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  • good science for drug studies

    Step 1: A drug company runs an in-house study (using fraudulent study design from the start) to "prove" that their drug is both safe and effective. If the study produces negative results, it is thrown out. If it produces positive results, proceed to step 2.

    Step 2: That same drug company uses in-house writers ("ghost writers") to write up the results of the study in a favorable light by discarding any data that doesn't fit the desired outcome. Note that these in-house writers are marketing people, not doctors or scientists, and they are on Big Pharma's payroll!

    Step 3: The drug company contacts a noted doctor or academic and offers to pay them a bribe (a "writing fee") to put their name on the paper as if they were the original author. In reality, the paper has already been completely written and the doctor needs to write nothing.

    Step 4: The paper is submitted to peer-reviewed academic journals (such as JAMA) for publication. Since the paper appears to have been independently written by an outside scientist or doctor, the journal is far more likely to consider it credible. Thus, it gets more easily published. The drug company reveals nothing about the true origins of the paper.

    Step 5: The drug company that sponsored all this forwards the peer-reviewed, published study to the FDA, claiming this is now "scientific fact" that proves their drug is both safe and effective. Since the study was published in a peer-reviewed medical journal, it must be true, right?

    Step 6: The FDA, which conducts no drug safety studies of its own, automatically believes the conclusions of the study (since it was published in a credible journal, after all), and therefore approves the drug for sale! From there, the FDA claims its decisions are based on the "gold standard of evidence-based medicine!"

    Step 7: Once the drug is approved by the FDA, the drug company then claims the drug has been declared safe and effective by an independent government agency, and therefore the drug must indeed be both safe and effective. In other words, even though the drug company fabricated much of the evidence used by the FDA to make their approval decision, the drug company still claims that the FDA's decision is an independent, science-based approval of their drug! Furthermore, the drug companies are now arguing that FDA approval should immunize them from any lawsuits or claims of harm stemming from their drugs. Amazing, huh?

    From here, doctors are medical personnel are taught that the drug is backed by good science and that the FDA has independently reviewed the evidence and approved the drug. Therefore, it's safe to prescribe to patients. What nobody has been told, however, is that the entire process -- from the drug studies to drug approvals -- was fabricated!
    "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

  • #2
    Gine, I cant be bothered to address all of the lies that you see fit to quote on this forum, but the blow is part of my speciality, s olet me put a few things straight. Not that I expect you to enter a discussion, because you never do, but just for the record:

    Originally posted by Gina View Post
    Step 1: A drug company runs an in-house study (using fraudulent study design from the start) to "prove" that their drug is both safe and effective. If the study produces negative results, it is thrown out. If it produces positive results, proceed to step 2.
    You forget: If the result is negative, discontinue the development of the drug, or improve it.

    Step 2: That same drug company uses in-house writers ("ghost writers") to write up the results of the study in a favorable light by discarding any data that doesn't fit the desired outcome. Note that these in-house writers are marketing people, not doctors or scientists, and they are on Big Pharma's payroll!
    Actually, no. The marketing people only come in after the drug is approved. You see, the medical community is not so easily fooled, so it is only when you want to advertise for the general populace that the spin-doctors are useful.

    Step 3: The drug company contacts a noted doctor or academic and offers to pay them a bribe (a "writing fee") to put their name on the paper as if they were the original author. In reality, the paper has already been completely written and the doctor needs to write nothing.
    If you can document such a case, I suggest you bring it to the attention of the proper authorities. That doctor will be in big trouble. They do, however, have ghost writers to do the basic writing, since being an excellen doctor is not the same as being good with words. The scientific content remains the responsibility of the doctor, and if he/she signs something that is false, he not only risks loosing his professional credibility and his job, he also faces legal actions.

    Step 4: The paper is submitted to peer-reviewed academic journals (such as JAMA) for publication. Since the paper appears to have been independently written by an outside scientist or doctor, the journal is far more likely to consider it credible. Thus, it gets more easily published. The drug company reveals nothing about the true origins of the paper.
    The ghose writer's name will appear on the author list.

    Step 5: The drug company that sponsored all this forwards the peer-reviewed, published study to the FDA, claiming this is now "scientific fact" that proves their drug is both safe and effective. Since the study was published in a peer-reviewed medical journal, it must be true, right?
    Wrong. The FDA (and authorities elswhere in the world) do not approve drugs based on articles in journals. The pharmaceutical company must forward all its original research results and reports to them. Nowadays, the FDA require this to be in electronic form, but formerly this would, for a new drug (as opposed to a copy of an already approved one), constitute hundreds of pounds of paper! The authority then audits this material, however, even if the material looks good, the company itself must also have an approval and be under regular audit.

    Step 6: The FDA, which conducts no drug safety studies of its own, automatically believes the conclusions of the study (since it was published in a credible journal, after all), and therefore approves the drug for sale! From there, the FDA claims its decisions are based on the "gold standard of evidence-based medicine!"
    No. See above.

    Step 7: Once the drug is approved by the FDA, the drug company then claims the drug has been declared safe and effective by an independent government agency, and therefore the drug must indeed be both safe and effective. In other words, even though the drug company fabricated much of the evidence used by the FDA to make their approval decision, the drug company still claims that the FDA's decision is an independent, science-based approval of their drug! Furthermore, the drug companies are now arguing that FDA approval should immunize them from any lawsuits or claims of harm stemming from their drugs. Amazing, huh?
    That is amazing. And the courts seem unimpressed, as they certainly should.

    From here, doctors are medical personnel are taught that the drug is backed by good science and that the FDA has independently reviewed the evidence and approved the drug. Therefore, it's safe to prescribe to patients. What nobody has been told, however, is that the entire process -- from the drug studies to drug approvals -- was fabricated!
    It is not possible to fabricate all this. And the implications, if someone did and was found out, would be devastating.

    Hans
    Last edited by MRC_Hans; 8th October 2008, 10:34 AM. Reason: Typos
    You have a right to your own opinion, but not to your own facts.

    Comment


    • #3
      Not a fabrication
      Lets look at just ONE EXAMPLE of drug fraud;
      The Financial Times reported in January 2005 that the total number of Vioxx deaths may have been underestimated in this original FDA report. The FDA now reportedly estimates that the total number of US Vioxx deaths may be between 89,000 and 140,000. This data has not yet been officially published by the federal government, though top FDA experts have publicly acknowledged these Vioxx deaths estimates. Worldwide Vioxx deaths are estimated to be between 150,000 and 200,000, though these estimates have not been confirmed officially.
      For years Merck had denied concerns that Vioxx posed a great threat to patient's cardiovascular safety. Had they acknowledged these concerns as they developed, many Vioxx deaths might have been avoided. Hundreds of suits have already been filed on behalf of those that have suffered greatly

      The Annals of Internal Medicine has followed up on a study published earlier this year in JAMA by the same authors, detailing a specific account of how Merck fraudulently concocted a major Vioxx study as a marketing campaign.

      Vioxx left tens of thousands of Americans dead.

      The class action lawsuits around Vioxx have centered around financial compensation for individuals and families that can prove Vioxx was the cause of a heart-related problem – which is not that easy to prove even if it is true.
      Merck has done everything in its power to limit the extent of the financial damage.
      Much of the data in the new study comes from these legal cases, and many questions about Merck remain unanswered.

      The researchers concluded the following about a key Vioxx study: “The trial was designed by Merck’s marketing division to fulfill a marketing objective;

      Merck’s marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination;

      and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members.”

      It is likely that this type of con game permeates the pharmaceutical industry and will continue to do so until drug company executives have criminal charges pressed against them by the Justice Department.

      Until that time liability-related lawsuits are simply a cost of doing business and are built into the sale price of the drug. Sending executives to jail for involuntary manslaughter would send a different message to the executive ranks of these drug companies, and safety for patients would improve immediately.

      Don’t expect help from the FDA, who let Vioxx on the market without proper warnings.

      The FDA has sided with drug companies and wants to prevent all patient law suits against Big Pharma.

      Since the Justice Department, FDA lawyers, and the White House are all on the same page – don’t expect justice any time soon. Vioxx has been off the market for some time. Merck is currently in the middle of trying to downplay its multi-billion dollar Vytorin fraud – the cholesterol-lowering drug that lowers numbers on paper and makes health worse.
      "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

      Comment


      • #4
        the drug companies are now arguing that FDA approval should immunize them from any lawsuits or claims of harm stemming from their drugs. Amazing, huh?

        here is the bill:

        HR.2900 S.1082

        On Wednesday, July 11, 2007 the House passed HR.2900 Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company.

        Both the House and Senate (S.1082) have made the fatally flawed assumption that the reason for so many deaths and injuries from drugs was due to the FDA's lack of resources. In reality, it is the INTENTION of FDA management that is the problem, combined with the simple fact that multiple drugs are extremely toxic and don't work as advertised. Giving the FDA more power and money will only cause the agency to speed more drugs onto the market faster with even less safety testing -- while abusing its power and actively stamping out competition to drugs.
        "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

        Comment


        • #5
          More Drug fraud not a fabrication Hans

          Lets look at another drug

          February 17th, 60 Minutes.(Public Tv USA)
          Randone was given Bayer Pharmaceutical's Trasylol to reduce blood loss during surgery. There are other reliable drugs that do the same thing at about $50 per unit but for some reason the $1,000 Trasylol was given.

          Trasylol was taken off the market last November in what Mrs. Randone's attorney, Marc Bern believes may be the next case of Vioxx.


          The FDA allowed the drug to stay on the market even after researcher Dr. Dennis Mangano warned an advisory committee that Trasylol doubled the risk of kidney and heart failure and had a 181 percent risk in the increase for stroke.

          Dr. Mangano says between the time of his published study in January, 2006 and November, 2007 when Trasylol was finally taken off the market,

          22,000 lives had been lost.

          His study, published in the New England Journal of Medicine in January 2006........................................
          "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

          Comment


          • #6
            Well Gina, I don't have the energy, nor inclination to address all that. You can spam stuff faster than I can ever hope to answer.

            Now, let's move on:

            Let us say you have made your point about conventional medicine, and I will concede that while I find your claims grossly exaggarated, then certainly all is not as it should be in the pharma industry (nothing new in this, I have always agreed to that).

            Now, please tell me:

            1) Who write and design the trials for homeopathy?

            2) Who approve those trials and their results?

            3) Who keep track of adverse events for homeopathy?

            There is more, but these will suffice for starters.

            Now is your chance to show that you can do more than spam.

            Hans
            You have a right to your own opinion, but not to your own facts.

            Comment


            • #7
              Hans posted:
              "I find your claims grossly exaggarated,....................................."


              Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists (opinion)

              There is lots more Hans,not a problem digging it up for you
              Merck
              drug companies | statins | prescription drugs | prescription drug profits | medical racket | pharmaceutical companies | medical fraud | Pfizer | statin drugs | corruption | bad medicine | pharmaceuticals | pharmaceutical industry | drug company profits
              "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

              Comment


              • #8
                Yes, yes, I already noted that there is plenty of dirt to dig up. Now, would you care to answer my questions, above?

                Hans
                You have a right to your own opinion, but not to your own facts.

                Comment


                • #9
                  Hans posted:
                  "You forget: If the result is negative, discontinue the development of the drug, or improve it."


                  Are you sure?

                  HPV Vaccine Victims Pile Up: $1.5B For MerckOctober 17, 2008Barbara Loe Fisher
                  "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

                  Comment


                  • #10
                    Is this true?
                    Is there an explanation as to how this has been allowed to happen? There can be no justification!
                    On so many occasions?
                    Surely once is tragic enough!
                    What steps is the pharmaceutical industry taking to ENSURE this sort of thing NEVER happens again?
                    What legislative safeguards are being put in place?

                    When we read statistics like these, it is all too easy to forget that each statistic represents a person with a life - with a family and friends.
                    HOW ON EARTH ARE THESE COMPANIES STILL TRADING?
                    By passing the cost on to the consumer?
                    Imagine if any other company was responsible for 89,000 deaths! - an airline for example!
                    I hope the individuals responsible for failing to prevent this tragedy were held suitably accountable!
                    These are my personal views and not necessarily my professional views.The content is for informational purposes only and should not be construed as medical advice. ALWAYS CONSULT YOUR LOCAL PHYSICIAN.

                    Comment


                    • #11
                      Medical fraud

                      ‘This is Medical Progress?’

                      Even the AMA wrote an article in the Journal, entitled ‘This is Medical Progress?
                      The questions posed were the following:
                      · Has the wide use of antibiotics led to the emergence of new resistant bacterial strains?
                      · Has the ecology of ‘natural’ or ‘hospital’ bacterial flora been shifted because of antibiotics use?
                      · Have nosocomial infections changed in incidence or severity due to antibiotic use?
                      · What are the trends of antibiotic use?
                      · Is the increasingly more frequent use of antibiotics presenting the medical community and the public with a new set of hazards that should be approached by some new administrative or educational measures?
                      · Are antibiotics used properly in practice?
                      Most of these questions can be answered in the affirmative, except of course the last, which deserves a loud and definitive NO! One of the conclusions arrived at was:
                      ‘Along with the dramatic decline in the rates of formerly lethal diseases, new and major hazards have also emerged, due to antibiotic therapy.’

                      This proves that the AMA is well aware of the deleterious effects and could easily understand the thesis. Simultaneously, we see they treat the issue as an administrative formality – as good bookkeepers are apt to do.
                      Do not accept or reject anything before you have investigated it and that on its own merits.

                      Comment


                      • #12
                        medical fraud 2

                        Failures to Test

                        Is it possible that drugs have been used in human organisms without being properly tested for long-term effects?
                        The most classical examples of adverse long-term effects from drugs that were supposedly tested properly are the following:
                        · Thalomide, which circulated in the 1950’s as a tranquiliser and produced the well-documented genetic defect known as phocomelia.
                        (Vithoulkas G. Homeopathy, Science for the New Man)

                        Of course phocomelia does not sound too bad and is a nice euphemism for severely malformed arms and legs. Hands sticking directly out of the shoulders are no exception and none of the thalomide victims can properly walk, since they do not have any legs or if they do, they are severely mal-formed. Back in those days it was an enormous scandal and many people were affected.

                        · Phenylbutazone is an anti-inflammatory drug, which produces suppression of the bone marrow. In 1983, the fact that 1200 deaths were attributable to this drug was kept quiet. The drug is still in use, although there is no apparent need for it, according to the WHO.
                        · Indoprophene, an anti-inflammatory drug taken off the market in 1985, because of certain allusions to the drug’s carcinogenesis.
                        · Clioquinol, an anti-diarrhoeic drug. On the record in Japan alone, there were 11,000 disability cases and 1,000 deaths. The major adverse effect was that it caused SMON (another abracadabra abbreviation, meaning Syndrome of Myelo-Optic Neuropathy. This indicates myelin damage to the optic nerve, causing blindness).
                        · Phenacetin, an analgesic that produces renal insufficiency.
                        · Several anti-conception pills have been taken off the market, due to their side effects and several others should be taken off, according to a 1999 survey in the UK, where it was found that women who use the pill run a much greater risk of breast cancer or cancer of the cervix.
                        · In 2005/2006 Merck was taken to court and ordered to pay $ 50 million to a man who suffered a heart attack from taking Vioxx.
                        (Vithoulkas G. Homeopathy, Science for the New Man)

                        Naturally, there are many more cases, but these suffice to impress upon the reader that drugs have oftener been indicated as too dangerous, without the Medical-Pharmaceutical Industrial Empire ever putting any effort in proper research. Rather they take their chances and hope the damage is not too large. That they also take their chances with your health does not enter their minds. They are more concerned with satisfying the shareholders.
                        Tests cost a lot of money and tests on long-term effects are even more expensive. To invest in them requires people to do and evaluate the tests, it requires labs and equipment, it requires above all, quite a lot of time and effort, without any benefit for the Industry whatsoever, for too many drugs would no longer pass the registrational red tape and be useless for the market. That they are useless for the market anyway is not a worry, for they have been approved.
                        Approval is granted all too easily, because there is never a demand for second trials, unless it is all too obviously needed. Those second trials are never conducted by an independent body and it is quietly assumed that the Industry will regulate itself. It is asking the fox to guard the chook pen. For who is controlling the controllers? The registration bodies are peopled with ex-industry captains and show little muscle in their demands for proper testing.
                        Such collusion of interests should raise the hackles of any researcher and any Government official and lead to demands of a thorough investigation. However, too many are in the pocket of the industry, often by the simple mechanism of holding stock in the Industry. Again we are left with the consumer as the enforcer of radical change. Only the people are able to make those changes by voting with their feet and their wallets. Whether such will happen depends on the courage people have to demand their inalienable rights and the ability to organise their revolt, in case these rights are refused.
                        Cooked Reports

                        The FDA investigations turned up various sorry aspects of what is touted as research: the submission of detailed reports and claims involving a series of two patients only. Claims of therapeutic miracles on patients who had not been adequately diagnosed. Physicians acting as surrogate drug company experts, who were delighted – at a price – to sign any endorsement, provided that somebody would tell them what to report.

                        · Some drug companies go so far as to design the ‘clinical experiment’, write the testing physician’s reports and then pay him for the use of his name.
                        · During the past few years it has been reported that cancer of the vagina – ordinarily an exceedingly rare type of cancer – has been detected in almost 100 young girls, whose mothers had been given Stilbestrol to prevent an apparently imminent spontaneous abortion. The first use of the drug for this purpose dates back to 1946. In 1953 two controlled trials demonstrated its complete lack of efficacy on the miscarriage. Yet the director of the Clinical Centre of the National Institute of Health testified that in the late 1940’s, the 1950’s and 1960’s, without any proof of benefit, thousands of women underwent Stilbestrol therapy.
                        · The increase in the use of drugs for both short-term and long-term treatment during the past decades has led to a corresponding increase in concern about their potential for inducing serious illnesses – illnesses that are potentially life-threatening or otherwise produce substantial incapacity, disability or death.
                        · Dr. Ley, Goddard’s immediate successor at the helm of the Food and Drug Administration, told at a hearing before the US Senate of one spot check, which turned up the case of the assistant professor of medicine who had reputedly tested 24 drugs for 9 different companies. ‘Patients who died while on clinical trials were not reported to the sponsor, an audit revealed. Dead people were listed as subjects of testing.
                        · ‘People reported as subjects of testing were not in the hospital at the time of the tests. Patient consent forms bore dates indicating they were signed by the subjects after the subjects died.’
                        · He also reports that in studies conducted by one commercial drug-testing firm, ‘patients who died, left the hospital or dropped out of the study were replaced by other patients in the tests without notification in the records. Over 40 people reported as participants in those studies were either dead or not in the hospital at the time of testing and during the entire study.’
                        (Vithoulkas G. Homeopathy, Science for the New Man)


                        We can see from these few examples that Pharmaceutical companies, when it suits their strategy, are willing to bend the rules for proper testing, publish false reports and follow unethical practises. We also know that such practises are common occurrences, of which we have given but few examples. There are many more instances where such practises are commonly occurring. There are so many, that we consider the tendency presented here to be sufficient to impress the reader of the seriousness of the problem.
                        Do not accept or reject anything before you have investigated it and that on its own merits.

                        Comment


                        • #13
                          Dear Kaviraj
                          Welcome,Thanks for your imput,well said!And so true!

                          Are you the same Kaviraj as
                          Vaikunthanath das Kaviraj? Author of "Homeopathy for Farm and Garden"?
                          The book is brilliant!
                          "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

                          Comment


                          • #14
                            Nuremberg Trials: Big Pharma's Crimes Against Humanity
                            After World War Two, scores of suspected Nazi war criminals were prosecuted by the Allies in the Palace of Justice in the city of Nuremberg, the birth-place of the Nazi Party.
                            IG Farben, Interessengemeinschaft Farben, (Association of Common Interests), became a powerful cartel of German chemical and pharmaceutical companies such as Bayer

                            A Thousand Patients Killed Each Month by Cardiac Bypass Anti-Bleeding Drug

                            8/13/2008 - (NaturalNews) The FDA's delay in taking Trasylol off the market led to 1,000 deaths each month for a year and a half,.............................................


                            (the aspirin manufacturer), BASF, AGFA, and Hoechst (now known as Aventis.) By 1933, the IG Farben group had become the largest chemical and pharmaceutical corporation in the world.

                            And even today, although it doesn't use the name IG Farben, its companies remain the most powerful transnationals on the planet in pharmaceuticals, chemicals, and agro-chemicals......................................... .....read entire article
                            "Great ideas often recieve violent opposition from mediocre minds"...................Einstein

                            Comment


                            • #15
                              The same Kaviraj

                              Yes Gina, I am that man who wrote homoeopathy for farm and garden.
                              Hence on the other thread i made reference to the placebo effect on plants.
                              us great magicians - hahahaha.
                              The point is that those who like to dismiss homoeopathy as moonshine medicine do not really care to understand - as should be clear from these threads.
                              They simply want to peddle their ignorance of the subject and not answer any serious questions.
                              If you give them quotes, they want you to say something yourself: if you do that, they want quotes.
                              They dont even realise that quoting previous authorities is how science works, but if you neglect that aspect they attack you for it.
                              What most of them also not realise is that healing is an art and not a science.
                              Do not accept or reject anything before you have investigated it and that on its own merits.

                              Comment

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