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