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Does Food and Drug Administration approval guarantee safety? If the Supreme Court rules as expected, patients might have no legal recourse if they are harmed by an FDA-approved medicine.

The case that will soon be decided by the Supreme Court involves a musician who was treated for a migraine. The medicine that was injected to stop her nausea was administered incorrectly. This led to gangrene of her arm and eventual amputation just below the elbow.

The Vermont Supreme Court upheld a Superior Court finding that the drug company was negligent because it did not provide adequate warning about the injection process. The manufacturer maintains that the FDA approved the prescribing information that was used and therefore the drug company has no liability.

In other words, FDA approval could get the pharmaceutical firm off the hook for any complications that might arise. Think of it as a Monopoly-style "get out of jail free" card.

This case could well set a precedent for all future pharmaceutical-related litigation. If FDA approval means that drug companies are not liable, then there will be no recourse if someone experiences a serious or even deadly adverse reaction.

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Take Vioxx, for example. At last count, tens of thousands of patients may have experienced heart attacks as a side effect of this arthritis medicine.

Questions about what the company knew about these potential problems and when it knew them have been raised. Many answers have been discovered only through the disclosure required in the process of lawsuits.

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Ephedra has admittedly resulted in the deaths of a handful of people. Ibuprofen has killed hundreds of thousands, even according to medicine's own research as published in JAMA and other "scientific" journals. If this is really about science and protecting the public, as is claimed by supporters of the ban, then why not protect the public from dangerous pharmaceuticals at the same time?

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Researchers at prestigious Harvard and Columbia Universities have confirmed the safety and effectiveness of ephedra supplements for weight loss in healthy Americans when used as directed with appropriate serving limits, warnings, and precautions. Here are their own powerful words about the effect and the safely of ephedra. "In this six-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg per day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events." This is but one of the numerous studies showing the effectiveness and safety of ephedra when taken responsibly.

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There are over 50 clinical studies on ephedra or ephedrine in which no medically serious adverse reports were reported. In fact, more than 20 studies have shown that ephedra preparations helped adults lose weight, if used as directed.

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Caraco Pharmaceutical Laboratories, Ltd. (Caraco) is engaged in the business of developing, manufacturing, marketing and distributing generic and private-label pharmaceuticals to the wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers throughout the United States and Puerto Rico. [SM]

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FOR YEARS, pharmaceutical companies have asked Congress to pass a law protecting them from liability lawsuits for drugs that have been approved by the US Food and Drug Administration. Members of Congress, knowing only too well the fallibility of the FDA in approving drugs and monitoring their safety after approval, have rightly refused.

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WASHINGTON, April 1, 2007 — Manufacturers of pharmaceuticals, medical devices and other health products spent nearly $182 million on federal lobbying from January 2005 through June 2006, a Center for Public Integrity study of disclosure records shows. Power of Many

Of that total, drug companies and their trade groups spent most of it, or $155 million, lobbying on a variety of issues ranging from protecting lucrative drug patents to keeping lower-priced Canadian drugs from being imported to the United States Drug interests employed about 1,100 lobbyists to do their bidding in each of the past two years.

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The dietary supplement industry collectively spends approximately $1.8 million per year on lobbying. For perspective, the top three industries that spend the most on lobbying are insurance companies ($120 million), electric utilities ($92 million) and drug manufacturers ($91 million). Of course, these industries are many times larger than the dietary supplement industry, which is currently at around $22 billion, so we would expect those industries to spend more.

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Big Pharma’s drug lobby machine (the Pharmaceutical Research and Manufacturers of America) increased its financial arm-twisting of Congress by 25% in 2007 – in an effort to ward off competition and lock in bogus psychiatric medication sales to children.

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In 2002, the drug industry spent a record $91.4 million on federal lobbying activities that are
required to be disclosed, a 12 percent increase from the previous year. This figure does not
include at least another $50 million spent to influence Congress through activities such as
advertising and other public relations, direct mail and telemarketing, and grants to advocacy
groups and academics pushing the industry’s position.

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Doctors are able to recommend these devices without telling patients their potentially dangerous side effects. Many patients might not understand the device does not have to be fully researched with the kind of vigorous testing the FDA applies to pharmaceutical drugs. So they may choose a new device which may be more expensive and not even as effective, all because of their misplaced faith in the FDA.

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Population control for money is the easiest way to describe the new Codex which is run by the U.S. and controlled by Big Pharma and the like to reduce the population to a sustainable 500 million - a reduction of approximately 93 percent. The FAO and WHO have the audacity to estimate that by the introduction of just the vitamin and mineral guideline alone, at a minimum 3 billion deaths (1 billion from starvation and another 2 billion from preventable and degenerative diseases of under nutrition, e.g., cancer, cardiovascular disease, and diabetes) will result.

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(November 07, 2008) A congressional investigation has revealed that a group of Harvard psychiatrists, instrumental in pushing the diagnosis of bipolar disorder in children and its off-label treatment with antipsychotics, concealed from university officials the millions of dollars they earned in consulting fees for the companies that make those drugs.

Iowa Sen. Charles E. Grassley requested the financial disclosure reports that Drs. Joseph Biederman, Timothy E. Wilens and Thomas Spencer had filed with Harvard University between 2000 and 2007. He then asked a handful of pharmaceutical companies for their own records on how much had been paid to the researchers in that time.

The numbers reported by the drug companies were much higher than those on the researchers' forms.
...
Upon being confronted with the discrepancies, the researchers admitted to having concealed certain consulting fees and upped their estimates.

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Upon being confronted with the discrepancies, the researchers admitted to having concealed certain consulting fees and upped their estimates. These new numbers still fell short of those reported by the drug companies.

Biederman, for example, originally told Harvard that he had received no money from Johnson & Johnson in 2001. When Grassley asked him to double check, Biederman admitted to receiving $3,500. The drug company's records, however, recorded payments of $58,169 to Biederman in that year alone.

A more thorough investigation revealed that Biederman and Wilens had received at least $1.6 million from the pharmaceutical industry between 2000 and 2007, while Spencer had received at least $1 million.
...
In that year, Biederman told Harvard that he had been paid less than $10,000 by Eli Lilly, when in fact he had received more than $14,000. This allowed him to conduct a study of Lilly's attention deficit disorder drug Strattera in children, using money from an NIH grant.

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"If there have been violations of NIH policy, and if research integrity has been compromised, we will take all the appropriate action within our power to hold those responsible accountable," NIH spokesperson John Burklow said. "This would be completely unacceptable behavior, and NIH will not tolerate it."

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The FDA passed, without review; new implanted defibrillator leads from Medtromix. 250,000 of these "improved" leads were implanted in people in the USA (I'm one) starting in 2004. The FDA never required testing of these leads. They really didn't have the funding from our government. Result? At least 5 people have died. Many more has been SHOCKED repeatedly causing great pain.
...
One person suffered many shocks in one 1/2 hour! ... because the leads malfunctioned. He didn't need the shocks (technicians can tell this by communicating with the defibrillator via a computer.). Bottom line - the FDA did not do their job! Now, their are multitudes of people (I'm one) that have no recoarce. We can't sue the FDA. We get no where with Medtronic. We now need to be checked every 3 months instead of twice per year. We never know when our defibrillators might go - it can happen right after we've been checked. I have been shocked several times. Each time, I was told that the shock was not necessary. ... I am scarred to drive, because a bad shock may cause me to kill someone. The FDA answers to know one. And, they are ineffectual at protecting the people. I can't sue the FDA under current law. This is our government at work for us!

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On October 15, 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

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(NaturalNews) A new screening test for variants of Creutzfeldt-Jakob diseases (vCJD), currently in final clinical trials, will reportedly identify those who harbor the disease in their blood. Early indications suggest that 1 of every 4,000 people tests positive. This is a substantially higher number than health experts had estimated.

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In more disconcerting news about the undesirable influence of pharmaceutical companies, a review published in the Journal of the American Medical Association has found that media reporting of studies on drug medications could skew public and medical opinion toward commercial interests.

Two factors contribute to this. Firstly, the mainstream media often fails to report the use of funding provided by drug companies for this kind of research. On top of that, both medical and mainstream reporters tend not to use generic names when referring to specific drug medications, but instead use their brand names.

And the study team found that these shortcomings existed even though the editors involved felt otherwise.
...
The researchers found that 42% of the news articles failed to disclose the fact that drug medication research had received funding from pharmaceutical companies. Even when they did, it was deep within the article and not prominently stated.

67% of 277 news articles which had reported on drug medications only used the drug's brand name at least half the time when referring to the medication. According to the study team, each year, up to $9 billion is spent in the US when medical doctors prescribe brand name drugs, even though a generic would have done the job too.

Compare these figures to the perceptions of the editors – about 88% of them had the impression that news articles which they published often or always stated the presence of company funding. Further, some 77% of them thought that their articles referred to drug medications by their generic name.

It is also worth noting that only 3% of the newspapers in question had formal written policies with regard to the disclosure of company funding, while only 2% had such policies with regard to the use of the generic names of drug medications.

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The five-year Jupiter study was stopped after two years, under the pretense of overwhelming success (normally studies are stopped because of adverse effects). Since the side effects of any statin are progressive and cumulative over time, it is likely that the real reason the study was stopped was to publish favorable results before the predictable adverse side effects had time to manifest. Even in this short two-year period there was a 20% increased risk for diabetes from taking Crestor – a fact that was conveniently downplayed.

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For starters, the study was halted two years early because it was claimed the results were so positive for the control group that it would have been unethical to continue denying the same drugs to the placebo group.

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Physicians and Big Pharma reps were practically falling over each other Sunday in a mad stampede to the stage in order to out-do each other on making the most outrageous claims surrounding statin drugs. One doctor said the drugs are so useful at saving lives that governments around the world should start prescribing them to practically everyone. Another said that tens of millions of adults should now be put on what he called "statin therapy." (It's therapy now, folks, not medicine!) Not to be outdone, a third doctor suggested the drugs be dripped into the public water supply in order to dose everyone!

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Now Medtronic is a manufacturer of medical devices. They make the angioplasty balloons among other things, and in this case Reigel died following a surgical procedure in which one of these angioplasty balloons exploded when it was in his artery.

This medical device killed him; what a stupid situation this is. Now the FDA said that this device was approved, and then the Supreme Court ruled that because the FDA said this device was approved, the family of Reigel (again who died) could not sue the device manufacturer. Do you follow this?

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"A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine frequently causes more harm than good. The number of people having in-hospital, adverse drug reactions (ADR) to prescribed medicine is 2.2 million. Dr. Richard Besser, of the CDC, in 1995, said the number of unnecessary antibiotics prescribed annually for viral infections was 20 million. Dr. Besser, in 2003, now refers to tens of millions of unnecessary antibiotics. The number of unnecessary medical and surgical procedures performed annually is 7.5 million. The number of people exposed to unnecessary hospitalization annually is 8.9 million. The total number of iatrogenic deaths shown in the following table is 783,936. It is evident that the American medical system is the leading cause of death and injury in the United States. The 2001 heart disease annual death rate is 699,697; the annual cancer death rate, 553,251.

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The US Senate Finance Committee charges that Stanford University failed to properly monitor alleged conflicts of interest involving Alan Schatzberg, who chairs the psychiatry department at Stanford University and who owns about $6 million in stock in Corcept Therapeutics, which participates in a National Institutes of Health study he oversees.
...
In the past, The San Jose Mercury News writes that Schatzberg insisted he is not directly involved in recruiting or testing patents, and discloses his financial interest in paper and talks.

However, in remarks and a letter to Stanford published on 23 June in the Congressional Record, Grassley noted that Stanford requires that Schatzberg disclose stock valued at more than $100,000. Yet Stanford didn’t require him to report profit of $109,000 by selling some Corcept shares in 2005, inform the school that his remaining 2.7 million shares are now worth about $5.8 million.
...
There were other examples of incomlete disclosure cited by Grassley, including in 2002, when Schatzberg didn’t report any income from Johnson & Johnson, but the drugmaker reported to Senate investigators that Schatzberg was paid $22,000 that year. And in 2004, Schatzberg reported receiving between $10,000 to $50,000 from Lilly, while the drugamker reported that Schatzberg was paid more than $52,000 that year.

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an ‘inconclusive’ 2002 study in the Journal of the American Academy of Child and Adolescent Psychiatry on AstraZeneca’s Seroquel was used to devise guidelines for treating bipolar disorder with antipsychotics.

The lead author was Melissa DelBello, a University of Cincinnati professor, who in 2003 received more than $100,000 from AZ, which sells Seroquel and paid her $80,000 in 2004. ... DelBello later reported $100,000 in outside income to the university between 2005 and 2007, although AZ says she was paid $238,000. She collected from other drugmakers, too.
...
Whatever the real numbers, there’s another issue - DelBello receives grant money from the National Institutes of Health and, as Grassley noted, “universities are supposed to monitor conflicts of interest when their researchers receive NIH grants.”
...
The NIH, however, is apparently loathe to do so. Last month, Norka Ruiz Bravo, the NIH deputy director for extramural research, told The New York Times that “for us to try to manage directly the conflict-of-interest of an N.I.H. investigator would be not only inappropriate but pretty much impossible.” She added that “I think (the system) is working to the extent that people are being honest and I think most people are honest.”
...
A University of Cincinnati spokesman, Richard Puff, promised to get back to us, but so far hasn’t.

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The study was completed in 5 months and purported to show that Ketek was as safe as the other treatment.
...
A routine FDA inspection of the practices of the physician who enrolled the most patients — more than 400 — uncovered fraud, including complete fabrication of patient enrollment. The inspector notified FDA criminal investigators, and the physician is currently serving a 57-month sentence in federal prison for her actions. Inspections of nine other sites enrolling high numbers of patients revealed serious violations of trial conduct, raising substantial concerns about the overall integrity of the study. In the end, 4 of the 10 inspected sites were referred for criminal investigation.

Despite these discoveries, FDA managers presented study 3014 to the advisory committee in January 2003 without mentioning the issues of data integrity.1 The managers have stated that they were legally barred from disclosing the problems to the committee because there was an open criminal investigation, but they have not explained why the data were presented at all, in view of the evidence of the study's lack of integrity. Unaware of the integrity problems, the committee voted 11 to 1 to recommend approval of Ketek.

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ORIGINAL: _jjp_

Can i sell cyanide with a claim to cure cancer on the package? It is a truthful statement.

The problem is when you choose to make claims of medicinal benefit you enter that grey area between drug and supplement.

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The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval...

In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, ...

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Previous research had found a similar bias toward reporting positive results for a variety of medications ... But the new analysis, reviewing data from 74 trials involving 12 drugs, is the most thorough to date. And it documents a large difference: while 94 percent of the positive studies found their way into print, just 14 percent of those with disappointing or uncertain results did.

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They found that 37 of 38 trials that the F.D.A. viewed as having positive results were published in journals. The agency viewed as failed or unconvincing 36 other trials, of which 14 made it into journals.

But 11 of those 14 journal articles “conveyed a positive outcome” that was not justified by the underlying F.D.A. review, said the new study’s lead author, Dr. Erick H. Turner, a psychiatrist and former F.D.A. reviewer

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For doctors, he said, “They end up asking, ‘How come these drugs seem to work so well in all these studies, and I’m not getting that response?’ ”

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According to the results of a new study, 10 of the 32 panel members of Food and Drug Administration advisory board who voted that the group of powerful pain killers continue to be sold had ties to the drug markers.

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Nearly one in three experts relied on by the Food and Drug Administration for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict, according to a Public Citizen study that is to appear Wednesday in The Journal of the American Medical Association. Just 1 percent of panelists were excluded because of those conflicts, which can include tens of thousands of dollars in corporate grants, contracts and consulting fees.

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A few weeks ago, devoted listeners of National Public Radio* were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

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A NaturalNews investigation has revealed that the FDA knew as early as 2003 that Human Papilloma Virus (HPV) was not linked to cervical cancer. Despite this knowledge, the FDA, along with key pharmaceutical companies, has continued to push for the use of HPV vaccinations as a defense against cervical cancer, even when its own research showed no link exists.

Today, NaturalNews publishes, "The Great HPV Vaccine Hoax Exposed," a special report that cites from numerous FDA documents and clinical studies to show that HPV vaccines are not only ineffective, they may actually be dangerous! As revealed in the special report, the Gardasil vaccine has been linked to a 44.6% increase in precancerous lesions in some women, raising serious doubts over the sensibility of mandatory vaccination policies.

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(NaturalNews) A group of scientists working in the FDA’s Center for Devices and Radiological Health division has revolted against the corrupt managers of its own department, accusing them of committing crimes by claiming, "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices."
...
The letter from the FDA's own scientists goes on to say, "It is evident that managers at CDRH have deviated from FDA's mission to identify and address underlying problems with medical devices before they cause irreparable harm, and this deviation has placed the American people at risk."

Congressman John, Dingell, chair of the committee which received the letter, went on to charge that these FDA bureaucrats "approved or cleared medical device applications in gross violation of laws and regulations..."