Workers in New York City now have a legal right to paid sick leave thanks to an incredibly successful campaign led by the Community Service Society of New York (CSSNY), a grantee of the Roadmaps to Health Community Grants Program, along with their key partner Make the Road-NY.

Until just a few months ago, 64 percent of low-income working New Yorkers lacked paid sick days – time they could take off from their jobs when they were sick or needed to care for an ill family member without losing a day’s pay. Having to make painful choices between earning a paycheck and taking care of one’s health or the health of one’s children threatens the health and financial security of these workers and their families. It also threatens the health of all of us. A 2011 study in the American Journal of Public Health concluded that a lack of paid sick leave led to an additional 5 million cases of adult H1N1 (swine flu), resulting in an estimated 23,000 additional hospitalizations and nearly 1,400 deaths. But we don’t need studies to tell us what is obvious – it isn’t good for any of us if people are forced to work when they’re sick or to send sick children to school, and paid sick days can have a beneficial impact on both the health and the financial security of struggling families.

In June of 2013, CSSNY and its coalition successfully overcame a mayoral veto to establish an ordinance that provided for up to five days a year of paid sick time for about one million New York City workers who previously had no legal access to that benefit. This year, on the heels of the election of new Mayor Bill de Blasio, an expansion of the original law passed as the first legislative initiative of the de Blasio administration, extending legal access to paid sick time to hundreds of thousands of additional workers. Workers began accruing sick time on April 1 and could start using the leave as of July 30.

CSSNY will continue educate the public about the new law and to collect stories – both positive and negative – about how implementation is going. This is an important part of making sure that the new law is enforced and workers can actually access the rights they now have. They will also use their annual Unheard Third survey to measure public awareness of the law. CSSNY already has a track record of using research to inform effective public education efforts. For example, in July 142 volunteers from Make the Road-NY handed out flyers about the paid sick leave law as part of a city-led day of action at subway stops. The city relied on CSSNY’s research to help determine which subway stops were chosen in an effort to target likely neighborhoods where workers would be eligible for this new benefit.

The impact of this campaign doesn’t stop in New York City. As the nation’s media and business capital, what happens in NYC attracts nationwide attention and has the power to influence similar efforts across the country. CSSNY’s successful campaign has inspired similar efforts in neighboring Jersey City and Newark, New Jersey, both of which passed paid sick leave laws modeled on New York’s. In addition, CSSNY was recently invited to do a presentation on the importance of paid sick leave to the Social Determinants of Health Working Group, a Medicaid redesign team in New York state. This team has begun looking carefully at the economic and social determinants of health, which are factors like education and employment that have a huge impact on the health of individuals. The team is interested in how addressing these factors might improve the health of Medicaid recipients and produce long-term cost savings. Specifically, they are considering what the state might achieve through workplace benefits, including the possibility of taking the paid sick leave policy statewide.

There’s no doubt that CSSNY and Make the Road-NY have helped lead a very impressive campaign over the past two years. With the support of the Roadmaps to Health Community Grants Program, they’ve used all of the advocacy capacities at their disposal – campaign development, communications, resource development, policy analysis and advocacy, coalition and stakeholder alliances, and grassroots organizing – and they’ve used those capacities strategically and effectively. This campaign can be a model for other cities and states, thereby helping not only low-wage workers in New York, but workers in other communities across the nation.

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Community Catalyst manages the Roadmaps to Health Community Grants program, which is funded by the Robert Wood Johnson Foundation. The program is an important element of the County Health Rankings & Roadmaps program and supports two-year efforts among local coalitions of community organizations, policymakers, business, education, health care, and public health professionals who are working to create positive policy or system changes on the social and economic factors that impact the health of people in their community. No Robert Wood Johnson Foundation funding was used for lobbying in the CSSNY project. 

Last month, the House of Representatives was scheduled to vote on an agricultural appropriations bill that included a new waiver process allowing local school districts to opt-out of the new nutrition requirements enacted in the 2010 Healthy Hunger Free Kids Act (HHFKA). Weeks have gone by and still the House has not voted. Reporters who cover the food industry speculate that delays mean that a compromise is in the works, while others hedge that this is just the first pie to be thrown in a much larger food fight to come. The fact that the Healthy Hunger Free Kids Act, a law that vastly improves child nutrition, has come under scrutiny is a cause for concern, not just for school meals, but for child wellness in general.

But let’s backtrack for a moment.

The school meals program, which includes breakfast, lunch, snack and now dinner in some areas, serves meals to approximately 31 million children in more than 100,000 school districts across the country. Children at or below 185 percent of the Federal Poverty Level are eligible for free and reduced lunch.

Four years ago advocates celebrated the bipartisan passage of the Healthy Hunger Free Kids Act. For the first time in 30 years, the law created sweeping reforms to the school meals program and gave the U.S. Department of Agriculture unprecedented authority to set new nutrition standards for food served in schools. The new standards are based on the Institute of Medicine’s recommended nutrition standards for children and involve increasing servings of fresh fruits, vegetables and whole grains, limiting salt and fat, and switching from whole and 2% milk to 1% and skim. In short, the Healthy Hunger Free Kids Act ensures that low-income children participating in the school meals program are able to eat healthy meals, a major win for communities and families.

Yet four years later, political support has shifted for the new school lunch rules. This could not come at a worse time.

According to the Centers for Disease Control and Prevention (CDC), one-third of children and adolescents in America are overweight or obese. The extent of this public health crisis is even more pronounced among children of color and children in low-income communities. Obesity has been found to increase a person’s risk for a myriad of other health issues, including diabetes, high blood pressure and other cardiovascular diseases, and various forms of cancer. The rise in obesity has brought along with it the appearance of these chronic diseases in children – diseases that had previously only ever been seen in adult patients. Furthermore, obesity in children dramatically increases the risk of obesity into adulthood. This has already placed enormous strain on our health care and economic systems, and promises to do so into the future if current trends are not adequately addressed.

There are a number of strategies to curb the childhood obesity epidemic. One important strategy includes ensuring that children are served healthy meals in school while reducing the availability of unhealthy foods. The Healthy Hunger Free Kids Act is a key component in that effort, and it is particularly important for children at high risk of obesity. And evidence shows that children like the new, healthier meals. According to a new survey of school administrators released by the Robert Wood Johnson Foundation, respondents at 70 percent of schools surveyed reported students liked the new meals by the end of the first year of implementation of the new rules. Given these signs that the law is doing as intended, we are left to wonder why lawmakers would want to change it.

As we work tirelessly to help children and their families obtain coverage and access health care, we want to remind folks of the importance of working in concert with other policies that help keep children healthy. For health advocates, this means supporting policies beyond coverage – such as the Healthy Hunger Free Kids Act. As we move forward, it will be important for all of us to integrate the important work of pediatricians inside the doctors’ office with community-based services and the policies that guide them. The Healthy Hunger Free Kids Act is an important step to ensure that our environment promotes childhood well-being and does not hinder or degrade it. We will continue to highlight policies that promote children’s health and wellbeing – stay tuned.

You can find additional Healthy Hunger Free Kids Act updates here and an infographic summarizing why healthier school meals matter here.

Today is CHIP’s 17th birthday! As we reflect on the success of this important program, a recent report nicely summarizes its impact. The Impact of the Children’s Health Insurance Program (CHIP): What Does the Research Tell Us?, a report by The Kaiser Commission on Medicaid and the Uninsured, highlights CHIP’s real impact on providing coverage for children from racially and ethnically diverse backgrounds. According to the Kaiser report, Medicaid and CHIP cover more than half of Hispanic children (52 percent) and Black children (56 percent) compared to a little over a quarter of white (26 percent) and Asian children (25 percent), according to the Commission’s issue brief. This report is timely given that just last week, the chairmen and ranking members of the House Committee on Energy and Commerce and the Senate Finance Committee issued a letter to all governors asking for feedback about CHIP.

As the Kaiser report shows, CHIP is an important initiative to reduce health disparities and increase access for children of color. Coverage is the first step in securing better health outcomes for all children. And for children from racially and ethnically diverse backgrounds, Medicaid and CHIP play a vital role in opening a doorway to needed health care and, over the long run, healthier and more productive lives. Further, a New York CHIP program study finds enrollment in CHIP almost eliminates racial and ethnic health disparities across multiple measures related to access, unmet need, and continuity of care. While more work needs to be done across multiple sectors including economic security, educational attainment, and healthy food access, CHIP plays an important role in moving the needle on health equity.

Communities of color are important allies in safeguarding CHIP and amplifying its role in turning the tide on health disparities. As we activate our bases and encourage our coalitions to raise their voices to secure continuation of CHIP, it is important to re-evaluate if all the right people are at the table. Are racially and ethnically diverse communities represented in children’s health coalitions? Are their voices represented around advocacy planning and strategy? What does meaningful engagement of communities of color look like?

Community Catalyst put together a list of the Top Ten Tips in Engaging Communities of Color for Policy Change to support advocates in their efforts to reach and engage coalition partners representing racially and ethnically diverse communities. Important takeaways include: finding the right messenger, practicing team building, engaging beyond education, and celebrating successes. These will be important strategies to deploy in building support for the continuation of CHIP.

To learn more about how state consumer advocates have put these tips into practice, check out our blog series, Health Equity in Focus

I recently attended a conference entitled "What Evidence is Essential for New Medical Products?" held at the American Association for the Advancement of Science in Washington, D.C., that probed the vexing dilemma of balancing the duty of the Food and Drug Administration (FDA) to assure the safety and efficacy of new drugs and medical devices versus the demand of patients for faster access to potentially life-saving cures.

The dilemma is best illustrated by the following "Tale of Two Drugs." When the AIDS epidemic first swept the country and the world in the 1980s, AIDS activists successfully pressured the government to speed up the drug approval process for AZT (zidovudine), a process that usually took many years before drugs came to market. Those suffering with AIDS were literally dying in the streets. Robert Yarochoan, an FDA official at that time, told the conference audience of the dramatic response of both the FDA and the pharmaceutical company Burroughs-Wellcome to expedite the approval of AZT. Countless lives were saved as a result.

The other tale also deals with a deadly disease that is ravaging the world—tuberculosis (TB) that is resistant to the usual antibiotics used to treat it. Jerry Avorn spoke about what appeared to be a promising drug called bedaquiline. In the laboratory, bedaquiline appeared to kill multi-drug resistant TB germs. Usually, the next step in the drug-approval process would be small-scale clinical trials where the drug is tested in actual patients suffering from the disease. This vital step in the drug approval process was skipped in order to bring a potentially life-saving drug to market quickly. Tragically, when the drug was used for the first time by real patients, it ended up having a fatality rate five times that of more standard drugs for multi-drug resistant TB.

Similar problems exist for medical devices. Devices, such as pens to inject insulin, that are very similar to devices that are already approved and on the market, only have to pass a cursory review to assure that they are essentially equivalent. Truly new devices or ones that are substantially different from existing ones must go through an intensive approval process, more like new drugs, in which they must prove both their safety and efficacy. Astonishingly, only 1 percent of devices go through this intensive review process according to medical journal editor Dr. Rita Redberg.

Dr. Redberg informed the conference about WINGSPAN, an implantable filter that was supposed to protect against second strokes. FDA did not require the device to go through the intensive review and the device turned out to increase strokes and death. Even worse, it remains on the market and more than 11,000 devices are still being implanted every year.

Stories like this illustrate the dangers of rushing drugs and devices to market. Pharmaceutical and medical device manufacturers continue to ratchet up the pressure on the FDA to expedite the approval process, both by directly lobbying FDA, and by enlisting the support of many patient advocacy groups and lawmakers. At present, more than half (56%) of newly approved drugs used an expedited-approval pathway. (Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category—implications for patients. N Engl J Med 2014;370:1252–8)
Congresswoman Rosa DeLauro (D-CT) spoke passionately about the dangers to patients in the present system, and has submitted a letter to FDA about her grave concerns about the proposed new accelerated drug approval guidelines. At the conference she also pledged to support giving the FDA the resources it needed to safeguard the nation's drug supply.
Dr. Peter Lurie, associate commissioner of FDA, defended the agency, noting that just because FDA approved a drug didn't mean doctors needed to prescribe it. But we know that drug company marketing strategies go into high gear once a drug is approved. Doctors then face intense pressures from industry, as well as pressure from patients who have been urged to "ask their doctors" on television ads about the latest drugs.

A number of other ideas emerged from the conference that offered more promise as a means of dealing with these dilemmas. In Europe, drugs that have been approved but where there is more uncertainty about their safety and effectiveness are labeled with a black triangle. Such a system could be used by FDA, which already mandates black box warnings to alert doctors to particularly dangerous side effects.

The FDA gives some new drugs a “conditional approval” and then requires the company to provide more data, but many companies fail to provide the data and there is no penalty. In some countries, however, where the government is the major purchaser of drugs, it pays the manufacturer a lower rate for the drug until it can produce convincing data about the safety of the drug. This provides a powerful financial incentive for drug companies to make good on their promise of more data. Public programs like Medicare and Medicaid could do this same in this country. The FDA should also consider including “sunset provisions” along with any conditional approval—the approval would end unless the additional data on safety and efficacy were provided in a specific timeframe.

Dr. Bernie Good from the Veterans Administration reported that the VA protects veterans by taking into account safety data when it decides whether to place a drug on the VA formulary. New drugs that have not undergone the full rigorous testing are less likely to be placed on the formulary. Medicaid programs also consider safety when deciding what to include in their list of approved drugs. This is not true for the Medicare program for the elderly, but is an idea worth pursuing.

Most importantly, the FDA must be given the financial resources it needs to do its job without depending on industry fees, which now pay for a large percentage of the costs of the drug approval process. The temptation is just too great for the agency to cut corners to avoid biting the hand that feeds it. While the FDA needs to have a good working relationship with industry, its mission is to serve the public's best interests. That mission must never be compromised.

Stephen R. Smith, M.D., M.P.H., Community Catalyst physician consultant

Two patients recently saw me within a two-week span asking for a prescription for Belviq (lorcaserin), a weight-loss drug. Both patients told me they had seen the drug advertised on television. Like most direct-to-consumer (DTC) ads, the one for Belviq ended with the advice to "ask your doctor about" it.

Based on my knowledge of weight loss drugs, my initial reaction was a negative one. The last weight-loss rage for phentermine+fenfluramine ("phen–fen") resulted in patients with damaged heart valves—an adverse effect that became evident only after millions of patients used the drug combination for many years. And with all the weight-loss drugs I have seen, the benefits in terms of weight loss were neither dramatic in magnitude nor long-lasting in duration.

That gut reaction notwithstanding, I recognized the patients' sincere desire to lose weight. Both were middle-aged women whose body-mass index (BMI) scores were above 30, thus putting them in the category of "obese." Belviq is approved by the Food and Drug Administration (FDA) for patients with a BMI of 30 or higher.

The first patient said she had been trying to lose weight on her own but had been unsuccessful. I thought this was a good opportunity for the patient and me to balance the pros and cons of taking the drug. I opened a recent issue of The Medical Letter that reviewed Belviq. Together, we read the indications for its use, how effective it was likely to be, and its side effects. After reading this information, I remained skeptical of her use of this drug, but she reiterated her fervent desire to try this drug as a means to lose weight. So I agreed to allow her to start the drug on a trial basis, so long as she agreed to stop taking it if was unable to lose 5 percent of her weight within three months. She agreed to that stipulation, which is included in the drug labeling.

A second patient of mine who asked for Belviq was struggling with weight loss, but she had already lost 5 pounds. I praised her successful efforts thus far with diet and exercise, noting that this was the best way to adopt a sustainable approach to weight control. When she reiterated her request for Belviq, I told her about the phen–fen disaster and the possibility that there could be hidden dangers with Belviq, as well. Though she still said she wanted the prescription, she agreed to continue on her own program of weight loss without drugs, with the understanding that we could revisit the question in a few months, depending on her continued progress.

These two cases highlight the controversy surrounding DTC advertising. Clearly, the TV ads for Belviq had motivated these patients to ask me for a prescription for the drug. In an ideal world, primary care providers would proactively engage their obese patients in discussions about weight loss without DTC advertising. Indeed, DTC advertising is not permitted by governments in the rest of the world other than in the United States and New Zealand. But here in the U.S. the FDA allows such advertising and physicians must be prepared to deal with DTC ad-driven patient demand.

Drug companies will do everything they can to maximize that demand and the sales that advertising promises. This can include promising consumers better outcomes, while downplaying the risks of taking a drug.

My patients were a perfect example of the outcome drug companies hope for, except for one thing. Both of my patients were covered by Medicaid, and in Connecticut where I practice, the state Medicaid program does not cover drugs for weight-loss, even though they cover other weight-loss treatments.

My patients were not the kind of patient that these DTC ads were intended to reach. The drug company wants to motivate patients with commercial insurance to go ask their doctors about Belviq. But commercial insurance companies should be just as careful as Medicaid in evaluating whether specific drugs with limited benefits should be covered. Our nation's ability to achieve sustainable, affordable health care for all depends on avoiding expensive treatments that are likely to be wasteful (because less expensive equally good alternatives are available),unnecessary or even counterproductive, because of risky side effects. 

For the time being, DTC advertising appears to be here to stay in the U.S., but that doesn't preclude steps that can be taken to mitigate its most worrisome features.

First, all DTC ads should be approved by the FDA before they are released to the public. This will assure that an accurate presentation of the risks and benefits is achieved.

Second, DTC advertising should be prohibited for at least two years after a drug is first released. This can help limit the extent of its use during the critical period of time when unknown rare but serious and potentially lethal side effects may become evident.

Third, the revenue generated from financial penalties levied against companies for false and misleading advertising should be used for public service advertising and educational activities that warn patients about the risks of prescription drugs and promote healthier alternatives.

Finally, medical students, residents, and practicing physicians must learn skills in communication to more effectively interact with patients who, having just seen an ad on TV, come in and “ask their doctor about….”

 

 Stephen R. Smith, M.D., M.P.H., Community Catalyst physician consultant