UnfoldingSky Posted September 24, 2014 Share Posted September 24, 2014 http://torontostar.newspaperdirect.com/epaper/viewer.aspx TOP DOCTORS BURY DRUG TRIAL PROBLEMS Researchers have risked patient safety, failed to report serious side-effects that their human test subjects suffered, botched scientific research of drugs — and Canadians would have no idea without records from the U.S. FDAHealth Canada only began its trial inspection program in 2002, and the data the regulator makes available shows it has not met its goal of inspecting 2 per cent of the country’s trials each year. Top Canadian doctors running clinical drug trials failed to report serious side-effects suffered by their human test subjects. The doctors, some of them esteemed researchers from Canada’s most prestigious hospitals and academic institutions, have also routinely broken rules designed to protect participants and botched research of new treatments. Using records obtained through U.S. freedom of information legislation, a Star investigation has found the following problems in the system designed to ensure new drugs are safe and effective: In 2012, a top Toronto cancer researcher failed to report a respiratory tract infection, severe vomiting and other adverse events. A clinical trial run by an Alberta doctor reported that patients responded more favourably to the treatment than they actually did. A Toronto hospital’s chief of medical staff ran a clinical trial of autistic children on a powerful antipsychotic, and he did not report side-effects suffered by four of the children. Numerous doctors across the country failed to tell participants that one of the goals of clinical trials was to test the safety of the drug they were taking. Health Canada inspects a small number of the 4,000 drug trials running at any one time across the country. The inspection results are kept secret. But the Star was able to learn about problems with some of the trials through records from the U.S. Food and Drug Administration. This is because the experiments, run by Canadian doctors and involving Canadian test subjects, were used to see if a drug was safe for the U.S. market and were therefore open to inspection by the FDA. Many of the drugs have also been approved in Canada. More at above link... I am not a medical professional and nothing I say is a medical opinion or meant to be medical advice, please seek a competent and trusted medical professional to consult for all medical decisions. Link to comment Share on other sites More sharing options...
btdt Posted September 24, 2014 Share Posted September 24, 2014 I am not seeing anything at the link... looked it up... http://torontostar.newspaperdirect.com/epaper/viewer.aspx "the FDA inspector uncovered a series of problems with the trial, including one the FDA said was “extremely” concerning: Patient information submitted by the pharmaceutical company to the FDA (to get the drug tamoxifen approved to treat cancer) did not match medical records found in Paterson’s possession. In several cases, the copies given to the regulator suggested the treatment worked better than the doctor’s own progress notes indicated. The inspection also found “possibly ineligible patients being enrolled in the study . . . and patients being incorrectly dosed.” Speaking to the Star, Paterson chalked some of the findings up to an “out-of-his-depth” inspector with no clinical trial experience and who used the most up-to-date standards to grade a study started years earlier. In one case, the inspector’s report says, the record submitted by the drug company said the patient’s response to the treatment involved “no change.” This was in direct conflict with the doctor’s record" I am wondering if inspectors go to the test subjects and ask them... I think they should. There has been a change in our health care in Canada in the last twenty years it has gone down the tubes. "The lawsuit went after three Hamilton institutions: McMaster University, Hamilton Health Sciences and Population Health Research Institute, a centre jointly operated by the university and the hospital network and that runs clinical trials in Canada and across the world. The institute’s Drs. Stuart Connolly and Salim Yusuf led the sole clinical trial for Pradaxa that played a significant role in the drug being approved in the United States and Canada. The lawsuit alleged the clinical trial failed to report side-effects and produced “tainted data” to get the drug approved. The road to Pradaxa’s approval had been bumpy." Think I would be not confident in taking this drug... just me I guess. "n May, Boehringer announced it would pay $650 million to settle 4,000 lawsuits against Pradaxa, emphasizing in a press release that it stands firmly behind the safety of the drug. The lawsuit naming the Hamilton institutions is one of them. The institutions told the Star they had no comment as the settlement process “is not complete.” They said they have “complete confidence” in the research." WARNING THIS WILL BE LONG Had a car accident in 85 Codeine was the pain med when I was release from hosp continuous use till 89 Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above. One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking. As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. http://survivingantidepressants.org/index.php?/topic/1096-introducing-myself-btdt/ There is a crack in everything ..That's how the light gets in Link to comment Share on other sites More sharing options...
btdt Posted September 24, 2014 Share Posted September 24, 2014 seriously now you link is working.. wth... ??? who know the glitches and mysteries of the internet are endless... WARNING THIS WILL BE LONG Had a car accident in 85 Codeine was the pain med when I was release from hosp continuous use till 89 Given PROZAC by a specialist to help with nerve pain in my leg 89-90 not sure which year Was not told a thing about it being a psych med thought it was a pain killer no info about psych side effects I went nuts had hallucinations. As I had a head injury and was diagnosed with a concussion in 85 I was sent to a head injury clinic in 1990 five years after the accident. I don't think they knew I had been on prozac I did not think it a big deal and never did finish the bottle of pills. I had tests of course lots of them. Was put into a pain clinic and given amitriptyline which stopped the withdrawal but had many side effects. But I could sleep something I had not done in a very long time the pain lessened. My mother got cancer in 94 they switched my meds to Zoloft to help deal with this pressure as I was her main care giver she died in 96. I stopped zoloft in 96 had withdrawal was put on paxil went nutty quit it ct put on resperidol quit it ct had withdrawal was put on Effexor... 2years later celexa was added 20mg then increased to 40mg huge personality change went wild. Did too fast taper off Celexa 05 as I felt unwell for a long time prior... quit Effexor 150mg ct 07 found ****** 8 months into withdrawal learned some things was banned from there in 08 have kept learning since. there is really not enough room here to put my history but I have a lot of opinions about a lot of things especially any of the drugs mentioned above. One thing I would like to add here is this tidbit ALL OPIATES INCREASE SEROTONIN it is not a huge jump to being in chronic pain to being put on an ssri/snri and opiates will affect your antidepressants and your thinking. As I do not update much I will put my quit date Nov. 17 2007 I quit Effexor cold turkey. http://survivingantidepressants.org/index.php?/topic/1096-introducing-myself-btdt/ There is a crack in everything ..That's how the light gets in Link to comment Share on other sites More sharing options...
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