Skip to content
Customize Consent Preferences

We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.

The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ... 

Always Active

Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.

No cookies to display.

Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.

No cookies to display.

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.

No cookies to display.

Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.

No cookies to display.

Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.

No cookies to display.

ALZHEIMER’S DRUG? FORGET ABOUT IT

The big “news” last week was, the first new treatment for Alzheimer’s disease in almost twenty years has been approved for use in the U.S. by the Food and Drug Administration.  
Of the more than 400 Alzheimer’s drugs that have been tried over the decades, most have failed. So far, Alzheimer’s is recognized as an irreversible disease that leaves in its wake devastation and heartbreak not just for its actual victims but for their friends and loved ones. 
And, its developer and manufacturer, Biogen, headquartered in Massachusetts, has announced a yearly price tag of $56,000 for the drug. A 9 June Financial Times article notes that the cost to patients will greatly exceed drug industry estimates that it would be priced between $10,000 and $24,000 annually. But Biogen is no stranger to such high prices; the company has been criticized for years for the high cost of its medicines meant to treat, for example, multiple sclerosis and spinal muscular atrophy. 
“One of the FDA’s Worst Decisions”
The Institute for Clinical and Economic Review takes issue with Biogen’s pricing on the grounds that the new treatment is actually worth $2,500 to $8,300 per year. And Michael Carome, director of Public Citizen’s health research group, is quoted as having objections that go beyond mere overpricing – those objections go beyond Biogen to the FDA itself, which Carome said was guilty of “one of the worst decisions the agency has ever made” in approving the drug, which was “green-lighted” in advance of conclusive clinical trials. 
The drug was apparently tested on only a subset of mild Alzheimer’s sufferers before being approved for the entire spectrum of sufferers, and negative effects may have been downplayed or ignored. 
The new drug is called aducanumab, and will be sold under Aduhelm brand. The FT article reports that many doctors and scientists say there is “scant evidence that it even works.”
The good news for the drug-maker, however, is that Biogen stock was up 38 percent last week, the highest in six years.
3 Resign in Protest from FDA Panel
In a related story, reported online by The New York Times and CNBC.com on 10 June, three members of the FDA’s Peripheral and Central Nervous System Advisory Committee have tendered their resignations in reaction to the agency’s approval of the drug. 
One of them, Dr. Aaron Kesselheim of Harvard Medical School, echoing Michael Carome’s remark, said it “was probably the worst drug approval decision in recent U.S. history,” and that it would “undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation, and the affordability of the health care system.”
TRENDPOST: We note this article to emphasize the true nature of government agencies. Despite a drug with questionable attributes and negative consequences, it is legal to be sold on the open market. 
Also, when the efficacy and side effects are questioned by the agency’s panel, they are dismissed. And as evidenced by those questioning the “Operation Warped Speed” COVID vaccination, they are banned from social media and the mainstream media.
Indeed, freedom of speech and freedom of thought are no longer the American way. Instead, you must believe what you are told and never question “authorities.”
We have also noted the revolving door between governments and the regulatory agencies and how the bottom line rules. Nothing could be more evident than Dr. Scott Gottlieb, who was the head of the FDA now sitting on the board of directors for mega-drug dealer Pfizer.
TRENDPOST: In the Spring 2017 Trends Journal, Bennett Daviss wrote a comprehensive article providing a keen overview of the disease and its suspected causes: “ALZHEIMER’S: DASHED HOPES, NEW DIRECTIONS.”