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Time to Reevaluate U.S. Mifepristone Restrictions

n engl j med 381;7 nejm.org August 15, 2019

body of research demonstrating its safety and effectiveness.” In fact, the FDA has approved clini- cal trials for alternative distribu- tion models for mifepristone in the United States.

Recent media reports indicate that, as access to clinics that sat- isfy the FDA restrictions shrinks, people are increasingly turning to the Internet to source mifepris- tone on their own from foreign manufacturers. The FDA cannot effectively control Internet sales, which are likely to grow further, nor can the safety of these foreign- sourced products be ensured.

Women should have access to

FDA-approved products whose safety and effectiveness are con- firmed. Since the evidence avail- able today indicates that the current restrictions are overly prescriptive, we urge the FDA to reevaluate whether they are still necessary.

Disclosure forms provided by the authors are available at NEJM.org.

From the National Academy of Medicine, Washington, DC ( J.E.H.); and the Chicago Community Trust, Chicago (H.D.G.).

This article was published on June 26, 2019, at NEJM.org.

1. Food and Drug Administration. Mife- pristone U.S. post-marketing adverse events summary through 12/31/2018. December

2018 (https://www .fda .gov/ media/ 112118/ download). 2. Cleland K, Smith N. Aligning mifepris- tone regulation with evidence: driving policy change using 15 years of excellent safety data. Contraception 2015; 92: 179-81. 3. National Academies of Sciences, Engi- neering, and Medicine. The safety and qual- ity of abortion care in the United States. March 2018 (https://www .nap .edu/ read/ 24950/ chapter/ 1). 4. Aiken ARA, Digol I, Trussell J, Gom- perts R. Self reported outcomes and adverse events after medical abortion through on- line telemedicine: population based study in the Republic of Ireland and Northern Ire- land. BMJ 2017; 357: j2011. 5. World Health Organization. Essential medicines and health products information portal: a World Health Organization resource. WHO drug information, vol. 19, no. 3, 2005.

A Plan to Continue Asbestos Use in the United States

A Most Reckless Proposal — A Plan to Continue Asbestos Use in the United States Philip J. Landrigan, M.D., and Richard A. Lemen, Ph.D.

Each year, nearly 40,000 Amer-icans die often painful, pro- tracted deaths from diseases caused by asbestos. These deaths occur in firefighters, police offi- cers, construction workers, miners, military veterans, shipyard work- ers, and maintenance workers whose exposures to asbestos are primarily occupational. Death also occurs in partners and children of such workers, whose only ex- posures to asbestos were from dust on clothing brought home from work by a family member. In the United States, treatment of asbestos-related diseases — in- cluding malignant mesothelioma, asbestosis, lung cancer, laryngeal cancer, and ovarian cancer1 — costs hundreds of millions of dollars each year.

The health hazards of asbes- tos were recognized in the early

20th century, but this informa- tion did not become widespread until a landmark 1964 publica- tion documented the association between asbestos exposure and cancer.2 In the years after that report, the amount of asbestos used in the United States fell by more than 99% — from more than 650,000 metric tons in 19633 to roughly 750 metric tons in 2018, according to data from the U.S. Geological Survey. The main drivers of this decline have been federal regulations that banned and restricted many uses of asbestos and aggressive litiga- tion on behalf of injured workers against companies that produced and used asbestos with full knowl- edge of its dangers.

Most asbestos-related deaths in the United States today are caused either by cancers of long

latency that resulted from expo- sures decades ago or by more recent exposures to asbestos in- stalled long ago in the form of insulation, pipe wrapping, roofing tiles, and siding in thousands of office buildings, schools, and homes. The populations at great- est risk for exposure to legacy asbestos are firefighters, mainte- nance workers, and people em- ployed in the construction and demolition industries. Great dili- gence is required of employers and federal regulators to protect these high-risk workers against occupational asbestos exposures.

But contrary to common be- lief among health professionals and the public, asbestos has never been permanently banned in the United States. The dominant le- gally permitted use of asbestos today is by the chemical-manu-

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A Plan to Continue Asbestos Use in the United States

n engl j med 381;7 nejm.org August 15, 2019

facturing industry in the produc- tion of chlorine and caustic soda in chloralkali plants. Asbestos is also allowed in sheet gaskets, oil-field brake blocks, and after- market brake pads and brake lin- ings for trucks and buses. These uses were outlawed years ago in most other developed countries, where asbestos has been replaced by safer, economically viable alter- natives.

In 1989, the Environmental Protection Agency (EPA) attempt- ed to ban asbestos under the Tox- ic Substances Control Act. This ban was overturned in 1991 by the Fifth Circuit Court of Ap- peals, which found in Corrosion Proof Fittings v. EPA, a case brought by the asbestos industry, that the EPA had failed to document that a ban was the “least burdensome” approach to controlling asbestos exposures.

In 2016, the EPA was given an- other opportunity to ban asbes- tos with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This bipar- tisan legislation was intended to modernize the Toxic Substances Control Act. It required the EPA to begin safety reviews, within 180 days, of 10 highly hazardous chemicals identified as top priori- ties for regulation. Asbestos was designated as one of these high- priority chemicals, and the EPA initiated a review. This review is currently stalled.

Under the Trump administra- tion, the EPA released a signifi- cant new use rule for asbestos in April 2019, which went into effect on June 24, 2019.4 Under the pre- text of protecting public health by prohibiting multiple uses of asbestos that had in fact been abandoned years or even decades earlier, this new rule creates loop-

holes that will permit continued and potentially expanded use of asbestos in the United States.

The new rule permits the con- tinued use of asbestos in chemi- cal manufacturing as well as in gaskets and brakes. It allows as- bestos mining to support such uses, a policy that could lead to the reopening of domestic asbes- tos mines that have been closed since 2002.3 It also permits con- tinued importation of asbestos into the United States. Most reck- lessly, we believe, the rule details a process whereby American in- dustries can propose new uses of asbestos for review by the EPA. If the actions permitted by this rule are carried out, we fear that an- other generation of American workers will be exposed to as- bestos and that a new wave of unnecessary, preventable diseases and deaths will follow.

Stimulated by the Trump ad- ministration’s support for the con- tinued use of asbestos and its announcement that it intended to issue a new rule, an asbestos- mining company in Russia — the country that produces the most asbestos — is reported to have printed President Donald Trump’s picture on bales of as- bestos that it ships overseas.5 Ac- cording to these reports, Trump’s image is surrounded by text read- ing, “Approved by Donald Trump, 45th President of the United States.”5

We believe that this adminis- tration’s brazen attempt to con- tinue and potentially expand as- bestos use in the United States is an affront to public health and human dignity. It signals accep- tance of the asbestos industry’s long-disproven claims that chrys- otile asbestos, the only form of asbestos on international markets

today, is safe and that it is pos- sible to work safely with asbes- tos. It ignores more than five decades of medical research that has established beyond any rea- sonable doubt that even in very small amounts, all forms of as- bestos, including chrysotile, can cause cancer.

On March 7, the Alan Reinstein Ban Asbestos Now Act of 2019 was introduced in both houses of Congress. This bill, named in honor of a California man who died of malignant mesothelioma, would ban the import, manufac- ture, processing, and distribution of all asbestos and asbestos-con- taining materials in the United States. The ban would take effect within 1 year after the Act’s pas- sage and would supersede the EPA’s new rule.

We believe the Ban Asbestos Now bill is long-overdue legisla- tion that deserves to be enacted into law. Industries should no longer be allowed to propose new uses for asbestos while ignoring its inevitable effects on human health. No state — red or blue — and no congressional district has been spared the ravages of asbestos exposure. Health profes- sionals can support this legisla- tion individually and through our state and national organizations in order to protect the health of all Americans.

Disclosure forms provided by the authors are available at NEJM.org.

From the Program in Global Public Health and the Common Good and the Global Ob- servatory on Pollution and Health, Boston College, Chestnut Hill, MA (P.J.L.); and the Rollins School of Public Health, Emory Uni- versity, Atlanta (R.A.L.). Dr. Landrigan and Dr. Lemen are former senior officials of the National Institute for Occupational Safety and Health, where Dr. Lemen served as deputy director. Dr. Lemen is a retired as- sistant surgeon general, U.S. Public Health Service.

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A Plan to Continue Asbestos Use in the United States

n engl j med 381;7 nejm.org August 15, 2019

This article was published on July 10, 2019, at NEJM.org.

1. Straif K, Benbrahim-Tallaa L, Baan R, et al. A review of human carcinogens — Part C: metals, arsenic, dusts, and fibres. Lancet Oncol 2009; 10: 453-4. 2. Selikoff IJ, Churg J, Hammond EC. As- bestos exposure and neoplasia. JAMA 1964; 188: 22-6.

3. Virta RL. Worldwide asbestos supply and consumption trends from 1900 through 2003. Reston, VA: U.S. Geological Survey, 2006. 4. U.S. Environmental Protection Agency. Restrictions on discontinued uses of asbes- tos: significant new use rule. Fed Regist 2019; 84: 17345-60. 5. Rosenberg E. ‘Approved by Donald Trump’: asbestos sold by Russian company

is branded with the president’s face. Wash- ington Post. July 11, 2018 (https://www .washingtonpost .com/ news/ business/ wp/ 2018/ 07/ 11/ approved - by - donald - trump - asbestos - sold - by - russian - company - is - branded - with - the - presidents - face/ ?utm_term= .cc299f8c9d74).

Mike’s Labels

Mike’s Labels Otis Warren, M.D.

Mike is a homeless chronic alcoholic. I know this be- cause I wrote his label right here on his medical record. The first sentence, variations of which ap- pear hundreds of times in his file, reads, “53-year-old homeless male, chronic alcoholic, presenting here via ambulance after being picked up behind a McDonald’s.” The EMS crew seemed ambiva- lent when they brought Mike in; they, too, knew his label. The nurses, recognizing Mike, started the “alcoholic protocol orders” long before I saw him: breatha- lyze, search belongings, transfer to the intoxication holding unit. In fact, all of us in Mike’s world know him by his labels — mark- ers that help us recognize him and place him firmly in the role in which we’ve cast him. They iden- tify his medicosocial conditions so we don’t have to go looking for new evidence of the root of his problems. We layer these labels and others on top of each other so that finding Mike the person be- comes difficult, if not impossible.

Mike wears three layers of pants. The outer one, a pair of jeans, once blue but now asphalt- gray, is strung around his waist with a woman’s belt. In its left front pocket, there’s a congealed

mass of papers, wet from the re- cent rain. I peel them apart and find old discharge instructions advising him to cut down on drinking, with phone numbers for local Alcoholics Anonymous (AA) chapters. A few pills (pheny- toin, possibly) and $1.57 fall out of his pocket with the papers. In his otherwise empty right front pocket sits something green and soft — a jalapeno pepper. A Guate- malan man he shelters with gave it to him a week ago, “for seizures.”

Years ago, Mike would have been called a “Skid Rower” — a label that harkens back to the days of the logging industry in the Pacific Northwest, when logs were skidded down city streets, attracting men who drank and slept on the curbs. Policy and re- search from the 1950s and 1960s used “Skid Rower” as the accept- ed term for people like Mike. Cit- ies around the country eventually carved out Skid Rows, not because they were logging towns, but be- cause of Mike’s predecessors — the Amerigo Vespuccis of the in- ner city, whose occupied territory was named after them. Though it’s pejorative and not “politically correct” (PC), “Skid Rower” ac- complished something that “home- less chronic alcoholic” can’t: it

painted people like Mike into their community, describing not only what they were but also where they stayed and where they came from.

Beneath the baggy outer layer of jeans hides a pair of sweat- pants, equally well aged. They are warm and moist. In these pockets, Mike keeps a half-smoked cigarette and a plastic bottle of vodka that’s one swallow away from empty. We set it aside, in- tending to return it later. Mike came to us last night singing loudly to the triage nurses, who were expecting him, “Honey, I’m home!” As I pull down his sweat- pants, I ask Mike if he’s home- less. He looks at me cockeyed and asks, “You mean, where do I stay? I stay behind the McDonald’s on Prince Arthur Street.”

“And if it’s cold?” I ask. “Then I stay here, with you.” So Mike “stays” places. “Home-

less” is our word for his situa- tion, our label for who he is. But outside the hospital, Mike stays in a world populated by housing advocates and social workers. When I talk with them about Mike, they refer to him as a “per- son who experiences homeless- ness.” This “person-first” label- ing liberates Mike, and homeless

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