The FDA

[jinx]

Congress moves to ban BPA in all food containers

Represenatives and senators in Congress yesterday introduced legislation to establish a federal ban on bisphenol A in all food and beverage containers. The bills, introduced by Rep. Edward Markey, D-Mass., and Sens. Dianne Feinstein, D-Calif., and Chuck Schumer, D-N.Y., greatly expand earlier efforts to limit the chemical from products used only by babies and children.
The move comes a day after Sunoco, the gas and chemical company, sent word to investors that it was now refusing to sell bisphenol A, commonly known as BPA, to companies for use in food and water containers for children younger than 3. Sunoco told investors that it could not be certain of the compound's safety. Last week, six baby bottle manufacturers, including Playtex and Gerber, announced that they would stop using BPA to make baby bottles.

So Sunoco, and some member of congress have reason to believe that BPA isn't safe, especially for children. There is quite a bit of evidence suggesting they are correct.

Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults.

Perinatal exposure to bisphenol-A alters peripubertal mammary gland development in mice.

But the FDA ignored that and other evidence when they declared BPA to be safe.

The excluded studies suggest bisphenol A, or BPA, could pose harm to children at levels at least 10 times lower than the amount the agency says is safe, according to the report written by outside scientists asked to review the agency's handling of the controversial substance.

The scientists took the FDA to task for basing its safety decision in August on three industry-funded studies. Another government agency, the National Toxicology Program, decided many other independent studies deserved consideration. The toxicology program concluded last month there is "some concern" that BPA alters development of the brain, prostate and behavior in children and fetuses.
The expert panel also found the FDA underestimated how much BPA babies ingest on several counts. For one, the agency failed to consider the cumulative effect of being exposed to BPA from dozens of products, a fundamental error that "severely limits the usefulness" of the FDA's safety estimate.

link

Instead, they relied only on the outcomes of 3 industry-funded studies. Are they idiots? Or...

The FDA subcommittee is chaired by Martin Philbert. He is the acting director of the University of Michigan's Risk Science Center, which received a $5 million donation in July from Charles Gelman, the retired head of a medical device manufacturing company and an ardent defender of BPA. Mr. Gelman told the Milwaukee Journal Sentinel, which reported the story, that he discussed his views with Dr. Philbert. Dr. Philbert told us that he put the kibosh on any discussion of BPA with Mr. Gelman once the context of his interest became clear.

link

But yeah, he took the money. And didn't disclose it.

Dr. Philbert did not disclose to the FDA Mr. Gelman's gift to the Risk Science Center. Dr. Philbert told us that the FDA form asked for disclosure of gifts from which the recipient personally stands to gain. The donation was made to the university with a stipulation to endow professorships and student scholarships at the center. The money won't start flowing until next year, when a permanent director is expected to be in place. Dr. Philbert is not under consideration for the post.

link

[Flint]

The FDA is the biggest bullshit scam, ever.

[Clodfobble]

Oh, but they're working extremely hard to make sure Cheerios doesn't hoodwink us ignorant fools with its claims that healthy food is good for you!

[Flint]

How awesome that our tax dollars go towards this very awesome service of totally ƒucking us over.

Want to cut the budget? Just eliminate the FDA. Since we already have to do our own research, anyway.

[xoxoxoBruce]

He is the acting director of the University of Michigan's Risk Science Center, which received a $5 million donation in July from Charles Gelman, the retired head of a medical device manufacturing company and an ardent defender of BPA.

Science is broken.

[jinx]

Originally Posted by Clodfobble

Oh, but they're working extremely hard to make sure Cheerios doesn't hoodwink us ignorant fools with its claims that healthy food is good for you!

Because they haven't yet paid off anyone who sits on an advisory committee. Fucked up enough, but no one will truly suffer if Cheerios has to change their advertising - not so with bioidentical thyroid meds.

We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

[Flint]

We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

Awesome! Good job, system. I love how the government institutions which presumably regulate an industry are actually agents of that industry.

Now, is this one of those situations where we just sit back and let the system do its job and everything will just sort of work itself out somehow?

[jinx]

You just don't get it flint. Everything bad is the other teams fault. If we just keep on voting for and defending the good team, and vilifying the other team and it's retarded supporters, everything will improve. The whole problem is that the other team exists at all, other than than that the system is perfect.

[classicman]

OMG Jinx -

[jinx]

FDA sells out to NJ Congressmen who got paid by ReGen

The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

[classicman]

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving
significant campaign contributions from ReGen, which is based in New Jersey,
but all said they ~snip~were not influenced by the money.

Yeh right

[jinx]

Freeze? What freeze? FDA in line for another budget boost

The Food and Drug Administration is a screaming exception to the Obama administration’s freeze on discretionary spending in the 2011 budget.

Overall, the FDA budget could grow by as much as 23% to just over $4 billion from the current $3.3 billion. But getting all of what the agency wants will require Congress to authorize more than a quarter-billion dollars of new fees on food facilities and generic drug makers.

[xoxoxoBruce]

That's because they've been given tobacco now.

[Happy Monkey]

That's good news. Especially as this:

A key industry lobbyist, Scott Faber of the Grocery Manufacturers Assn., said that his organization wasn’t necessarily opposed to fees but wanted the money spent on improving food safety science as opposed to facility inspections.

implies that it currently is expected to increase inspections. I hope Mr. Faber doesn't get his way.

[katfiche]

An FDA internal report found serious deficiencies within the organization in dealing with the rapid advancement in scientific discoveries.

http://www.fda.gov/ohrms/dockets/ac/...Technology.pdf

Combining this with budget cuts and outside pressures, one can only conclude that the FDA is broken.

I follow alternative treatments for cancers. I've always been fascinated by the photographic evidence available on the internet for utilizing bloodroot in the treatment of skin, and other cancers. Recently, I discovered a friend of mine had previously treated a skin cancer on his leg using his own concoction of ingredients, the primary effectual ingredient was bloodroot. I found out because he was again treating another cancer on his forearm. I watched the progress as it attacked the cancer, but spared the normal cells. What resulted was him eventually removing an octopus like growth from his arm.

To any naysayers, he had a biopsy done and the cancer was confirmed prior to the treatment. His doctor has asked for a sample of the paste he made. In viewing the cancerous tissue, I can say for certain that if surgery had removed the growth entirely, the scar would have been horrendous, compared to the small round scar it is now settling down as. There is/used to be a site which documented several cases of breast cancer being treated by this method.

Justification for abortion is made by proclaiming that women have a right over their own body, so why isn't similar reasoning used to allow us to decide our own medical treatment in other areas?

Incidentally, Curaderm BEC5 was also found to be highly effective in treating skin cancer in a UK study. It is sold within the US, but only with the claims for removing age spots.

There are many products out there which are safer, and more effective at treating illnesses than their pharmaceutical counterparts. But, a lack of funding for research, along with outright quashing by pharmaceutical companies prevents them from being marketed as such.

Not to totally bash the pharmaceutical companies, some products they offer are superior because of standardization. Unfortunately, some aren't because of a lack of recognition of complementary compounds.