FDA Analysis of Tobacco Graphic Warning Labels Found to be Flawed

Graphic warning labels (GWLs) on cigarette packages reduce smoking prevalence.  A recent article in Tobacco Control found that that FDA’s approach to estimating the impact of GWLs on smoking rates is flawed.  Using data from an analysis of the Canadian GWLs, the authors estimate that if the USA had adopted GWLs in 2012, the number of adult smokers in the USA would have decreased by 5.3–8.6 million in 2013.

Lobbyists Clash Over Proposed E-cigarette Restrictions in D.C.

The Washington Post reported last week that tobacco industry lobbyists and public health advocates battled it out in a D.C. Council committee chamber over whether the city should restrict electronic cigarettes from all of the same places that it bans those rolled with tobacco. In the absence of any federal guidelines on the increasingly popular devices, states and cities have scrambled to decide how to treat them. On Thursday, those for and against a bill to create “parity” with tobacco cigarettes, restricting them from all indoor areas, patios and bus stops, presented wildly different views of the battery-operated inhalers.

FDA Removes Marketing Limits on Diabetes Drug Avandia

The Food and Drug Administration, in a U-turn from its position three years ago, removed restrictions on diabetes drug Avandia, reports the Wall Street Journal, and said it no longer had serious concerns over the drug’s heart-attack risk. One prominent Avandia critic, Steven Nissen of the Cleveland Clinic, predicted doctors wouldn’t return to prescribing the drug. “I do not think this decision is in the public interest,” said Dr. Nissen, the clinic’s chairman of cardiovascular medicine and a prominent researcher who presented evidence of the drug’s risk.

Brady Advocates Call on Congress to Expand Law to Online and Gun Show Sales Now

Hundreds of gun violence prevention advocates from around the country took to the halls of Congress last week calling on members to expand effective Brady background checks to online and gun show sales.  The lobby day is the culmination of a three-day summit put on by the Brady Campaign that brought in hundreds of leaders and activists in the gun violence prevention movement and related organizations to discuss solutions in the areas of policy, legal action, and health and safety education. The theme of the event is “Make Your Voice Matter.”

Questions About India’s Drug Industry

On May 13, 2013, writes the Indian newspaper The Hindu, Indian pharmaceutical manufacturer Ranbaxy pleaded guilty to seven felonies relating to drug manufacturing fraud and agreed to cough up $500 million to settle the case brought by the U.S. Department of Justice (DoJ) after eight years of investigation. The vast evidence in the case included inspection reports compiled after multiple US FDA visits to Ranbaxy plants in India — in Paonta Sahib, Himachal Pradesh, and Dewas, Madhya Pradesh. Now two more major Indian pharmaceutical companies are coming under legal scrutiny. 

U.S. Demands in Trans-Pacific Partnership Agreement Text, Published Today by WikiLeaks, Contradict Obama Policy and Public Opinion at Home and Abroad

Secret documents published today by WikiLeaks and analyzed by Public Citizen reveal that the Obama administration is demanding terms that would limit Internet freedom and access to lifesaving medicines throughout the Asia-Pacific region and bind Americans to the same bad rules, belying the administration’s stated commitments to reduce health care costs and advance free expression online, Public Citizen said today.

 

More information about the Trans-Pacific Partnership negotiations is available at www.citizen.org/tpp

European Alcohol NGOs Quit EU Alcohol Forum to Protest Lack of Action on Alcohol Control Policies

Eurocare, the European Alcohol Policy Alliance, announced that last month, several of its members left the European Alcohol and Health Forum (EAHF), a European Commission body formed to address and reduce alcohol-related harm. The NGOs have been disillusioned with the ability of EAHF to provide effective and efficient changes to reduce alcohol-related harm across the EU. A call for stronger regulations, abandoning of the self-regulation policy and exclusion of industrial interests follows the announcement.

Johnson & Johnson Agrees to Pay $2.2 Billion in Drug-Marketing Settlement

Johnson & Johnson will pay $2.2 billion to resolve civil and criminal allegations involving the marketing of off-label, unapproved uses for three prescription drugs, Justice Department officials announced Monday, reports the Washington Post. The cases, which date from the late 1990s through the early 2000s, involve alleged kickbacks to doctors and pharmacies to promote the antipsychotic drugs Risperdal and Invega, and a heart drug, Natrecor. The widely anticipated agreement was one of the largest health-care fraud settlements in U.S. history.

Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs

A recent study by researchers at Harvard and York Universities found that millions of patients suffer from adverse reactions to prescription drugs they take to get better. Patients experience an estimated 81 million adverse reactions a year. Although most of these are medically minor, about 2.7 million hospitalizations and 128,000 deaths are attributed to properly prescribed drugs. Prescription drugs are the 4th leading cause of death. Hospitalizations and deaths from prescribing errors, overdose, and self medication would add to these totals.