2018 Year in Review: Consumer Health & Safety
In a year when health care protections came under attack and prescription drug prices continued to be a top concern of Americans, Public Citizen’s doctors, health researchers, lobbyists and organizers worked to develop and promote solutions.
A Medicare Milestone
In 2018, the Trump administration’s continued attempts to erode Affordable Care Act protections helped drive Medicare-for-All into the mainstream. Such a system would expand health care coverage to everyone in the U.S., regardless of income. Grassroots support is growing, with more and more of the public mobilizing around the tenet that health care is a human right.
In February, activists from Public Citizen and a large coalition delivered more than a million signatures to key U.S. senators, urging them to support a Medicare-for-All proposal introduced by Sen. Bernie Sanders (I-Vt.) known as S. 1804. Sanders’ bill attracted 16 co-sponsors, while more than half of Democrats in the U.S. House of Representatives have sponsored Medicare-for-All legislation (H.R. 676).
In July, activists across the nation celebrated the 53rd anniversary of Medicare being signed into law. Public Citizen organized – in Congress and in communities across the country – to push elected officials to support Medicare-for-All.
Also in July lawmakers formed a Medicare-for-All caucus, which nearly 80 members of Congress have joined. The announcement was made at a press conference at which lawmakers and Public Citizen President Robert Weissman spoke about the need for everyone in the U.S. to finally have access to the care they need, without high out-of-pocket costs or insurance companies getting between them and their doctor. The caucus is poised to do the hard work of organizing to build a legislative majority, but it won’t be easy; a study Public Citizen released in October found that three-fourths of health care lobbyists in 2017 worked on behalf of Big Pharma, insurance and hospital industries.
As the year ended, Public Citizen laid the groundwork to significantly ratchet up its Medicare-for-All campaign. We hired a full-time campaign director to build a strong grassroots movement that will translate public demand into political power and capitalize on the momentum.
Making Medicines Affordable
As a candidate, Donald Trump pledged to lower prescription drug prices. In 2018, when the White House released proposals it said would address high medication prices, Public Citizen responded quickly, pointing out the many ways the Trump administration failed a major litmus test on medicine affordability. We also seized the opportunity to provide the media and public with a detailed analysis of Trump’s budget as well as recommendations for reforms that truly would lower prices.
Our analysis helped policymakers and the public understand how the Trump administration did not target the root causes of high U.S. drug prices. It failed to leverage government negotiating power, stop price spikes or curb the monopoly abuses of industry. The analysis also laid out potential paths forward to make a real difference in the lives of Americans struggling to afford their medicines.
Public Citizen experts and activists worked with lawmakers to turn those proposals into reality. We provided expertise to U.S. Rep. Lloyd Doggett (D-Texas), who in July unveiled the “Medicare Negotiation and Competitive Licensing Act of 2018,” to allow Medicare to negotiate directly with pharmaceutical corporations and authorize generic competition when negotiations fail. This legislation would authorize the federal government to negotiate directly with pharmaceutical manufacturers, just as the government already does for veterans. At a press event in July, representatives from Public Citizen and other groups spoke about the benefits of negotiations and relying on generic competition to address monopoly pricing abuses. To date, Doggett’s legislation has more co-sponsors (100) than any other medication pricing bill in Congress.
We also worked with Sanders and Rep. Ro Khanna (D-Calif.) on the Prescription Drug Price Relief Act of 2018, which they introduced in November. The act requires the U.S. Secretary of Health and Human Services to license generic and biosimilar competition on patented prescription products when they are deemed excessively priced or cost more than the median in Canada, the United Kingdom, Germany, France and Japan.
An important component of the access to medicines movements is cultivating a grassroots base – and you showed up in 2018. About 90,000 Public Citizen supporters took action on drug pricing; 15,000 called their legislators. And we organized a conference in June that drew more than 100 advocates, organizers and lawmakers from around the country to share tips on how to effect policy changes that will make medicines affordable.
In May, almost four years after Public Citizen first petitioned the U.S. Food and Drug Administration (FDA) to do so, the agency announced that it had directed companies to stop marketing over-the-counter infant teething products containing the topical pain reliever benzocaine. Public Citizen first sounded the alarm on benzocaine’s harmful side effects in 2014, and in 2017, it sued to compel the FDA to respond to the citizen petition. The agency action means parents can rest easier knowing their infants are safe from an ingredient that can cause a life-threatening blood disorder.
And in July, the FDA partially granted a December 2017 petition from Public Citizen to temporarily prohibit the use of heart-toxic cesium chloride – which has been promoted as an alternative treatment to cancer – in pharmacy compounding. In 2016, the agency’s own reviewers had concluded that cesium chloride is “not safe for human use” and “has not been shown to be efficacious for the prevention or treatment of any form of cancer.” The FDA’s action came just hours after the Public Citizen had sued the agency for not responding to the petition. Though the agency denied Public Citizen’s additional request – also contained in the petition – for the agency to make the ban permanent through regulation, it indicated it may eventually pursue such action.
- In March, Public Citizen called on the U.S. Department of Health and Human Services (HHS) Inspector General to launch an investigation into officials at the National Institutes of Health (NIH), including staff of the National Institute on Alcohol Abuse and Alcoholism, who had solicited donations from the alcohol industry to fund a major study on the health effects of alcohol – a violation of NIH rules. The NIH announced in June that it would halt the study, based on recommendations from an NIH advisory committee.
- An updated Public Citizen report released in March found that criminal penalties against drug makers that engage in illegal activities have plummeted and prosecutions of drug executives remain extremely rare. The report, which looked at federal and state criminal and civil penalties from 1991 through 2017, also noted that despite government authority to do so, parent pharmaceutical companies never have been banned from participating in Medicare and Medicaid for their illegal activities, which have endangered public health and hurt taxpayers.
- In May, we teamed up with Baltimore’s health commissioner to demand that the Trump administration authorize generic competition for lifesaving naloxone therapies with easy-to-use delivery devices, such as Narcan and Evzio. Generic competition would slash prices for these critical therapies for victims of opioid overdose. Narcan sells to public providers like Baltimore for $37.50 a dose while generic naloxone is available for 15 cents per dose in India.
- Also in May, 21 physician leaders, including two experts from Public Citizen, published a comprehensive pharmaceutical reform proposal that would lower prescription drug costs and improve medication safety.
- In August, we demanded that HHS halt and investigate a clinical trial involving seriously ill sepsis patients that is funded by the NIH and carried out at dozens of institutions nationwide. The design of the trial is deeply flawed and exposes subjects to unacceptable dangers, included increased risks of organ failure and death.
- In October, Public Citizen called on the U.S. Food and Drug Administration (FDA) not to approve a new, superpotent opioid known as sublingual sufetanil tablet that is to be sold under the brand name Dsuvia. Public Citizen partnered with Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, to speak out against the medication.
- Following a request by Public Citizen and 64 experts, FDA inspectors in October found serious violations in high-risk clinical trials conducted by a Minnesota hospital. The investigation confirmed Public Citizen’s suspicions that the medical center performed risky sedation experiments with the dangerous general anesthetic ketamine on unwitting emergency patients who were agitated. Public Citizen is demanding that the agency impose severe sanctions on the Hennepin County Medical Center for the serious ethical and regulatory lapses that occurred during the oversight of the ketamine trials and other studies.
- In December, Public Citizen released a groundbreaking study that found that nurses rarely face reportable punishment for sexual misconduct. Over nearly 14 years, fewer than 900 U.S. registered and licensed nurses had adverse-licensure or malpractice-payment reports in the National Practitioner Data Bank because of sexual conduct, which suggests many nurses who engage in such misconduct go unpunished.