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?

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