Sick of drug ads? Try Damnitol!

By GottaLaff

Weary of all those repetitive drug ads? Take two Damnitol and call me in the morning. This blog post brought to you by....

In 1997 [...] the Food and Drug Administration -- encouraged by the Clinton administration -- relaxed its rules on this issue. The pharmaceutical industry was given a green light to bypass providers and market its wares directly to consumers.

To gauge the effect of that change, just follow the money. The year before the ruling, drug companies spent $595 million on DTC advertising, according to the Food and Drug Law Journal. Within a year of the change, their spending rose to $844 million. By 2000, it shot up to $2.24 billion. And an August 2007 New England Journal of Medicine article put the total for all drug-related marketing in 2005 at $29.9 billion, with $4.1 billion spent annually on DTC advertising. That's more than $11 million a day.

We'll be right back after this commercial break. Ask your doctor if your heart is healthy enough for Levitra. You should not take Levitra if your doctor determines that sexual activity poses a health risk for you. Men who experience an erection for more than four hours should seek immediate medical attention. Now back to our blog post.

If Congress is serious about lowering healthcare costs, including for vastly expensive (price-controlled) pharmaceuticals, it can start by reversing the 1997 FDA ruling and banning DTC advertising. That is because such costs are always passed on to providers, and then to patients, in the form of higher prices, co-pays and premiums. Even when insurance providers decline coverage for treatments such as "eyelash hypotrichosis," as mine does, they -- and eventually consumers -- end up subsidizing the treatments because the drug makers inflate prices on regimens that are covered. Above all, there are so many more urgent needs in pharmaceutical research, including dealing with the H1N1 virus and the spiraling rates of HIV infection.

We'll return to our blog post right after this: Stop taking Fosamax or Fosamax Plus D and call your doctor right away if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems, which can include irritation, inflammation, or ulceration of the esophagus. If you develop severe bone, joint, and/or muscle pain at any time, contact your doctor. Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea."

Healthcare reform involves a lot more than the bottom line. It's also an opportunity to weigh priorities, push preventive care and reestablish our fundamental needs in public health. If the pharma ads on TV are any indication of our priorities, it's time for some serious discussion.

Stay tuned for more of our blog post right after this: As with all medications, you may experience side effects when you take Wellbutrin XL. The most common side effects are weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often. Seizures may occur.

Now back to The Political Carnival. Having trouble getting through this post due to depression, high blood pressure, anger management, bipolar disorder, or Republican Syndrome? Ask your family doctor about ...

FDA to approve 'morning after' birth control pill for 17-year-olds

Oh course, that which makes the most sense will cause the most noise from the wingers.

WASHINGTON -- The Food and Drug Administration, reversing field, will allow 17-year-olds get the 'morning-after' birth control pill without a doctor's prescription, a government health official said today.

The official, who spoke on condition of anonymity, said the agency will comply with a federal judge's order overturning a Bush administration policy that restricted access. The official was not authorized to speak publicly before the FDA announcement, expected later today.

Last month, U.S. District Judge Edward Korman ruled in a New York lawsuit that Bush administration appointees let politics, not science, drive their decision to allow over-the-counter access to the pills only for women 18 and older. Korman ordered the agency to let 17-year-olds get the medication, and separately to evaluate whether all age restrictions should be lifted.

House Approves Bill To Regulate Tobacco Products

By GottaLaff

Speaking of smokers, how about legalizing marijuana:

The House has approved legislation that for the first time would give the government powers to regulate tobacco products.

The measure, passed by a 298-112 vote, was a significant victory for anti-smoking groups that have long sought to subject cigarettes to the same government scrutiny that food items on the nation's grocery shelves face.

Under the bill, the Food and Drug Administration would be able to regulate, but not ban, cigarettes and other tobacco products. The FDA could make ingredients public, ban flavoring and prohibit marketing campaigns.

The Senate is expected to pass the bill, and Prez O is expected to sign it.

H/t: BuzzFlash

Internal FDA Doc Reveals Agency Stopped Enforcing Safety Standards

By GottaLaff

Fraudulent wars in other countries aren't the only things that kill people. Under Bush, American lives were also put at risk due to irresponsible lack of oversight right here at home:

Since 2006, the Food and Drug Administration has ignored its own internal regulation and stopped requiring manufacturers of medical devices – such as pacemakers, heart valves and other life-sustaining inventions – to meet specific safety requirements before they are deemed safe enough to be implanted in humans.

As the Project on Government Oversight reveals in a special report today based on internal FDA document obtained by POGO, senior officials within the FDA made this decision without public notice. Manufacturers have been trusted to monitor themselves ever since.

The problem is particularly alarming because last year the U.S. Supreme Court ruled that patients harmed by these devices have no right to sue the manufacturers, if the device was approved by the FDA.

Talk about having our hands tied... Is there a remedy? I mean other than wishing BushCo into the corn field.

Congress could [...] boost funding for the FDA and require it to enforce those laboratory safety standards the agency effectively discarded. Second, it could pass the Medical Device Safety Act of 2008, which would nullify the Supreme Court’s decision in Riegel v. Medtronic last year and restore the rights of patients injured by medical devices to sue the companies that made them — restoring a critical incentive for manufacturers to ensure the safey of their own products.

But all of that will take time. And many, many people don't have that luxury.

VIDEO-- The ugly Bush stain: Late move on drugs by Bush FDA could be dangerous

By GottaLaff

Another deadly, typically noxious, ugly Bush stain that Bush's own Veterans Affairs Department disapproved of:

In the waning days of the Bush administration, the Food and Drug Administration finalized new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly for patients.

The move came despite criticism from Bush's own Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It also was crafted despite efforts by state and federal law-enforcement experts to clamp down on off-label drug marketing. [...]

As the Obama administration reviews all the midnight rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing.

Congressional leaders from both parties criticized the guideline when it was proposed last year. [...]

In the House of Representatives, Rep. Henry Waxman, a California Democrat, called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority.

Once again, BushCo's priority is profit, not people. "Pro-life" is a term that should never be exploited again. This bunch of thugs is anti-choice, anti-humanity, anti-American.

FDA "fundamentally broken"; scientists ask Obama for help

By GottaLaff

I'm not a big fan of defective medical devices, are you? I mean, not counting any that the Nation of Dick might sport:

A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.

The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as a place where honest employees committed to integrity can't act without fear of reprisal.

"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.

The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.

What?! BushCo politicizing? Again? Pfft. That's so Alberto Gonzales ago.

The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."[...]

The group says they have taken their concerns to the head of the FDA, Commissioner Andrew von Eschenbach, and his assistant commissioner for accountability and integrity, attorney Bill McConagha. The scientists say no one has been held accountable, and say some of the problematic managers have been promoted and rewarded.

I'm feeling a few more Medals of Freedom coming on.

The agency has been under fire from both parties in both Houses of Congress as being too close to industry. Several leading politicians, including Sen. Chuck Grassley have complained that FDA leaders often ignore or suppress their own scientists' opinions on safety issues involving drugs and devices. [...]

The group said there needs to be a complete restructuring of the evaluation and approval process, and that Mr. Obama needs to sign new legislation giving protection to government employees who speak out against corruption.

IMHO, P.E. Obama already needs another vacation.

Melamine-avegamin, now with bonus video!

By GottaLaff

Open wi-i-ide, babies! Time for your daily minimum requirement of--yummy!-- melamine:

Two months ago, federal food regulators said they were unable to set a safety threshold for the industrial chemical melamine in baby formula. Now, however, they found a way to settle on a standard that allows for higher levels than those found in U.S.-made batches of the product.

Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.

The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, were analyzed several weeks ago.

The FDA had said in early October it was unable to set a safety contamination level for melamine in infant formula.

Who's Mommy's little melaminer? Hmmm? Puts hair on your chest! Makes you grow big and strong... for as long as you survive, that is.

The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.

The problem of melamine in infant formula first surfaced in China in September.

Vitamins? Check. Minerals? Check. Melamine? Double check.

The agency still will not set a safety level for melamine if cyanuric acid is also present [...]

A scientist for a national consumer group said it was irresponsible of FDA to assure the public that infant formula is safe based on tests of only 74 samples, especially since cyanuric acid is a byproduct of melamine, making it likely that they will be found together. [...]

Earlier this week, members of Congress and the Illinois attorney general demanded a national recall, something FDA said made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found. [...]

Melamine can legally be used in some food packaging, and can rub off into food from there. It's also part of a cleaning solution used on some food processing equipment.

I want a big, heaping spoonful right now! What a taste treat! Maybe if Big Biz were forced to ingest "safe levels" of the stuff, they'd be less inclined to feed it to our newborns.

But that wacky FDA. Who's gonna stop 'em? They're always looking out for our well-being, as you can see from these excerpts from a terrific article Bucky sent my way:

Up to 90 percent of the infant formula sold in the United States may be contaminated with trace amounts of melamine, the toxic chemical linked to kidney damage, according to recent tests. The FDA’s test results, which the agency hid from the public and only released after the Associated Press filed a Freedom of Information Act request, showed that Nestle, Mead Johnson and Enfamil infant formula products were all contaminated with melamine. [...]

Prior to these test results being made public, the FDA had published a document on its website that explained there was no safe level of melamine contamination in infant formula. Specifically, the FDA stated, “FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.”

Once tests found melamine in U.S.-made formula products, however, the FDA changed its story. As of today, the FDA has now officially declared melamine to be safe in infant formula as long as the contamination level is less than one part per million (1 ppm).

Astonishingly: The FDA has no new science to justify its abrupt decision declaring melamine to be safe!

Go read the rest. Then have yourself a nice big bottle of Melamine-avegamin! It's so tasty, too! So everybody get a great big bottle of... this stuff: