EPA’s Rollback of Chemical Disaster Rule Would Put Houstonians at Risk
The Houston area is home to two-thirds of the toxic chemicals that are stored by all large chemical facilities in Texas, a new Public Citizen report shows. The data underscores the importance of Obama-era safeguards that the Trump administration is trying to roll back. In Texas, large chemical facilities use 2.4 bil- lion pounds of toxic chemicals and 38.5 billion pounds of flammable chemicals, Public Citizen calculated after reviewing publicly available data. Two-thirds of those chemicals are stored in the eight-county area of the Houston region. The facilities within the region use 51 toxic chemicals – many of which are hazardous or carcinogenic, including chlorine, chloroform, formaldehyde and hydrofluoric acid. The high
concentration of chemical facilities in the greater Houston area, which collectively store about 30 billion pounds of flammable chemicals, makes the region highly prone to chemical disasters.
Following an explosion at a Texas fertilizer facility in 2013 that killed 15 people and injured 160, the Obama administration issued a rule to protect workers, first responders and communi- ties from potentially injurious or life-threatening chemical exposure. But under President Donald Trump, the U.S. Environmental Protection Agency (EPA) has attempted to delay the rule.
The good news: The U.S. Court of Appeals for the District of Columbia Circuit ruled in August that the EPA can’t delay enforcement of the chem- ical disaster rule. Public Citizen filed an amicus brief in the case, Air Alliance Houston v. EPA.
— Rhoda Feng
Florida Case Addresses Unwanted, Auto-Dialer Text Messages
An unwanted, auto-dialer text message may be a nuisance, as well as a violation of consumer protection law. But when can the recipient of an unlawful text message take the sender to court?
A case in Florida that Public Citizen will argue in October could clarify the answer to this ques- tion for future cases that hinge on text messages sent in violation of the Telephone Consumer Protection Act (TCPA), which prohibits compa- nies from making auto-dialer calls to cell phones without consent.
The Florida case is based on a text message that plaintiff John Salcedo alleges he received from defendants Alex Hanna and the Law Offices of Alex Hanna, P.A. in August 2016. Lengthy and impersonal, the alleged three-part message included a photo, a coupon and bilingual text encouraging him to call the firm.
Mr. Salcedo, who states that he is a former client of defendants, filed a lawsuit in the U.S. District Court for the Southern District of Florida, claiming that defendants’ message violated the TCPA, invaded his privacy, wasted his time and made his phone unavailable for other activities

while he addressed the message. Styled as a class action, the suit also alleges that defendants sent auto-dialer text messages to other former clients.
The law firm that sent the texts filed a motion to dismiss the case, arguing that Salcedo could not pursue the case because the text message caused him no injury. Under the U.S. Constitution, a federal lawsuit can proceed only if a plaintiff suffered an injury that is “concrete,” a require- ment that the Supreme Court emphasized in a 2016 opinion titled Spokeo, Inc. v. Robins.
The district court ruled in Salcedo’s favor. After it refused to toss out the case, the defendants appealed to the U.S. Court of Appeals for the Eleventh Circuit. Public Citizen will argue on Salcedo’s behalf on Oct. 2. Since the Supreme Court’s decision in Spokeo, two other federal courts of appeals have addressed questions simi- lar to the one presented here, in TCPA lawsuits. Both of those courts concluded that the plain- tiffs alleged concrete harms, and thus could move forward with their suits. And long before the TCPA became law, the U.S. Supreme Court recognized the “right to be let alone” as “the most compre- hensive of rights and the right most valued by civilized men.” Salcedo is seeking relief including
$500 in statutory damages for each text placed in violation of the TCPA and an injunction against future violations. — Rhoda Feng

Unethical Clinical Trials in Minnesota Should Be Investigated

Public Citizen is urging the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to investigate two clinical trials conducted in Minnesota in which patients were experimented on without their knowledge or consent.
The trials were designed to test the safety and effectiveness of the dangerous general anesthetic ketamine — used to treat agitated patients — compared with other potent sedative drugs. The trials were conducted without the informed con- sent of the subjects and in violation of federal human subjects protection regulations, Public
Citizen and 64 doctors, bioethicists and academ- ics said in a letter to the two agencies.
Researchers at the Hennepin County Medical Center in Minneapolis — where the trials were conducted — and the center’s institutional review board (IRB) erroneously determined that the trials involved only minimal risk to the subjects, Public Citizen maintains. Based on that conclusion, the IRB waived informed consent requirements. In fact, the experiments far exceeded the minimal risk threshold, so patients should have been told they were part of an experiment.
The first trial, which began in October 2015 and ended in September 2016, compared ket- amine with the schizophrenia drug haloperidol and involved 146 unwitting subjects. That trial found that ketamine was much more likely to cause serious adverse events than haloperidol. Notably, subjects receiving ketamine were 10 times more likely to have breathing problems that required placing a breathing tube in the subjects’ tracheas than those receiving haloperidol.
The second trial, which compared ketamine to midazolam, began in August 2017 — well after results of the first trial demonstrating ketamine’s harms were known to the researchers — and was supposed to involve up to 420 subjects.
Before the first trial testing ketamine and halo- peridol began, some of the trials’ researchers had published an article about the dangers of using ketamine for agitation and advised that the drug should be used only in patients with the most seri- ous levels of life-threatening agitation, not those with lesser degrees of agitation, as was the case in both of these trials.

Hennepin suspended the clinical trial on June 25, after troubling details were exposed by the Star Tribune. Yet following the trial’s suspension, the institution has defended the trials and has misrepresented them as “observational studies” involving “low risk,” Public Citizen’s letter said.
Public Citizen is urging the FDA and OHRP to investigate the conduct and oversight of the two trials as well as how many other ongoing and prior clinical trials conducted by Hennepin have or had similar serious regulatory and ethical lapses. — Rhoda Feng
from katrineelizabethsackett32463 whitelady (5'21/2)(5'3)
found in public citizens news sept oct issue
today is nov 2018

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