FDA approves Johnson & Johnson’s ketamine-like drug to treat severe depression

Nasal spray the first major innovation in depression drugs since Prozac

WASHINGTON — A mind-altering medication related to the club drug Special K won U.S. approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. The nasal spray from Johnson & Johnson JNJ, +0.21% is a chemical cousin of ketamine, which has been used for decades as a powerful anesthetic to prepare patients for surgery. In the 1990s, the medication was adopted as a party drug by the underground rave culture due to its ability to produce psychedelic, out-of-body experiences. More recently, some doctors have given ketamine to people with depression without formal FDA approval.

The Food and Drug Administration approved Spravato as a fast-acting treatment for patients who have failed to find relief with at least two antidepressants. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA. There have been no major pharmaceutical innovations for depression since the launch of Prozac and related antidepressants in the late 1980s. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in.

Ketamine and J&J’s version work differently than those drugs, targeting a chemical called glutamate that is thought to restore brain connections that help relieve depression. When the drug works, its effect is almost immediate. That speed “is a huge thing because depressed patients are very disabled and suffer enormously,” said Dr. John Mann, a psychiatrist and researcher at Columbia University. If the drug doesn’t work, physicians can quickly switch to other options, he noted.

The FDA approved Spravato, known chemically as esketamine, based on study results that showed patients taking the drug experienced a bigger improvement in their depression levels than patients taking a sham treatment, when measured with a psychiatric questionnaire. The drug is designed to be lower-dose and easier to use than ketamine, which is normally given as an intravenous infusion.

Robin Prothro, 60, began taking antidepressants more than 20 years ago. But she says none of the five medications she tried relieved the depression that has stymied her personal and professional life. Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she’s returned to hobbies she abandoned years ago, like gardening. She takes the drug every two weeks at her psychiatrist’s office while reclining in a comfortable chair. “You can feel it coming on, it’s a strong drug,” she said, describing colors and shapes that drift before her eyes. “I just let the drug work. I close my eyes and my mind is amazingly quiet.”

https://www.marketwatch.com/story/fda-approves-johnson-johnsons-ketamine-like-drug-to-treat-severe-depression-2019-03-05

New York regulators subpoena Trump Organization’s insurance broker

Move comes after Michael Cohen testifies about misleading insurers

NEW YORK — New York regulators have sent a subpoena to the Trump Organization’s longtime insurance broker, a request that comes days after President Donald Trump’s former attorney, Michael Cohen, told Congress the president had misled insurers about the value of his assets. The brokerage, Aon, told The Associated Press on Tuesday it intends to cooperate with the inquiry by New York’s Department of Financial Services, the agency that regulates the insurance industry. Donna Mirandola, a spokeswoman for the brokerage, declined to discuss the specifics of the request. “We do not comment on specific client matters,” she wrote in an email. The Department of Financial Services declined to comment. The Trump Organization did not return messages seeking comment.

The document request comes amid a flurry of criminal, civil and congressional investigations into the president and his business dealings by multiple agencies, including two U.S. House committees controlled by Democrats. The New York Times, which first reported the subpoena, said the nine-page subpoena sought a wide range of records but did not allege any specific wrongdoing. The newspaper said the subpoena sought communications and records regarding Aon’s business with Trump over the past 10 years and internal Aon contracts and records relating to Trump. During testimony before the House Oversight Committee last week, Cohen presented three years of Trump’s financial documents he said showed Trump inflated the value of his assets in part to lower his insurance premiums. He said Trump would provide the falsified statements to insurers “so that they would understand that the premium, which is based sometimes upon the individual’s capabilities to pay, would be reduced.” The Trump Organization hasn’t commented on the specifics of Cohen’s allegations, but Trump, in several tweets, called his statements to congress “fraudulent and dishonest.”

Experts said Trump would have an incentive to exaggerate his wealth for some types of insurance, including surety bonds. Local governments often require developers to get this kind of coverage so, if the developer goes bankrupt, there is backup money to go ahead with paving roads and other infrastructure projects promised by the developer. Another possibility is what’s known as a “retrospectively rated” insurance policy, which can act as a quasi-loan to the company buying the coverage. With these policies, if there were a fire at one of Trump’s buildings or big worker’s compensation claims and an insurer paid Trump for the losses, Trump would then be required to hand back to the insurer part of that payment years into the future.

It isn’t clear if the Trump Organization has taken out such policies. Asked in his testimony about who at the Trump Organization would know about the alleged insurance maneuvers, Cohen mentioned three executives, including Chief Financial Officer Allen Weisselberg, who began working for the Trump family four decades ago. The House Intelligence Committee said it plans to invite Weisselberg to testify. The House Judiciary Committee announced its own wide-ranging inquiry Monday into “alleged obstruction of justice, public corruption and other abuses of power by President Trump, his associates and members of his administration,” seeking documents from dozens of people in Trump’s inner circle and business. Trump has castigated those investigations, initiated after Democrats won control of the House, as meritless and politically motivated.

https://www.marketwatch.com/story/new-york-regulators-subpoena-trump-organizations-insurance-broker-2019-03-05

>>5531859

I have seen many turn into a different person over a short period of time on these drugs and not in a good way either..I have no trust in any of big pharma's remedies when it concerns the brain or pain.

>>5531943

Pretty much looking like this. I think more to the point is the effort to change the narrative before big news hits. A usual move for them to bury the report or reports…doubtful it will take hold imho.