JMS Posted June 17, 2008 Author Share Posted June 17, 2008 http://www.fda.gov/CDRH/DEVADVICE/ide/irb.shtml While IRBs can be more inclusive and/or restrictive, under the statute, exemptions to IRB approval include research activities in which the only involvement of human subjects will be in one or more of the following categories: http://en.wikipedia.org/wiki/Varenicline There are exemptions to IRB approval. Either way the FDA knew about the side effect before the study started. Pfizer who informed the FDA dammed well knew. Informed concent requires the pations to be aware of the concequences and to be able to make a reasoned decision. In this case the soldiers were diagnosed psychiatric patients suffering for PTSD so the latter is in question. And the former, the side effects were not even told to the patients. Link to comment Share on other sites More sharing options...
Special K Posted June 17, 2008 Share Posted June 17, 2008 There are exemptions to IRB approval. There are no exemptions to IRB approval in these types of clinical trials. Here are the exemptions you talk about: The federal regulations provide for exemption from review for certain kinds of research described in this chapter (e.g., reviews of records or surveys) if certain conditions are met, unless: (1) information will be recorded by investigators in such a manner that subjects can be identified directly or through identifiers; and (2) disclosure of subjects' responses could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation). The exemptions appear at Federal Policy §___.101(. In fulfilling the provisions of their institution's Assurance, however, individual IRBs may have policies that require the review of all research involving human subjects, whether or not the research is subject to federal regulation, including research that is exempt from review under the regulations. [see Federal Policy §___.103((1).] Some Sections in this chapter will describe certain kinds of research as "exempt from IRB review." This exemption refers to research subject to the federal regulations. IRBs should follow the written policies established by their institutions. [see Guidebook Chapter 1, Section A, "Jurisdiction of the Institutional Review Board."] http://www.hhs.gov/ohrp/irb/irb_chapter4.htm Exemptions did not pertain to this trial. Link to comment Share on other sites More sharing options...
JMS Posted June 17, 2008 Author Share Posted June 17, 2008 Here's a link to the responsibilities of the IRB, but I'd like for you to pay attention to this paragraph in particular:Finally, consent to participate must be voluntarily given. The conditions under which an agreement to participate is made must be free from coercion and undue influence. IRBs should be especially sensitive to these factors when particularly vulnerable subjects are involved. http://www.hhs.gov/ohrp/irb/irb_introduction.htm Therefore, informed consent was given. So informed concent in your view doesn't deal with actually informing the patient of the concequences of his actions... If you can get his signature on the document without yanking out his toenails it's PLAY BALL... according to Keastman.... Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. Mr. Caplan, who reviewed the consent and notification forms for the study at the request of The Times and ABC News, said the VA deserved an "F" and that it has an obligation to end the study, given the vulnerability of veterans with PTSD and the known side effects of Chantix. "Continuing it doesn't make any ethical sense," he said. But then again Caplan is just the dean of bioethics from an ivy league school... WHO's actually read the consent forms... I guess he's not a good judge on the matter either... Link to comment Share on other sites More sharing options...
Special K Posted June 17, 2008 Share Posted June 17, 2008 Nope, never said that...but I'm not surprised you would jump to that conclusion after your leaps in logic throughout this story.... Informed consent isn't dictated by me obviously, but my the internal review boards in the study, but nice try. FDA revealed side effects AFTER study was initiated, not BEFORE the study was initiated. If the PI's and IRB members knew this before initiation of the study, I would say you have a case. However, they were not informed until AFTER the study began. Informed consent of relevant information at the time was given to the patients. Link to comment Share on other sites More sharing options...
JMS Posted June 18, 2008 Author Share Posted June 18, 2008 Nope, never said that...but I'm not surprised you would jump to that conclusion after your leaps in logic throughout this story.... You said informed consent was given. Mr Caplain gave the VA an F after reading the consent forms and called for the immediate termination of the study. Clearly you are in disagrement with Mr Caplain. Informed consent isn't dictated by me obviously, but my the internal review boards in the study, but nice try. Didn't you say informed consent was given? Therefore informed consent was given.. #46 FDA revealed side effects AFTER study was initiated, not BEFORE the study was initiated. If the PI's and IRB members knew this before initiation of the study, I would say you have a case. However, they were not informed until AFTER the study began. Informed consent of relevant information at the time was given to the patients. Pfizer informed the FDA of the side effects before the study started. So Pfizer who was conducting the study knew of the side effects before the study started. The only ones who were informed two weeks after the study started was the VA. Either way keastman you are directly controdicting the dean of bio ethics at an ivy league University, when you claim informed consent was given and the patients were protected..... And you are being personally insulting while doing so. It just makes you very tireing to carry on a discussion with you. Link to comment Share on other sites More sharing options...
Special K Posted June 18, 2008 Share Posted June 18, 2008 Again, you're having trouble with the whole informed consent and timeline thing, JMS. How are they supposed to warn patients of potential side effects if they didn't know there were side effects? Like you said, FDA did not alert them of side effects until AFTER the study was initiated. Therefore, in the eyes of the law, patients signed informed consent. Try again. Regarding the timeline: NOV- Pfizer alerted FDA of potential side effects of the drug. JAN. - FDA alerted the VA FEB. - VA sent letters to patients. The reason a lot of this took so long was the ridiculous bureaucratic red tape each agency had to go throw to get the warning out. Pfizer abided by ethical rules and regulations by alerting FDA. FDA took forever to alert the VA (go figure...a government office took forever in getting something done!) VA had to go through IRB approval process before they could send out ANYTHING warning patients. The only possibly legitimate ethical concern in this case is the vulnerable population that was targeted. Researchers have to be very careful in setting up these types of clinical trials. They have to provide rationale for why the particular population they are targeting for the study. VA's rationale was that there is a high rate of smokers in PTSD patients, therefore, they wanted to runa smoking cessation intervention study utilizing a variety of smoking cessation drugs and techinques. The IRB approved this study. Therefore, board members evidently felt that VA's rationale was strong enough to target this population to approve a human subject study. This is a case of inefficiency in the alert process...NOT a government conspiracy to treat veterans as lab rats. To think this was some kind of conspiracy is insane. Link to comment Share on other sites More sharing options...
Special K Posted June 18, 2008 Share Posted June 18, 2008 Also, please explain how am I being personally insulting to you? I simply stated that you are misunderstanding what informed consent is. Link to comment Share on other sites More sharing options...
JMS Posted June 18, 2008 Author Share Posted June 18, 2008 Again, you're having trouble with the whole informed consent thing, JMS. Informed consent isn't that hard a concept. I think I grasp it's complexities. How are they supposed to warn patients of potential side effects if they didn't know there were side effects? Like you said, FDA did not alert them of side effects until AFTER the study was initiated. The study was at the VA, but the study was being conducted by and paid for by pfitzer the drug company. The drug company and the FDA knew about side effects before the trial began. The drug company informed the FDA almost a month before the study began of the side effects. Therefore, in the eyes of the law, patients signed informed consent. Try again. The patients signed a consent form... True enough.. But if the drug company didn't tell them the side effects of the drugs they were taking,, WHICH THEY KNEW ABOUT BEFORE THE STUDY... then the consent wasn't informed consent... I don't think that's a hard concept to grasp. Where are we misconnecting? Which part of the chain of logic do you disagree with... Pfitzer told the FDA a month before the study began about the side effects. Pfitzer paid for and was directly responsible for the study. The IRB is part of the FDA, and thus was also aware of the side effects before the study began. The VA was informed only after the study was begun, by the FDA. Legally it's not possible to give informed consent if the patient isn't informed of the KNOWN consequenses of his consent. And clearly by this chain of events pfitzer, the FDA, and therefore the IRB knew of the side effects prior to the start of the study and did not make them availible to the patients.. Link to comment Share on other sites More sharing options...
JMS Posted June 18, 2008 Author Share Posted June 18, 2008 The only possibly legitimate ethical concern in this case is the vulnerable population that was targeted. Researchers have to be very careful in setting up these types of clinical trials. They have to provide rationale for why the particular population they are targeting for the study. How do you account for the dean of the University of Pennsylvania's bio ethics department who reviewed the case disagrees with your opinion. He haveing had the benifit of reviewing the actual consent forms, gave the VA and F for their consent process. This is a case of inefficiency in the alert process...NOT a government conspiracy to treat veterans as lab rats. To think this was some kind of conspiracy is insane. And yet every expert who we've heard from on the subject, not directly involved in approving the study, from the article disagrees with you. Link to comment Share on other sites More sharing options...
Special K Posted June 18, 2008 Share Posted June 18, 2008 Unfortunately you don't understand the IRB process. Plain and simple. Just b/c Pfizer alerts the FDA, doesn't mean people on the IRB knew of the effects of the drug before approving the study. Get that? Someone in the FDA was alerted, but that DOES NOT mean the IRB was privy to that alert before approving the study. Do you not realize that that's how the government works? It takes MONTHS for information to get to the "right" person. Sure, the FDA was alerted, but its inefficient system of information relay clearly screwed things up. Go figure, the government 1) Screwed crap up AND 2) took forever to get anything done. Conspiracy theory this proves not. Inefficiency? Yes. There needs to be more streamlined process of information sharing so that it doesn't take forever to pull a drug from a trial. This whole story begs the question: If people truly believe the FDA was involved in a conspiracy (which I HIGHLY doubt), why are these same people advocating more government involvement in health care??? Link to comment Share on other sites More sharing options...
Special K Posted June 18, 2008 Share Posted June 18, 2008 And yet every expert who we've heard from on the subject, not directly involved in approving the study, from the article disagrees with you. I guess that means I need to jump off a bridge when they do? Link to comment Share on other sites More sharing options...
Thiebear Posted June 18, 2008 Share Posted June 18, 2008 From what I see this was an IRB approved study. So here's a little breakdown for what happened here:1. Study was devised and sent to IRB for approval 2. IRB approved of study 3. Study commenced 4. 2 weeks into the study FDA alerted PI's that there was a linkage between mental health side effects and this particular drug. 5. IRB was notified 6. PI's had to wait for IRB approval to send out warning letters. If you know ANYTHING about the IRB you can see how it took PI's FOREVER to get approval to alert patients. Everything has to go through this board before reaching the patients. 4. This is correct... The bureaucracy is awful. but Cheney was not holding the needle. Link to comment Share on other sites More sharing options...
Redskins Diehard Posted June 18, 2008 Share Posted June 18, 2008 And yet every expert who we've heard from on the subject, not directly involved in approving the study, from the article disagrees with you. Are there any other experts other than the guy from PENN? I can't really tell from the article if the guy meant the consent form gets an F going forward because of the new information, or if it would have received an F before the revelations about other side effects. By the way, seems to me that the only way to know that there are those side effects for PTSD patients is to give some PTSD patients the drugs and observe the side effects. Link to comment Share on other sites More sharing options...
JMS Posted June 18, 2008 Author Share Posted June 18, 2008 Are there any other experts other than the guy from PENN? There are a bunch of articles on this Chantix drug. Of all perscription drugs sold in the country... Chantix accounted for more reports of serious harm to teh patient by the FDA than any other drug in the country... in the 4th quarter of 2007... I've been reading about the drug, Chantix. There are lots of articles about it, and lots of expert statements. Only those associated with Pfizer are defending it. FAA bans anti-smoking drug Chantix for pilots, air controllers, By the end of 2006, Chantix registered among a relatively small group of 35 drugs, out of all medications, that accounted for 100 or more reports of serious harm per calendar quarter. Other medications in this group tend to be powerful painkillers and drugs that affect the immune system. By the middle of last year, Chantix ranked third among all drugs in reported problems. It moved into first place in the last quarter of 2007, with 988 reports. http://www.latimes.com/features/health/la-na-smokedrug22-2008may22,0,2181248.story Pfizer's Chantix Going Up In Smoke In the fourth quarter of 2007, Chantix accounted for 988 serious injuries reported to the FDA, more than any other individual drug during that time period. http://www.forbes.com/2008/05/21/pfizer-chantix-ismp-markets-equity-cx_lal_0521markets34.html By the way, seems to me that the only way to know that there are those side effects for PTSD patients is to give some PTSD patients the drugs and observe the side effects. The house announced today they were demanding the study be stopped. It was still going on as of this morning..... House panel chair: Stop drug tests on veterans House Veterans' Affairs Committee Chairman Bob Filner on Wednesday demanded that the Department of Veterans Affairs (VA) immediately terminate experiments in which a drug now linked to psychotic and suicidal behavior is being administered to soldiers suffering from post-traumatic stress disorder (PTSD). "The VA must immediately suspend this study until a comprehensive review of the safety of the protocol is conducted," http://www.washingtontimes.com/news/2008/jun/18/house-panel-stop-drug-tests-on-veterans-now/ Link to comment Share on other sites More sharing options...
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