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.

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

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.

Read about Lethal But Legal: Corporations, Consumption and Protecting Public Health, a new book by Nicholas Freudenberg

Lethal But Legal: Corporations, Consumption, and Protecting Public Health

By Nicholas Freudenberg published by Oxford University Press in February 2014 with new paperback edition with an afterword by the author released in March 2016.

“In his new book, “Lethal but Legal: Corporations, Consumption, and Protecting Public Health” Freudenberg’s case is that the food industry is but one example of the threat to public health posed by what he calls “the corporate consumption complex,” an alliance of corporations, banks, marketers and others that essentially promote and benefit from unhealthy lifestyles. It sounds creepy; it is creepy. .. Freudenberg details how six industries — food and beverage, tobacco, alcohol, firearms, pharmaceutical and automotive — use pretty much the same playbook to defend the sales of health-threatening products. This playbook, largely developed by the tobacco industry, disregards human health and poses greater threats to our existence than any communicable disease you can name.” – Mark Bittman, contributing op-ed writer, New York Times

“A superb, magnificently written, courageous, and compelling exposé of how corporations enrich themselves at the expense of public health—and how we can organize to counter corporate power and achieve a healthier and more sustainable food environment. This should be required reading for anyone who cares about promoting health, protecting democratic institutions, and achieving a more equitable and just society.” Marion Nestle, Professor of Nutrition, Food Studies, and Public Health, New York University; author of Food Politics: How the Food Industry Influences Nutrition and Health.

In this century, it is estimated that one billion people will die prematurely because of tobacco use, according to “Lethal but Legal,” a smart new book about corporate irresponsibility by Nicholas Freudenberg, a professor of public health at City University of New York. Put that one billion in perspective. That’s more than five times as many people as died in all wars of the 20th century. Freudenberg notes that smoking grew in part because of deliberate manipulation of the manipulation of the public by tobacco companies. For example, tobacco executives realized that they could expand their profits if more women smoked, so they engineered a feminist-sounding campaign to get females hooked: “Women! Light another torch of freedom! Fight another sex taboo!”Nicholas Kristof in the New York Times

“A reservoir of constructive indignation that can arouse all Americans who adhere to basic human values.” ―Ralph Nader

Nader Recommends New Book Lethal but Legal to Provoke Conversation in 2014

“Freudenberg is optimistic that, despite the enormity of the challenges facing us as we confront the power of the multinational companies, a tipping point will be reached when the many thousands of pro-health organisations around the world come together and create the political power—and therefore the political will—necessary for success. Lethal But Legal buoyed my optimism.” Robert Beaglehole, The Lancet

“A real eye-opener. Freudenberg lays out the labyrinth of connections between corporate misbehavior and the health of the world, then gives a roadmap to fix it. I love this book.”Cheryl G. Healton, Director, NYU Global Institute of Public Health; former President and CEO, American Legacy Foundation

 “After documenting how multinational corporations manipulate us into hyperconsumption, this book goes on to identify the strategies we can, together, use to liberate ourselves.” Richard Wilkinson, Emeritus Professor of Social Epidemiology, University of Nottingham

Watch Marion Nestle, Professor  in Nutrition, Food Studies, and Public Health at NYU and Laura Berry, Executive Director of  the Interfaith Center on Corporate Responsibility discuss Lethal but Legal: Corporations, Consumption and Protecting Public Health on CSPAN Books.

Lethal but Legal examines how corporations have shaped ― and plagued― public health over the last century, first in industrialized countries and now in developing regions. It is both a current history of corporations’ antagonism towards health and an analysis of the emerging movements that are challenging these industries’ dangerous practices. The reforms outlined here aim to strike a healthier balance between large companies’ right to make a profit and governments’ responsibility to protect their populations. While other books have addressed parts of this story, Lethal but Legal is the first to connect the dots between unhealthy products, business-dominated politics, and the growing burdens of disease and health care costs. By identifying the common causes of all these problems, then situating them in the context of other health challenges that societies have overcome in the past, this book provides readers with the insights they need to take practical and effective action to restore consumers’ right to health. Nicholas Freudenberg, DrPH, is Distinguished Professor of Public Health at the City University of New York School of Public Health and founder and director of Corporations and Health Watch, an international network of activists and researchers that monitors the business practices of the alcohol, automobile, firearms, food and beverage, pharmaceutical, and tobacco industries. 
Lethal but Legal is available from:

amazon-logoBarnes__Noble_t250logo

 

     

 

 

 

 

For more information, contact us.

Read book excerpts and op-eds by Nick Freudenberg

Top lessons from 50 years of fighting the tobacco industry, The Guardian, January 21, 2014

CVS stores will no longer sell cigarettes. It’s the health over profit revolution, The Guardian, February 5, 2014.

McDomination: How corporations conquered America and ruined our health, Salon, February 23, 2014

How Washington dooms millions of Americans to premature death, The Daily Beast, February 25, 2014

How corporate America exports disease to the rest of the world, Salon, March 2, 2014.

Insatiable: Sizing Up the Corporate-Consumption Complex, The American Interest, March 3, 2014

Why Taming Corporation Promotion of Dangerous Consumer Products is Vital to Improving Public Health Scholars Strategy Network, March 2014

Profit Above Safety, Slate, April 1, 2014

GM’s $35 Million Fine Is A Downpayment On Fixing America’s Regulation, Talking Point Memo, May 20, 2014

 

FDA and Johnson & Johnson Fail to Act on Acetaminophen Risks

During the last decade, more than 1,500 Americans died after accidentally taking too much of a drug renowned for its safety: acetaminophen, one of the nation’s most popular pain relievers. Acetaminophen – the active ingredient in Tylenol, produced by McNeil Consumer Healthcare, a unit of Johnson & Johnson – is considered safe when taken at recommended doses. Yet a new investigation by Pro Publica shows that federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose, which the agency calls a “persistent, important public health problem.” The FDA has repeatedly deferred decisions on consumer protections even when they were endorsed by the agency’s own advisory committees, records show.

Bribery Scandal Dents Big Pharma Sales in China, GSK Hardest Hit

A crackdown on corruption in China’s pharmaceutical sector, reports Reuters, has hurt sales at international and local firms, with many doctors at Chinese hospitals refusing to see drug representatives for fear of being caught up in the widening scandal. Britain’s GlaxoSmithKline Plc, the group at the center of the furor, has suffered the most. Industry insiders expect its China drug sales growth to slow sharply or even reverse in the third quarter after a 14 percent year-on-year rise in the last three months.

How a Cabal Keeps Generics Scarce

According to the American Society of Health-System Pharmacists, a group that maintains a closely watched drug-shortage database, reports the New York Times, 302 drugs were in short supply as of July 31, up from 211 about a year earlier.  About a year ago, President Obama signed a law that was supposed to end chronic shortages of lifesaving drugs. But the critical lack of generic drugs continues unabated. It is a preventable crisis that is inflicting suffering on patients and, in some cases, causing needless deaths.

Painkillers, Profits and Politics

In a blog on Open Secrets, Monica Vendituoli reports that two lawmakers on the House Energy and Commerce Subcommittee on Health (Chairman, Rep. Joe Pitts (R-PA.) and Rep. Michael Burgess (R-TX), the subcommittee’s vice chairman) appear to be favorites of the companies that produce some of the most popular painkillers, drugs that are increasingly associated with overdose deaths.