Alton Brown is less likely to kill people by recommending unproven procedures. False analogy!
On Jan 8, 2013, at 8:11 PM, Horton, Joseph J. wrote: > Hello Ken: I live in a small town and have a love-hate relationship with > Wal-Mart. I will try a different comparison. I would like my physician to be > able to be a like the Food Network's Alton Brown. For those who are not > familiar with Mr. Brown, he believes that every device in his kitchen should > be able to perform multiple tasks. He will do things like cut cakes with saw > blades, or turn a military surplus footlocker into a meat smoker. Now the > people at the hardware store and the cooking supply store have products to > sell. Some of the people at the store will try to sell things that we do not > need or could be harmful if misused. I am willing to let Alton talk with the > people at the store about alternative uses for their products. Alton and I > may then consider how best to prepare dinner. If there is fraud involved, I > want the people engaging in it prosecuted. > > I do understand that the FDA will not be coming in their black helicopters to > keep Alton from giving me a saw for cutting cakes. I do not want the black > helicopters showing up at the hardware store on the assumption that any > non-traditional use of saws should not be discussed between sales people and > cooks. > > Joe > > Joseph J. Horton, Ph. D. > Box 3077 > Grove City College > Grove City, PA 16127 > 724-458-2004 > [email protected] > > In God we trust, all others must bring data. > > ________________________________________ > From: Ken Steele [[email protected]] > Sent: Tuesday, January 08, 2013 5:52 PM > To: Teaching in the Psychological Sciences (TIPS) > Subject: Re: [tips] Failure of Critical Thinking: When Advertising Trumps > "Truth" > > Hi Joe: > > One difficulty I have with evaluating your argument is that I > don't know the specific details of your case. This is not a call > to reveal private details but it is difficult for me to plumb > your benefit/danger ratios without details. > > I think Mike P's point is that dealing with Big Pharma is like > dealing with Walmart, an aggressive and well-financed > organization with a clear goal. Your point is that the entire > world is not all like Walmart, or that there are good deals to be > had at Walmart if you are a smart shopper. > > Both seem plausible positions, but are we talking about canoes or > cannolis? > > Ken > > PS - Sorry to all who must live with a Walmart analogy; it is my > world and there is not a fresh cannoli to be purchased in Boone. > > --------------------------------------------------------------- > Kenneth M. Steele, Ph.D. [email protected] > Professor > Department of Psychology http://www.psych.appstate.edu > Appalachian State University > Boone, NC 28608 > USA > --------------------------------------------------------------- > > > On 1/8/2013 4:47 PM, Horton, Joseph J. wrote: >> Mike my point is that there is potential harm when the FDA >> limits available treatments. Unless there is fraud involved, I >> am all for open communication between pharmaceutical >> companies, physicians and their patients. >> >> I certainly appreciate the role of well-done clinical trials. >> (Note my signature file.) In the case of the drug I take, the >> patent protection expired decades ago. No clinical trials will >> be done. The potential side effects are well known. I am >> probably in more danger from taking low dose aspirin daily. I >> have to make decisions with less than perfect information >> every day. I support letting information freely flow so people >> can evaluate the evidence and make the most informed decisions >> possible. >> >> Have a lovely evening, Joe >> >> Joseph J. Horton, Ph. D. Box 3077 Grove City College Grove >> City, PA 16127 >> >> 724-458-2004 [email protected] >> >> In God we trust. All others must bring data. >> >> -----Original Message----- From: Mike Palij >> [mailto:[email protected]] Sent: Tuesday, January 08, 2013 1:33 PM >> To: Teaching in the Psychological Sciences (TIPS) Cc: Michael >> Palij Subject: RE: [tips] Failure of Critical Thinking: When >> Advertising Trumps "Truth" >> >> On Tue, 08 Jan 2013 08:59:25 -0800, Joseph J. Horton wrote: >>> I am not particularly disturbed by this ruling depending >>> upon just what claims are being made. If it is clear the >>> claim is based on a collection of anecdotes rather than >>> empirical study informing physicians that others have found >>> a drug useful seems fine. >> >> I suggest reading the following blog entry from a legal firm >> that maintains the blog as a source of information on legal >> issues involving the FDA: >> http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/12/a-deep-dive-into-the-second-circuits-caronia-decision-potential-next-steps-and-potential-enforcement.html >> >> >>> I say this as one who regularly takes a drug for off label >>> use. >> >> I am not sure how this is relevant since mere personal >> experiences do not constitute data, only anecdote (at best a >> case study if done systematically but case studies are not >> scientific studies). That being said, I too have had >> conditions where there was no established treatment and have >> received numerous drugs off-label, none of which worked (you >> don't know how much I hoped for a good placebo effect). A >> major problem with off-label drug treatment are the >> side-effects which can be significant. Sometimes one thinks >> one is taking a step forward but winds up taking two steps >> back. >> >>> It is a generic drug and has been for a very long time. Thus >>> it costs very little. No one would invest the time and money >>> to conduct a clinical trial for my issue. Yet the drug has >>> dramatically improved my quality of life. Were the FDA to >>> take away my physician's ability to prescribe it for me, I >>> would be quite disappointed. >> >> With all sincerity, I am glad that the drug has done you good >> but I hope you realize that if it is being used off-label: (a) >> there is no empirical research evidence that the drug is the >> cause of the improvement (that is one of the major problems >> with using a drug in an off-label manner though there may be >> various crappy "open label" studies -- studies where >> participants and researchers know who is receiving the drug, >> possibly with no placebo control) and (b) even if the "Caronia >> case" goes in favor of the FDA on appeal, your doctor can >> still treat you with the off label drug because the FDA's >> focus is on the marketing of the drug. >> >> Below I quote from the legal blog I cite above but I give >> warning that the quote is long. It does, however, provide >> much significant context: >> >> NOTE: the FDA prosecutes off label marketing as a violation >> of interstate commerce law; see the blog for details |On >> November 30, 2009, a jury found Alfred Caronia guilty of >> misdemeanor |conspiracy to introduce misbranded drugs into >> interstate commerce. His |conviction was based on off-label >> statements he made while employed |as a pharmaceutical sales >> representative for Orphan Medical, Inc. ("Orphan"). >> |Specifically, Caronia verbally promoted the drug Xyrem, a >> central nervous |system depressant approved only for the >> treatment of certain categories |of narcolepsy patients, to >> treat a variety of other conditions including insomnia, >> |fibromyalgia, and Parkinson's. He also promoted Xyrem for >> use in an |unapproved patient population - individuals under >> the age of 16. | |The government began its investigation of >> Orphan in 2005, when former |Orphan saleswoman Shelley >> Lauterbach filed a qui tam suit against the |company. During >> the course of the investigation, Caronia was recorded |on two >> occasions discussing off-label uses of Xyrem. On both >> occasions, |Caronia was recorded speaking alongside Dr. Peter >> Gleason, a doctor |that Caronia had engaged to participate in >> "speaker programs" intended |to educate other physicians about >> Xyrem. Caronia and Dr. Gleason |discussed off-label uses for >> Xyrem with Dr. Jeffrey Charo, an undercover |informant for the >> government. In 2006, the government filed charges against >> |Orphan, Dr. Gleason, Caronia, as well as David Tucker (a >> former Orphan |sales manager) for conspiring to promote Xyrem >> for off-label uses, and |thereby introduce a misbranded drug >> into interstate commerce. | |In March 2007, David Tucker >> pleaded guilty to a single felony misbranding |charge. In >> July 2007, Orphan pleaded guilty to felony charges, and its >> |parent company, Jazz Pharmaceuticals, Inc., agreed to pay $20 >> million and |enter into a Corporate Integrity Agreement to >> resolve both criminal and civil |charges. In August 2008, Dr. >> Gleason also pleaded guilty to criminal misbranding |charges. >> | |Caronia, however, did not plead guilty and filed a motion >> to dismiss his case |based inter alia on First Amendment >> grounds. The District Court denied his |motion, but noted >> that the allegations against Caronia included First >> |Amendment-protected speech. Nevertheless, the District Court >> concluded |that the government's interpretation of the FDCA >> was constitutional under the |commercial speech doctrine >> because it did not limit speech more than was |necessary to >> achieve the government' objectives. On appeal of Caronia's >> |criminal conviction, the Second Circuit disagreed. >> >> It is the Second Circuit's judgment that served as the basis >> for the Nature Med article. The blog entry goes into what >> possible follow-up actions that the FDA may engage in. >> >> -Mike Palij New York University [email protected] >> Paul Brandon Emeritus Professor of Psychology Minnesota State University, Mankato [email protected] --- You are currently subscribed to tips as: [email protected]. To unsubscribe click here: http://fsulist.frostburg.edu/u?id=13090.68da6e6e5325aa33287ff385b70df5d5&n=T&l=tips&o=22785 or send a blank email to leave-22785-13090.68da6e6e5325aa33287ff385b70df...@fsulist.frostburg.edu
