Mike Adams, the Health Ranger
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 Senate passed the FDA "drug safety" bill today (S.1082) with a 93-1 vote. A key amendment that would have called for genuine drug safety protections for consumers -- the Grassley amendment 1039 -- was defeated by a single vote (47 to 46). The new law deepens financial ties between Big Pharma and the FDA, doubling the amount of money directly paid to the regulator by drug companies, but it fails to explicitly protect foods and nutritional supplements from overreaching FDA regulation efforts. |
| Very few provisions were accepted that addressed the serious issues of corruption, conflicts of interest, television drug advertising or genuine drug safety.
Health freedom advocates are now characterizing the final bill as the, "Big Pharma Protection Act of 2007" due to its emphasis on protecting the monopoly drug market in the United States while doing very little to accomplish its stated goals of increasing the "safety" of prescription drugs.
Analysis by Mike Adams (opinion)
The passage of S.1082 is a terrible defeat for Americans, but a huge victory for Big Pharma and the FDA. |
Mike Adams, the Health Ranger
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 This is absurd, and it shows who's really in charge when it comes to drug safety (the drug companies themselves!).
Then again, all this assumes the FDA actually wants to protect the public, and I don't believe the agency wants to. I think the FDA just pretends to protect the public in order to meet the minimum regulatory requirements that prevent a real Congressional inquiry. The FDA seems to be merely going through the motions of regulating drug companies, without actually pursuing the task with any genuine sense of purpose.
It's like an empty shell of a government regulator. |
Mike Adams, the Health Ranger
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| Waking up the American public to the larger issue of drug safety is a much more challenging task. Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental research foundation. I will fully document in a subsequent article that this is not the case. It is actually the tool by which Big Pharma and Big Biotech will lock in their profits for the next 50 years, as FDA joins them in the drug development and marketing business. This is one of the greatest safety threats in the history of America. |
| As shameless as ever, this dangerous law has been sold to consumers as a "drug safety" bill.
But prescription drugs are not safe, even if they are purchased at the highest retail prices in the world. (Paying more for a drug does not make it safer.) FDA-approved prescription drugs have killed far more Americans than all the terrorists events recorded in American history, combined! The FDA is the single greatest threat to the health and safety of the American people, and today, with the passage of S.1082, the U.S. |
| A key amendment that would have called for genuine drug safety protections for consumers -- the Grassley amendment 1039 -- was defeated by a single vote (47 to 46). The new law deepens financial ties between Big Pharma and the FDA, doubling the amount of money directly paid to the regulator by drug companies, but it fails to explicitly protect foods and nutritional supplements from overreaching FDA regulation efforts. |
Mike Adams, the Health Ranger
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 David Graham, the FDA drug safety researcher who now warns about Bextra, Crestor and other drugs, while ridiculously insisting it is the "world gold standard in drug safety." It is precisely this arrogance, this departure from reality, that makes the FDA so utterly dangerous to the American public. Because it's one thing to make a series of drug safety mistakes that have killed (yes, killed) literally hundreds of thousands of Americans, but it's another thing altogether to insist that the system is working just fine. It's the best in the world, according to the FDA. And that's downright scary. |
Mike Adams, the Health Ranger
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| That is exactly the purpose of the Foundation, which was included in the drug safety legislation Senator Enzi and I introduced last year. The Foundation will be financially supported by industry and philanthropic donated funds. A chief scientist at FDA will promote intramural research and coordinate it with efforts at the Foundation.
Mr. HATCH. That explanation is very helpful. What, specifically, would the role of the Foundation be with respect to dietary supplements?
Mr. KENNEDY. |
Mike Adams, the Health Ranger
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 Thus, the very agency currently in control of drug safety information is not even genuinely interested in drug safety! (Case in point: The FDA voted to put Vioxx back on the market even after knowing it likely killed over 60,000 Americans!)
If the FDA is the "watchdog" of drug safety, then who is watching the watchdog? As it turns out, groups like CSPI and Public Citizen are doing the job the FDA refuses to do. If it wasn't for lawsuits from groups like these, the FDA would have done virtually nothing over the last ten years to protect the public from dangerous drugs. |
Mike Adams, the Health Ranger
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 They can't believe that the Food and Drug Administration would censor and suppress drug safety information. They think the FDA is looking out to protect them. The heroic FDA, protecting American consumers from greedy drug companies selling dangerous drugs, putting public safety first and corporate profits last. Of course, that's all a myth. |
| The FDA: Censoring its own drug safety scientists to make sure they don't go public with their information about how dangerous these drugs are. The FDA: Under the table deals with drug companies? Maybe. Lots of political influence with the leaders of drug companies? Probably. Covering up facts about the dangers of prescription drugs? Most definitely. Absolutely. Without question.
This is the FDA that we have here in the United States, running the drug industry. Running it! |
Mike Adams, the Health Ranger
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 It's called off-label drug use, and it's a common practice that promotes the sale of prescription drugs and circumvents the so-called "gold standard" drug safety procedures the FDA claims to enforce.
Here's how it works: once a drug gets approved for any condition, whether it's a skin disorder, a mental disorder, or a cardiovascular problem, it can then be legally prescribed by doctors for everything. In other words, a drug approved for heart disease can be prescribed for diabetes, even though there's absolutely no testing done whatsoever with the drug on diabetes patients. |
| Overall, the FDA’s off-label use rules make a complete mockery of the drug safety approval process in the United States, and they demonstrate how safety approval is really just a rubber-stamping exercise that allows the most profitable and influential corporations in America to push their products onto people who not only don't need them, but who are very likely to be harmed by them.
It also makes a mockery of conventional medicine's criticism of natural therapy. |
Mike Adams, the Health Ranger
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| I am opposed to the amendment being prepared by Durbin, as food safety is a completely different issue and must be kept out of drug safety legislation so that there can be no confusion between drug safety and food safety laws - which are quite different.
Sincerely,
About Byron Richards: Richards is the founder of Wellness Resource (www.WellnessResources.com) and author of Fight For Your Health! |
Mike Adams, the Health Ranger
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 As Bill Baughan, a senior policy analyst with Consumers Union (Consumer Reports), said, "Consumers expect Congress to take their concerns about drug safety seriously, and deliver legislation that will prevent future Vioxx-type disasters. Failure to act this year on the strongest possible bill, when more than 80 pecent of Americans agree that Congress should do whatever is necessary to ensure drug safety, would equate to gross legislative malpractice. |
Craig Pepin-Donat
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 In February 2005, the FDA announced the formation of the drug safety Board, an independent entity to "oversee the management of drug safety issues and provide emerging information to health providers and patients about the risks and benefits of medicines."13 The truth is that even with these improved systems in place, we continue to hear horrific stories about previously approved drugs that have caused either life-threatening side effects or, in some cases, death. |
Mike Adams, the Health Ranger
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 Vioxx alone -- which was approved by the FDA and heavily pushed by drug company advertising -- reportedly killed well over 50,000 Americans according to the FDA's own senior drug safety scientist Dr. David Graham. The idea that prescription drugs are safe is ludicrous, and trying to "ensure drug safety" by forcing Americans to pay the highest prices in the world for dangerous synthetic chemicals is a logical fallacy and nothing more than a thinly veiled attempt to protect the profiteering drug racket while claiming to be protecting the public. |
Craig Pepin-Donat
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| In February 2005, the FDA announced the formation of the drug safety Board, an independent entity to "oversee the management of drug safety issues and provide emerging information to health providers and patients about the risks and benefits of medicines."13 The truth is that even with these improved systems in place, we continue to hear horrific stories about previously approved drugs that have caused either life-threatening side effects or, in some cases, death. |
Mike Adams, the Health Ranger
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| If the FDA is the "watchdog" of drug safety, then who is watching the watchdog? As it turns out, groups like CSPI and Public Citizen are doing the job the FDA refuses to do. If it wasn't for lawsuits from groups like these, the FDA would have done virtually nothing over the last ten years to protect the public from dangerous drugs. The FDA only takes action after being hammered by lawsuits, Senators or Congressional testimony from its own drug safety scientists (whom the FDA tries to silence before they can speak out, by the way). |
Shannon Brownlee
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 In the debate over prescription drug prices, drug safety, and oversight from the FDA, the assumption has been that everybody has access to the same data and that everybody, from drug safety officers to doctors to insurers, is equally capable of assessing the merits and dangers of a drug. That's not the case. In fact, maybe the real problem with prescription drugs, and indeed with medical technology in general, is not so much that they cost too much or that they're too dangerous or that they don't always work the way they're supposed to. |
Mike Adams, the Health Ranger
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| Because it's one thing to make a series of drug safety mistakes that have killed (yes, killed) literally hundreds of thousands of Americans, but it's another thing altogether to insist that the system is working just fine. It's the best in the world, according to the FDA. And that's downright scary. |
Mike Adams, the Health Ranger
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| Dorgan amendment proposes free trade for medicine
The Dorgan amendment, entitled, "Pharmaceutical Market Access and drug safety Act of 2007," proposes what is essentially a free trade policy on prescription medications. It would allow Americans to buy their drugs from certain certified organizations registered as valid importers or exporters. The bill states, "... |
| Senators voted on an amendment to the 2007 Prescription Drug User Fee bill that aims to reform the FDA and enhance drug safety. This amendment, known as the "Dorgan Amendment No. 990," threatened to break Big Pharma's monopoly over pharmaceutical sales and allow U.S. consumers, cities, states and businesses to purchase their pharmaceuticals from safety-certified pharmacies located in Canada, Japan, the U.K. and other nations.
Americans currently pay the highest prices in the world for prescription drugs. |
Mike Adams, the Health Ranger
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| Please Amend to Protect Dietary Supplements
May 9, 2007
The Honorable (Senator First and Last Name)
Address
Dear Senator Last Name;
The issue of drug safety is of the utmost importance to myself and all Americans. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use S.1082 to undermine my access to safe and effective dietary supplements.
There must be no confusing the safety of drugs and the safety of food and food ingredients -- which are governed by different laws. |
Mike Adams, the Health Ranger
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| Fudging the numbers, sidestepping reality
The White House reportedly opposes the drug safety disclosure requirements for two reasons: 1) It claims the public wouldn't understand the information, and 2) It claims the FDA has no way to validate the accuracy of the information.
Of course, the whole point of publishing this information is to achieve open disclosure so that doctors, scientists, medical staff and the public can exercise additional oversight on the FDA and Big Pharma. |
Mike Adams, the Health Ranger
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 Such a relationship with private industry is an unprecedented conflict of interest, totally at odds with drug safety. The current commissioner of the FDA, Andrew von Eschenbach, M.D. is little more than a Big Biotech sales rep with massive industry connections.
The House, like the Senate, will continue to allow direct to consumer advertising of new drugs with unknown risks -- a flagrant safety risk that will cost many people their lives. Congressional leaders said they couldn't prevent this advertisement for fear of violating the first amendment rights of drug companies. What a joke. |
Mike Adams, the Health Ranger
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| Of course, the whole point of publishing this information is to achieve open disclosure so that doctors, scientists, medical staff and the public can exercise additional oversight on the FDA and Big Pharma. drug safety should not be carried on behind closed doors, in dark corridors, and through under-the-table bribery deals. The safety of pharmaceuticals should be openly disclosed and debated. The White House, it now seems, does not want the public to learn the truth about drug trial results. |
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