The six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal.

“The scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the letter states. Because of the corrupt conditions, the scientists say that the agency is “fundamentally broken” and as such is “failing to fulfill its mission.”

The scientists who penned the letter all work in the Center for Devices and Radiological Health,” a division of the FDA that “regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines,” according to a report by CNN.

“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” according to the letter, which was addressed to President-elect Obama’s transition team leader, John Podesta.

The complaints of the scientists in the Devices and Radiological division iterate many of the same grievances raised by scientists from the FDA’s drug review division when Merck’s painkiller Vioxx came under fire in 2004.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the letter states. “Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal.”

Occasionally, scientists and doctors examining medical devices and equipment have been told during the approval process to ignore FDA regulations. The letter also charges that managers lacking the right level of knowledge and experience are authorized to push products through the approval process while ignoring concerns about safety and efficacy.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

The letter also charges that devices entering the market have been improperly labeled, and that manufacturers have been allowed to market their products without the FDA’s approval.

Internal investigations of these charges has amounted to “absolutely nothing,” according to the scientists. “No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted.”

In response to the accusations, FDA spokeswoman Judy Leon said “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

SOURCE: Chantix Recall › FDA scientists say their agency is corrupt and broken

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?