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Is the FDA in the pocket of Big Pharmacuetical companies regarding vaccines?

freedomforever 2008/07/29 20:35:02
yes... i think.......
no..the FDA wouldnt do that to us because....
my thoughts are.......
idk.......because
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The article from the Friends of Freedom website essentially shows that the FDA is not doing its job of protecting children and adults. It makes it look more like the FDA is protecting the rights of big pharma to make more money. Please read this article and give me your opinion.

'Big Pharma Bullies Food & Drug Admin'


E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER
Vienna, Virginia www.nvic.org

UNITED WAY/COMBINED FEDERAL CAMPAIGN
#9119
* * * * * * * * * * * * * * * * * * * * * * *

"Protecting the health and informed consent rights of children since 1982."

BL Fisher Note: The strong arm tactics used by drug companies making and selling drugs is the same for drug companies making and selling vaccines. The pharmaceutical industry intimidates the FDA and pays influential doctors to grease the skids when it comes to regulating vaccines for safety. And then they whine to Congress about how unnecessary government regulations and defending lawsuits for injuring and killing people with their vaccines hurts their ability to make those risky vaccines available to the public! Until the public wakes up and realizes that they have to inform their legislators about what is happening and put an end to this dangerous game, the health and well being of our nation will continue to be in jeopardy.

www.washingtonpost.com/wp-dyn/articles/A58470-2004Nov17.html

The Washington Post
Thursday, November 18, 2004; Page A01

In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health.

From 2001 to 2004, three important drugs were taken off the market, compared with 10 that were recalled from 1996 to 2001.

Two of the three were withdrawn in the very early months of the Bush administration. The third, the blockbuster arthritis drug Vioxx, was pulled in September at the initiative of its maker, Merck & Co., without FDA involvement.

In the same period, the number of warning letters sent by the FDA's drug marketing office challenging misleading or dishonest drug advertising also plummeted. From 1996 to 2001, the agency issued about 480 cease-and-desist letters. Over the past four years, the total has been about 130.

The decrease in FDA enforcement has come despite a steadily rising number of reports of potentially harmful side effects from approved drugs. From 1996 to 2004, the annual number of these "adverse events" almost doubled.

Few doubt the FDA remains the world's gold standard for drug regulation, and the agency fiercely defends its record. Nonetheless, Steven Galson, acting director of the FDA Center for Drug Evaluation and Research (CDER), said his agency "has learned some important lessons in the past year and will make some changes" based on an upcoming Institute of Medicine study and its own reviews. The agency has "taken the criticism to heart," he said. He added, however, that some of the falloff in recalls may be the result of a decline in new drug approvals.

Concerns about the FDA's safety monitoring have been growing ever since Congress required in 1992 that the industry assume a significant share of the costs of evaluating new drugs. These "user fees" now pay for more than half of CDER's annual budget of almost $500 million, and the percentage is growing steadily.

Those concerns have taken on new urgency since the calamitous withdrawal of Vioxx, a move that focused sharp attention on whether the agency has become lax in overseeing the drug supply and too cozy with the industry.

Recent events "pretty clearly indicate the safety surveillance system isn't working," said Jerry Avorn, a Harvard University drug safety specialist and author of "Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs."

"It's a little like driving drunk," he said. "You can go for a number of trips inebriated and not get in an accident, but the risk is there and eventually you'll have a crash."

Some of the criticism comes from unexpected places. Sen. Charles E. Grassley (R-Iowa) has taken a lead role and will chair a Senate hearing today regarding the agency's track record on drug safety.

The hearing will focus on how Vioxx stayed on the market despite early warnings that it might increase the risk of heart attack and stroke -- allegations of foot-dragging that Merck and the agency say are unfounded. But in a larger sense, the FDA's entire drug review and post-market surveillance programs will also be on trial.

"The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny," Grassley said. "One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must be the FDA's first and only concern."

Among Grassley's proposals is that the agency's relatively small Office of Drug Safety be beefed up and made more independent of the Office of New Drugs, the division that reviews and approves drug applications. (This year, the safety office received less than $24 million of CDER's budget of almost $500 million.) Grassley and other critics contend the safety office is reluctant to admit that drugs may have been approved in error. An independent safety office, he said, would not feel as constrained.

Curt Furberg, a drug safety expert at Vanderbilt University and a member of the FDA's advisory panel on drug safety and risk management, also said the Office of Drug Safety should be more independent. Furberg, who was uninvited from an important upcoming FDA drug advisory panel after he publicly questioned the safety of other drugs in the same family as Vioxx, argued that the FDA needs basic structural changes.

"I think what we've seen in the United States is that the FDA and industry have gotten very successful at getting drugs to the market based on their efficacy," he said in an interview. "But that has come at a cost: We are discovering the safety problems here after the drug has been on the market and widely used. . . . This is why I say safety has become a stepchild to the agency and the process."

While acknowledging there have been weaknesses in the FDA's safety oversight, Galson said there is no reason for an independent safety office -- in part because that would deprive safety monitors who evaluate a drug's risks of the best information about their benefits. He also defended the drop in enforcement letters about misleading advertising, saying the agency is relying more on providing companies better guidance before they start marketing.

Galson said that he sees no meaning in the decrease in the number of drugs taken off the market, but that the increase in adverse-event reports "was of some concern."

The perception that the FDA has tilted from its public health mandate toward a focus on industry needs has been reinforced for some in Congress by court cases in which the agency intervened on the side of drug and medical device makers sued by patients claiming they were harmed.

Invoking the legal theory of "federal preemption," the government has argued in at least five cases that such lawsuits threaten to disrupt a regulatory system established to ensure the flow of new and useful products. Rep. Maurice D. Hinchey (D-N.Y.), saying the court filings showed the FDA is being taken "in a radical new direction," persuaded the House to cut $500,000 from the general counsel's budget to show its displeasure.

Industry officials disputed the notion that the FDA has become less aggressive on safety issues.

The small number of drug withdrawals since 2001 reflects the fact that fewer new drug applications have been submitted and approved, and that the FDA has been more active in looking for signs of liver- and heart-damaging side effects before approving new drugs, said Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA). As a result, some potentially dangerous drugs never made it to the market, he said. The FDA has required stricter monitoring and management of patients to minimize the risk for others, he added.

"Drugs are approved based on an evaluation of both the benefits and the risks," Goldhammer said. "There is no drug on the market without some risk."

He argued that the post-marketing surveillance system, which requires manufacturers to report deaths and life-threatening reactions to drugs within 15 days, is working well. The real problem, he said, is how to draw conclusions from that data, which is why PhRMA has been working with the FDA for more than a year to improve data-mining techniques for combing through computer databases to find patterns.

When Congress introduced drug industry user fees in 1992, all the money was earmarked for hiring people to speed the drug review process. It was not until 2002 that Congress allowed some of the money to be used to boost post-market drug safety surveillance.

The 2002 funding package set aside $75 million over five years from user fees to add more than 100 positions to the drug safety office, Goldhammer said.

The user fee funding has shortened the average time for new drug reviews from 32 to 13 months, with some priority drugs passing muster in six months, he said, but that has not led to less careful reviews.

"The FDA spends more than $2 million doing a new drug review," he said. "That's 13 person-years looking at safety, efficacy and the manufacturing process. That is a significant effort that has been lost in this whole debate."
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Top Opinion

  • Angel 2008/07/29 23:21:39
    yes... i think.......
    Angel
    +16
    FDA is money greedy just like the Pharmacuetical companies, i think they work together and are both corrupt

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  • TechnoZeus crsone 2008/08/16 15:11:12
    TechnoZeus
    We need someone to regulate the regulators. :)
  • crsone TechnoZeus 2008/08/16 22:35:25
    crsone
    Yup
  • ☠Marz555☠ 2008/07/30 17:37:06
    yes... i think.......
    ☠Marz555☠
    +1
    Fuk big pharma......
    http://joox.net/cat/2/id/1587
    'Sicko- Full Movie"
  • RubyTuesday 2008/07/30 11:25:25
  • Stix 2008/07/30 02:15:47
    yes... i think.......
    Stix
    +1
    The FDS stand with their arms extented for pay offs at the cost of human life.
    A blind eye to reports on medications that are harmful to the health of patients.
  • freedom... Stix 2008/07/30 14:21:22
    freedomforever
    absolutely, i have seen testomonials in congress and other similar hearing or venues, and there have been hundreds of people, parents etc giving testimony about the dangers and hazards( mostly on the deaths resulting from taking them) of some psychotropic drug and the committee will ignore all the testimony and vote in favor of the drug company...
  • NICKI70 2008/07/30 01:09:35
    yes... i think.......
    NICKI70
    +1
    IF they can make a buck they will and i doesnt matter who gets hurt/
  • freedom... NICKI70 2008/07/31 00:33:13
    freedomforever
    +1
    that is the sad part, there are people getting hurt and dying ! there are many case histories of this.....
  • DrTim 2008/07/30 00:07:25
    yes... i think.......
    DrTim
    +2
    Theres Money to be made!
  • KAT 2008/07/29 23:34:53
    yes... i think.......
    KAT
    +2
    oh yeah, its no way some of the drugs that are being allow should even pass
  • Angel 2008/07/29 23:21:39
    yes... i think.......
    Angel
    +16
    FDA is money greedy just like the Pharmacuetical companies, i think they work together and are both corrupt
  • mk, Smartass Oracle 2008/07/29 23:12:51
  • Dogg ~ Ready for war 2008/07/29 23:09:08
    yes... i think.......
    Dogg ~ Ready for war
    +4
    And this is not new news. This has been going on for some time
  • Magzilla 2008/07/29 21:12:14
    yes... i think.......
    Magzilla
    +4
    Yes they are. The FDA is corrupt!
  • freedom... Magzilla 2008/07/29 21:21:32
    freedomforever
    +4
    thanks magz!! i like that you are direct and to the point ! there are things one can do to make changes on that website.....
  • Magzilla freedom... 2008/07/29 21:47:24
    Magzilla
    +4
    One thing that bothers me most about the FDA is that they refuse to recognize natural cures because it can't be patented. They support and promote pharmaceutical companies into making synthetic drugs to do what natural herbs can do, and in turn the drug does more harm to the body than good. It is disgusting.
  • Hairles... Magzilla 2008/07/29 23:17:58
    HairlessKat the Gnostic
    +3
    not only do they not recognize them they are trying to ban and or regulate them now so you can only get them via a prescription if something is touted as good for you..... screwed up thing about that is, whats next, will oranges be by script only??
  • Magzilla Hairles... 2008/07/29 23:21:56
    Magzilla
    +3
    No kidding. It is appalling.
  • freedom... Magzilla 2008/07/30 07:07:46
    freedomforever
    +1
    yu are basically right, in one way i am glad that it is not profitable for the big pharma to make or use natural cures cus they woudl just mess it up with their greed, but then i guess it would certainly get a lot of push like drugs are getting !
  • Magzilla freedom... 2008/07/30 15:30:10
    Magzilla
    +1
    The problem with what is happening is that the doctors can't even suggest a natural remedy. They could loose their licence to practice if they suggest natural remedies to people.
  • freedom... Magzilla 2008/07/30 15:41:52
    freedomforever
    +1
    what ? whats that about...i didnt know that..it must be the big pharma putting some sort of pressure on the docs, cuz more and more people are finding out there are better cures for what ails them instead of drugs so the drug companies are trying to fight back...please tell me what you know about this? loose their license for suggesting natural remedies, wtf?
  • Magzilla freedom... 2008/07/30 15:48:12
    Magzilla
    +1
    The arguement is that the natural remedies cannot be regulated and they say they haven't been tested (total b.s.) so they really don't know how effective they are.
    I need to get my sources together for you. I doubt I'll send it to you today but I should have it to you by tomorrow.
  • freedom... Magzilla 2008/07/30 15:54:08
    freedomforever
    +1
    thank you..no worries on how long it takes, i have heard this lame argument before but i hadnt heard that they are trying to get doctors in trouble for suggesting them, its hard enough to get them educated to use them much less have someone trying to punish them for trying to actually make people healthy...i want to know how they are going about it
  • Magzilla freedom... 2008/07/30 16:41:52
    Magzilla
    +1
    Yeah, the links I am going to email you will tell you all about it. I'll try to find the actual code for you too.
  • freedom... Magzilla 2008/07/30 17:15:44
    freedomforever
    +1
    double raves !!you are wonderful !! thanks magzilla !!
  • Magzilla freedom... 2008/07/30 18:01:26
    Magzilla
    +1
    You're Welcome! (^_^)
  • HairlessKat the Gnostic 2008/07/29 20:45:51 (edited)
    yes... i think.......
    HairlessKat the Gnostic
    +4
    the fda is getting its pockets filled by all the pharms which is why the majority of those addicted to opiates are now using oxy instead of heroin, amphetamines instead of speed/coke, and benzopines...... they approve the drugs and let doctors distribute them like common corner drug dealers , though less knowlegable about the actual dangers of their products most likely because its all whitewashed will lies about being less addictive and not the same as those dirty 'street' drugs... and its all 'legal' that way. Its a load of crap and I have little doubt that the new HPV vaccine will turn out to cause some issue too the longer its used.

    My youngest had to have the chicken pox vaccine and that just makes NO sense .. pox as an adult is deadly... as a child in the marjority of cases it is easily shaken off unless the child already has an underlying health problem to begin with or is on steroid which suppress the immune system.

    And I wont even go back off on my tangent about SSRI dangers being covered up in almost every single school shooting,, but if anyones interested check out my blogs because theres a site that lists them with news articles and info about what drugs they were linked to in each instance..

    Oh yeah, almost forgot... check out the reality of what floride was 'grandfathered' in to the FDA as.. it wasnt as a tooth dentifice.. most like a mouse poison!

    Thanks for sharing this article
  • freedom... Hairles... 2008/07/29 20:53:45
    freedomforever
    +3
    Kat...your information is always so valuable !! your viewpoint is hightly valued by me !!

    kat information valuable viewpoint hightly valued
  • Hairles... freedom... 2008/07/29 21:06:40
    HairlessKat the Gnostic
    +3


    Thankgod for all the light bringers like you Freedom!! ((HUGS))
  • freedom... Hairles... 2008/07/29 21:22:37
    freedomforever
    +3
    hugs back atcha !

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