Guest guest Posted July 23, 2004 Report Share Posted July 23, 2004 > " HSI - Jenny Thompson " > <HSIResearch > Guarded Response > Thu, 22 Jul 2004 09:20:41 -0400 > > Guarded Response > > Health Sciences Institute e-Alert > > Thursday July 22, 2004 > > ************************************************************** > > Dear Reader, > > When my friend, Kelly, had a physical a few years > ago, her doctor > asked how things were going in her life. Things > weren't good. > Kelly's job was stressful, her marriage was on the > rocks, and a > family member had recently died. She admitted that > she felt pretty > blue most of the time. Her doctor asked her if she'd > like to try > Prozac. > > The idea shocked her. She'd never thought of herself > as someone > who would take an antidepressant drug. But she was > also intrigued. > The idea of a mental boost to help get through the > day was > appealing. So her doctor gave her a free sample pack > of Prozac, > and wrote a prescription to start off on a low dose. > > > Later Kelly told me that on the drive home from her > doctor's office > her spirits were better than they'd been for months. > She felt > empowered and hopeful – like a dark cloud had > lifted. In short, she > didn't feel the least bit depressed. And at this > point she hadn't > taken her first dose of the Prozac. > > What Kelly was experiencing was similar to a placebo > effect. What > she needed most in her life was not a drug, but the > feeling that > someone – or something – was in her corner, offering > a helping > hand. And it's people like Kelly who have been > messing up the > results of clinical trials for antidepressant drugs. > In some cases the > positive results in these trials were stronger among > placebo > subjects than those taking the drugs. > > Well... we can't have that! So now drug companies > are devising > ways to weed out study subjects like Kelly – > subjects known as > " placebo responders. " > > ---------- > > Cordially uninvited > ---------- > > > Now, you know I'm not one to put a lot of stock in > headlines, but > the recent headline of a Wall Street Journal (WSJ) > article summed > up the situation in a nutshell: " Drug Makers Seek to > Bar 'Placebo > Responders' From Trials " > > The WSJ article reports that Eli Lilly (maker of > Prozac) and Pfizer > (maker of Zoloft) are funding research on brain > imaging at the > University of California, Los Angeles. This research > is designed to > identify disruptions in sleep and thought processes > experienced by > depressed subjects. But some depressed patients > don't experience > these disruptions, and it's these patients who are > believed to be > placebo responders. > > According to WSJ, Pfizer researchers have also > conducted studies > indicating that placebo responders may be identified > through DNA > testing. > > It's an efficient plan: Spot the troublemakers, keep > them out of the > trials, and the outcome will probably be much more > in line with > desired results. The key word here is " desired. " > Accurate results > are secondary to desired results when an FDA > approval of a cash > cow pharmaceutical is in the balance. > > Drug companies claim that the techniques designed to > exclude > placebo responders would only be used for early > trials – not for > FDA approval trials. > > Naaa! They wouldn't do that! They have too much > integrity! > > But think about it: That very claim indicates an > awareness that – at > worst – there may be something unethical about this > practice, > while – at best – it corrupts the basic design of > clinical studies. > > --------- > > Going off the gold standard > --------- > > > Kay Dickersin, a professor at Brown University and > the director > for the Center for Clinical Trials and > Evidence-Based Healthcare at > Brown, told WSJ that placebo responder screening > encourages bias > with a " subtle manipulation " of trial results. I > think Professor > Dickersin is being charitable. This manipulation is > not so subtle at > all. > > The gold standard for clinical trials calls for > three elements: > > * Placebo-control (one group receives an active > agent while > another receives a placebo) > * Double-blinding (neither the subjects nor those > who administer > the study are aware of which subjects receive > placebo) > * Randomization (once the group of study subjects > are in place, > they are randomly assigned either placebo or > active agent). > > So when you're studying the effects of an > antidepressant on mildly > depressed subjects, and you remove any subjects who > qualify as > mildly depressed but who will probably respond to > placebo, then > you're compromising the randomization. The results > of your trial > will indicate how a drug works only on those > subjects who are not > placebo responders. The implication: The drug won't > be tested on > placebo responders, but it doesn't matter because, > you know, > ANYthing works on them! > > --------- > > Included out > --------- > > > Research that involves brain imaging and genetics > doesn't come at > bargain prices. So the fact that two huge drug > companies are > willing to underwrite such expensive research > reveals to what > lengths companies will go to tip the balance of > clinical trials in > their favor. Now, with new antidepressants in > development for > both Pfizer and Lilly, just think how successful > upcoming trials > might be if those pesky placebo responders simply > get included > out. > > P.S.: Kelly did try the Prozac, but stopped using it > after one month. > She said the drug made her feel woozy. So she > started taking St. > John's Wort and that was enough to see her through a > mild > depression during a tough time. > > ************************************************************** > ...and another thing > > " A rose hip by any other name... " > > Vitamin C terminology is the subject of a recent > e-mail, signed by > HSI members Ginger and Larry. G & L write: > > " It seems to me that someone is missing the fact > that vitamin C is > NOT the exact same item as ascorbic acid, ever > though it is often > measured that way. The entire complex of C includes > elements > that Jonathan V. Wright and others have written > about often and I > feel, as a chiropractor learning as much as I can > from the big guys > about nutrition, that there is something there that > should be taken > into account. Comments? " > > It's true that the terms " vitamin C " and " ascorbic > acid " are often > used interchangeably, but shouldn't be. In the > e-Alert " Attack of > the Vapors " (1/6/04), here's what HSI Panelist Allan > Spreen, > M.D., had to say about ascorbic acid: > > " This is the standard form of vitamin C. Calcium > ascorbate is one > of the salt forms of the nutrient (as opposed to the > acid form). It is > usually synthetic, as are other forms, such as > sodium ascorbate, > magnesium ascorbate, etc. It tends to be bitter, > while ascorbic acid > is sour. " > > And on the natural vs. synthetic forms of vitamin C, > Dr. Spreen > again: " The synthetic vitamin C molecule is > chemically identical to > natural forms. The difference arises in other > nutrients that > accompany the C, such as bioflavonoids, which make > the C more > effective. That's not to say that I don't prefer > natural; it's just that > it's very hard to come by, and extremely expensive. " > > > " Attack of the Vapors " provides a compact but > thorough look at > vitamin C, courtesy of Dr. Spreen, and can be easily > found by > going to our web site (www.hsibaltimore.com), and > using the > " Search the e-Alert archives " feature to find > e-Alerts on this and > many other health and nutrition topics. (In this > case, just use the > keywords " Spreen " and " ascorbic " to find the vitamin > C e-Alert.) > > To Your Good Health, > > Jenny Thompson > Health Sciences Institute > > > Sources: > " Drug Makers Seek to Bar 'Placebo Responders' From > Trials " > Leila Abboud, The Wall Street Journal, 6/18/04 > Quote Link to comment Share on other sites More sharing options...
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