Chantix Risks Once Again

Since 2007 Natural Health News has been covering Chantix (Champix).  Today a new report show continuing risk with the drug.

FDA Warns of MI, PAD Risk With Chantix

By Peggy Peck, Executive Editor, MedPage Today
Published: June 16, 2011

WASHINGTON -- The FDA warned today that smokers with a history of heart attack or stroke who use the smoking cessation drug varenicline (Chantix) may increase their risk of a second heart attack or new onset peripheral vascular disease.
The agency said an additional warning will be added to the drug's label and prescribing information describing a small, but measurable increase in the risk of cardiovascular events including nonfatal myocardial infarction, angina, and need for coronary revascularization.
Additionally, the label will warn that use of varenicline may increase the risk for a "new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease" among persons with a history of cardiovascular disease.
In its announcement, the FDA noted that smoking significantly increases the risk of cardiovascular events, so it advised physicians and patients to weigh the known benefits of varenicline treatment "against its potential risks when deciding to use the drug in smokers with cardiovascular disease."
The FDA decided to add the warnings after it reviewed data from a randomized, double-blind, placebo-controlled study of 700 smokers with a history of cardiovascular disease who were treated with varenicline or placebo.
The FDA said it was "continuing to evaluate the cardiovascular safety of Chantix" and had ordered the drug's maker to conduct a meta-analysis of data from all varenicline studies as part of an ongoing review of the drug's cardiovascular safety.
Concerns about cardiovascular safety come on top of previous reports of increased risk of suicidal ideation association with varenicline, which is marketed by Pfizer.

Selections from Natural Health News

Natural Health News: CHANTIX Gets High Danger Rating

Feb 01, 2011

The latest January 2011 QuarterWatch (analyzing FDA's MedWatch adverse effect reports for Quarter 2 of 2010) found that despite prominent label warnings, the stop-smoking drug varenicline (CHANTIX) continues to pose ...

Natural Health News: Chantix Still A Danger to Health

Dec 17, 2010

A reader was looking for natural alternatives to Chantix/Champix, so I thought I'd provide some information based on methods I've suggested to people over the years that have been very helpful. I generally suggest that ...

Natural Health News: More on the dangers of Chantix

Feb 02, 2008

"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, ...

Natural Health News: The Chantix File Expands

Jun 18, 2008

Yes, Chantix is associated with a large number of suicides, but what is more devastating is the recruiting of our already abused soldiers to test the drug, and just for thirty pieces of almost worthless paper. ...

Drugs for Profit, the Same for Care

Pfizer worries about financial impact of the Aricept 10mg dose patent approval ending so it gets double dose OK from FDA.

Aricept 23 mg failed to demonstrate a clinically meaningful benefit

Public Citzen petitioned  FDA Commissioner to immediately removal from market Pfizer's Alzheimer's drug, Aricept  23 mg dose, because of serious safety hazards and failure to demonstrate efficacy. The petition also urges FDA to add a label warning on Aricept and generic donepezil (5 mg and 10 mg) stating: "Use of 20 mg per day is counter indicated."

Aricept  (donepezil) 23 mg was approved July 23, 2010 on the basis of a single clinical trial (Study 326) --despite the recommendation by both FDA medical reviewers and statistical reviewers NOT to approve the drug  because it had failed to demonstrate efficacy but significantly increased risks to patient safety.

Patients in the trial had already been taking Aricept 10 mg for three months. They were randomized to Aricept  at either 10 mg dose or 23 mg.  Complete article

Vitamins for Alzheimers

Natural Health News: The TSH Test Can't Tell You About Thyroid Health

May 04, 2011

UPDATE: 3 February 2010 In the brain of his low dose test animals, Isaacson observed a tangling of capillary blood vessels, reduced oxy... Vitamins for Alzheimer's. September 2010 Good News for B Vitamins and Your Brain Ranks now in the ...

Natural Health News: Vitamins for Alzheimer's

Dec 27, 2009

Vitamins for Alzheimer's. September 2010 Good News for B Vitamins and Your Brain Ranks now in the TOP10 out of 3.9 M Access the May 2007 issue of herbalYODA Says! that focuses on vitamin B12 with a donation to help us continue this work ...

Additional Resources: Health, Vitamins and Alzheimer's

Dec 13, 2008

REF: High-dose vitamin B12 for at-home prevention and reversal of Alzheimer's disease and other diseases. REF: Vitamin C, E, Selenium. Daniel Fabricant, Ph.D., writes about the JAMA study denouncing the benefit from Vitamins C and E. ...

For-profit hospice industry raises worries

BLOOMINGTON, Ind., May 19 (UPI) -- End-of-life hospice care is being dominated by investor-owned chains that cherry-pick patients and cut labor costs to maximize profits, U.S. researchers say.
Dr. Robert Stone, an emergency medicine physician in Bloomington, Ind., and Joshua Perry of Indiana University say end-of-life hospice care was once the province of charitable organizations, but 52 percent of hospices are now part of the for-profit sector.
For-profit hospice industry grew by 128 percent from 2001 to 2008, while the non-profit sector grew by only 1 percent. During the same period, government-sponsored hospices increased by 25 percent.
"Research shows that for-profit hospices, and especially publicly traded chain providers, generate higher revenues than their non-profit counterparts," Stone says in a statement. "They do this in part, studies show, by selectively recruiting longer-term patients, most of whom do not have cancer, thereby gaming the Medicare payment system."  Complete Article

Hospice Patients Alliance

Selections from Natural Health News

Paging Doctor Nurse

Apr 16, 2010

Dying hospice patients have been denied morphine in their final hours because a doctor couldn't be reached in the middle of the night, nurses told The Associated Press. Massachusetts, the model for the federal health care overhaul,

Ultrasound in Cancer Detection

Oct 07, 2009

Ellen Wild told The Times that her father died at a hospice in Edina, Minn., on Sept. 18. This information is provided by Creating Health Institute through our Health Matters(c) project.

Hawking Retires

Oct 24, 2008

This item is important to me in relation to a recent case of the demise of a person with ALS in N. Idaho, through the hospice system. Dr. Hawking is renown as one of the great minds of our times, and yet with ALS (Lou Gehrig's disease)

1984 is Now

Aug 15, 2008

I received this article from Hospice Patient's Alliance. If people contemplate and really see the sanctity of life, their "quality of life" arguments fall away and they will understand that we are here to care for each other, ...

An Interesting Take on How You Can Trust the FDA

Most who know me know that I have worked in mental health and psych for many years, albeit, mainly with a keen interest in natural mental health.

I believe nutrition has a very important role in health, physical and mental.  However, with the furor over S510 it does concern me that good, sound nutrition won't be part of the landscape.

And as you can see here in the following three articles, leaving it to the FDA leads us down a very slippery slope.

Looks like more and more no one in Congress or government is doing too much of a good job for the electorate these days.

And outside the issue of risky antidepressant drugs, FDA allows so many more that we have alerted our readers to their dangers for many, many years... 

The antidepressant reboxetine: A headdesk moment in science

By SciCurious Nov 30, 2010 08:44 AM 

Every so often there comes a truly "headdesk" moment in science. A moment where you sit there, stunned by a new finding, and thinking, blankly..."ok, now what?"
For psychiatry and behavioral pharmacology, one of those moments came a few weeks ago with the findings of a meta-analysis published in the British Medical Journal (Eyding et al., 2010). The meta-analysis showed that an antidepressant, reboxetine (marketed by Pfizer in Europe, but not in the US, under the names Edronax, Norebox, Prolift, Solvex, Davedax or Vestra) doesn’t work. Not only does it not work, it REALLY doesn’t work, and it turns out that Pfizer hadn’t published data on the putative antidepressant from 74% of their patients. Some people have reported that the study found that reboxetine was even "possibly harmful," but that’s not quite true. What the study DID find is that reboxetine produced more side effects (noted as "adverse events") than placebo (as might be expected), but with no positive effects at all. While many antidepressants on the market today are not great, most are effective in around 60% of patients, reboxetine turns out to be even worse than that.
SOURCE and complete article

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The next two reports come from the Alliance for Human Research Protection news feed, www.ahrp.org

A letter of complaint by the Project on Government Oversight (POGO) was sent to the director of the National Institutes of Health, documenting $66.8 million in NIH grants over the last five years awarded to a handful of psychiatrists who used ghostwriters for scientific publications. 

The instances in the letter involve ghostwriting by only one company--Scientific Therapeutics Information-- and involve only one drug--GlaxoSmithkline's antidepressant, Paxil.

Duff Wilson of The New York Times reports that previously sealed GlaxoSmithKline documents reveal that a textbook in psychiatry, whose listed authors are  Charles Nemeroff, MD and Alan Schatzberg, MD, was actually ghostwritten by Sally Laden of STI. GSK paid the ghostwriter and the "authors" who penned their names to the book.

The sheer audacity prompted former FDA commissioner, Dr. David Kessler to exclaim: "To ghostwrite an entire textbook is a new level of chutzpah. "I've never heard of that before. It takes your breath away."  Surely that is a
dubious distinction in academic medicine!

and

On November 23, 2010, Terry Vermillion, Director of FDA's Office of Criminal Investigation announced his  retirement next month amid a brewing scandal involving corrupt practices.

The announcement came after complaints by Republicans in Congress who raised concern about his misdirection of the Office's resources: instead of pursuing drug companies and researchers who commit crimes when seeking FDA approval for drugs, OCI pursued drug-abuse cases--which are the purview of the Drug Enforcement Agency.

The issue came to a head when Senator Chuck Grassley sent a complaint to the Acting Comptroller General of the General Accounting Office (GAO) about a "less than stellar" GAO investigative report which whitewashed misconduct at OCI. 

The investigation and the report were compromised by a GAO mole who tipped off someone at the Office of Criminal Investigations.
http://online.wsj.com/public/resources/documents/grassleyletter.pdf