# Pitting the FDA **URL:** \ **Category:** The BBQ Pit\ **Created:** [July 17, 2012, 3:45pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529 "2012-07-17T15:45:03Z")\ **Posts on this page:** 17\ **Page:** 2
**Author:** ![SnakesCatLady](https://avatars.discourse-cdn.com/v4/letter/s/4af34b/32.png) [@SnakesCatLady](https://boards.straightdope.com/u/SnakesCatLady)\ **Post date:** [July 17, 2012, 9:35pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/21 "2012-07-17T21:35:54Z")
I participated in a drug study when Mirapex, a drug already approved for use in Parkinson’s Disease, was being studied for relabeling as a treatment for Restless Legs Syndrome. After my physical exam I was shown into a room with a HUGE notebook - easily 10 inches thick - which contained EVERY side effect ever reported for the drug. I looked through the first few pages - the most common side effects - and decided to go through with the study. The only side effect I noticed was unusually vivid dreams, which was one of the most common side effects reported. ---
**Author:** ![Bilbo1967](https://avatars.discourse-cdn.com/v4/letter/b/7bcc69/32.png) [@Bilbo1967](https://boards.straightdope.com/u/Bilbo1967)\ **Post date:** [July 17, 2012, 9:43pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/22 "2012-07-17T21:43:59Z")
If you need to take drugs to do your job, you probably need a different job. ---
**Author:** ![Mr.Miskatonic](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/mr.miskatonic/32/310_2.png) [@Mr.Miskatonic](https://boards.straightdope.com/u/Mr.Miskatonic)\ **Post date:** [July 17, 2012, 9:48pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/23 "2012-07-17T21:48:01Z")
Someone recently commented that if aspirin were introduced today, it would not get FDA approval. ---
**Author:** ![Buck\_Godot](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/buck_godot/32/6573_2.png) [@Buck\_Godot](https://boards.straightdope.com/u/Buck_Godot)\ **Post date:** [July 17, 2012, 9:57pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/24 "2012-07-17T21:57:41Z")
> [@lazybratsche](#): > > Headaches: Reported in 17/645 test subjects on Nuvagil (vs 9/445 on placebo) > Nausea: 7 (vs 3) > Dry mouth: 4 (vs 1) > Insomnia: 5 (vs 1) > Dizziness: 5 (vs 2) > which are probably real, though hardly common side effects. Actually I suspect that most of those are probably not real. The probability of getting a difference as large as 5/645 versus 2/445 by chance alone is 40%, Based on my reading of the labels of medications it appears to me that they report any side effect that occurred more frequently in the test subjects than in the placebo, regardless of statistical significance. Better safe than sorry. ---
**Author:** ![digs](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/digs/32/14889_2.png) [@digs](https://boards.straightdope.com/u/digs)\ **Post date:** [July 18, 2012, 6:16am UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/25 "2012-07-18T06:16:27Z")
Sounds like the time is right for [a drug with nothing but side effects…](http://www.youtube.com/watch?v=p_27DUYQeJw) ---
**Author:** ![Ambivalid](https://avatars.discourse-cdn.com/v4/letter/a/a5b964/32.png) [@Ambivalid](https://boards.straightdope.com/u/Ambivalid)\ **Post date:** [July 18, 2012, 6:43am UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/26 "2012-07-18T06:43:59Z")
> [@digs](#): > > Sounds like the time is right for [a drug with nothing but side effects…](http://www.youtube.com/watch?v=p_27DUYQeJw) Pretty funny. ---
**Author:** ![Tom\_Tildrum](https://avatars.discourse-cdn.com/v4/letter/t/e95f7d/32.png) [@Tom\_Tildrum](https://boards.straightdope.com/u/Tom_Tildrum)\ **Post date:** [July 18, 2012, 1:15pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/27 "2012-07-18T13:15:08Z")
> [@Morgenstern](#): > > Interesting, a drug to keep you awake that has a side effect of fatigue? Many drugs will have the opposite of their intended effect as a reported side effect. Whatever the bodily process is that’s being tinkered with, some people will react in the other direction. ---
**Author:** ![Fiveyearlurker](https://avatars.discourse-cdn.com/v4/letter/f/da6949/32.png) [@Fiveyearlurker](https://boards.straightdope.com/u/Fiveyearlurker)\ **Post date:** [July 18, 2012, 2:07pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/28 "2012-07-18T14:07:35Z")
As a scientist at a pharmaceutical company, if my neighbor tells me that he knows a guy who died in a car crash, and mentions that that guy was on our drug (even if it is a drug for asthma, or something I can’t imagine has anything to do with the car crash) I’m instructed, under no uncertain terms, that I must report this to the company and that they will report it to the FDA. Despite the idea that companies and the FDA play fast and loose, we take these things pretty seriously. ---
**Author:** ![Sudden\_Kestrel](https://avatars.discourse-cdn.com/v4/letter/s/ecd19e/32.png) [@Sudden\_Kestrel](https://boards.straightdope.com/u/Sudden_Kestrel)\ **Post date:** [July 18, 2012, 2:13pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/29 "2012-07-18T14:13:04Z")
> [@dngnb8](#): > > I heard a new medication today called Nuvigil. It is now being prescribed for Shift Differential syndrome. The inability to stay awake because you have a split shift. It’s hardly a new drug. According to its [Wikipedia page](http://en.wikipedia.org/wiki/Armodafinil) > [@](#): > > Armodafinil (Nuvigil) is a stimulant-like drug produced by the pharmaceutical company Cephalon Inc., which was approved by the FDA on June 15, 2007. It’s also just a “purer” form of the even older drug modafanil (Provigil), which has been available in the US since 1998 and the UK since 2002. Now that we’re clear on that, carry on with your hysteria. I’d join in, but my Nuvigil is making me too sleepy. ---
**Author:** ![dngnb8](https://avatars.discourse-cdn.com/v4/letter/d/977dab/32.png) [@dngnb8](https://boards.straightdope.com/u/dngnb8)\ **Post date:** [July 18, 2012, 4:05pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/30 "2012-07-18T16:05:43Z")
> [@Sudden\_Kestrel](#): > > It’s hardly a new drug. According to its [Wikipedia page](http://en.wikipedia.org/wiki/Armodafinil) > > It’s also just a “purer” form of the even older drug modafanil (Provigil), which has been available in the US since 1998 and the UK since 2002. > > Now that we’re clear on that, carry on with your hysteria. I’d join in, but my Nuvigil is making me too sleepy. LOL@Hysteria. BWAAAAAAA NEW DRUGS! By the way, since you linked wiki, you might want to read it to find out what it does. ---
**Author:** ![Sudden\_Kestrel](https://avatars.discourse-cdn.com/v4/letter/s/ecd19e/32.png) [@Sudden\_Kestrel](https://boards.straightdope.com/u/Sudden_Kestrel)\ **Post date:** [July 18, 2012, 4:41pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/31 "2012-07-18T16:41:12Z")
> [@dngnb8](#): > > LOL@Hysteria. BWAAAAAAA NEW DRUGS! > > By the way, since you linked wiki, you might want to read it to find out what it does. I know what it does, you moron. I’ve been taking your scary “new” medication for years. ---
**Author:** ![YogSothoth](https://avatars.discourse-cdn.com/v4/letter/y/8edcca/32.png) [@YogSothoth](https://boards.straightdope.com/u/YogSothoth)\ **Post date:** [July 18, 2012, 4:58pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/32 "2012-07-18T16:58:27Z")
I’m getting the drug just for the side effects! 😃 ---
**Author:** ![bouv](https://avatars.discourse-cdn.com/v4/letter/b/bc8723/32.png) [@bouv](https://boards.straightdope.com/u/bouv)\ **Post date:** [July 18, 2012, 5:02pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/33 "2012-07-18T17:02:12Z")
> [@Ferret\_Herder](#): > > I have reported deaths due to complications from AIDS, heart attack, and murder. Side effects may include headache, nausea, and getting stabbed in the face. ---
**Author:** ![Indistinguishable](https://avatars.discourse-cdn.com/v4/letter/i/90ced4/32.png) [@Indistinguishable](https://boards.straightdope.com/u/Indistinguishable)\ **Post date:** [July 18, 2012, 5:14pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/34 "2012-07-18T17:14:29Z")
> [@lazybratsche](#): > > Possible and very likely. The full FDA labels for a drug include the data on side effects. For example, here’s the [label for Nuvagil](http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021875s005s008s015lbl.pdf) (big-ass PDF warning), on page 27 there’s side effect information. > > Headaches: Reported in 17/645 test subjects on Nuvagil (vs 9/445 on placebo) > Nausea: 7 (vs 3) > Dry mouth: 4 (vs 1) > Insomnia: 5 (vs 1) > Dizziness: 5 (vs 2) > which are probably real, though hardly common side effects. It looks to me like you’ve misinterpreted the chart. It’s saying headaches were reported in 17 PERCENT of the 645 test subjects, and so on for the rest. (Specifically, on page 29, we are told that headaches were reported in 23% of the 198 subjects who received 250 mg, and in 14% of the 447 subjects who received 150 mg, for a combined 17% of 645 subjects. I think we can agree that these are significant percentages. And every mentioned incident occurred with frequency at least 1% greater (in absolute terms) among medicine-takers than placebo-takers.) ---
**Author:** ![Revtim](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/revtim/32/1042_2.png) [@Revtim](https://boards.straightdope.com/u/Revtim)\ **Post date:** [July 18, 2012, 5:17pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/35 "2012-07-18T17:17:43Z")
I’ve taken the stuff because of daytime sleepiness due to sleep apnea, and I _love_ it. Expensive as fuck though, a month’s supply, even with insurance paying for some of it, was around $300. I’m not taking it regularly because of that. But it works perfectly for me, no side effects, and I feel very wakeful and alert. The predecessor, provigil, is supposed to have generic versions at some point, I thought. ---
**Author:** ![lazybratsche](https://avatars.discourse-cdn.com/v4/letter/l/ba8739/32.png) [@lazybratsche](https://boards.straightdope.com/u/lazybratsche)\ **Post date:** [July 18, 2012, 6:07pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/36 "2012-07-18T18:07:36Z")
> [@Indistinguishable](#): > > It looks to me like you’ve misinterpreted the chart. It’s saying headaches were reported in 17 PERCENT of the 645 test subjects, and so on for the rest. (Specifically, on page 29, we are told that headaches were reported in 23% of the 198 subjects who received 250 mg, and in 14% of the 447 subjects who received 150 mg, for a combined 17% of 645 subjects. I think we can agree that these are significant percentages. And every mentioned incident occurred with frequency at least 1% greater (in absolute terms) among medicine-takers than placebo-takers.) My mistake. I suppose that would make some of those side effects fairly common, particularly headaches. But those 1% (vs 0% placebo) side effects are entirely in the range of statistical noise, and 1% is itself a pretty arbitrary cutoff. ---
**Author:** ![Indistinguishable](https://avatars.discourse-cdn.com/v4/letter/i/90ced4/32.png) [@Indistinguishable](https://boards.straightdope.com/u/Indistinguishable)\ **Post date:** [July 18, 2012, 6:10pm UTC](https://boards.straightdope.com/t/pitting-the-fda/628529/37 "2012-07-18T18:10:04Z")
Yes, I agree with that. It’s just not quite as bad as “If even a single patient reports it, it goes in”. [Previous page](https://boards.straightdope.com/t/pitting-the-fda/628529.md?page=1)