WhyQuit

WhyQuit reports that in surveys and scientific studies, more people were found to have successfully quit smoking long term using the cold turkey method than nicotine replacement therapies (NRT). NRT delivers smokeless nicotine to the user through chewing gum, lozenges, patches, and nasal sprays. NRT manufacturers typically tout their products as effective ways to ease nicotine withdrawal symptoms, which, in theory at least, should help smokers to quit. However, the vast majority of NRT users either resume smoking or become as addicted to expensive nicotine gum, patches, and lozenges.

Although no studies have compared cold turkey to Chantix, researchers have studied Chantix against NRT. While one study showed that Chantix appeared to be more effective than NicoDerm CQ in the short term, after a year, the success rate was statistically the same for both Chantix and NRT users. According to WhyQuit, the study forced Pfizer researchers to report that there were “no significant differences” between Chantix and NRT, but Pfizer’s ads do not mention the statistic.

If cold turkey is more effective than Chantix, and NRT is about the same, “why assume Chantix’s long list of serious use risks in exchange for little or no benefit?” WhyQuit asks.

The organization says that without support, “Chantix is probably worthless.” While counseling and support have proven their ability to drastically boost the chances of quitting permanently, Chantix has never been tested as a stand-alone smoking cessation aid. The drug is packaged with a support plan that includes a toll-free number and a web site to which consumers may turn for extra support. Pfizer hasn’t said what percent of Chantix users take advantage of the support program, but if the support seekers were subtracted from the total number of successful Chantix quitters, then the success rate would likely plummet.

Also, if Chantix were as helpful as Pfizer claims, then smoking rate in America ought to be descending. Since Chantix first appeared on the market, however, the adult smoking rate actually increased by one percent.

A third point of contention WhyQuit makes concerns the placebo studies that researchers conducted to gauge the effectiveness of Chantix. “Use of placebo controls in drug addiction studies is license to steal,” WhyQuit says, asserting that test subjects who experience severe withdrawal symptoms certainly know that they’ve been given a placebo rather than a drug that is supposed to mitigate those symptoms. Such studies allow Pfizer to exaggerate the efficacy of Chantix.

Fourthly, WhyQuit calls Pfizer out on its ads displaying people who claim, “I honestly love smoking,” saying that the ads mess with the drug-addicted brains of smokers. Pfizer adds appeal to Chantix by telling consumers that they may continue to smoke through the first week of treatment.

“It isn’t that we loved smoking but that we didn’t like what happened when we didn’t smoke,” WhyQuit claims.

“Drug addiction is about living a lie,” WhyQuit says. A dopamine reward pathway that convinces the addict that “nicotine use defines who they are, gives them their edge, helps them cope and that life without smoked nicotine would be horrible. Pfizer knows this and is now playing upon it.”

Finally, WhyQuit asserts that “what Pfizer will never teach smokers is that cold turkey accounts for far more long-term success stories each year than all other quitting methods combined.” After 3 days of nicotine abstinence, physical withdrawal symptoms dissipate and the brain works to heal its receptors. Counseling and support help cold turkey quitters with the emotional and psychological aspects of quitting smoking.

SOURCE: Chantix Recall › Support group says Chantix ads conceal important information

Data pulled from the FDA’s Adverse Event Reporting System (AERS) between October and December of 2008 suggested that Chantix may be linked to the side effects. The FDA will continue to monitor Chantix for an unspecified length of time until it determines what, if any, regulatory action is needed.

The FDA does not fully test prescription drugs for safety before allowing them to enter into the market. Why? It’s a matter of logistics more than anything. Typically, FDA studies are designed to measure a drug’s effectiveness using thousands of patients who willingly participate in pre-market clinical trials. These patients obviously represent a very small slice of U.S. population. The FDA also relies on studies conducted by the pharmaceutical companies themselves to determine how effective test drugs are. If new drugs that have passed tests for efficacy appear to be reasonably safe, then FDA researchers give them the green light.

The FDA, incidentally, reviewed Chantix in six months rather than the regular review time of 10 months.

The millions of people in the U.S. and around the world who started taking Chantix when it debuted on the world market in May 2006 became patients in the world’s first mass clinical trial. Most people assume that the FDA seal of approval means that the drug will be perfectly safe, but the truth is that most of a drug’s risks are not known until it is prescribed to millions of consumers.

The first reports of adverse events linked to Chantix emerged just months after the drug was released to the public. On February 1, 2008, the FDA issued a statement saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”

By May 2008, Chantix was linked to more than 3,000 reports of serious side effects. By November of the same year, data from the FDA’s Adverse Event Reporting System showed that more reported serious injuries resulted from Chantix than any other prescription drug.

SOURCE: Chantix Recall › FDA monitoring Chantix for serious risks, new safety concerns

Such a finding would steer attention away from the host of negative side effects that Chantix is known to have. Moodiness, erratic or unpredictable behavior, depression, blackouts, memory loss, confusion, and suicidal thoughts and actions are some of the psychiatric side effects reported by many Chantix users. Non-psychiatric reactions such as sleeplessness and nausea are just as prevalent.

Soon after news of Chantix’s dark side emerged, the drug seemed to enter a tailspin. Pfizer yanked its commercials from the airwaves, numbers from the Institute of Safe Medicine Practices and the FDA revealed it to be one of the most dangerous drugs on the market, and sales and revenues plummeted.

Now that sales have steadied, the time is right for Pfizer to give its lackluster blockbuster a boost. According to CNN, “a study that demonstrates Chantix helps prevent heart attacks could mitigate the safety issues and revive sales, though there is the risk that a negative result would further damage sales.”

According to the CNN report, the study would examine whether Chantix reduces “the risk of subsequent heart attacks in smokers who have already had one.”

However, people who stop smoking, whether they use Chantix or some other smoking-cessation aid, will have already reduced their risk of heart attack simply by quitting smoking, so such studies would seem redundant.

But there you have it. If suicidal tendencies were considered a positive benefit of Chantix, you can bet Pfizer would be spending millions on finding more about that link.

According to the CNN report, Pfizer will decide whether to fund such a study by the end of the year.

SOURCE: Chantix Recall › Pfizer might fund study of Chantix and reduced risk of heart attack

The Journal Sentinel explains that Wisconsin physicians must complete 30 credits worth of continuing medical education (CME) courses every 2 years by law. The courses, which UW offers online, earn doctors up to 2 credits per course. Of the 9 online CME courses, the Journal Sentinel found that 4 were funded by pharmaceutical companies. Doctors may take those courses free of charge, but must pay a fee to enroll in any of the university-funded courses.

Pfizer is one of the companies funding an online course at UW that instructs doctors how to help their patients quit smoking. Pfizer gave UW $12.3 million for the course, which showcases Chantix as the latest and greatest smoking cessation method. The course materials do not mention the serious risks of taking Chantix, even though numbers pulled from the Food and Drug Administration’s Adverse Event Reporting System revealed that Chantix topped the list of the country’s most dangerous drugs.

Chantix has developed a favorable reputation among some people who have successfully quit smoking while taking the drug, but it has also been linked to a number of suicides and other episodes of abnormal and psychotic behavior.

Another CME course on premenstrual dysphoric disorder offered by UW is also funded by Pfizer. The course was designed by psychiatrists who have financial ties to the drug company. The course cites Xanax as a form of treatment for the disorder, “but fails to point out that only 37% of women who took it had significant improvement, compared with 30% who got a placebo.

The course also does not mention Xanax’s side effects, including the potential of dependency,” said the Journal Sentinel. “Several of the drugs promoted in the course are not approved by the FDA to treat the condition and have serious side effects not mentioned on the course Web site, including depression, stroke and blood clots,” the paper reported.

The Journal Sentinel points out that no written agreement between the drug companies and the university exists, but reciprocation is nevertheless expected.

“What you are seeing in Wisconsin is just another example of what is going on all over the country,” Arnold Relman, professor emeritus at Harvard Medical School and a former editor of the New England Journal of Medicine, told the Journal Sentinel.

“It’s unethical, and it is not in the public interest because it is going to bias doctors to use certain drugs,” he told the paper.

Daniel Carlat, a clinical professor of psychiatry at Tufts University Medical School, told the Journal Sentinel that “drug companies have found this to be a highly effective way to attract the attention of physicians.” To stay licensed, doctors must enroll in the classes. Therefore, companies such as Pfizer have a captive audience, he explained.

According to the Journal Sentinel, “Critics say the practice increases medical costs by encouraging doctors to write prescriptions for expensive brand-name drugs and by exaggerating the frequency and prevalence of rare conditions. It also promotes the use of drugs not approved for the ailments.”

Ten years ago, pharmaceutical companies spent $302 million on doctor education courses. In 2006, that amount had swollen to $1.2 billion.

“Drug companies have essentially hijacked the highest level of medical education we have in this country,” Carlat told the Journal Sentinel.

SOURCE: Chantix Recall › Pfizer and other drug companies fund medical courses

For many people, however, (including me), the Chantix experience isn’t one of wild extremes. It’s more like a strange trip through life with a brain that feels somehow different from the brain you had before. You feel normal and behave normally most of the time, but occasionally you find yourself saying or doing something that is not you, and the realization that accompanies this uncharacteristic behavior leaves you feeling disembodied and maybe even a little crazy.

New York magazine recently published an excellent article by a guy who recounts his own journey through a landscape made murky by Chantix. If you are one of the people who are seriously considering taking Chantix but trepidatiously wonder what it will be like for you, read Derek De Koff’s story, which echoes the experiences of so many people in blogland.

De Koff writes, “After a few weeks on Chantix, I had managed to stop smoking altogether—but it didn’t feel like a triumphant turn of events. I’d become rather reclusive, avoiding calls from friends, and basically just shuttling back and forth between my office and my apartment. I began to dread six o’clock; it meant I had to walk through the streets again. The subway was now out of the question; it made me too nervous. I stopped going to the gym, too.

“I wondered whether Chantix was zapping my brain’s pleasure-delivery system to such a degree that not only did I find no reward in cigarettes, but I also found no reward in socializing, exercising, writing, or any of my usual self-stimulating tricks. I’d pace the floor, sit on the bed, channel surf, pace some more, try to read, but the room had a stale, sinking feeling.”

So many people have such enormous expectations of Chantix, but the basic truth is that it may work for you (at least in the short term) and it may not work for you at all. If you decide to use it, monitor your behavior closely. I’m one of the people who took Chantix unsuccessfully. Ultimately it was the power to control my own thoughts that worked for me, bolstered by the fact that I had spent hundreds of dollars on a drug that did nothing but make me feel weird, half crazy, and “out of it” most of the time.

SOURCE: Chantix Recall › The Chantix experience: salvation, downfall, or just plain strange?

If Rep. Henry Waxman (D-Cal.) has his way, such ads will be a thing of the past, unless the advertised drug has proven to be safe over time. Waxman has renewed the push to give regulators the power to ban direct-to-consumer (DTC) advertising for new prescription drugs when their safety profiles aren’t fully known. The would-be legislation, which emerged in 2007 but ultimately failed to pass, is plowing ahead in the wake of some heavily promoted but beleaguered blockbuster drugs.

Chantix, along with other new “blockbuster” drugs such as Vioxx and Vytorin, were more or less indicted after tests and reports brought unknown risks to light, and all of them made billions in profit before negative news rained on their parade.

Rep. Waxman, who becomes chairman of the House of Representatives Energy and Commerce Committee when the new Congress convenes in January, has expressed his interest in revisiting the drug ad issue.

“It is these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a Prescription Project conference.

Merck’s blockbuster anti-inflammatory drug Vioxx was taken by approximately 20 million people before its risk of cardiac events became known. Likewise, millions of people took Vytorin before one test exposed it as a dud and another a possible cancer risk. And still millions more took Chantix before researchers understood the risks the drug posed for depression, suicide, and other serious side effects. Chantix now tops the list of the most dangerous drugs available in the U.S.

To help ease the dangers posed by new medicines, Congress sought last year to give the FDA the authority to ban the television advertising of new prescription drugs for as long as three years if it was deemed necessary to protect the public. The ban would not be a blanket ban on all new prescription drugs, but would be enacted on a case by case basis.

Exaggerated benefits and minimized perception of side effects are two pitfalls of DTC advertising for the general public. Excessive prescribing is another, but that seems to be the whole point, at least from the drug manufacturers’ point of view. Television ads for new prescriptions aren’t made with the public’s good in mind. They’re made to maximize profit. Advertising for profit is the American way, but when it amounts to messing with the health of millions, clearly some restraint is needed.

According to a report by Reuters, drug makers claim that their ads are informative to the general public. They say they have adopted voluntary guidelines which make them refrain from advertising for “an appropriate amount of time” so that doctors can be informed of the new drugs first.

An example of such restraint is Merck’s marketing of the diabetes drug Januvia.

According to Reuters, “the product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of [Januvia] to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”

Whatever restraint is exercised, no time is wasted in infiltrating the market.

The 2007 attempt to reign in advertising for new drugs failed after some lawmakers objected it would violate constitutionally protected free speech. Congress instead granted the FDA authority to fine drug companies for false or misleading advertising.

SOURCE: Chantix Recall › Will those long Chantix commercials disappear again?

Now the country is seeing a near-perfect reversal of the 1990s trend. The number of new cancer cases has shrunk nearly one percent on average from 1995 to 1999. The death rate among cancer victims has decreased by nearly two percent from 2002 to 2005.

Researchers attribute the decline in cancer to a parallel decline in smoking, noting that cancer mortality rates would have remained virtually unchanged if Americans hadn’t quit and refrained from starting in larger numbers as they have been doing.

The Centers for Disease Control and Prevention (CDC) released a November report showing that nearly 21 percent of adults smoked in 2004. However, in 2007, the number of adult smokers dropped to under 20 percent.

It’s true that the smoking cessation market has exploded in the last 15 years with a remarkable number of gums, patches, devices, and prescription drugs. And, although more and more people continue to quit, the drop in smoking appears to be tethered to prevention and social initiatives more than anything else.

So just what are the most effective ways to slash smoking rates? Make smoking costlier by hiking tobacco taxes and make it more inconvenient by banning it from public areas, researchers say. Educating young people and providing counseling during smoking cessation are also effective ways to keep the smoking numbers down.

A lot of people may argue that a smoker has enough willpower to smoke no matter how inconvenient and expensive it becomes. As someone who used to smoke, I agree with that argument. But I also know that the growing inconvenience was accompanied by the growing aggravation of constantly having to plot and plan ahead and work around the rules and worry, often in advance, about the next opportunity to light up. And that in turn nurtured the resentment of being enslaved by cigarettes … of being trapped and ever aware of the lingering panic. I believe these feelings impelled me to quit. I’d probably still be smoking if I were allowed to light up any time anywhere and not worry about what other people thought.

California is an example of just how effective well managed anti-tobacco programs can be. While cancer rates and deaths climbed everywhere else in the mid- and late 1990s, they declined in California. In 1990, California became the first state to implement a broad anti-smoking agenda. Consequently, cancer death rates fell nearly three percent a year from 1996 to 2005.

Is Chantix playing a role in these downward trends? It’s too early to tell. The drug has been on the market for just over 2 years, but already some studies show that the drug isn’t any more effective than the patch in helping people quit smoking for a year or longer. It will be interesting to track the success of Chantix and the impact it has, if any, on smoking and cancer rates in the years to come.

Sources: USA Today

SOURCE: Chantix Recall › the decline of smoking, cancer rates, and Chantix

Zug.com, a reader-powered comedy website, announced a contest it is holding for the most hilarious Chantix story. The person who submits the funniest account of his or her Chantix side effects will win $500.00 — enough money for another 5 months of prescriptions.

As bizarre as the contest sounds, Zug.com isn’t joking.

“We looked at all those side effects and we thought: pure comedy,” said ZUG.com editor-in-chief Sir John Hargrave in a statement. “In the bizarre dreams category alone, there’s just incredible humor potential for our site.”

A webpage for the contest, which runs through November 2008, asks, “Have you tried Chantix? Did you experience weird dreams, strange side effects, or violent mood swings? Write up your funniest description of the weird dreams or bizarre side effects of quitting smoking on Chantix, then submit them …”

It should be interesting to see how this contest is received by the public. Chantix was linked to more reports of adverse reactions and death than any other drug in the first two quarters of 2008. Controversy continues to escalate and broaden as the drug’s safety comes under close scrutiny by the Food and Drug Administration and is prohibited or banned outright by some government and professional organizations.

Irreverence is often a big part of comedy. The ability to laugh at one’s self is tantamount to (and nobler than) laughing at others. Still, though, it seems like there may be a line here that has been stepped on, if not crossed. Can Chantix reactions really provide fodder for the comedy mill? Are the side effects really a laughing matter?

SOURCE: Chantix Recall › Are Chantix reactions a laughing matter?

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.

“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.

Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.

“It appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle,” FMCSA Administrator John H. Hill said in a public statement.

Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.

Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.

SOURCE: Chantix Recall › Researchers recommend new Chantix warnings

Heralded by many doctors and other experts as the most promising smoking cessation aid yet developed, for the unique way in which it blocked nicotine from reaching key receptors in the brain, Chantix was set to take over the stop-smoking world. The prevailing attitude seemed to be “it’s high tech, therefore it’s better.”

But is Chantix better? A study comparing the effectiveness of Chantix to NicoDerm CQ reveals that in the short term, yes, Chantix is better. In the long term, however, the same study indicates there is no difference. The study randomly administered either 12 weeks of Chantix or 10 weeks of the NicoDerm patch to 746 participants and followed their progress for a year. Chantix showed a higher rate of success over NicoDerm during the last 4 weeks of treatment. After a year, however, the rates of success were statistically the same.

While browsing the web for the latest news about Chantix, I come across a lot of emails, blog posts, and reader comments written by people who are taking Chantix or are considering taking it. It occurred to me today that this blog could serve as a forum for discussing smoking cessation methods and comparing them to Chantix. As a former user of Chantix, I actually have more than the FDA-recommended 12-week experience with the drug, but that’s another story and I’ll save it for another post!

SOURCE: Chantix Recall › Is Chantix better than nicotine replacement?

“Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions,” Lisicki said. “If not, then the VA secretary must take decisive action to terminate their employment.”

Lisicki issued the off-with-their-heads statement in response to reports (link) that the VA may have acted irresponsibly in its study of Chantix using veterans with Post Traumatic Stress Disorder (PTSD).

The VA originally said that 940 veterans with PTSD were enrolled in the study, but only 143 of them were receiving Chantix. (link) However, The Washington Times revealed the number of PTSD veterans receiving Chantix was actually 68 percent higher than the VA originally acknowledged: 241, as opposed to 143.

Of the 241 test subjects, there were 114 reported adverse effects, including 22 psychiatric events.

The VA also prescribed Chantix to some 32,000 other veterans. From that group, 27 were admitted to VA hospitals for apparent psychiatric disorders. Among those, 11 had attempted suicide, 9 had suicidal thoughts, six suffered from hallucinations, and 1 attempted homicide.

Last month, ABC News and The Washington Times revealed (link) the VA’s failure to notify the study’s veterans about the potential psychiatric hazards of Chantix until three months after the FDA’s initial warnings.

Secretary of Veterans Affairs James B. Peake, M.D. insists that the VA has nothing but the veterans’ best interests in mind in determining courses of treatment. After the joint ABC News / Washington Times broke, allegations emerged implying that big pharmaceutical companies and universities may be funding and compromising VA research and care. Dr. Peake called the allegations “ridiculous.”

Still, Dr. Peake has ordered four internal investigations of the Chantix study and the VA’s general operations, ostensibly to safeguard against repeating similar blunders in the future.

To Lisicki and many veterans, the VA’s neglect in informing PTSD veterans about the dangers of Chantix, followed by the administration’s unapologetic attitude, is inexcusable.

“Professional ethics and common sense just dictate that clinicians would stop their patients from taking the drug just to err on the side of safety for the veterans and their families,” Lisicki said.

If the VA tests Chantix on veterans with PTSD, then how would it be able to determine if the emotional and behavioral problems are caused by the drug or the psychological trauma? Wouldn’t being able to differentiate between two possible causes determine the best course of treatment?

Aren’t our veterans worthy of an administration that treats them with genuine care and, perhaps above all, compassion?

SOURCE: Chantix Recall › More veterans enrolled in Chantix study than originally revealed

Chantix is known to create or worsen several neuropsychiatric conditions including suicidal thought and actions.

All of the 940 veterans in the VA study had been diagnosed with Post Traumatic Stress Disorder (PTSD). 143 of those veterans were selected to receive Chantix. Those veterans were given the drug and $30 monthly payments.

The FDA published its first Chantix warning on Nov. 20, 2007, with subsequent warnings from the FDA and the manufacturer Pfizer. Three months passed, however, before the VA notified all relevant doctors and staff involved in the study, and even then, there was no mention of suicide.

James Peake, Veterans Affairs Secretary, said that the 940 veterans in the study would receive a personal warning letter from him. Another 31,000 additional veterans would receive the same warning, he told The Washington Times.

Peake also disclosed that 26 of the study’s PTSD veterans experienced adverse events, including three reports of contemplated suicide.

The drug’s propensity to ignite suicidal thoughts and actions, especially in patients with heightened emotional and mental volatility, was the central concern of those calling for an end to the VA study.

While the VA does not intend to stop the study prematurely, it has said that it will end the study if necessary. New subjects are not being enrolled in the study.

SOURCE: Chantix Recall › VA warns veterans about the dangers of Chantix

That snowball appears to be gaining speed and momentum. At least five congressman have queried the VA over the Chantix tests, and now a number of veteran’s groups are adding their voice to the chorus of anger.

The VA study proceeded without interruption even after FDA warnings surfaced announcing a strong link between Chantix, depression and suicide, and other adverse side effects. Since the story broke, the VA has been trying to brush aside concerns, claiming that it took reasonable action and notified all the appropriate people. However, based on all reports so far, the only people who weren’t notified were the veterans participating in the study.

Paul Rieckhoff, executive director of Iraq and Afghanistan Veterans of America, told ABC News that “it is
unacceptable for even one veteran to have been misled about the possible side effects of Chantix.”

The VA had previously dismissed claims that it acted irresponsibly, saying that the actions of one soldier weren’t enough to justify discontinuing a study that had potential value for many more veterans.

That one soldier is James Elliot, a US Army sniper with PTSD. Mr. Elliot had a run in with police a couple months after he began taking Chantix.

“Are you going to shoot me? Shoot me,” Mr. Elliot told cops when they found him in the street packing a loaded gun.

After hearing that the VA neglected to warn him about the risks of Chantix, Mr. Elliot claimed that he felt like a “Lab rat, guinea pig, disposable hero.”

“Our nation’s veterans are not guinea pigs,” said Paul Rieckhoff.

Paul Sullivan, executive director of Veterans for Common Sense (VCS), expressed his disappointment in the VA. “The VA should have done a better job protecting the human rights of our veterans,” he said.

“While VCS supports research to assist veterans, VA must bear a heavy burden of responsibility with these experiments on veterans diagnosed with PTSD,” said Sullivan, who wants the study to be suspended immediately.

SOURCE: Chantix Recall › Veterans groups react to VA Chantix tests

Yesterday, Senators John Cornyn (R-TX) and Barack Obama (D-IL) rebuked the VA and demanded an investigation. Both the White House and VA officials dismissed the criticism, with White House deputy press secretary Tony Fratto calling the story an example of “irresponsible reporting.”

Today, however, more congressman are voicing their anger over the study, demanding answers, and calling for action.

Congressmen Bob Filner (D-CA), who is Chairman of the House Committee on Veteran Affairs, together with Rep. Ed Markey (D-MA), and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veteran’s Affairs. In it, they voiced their alarm over the reported allegations and demanded copies of paperwork involved in the studies.

“Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans,” said Rep. Markey today.

The Congressmen sate in their letter, “When you’re taking advantage of a very vulnerable population, people who have served the country, and the agency that’s responsible for their welfare isn’t putting their welfare first, that’s a pretty serious breach of ethics.”

SOURCE: Chantix Recall › Outcry grows over VA Chantix tests

Today ABC reports that Senators Barack Obama (D-IL) and John Cornyn (R-TX) are demanding an investigation.

In the study, the VA gave 140 US soldiers with PTSD Chantix, not revealing to them that the drug had been linked to a number of physical and psychological side effects, including anxiety, nervousness, tension, depression, suicidal thoughts, attempted suicide, and actualized suicide. The Food and Drug Administration issued Chantix warnings months before the VA was compelled to notify the participating veterans.

Senator Cornyn told the VA Secretary to start asking questions and to take whatever measures are necessary to “identify the responsible parties, provide appropriate care to any veterans who have undergone this testing, and ensure that any unethical practices are immediately brought to a halt.”

Barack Obama made a public statement on the issue, saying “It is outrageous and unacceptable that our government would irresponsibly endanger veterans who have already sacrificed so much for our country.”

Despite the outcry, the White House wasn’t compelled to take action, finding apparently no fault in enlisting veterans with PTSD in a smoking cessation study and giving them a drug known for its potential to create a range of emotional and psychological havoc.

Deputy Press Secretary Tony Fratto dismissed the story as “irresponsible reporting,” claiming that the behavior of one soldier with PTSD taking Chantix was not concern enough to halt the entire study.

Barack Obama issued a statement on the matter today on his web site.

“Our veterans – particularly those suffering from mental health injuries – should have the very best health care and support in the world, they should never be needlessly exposed to drugs without proper notification of the dangers involved or effective monitoring of the side effects. I will immediately be asking for a full and thorough investigation of how our government could yet again let down our veterans and their families who have given so much to their country, and who have paid so much for the failures of civilian leadership in Washington,” said Senator Obama.

“It is time to demand accountability and to ensure that this kind of breach of trust never takes place again,” Obama said.

SOURCE: Chantix Recall › Senators Obama and Cornyn question VA over Chantix tests

According to the news organizations, the Veterans Administration chose to administer Chantix to 140 Iraq and Afghanistan veterans who have been diagnosed with Post Traumatic Stress Disorder (PTSD), ignoring Food and Drug Administration warnings that the drug has been linked to vivid dreams, psychiatric illnesses, and suicide, to name just a handful of the drug’s potential adverse effects.

The VA waited more than three months before it began notifying the veterans of the dangers of Chantix. Even then, the attitude was rather flip. Dr. Miles McFall, one of the VA study’s administrators, told ABC news that the drug warnings “didn’t justify an emergency warning at that level.” Dr. McFall said this even after one of the study’s subjects suffered from a severe mental collapse after he began taking Chantix.

38-year-old James Elliot, a US Army sniper, snapped one night and left his house with a loaded gun. His fiancée called police, warning them that Elliot was a soldier with PTSD and had left the house in a mentally unstable condition. Police Tasered Elliot and placed him under arrest that night.

When Elliot learned that the VA had withheld the Chantix warnings from him and others in the study, he told ABC news that he felt like a “Lab rat, guinea pig, disposable hero.”

The VA notified the soldiers taking Chantix three weeks after Elliot’s incident. In its letter to the PTSD veterans, the VA stated that Chantix had been linked to adverse side effects, including “anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide.”

The Chantix study is just one in 25 studies that the VA is conducting on our veterans. It’s understandable that the side effects of new drugs do not become fully known for months or even years after their debut on the market. However, withholding known drug warnings, especially from veterans with PTSD, is unconscionable.

Arthur Caplan, director for Bioethics at the University of Pennsylvania and one of the country’s top medical ethicists, expressed his feelings about this case to ABC News. “How this study continued in the face of these difficulties is almost impossible to understand … Why take the group most a risk and keep them going? That doesn’t make any sense, once you know the risk is there,” he said.

SOURCE: Chantix Recall › VA testing Chantix on veterans with Post Traumatic Stress

Factoring into the decision was the fact that Smith did not have any prior record of criminal activity or psychiatric disorders, the AP report says.

This incident is the latest in a crop of reports that Chantix is responsible for serious psychiatric problems, including depression, suicidal thoughts, suicide, and aggressive behavior. On Feb. 1, the FDA issued a public advisory about the possibility for these adverse serious side effects.

SOURCE: Chantix Recall › Charge dropped due to Chantix use

As a result of these reports, the FDA issued a public advisory, and required new safety warnings on the label. However, the FDA said it is still not sure if the side effects are attributable to Chantix, or may stem from nicotine withdrawal itself, which may worsen underlying existing psychiatric symptoms.

The Star-Ledger report says the FDA was spurred to more closely examine Chantix after a case in Dallas, Texas, involving musician Carter Albrecht, who was fatally shot after a night of “uncharacteristically violent behavior,” which his family attributed to his Chantix use.

According to the Star-Ledger, Pfizer said there were no suicides attributed to the drug during clinical trials, and they did not note any differences in behavior in clinical test subjects. However, the company also says that no people with known existing psychiatric disorders were used in the trials.

The drug is currently undergoing further study.

SOURCE: Chantix Recall › Dark side of Chantix comes to light