clinical trials

  1. FDA cover-up… EXPOSING you to BIG risks? [Shocking New Report]

    If the FDA ever shut down… it would be an improvement!

    Because they’re not just FAILING to PROTECT you.

    No, my friend, it’s gone FAR past that point.

    These creeps are actively working AGAINST you

    AIDING and ABETTING a massive Big Pharma fraud to rob you of both your dollars and your health.

    A new report blows the lid off the industry’s worst-kept secret

    EXPOSING how the FDA literally looks the other way when it discovers shenanigans in drug trials.

    It shows why you should never… ever… EVER… trust that “hot” new drug on the market.

    Heck, when you see what I’m about to share today, you might NEVER trust ANY medication EVER again!

    The UGLY TRUTH about drug research misconduct

    A staggering new report in JAMA finds that every single year, the FDA uncovers some 200 cases of research misconduct in clinical trials during its site inspections.

    Those cases include 3 of the biggest sins in medical research:

    1. FAILURE to obtain informed consent
    2. FALSIFICATION of data, and
    3. VIOLATIONS in adverse event reporting.

    But instead of coming down hard on these crooks…

    The feds COVER FOR THEM! They say it’s “confidential commercial information”… and don’t breathe a word of it.

    Yeah, outright lies are now protected by YOUR government -- because they’re CORPORATE secrets.

    They’ve chosen a side here… and it’s not yours.

    We’re not talking MINOR violations, either.

    In one instance, FDA inspectors found misconduct including FRAUD at 24 of 36 research sites in China where the anticoagulant drug apixaban was under study.

    The companies behind the drug said excluding the data would ruin the study. So, guess what? The feds let them publish the data with NO MENTION of the problems they uncovered.

    This study… built around FRAUDULENT data… has now been cited close to 7,000 times.

    It was even used to create clinical guidelines!

    In another case, the feds found widespread data FAKERY

    Including omitting HUNDREDS of serious adverse side effects for the anticoagulant drug rivaroxaban.

    Same deal with this study as with the other one I just mentioned.

    It got published anyway… it’s been cited more than 1,000 times… and it’s been used in clinical guidelines.

    Those are just 2 of the more than 200 times this happens EVERY YEAR.

    Now, there may be NOTHING you can do to change this SHADY system

    But there’s PLENTY you can do to protect yourself.

    Start by giving yourself the most important “medicine” of all: a heaping dose of skepticism.

    As the study shows, FDA approvals… glowing media reports… slick TV ads… and even your own doctor’s advice are ALL built around those clearly crooked studies.

    Tune it all out.

    If you’re in good health, thank your lucky stars… then work to keep it that way. Eat right… take your vitamins… and get out of the house a little each day.

    If you’re facing something, start with the basics -- lifestyle changes first and non-drug treatments second.

    And if that fails, NEVER get hoodwinked into “newer, better” drugs – not when an old standby is available.

    I’m not saying the old drugs are great. Many aren’t.

    But they’ve been around a while – and that means there’ve likely been MORE studies, giving you a much clearer picture about BOTH the benefits AND the risks.

    At least then you can make an informed decision.

    In Your Corner,

    Dr. Allan Spreen

  2. The Good, the Bad and the Ugly about the H1N1 vaccine

    The H1N1 virus (swine flu) has had a relatively mild run in the U.S. so far, with about 550 virus-related deaths reported to the CDC. Worldwide, it's caused about 2,000 deaths.

    Unfortunately, we haven't seen the end of H1N1. Government officials say as many as 60 million Americans could get hit with the virus this winter.

    But don't worry. The CDC has it under control. The new H1N1 vaccine will protect you from this deadly pandemic!

    Officials at the CDC plan to have 45 million doses of it ready by October 15th for when flu season starts to take off. Plus, the government will keep pumping out 20 million doses a week throughout flu season. Eventually, the CDC hopes to vaccinate millions of Americans against the virus.

    (Plus, if they think they're running short on supplies...there's a little something called an adjuvant that they can add to the vaccine to make it stretch. More on that pearl of an ingredient in a moment.)

    The CDC wants children (and their caregivers) and pregnant women to get vaccinated first. Then they want to move on to adults between the ages 25 and 64 who have compromised immune systems. Why aren't older adults on that list, you ask? Well, that's because a similar H1N1 flu went around in 1957, so anyone born before then may already have some immunity to the virus.

    Questions about efficacy and safety
    Now, I know that the H1N1 virus has got a lot of you worried. But here's something to keep in mind as you hear the word "pandemic" thrown around by newscasters urging you to get the H1N1 vaccine this fall.

    Roughly 36,000 Americans die each year because of complications due to the seasonal flu. Even if the swine flu reaches that scale this winter -- which it won't -- it's still a bad idea to get the new vaccine.

    First of all, just because you get the new vaccine, doesn't mean that you're 100 percent protected against the H1N1 virus. You could still get it. In fact, the government has been pretty cagey about the vaccine's effectiveness. You won't find them going on record anywhere giving us any real data about how effective the H1N1 vaccine will be. The best offer you'll hear is that it will be about as effective as the seasonal flu vaccine. And maybe that's why about half of one group of care workers -- when surveyed -- said they won't get the H1N1 vaccine when it's ready.

    Safe as mother's milk?
    I also have serious questions about the vaccine's safety. Clinical trials for the vaccine involving adults and children began in July. In Maryland, officials had to sweeten the deal to encourage mothers to enroll their children in the clinical trial. In fact, they are handing out a $40 gift card to Target every time a mother brings her child into the clinic.

    Before it's all said and done, the vaccine will get tested only on about 4,500 human guinea pigs before rolling out to millions of Americans. But don't worry, in an August teleconference, government officials said the vaccine appears to be safe with no serious side effects. Riiight.

    Remind many people have been given the vaccines...4,500? And how long have we been watching these people for adverse effects...three months?

    Okay, so based on a sample of 4,500 people, we'll know everything there is to know about the long-term effects of this vaccine by mid-October!

    Heck! It took me longer to paint my house than it will take the CDC to develop, test, and market this brand-spanking-new vaccine that will be given to millions of Americans. I guess the government can be efficient when it wants to be.

    It's just that I don't have a whole lot of faith in our government or the drug makers to get this right. First of all, the last time they pushed through a vaccine for the swine flu, the vaccine caused a paralyzing condition called Guillain-Barre Syndrome. How do we know the kind of same thing won't happen with the 2009 vaccine?

    In fact, it's possible that the H1N1 vaccine will roll out to the general public before the FDA's even had a chance to review all the data from this summer's clinical trials!

    To be continued...
    Next week, I'll continue my rant about the H1N1 vaccine. I'll also tell you all about a dangerous ingredient called an adjuvant the government may add to the vaccine to make it more potent.

    Plus, the head of the Department of Health and Human Services has enacted a law that protects Big Pharma from any lawsuits brought against the new vaccine. So even if the H1N1 vaccine kills thousands of people, the drug companies can't be sued. Learn all about Big Pharma's big fat carte blanche next week, plus how you can protect yourself against H1N1 without getting the vaccine.

  3. The art of misdirection

    I’m not a salesman. In fact, I’m pretty sure I couldn’t sell water in the Sahara. But there’s one thing I do know about sales: the glossier the sales pitch, the shoddier the product. That’s certainly true of antidepressants on the market today. These slick ad campaigns pull you in and get you thinking, “Maybe I do need a pick-me-up.” Just take one little pill and you’ll turn into a happy, bouncing, smiley face again. It’s called the art of misdirection. Magicians have used it for centuries. They get your attention with a flourish of their right hand, so you won’t see what’s in the left. Drug makers know their antidepressant doesn’t work much better than a placebo, but golly those ads are so darn cute. Plus, drug makers now have a new tactic: once you get FDA approval, just throw away any data that doesn’t support your product. In essence that’s what drug makers did for about a third of all the data they collected during clinical trials of many different antidepressant drugs. That’s according to a report out in last month’s Journal of American Medicine analyzing data for 12 different drugs in 74 clinical trials. I wanna know what’s in Big Pharma‘s trashcan I know, you’re wondering how can 1/3 of the data just—poof—disappear. Well, it’s much easier than you think. Let me explain… If you review all the published data on antidepressants, you’ll see that about 60 percent of people taking them experience significant relief from depression. About 40 percent of people taking a placebo start to feel better. Not bad, right? The drugs work about 20 percent better than a sugar pill. Well, it turns out, that’s not the whole story. Drug makers must conduct dozens of clinical trials before getting FDA approval. Some of the results get published in medical journals and some just get filed away in a cabinet, never to be seen again. Any guesses which studies get filed away? You got it, the ones that don’t make you “happy.” In fact, according to the JAMA report, 94 percent of studies showing positive results for antidepressants got published. Meanwhile, just 14 percent of those with disappointing or uncertain results got published. So when you take the negative results into account, antidepressants sound far less appealing. The drugs still outperform placebos, but by a far more modest margin. To be honest, I doubt the integrity of most of the data on antidepressants (published or unpublished!). Drug companies certainly are masters of “misdirection,” but don’t be fooled. You can overcome depression without drugs. Ideally, depression can be averted by following a nutritious diet. One of the best ways to maintain your mood and sense of well-being on a day to day basis is to get more omega-3 fatty acids. In fact, according to a new study published in the journal Nutrition, women who have the highest intake of omega-3 fatty acids reduce their depression by nearly 30 percent! When you consider that many popular SSRI antidepressant drugs (selective serotonin reuptake inhibitors) barely outperform sugar pills in clinical testing, a regimen of omega-3 fatty acids might be a better alternative, especially for someone suffering from mild or moderate depression. We talked about fatty acids in the Guide to Good Health from two weeks ago. Fish oil is the best source. But most of us don’t eat enough fish to really boost omega-3s, so I usually recommend a high-quality fish oil supplement. But, remember fatty acids increase free radicals in your body. Unchecked, these molecules can cause cancer and disease in the body. So always take some extra antioxidants like vitamin E and selenium along with the fish oil to neutralize the free radicals. What about supplements? If depression‘s really got a hold of you, you must get help from a qualified physician. However, there are non-prescription alternatives that can be most helpful, such as taking St. John’s Wort. Ignore the naysayers because there’s plenty of hard data showing that it does give you a boost. I’d go for 300 mg of a 0.3% standardized extract three times a day. Avoid amino acid supplements and extended sun exposure during the trial, as these may lessen the therapeutic effect. Unlike antidepressant drugs, which can take 30 days to take effect, St. John’s Wort starts working in a few days. You could also try the amino acid SAMe (s-adenosylmethionine) at 400 to 1200 mg/per day. It’s more expensive than St. John’s Wort, but highly effective and has been used a lot in Europe to naturally correct depression. Some nutritionists believe it’s best suited to treat depression expressed as low energy and low motivation unrelated to anxiety. Tryptophan and DLPA (dl-phenylalanine) are two more amino acids that can be effective in improving depression if taken between meals (but not along with the other efforts). Given the safety issues and efficacy questions for most prescription drugs on the market, you’re much smarter to give these natural options a try first. In my opinion, they’re just as effective—and much safer—than any RX solutions.

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