Big Pharma Routinely Suppresses Data from Clinical Trials—but FDA Approves These Dangerous Drugs Anyway!

January 17, 2012
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Drug research, even from clinical trials sponsored by the federal government, is routinely suppressed, according to a new study in the British Medical Journal (BMJ), an international peer-reviewed medical publication. The study found that less than half of all NIH-funded clinical drug trials were published in a medical journal within two and a half years of the trial’s completion—with fully one-third of trial results remaining unpublished even four years after the trial. Why? Because the drug manufacturers didn’t like the data.

One example cited in the study was the FDA-approved diabetes drug Avandia, which in 2007 was found to increase heart attacks and cardiovascular deaths—even though the drug’s maker, GlaxoSmithKline, had known about the risk before the drug was approved. The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.

Not only does this irresponsible practice harm patients, it also increases healthcare costs. Eugene Carragee, a Stanford University orthopedic surgeon and editor-in-chief of the Spine Journal, spearheaded an unprecedented independent analysis showing that the medical device manufacturer Medtronic—not to mention a circle of orthopedic surgeons who received millions of dollars in royalties from the company—systematically failed to report serious complications with Medtronic’s bone-growth stimulating back surgery device known as Infuse. The results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers.

For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing that the drug provided no benefit in improving artery health. During that time, the drug was heavily marketed to consumers in TV ads; the marketing was only halted in 2008 after a congressional investigation was launched.

In 2003, a clinical trial of Multaq, a drug that treated cardiac arrhythmias, was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for atrial fibrillation in certain patients—just not as a means to reduce deaths!

Why does FDA approve drugs whose data have been suppressed by the manufacturer? Is it because FDA depends on Big Pharma for its budget—and needs drug companies to hire former FDA employees. The Wall Street Journal reported that FDA advisers, in a recent vote, said the benefits of four popular Bayer AG birth control pills outweigh the blood clot risk. What the FDA didn’t disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers, or researchers!

Despite the FDA’s bias in favor of drugs and against supplements, there are tremendous shortages of some drugs (though no shortage of supplements—so far!). This drug shortage prompts some hospitals to engage in price gouging, so a drug that usually costs $26 is being offered for $1,200. Moreover, the FDA artificially inflates drug prices—especially generic drug prices, which should be far lower than they are—as we have reported previously.

The shortage in the US drug market also makes foreign counterfeit drugs more popular. Recently, some 65 million counterfeit pills were seized in China; no word yet on how many of them had already made their way to the US.

If this is the way FDA oversees dangerous drugs, what will happen if we give them the same authority over supplements? It’s not just that the agency doesn’t have the knowledge to properly oversee supplements—they also don’t have the capacity. If they can’t keep up with the hundreds of drugs already under their purview, how will they cope with the thousands of supplements on the market? One way, of course, is for them to drastically reduce the number of supplements that can be marketed—one inevitable result of the NDI draft guidelines that we have been campaigning against.

There must be sincere and honest people working for the US Food and Drug Administration, but it is currently being run in a corrupt and incompetent way. It desperately needs to be reformed. Please help us in our ongoing campaign to overhaul the agency by signing our petition to Congress. As we say in the petition, “Everything about the FDA must be taken apart, reviewed, redefined, and re-created so that it supports, not obstructs, the mission of advancing medical science and vibrant good health for all.” Please take action today!

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16 Responses to “Big Pharma Routinely Suppresses Data from Clinical Trials—but FDA Approves These Dangerous Drugs Anyway!”

  1. Marshall Mcdunn says:

    You have created a fantastic document with plenty of reliable information that will serve us all

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  2. Lou says:

    “The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.”

    Folks how can anyone who is cognizant of this criminality take toxic drugs? I have never understood this. Yes it takes a little time to understand your problem and address it by SALUBRIOUS means.

    We have the power to render big pharma and the FDA innocuous by totally rejecting them.

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  3. Janet Burke says:

    I usually lurk on this site, reading initial posts and associated comments, and now would like to share some constructively intended personal observations. I agree most medical research is funded by a larger percentage of corporations than in the past 40 years, but that’s because we repeatedly voted to limit federal and foundation funding. If an individual, such as R Paul, takes office and zaps FDA I am afraid we will set ourselves up to a multitude of high tech snake oil salesmen, which would equal some of our complaints about big pharma. Research has clarified that hemp byproducts are not addictive and can aid in reduction of a vast arry of medical issues, but there is not curative documentation … So what can we do to protect us and ours? Any of us who are ill, no matter what country we live in need to learn about our medicines (big-pharma, traditional Chinese, nutritional, etc.) and the interactions typical of bodies conditions. If you believe in a study, double check the size of the sample group tested and that the folks tested had equalized physical conditions. One test subject who is half your age or four times your age makes me wonder about conclusion validity. The responsibility for our own lives, and debate with our doctors, share our research findings and go for a compromise. I have done this for the past 15 years – if you are willing to take owenership in your care without closing your mind to compromise -even highly educated medical professionals do give in and think. Somehow, when you passively standup for what you believe it also makes you feel better than if you blame others for your issues.

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  4. Hendog says:

    I agree 100% with Sandra Eisner..if you want this CRIME to end we MUST put the man into office who will put a stop to these CRIMINALS! Its Ron Paul or NOBODY. I read the comments on here and it TRULY is CRIMINAL what gets promoted as SAFE MEDICINE..There is a plant like no other that grows like a weed, is NON TOXIC, (which means no matter how much of this you consume it is NOT LIVER TOXIC and in the recorded history of Mankind no one has ever Over Dosed on this all natural substance) there is not another Plant that grows on EARTH that has more Medicinal properties then the CANNABIS HEMP PLANT. this plant is a gift like no other from God and for no other reasons other then GREED this God Send has been demonized and lied about for better then 85 years. What the Hemp Oil does for Cancer/Diabetes/Parkinson/..the list goes on..NOTHING that Big Pharma can produce can hold a match to this all natural NON TOXIC substance..NOTHING! They offer POISON. Liver Toxic health destroying POISONS..aka medicine for the masses. Research the truth about the miracle substance Cannabis Oil..the criminals cannot PATENT this plant and make Billions so they lie about it and lets face it people..DISEASE is a Multi Trillion Dollar Industry and they will be damned and you will be dead before they allow this all natural nontoxic medicine to be able to grow in your backyard. Not only do we need this plant for its medicine..the Food Fiber and FUEL (no more DRILL BABY DRILL) how about Plant Baby Plant!?? Try to find a better plant to provide FUEL FOR EVERYTHING..I’ll save you the time doing the research..Theres not another plant on earth that even comes close..and if you say “What about Corn?” Im going to slap ya. Thats another joke..planting CORN for fuel, which needs chemical fert. to grow. Chemical insecticides to keep it free from bugs..cost a ton to harvest and a ton to manufacture the fuel..and the fuel is CRAP and the Fed. Gov. gives them Tax Payer $ to keep this Operation in “the Green” You know what you get when you utalize the Hemp Plant? NONE OF THE ABOVE. Hell Henry Ford Fueled his first vehicals with it..made his Car Body Panels out of the Cannabis Resin..10X stronger then steel, light weight, cant rust or DENT..Old henry Ford took a Sledge Hammer to the trunk panel and pounded away on it ..bounced right back into shape. He even predicted that the the Hemp Plant was going to be a MULTI BILLION $ industry..(way back then a BILLION was todays TRILLIONS) but along comes the DuPonts and other greedy criminals..and here we are today. This dont need to be..WE MUST STOP THIS. There is only one who can steer this country back to greatness and shine the light of TRUTH on these Cock Roaches..Its DR. RON PAUL or nobody.

       1 likes

  5. susan says:

    I write about this constantly – as a nutritionist I am most concerned about my clients taking drugs instead of taking responsibility for food choices. What is going on with the clowns at the FDA certainly makes me want to shout out to just close the place down. It is getting embarrassing that they even now want to reclassify walnuts as a drug!

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  6. MountainHome says:

    Of course data is going to be suppressed. Great article. Thanks!

       0 likes

  7. I think , we must use supliment on corect balanse. overdose is dangerou.
    and about mental disease patient will be good by eating animal blain
    so animal blain contains good fuctors , i think

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  8. Joan says:

    We knew Big Pharma is only out for money.They will throw anything up on the market.(A year or so later–the lawyers’ ads: “If you have taken this drug and died or become very ill, call us.”
    But for FDA to pass them is TOO ugly.What do we NEED FDA for, if not to guard our food & drugs? Does Big Pharma PAY FDA? Looks that way.
    I know many people who counsel to accept only drugs from at least 20 years ago.Before al THIS.

       0 likes

  9. Chel Stith says:

    I want the Food and Drug Administration to stand up for us and not allow the drug companies to push through their new drugs on us without full disclosure. It is YOUR RESPONSIBILITY to safeguard us.

       0 likes

  10. Mary DeForest says:

    Statins are in every lipid reducing medicine-not just the one you mentioned. Since the late 1990s the FDA, AMA, and specialists have said that statins don’t work. They do permenent damage to the limb muscles-sometimes leading to amputation, damage the kidneys, the new one is that it causes type II diabetis. My legs began feeling heavy. None of the FDA warnings say anything about heaviness in the limbs. I have severe cramps in my feet, legs, and hands.
    They warn about hypothyroid putting the patient more at risk-I have hypothyroid, my doctor was treating me for hypothyroid. In Europe they are required to prescribe CoQ-10. I learned about that after the damage was done.
    I have back spasms from the pain-they think that some Alzhiemer’s patients are suffering from statin side effects. I wish that I could amputate my right lower leg from the pain. Look up He’s worse off than I. He was a NASA MD

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  11. coalmine canary says:

    When I was told I had to take radioactive iodine for a medical condition, I cringed at the thought. Thank God I had some medical terminology background. Based on that, I read studies on the government medical database, http://www.pubmed.gov, where I was shocked at what I found. Of course, this is only the tip of the iceberg:

    I read six (not just one) European study. All of them were unanimous and vociferous:

    “This is an extremely dangerous drug. Side effects of leukemia are widely under-reported. Use this drug only as a last resort, when operations are contra-indicated”.

    The American studies? Again I read about six of them, not just one. Words to this effect: “What a fine drug. The occasional side effect of leukemia may happen, but….”

    Why such a discrepancy?

    A nurse practitioner told me that “the drug studies are done in the pockets of the pharmaceutical industries. They pay major universities for a biased result. People think that because it has the University’s name on it, the study is credible. It’s not necessarily always true”.

    I talked to my doc, who shouted at me and tried to intimidate me into taking the drug. I refused, digging my heels in. I really had to fight him, verbally! Huh?

    Then another practitioner told me:

    The insurance companies “encourage” the doctors to prescribe this drug, because it is a one-time treatment, requires only one hospital overnight stay, there are very few followups needed.

    Hmmmm…..

    I am so glad I refused to take this drug. A friend who had taken it, later came down with ovarian cancer, six months later. She fought it for many years and finally succumbed. Theoretically, this drug would have had nothing to do with that since after all, it “only” causes lymphatic cancer. Yet, tell me that even if she had a medical vulnerability, this drug also did not help it along? Come on, what a lame “excuse” to “beg off” in this way, as the Big PHarma criminals typically do.

    And that is just what they are. Criminals. Jail ought to be legislated for this kind of public deception.

    Another drug was said by a major physician, who I am not going to name, that it caused holes to be punched in peoples’ esophagus as it goes down. Those who developed holes as “Side effect” (what a nice euphemism, eh? More like, organ damage) were lumped into the pre-existing conditions category of the study. So that is how the drug company faked the outcome, said the doc. And the FDA looked the other way! Further, said the doc, this osteoporosis drug barely even works.

    My god!

    Jail those criminals. “First, do no harm” is a medical school oath. Hold them to it! Some of them are even murderers, if you think about it.

       1 likes

  12. I was prescribed a heart muscle medication even though the prescribing physician had not received baseline information on heart function efficiency from my previous medical provider. I obtained results from Echocardiograms dome 5 and 10 years previous which showed no deterioration over that 10 year period. The new physician thought it was a good idea to prescribe something even though I had no complaint coming into the physical exam. I had told the physician: “If it ain’t broke, don’t fix it”. Forget what the patient wants of thinks. Do you know what the difference between a Doctor and God is? God doesn’t think he’s a Doctor.

       1 likes

  13. Bobbi Scogin says:

    What a shame that time and time again, the public is being lied to so that Big Pharma can prosper. Thank you for enlightening us about this. I posted your link to my facebook, so that more people can be informed. I’m glad to see more and more people are becoming aware of the benefits of a good diet and high quality supplements. I believe that the body heals itself when provided with the nutrition which comes from wholesome foods. We need to protect our right to the freedom to choose our supplements without interference from the FDA!

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  14. You are doing great work, and only the power of the internet will enable correct infomation to overcome the enormous misinformation inflicted on the public.
    It is a hard slog but peristence will pay off.
    Once again, Congratulations for your efforts.
    Cheers
    Philip Martin

       0 likes

  15. Sandra Eisner says:

    While in college I took all necessary classes to become a registered dietitian. But, I “butted heads” with the FDA and ADA wa-a-y too much so I ended up with a minor in biochem. (major math/computer science). FDA is one of the agencies Ron Paul wants to do away with. So do I! I’ve found where nutrition & supplements promote health much better than anything Big Pharma wants. That is – to poison us! All they’re interested in is how much money they can make; they don’t care about the patients’ health at all. I’d also like to have grass fed beef, free-ranging eggs, and raw milk (and venison when we could get it). I was raised on these and they didn’t make anyone sick. Also, I do and always have avoided fluoride until I was in my late 40’s. No cavities. The year I turned 60 I had 11. I know the few medical problems I now have are due to malnourishment largely due to FDA “guidelines”. They don’t know what they’re talking about!

       1 likes

  16. Robert Cruder says:

    Many studies are never published because they failed to show any statistically relevant results. Academic partisipants may submit such studies for publication in response to the demand of “publish or perish” but journals are not required to accept them. There is a cottage industry in collecting inconclusive studies and aggregating them to get results of sufficient statistical power to publish. This is called meta-analysis.

    If every unpublished study were an indictment of the hypothesis or the participants then the worst blows would fall on the NIH National Center for Complementary and Alternative Medicine whose grantees have published perhaps a third of the funded studies, some as late as 10 years after the study was completed. They are still handing out grants for homeopathy, chiropractic and healing-touch when none of those have ever published a positive result.

    The NCCAM site relates the results of a study published in the journal Stroke which showed that soy protein supplements containing isoflavones do not significantly reduce the progression of atherosclerosis. At first there appeared to be an average 16% reduction in progression but the sample size was small enough for the few positive responses to have occurred by chance.

    Would you demand that this study receive greater press or does the demand for openness only apply to studies critical of the competition?

       0 likes

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