debris from roadways, breaking up tree limbs, and removing hazardous obstructions for the public’s safety. Nurses in many of the affected areas stayed and watched over the sick as the storm raged and in some cases helped evacuate patients when hospitals lost power and their generators failed. Transportation workers including New York City bus drivers transported patients to hospitals.

Pulling together in tough times and helping fellow Americans is what many of these union members do in times of crisis. In addition, nearly 2,000 utility workers from around the country are making their way to the affected states.

The difference in federal disaster relief in presidential administrations is also striking. FEMA, the Federal Emergency Management Agency, during Hurricane Katrina, was hopelessly ineffectual and weak in responding. During Hurricane Sandy, we see a very different agency. More than 500 U.S. Department of Health and Human Services workers have provided emergency medical care and public health assistance. The Pentagon is said to have mobilized and deployed 10,000 National Guard troops in 13 states including 10 Blackhawk helicopters, sent 100 pumps to New York to siphon water from tunnels, and they have also sent 120 medical personnel and 573 vehicles to storm revenged areas.

We owe a large and heartfelt thank you to our public employees and union members for running into the face of danger, rescuing our fellow citizens in times of crisis, and helping to put communities back together in the wake of natural disasters, fires, terrorist attacks and accidents. That is why the NCL finds the tendency – among some elected officials and in the media – to malign public workers because they negotiate well-deserved wages and benefits for their members – so offensive.

The right to know is a winning proposition – National Consumers League

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By Teresa Green, Linda Golodner Food Safety & Nutrition Fellow

One of my colleagues votes in California and so, along with her ballot, she received a booklet entitled “Official Voter Information Guide.”  This booklet includes arguments for and against each ballot initiative. The initiative we are most interested in here at NCL is Proposition 37, an initiative that would require genetically engineered foods be labeled.

NCL is a proud member of a group called “Just Label It,” which argues that consumers have the right to know whether the foods they eat contain genetically engineered foods or not.

Why is the California ballot initiative so important?  The reason is that if Proposition 37 passes in California, it is likely to have a nationwide impact.  This is because food companies are unlikely to produce one label for California and another for the rest of the country.  Instead, they are more likely to produce one label which meets the California law and thus provides more information to consumers across the country.

The ballot initiative has gotten both sides of the issue energized.  Unfortunately for proponents of the measure, the food industry, Proposition 37’s major opponents, has vastly outspent pro-labeling advocates.  Total spending by food companies has been around $45 million.  This infusion of cash into the state has paid off; while polls earlier in the year indicated popular support for the measure, more recent polls show that support has dropped by 17 percentage points since September alone.

Whether the measure passes or not, labeling of GMOs will continue to be an important issue and one that we predict will not be tabled even if Proposition 37 is defeated in California this election.

Meningitis outbreak: how could it have happened? – National Consumers League

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By Sally Greenberg, NCL Executive Director

It’s hard to accept that 29 patients have now died and 338 are sick across 18 states from meningitis because the injectable steroid medications they were administered for pain were contaminated with fungus. The drugs were prepared by the New England Compounding Center (NECC) and shipped across the United States. After the outbreak, an FDA investigation showed in the first nine months of the year, NECC’s so-called “internal monitoring program” showed mold or bacterial contamination at more than 80 locations, including numerous places in its “clean rooms” where sterile drugs are made. In more than half the cases, the company’s own testing showed bacteria and mold above its “action” limits, but NECC took no action.

It gets worse. After the steroid was recalled, the FDA also found that 83 vials from one lot of the tainted steroid contained “greenish black foreign matter.’’ Another 17 vials had white material floating in them. Further testing found that another 50 out of 50 vials from the same lot had “viable microbial growth.”

A lot of people are asking how this could have happened. Indeed, the outbreak raises many difficult questions – how could the system of regulation and oversight patients have come to rely on have broken down so completely?  How could patients have been injected with obviously contaminated drugs? What happened to the internal oversight at NECC? Why didn’t someone on staff at NECC blow the whistle before these drugs were shipped?  Why wasn’t the Board of Pharmacy in Massachusetts conducting the oversight needed to make sure a compounding pharmacy like NECC was maintaining safe practices? Why didn’t the FDA have jurisdiction to oversee what was clearly drug manufacturing, not simply drug compounding?

NCL’s concern is with the 14,000 patients who received the injectable drugs, those who are sick from meningitis and the families of those who have died from the outbreak. We issued a fact sheet and press release in the last week asking these questions, providing information for patients, and calling for legislation to ensure proper regulation of compounding pharmacies.

We’ve learned a lot about the compounding pharmacy industry. NECC is part of the International Academy of Compounding Pharmacists (IACP), the industry’s Texas-based trade association, which until this disastrous NECC outbreak, has argued that existing regulations are more than adequate to protect patients.

The FDA in 2001 testified before at a US Senate hearing that the agency surveyed drugs from 12 compounding pharmacies, including hormones, antibiotics, steroids and drugs to treat glaucoma, asthma and erectile dysfunction and ten of the 29 drugs failed one or more quality tests, including nine that failed potency testing, some with less than 70 percent of their declared potency. By contrast, in its analyses of more than 3,000 samples from drug manufacturers, who are subject to FDA oversight, only four had quality problems.

Even after the FDA testified about its findings, Congress killed legislation to give the agency oversight on pharmacy compounding. It was the first in a series of failures to regulate a clearly problematic industry, one that had managed to fight its way out of effective regulation through lobbying and political donations.

In a recent article, one patient group provided this quote about IACP: “They mobilize their members, they scare patients and parents, and they flood Capitol Hill,” said Sandra Fusco Walker, director of patient advocacy at Allergy & Asthma Network Mothers of Asthmatics. “They are dedicated to making sure they never have FDA oversight.”

In the coming months, NCL will be on the front lines on behalf of patients to see that what happened in the shipping and administration of contaminated drugs is never allowed to take place again. We are working with Congressman Edward Markey (D-MA), a member of the House Energy and Commerce Committee, which has jurisdiction over the FDA and health issues generally. The Congressman, a longstanding champion of consumers and patients, has introduced a bill to close the gaping hole in regulation of compounding pharmacies.

Getting to know Linda Hilton and Crossroads Urban Center – National Consumers League

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By Sally Greenberg, NCL Executive Director

In early October, NCL presented Linda Hilton, advocacy director of Salt Lake City’s Crossroads Urban Center, our Florence Kelley award.  This recognition is reserved for an advocate working outside of Washington DC – often an unsung hero doing heroic work – like advocating for low-income consumers against payday lenders or check cashing operations, fighting sub-prime lending, or exorbitant college loans.

I had occasion to visit Linda in Salt Lake City several weeks after she received our award and observed, first hand, how deserving a recipient she was. Like Florence Kelley, Hilton is indefatigable on behalf of the working class and poor in her native Salt Lake City.

The Crossroads Center is located on the outskirts of downtown Salt Lake City. The Saturday afternoon of my visit a homeless man was asleep in front of the Center. Linda leaned over and asked him by name if everything was okay. About 30 percent of Crossroads’ clients are homeless; that number includes hundreds of homeless families. The man camping out on the lawn of the Center nodded yes. She and I walked inside and she showed me around.

The Center provides vital services to low and middle-income Salt Lake residents. It operates 9-5, Monday –Friday, which in itself is unusual. Linda told me that often when it opens on Monday morning, a line of people are waiting outside – many of them are lined up simply to use a bathroom because they have no other access to toilets or water and sinks for washing. The Center’s staff are also able to cut through the red tape for the clients, a critical resource for anyone trying to get government benefits.

For example, someone entitled to Food Stamps but whose benefits have gotten cancelled or whose paperwork is missing can get same day emergency access to food because Crossroads professional staff has the contacts and knows who to call. The Center provides vouchers for gas for the working poor, many of whom may have jobs but don’t make enough on minimum wage jobs to fill their gas tanks. Bus passes are also distributed so people can get to doctor’s appoints, apply for services and get to work.

Crossroads Center also has a robust network of doctors and even dentists – dental care is especially hard access for low-income families – who are willing to provide free medical and dental services for Crossroad’s clients.

Finally, I got a close look at supplies in the food pantry. Cans of Bumble Bee tuna, Skippy Peanut Butter, canned chicken and beef chili lined the walls, along with bags of lentils and black beans, crackers and chips. Also, boxes of toothbrushes and toothpaste, along with hotel size bottles of shampoo, conditioner and body lotion, were stacked at the Food Bank. I stay in hotels a lot for work and often leave the cosmetics behind. But now I’ve started a collection which I’ll donate to our local homeless drop in center near my home in DC.

Linda showed me the chart they use – if you are a family of three the food pantry has a set list of what you need to eat for several days; if you’re a family of ten, that list is a lot longer. On another whiteboard was NC – for the homeless or others who have no way to cook. They get canned and other food that doesn’t need to be heated up.

Finally, Linda also leads the Coalition for Religious Communities, which does advocacy work on behalf of the very people Crossroads serves. Her critical work in advocating for the reduction reducing sales tax on food in the state of Utah and fighting payday lenders is directly influenced by her day-to-day connections with Crossroads’ clients. She tells the stories much better than I can. (Read what she had to say about her work in her remarks here.) I couldn’t be more proud that Linda Hilton accepted the Florence Kelley award and that NCL gave her the much deserved recognition for her remarkable advocacy on behalf of Utah’s most needy.