Swine flu vaccination effort starts Monday: CDC

[Zoom-boing]

the annual death toll from the regular flu is between 250,000 and 500,000 one region with only ten cases of swine flu had one thousand deaths

Link?

Every year in the United States, on average:

* 5% to 20% of the population gets the flu;
* more than 200,000 people are hospitalized from flu-related complications; and
* about 36,000 people die from flu-related causes.

CDC - Seasonal Influenza (Flu) - Key Facts About Seasonal Influenza (Flu)

it was from a cnn article, Regular flu has killed thousands since January - CNN.com

"Worldwide, the annual death toll from the flu is estimated to be between 250,000 and 500,000." I thought you meant in the U.S.

 

[xotoxi]

I think that vaccinations should be mandatory. Anyone refusing should be executed.

If you can think of any other way for tracking nanochips to be inserted into the body, let me know.

Good idea, I heard half of congress refused the vaccine.

The method of excution should be tasering while being waterboarded.

Teach them mofos a LESSON!

 

[KittenKoder]

KK, do you have R.A.?

Yep ... and I was prescribed Vioxx for it and stupidly took it in spite of the FDA allowing it without full testing.

Did it help? Did you have heart problems related to the medication?

Oh yeah, it "helped" for as long as I was taking it, but the damage was not worth it. Aspirin would have been a better choice.

 

[REVxERIK]

Link?


CDC - Seasonal Influenza (Flu) - Key Facts About Seasonal Influenza (Flu)

it was from a cnn article, Regular flu has killed thousands since January - CNN.com

"Worldwide, the annual death toll from the flu is estimated to be between 250,000 and 500,000." I thought you meant in the U.S.

nope. i should've been clearer on that

 

[KittenKoder]

... is no longer on the market.

However, when it first was allowed by the FDA it was also fully endorsed by the AMA and doctors gave it out like candy to us with arthritis.


... kinda like what they are doing with this new vaccine. Look what happened to the relitively untested Vioxx ... that's what is likely to happen with the new vaccine as well.

I guess you should watch the videos, too

No. I don't "need" to.

But you should do research on your own instead of just watching some videos for a change.

 

[Emma]

Vioxx ...

... is no longer on the market.

However, when it first was allowed by the FDA it was also fully endorsed by the AMA and doctors gave it out like candy to us with arthritis.

Why is that?

Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck.

The drug was approved by the FDA in May 1999 for the relief of osteoarthritis and menstrual pain, and later for treatment of the signs and symptoms of rheumatoid arthritis. At that time, studies didn't show any significant risk of heart disease related to Vioxx.
-------

A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked.

Baystate Medical Center, Springfield, Mass., said that its former chief of acute pain, Scott S. Reuben, had faked data used in the studies, which were published in several anesthesiology journals between 1996 and 2008.

The anesthesiologist allegedly faked data in 21 studies on the use of various painkillers, including Vioxx.

The hospital has asked the medical journals to retract the 21 studies, some of which reported favorable results from the use of painkillers like Pfizer Inc.'s Bextra and Merck & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. And he wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Dr. Reuben had been a paid speaker on behalf of Pfizer's medicines, and it paid for some of his research.

http://online.wsj.com/article/SB123...a&loomia_si=t0:a16:g2:r1:c0.0270612:b22894832

http://www.nytimes.com/2008/04/15/business/15cnd-vioxx.html


In April 2002, the FDA followed its advisory panel's recommendation and required that Merck note a possible link to heart attacks and strokes on Vioxx's label.

"Meanwhile," Topol writes in The New England Journal of Medicine, "Merck was spending more than $100 million a year in direct-to-consumer advertising — another activity regulated by the FDA and a critical mechanism in building the 'blockbuster' status of a drug."

Direct-to-consumer advertising was meant to heighten awareness of drugs, not to hype them, says pharmacologist Raymond Woosley, vice president for health sciences at the University of Arizona. "Do we need to be told how much greater one drug is than the other?" Woosley asks. "The public can't understand the subtle differences."

Merck continued to minimize unfavorable findings up to a month before withdrawing Vioxx. On Aug. 26, the company fired off a press release refuting Graham's study. "Merck stands behind the efficacy, overall safety and cardiovascular safety of Vioxx," it said.

Only randomized, controlled trials, in which patients are randomly assigned to treatment groups (the type of study that first raised heart concerns back in 2000) can provide unimpeachable data about a drug's safety and effectiveness, the release pointed out.

Finally, late last month, Merck confronted unfavorable findings that it could not explain away. Merck had sponsored a three-year, 2,600-patient randomized trial to see whether Vioxx, like Celebrex, could claim that it protects against the recurrence of colon polyps, which can become cancerous.

Again, the study backfired. After 18 months of treatment, researchers observed a higher heart attack and stroke risk in patients on Vioxx, Merck says. The drug was compared with a placebo and not another NSAID, so Merck could not divert blame away from Vioxx. Merck has not yet reported the study results, but the FDA says 3.5% of the subjects on Vioxx had suffered a heart attack or stroke, compared with 1.9% on placebo.

http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm

 

[bill777]

I have to ask, KittenKoder and Emma.....do you agree or disagree? It appears to me that you actually agree.

 

[KittenKoder]

... is no longer on the market.

However, when it first was allowed by the FDA it was also fully endorsed by the AMA and doctors gave it out like candy to us with arthritis.

Why is that?

Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck.

The drug was approved by the FDA in May 1999 for the relief of osteoarthritis and menstrual pain, and later for treatment of the signs and symptoms of rheumatoid arthritis. At that time, studies didn't show any significant risk of heart disease related to Vioxx.
-------

A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked.

Baystate Medical Center, Springfield, Mass., said that its former chief of acute pain, Scott S. Reuben, had faked data used in the studies, which were published in several anesthesiology journals between 1996 and 2008.

The anesthesiologist allegedly faked data in 21 studies on the use of various painkillers, including Vioxx.

The hospital has asked the medical journals to retract the 21 studies, some of which reported favorable results from the use of painkillers like Pfizer Inc.'s Bextra and Merck & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. And he wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Dr. Reuben had been a paid speaker on behalf of Pfizer's medicines, and it paid for some of his research.

So the FDA doesn't really research the medications ... thanks for proving my "big picture" here.

There were and are perfectly valid medications that could have been allowed but were denied until after the recall, ask yourself why the FDA does this. As I said, you need to do more research on the subjects instead of taking people's word for it.

Medications that are allowed in the US by the FDA are often proving fatal lately, while medications that have been denied by the FDA which are produced by smaller companies have proven their medications are safer and effective. Many procedures which the FDA has denied are the same, and the AMA bad mouths anything that they don't like even though world wide these procedures and medications have proven much better than what we have in the US. Long life means nothing if you are caused suffering and disability because of the medications and procedures.

 

[KittenKoder]

I have to ask, KittenKoder and Emma.....do you agree or disagree? It appears to me that you actually agree.

This is why discussion is important. Many times agreements cross and hard line groups and generalizations are not good. I will never take anything the FDA approves unless it's been on the market for more than 10 years now, it's my rule for any product really but medications are my biggest problem now. My history has proven the FDA and AMA are not to be trusted.

 

[Shorebreak]

So the FDA doesn't really research the medications ... thanks for proving my "big picture" here.

There were and are perfectly valid medications that could have been allowed but were denied until after the recall, ask yourself why the FDA does this. As I said, you need to do more research on the subjects instead of taking people's word for it.

Medications that are allowed in the US by the FDA are often proving fatal lately, while medications that have been denied by the FDA which are produced by smaller companies have proven their medications are safer and effective. Many procedures which the FDA has denied are the same, and the AMA bad mouths anything that they don't like even though world wide these procedures and medications have proven much better than what we have in the US. Long life means nothing if you are caused suffering and disability because of the medications and procedures.

The FDA does not research new drugs. The drugs go through clinical trials that are run by the drug manufacturer. It is the manufacturers responsibility to provide accurate clinical data to the FDA in order to approve efficacy, safety, stability etc. for regulatory review. Much of the approval process is based upon the claims of the drug manufacturer as weighed against the results of trials.

For example, in my NDA (New Drug Application) i will state that my product will treat x,y, z symptoms of disease A, over x period of time, under y conditions, for patients who fit profile A. My requirement is to demonstrate favorable results in a clinical study against an identical study performed with a placebo. Study participants do not know if they received the actual new drug or the placebo. Adverse reactions must be recorded and must have minimal overall impact on the health and well being of the patient.

Other portions of the NDA include labeling, packaging, storage stability testing, efficacy, manufacturing processes, etc. But in all cases, the regulatory activity is based upon the level of completeness and detail that's contained within the submission package, not external testing conducted by the FDA. That is not what the FDA does. If the clinical data has been altered and adverse reactions have been omitted or under reported, there is no way for the FDA to know unless it launches an investigation.

Which explains why you will typically find that the appointed head of the FDA is usually a pharmaceutical insider, appointed from either a pharma board of directors or directly from a CEO position with a large pharma corporation. A poorly designed drug can slip past regulators if data and/or clinical testing is falsified in the NDA phase. But you need the fox to be inside the henhouse when the blockbuster drug proves to be a killer. It's the only way to mitigate the damage and prevent the public from knowing the full scope of corruption and lies that we are being administered by big pharma.

And that's coming from someone who spends their days trying to make sure that pharma gets it right.

 

[Emma]

However, when it first was allowed by the FDA it was also fully endorsed by the AMA and doctors gave it out like candy to us with arthritis.

Why is that?

Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck.

The drug was approved by the FDA in May 1999 for the relief of osteoarthritis and menstrual pain, and later for treatment of the signs and symptoms of rheumatoid arthritis. At that time, studies didn't show any significant risk of heart disease related to Vioxx.
-------

A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked.

Baystate Medical Center, Springfield, Mass., said that its former chief of acute pain, Scott S. Reuben, had faked data used in the studies, which were published in several anesthesiology journals between 1996 and 2008.

The anesthesiologist allegedly faked data in 21 studies on the use of various painkillers, including Vioxx.

The hospital has asked the medical journals to retract the 21 studies, some of which reported favorable results from the use of painkillers like Pfizer Inc.'s Bextra and Merck & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. And he wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Dr. Reuben had been a paid speaker on behalf of Pfizer's medicines, and it paid for some of his research.

So the FDA doesn't really research the medications ... thanks for proving my "big picture" here.

I never said the FDA conducted trials. That's not their job.

(a) Necessity of effective approval of application. No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.

(b) Filing application; contents.

(1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such person shall submit to the Secretary as a part of the application (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; 1 (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug and (G) any assessments required under section 505B. The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish information submitted under the two preceding sentences. The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).

SEC. 505. [21 USC §355] New Drugs





Clinical trial - Wikipedia, the free encyclopedia

Phase IV

Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

 

[Emma]

So the FDA doesn't really research the medications ... thanks for proving my "big picture" here.

There were and are perfectly valid medications that could have been allowed but were denied until after the recall, ask yourself why the FDA does this. As I said, you need to do more research on the subjects instead of taking people's word for it.

Medications that are allowed in the US by the FDA are often proving fatal lately, while medications that have been denied by the FDA which are produced by smaller companies have proven their medications are safer and effective. Many procedures which the FDA has denied are the same, and the AMA bad mouths anything that they don't like even though world wide these procedures and medications have proven much better than what we have in the US. Long life means nothing if you are caused suffering and disability because of the medications and procedures.

The FDA does not research new drugs. The drugs go through clinical trials that are run by the drug manufacturer. It is the manufacturers responsibility to provide accurate clinical data to the FDA in order to approve efficacy, safety, stability etc. for regulatory review. Much of the approval process is based upon the claims of the drug manufacturer as weighed against the results of trials.

For example, in my NDA (New Drug Application) i will state that my product will treat x,y, z symptoms of disease A, over x period of time, under y conditions, for patients who fit profile A. My requirement is to demonstrate favorable results in a clinical study against an identical study performed with a placebo. Study participants do not know if they received the actual new drug or the placebo. Adverse reactions must be recorded and must have minimal overall impact on the health and well being of the patient.

Other portions of the NDA include labeling, packaging, storage stability testing, efficacy, manufacturing processes, etc. But in all cases, the regulatory activity is based upon the level of completeness and detail that's contained within the submission package, not external testing conducted by the FDA. That is not what the FDA does. If the clinical data has been altered and adverse reactions have been omitted or under reported, there is no way for the FDA to know unless it launches an investigation.

Which explains why you will typically find that the appointed head of the FDA is usually a pharmaceutical insider, appointed from either a pharma board of directors or directly from a CEO position with a large pharma corporation. A poorly designed drug can slip past regulators if data and/or clinical testing is falsified in the NDA phase. But you need the fox to be inside the henhouse when the blockbuster drug proves to be a killer. It's the only way to mitigate the damage and prevent the public from knowing the full scope of corruption and lies that we are being administered by big pharma.

The only reason why Merck pulled Vioxx was because of liability issues. Even though the drug had significant side-effects that were potentially fatal, their concern was with the bottom line. Something for the tort-reformers to consider...

 

[Emma]

I have to ask, KittenKoder and Emma.....do you agree or disagree? It appears to me that you actually agree.

I'm not sure

KK is convinced the H1N1 vaccine is padding *someone's* pockets (I'm not sure who). I don't agree with that. She's convinced that the FDA approves new drugs without adequate testing. That's the point of phase IV trials. And it seems to be a damned if you do kinda situation. They are criticized for making researchers jump through all the hoops and thereby delaying drugs reaching the market, yet when it's found that drugs released on the market have serious side effects (perhaps not evident in pre-market trials or through less-than-honest data provided to the FDA), they are slammed for approving the drugs too soon.

 

[bill777]

Emma, I think you're being very reasonable. You want the drugs out there but you acknowledge when they go wrong. I also think that KK is right when she says that there is a history of these things going wrong, so the FDA and the pharma companies need to be watched. I still think you two are on the same side.

 

[Shorebreak]

The only reason why Merck pulled Vioxx was because of liability issues. Even though the drug had significant side-effects that were potentially fatal, their concern was with the bottom line. Something for the tort-reformers to consider...

Yes, that was the reason proivided by Merck.

But my grandfather had a saying... "if you believe everything you hear on the news, I've got some great oceanfront property for you in Arizona. Cheap."

I think most of us have reached the understanding that if you heard it from corporate news or syndicated radio, unti proven otherwise, assume that it's a distortion at best, and quite possibly an outright lie.

 

[Emma]

The only reason why Merck pulled Vioxx was because of liability issues. Even though the drug had significant side-effects that were potentially fatal, their concern was with the bottom line. Something for the tort-reformers to consider...

Yes, that was the reason proivided by Merck.

But my grandfather had a saying... "if you believe everything you hear on the news, I've got some great oceanfront property for you in Arizona. Cheap."

I think most of us have reached the understanding that if you heard it from corporate news or syndicated radio, unti proven otherwise, assume that it's a distortion at best, and quite possibly an outright lie.

My grandfather had a saying too:

"Go out to the kitchen and tell your Grandma to bring me a beer."

 

[KittenKoder]

Okay, finally got the admittance I was looking for. Since the FDA does not test the drugs and procedures themselves, why are they the ones in power to accept or deny them?

Would you eat berries that a bird eats?

 

[Emma]

Okay, finally got the admittance I was looking for. Since the FDA does not test the drugs and procedures themselves, why are they the ones in power to accept or deny them?

Would you eat berries that a bird eats?

Who would you have approve (or deny) NDAs? Those doing the research? Are you serious?

BTW, it's no big secret or conspiracy that the FDA doesn't conduct the research.

 

[KittenKoder]

Okay, finally got the admittance I was looking for. Since the FDA does not test the drugs and procedures themselves, why are they the ones in power to accept or deny them?

Would you eat berries that a bird eats?

Who would you have approve (or deny) NDAs? Those doing the research? Are you serious?

BTW, it's no big secret or conspiracy that the FDA doesn't conduct the research.

I didn't call it a conspiracy, just that people are too lazy to do their own research (I was once one myself) and just take the FDA's word for it. After research I found that they are more like mob bosses than anything anyway. People should do their own research and the FDA really shouldn't exist, it puts all the power into a few large companies and does nothing but decrease the quality of products and services in the US.

The berries example, how do you find out which are safe to eat?

 

[bill777]

I agree with Emma. What are you supposed to do? There are way to many new drugs coming online every month for the FDA to be solely responsible, which brings us to KK. You have to be aware of what's out there, what's been reliably tested, and what hasn't. It's a matter of personal responsibilty. Caveat Emptor.