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Category: Trump Administration

  • Trump Says Ketamine Derivative Can Help Veterans With Depression

    Trump Says Ketamine Derivative Can Help Veterans With Depression

    Trump recently told reporters that he has instructed “top officials” at the VA to order esketamine.

    President Donald Trump ordered the Department of Veterans Affairs (VA) to purchase a large amount of a ketamine derivative as a means of combating rising suicide rates among military veterans.

    While en route to a veterans’ conference in Kentucky, Trump told reporters that he has instructed “top officials” at the VA to order esketamine, a medically viable variation of ketamine in nasal spray form that has been approved by the Food and Drug Administration (FDA) for treatment of depression.

    Trump’s Request

    Trump’s request countered a decision by the VA’s medical board to exclude esketamine from the list of drugs in its hospital system, save for extreme cases without results from any other medication.

    Trump told reporters that esketamine—which is marketed under the brand name Spravato by troubled pharmaceutical company Johnson & Johnson—has had a “tremendously positive” effect in tests involving patients with depression.

    However, as The Atlantic noted, test results produced a very different result, with just one of three clinical trials showing any benefit. And though approved for use by the FDA, the agency’s support hinged on using the drug with an oral antidepressant, and only in cases of severe depression that have not shown response from other treatments. The FDA even published a report in mid-August 2019—a week before the president’s statement—that viewed esketamine as less reliable than a placebo.

    The VA’s Stance

    The VA did not comment on its decision to exclude esketamine from its drug supply in 2019, but did note that it would be available for “occasional use” in extreme cases of depression. The president’s comments did not appear to change that stance: spokesperson Susan Carter told The Atlantic that it will “closely monitor” esketamine use in veterans and may consider revising its guidelines “if warranted.”

    Ketamine—an anesthesia medication used to assist sedatives and painkillers in cases of surgery or major injuries—is also known as a recreational drug for its hallucinogenic properties. More recently, the drug has been put forward as treatment for a host of mental disorders, including treatment-resistant depression, obsessive-compulsive disorder and post-traumatic stress disorder. Though small clinical trials have yielded some positive results, others have shown that ketamine’s effectiveness as a depression treatment is limited.

    View the original article at thefix.com

  • Trump Administration May Remove Privacy Rules For Patients With Addiction History

    Trump Administration May Remove Privacy Rules For Patients With Addiction History

    Relaxing privacy rules about patients’ addiction histories could save lives, the administration argues.

    The Trump administration could soon weaken patient privacy laws for people who have received treatment for addiction. The intent is to stop doctors and other types of treatment centers from unknowingly providing prescription pain pills or other addictive drugs to patients who have a history of addiction.

    The proposed change would let medical providers add addiction treatments into patients’ standard medical records. Health Secretary Alex Azar hopes to make changes to the rules because he believes they prevent doctors and other health care professionals from getting crucial information that patients themselves have already agreed to share.

    These regulations “serve as a barrier to safe, coordinated care for patients,” Azar argued. “The information is currently so tightly restricted that even with the patient’s consent to share information, some health care providers are unwilling to record needed information on a patient’s health or treatment.”

    Jessie’s Law

    To bolster his point, Azar pointed to Jessie’s Law, which gets its namesake from a patient named Jessica Grubb. She was prescribed oxycodone after knee surgery despite having told her doctors about her history of addiction and died from an overdose the night she was released from the hospital.

    Similar laws have been bandied about in the halls of Congress. Despite initial bipartisan support, the bills lost steam in the Senate.

    Avoiding Stigma

    Not everyone sees eye-to-eye with Azar’s point of view. Opioid abuse advocacy groups, such as the American Association for the Treatment of Opioid Dependence and the Legal Action Center, have voiced concerns regarding involuntarily including such information on patient medical records.

    In their view, some patients might dodge the much-needed treatments in order to avoid the heavy stigma that comes with addiction treatment. According to these groups, just 10% of Americans suffering from substance use disorder sought treatment last year, and that number could be even lower if such regulations were passed.

    But Azar’s camp remains unconvinced in the face of an increasingly concerning epidemic.

    “All of the changes that we are proposing still are premised on patient consent,” said Azar.

    Having this information be accessible is crucial “to determine whether a patient was receiving treatment for opioid use disorder,” Azar argued. “And that is information that could save a patient’s life.”

    View the original article at thefix.com

  • Trump Celebrates Overdose Death Decline, But Drug Policy Remains Chaotic 

    Trump Celebrates Overdose Death Decline, But Drug Policy Remains Chaotic 

    While the decline is a positive step, many remain concerned about drug research and the lack of leadership in the DEA.

    President Trump is celebrating—and claiming credit for—the first drop in the overdose death rate in decades, but political insiders say that his White House remains unorganized, especially when it comes to drug policy. 

    During an event last month that highlighted the overdose death decline, Trump said, “This is a meeting on opioid[s] and the tremendous effect that’s taken place over the last little period of time.”

    “They’re going to make the political argument that they’re winning,” Regina LaBelle, Obama-era chief of staff for the Office of National Drug Control Policy (ONDCP), told STAT News. “Which they can say, since deaths are down. But I get concerned that we’re going to take our eye off the ball on the broader issue of addiction.”

    One major concern that some people have is that the Drug Enforcement Administration (DEA) remains without a leader. It’s been that way for more than two years, which Clinton-era “drug czar” General Barry McCaffrey finds absurd. 

    “The White House is so disorganized and dysfunctional that they can’t pluck an apple sitting at eye level in front of them,” he said. “Why wouldn’t you have a DEA administrator, for God’s sake? In 14 workdays, you could come up with a dozen superlative people with political chops who would take that job.”

    The Fight For Drug Research

    While the DEA does not have a leader, the agency finds itself at odds with other government agencies. On June 20, one DEA official asked Congress to classify all fentanyl analogues as Schedule I substances. The DEA has argued that this is necessary for law enforcement, but others, including a researcher from the National Institute on Drug Abuse (NIDA), say that this would inhibit research on opioids and treatment for opioid use disorder. 

    As part of the process, the DEA expressed its desire to control drug classifications without input from the Food and Drug Administration (FDA) and the NIDA.

    Senator Dick Durbin (D-Ill.) was so concerned by this power grab that he led a group of eight Senators (including one Republican) who authored a letter expressing their worries. 

    “We are concerned that the failure to engage necessary health experts vests far too much authority to a law-enforcement agency and may result in action that will deter valid, critical medical research aimed at responses to the opioid crisis,” the senators wrote. 

    Michael Collins, director of national affairs for the Drug Policy Alliance, said that the agency is “playing on people’s fear in order to make a power grab that predates the fentanyl crisis.”

    “We are being asked to give DEA control of the scheduling process and give up due process and allow more prosecutorial power—and give up researching these substances and potentially saving lives as a result of that research,” he said. 

    View the original article at thefix.com