Washingtonians Come Together! Washington Peeps

[Greg Richardson]

Quote:


Mikey. You are correct. I have had a Doctor who I got to know well enough to tell me the whole sick story.

CYA he says costs him so much money because there is no tort reform which in turn costs everyone else time, money, and WORRY over tests that aren't necessary.

People, politicians, talk about health care changes but they never get to the bottom line of why it costs so much besides the legal drug cartels called pharmacies and all the other product and service kickbacks .

I was in the hospital less then 16 hours two years ago.
8K for that time and I'm still paying on it.
I asked for an itemized bill.
What an education that was.

Because of my condition at time of admittance my head wasn't thinking clearly because if it was my bill be 1/3 of that.
Yes Mikey...................... YOU are in CHARGE!

That will shock many Doctors but so be it.

Reform of any kind without tort reform is nothing but a band-aid on an a gushing wound 100 times bigger than the band-aid.

Our government wants you and I to pay tax after tax but when it's time to enforce anything related to the legal drug cartels the back pockets are filled the politcal favors are done and once again we the people of to many became sheep in this country suffer once again.

My next post will show a perfect example of what I'm talking about.
Our country has turned into one big joke at our expense that countries like Japan and China have a great laugh selling us CRAP that we pay huge $$$ for.
Money has become many people's God and people suffe rand die because of it.

 

[Greg Richardson]

Trade group told compounding pharmacies how to skirt the FDA
The trade group representing compounding pharmacists, like the one that made a drug linked to the recent outbreak of meningitis, tutored pharmacists on how to sidestep requests by the Food and Drug Administration worried that compounders across the country might be selling a substandard drug, possibly made with Chinese ingredients.
By WALT BOGDANICH and SABRINA TAVERNISE
The New York Times
Originally published October 22, 2012 at 9:44 PM | Page modified October 23, 2012 at 11:26 AM





A year before people began dying of meningitis caused by a tainted drug from a compounding pharmacy in Massachusetts, the Food and Drug Administration worried that compounders across the country might be selling another substandard drug, this one possibly made with Chinese ingredients.

But when the FDA began seeking samples to test, the trade group representing compounding pharmacists went on the offensive. Instead of encouraging members to help the agency determine if the injectable drug, used to reduce the risk of premature birth, was substandard, the group tutored pharmacists on how to sidestep requests.

In an email to members, the International Academy of Compounding Pharmacists suggested they respond to any request for samples by saying: "We do not compound or distribute 'samples' of any of our prescription medications to anyone." And if a compounded drug were on the premises, the trade group added, a pharmacist should say it was awaiting pickup by a patient.

A spokesman for the trade group said the instructions were intended to guard against unauthorized release of samples to corporate competitors and not to hinder the FDA investigation. But the memo is emblematic of the industry's frequent and often successful attempts to fend off regulators at a time when concerns are growing about the quality of compounded drugs and the uncertain provenance of their ingredients, some of which originate in China and flow through various repackagers and middlemen with little extra scrutiny, according to interviews with health experts and government records.

Drugs made by compounders — who mix or alter ingredients to create customized medicine for a specific patient — are rarely tested, unless someone is harmed or a complaint is filed. In Texas, a hub of compounding pharmacies and one of only two states that randomly test compounded drugs, random tests by the state's pharmacy board over the last several years found that as many as one in four compounded drugs was either too weak or too strong. The testing results are just slightly better in Missouri, the other state that randomly tests. Potency varied by as much as 300 percent in the Missouri tests.

And records of FDA drug seizures at U.S. borders, as well as several criminal cases, point to a link between drug compounders and Chinese manufacturers, some not registered with the FDA. Records analyzed by The New York Times show that in 62 cases over the last decade, the FDA blocked the importation of drugs for use in compounding; nearly half were from China, one of the largest producers of raw pharmaceutical ingredients, where many manufacturers operate outside the regulatory net.

The FDA said Friday that investigators did not believe the original ingredients used by the Massachusetts pharmacy, the New England Compounding Center in Framingham, were the source of the crisis unfolding in 16 states, where at least 297 people have contracted meningitis and 23 have died. (Authorities have yet to disclose the name or location of the compounder's supplier or suppliers.) Those affected had been treated for back and neck pain with contaminated steroid injections produced at the compounding center.

Modern supply chains are a maze of importers, repackagers and dealers. But while large drug companies, bound by FDA rules, must keep meticulous track of who has handled their raw materials, compounding pharmacies are not bound by those guidelines, even though some have grown so large that they resemble commercial manufacturers.

Michael Chappell, a former high-ranking FDA official who helped to oversee the agency's regulatory policies, said federal officials have had difficulty at times getting answers to questions about where compounders bought their ingredients.

"Is it being repackaged in the back of a '57 Buick in a parking lot somewhere?" Chappell asked. "The answer was always, 'We get them from our suppliers.' But what do you know about that supplier? Who makes the original chemical?"

Some compounding pharmacies have taken advantage of the legal no man's land in regulation. The FDA can inspect them and issue warnings, but the agency says states have ultimate jurisdiction.

The FDA has authority if it decides a compounding pharmacy is manufacturing, and not simply mixing drugs for individual patients. But to make that determination, the agency has to look at a pharmacy's records to see its volume, and pharmacies argue the law does not require them to produce those records.

Some consumer advocates say the FDA has the authority to investigate compounding pharmacies but often chooses not to.

Unlike commercial drug manufacturers, compounding pharmacies are not bound by the agency's so-called good-manufacturing practices, which require companies to report incidents when their medicine might have harmed patients. Usually the FDA learns about such cases only through the media or voluntary reporting.

In 2001, the agency looked at samples of compounded products from 12 different pharmacies, including antibiotics, steroids, and drugs to treat glaucoma and asthma, and found a third of the products failed one or more standard quality tests, mostly having to do with potency. A similar FDA survey in 2006 found the failure rate about the same.

KV Pharmaceuticals, a large drug company in St. Louis, did not rely on the government to assess the quality of compounded drugs that competed with its FDA-approved product, Makena, used to reduce the risk of premature birth. KV hired a corporate intelligence firm to obtain and test samples of the compounded version, 17P, for potency and purity.

In January, the company's researchers published their findings, alleging that 80 percent of the drug did not meet purity specifications. Michael J. Jozwiakowski, a co-author of the study, said the only companies they could find that manufactured the active pharmaceutical ingredient, available to compounders, were Chinese companies not registered with the FDA. One sample contained nothing but glucose.

When the FDA was given the data last fall, the agency decided to take its own samples of the compounded version, prompting the International Academy of Compounding Pharmacists, the trade organization, to offer its members advice on how to respond to FDA requests, in an emailed member alert titled, "F.D.A. Calling Compounders about 17-P."

The trade-group spokesman, David Miller, said the alert, despite its title, was intended to defend against data collectors from KV Pharmaceuticals, which member pharmacies said had been calling asking for samples.

"There was no evidence that any of the calls pharmacies received were coming from a genuine governmental official," Miller said. "Regulators do not 'call around' asking for information. They come to a pharmacy with an official inspection form."

He denied that the alert contained language instructing members not to cooperate with federal regulators.

"There is not one word in that document that says do not comply with a regulator," he said.

Dr. Michael Carome, deputy director of Public Citizens' Health Research Group, a nonprofit consumer organization, said the group's advice to members should have been to cooperate fully and answer all their questions. Instead, Carome said, the group suggested answers "for which the implicit, if not explicit message was to stonewall and obstruct" the FDA's attempt to assess the compounded drug.

The FDA said in June that after obtaining and testing 13 samples of the compounded drug, it had found no significant quality problems. KV Pharmaceuticals filed for bankruptcy this year, and it is suing the FDA.

 

[FlyRobinFly]

Hi everyone!!

New to this site and new to chickens.

I'm from Lynden, just bought a house here a year ago. I have two EEs and two Buff Orps in my backyard and they are so fun to watch! They are each 18 weeks old and I'm getting excited that I'm not to far away from getting fresh eggs (hopefully, that is!).

Glad to be part of this great community. I have learned a lot in a short period of time from you all!!

Glad you're enjoying your chickens!

 

[Chickielady]

So no plucking or GUTTING????

Nope.
Wring the neck (or whatever) then turn over, slice breast skin open, remove breast.

 

[mikeyb]

Well dang. I wasn't going to address this child-sport discussion.
1st. Team sports teach a number of things to children. Working together can achieve a goal. Then "team" is just that. Every member is valuable, not just the starters.
2nd. Teaches the individual to be gracious in winning or losing. A winner will congratuate the other team for their good play and effort and the competition they provided. The losing teaches so much more. How to face adversity, how to accept disapointment and to congradulate the other team for their victory.
Trophies for participation is good for the little people. When they get older, about 9 or so they understand to compete is to strive to win and winning is a lot more fun then losing.
Today I don't see sandlot ballgames (softball/baseball/touch football) being played. This is where the child learns that performance matters. The group chooses sides and the last person chose is well not just very good in the leaders eyes. Yes, it is troubling (as I have been on the end of that stick) but it is a valuable learning moment.
Today you now have try-outs for little league baseball, for basketball and for football. How disappointing is it do you think it is for the kid when he/she don't make the cut?
I could go on and on. Competition builds character and self-confidence in one's self. It truely is "not whether you win or lose, but how you play the game".
At some point in a young child's life parents have to let go a tad and let their child compete, to win or lose.

 

[FlyRobinFly]

Quote: Hey Jules!

I would think, print out a M and cut it out so that you have a "negative" template. Hold over Buckeye back and spray. Remove template and voila!

Buckeyes acceptable to diehard Michigan relatives!

 

[Chickielady]

Hey Jules!

I would think, print out a M and cut it out so that you have a "negative" template. Hold over Buckeye back and spray. Remove template and voila!

Buckeyes acceptable to diehard Michigan relatives!

Oh yeah !
The Michigan State Buckeyes !!!!!!!!!!!!!!!!

And these come from Alabama !!!!!!!!!!!!

 

[FlyRobinFly]

I just posted in the new members section and was told to come here too.

Briefly: new to having chickens (new to country life for that matter). Bought a house near Yacolt, WA in July. Loving it! Learning how to care for the chickens we inherited with the property. Hoping to learn lots more on these forums. Slightly overwhelmed too.

 

[pettec63]

Well, yesterday's weather SUCKED!! But, although it is cool today, the sun is out!
Wanted to report that I emailed my new provider at the VA in Yakima.....and guess what??
OMG!! she got RIGHT back to me!!

Unbelieveable !!! LOL! Had I known that three years ago when I moved back here, I wouldn't have gone back to Richland!! But, I went back to the same provider that had seen me 4 years previous, hmmm continuity of care and the VA?? Can we say Oxymoron!!! LOL!! ( I think that's what I meant to say) !! ???

hello to all the newbies!! glad your here!
CL so glad your feeling better!
Man, I can't believe I was all the sudden 400 posts behind!!!

I have been having goat conversations with Nikki cause I'm sure she told you her kiddos were having problems, anyway, I finally told her to call me and we had a very nice conversation!! We found out we are cut from the same cloth! It's unfortunate that there are people out there, who raise animals to sell, who aren't honest, or just don't care, I haven't figured out which maybe both! Anyway, we had a good conversation and I hope gave her some information she can use!
Another great Washingtonian peep!!!
Nice to meet ya Nikki!!

 

[Chickielady]

Isn't this cute ?????
Maybe CR could build something like this, little chicken coop tissue boxes or ?