Two Cheers for Air Pollution Control: Triumphs and Limits of the Mid-Century Fight for Air Quality

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As President Trump, the auto industry and the state of California battle over air pollution standards,  a new  article in Public Health Reports analyzes the early years of 20th-century air pollution control in Los Angeles. In both scholarship and public memory, mid-century efforts at the regional level were overshadowed by major federal developments, namely the Clean Air Act and creation of the US Environmental Protection Agency in 1970.

Continue reading Two Cheers for Air Pollution Control: Triumphs and Limits of the Mid-Century Fight for Air Quality

In Runup to 2020 election, Renewed Action to Regulate the Pharmaceutical Industry

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Overt the last several years, the pharmaceutical industry has been accused of inappropriately and misleadingly advertising prescription drugs to consumers, charging exorbitant prices, paying competitors not to release less expensive generic drugs, and negotiating trade agreements that benefit the industry at the expense of the public.   As public concern about these practices grows and as the 2020 election gets closer, Big Pharma is getting closer scrutiny.

A few recent actions illustrate this new climate. Earlier this month, reports The New York Times, the Trump administration announced that  for the first time will, it will require pharmaceutical companies to include the price of prescription drugs in television advertisements if the cost exceeds $35 per month.  The move is the most visible action the administration has taken so far to address the rising cost of prescription drugs. It has been a key issue for American voters and one that both Republicans and Democrats have vowed to address.

In Congress, Reps. Judy Chu (CA-27) and Devin Nunes (CA-22) last month  introduced the Sunshine for Samples Act of 2019. This bill would amend the Sunshine Act, which requires pharma companies to report payments to doctors,  to require companies that manufacture drugs, devices, biologics, or medical supplies to publicly make available the number and value of free drug samples given to health care providers and charities each year. The bill closes a loophole in the Sunshine Act and does not prevent drug and device manufacturers from continuing to provide free samples, nor does it add any new burdens to providers under the Open Payment Programs.

Both the Federal Trade Commission and Congress have also acted to oppose “pay for delay” a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines. These drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market.  Last month , Congressman Jerrold Nadler introduced H. R. 2375 , the Preserve Access to Affordable Generics and Biosimilars Act. The bill proposes to prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

These recent actions suggest that the 2020 election will provide public health professionals and advocates with opportunities to educate the American people and elected officials about the practices of the pharmaceutical industry and to counteract pharma’s extensive spending to influence Congress.

 

 

The Oil Industry’s Covert Campaign to Rewrite American Car Emissions Rules

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When the Trump administration laid out a plan this year that would eventually allow cars to emit more pollution, reports The New York Times, automakers, the obvious winners from the proposal, balked. The changes, they said, went too far even for them.

But it turns out that there was a hidden beneficiary of the plan that was pushing for the changes all along: the nation’s oil industry.

In Congress, on Facebook and in statehouses nationwide, Marathon Petroleum, the country’s largest refiner, worked with powerful oil-industry groups and a conservative policy network financed by the billionaire industrialist Charles G. Koch to run a stealth campaign to roll back car emissions standards, a New York Times investigation has found.

report released at the  First WHO Global Conference on Air Pollution and Health earlier this year found that air pollution – both ambient and household – is estimated to cause 7 million deaths per year, 5.6 million deaths are from noncommunicable diseases and 1.5 million from pneumonia. The wider economic impacts of premature deaths due to ambient air pollution amount to US$ 5.7 trillion in welfare losses, or 4.4% of the global Gross Domestic Product (GDP) in 2016.  Motor vehicles are a primary cause of ambient pollution. The Trump-Marathon plan to allow more automobile pollution will increase this health and economic burden, as well as contribute to global warming.

What rules for e-cig?

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Earlier this month, the U.S. Food and Drug Administration proposed new rulesthat would restrict  flavored e-cigarettes and tobacco products that have lured young people into vaping and smoking.Fast Company, a media outlet that “chronicles how changing companies create and compete”, recently published a profileof  Juul, a company founded in 2017 to make and sell  e-cigarettes.   Juul is now valued at more than $16 billion and controls 72% of the U.S. e-cigarette market.   It’s also hooking teens on nicotine and drawing scrutiny from the FDA. Can the company innovate its way out of a crisis it helped create, asks Fast Company?

Another story last week, this one in The New York Times, describes how Matt Murphy, a high school senior then 17 years old in Reading , Massachusetts, become addicted to Juul.  “It was love at first puff,” said Matt, now 19.  As the United States debates what rules will govern the marketing of e-cigarettes, public health researchers and advocates will have to digest and synthesize a growing body of literature — and misleading claims.   Two recent reviews, cited  below, can help readers to begin to sort through this evidence.

Breitbarth AK, Morgan J, Jones AL. E-cigarettes-An unintended illicit drug delivery system. Drug and alcohol dependence. 2019(88): 144-149.

Unger M, Unger DW. E-cigarettes/electronic nicotine delivery systems: a word of caution on health and new product development. Journal of thoracic disease. 2018;10(Suppl 22):S2588.

Corporate Efforts to Derail Mass Transit

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In 1985, two urban policy scholars, J. Allen Whitt and Glenn Yago,  wrote:

The urban transportation systems that carry us around are not solely the result of technological innovation or efficiency. They are also a product of the rising and sinking political and market power of industrial interest groups, the changing relations among social classes, the politics of urban development struggles, and the inherent dynamics of the economic system… These factors, particularly corporate control of transportation policy, have profoundly shaped urban streetcar, automobile, bus, and rail transport in the United States during this century. We conclude that this private dominance over urban transportation policy has often led to narrow, profit-seeking behavior that has thwarted the development of more effective public transit.

This week, The New York Times reported that in the last few years Americans for Prosperity, the conservative group financed by oil billionaires Charles and David Koch has contributed hundreds of thousands of dollars to defeat plans to expand or improve mass transit in  Little Rock, Phoenix, Nashville, southeast Michigan,  and central Utah. The group has also contributed to effort to defeat more than two dozen transit-related measures such as states proposals to raise gas taxes to fund transit or transportation infrastructure.

“Stopping higher taxes is their rallying cry”,  Ashley Robbins a transportation researcher at Virginia Tech, told The New York Times. “But at the end of the day, fuel consumption helps them.”   Although Americans for Prosperity opposes pubic spending on mass transit, it supports spending tax money on highways and roads.  Koch brother-owned industries produce gasoline, asphalt, seatbelts, tires and other auto parts, businesses that could be harmed by new investments in mas transit.

Public health research shows that improving mass transit and reducing automobile use can  bring multiple health and environmental benefits:  less premature mortality from lung disease, fewer asthma symptoms, more physical activity and less sedentary time, fewer injuries and deaths from auto crashes, more social interactions and less isolation, less road rage, more walkable and attractive  cities, less air pollution, reduced carbon emissions, less urban sprawl.

Despite these benefits, for more than a century public policy at the federal, regional, state and local levels has been disproportionately influenced by commercial interests that favor increased automobile use over the well-being of our population and our environment.  Public health professionals and researchers need to explore new ways to bring this debate about democracy, health and the environment into the policy and political arenas.

Juul: Does new e-cigarette save or cost lives?

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The rapid growth of a new brand of e-cigarette known as Juul has attracted media and public health advocates’ attention.  According to The New York Times, school officials, struggling to control an explosion of vaping among high school and middle school students across the country, fear that the devices are creating a new generation of nicotine addicts.

Since launching about two years ago, reports BuzzFeed News, Juul has become one of the hottest e-cigarettes on the market. It’s been called “the iPhone of e-cigs” and it has gained somewhat of a cult following among young adults. Shaped like a USB device and easy to conceal, Juul is made by a San Francisco-based company that has received venture capital money.

Following the playbook of cigarette and alcohol manufacturers, who long ago learned that the best way to market their products to children and young people was to claim they were only for adults, Ashley Gould, the chief administrative officer of Juul, told the Times that the company’s products are intended solely for adults who want to quit smoking. Among the flavors Juul markets are fruit medley and crème brulee.

A new study published in PLOS One assesses the net gains and losses from the spread of  vaping.  The authors calculated the expected years of life gained or lost from the impact of e-cigarette use on smoking cessation among current smokers and transition to long-term cigarette smoking among never smokers for the 2014 US population cohort.  Their conclusion: “e-cigarette use currently represents more population-level harm than benefit. Effective national, state, and local efforts are needed to reduce e-cigarette use among youth and young adults if e-cigarettes are to confer a net population-level benefit in the future.”

To counteract the rapid spread of e-cigarettes, seven public health and medical groups, and several individual pediatricians, filed suit in federal court in Maryland challenging a U.S. Food and Drug Administration (FDA) decision that allows electronic cigarettes and cigars – including candy-flavored products that appeal to kids – to stay on the market for years without being reviewed by the agency. According to Industrial Safety and Hygiene News,  The lawsuit was filed by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians.

Although the groups strongly support the FDA’s new efforts to reduce nicotine levels in cigarettes to minimally or non-addictive levels, they also believe that the FDA’s August 2017 decision to exempt e-cigarettes and cigars from agency review for years to come is unlawful and harms public health.

Can litigation change pharma practices that contribute to opioid epidemic?

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As journalistic and legislative scrutiny of the role of the pharmaceutical industry in the opioid epidemic continues, several new reports focus on the potential of litigation to curb Big Pharma abuses.

In The New England Journal of Medicine, Rebecca Haffajee and Michelle Mello, two public health lawyers, examine drug companies’ liability for the opioid epidemic. They describe five legal rationales for litigation against opioid makers and distributors that federal and state government agencies have used:

  1. Blaming the industry for unreasonably interfering with public health by oversaturating the market with drugs and failing to guard against misuse and diversion,
  2. Charging the industry with deceptive marketing that makes false claims about effectiveness and addictiveness,
  3. Accusing the industry for lax monitoring of suspicious opioid orders, a potential violation of the federal Controlled Substance Act,
  4. Asserting that the industry continued to promote opioid use despite mounting evidence lining the product to adverse health outcomes,
  5. Alleging that the industry accrued profits at the government’s expense through unfair business practices.

The authors outline some of the challenges facing litigation against  opioid manufacturers but conclude that “litigation could help alleviate the opioid epidemic by changing industry practices and building public awareness.”

In an Oklahoma lawsuit recently described in The New York Times, a lawyer is using the Cherokee Nation tribal court to sue Walmart, Walgreens and CVS Health, as well as McKesson and other major drug distributors,  for violating federal drug monitoring laws(reason 3 above)  and enabling prescription opioids to flood into the Cherokee nation.  “I believe these companies target populations” Todd Hembree, the Cherokee Nation attorney general, told The New York Times. “They know Native Americans have higher rates of addiction. So when they direct their product here, they shouldn’t be surprised to find themselves in a Cherokee court.”

The Washington Post and 60 Minutes investigated the failure of the U.S. Department of Justice to follow the recommendation of a Drug Enforcement Agency task force working across 11 states to  revoke registrations to distribute controlled substances at some of the  30 drug warehouses of The McKesson Corporation, the nation’s largest drug company.  The DEA team wanted to fine the company more than $1 billion and bring the first criminal case against a drug distribution company.   Instead, reports The Post, “top attorneys at the DEA and the Justice Department struck a deal earlier this year with the corporation and its powerful lawyers, an agreement that was far more lenient than the field division wanted…. Although the agents and investigators said they had plenty of evidence and wanted criminal charges, they were unable to convince the U.S. attorney in Denver that they had enough to bring a case.”

Note to Corporations and Health Watch readers:  Our next post will be on January 3,2018. Happy New Year!

F.D.A. Urges Court to Block New York City’s Calorie Count Law

The Food and Drug Administration has filed court papers in support of an effort to overturn a New York City law requiring calorie counts to be posted by certain establishments, reports The New York Times, at least the second time the Trump administration has inserted itself into a local case. The plaintiffs have asked a judge to grant an injunction to keep the city from enforcing the law, which it plans to start doing on August 21. In response, New York City Health Commissioner Mary Bassett observed, “The F.D.A. has taken the position that chains can stop providing customers with critical nutrition information. Poor nutrition is fueling an epidemic of chronic diseases, and this basic information should be accessible and transparent to all.”

German Carmakers Face Potential New Scandal Over Antitrust Issues

Germany’s high-end carmakers face a potentially destructive new scandal after European antitrust authorities said on Saturday that they were looking into allegations that Volkswagen, Daimler and BMW colluded illegally to hold down the prices of crucial technology, including emissions equipment, reports The New York Times. The emissions scandal, which came to light nearly two years ago, may now be spreading to rivals. Growing awareness of the harmful effects of diesel fumes has prompted European cities to consider bans of diesel cars and has led consumers to reject cars with diesel engines, a largely German innovation that traditionally accounted for half the market. The backlash could take on a new, far broader dimension if it turns out that the excess emissions were the result of illegal collusion by a de facto cartel. The investigation could also lead to billions of euros in fines.

Big Pharma by the Numbers

A recent article in The New York Times provided insights into the pharmaceutical industry’s efforts to ensure that any new policies to lower drug prices would not hurt their profits.

In the first quarter of this year, the pharmaceutical and health products industry spent $78 million on lobbying, 14% more than in the same period last year.

In the 2016 election cycle, the industry contributed more than $58 million to the election campaigns of members of Congress and presidential candidates, a 20% jump from the 2012 cycle

The industry pays 1,100 lobbyists, more than two for each member of Congress.

Last year Representative John Shimkus, Republican from Illinois, helped persuade the Obama Administration to kill a project that would have lowered drug prices in Medicare Part B, which spent $24.6 billion on prescription drugs in 2015. In the last election cycle, Shimkus received $300,00 in drug industry contributions.