The Federal Aviation Administration on Wednesday removed the smoking cessation drug Chantix from the list of medications considered safe for pilots and air-traffic controllers after a new study linked the medication to mental confusion and other problems that could put passengers at risk.
FAA spokesman Les Dorr said the agency took that step after reviewing the study, which raises concerns about Chantix use by people operating vehicles.


QUIT SMOKING: Social contacts are major motivators

The study links the drug to loss of consciousness, lapses in alertness, dizziness and muscle spasms. Dorr said the FAA has not heard of crashes linked to Chantix. The FAA will send letters about the change to the Aircraft Owners and Pilots Association, pilots' unions and people "we know are taking" the drug.

The study was posted online by the non-profit Institute for Safe Medication Practices. Co-author Curt Furberg, a Wake Forest University medical epidemiologist, said he and his coauthors felt "this was too important" to submit first to a medical journal, which could take six months or more to publish.

http://www.usatoday.com/news/health/2008-05-21-chantix-smoking_N.htm?csp=1

Strange that there is a pill for each of these side effects.

Also strange that many people smoke to alleviate these same problems in their daily lives.

Don't mess with mother nature!

champix also proposed to be banned for truckers and recommended for train drivers.

http://www.injuryboard.com/ natio...googleid=240176

Now the trucking industry wants drivers of big-rigs to stay off the drug.

The Federal Motor Carrier Safety Administration oversees the interstate trucking and bus industry. Thursday it issued a warning to medical examiners who qualify truckers for commercial driving licenses against issuing licenses to users of Chantix.

“We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury. Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices.

http://www.injuryboard.com/national-news/chantix-use-ba...aspx?googleid=240176

May I fix the link?

Big pHARMa-Part 1
Gary K.

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.


http://articles.mercola.com/sites/articles/archive/2008...n-china.aspx?source=

Dirty Drug Industry Secret: Their Pills are Made in China

Not long ago, the FDA warned Americans not to buy prescription drugs from Canada because they might be "contaminated by terrorists." What the FDA didn’t bother to mention, however, is that most pharmaceutical drugs purchased in the United States are manufactured in places like China and Puerto Rico.

Foreign drugs were dangerous, the FDA warned, because they were not subjected to rigorous quality control requirements -- the implication being, of course, that brand-name pharmaceuticals sold in the United States are not contaminated.

This has been proven to be yet another lie.

Heparin, a blood-thinning drug made by Baxter International, was recently discovered by consumers to be manufactured in China, where the quality controls were so low that this FDA approved, brand-name drug was apparently deliberately contaminated with an adulterated chemical.

It has now resulted in the death of dozens of consumers in the United States.

The very scenario dreamed up by the FDA to warn consumers away from pharmaceuticals purchased in Canada or Mexico turns out to be true -- for a brand-name drug sold at monopoly prices in the United States.

The FDA has not inspected 93 percent of the factories that manufacture pharmaceuticals outside the United States, and many of the pharmaceuticals manufactured for U.S. drug companies are contaminated with metal parts from the gears of processing machines or flecks of paint from factory walls.

Many brand-name drugs are NOT tested for contaminants before being sold to consumers in the United States, Canada and other countries, regardless of where they were manufactured.

Sources:
Organic Consumers Organization May 1, 2008

Dr. Mercola's Comments:
How many more people have to die before the U.S. Food and Drug Administration (FDA) steps up to the plate and begins protecting Americans instead of harming them?

The drug industry is clearly manipulating and controlling the FDA like a puppeteer does a marionette. They both want you to believe that prescription drugs are ONLY safe if they come from the United States -- where drug costs are at a premium and Americans spend 10 times the amount on drugs that people in, say, Canada do.

Most Drugs Sold in the United States are Imported

And this is the key that you need to remember. Your name-brand drugs were probably made in China, or another country. And they probably will not say so on the label.

Disconcerting? Yes. But that’s not even the tip of the iceberg. As this article so rightly pointed out:

Many U.S. drugs are made in China -- a country with some of the lowest quality control standards in the world.

The drugs are often NOT tested for contaminants before they’re sold in the United States.

93 percent of the foreign factories that make drugs for the United States have never been inspected by the FDA.

So as much as the FDA and the drug industry like to go on about the rigorous quality control measures in place in the United States, the bottom line is that there’s no guarantee that the pills you take are contaminant-free.

Federal law does not require inspections of foreign drug makers, and even if one does occur, it does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.

Meanwhile, the reason why contaminated heparin (the blood-thinning drug that recently caused hundreds of adverse reactions and deaths) made its way easily into the hands of Americans is that the FDA inspected and approved the wrong drug plant!

Are you feeling as safe and secure as I am?

You would think that in a country as “advanced” as the United States, contaminated prescription drugs would be a moot point. Yet, they are constantly surfacing, killing and injuring innocent people who believe they are doing right by their health.

But the sad reality is that even under the best circumstances -- when they’re not contaminated -- prescription drugs kill.

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.

So please, let’s all take a giant step back and get away from the flawed notion that drugs are going to make you healthy.

The FDA can't even monitor the manufacturing of prescription drugs, how do people expect this agency of to be able to monitor the level of nicotine in cigarettes?

Big pHARMa-Part 2

Health authorities(as their drug company masters tell them to) state that smoking is BAD and drugs are GOOD.
Gary K.

Dirty Drug Industry Secret: Their Pills may be contaminated.

Foreign drugs were dangerous, the FDA warned, because they were not subjected to rigorous quality control requirements -- the implication being, of course, that brand-name pharmaceuticals sold in the United States are not contaminated.

This has been proven to be yet another lie.
http://www.abcnews.go.com/WN/story?id=4320554&page=1

How the FDA Checks Foreign-Made Drugs Sold in the U.S.
By LISA STARK and DANA WACHTER
Feb. 21, 2008

"Roughly 80 percent of active pharmaceutical ingredients are made outside our country," former FDA official Peter Barton Hutt said.

The nations that make the most drugs for the U.S. market are China, with 714 plants registered to make pharmaceuticals for the United States, and India, with 410. But the FDA says many of those facilities don't currently ship drugs to the U.S.

The agency is required to inspect U.S. plants every two years, but that isn't the case with foreign plants. Those facilities are put on priority lists based on the last time they have been inspected, or if they have new drugs being put on the market, versus drugs that are currently being manufactured.

There are two kinds of inspections - one is done when a plant first begins manufacturing a drug for the U.S. - the other are ongoing inspections. The FDA insists it certifies the good manufacturing process of all plants - foreign and domestic - when they begin manufacturing a drug. It was only because the agency confused the Chinese Heparin plant with another facility, that this was not done in this case, the FDA says.

It's also a staffing issue, the actual staff inspecting the plants overseas are mostly volunteers, and have certain schedules to follow when traveling and inspecting. It is estimated that the FDA inspects just 7 percent of foreign plants a year, and at that rate, it could take 13 years to check each plant.

Last year, for example, the FDA inspected only 14 plants in China, and 65 in India.

Another problem: The FDA doesn't even know exactly how many plants there are making drugs that wind up being prescribed for patients in the United States.

According to two different research databases, there are two very different numbers for overseas plants. One lists about 3,000 plants that are recorded to be inspected, and the other indicates there are about 6,800. The FDA has concluded there are about 3,249, but it still isn't sure.

http://www.peoplespharmacy.com/archives/editorial/quest...oreignmade_drugs.php

The People's Pharmacy® with Joe and Terry Graedon

www.PeoplesPharmacy.com

Questions About Quality Of Foreign-Made Drugs

Newspaper Columns, Editorial March 10, 2008

There was a time when most of the medicines we purchased in our neighborhood drug stores were made in America. These days, though, medicines come from all over the globe.

The current scandal surrounding heparin, an injectable blood thinner used during surgery and dialysis, revealed weaknesses in the regulatory process.

Investigations reveal that some plants processing heparin do so as a sideline to their sausage-casing business. As a result, these firms are not registered as pharmaceutical companies and are exempt from regulation by the Chinese equivalent of the FDA.

Pig intestines are purchased from slaughterhouses, often with no paperwork to enable anyone to track the source. If the animals were sick, there is no way to detect the disease.

Some factories are literally cottage industries with low standards of sanitation and quality control. Raw heparin may be spread out on a table in a courtyard to dry. This crude ingredient is sold to middlemen who then sell it to manufacturers around the world. Their records may also be deficient.

The problems with heparin may be especially dramatic but could represent the tip of the iceberg.

Many firms in China making drug ingredients are registered as chemical companies rather than pharmaceutical manufacturers. As a result, they may escape scrutiny by the Chinese drug regulatory authorities and the U.S. FDA.

Raw ingredients for many medicines are traded around the globe and the original source may be obscured in the process.

http://www.naturalnews.com/023149.html

Heparin Contamination Fiasco Reveals Dirty Secret of Drug Industry: Their Pills are Made in China!
by Mike Adams

Three astonishing facts about brand-name pharmaceuticals
So far, then, there are three astonishing facts that have come out of the recent news about Heparin:

Fact #1: Most U.S. prescription drugs aren't even made in the U.S.

Fact #2: Many U.S. prescription drugs are made in China, a country widely known to have the lowest quality control standards in the world.

Fact #3: U.S. drug companies don't even run quality control checks on the drugs they import from China!

That third fact should send a chill up your spine. What it means is that U.S. drug companies contract with cheap, low-end Chinese chemical factories to manufacture their drugs at something like two cents a pill (which they can mark up to $20 a pill or more...), and then they import these Chinese-made pills and don't even test them before selling them to U.S. consumers!

Big Pharma, it seems, just skips that step. Whatever the Chinese throw into their pill bottles, U.S. drug companies just buy it and pass it on to patients and consumers without bothering to test the pills before selling them. Wow. Talk about trading safety for profits...

So much for the "safety" of Big Pharma's drugs sold in the United States, huh? This isn't something you hear in Big Pharma's TV ads, is it? "Buy Vytorex. Made in China! Never tested for contaminants! Take at your own risk!"

The top ten disturbing facts about the pharmaceutical industry's quality control problem
In summary, be sure to remember these ten facts about the pharmaceutical industry and its quality control failures:

Fact #1: Most pharmaceuticals sold in America are NOT made in America. Drug companies routinely try to hide this fact.

Fact #2: Many brand-name pharmaceuticals are contaminated with adulterated chemicals, metal shavings from factory machine parts, or other undesirables.

Fact #3: Many brand-name drugs are NOT tested for contaminants before being sold to consumers in the U.S., Canada and other countries.

Fact #4: The FDA does not inspect most factories that make drugs outside the U.S. (93% are never inspected)

Fact #5: There is no law requiring drug companies to state their drugs are "Made in China."

Fact #6: Even when pharmaceuticals are not contaminated with deadly chemicals, they're still often made with other deadly chemicals that are intentionally part of the recipe!

Fact #7: The FDA's response to the Heparin contamination discovery reveals the agency to be a pack of bumbling idiots who have no grasp whatsoever on quality control. They only discovered the drug contamination AFTER people started dropping dead.

Fact #8: If you take pharmaceuticals, you are playing a form of Big Pharma's Russian Roulette with your life. There is no guarantee that any pill you take is safe or that it has ever been tested for contamination.

Fact #9: The pharmaceutical industry has deceived consumers by implying that drugs bought in the U.S. are somehow safer than drugs purchased in Canada, Mexico or elsewhere.

Fact #10: There are fewer inspections required for imported pharmaceuticals than there are for imported orchids!

And finally, consider this: Big Pharma is now pushing the Supreme Court to grant the industry blanket immunity for all pharmaceuticals, a move that would immediately lift any and all testing requirements and quality control measures since the drug companies would no longer be liable for what's in their pills! See this story for more details: http://www.naturalnews.com/023042.html

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.

It is no wonder that the drug companies and their health care puppets are so anxious to keep people blindly focused on cigarettes and smoking.
Gary K.

Big pHARMa-Part 3

An article in the Journal of the American Medical Association reported that an estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and properly administered.

More than 2 million more suffer serious side effects.

Please note that there are three(3) times as many nursing homes as hospitals, then there are the mental facilities and prison facilities.

There are the people that get their medicines at a pharmacy and die without ever going into a hospital.

Nursing homes alone might add another 318,000 deaths and 6 million serious side effects!!!

Drug company drugs may be causing well over 424,000 deaths and well over 8 million cases of serious side effects each and every year.

In watching the hearings on C-Span that drugs manufactured in China that are not intended to be distributed to citizens of China are not checked by the Chinese authorities, ever.

This plant produced this drug exclusively for export, neither Chinese or American government officials ever checked this product.

The plant is state of the art, but the raw materials have become scarce in China, pig production is way down.

It is like they put dirt in one end of the production line and shipped a labeled product from the other.

It is no wonder that the drug companies and their health care puppets are so anxious to keep people blindly focused on cigarettes and smoking.
Gary K.

Big pHARMa-Part 4

Lipitor is a multi-billion dollar seller!

What this means is that for every 100 people who took the drug over 3.3 years, three people on placebos, and two people on Lipitor, had heart attacks.

That means that taking Lipitor resulted in just one fewer heart attack per 100 people.
The NNT, in this case, is 100. 100 people have to take Lipitor for more than three years to prevent one heart attack. And the other 99 people, well, they’ve just dished out hundreds of dollars and increased their risk of a laundry list of side effects for nothing.

A gambler would say that the odds against Lipator being effective are 99-1.

Casinoes give much better odds than that at crap tables and roulette wheels and still make a ton of money and gamblers manage to lose a ton of money.

Drug companies make a ton of money and those other 99 people, well, they’ve just dished out hundreds of dollars and increased their risk of a laundry list of side effects for nothing.

http://articles.mercola.com/sites/articles/archive/2008...ecret.aspx?source=nl

Number Needed to Treat(NNT)

When the NNT statistic was first developed in 1988, it was intended to help you make a decision about whether or not to take a drug.

After all, having it put in simple terms such as “Out of every 50 people who take this drug, perhaps one heart attack will be prevented, and the other 49 people will receive no benefit,” puts things into perspective … a perspective that the drug companies do not want you to see.

One of the most blatant examples of how drug companies have hidden NNT for their own self-serving purposes lies with cholesterol drugs.

These drugs, which can cause side effects like liver damage, muscle weakness, cognitive impairment and many, many others, are touted as miracle pills that can slash your risk of a heart attack by more than one-third.

Well, BusinessWeek actually did a story on this very topic earlier this year, and they found the REAL numbers right on Pfizer’s own newspaper ad for the cholesterol-lowering drug Lipitor.
http://www.businessweek.com/print/magazine/content/08_04/b4068052092994.htm

Upon first glance, the ad boasts that Lipitor reduces heart attacks by 36 percent. But there is an asterisk. And when you follow the asterisk, you find the following in much smaller type:

"That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor."


What this means is that for every 100 people who took the drug over 3.3 years, three people on placebos, and two people on Lipitor, had heart attacks. That means that taking Lipitor resulted in just one fewer heart attack per 100 people.

The NNT, in this case, is 100. 100 people have to take Lipitor for more than three years to prevent one heart attack. And the other 99 people, well, they’ve just dished out hundreds of dollars and increased their risk of a laundry list of side effects for nothing.

Not to mention that this study was funded by the industry, which means their results may already be skewed, and the actual benefit may be even LESS than what they found.

Many Drugs are “Worse Than a Lottery Ticket”

According to Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill, in Business Week:

"Anything over an NNT of 50 is worse than a lottery ticket; there may be no winners."

Well, the NNT for some cholesterol-lowering drugs has been figured at 250 and up, even after taking them for five years!

"What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? How many would take that?" Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles, asked Business Week.

The answer, of course, is few to none. And that is exactly why you have probably never heard of NNT before.

The Moral of the Story: Don’t Trust the Drug Companies

They have many tricks up their sleeves other than NNT, and they are masters at twisting the results of their studies to appear in a positive light.

So anytime you hear about how great a drug is, be very suspicious. You wouldn’t simply buy a car without finding out the real bottom line, right? So don’t blindly accept the numbers that the drug companies peddle either.

One thing you can do is ask your doctor or pharmacist to tell you the NNT for any prescription you’re considering. Even better is to assume that most drugs offer little benefit, and only take them as an absolute last option.

http://prescriptionaccess.org/blog/?p=262

GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors

GlaxoSmithKline (NYSE:GSK) sells a popular brand-name prescription drug for migraines, Imitrex. 2007 U.S. sales of Imitrex were $1.12 billion, making it a “blockbuster” in drug industry parlance. A single pill of Imitrex costs about $25.

Glaxo has certainly done its part over the years to preserve its market share on drugs with expiring patents and to prevent consumers from having access to more affordable generic versions, as alleged in several lawsuits that we here at PAL have been involved in (see Relafen and Augmentin, for example).

Well, $1.12 billion in annual sales is too good to just give up, right? Even if Imitrex’s patent is expiring next February? Not surprisingly, then, Glaxo has done a number of things to keep a generic version of Imitrex (sumatriptan) off the pharmacy shelves:

Later this year, Glaxo will begin selling an “authorized generic” version of Imitrex.

Authorized generics really should be called “fake” generics, because they’re most often not generics at all, but the company’s own pill technically sold by a different company, under a license.

In this case, the shill licensee is Dr. Reddy’s, a generic drug company that originally challenged Glaxo’s Imitrex patent and then settled when Glaxo sued them for patent infringement.

Also later this year (December 2008), Ranbaxy, another generic drug maker, will also begin selling a generic version of Imitrex. Again, this stems from a settlement between Glaxo and the generic maker.

Great, right? Two generic versions of Imitrex will be available by the end of the year! Huzzah! A victory for patients, right?

Not so fast! You don’t think Glaxo is going to let its billion dollar baby leave home so easily, do you?

Introducing GSK’s Treximet! Treximet was just approved by the FDA for acute treatment of migraines in adults.

Is Treximet a fabulous new breakthrough treatment for migraines?

Umm… No.

It is a combination of Imitrex (soon to be available as a generic) and naproxen sodium (commonly known as Aleve, available Over the Counter).

So Treximet is a combination of (a) a soon to be generic drug and (b) an Over the Counter drug. Yet you can be sure that Treximet’s price will be similar to what Imitrex costs right now ($25 a pill) and there’s a good chance it will be more expensive, as new drugs typically are ($30 a pill? More? Who knows?).

How much would it cost a patient to take these 2 drugs separately?

Naproxen sodium can be had for about 8 cents a pill. A single Aleve pill has 220 mg of naproxen sodium. There’s 500 mg of naproxen sodium in Treximet, so a patient would have to take about 2 1/4 Aleve pills to get to 500 mg. Since you can’t really take 1/4 of a pill, let’s assume most patients would take 2. 2 pills would give you 440 mg, so that’s pretty close to the 500 mg. Cost: 16 cents.
We don’t yet know how much generic Imitrex will cost. But the price of a generic typically drops to about 30% of the brand-name’s price within 6 months of the drug’s patent expiring and more generic companies introducing their own versions.

So it’s safe to assume that generix Imitrex will cost about $7.50 by middle of 2009. (Even before then, the price of generic Imitrex will begin dropping from the current price of $25 a pill.) Cost: $7.50

So, by spending $7.50 on generic Imitrex and 16 cents on over-the-counter Aleve, you can get the same thing you’d get in a Treximet — which is very likely to cost $25 or more.

Why would you bother with the Treximet? I guess it’s fewer pills to take, but is that worth at least $18 in additional cost?

Interesting, Glaxo apparent didn’t even try to compare Treximet to a standalone-combination of Imitrex and naproxen sodium. Their press release on the FDA approval says:

“Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone.”

In other words, Treximet worked better than just Imitrex, or just naproxen sodium, or nothing at all.

This is kind of like saying that a chocolate cake tastes better than eating the ingredients separately (a bowl of flour, a few eggs, some chocolate) or eating nothing at all.

Here’s some other things I think you can safely gaze into the crystal ball to see:

Glaxo’s pharmaceutical salespeople will descend on doctors’ offices like ants at a picnic and aggressively pitch Treximet to doctors of all kinds (neurologists, headache specialists, internists and family physicians).

TV ads will appear in prime time singing the praises of this “new” treatment for migraines. People frolicking through fields of flowers may or may not appear.

Is this the kind of “breakthrough treatment” that PhRMA is always arguing justifies the high cost of prescription drugs?

This type of putting “old wine in new flasks” is straight from Big Pharma’s tired playbook. Instead of engaging in the harder, more long-term process of discovering genuinely new medications, drug companies instead “tweak” existing blockbuster drugs in the most minor of ways, including:

Combining two existing drugs, such as was done with Vytorin (made up of Zocor, which had gone generic, and Zetia)
Making a “extended release” version (once a day, once a month, etc)
Making a “new” version that’s just a chemical tweak of the original but not any better (as Nexium is of the now-generic and over-the-counter Prilosec)

Conclusion: Migraine sufferers, don’t be suckered by Glaxo’s poorly-concealed bait and switch.

The FDA has received more than 3,000 reports of serious problems involving Chantix, but Pfizer said that had to be put into context, since more than 5 million people in the U.S. had taken the medication.

The company said that no direct cause and effect had been proved between the drug and the problems.

The FDA is most concerned about reports of mental health problems,including more than 400 cases involving Chantix users who reported
suicidal thoughts and more than 30 who killed themselves.

------------------------------------------------
Let's put that into context with smoking.

There has been: "No direct cause and effect had been proved between the drug and the problems."

If all 50 million smokers were on Chantix, there would be 4,000 users who reported suicidal thoughts and more than 300 who killed themselves.

Smoking does not cause suicidal thoughts and smoking would be a damned slow way to commit suicide!!!

Damn drug companies!

Gary K.

That would leave 3,700 mental health patients taking drugs to treat their problems.

A win win situation for the drug companies.

How is this different from their claims against tobacco companies? If you use a tobacco product as intended, it will kill you.

If you take our products, they will generate income for the entire medical profession.