New drug on horizon in fight against early Alzheimer’s

by Joseph Choi and Nathaniel Weixel 

Patients in the early stages of Alzheimer’s disease and their caregivers may have another drug by the end of this year that could slow inevitable memory loss.

Eli Lilly said it expects the Food and Drug Administration (FDA) to act by the end of the year on its application for approval of its monoclonal antibody called donanemab.

 

Donanemab slowed Alzheimer’s disease progression by 35 percent relative to placebo in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease. 

 

In practical terms, that translated to delaying progression by about four months. It also means the drug performs at least as well as the newly approved Leqembi (lecanemab), which was found to reduce progression by about 27 percent.

 

Both donanemab and Leqembi are part of a new class of Alzheimer’s drugs called anti-amyloid treatments, because they target amyloid plaque in patients’ brains. They offer promise, but serious questions remain.

 

Both significantly reduce the levels of plaque, but there’s debate about how much that will actually help.

 

Supporters argue that for the patients who benefit, the drugs can stave off memory loss long enough to buy them a few extra months with family and loved ones.

 

The main safety concern is brain swelling or bleeding, which is often mild but sometimes can be serious or even fatal. During Lilly’s trial, three deaths were attributed to the drug. 

 

Patients using the treatments need repeated brain scans to monitor for those side effects, which can be costly if they’re not covered by Medicare or private insurance.  

 

The Centers for Medicare and Medicaid Services on Monday proposed to expand its coverage of PET scans that are used to help diagnose Alzheimer’s disease, which would likely ease at least some of the cost concerns. Currently, Medicare will only cover one PET scan per lifetime of a patient, and then only if they are participating in clinical trials.

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New drug on horizon in fight against early Alzheimer’s

One of America’s most popular drugs — first aimed at schizophrenia — reveals the issues of ‘off-label’ use

The first warning came a dozen years ago, when the Food and Drug Administration accused the drug company AstraZeneca of “false or misleading” information about health risks in the marketing material for its blockbuster medication Seroquel, an antipsychotic developed to treat schizophrenia but increasingly prescribed “off label” for insomnia.

What followed was an onslaught of litigation by state attorneys general, who charged AstraZeneca with fraudulently promoting Seroquel for unapproved uses, and by individual patients, who claimed that it had failed to alert consumers about some of the drug’s most pernicious side effects. Although the company never admitted wrongdoing, by the end of 2011 it had paid out more than $1 billion to settle many of the cases.

Another product might have been derailed, but not Seroquel. Despite generic competition and lingering lawsuits, AstraZeneca’s annual reports show Seroquel remained a blockbuster, with $3.6 billion in sales from 2014 to 2016. In the drug’s titanic success and its strong link to off-label prescribing lies a cautionary tale — about the sometimes conflicting forces within health care, the relationship between medications and marketing, and the limits of regulatory protections.

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One of America’s most popular drugs — first aimed at schizophrenia — reveals the issues of ‘off-label’ use

14 Lies That Our Psychiatry Professors in Medical School Taught Us

Dr. Gary Kohls

Myth # 1:

“The FDA (US Food and Drug Administration) tests all new psychiatric drugs”

False. Actually the FDA only reviews studies that were designed, administered, secretly performed and paid for by the multinational profit-driven drug companies. The studies are frequently farmed out by the pharmaceutical companies by well-paid research firms, in whose interest it is to find positive results for their corporate employers. Unsurprisingly, such research policies virtually guarantee fraudulent results.
Myth # 2:

“FDA approval means that a psychotropic drug is effective long-term”

False. Actually, FDA approval doesn’t even mean that psychiatric drugs have been proven to be safe – either short-term or long-term! The notion that FDA approval means that a psych drug has been proven to be effective is also a false one, for most such drugs are never tested – prior to marketing – for longer than a few months (and most psych patients take their drugs for years). The pharmaceutical industry pays many psychiatric “researchers” – often academic psychiatrists (with east access to compliant, chronic, already drugged-up patients) who have financial or professional conflicts of interest – some of them even sitting on FDA advisory committees who attempt to “fast track” psych drugs through the approval process. For each new drug application, the FDA only receives 1 or 2 of the “best” studies (out of many) that purport to show short-term effectiveness. The negative studies are shelved and not revealed to the FDA. In the case of the SSRI drugs, animal lab studies typically lasted only hours, days or weeks and the human clinical studies only lasted, on average, 4- 6 weeks, far too short to draw any valid conclusions about long-term effectiveness or safety!

Hence the FDA, prescribing physicians and patient-victims should not have been “surprised” by the resulting epidemic of SSRI drug-induced adverse reactions that are silently plaguing the nation. Indeed, many SSRI trials have shown that those drugs are barely more effective than placebo (albeit statistically significant!) with unaffordable economic costs and serious health risks, some of which are life-threatening and known to be capable of causing brain damage.
Myth # 3:

 “FDA approval means that a psychotropic drug is safe long-term”

False. Actually, the SSRIs and the “anti-psychotic” drugs are usually tested in human trials for only a couple of months before being granted marketing approval by the FDA. And the drug companies are only required to report 1 or 2 studies (even if many other studies on the same drug showed negative, even disastrous,  results). Drug companies obviously prefer that the black box and fine print warnings associated with their drugs are ignored by both consumers and prescribers. One only has to note how small the print is on the commercials.

In our fast-paced shop-until-you-drop consumer society, we super-busy prescribing physicians and physician assistants have never been fully aware of the multitude of dangerous, potentially fatal adverse psych drug effects that include addiction, mania, psychosis, suicidality, worsening depression, worsening anxiety, insomnia, akathisia, brain damage, dementia, homicidality, violence, etc, etc.
But when was the last time anybody heard the FDA or Big Pharma apologize for the damage they did in the past? And when was the last time there were significant punishments (other than writs slaps and “chump change” multimillion dollar fines) or prison time for the CEOs of the guilty multibillion dollar drug companies?  (Continue Reading)

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14 Lies That Our Psychiatry Professors in Medical School Taught Us

Petition to the FDA; Regulate Nursing Home Injuries and Deaths

Family members expect bed rails to protect the parents, grandparents, and great grandparents spending their nights in nursing home beds.

Warning labels are not placed on the bed rails that have strangled and injured Senior Citizens for years. The FDA finally issued a warning in 1995 about the dangers of bed rails.You've heard about that, right? Exactly. No one has. And so the deaths and injuries continued.

After the FDA's ineffective warning, officials discussed placing warning labels on bed rails. But, manufacturers resisted, so the FDA let it slide.

Shoving the issue of bed rail safety labeling under the rug won't hide the needless deaths and injuries that vulnerable senior citizens face. Putting a warning label on a product that needs it, however, will save lives.

SIGN the Petition - FDA: Regulate Nursing Home Injuries and Deaths