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Did the FDA murder 32 Americans?

26 Jan
Economists have long produced studies on how having a state monopoly on quality assurance, instead of a vibrant market of competing consumer information providers, keeps new drugs off the market and raises their prices, leading to reduced health outcomes for everyone.

But the FDA also lets bad drugs on the market all the time, and doctors and patients are lulled into relying on them, thinking they are doing their job.

32 people died this winter from spinal meningitis.  And the FDA new about the problem for over 2 years.

As Hillary Clinton would say:  “What does it matter?”


FDA warning to meningitis-linked firm came long after inspection



BOSTON | Wed Nov 21, 2012 9:29am EST Reuters

Nov 21 (Reuters) – The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.

The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA’s average response, according to letters released by a Freedom of Information Act request from Reuters.

The FDA issued the warning letter in December 2006. It was based on an inspection of NECC that began in September 2004 and ended on Jan. 19, 2005, according to the documents.

“This prolonged gap between inspection and warning letters does not comply with FDA’s procedures,” NECC’s chief pharmacist, Barry Cadden, wrote in a Jan. 5, 2007 letter to FDA compliance officer Ann Simoneau.

In follow-up correspondence, FDA officials apologized for the “significant delay” in correspondence time between the inspection and the warning letter. While the FDA conceded the gap was unusual, it in no way diminished the regulator’s “serious concerns” about NECC’s pharmacy operations, documents showed.

FDA murders 32 Americans

26 Jan
Economists have long produced studies on how having a state monopoly on quality assurance, instead of a vibrant market of competing consumer information providers, keeps new drugs off the market and raises their prices, leading to reduced health outcomes for everyone.

But the FDA also lets bad drugs on the market all the time, and doctors and patients are lulled into relying on them, thinking they are doing their job.

32 people died this winter from spinal meningitis.  And the FDA new about the problem for over 2 years.

As Hillary Clinton would say:  “What does it matter?”


FDA warning to meningitis-linked firm came long after inspection



BOSTON | Wed Nov 21, 2012 9:29am EST Reuters

Nov 21 (Reuters) – The U.S. Food and Drug Administration took 684 days to issue a warning letter after uncovering serious issues at the pharmacy at the center of the deadly U.S. meningitis outbreak, newly released documents showed.

The New England Compounding Center (NECC) chastised the FDA for taking so long, telling the agency its response time was nearly 18 months longer than the FDA’s average response, according to letters released by a Freedom of Information Act request from Reuters.

The FDA issued the warning letter in December 2006. It was based on an inspection of NECC that began in September 2004 and ended on Jan. 19, 2005, according to the documents.

“This prolonged gap between inspection and warning letters does not comply with FDA’s procedures,” NECC’s chief pharmacist, Barry Cadden, wrote in a Jan. 5, 2007 letter to FDA compliance officer Ann Simoneau.

In follow-up correspondence, FDA officials apologized for the “significant delay” in correspondence time between the inspection and the warning letter. While the FDA conceded the gap was unusual, it in no way diminished the regulator’s “serious concerns” about NECC’s pharmacy operations, documents showed.


Would AIDS already be cured if we had a free market?

26 Jan
BigHomo: Would AIDS already be cured if we had a free marke…: The FDA famously reduces the speed with which new drugs and treatments come to market, and imposes costs and burdens that mean many drugs a…

Would AIDS already be cured if we had a free market?

The FDA famously reduces the speed with which new drugs and treatments come to market, and imposes costs and burdens that mean many drugs a never created and many small pharmaceutical companies never even get started.  Only giant corporations can deal with the regulations, and so they are happy to be protected from new competitors.  Socialist historian Gabriel Kolko wrote definitive works on how progressives, the New Deal, and regulatory agencies simply serve big business.  Most innovation in today’s economy occurs in Internet related firms, because they were too new and too over the heads of regulators for them to begin regulating.

Now an AIDS cure may come, not from the giant budgets of NIH and the federal government, but from a smaller Australian research institute:

Queensland scientist develops treatment to ‘keep HIV in check’

Daanuary 16, 2013 Natalie Bochenski




Queensland researchers believe they’ve hit upon a “light switch” protein within the HIV virus, which can be flicked off to stop it developing into full-blown AIDS.

The Queensland Institute of Medical Research believes it may be developed into the closest thing modern medicine will get to a cure.
“This has the possibility – not to eliminate the virus – but hopefully to allow us to reconstitute a human immune system that is resistant to HIV,” Associate Professor David Harrich said.
He said they experimented on a normal protein usually used by the HIV virus to replicate itself in human cells and mutated it to create the “Nullbasic” protein.
“We now have a very potent protein that can stop HIV from growing in cells,” he said.


“Instead of being an activator of HIV, it’s an inhibitor of HIV.”
Associate Professor Harrich runs the only research lab in Queensland working on Human Immunodeficiency Virus, and hopes to proceed to animal trials later this year.
“The reason we got so encouraged was because of just how well this protein worked in the cell culture, so we’re fairly convinced the animal model study will be successful,” he said.
With animal then human trials predicted to take five to 10 years, Associate Professor Harrich said the ultimate goal would be to develop a gene therapy treatment – similar to therapies provided to people with cancer – that would replace current regimes of antiretroviral drugs.
“With a single therapy that you would have long-lasting protection from the virus and could lead a drug-free life,” he said.
For Associate Professor Harrich, the result comes after more than 20 years of working on the virus, including in the early days of the AIDS epidemic when he was resident at the University of California, which was heavily involved in its identification and early treatment.
“So this whole project that I’m working on right now actually started in that same lab in UCLA,’’ he said.
The findings have been published in the journal Human Gene Therapy.
He said as exciting as this development was, it was no reason to ease up on public health such as practising safe sex and not sharing needles.
“Prevention is still the best cure,” he said.
“Where we come in is when it’s too late.” 
Around the world, researchers are working on several approaches to improve the treatment of HIV and a global strategy to find a cure was unveiled in Washington last year.
The Alfred hospital’s Infectious Diseases Unit director, Professor Sharon Lewin, is pioneering one approach.
Professor Lewin, who is also co-head of virology at Melbourne’s Burnet Institute, is testing the ability of an existing drug to ‘‘wake up’’ the virus in cells where it hides and lies dormant. The theory is the reawakened virus would kill the cell it inhabits, thereby self-destructing.
Another potential cure under investigation internationally involves boosting the immune system to mimic a group of HIV patients who can control the virus naturally.
This group of patients, known as ‘‘elite controllers’’, have low levels of the virus which don’t require drug treatment.
– with AAP
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Posted by Bruce Majors at 9:50 PM  

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