1
00:00:02,040 --> 00:00:06,040
Speaker 1: Welcome back to Behind the Bastards, the only podcast with

2
00:00:06,160 --> 00:00:10,119
Speaker 1: more worms than the average bottle of milk in a

3
00:00:10,200 --> 00:00:15,120
Speaker 1: century ago. Tougs of worms and filled with them. Love

4
00:00:15,200 --> 00:00:19,279
Speaker 1: your new tagline. It's great, thank you, thank you. It's

5
00:00:20,000 --> 00:00:24,160
Speaker 1: We're gonna move on from discussing horrible old timey foods

6
00:00:24,200 --> 00:00:25,840
Speaker 1: before there were any kind of laws about what you

7
00:00:25,840 --> 00:00:27,840
Speaker 1: could do with foods. But I just came across an

8
00:00:27,920 --> 00:00:30,760
Speaker 1: article in the Guardian. Uh, you know there's that truck

9
00:00:30,760 --> 00:00:34,440
Speaker 1: convoy trying to do with January six in Canada all

10
00:00:34,479 --> 00:00:37,000
Speaker 1: about next week. Yeah, there's an article in the Guardian

11
00:00:37,040 --> 00:00:40,640
Speaker 1: called Canada trucker's vaccine protests spirals into calls to repeal

12
00:00:40,720 --> 00:00:47,199
Speaker 1: all public health rules. My favorite, my favorite response on

13
00:00:47,240 --> 00:00:49,600
Speaker 1: Twitter is someone who's posted a picture of a sign

14
00:00:49,680 --> 00:00:52,479
Speaker 1: outside of a swimming pool that says person is currently

15
00:00:52,520 --> 00:00:55,320
Speaker 1: having active diarrhea or who have had active diarrhea within

16
00:00:55,360 --> 00:00:57,480
Speaker 1: the previous fourteen days shall not be allowed to enter

17
00:00:57,480 --> 00:01:00,200
Speaker 1: the pool water. And he's just responded, He's just most

18
00:01:00,240 --> 00:01:03,080
Speaker 1: of that and said in all caps, oh, captain, my captain.

19
00:01:07,160 --> 00:01:09,120
Speaker 1: This concludes the part of the episode where I read

20
00:01:09,160 --> 00:01:12,880
Speaker 1: to you from Twitter, mad, what you you got a

21
00:01:12,880 --> 00:01:18,200
Speaker 1: podcast compare yourself a gun but yourself a gun past.

22
00:01:18,920 --> 00:01:21,679
Speaker 1: It's uh. You know, this is what separates us from

23
00:01:21,720 --> 00:01:24,600
Speaker 1: any other TV rewatch podcast as uh I do a

24
00:01:24,640 --> 00:01:28,000
Speaker 1: parody song every week that does the synopsis of the episode.

25
00:01:28,640 --> 00:01:31,920
Speaker 1: Is it good kind of tow? People like it? Oh? No,

26
00:01:32,280 --> 00:01:37,280
Speaker 1: do I do it? Yes? Insistently? U what a plug?

27
00:01:37,720 --> 00:01:43,679
Speaker 1: Everyone loves that hot damn Matt. Now now that we

28
00:01:43,720 --> 00:01:46,880
Speaker 1: have really we've laid the groundwork here, it is time

29
00:01:46,920 --> 00:01:49,600
Speaker 1: to move on to the true bastard of our episode,

30
00:01:49,640 --> 00:01:52,760
Speaker 1: the f d A. We've had it's it's it's Anakin

31
00:01:52,840 --> 00:01:55,520
Speaker 1: Skywalker phase here and now we're about it's about to

32
00:01:55,560 --> 00:02:00,560
Speaker 1: go full Vader, right, That's that's today's story. Pub poisoned

33
00:02:00,640 --> 00:02:04,560
Speaker 1: back in the food Yeah, actually, yes, that is a

34
00:02:04,600 --> 00:02:07,520
Speaker 1: part of what's happening in this period. Um, of course,

35
00:02:07,520 --> 00:02:08,919
Speaker 1: it is much bigger than that. We're actually going to

36
00:02:08,960 --> 00:02:11,359
Speaker 1: focus a bit more in the pharmaceutical industry today. There's

37
00:02:11,400 --> 00:02:14,080
Speaker 1: a lot to say about food though. So we ended

38
00:02:14,160 --> 00:02:16,600
Speaker 1: last episode with the creation of the f d A

39
00:02:16,680 --> 00:02:19,440
Speaker 1: in nineteen thirty eight, after eight years after the death

40
00:02:19,440 --> 00:02:23,679
Speaker 1: of Harley Whitley. Harvey Whitley, he dies in nineteen thirty uh.

41
00:02:23,680 --> 00:02:26,600
Speaker 1: And the FDA was initially taxpayer funded. Right again, so

42
00:02:26,800 --> 00:02:29,240
Speaker 1: all of its money at first comes from the American

43
00:02:29,280 --> 00:02:32,120
Speaker 1: people because its job is to be a watchdog for

44
00:02:32,160 --> 00:02:36,679
Speaker 1: the American people and to make sure they're eating. That's changed. Oh, yes,

45
00:02:36,960 --> 00:02:39,600
Speaker 1: that's a big part of our story today, Matt. So

46
00:02:39,680 --> 00:02:42,919
Speaker 1: at first it is taxpayer funded, and as a taxpayer

47
00:02:42,960 --> 00:02:47,680
Speaker 1: funded organization, it experiences a titanic success very early on.

48
00:02:47,960 --> 00:02:51,080
Speaker 1: When we've actually discussed previously on the show. In the

49
00:02:51,160 --> 00:02:54,280
Speaker 1: late nineteen fifties, the grun in Tall Corporation of Germany,

50
00:02:54,320 --> 00:02:58,080
Speaker 1: which was a pharmaceutical concern staffed mainly by Nazis, tried

51
00:02:58,120 --> 00:03:01,600
Speaker 1: to get approval to sell their blockbust a new sleeping pill, philidamide,

52
00:03:01,760 --> 00:03:04,760
Speaker 1: which may have initially been tested on concentration camp inmates

53
00:03:04,800 --> 00:03:08,120
Speaker 1: in the United States now for the person and it

54
00:03:08,200 --> 00:03:09,920
Speaker 1: was like some other company that was trying to sell

55
00:03:10,040 --> 00:03:12,519
Speaker 1: the product for gruden Tal was buying and wanted to

56
00:03:12,520 --> 00:03:14,960
Speaker 1: sell in the U S. Whatever, Like you know, corporations work.

57
00:03:15,520 --> 00:03:17,560
Speaker 1: But this company that wants to sell palidamide in the

58
00:03:17,680 --> 00:03:20,240
Speaker 1: U s as a sleeping pill, UH, has to go

59
00:03:20,280 --> 00:03:22,600
Speaker 1: to the FDA to get approval, right, and the person

60
00:03:22,680 --> 00:03:27,280
Speaker 1: they come before is Francis Oldham Kelsey. Now Francis Kelsey

61
00:03:27,320 --> 00:03:30,040
Speaker 1: had earned a PhD the same year the FDA was founded,

62
00:03:30,080 --> 00:03:32,799
Speaker 1: and she had been hired in nineteen sixty after six

63
00:03:32,880 --> 00:03:36,160
Speaker 1: years of teaching pharmacology at the University of South Dakota.

64
00:03:36,680 --> 00:03:38,440
Speaker 1: Um So, her job, she's one of the people who's

65
00:03:38,440 --> 00:03:41,560
Speaker 1: supposed to evaluate new medical sins and substances and decide

66
00:03:41,560 --> 00:03:44,000
Speaker 1: whether or not they get FDA approval. One of her

67
00:03:44,160 --> 00:03:47,000
Speaker 1: very first assignments for the FDA was the litamide and

68
00:03:47,080 --> 00:03:49,440
Speaker 1: her job is essentially to review the evidence of drug

69
00:03:49,520 --> 00:03:52,800
Speaker 1: safety provided by the manufacturer, because that's what that nineteen

70
00:03:52,840 --> 00:03:54,800
Speaker 1: thirty eight law, in the nineteen o six law had

71
00:03:54,800 --> 00:03:57,600
Speaker 1: gradually established that if you want to sell a medicine,

72
00:03:57,760 --> 00:03:59,680
Speaker 1: you have to prove it works and that it doesn't

73
00:03:59,760 --> 00:04:02,200
Speaker 1: kill people, or at least it doesn't kill too many people, right,

74
00:04:02,320 --> 00:04:05,640
Speaker 1: any kind of effect. Yeah, you have two shows. You

75
00:04:05,640 --> 00:04:07,680
Speaker 1: have to prove it alike, be worth it, you know.

76
00:04:08,360 --> 00:04:11,840
Speaker 1: Um So, it's her job to review all of that evidence. Now,

77
00:04:11,960 --> 00:04:14,000
Speaker 1: Solidamite is at this point in use in like forty

78
00:04:14,080 --> 00:04:16,800
Speaker 1: six nations around the world, including most of Europe. But

79
00:04:16,960 --> 00:04:19,800
Speaker 1: Dr Kelsey thought their data was shipped. She actually looks

80
00:04:19,800 --> 00:04:21,520
Speaker 1: at the evidence they have that this stuff is safe,

81
00:04:21,520 --> 00:04:23,360
Speaker 1: and she's like, because one of the big things they're

82
00:04:23,440 --> 00:04:25,560
Speaker 1: selling this as is it's like this is finally a

83
00:04:25,600 --> 00:04:29,279
Speaker 1: safe sleeping pill for pregnant women, right, and they're they're

84
00:04:29,279 --> 00:04:31,120
Speaker 1: saying that based on nothing, and in fact, a lot

85
00:04:31,200 --> 00:04:33,280
Speaker 1: of the data they have suggests that, like, no, it's

86
00:04:33,320 --> 00:04:35,960
Speaker 1: actually like it's fine for women who are nursing. They

87
00:04:35,960 --> 00:04:38,279
Speaker 1: do show that that, like, it's probably okay for women

88
00:04:38,279 --> 00:04:41,000
Speaker 1: who are nursing to have it, but there's there's evidence

89
00:04:41,000 --> 00:04:43,680
Speaker 1: that it's really bad for pregnant women. Um, and there's

90
00:04:43,720 --> 00:04:49,440
Speaker 1: really tried out and Nazi concentration camps. Well, that is debatable.

91
00:04:49,520 --> 00:04:51,800
Speaker 1: We talked about this in the episode. Yeah, there's a

92
00:04:51,880 --> 00:04:54,480
Speaker 1: lot of evidence that suggests that it's not ironclad. So

93
00:04:54,520 --> 00:04:56,680
Speaker 1: I don't want to be like saying, but there is

94
00:04:56,720 --> 00:04:59,680
Speaker 1: some evidence that's because they were they were Nazi doctors

95
00:04:59,680 --> 00:05:02,200
Speaker 1: who were in concentration camps are the people who are

96
00:05:02,200 --> 00:05:04,120
Speaker 1: doing all of the medical testing for Grooon at all,

97
00:05:04,360 --> 00:05:06,400
Speaker 1: and there's evidence that they just like took this drug

98
00:05:06,440 --> 00:05:09,960
Speaker 1: they've been testing in camps and like tried to launder its. Robert,

99
00:05:10,040 --> 00:05:12,960
Speaker 1: I'm not about nuance. We're gonna call it anti semitic

100
00:05:13,000 --> 00:05:17,560
Speaker 1: ambient and anti semitic ambient. That's right. So anti semitic

101
00:05:17,600 --> 00:05:20,000
Speaker 1: ambient is in use all over the world. Um. But

102
00:05:20,040 --> 00:05:21,880
Speaker 1: Francis Kelsey is like, I don't give a shit about

103
00:05:21,880 --> 00:05:24,000
Speaker 1: what the rest of the world says. This data doesn't

104
00:05:24,040 --> 00:05:26,400
Speaker 1: convince me, and it's my job to say whether or

105
00:05:26,400 --> 00:05:30,040
Speaker 1: not this ship is safe, So I don't give you approval. UM.

106
00:05:30,080 --> 00:05:32,200
Speaker 1: So she turns them down, and then they try to

107
00:05:32,200 --> 00:05:35,440
Speaker 1: pressure her boss, and her boss backs her to the hilt.

108
00:05:35,720 --> 00:05:38,800
Speaker 1: Her boss is like, no, Frances is fucking great scientist,

109
00:05:38,960 --> 00:05:41,000
Speaker 1: and she's right about this, and we're not gonna fucking

110
00:05:41,040 --> 00:05:43,880
Speaker 1: self phillidamite in the United States, and the litamite has

111
00:05:43,960 --> 00:05:46,080
Speaker 1: never approved for use on a wide scale in the

112
00:05:46,160 --> 00:05:48,560
Speaker 1: U S. There's a couple of like trials and stuff.

113
00:05:49,320 --> 00:05:52,479
Speaker 1: A handful of Americans do take it um, but nothing

114
00:05:52,520 --> 00:05:55,080
Speaker 1: like what happens in Europe, where millions of people take

115
00:05:55,120 --> 00:05:58,840
Speaker 1: the litamide. Roughly one year after she turns down philidamide,

116
00:05:59,040 --> 00:06:02,799
Speaker 1: scientists and Urbany and Australia proved that the litamide caused

117
00:06:02,880 --> 00:06:05,680
Speaker 1: a whole host of debilitating birth defects. Babies were being

118
00:06:05,680 --> 00:06:08,120
Speaker 1: born without lungs or with their arms coming directly out

119
00:06:08,120 --> 00:06:10,960
Speaker 1: of their shoulders and like no actual like like foe

120
00:06:11,080 --> 00:06:13,039
Speaker 1: arms and ship. You can find pictures if you want.

121
00:06:13,080 --> 00:06:16,240
Speaker 1: Tens of thousands of children are disabled, hundreds of thousands

122
00:06:16,240 --> 00:06:18,080
Speaker 1: of children that are disabled, Tens of thousands are killed

123
00:06:18,120 --> 00:06:20,480
Speaker 1: as a result of the litamide. Um, but none of

124
00:06:20,520 --> 00:06:22,960
Speaker 1: those are in the US, thanks to Dr Kelsey and

125
00:06:23,000 --> 00:06:25,720
Speaker 1: the f d A. This is a huge success. Is

126
00:06:25,760 --> 00:06:29,120
Speaker 1: exactly what it's there for, right, that's for this is

127
00:06:29,160 --> 00:06:32,040
Speaker 1: a bullet proof vest stopping a bullet from entering your body.

128
00:06:32,120 --> 00:06:34,880
Speaker 1: This is like exactly why we have this thing in

129
00:06:34,920 --> 00:06:37,839
Speaker 1: proof that it is worth every goddamn penny. Um. And

130
00:06:37,880 --> 00:06:40,320
Speaker 1: Americans at the time recognize that they have dodged a

131
00:06:40,480 --> 00:06:44,360
Speaker 1: huge bullet. H The ship that happens with the litamide

132
00:06:44,400 --> 00:06:49,039
Speaker 1: inspires the passage of the nineteen sixty two Drug Amendments.

133
00:06:49,080 --> 00:06:51,840
Speaker 1: This bill is why ads for new medicines always end

134
00:06:51,920 --> 00:06:54,279
Speaker 1: with like forty seconds of a dude talking very fast

135
00:06:54,279 --> 00:06:57,919
Speaker 1: about the side effects experience. Like that's that's where that starts,

136
00:06:58,000 --> 00:07:00,720
Speaker 1: like being mandatory, right, um, And there's a bunch of

137
00:07:00,760 --> 00:07:03,320
Speaker 1: other good stuff and it including it forces a comprehensive

138
00:07:03,440 --> 00:07:06,760
Speaker 1: reclassification of all available drugs based on whether or not

139
00:07:06,800 --> 00:07:09,040
Speaker 1: they actually do anything. So there were all this medicine

140
00:07:09,040 --> 00:07:11,280
Speaker 1: that was like grandfathered in when the FDA gets created,

141
00:07:11,280 --> 00:07:13,040
Speaker 1: and they're right, well, actually, why the funk are we

142
00:07:13,080 --> 00:07:15,240
Speaker 1: doing that? We should make sure this stuff all works.

143
00:07:15,320 --> 00:07:20,240
Speaker 1: You know, I don't care we got tested. I understand

144
00:07:20,320 --> 00:07:23,400
Speaker 1: that dark defeats the bright, but we gotta test it.

145
00:07:23,600 --> 00:07:25,760
Speaker 1: I'm not a big law fan, but the nineteen sixty

146
00:07:25,760 --> 00:07:29,840
Speaker 1: two drug ammendments are pretty comprehensively, like a good, good,

147
00:07:30,000 --> 00:07:32,920
Speaker 1: good call, you know. Um So, the f D a

148
00:07:33,000 --> 00:07:36,280
Speaker 1: huge fucking hit at this point, right, Like, that's that's

149
00:07:36,320 --> 00:07:38,080
Speaker 1: I mean, that's worth all the money we'd spent on

150
00:07:38,120 --> 00:07:40,720
Speaker 1: it forever if they just stopped the litamide. And obviously

151
00:07:40,720 --> 00:07:43,440
Speaker 1: there's other ship they're stopping their ship they're making safer.

152
00:07:43,480 --> 00:07:46,239
Speaker 1: There's stuff that they're you know, medications that they're limiting

153
00:07:46,240 --> 00:07:48,320
Speaker 1: the scope of that too many people don't take them.

154
00:07:48,480 --> 00:07:51,680
Speaker 1: The FDA is doing fucking gang busters, and it's it's

155
00:07:51,760 --> 00:07:55,680
Speaker 1: first few decades in existence. Um So, that's dope as hell.

156
00:07:55,720 --> 00:07:58,240
Speaker 1: And President Kennedy even gives the agency a shout out

157
00:07:58,240 --> 00:08:00,840
Speaker 1: in nineteen sixty two shortly but or being gunned down

158
00:08:00,840 --> 00:08:04,400
Speaker 1: by Bernard Montgomery Sanders. And it's worth noting that this

159
00:08:04,520 --> 00:08:10,000
Speaker 1: massively but I mean, okay, look, there is the theory

160
00:08:10,040 --> 00:08:13,000
Speaker 1: that Orenthal James Simpson, who was a young adult at

161
00:08:13,000 --> 00:08:15,600
Speaker 1: this period of time, may have taken part in the

162
00:08:15,640 --> 00:08:20,080
Speaker 1: assassination of John Fitzgerald Kennedy. He was a very fast runner.

163
00:08:20,480 --> 00:08:22,920
Speaker 1: I believe that he may have been providing the ammunition

164
00:08:22,960 --> 00:08:25,520
Speaker 1: to Bernie Sanders. Um, there's no way to know that

165
00:08:25,560 --> 00:08:29,960
Speaker 1: he wasn't you know. That's why proved me wrong. Yeah,

166
00:08:30,000 --> 00:08:32,720
Speaker 1: what are you gonna do? Show me that Bernie Sanders

167
00:08:32,760 --> 00:08:36,040
Speaker 1: and O J and the Juice didn't collaborate together to

168
00:08:36,080 --> 00:08:39,760
Speaker 1: assassinate John Fitzgerald Kennedy. Prove it. I hope that we

169
00:08:39,800 --> 00:08:45,600
Speaker 1: all did a headshake in Unison when that happened. So

170
00:08:46,160 --> 00:08:49,800
Speaker 1: it's worth noting that this, uh, this, this massive early

171
00:08:49,920 --> 00:08:52,440
Speaker 1: dub for the f d A was due in part

172
00:08:52,480 --> 00:08:54,920
Speaker 1: to the agency's independence in large part. Really like the

173
00:08:54,960 --> 00:08:57,840
Speaker 1: fact that this this is there's no ties to anybody

174
00:08:57,880 --> 00:09:00,000
Speaker 1: but the U. S. Taxpayer. That is the only response

175
00:09:00,000 --> 00:09:02,880
Speaker 1: posibility the f d A has. There's a shipload of

176
00:09:02,920 --> 00:09:06,079
Speaker 1: money to be made in approving like philidamide right, Like

177
00:09:06,360 --> 00:09:08,640
Speaker 1: they could have been like that, Like that company would

178
00:09:08,640 --> 00:09:11,480
Speaker 1: have made millions before they realized that it was harming

179
00:09:11,840 --> 00:09:16,040
Speaker 1: babies at a scale almost inconceivable. But the only FDA

180
00:09:16,080 --> 00:09:18,400
Speaker 1: doesn't give a shit about anybody's profits. All they care

181
00:09:18,440 --> 00:09:21,360
Speaker 1: about his safety. And Dr Kelsey looked at the data

182
00:09:21,360 --> 00:09:23,840
Speaker 1: and was like, no, funk, this ship responsible only to

183
00:09:23,880 --> 00:09:28,240
Speaker 1: the taxpayers, because that's what government is supposed to do. Well,

184
00:09:28,240 --> 00:09:31,160
Speaker 1: that's not how the FDA works anymore. Um. And to

185
00:09:31,280 --> 00:09:33,760
Speaker 1: explain why things changed, I'm going to read a quote

186
00:09:33,760 --> 00:09:36,199
Speaker 1: by a write up from Michael White of the University

187
00:09:36,240 --> 00:09:40,680
Speaker 1: of Connecticut School of Pharmacy. Quote. The first US case

188
00:09:40,720 --> 00:09:43,800
Speaker 1: of HIV induced AIDS occurred in nineteen eighty one. It

189
00:09:43,880 --> 00:09:47,920
Speaker 1: was rapidly spreading, with devastating complications like blindness, dementias, severe

190
00:09:47,960 --> 00:09:51,280
Speaker 1: respiratory diseases, and rare cancers. Well known sports stars and

191
00:09:51,320 --> 00:09:55,079
Speaker 1: celebrities died of AIDS related complications. AIDS activists were incensed

192
00:09:55,080 --> 00:09:58,000
Speaker 1: about long delays and getting experimental HIV drugs studied and

193
00:09:58,040 --> 00:10:00,480
Speaker 1: approved by the f d A. In nineteen nine two,

194
00:10:00,520 --> 00:10:04,000
Speaker 1: in response to intense pressure, Congress passed the Prescription Drug

195
00:10:04,120 --> 00:10:07,040
Speaker 1: User Fee Act. It was signed into law by President

196
00:10:07,080 --> 00:10:10,720
Speaker 1: George H. W. Bush. With the Act, the FDA moved

197
00:10:10,720 --> 00:10:13,560
Speaker 1: from a fully taxpayer funded entity to one funded through

198
00:10:13,559 --> 00:10:18,920
Speaker 1: tax dollars and new prescription drug user fees. Manufacturers pay

199
00:10:18,960 --> 00:10:22,160
Speaker 1: these fees when submitting applications to the FDA for drug review,

200
00:10:22,320 --> 00:10:24,640
Speaker 1: and annual user fees based on the number of approved

201
00:10:24,720 --> 00:10:28,400
Speaker 1: drugs they have on the market. Now surface level go

202
00:10:28,400 --> 00:10:31,240
Speaker 1: back in time. Number one. This is in response to

203
00:10:31,280 --> 00:10:33,800
Speaker 1: a real problem, right, the and this we saw this

204
00:10:33,840 --> 00:10:37,680
Speaker 1: with like COVID. Right, sometimes you can't afford to take

205
00:10:37,720 --> 00:10:41,160
Speaker 1: as much time, you know, testing ship because there's a

206
00:10:41,280 --> 00:10:44,080
Speaker 1: real immediate fucking plague and you might just need to

207
00:10:44,120 --> 00:10:45,800
Speaker 1: like throw some ship out there. And maybe there will

208
00:10:45,800 --> 00:10:48,200
Speaker 1: be some side effects with the boosters and ship I.

209
00:10:48,480 --> 00:10:50,880
Speaker 1: You know, some people like there are some side effects

210
00:10:50,880 --> 00:10:53,160
Speaker 1: and ship um that we probably would have caught and

211
00:10:53,200 --> 00:10:55,560
Speaker 1: maybe even minimized if we had not been dealing with

212
00:10:55,600 --> 00:10:58,120
Speaker 1: a global play, right, Like you gotta fucking get shipped out.

213
00:10:58,160 --> 00:11:02,280
Speaker 1: You know, that's a reasonable problem. The way they one

214
00:11:02,320 --> 00:11:04,360
Speaker 1: of the ways they deal with this is that like

215
00:11:04,720 --> 00:11:08,880
Speaker 1: they make this partially funded by the pharmaceutical drug companies,

216
00:11:09,200 --> 00:11:12,600
Speaker 1: and they allow ways for the FDA to expedite um

217
00:11:12,800 --> 00:11:15,920
Speaker 1: pharmaceutical drug approvals. And this is where all the problems

218
00:11:15,920 --> 00:11:17,760
Speaker 1: start to come in. Right, But you have to note

219
00:11:17,760 --> 00:11:20,280
Speaker 1: that it does kind of sound surface level reasonable to

220
00:11:20,320 --> 00:11:22,360
Speaker 1: a lot of people. And this is kind of the

221
00:11:22,360 --> 00:11:24,280
Speaker 1: way a lot of the government works really. Right, you

222
00:11:24,360 --> 00:11:25,880
Speaker 1: go to the d m V. You have to pay

223
00:11:25,920 --> 00:11:28,160
Speaker 1: fees to apply for stuff, right to get like register

224
00:11:28,160 --> 00:11:31,559
Speaker 1: a car, get a license. Why wouldn't big pharmaceutical companies

225
00:11:31,600 --> 00:11:33,720
Speaker 1: have to pay the FDA for drug review and other stuff?

226
00:11:33,760 --> 00:11:35,760
Speaker 1: You know, you can make a case to most people

227
00:11:35,800 --> 00:11:37,760
Speaker 1: on both sides of the political spectrum that this is

228
00:11:38,040 --> 00:11:42,480
Speaker 1: a reasonable idea, right um. And obviously the reason why

229
00:11:42,520 --> 00:11:44,560
Speaker 1: you don't do that for the f d A is

230
00:11:44,600 --> 00:11:47,240
Speaker 1: because it might lead to a situation wherein those companies

231
00:11:47,280 --> 00:11:49,960
Speaker 1: are all paying the FDA for the FDA to exist.

232
00:11:50,320 --> 00:11:52,920
Speaker 1: And when the people funding your organization are the folks

233
00:11:52,920 --> 00:11:55,679
Speaker 1: with a vested interest in you saying yes to their drugs, well,

234
00:11:55,960 --> 00:11:58,240
Speaker 1: that can cause some problems. You are no longer the

235
00:11:58,280 --> 00:12:01,680
Speaker 1: independent organization that stopped philetamide from hitting the streets. You

236
00:12:01,720 --> 00:12:04,920
Speaker 1: know it was there was a short sighted move on

237
00:12:05,000 --> 00:12:07,560
Speaker 1: that law. You know, I got where they were coming

238
00:12:07,600 --> 00:12:11,280
Speaker 1: from But uh, it sounds bad. You get why people

239
00:12:11,320 --> 00:12:13,920
Speaker 1: could be convinced that this was a good idea because

240
00:12:13,920 --> 00:12:16,280
Speaker 1: it sounds like a tax. It sounds like, Oh, all

241
00:12:16,320 --> 00:12:19,480
Speaker 1: we're doing is like making you know, you're you're still

242
00:12:19,480 --> 00:12:21,360
Speaker 1: going to get the money from the taxpayers, but you're

243
00:12:21,360 --> 00:12:24,560
Speaker 1: also we're gonna a tax these companies for you even applying.

244
00:12:24,559 --> 00:12:31,240
Speaker 1: And it's like it is tying these salaries of uh,

245
00:12:31,400 --> 00:12:34,600
Speaker 1: the of of the people who work for the FDA

246
00:12:34,760 --> 00:12:38,040
Speaker 1: to the pharmaceutical industry. You know, that's that's what it's doing,

247
00:12:38,360 --> 00:12:43,080
Speaker 1: and that's not great, you know. Um So, over the years,

248
00:12:43,160 --> 00:12:46,240
Speaker 1: new fees were introduced for the approval of generic drugs,

249
00:12:46,240 --> 00:12:49,600
Speaker 1: over the counter drugs, biosimilar drugs, animal medications, as well

250
00:12:49,640 --> 00:12:54,160
Speaker 1: as medical devices. The FDA develops a complex system of waivers, refunds,

251
00:12:54,160 --> 00:12:56,600
Speaker 1: and exemptions dependent on the category of drug and the

252
00:12:56,600 --> 00:12:59,960
Speaker 1: total number of drugs the manufacturer had approved. A LABYRINTHI

253
00:13:00,000 --> 00:13:03,440
Speaker 1: an expensive bureaucracy developed, and the proceeds from this bureaucracy

254
00:13:03,480 --> 00:13:06,000
Speaker 1: grew to account for forty of the f d a's

255
00:13:06,280 --> 00:13:11,040
Speaker 1: five point nine billion dollar budget. But wait, there's more.

256
00:13:11,559 --> 00:13:14,520
Speaker 1: Sixty five percent of the funding for human drug regulation

257
00:13:14,600 --> 00:13:18,920
Speaker 1: comes directly from user fees submitted by pharmaceutical companies. Now

258
00:13:18,960 --> 00:13:22,040
Speaker 1: this has had some positive outcomes because their funding comes

259
00:13:22,040 --> 00:13:24,560
Speaker 1: from these fees. The FDA has gotten a lot faster

260
00:13:24,720 --> 00:13:28,079
Speaker 1: at responding to manufacturers about what they need in their applications.

261
00:13:28,320 --> 00:13:30,800
Speaker 1: The whole process of getting new medicines approved has gotten

262
00:13:30,880 --> 00:13:34,160
Speaker 1: a lot speedier. Seven it took twenty nine months to

263
00:13:34,160 --> 00:13:38,240
Speaker 1: get FDA approval or denial. By fourteen, it took thirteen months.

264
00:13:38,440 --> 00:13:41,520
Speaker 1: By two eighteen, it was down to ten months. President

265
00:13:41,559 --> 00:13:44,360
Speaker 1: Trump personally promised to streamline the process by which drugs

266
00:13:44,360 --> 00:13:47,240
Speaker 1: were approved, and his administration seems to have delivered in

267
00:13:47,240 --> 00:13:50,560
Speaker 1: this respect. Now that can be good, as we've seen

268
00:13:50,600 --> 00:13:55,000
Speaker 1: in the COVID responses. Sometimes you need stuff approved very rapidly,

269
00:13:55,559 --> 00:13:59,079
Speaker 1: but usually you don't. One of the things that these

270
00:13:59,120 --> 00:14:01,240
Speaker 1: changes have done is they've led to an increase from

271
00:14:01,280 --> 00:14:04,080
Speaker 1: thirty eight percent to sixty one in the number of

272
00:14:04,080 --> 00:14:07,640
Speaker 1: first time approvals on new drug applications in diseases where

273
00:14:07,640 --> 00:14:10,520
Speaker 1: there are a few existing medications and even more streamlined

274
00:14:10,520 --> 00:14:13,640
Speaker 1: approval process means that eight nine percent of applications get

275
00:14:13,640 --> 00:14:16,480
Speaker 1: approved the first time, often and under eight months. This

276
00:14:16,559 --> 00:14:19,080
Speaker 1: is all coincided with a huge surge in the number

277
00:14:19,160 --> 00:14:21,600
Speaker 1: of new drug applications because you can get them said

278
00:14:21,680 --> 00:14:22,960
Speaker 1: yes a lot quicker and get him out there and

279
00:14:22,960 --> 00:14:26,440
Speaker 1: start making fucking money. So that is impressive if you

280
00:14:26,480 --> 00:14:28,120
Speaker 1: don't account for the fact that an awful lot of

281
00:14:28,120 --> 00:14:31,560
Speaker 1: these new drugs getting expedited approvals are fucking horrible. And

282
00:14:31,560 --> 00:14:33,760
Speaker 1: I'm gonna quote from Michael White from the University of

283
00:14:33,800 --> 00:14:37,520
Speaker 1: Connecticut here. While the number and speed of drug approvals

284
00:14:37,520 --> 00:14:39,640
Speaker 1: have been increasing over time, so have the number of

285
00:14:39,680 --> 00:14:42,040
Speaker 1: drugs that end up having serious safety issues coming to

286
00:14:42,120 --> 00:14:45,520
Speaker 1: light after FDA approval, and one assessment, investigators looked at

287
00:14:45,520 --> 00:14:48,560
Speaker 1: the number of newly approved medications that were subsequently removed

288
00:14:48,560 --> 00:14:50,560
Speaker 1: from the market or had to include a new black

289
00:14:50,600 --> 00:14:53,120
Speaker 1: box warning over sixteen years from the year of approval.

290
00:14:53,800 --> 00:14:56,080
Speaker 1: These black box warnings are the highest level of safety

291
00:14:56,120 --> 00:14:59,160
Speaker 1: alert that the FDA can employ, warning users that are

292
00:14:59,280 --> 00:15:02,240
Speaker 1: very serious verse event could occur before the user fee

293
00:15:02,280 --> 00:15:05,440
Speaker 1: was approved of medications were removed or had new black

294
00:15:05,480 --> 00:15:09,400
Speaker 1: box warnings as compared to twenty seven percent afterwards. Now

295
00:15:09,400 --> 00:15:12,120
Speaker 1: that jump alone is not great, right, but it's also like,

296
00:15:12,440 --> 00:15:15,520
Speaker 1: you know, six percent, that's not the worst thing in

297
00:15:15,560 --> 00:15:17,960
Speaker 1: the world, But when you really dig into the data,

298
00:15:18,120 --> 00:15:20,960
Speaker 1: it's it sounds a lot worse than that. Actually, matt um,

299
00:15:21,240 --> 00:15:23,000
Speaker 1: it does. It does. And I'm gonna quote now from

300
00:15:23,000 --> 00:15:25,600
Speaker 1: a write up I found by CNN, about a third

301
00:15:25,640 --> 00:15:27,760
Speaker 1: of the drugs the FDA approved between two thousand and

302
00:15:27,800 --> 00:15:29,680
Speaker 1: one and two thousand ten were involved in some kind

303
00:15:29,680 --> 00:15:31,960
Speaker 1: of safety event after reaching the market, According to a

304
00:15:31,960 --> 00:15:34,240
Speaker 1: study published in Tuesday in the Journal of America the

305
00:15:34,280 --> 00:15:37,360
Speaker 1: American Medical Association. The authors found that in that time,

306
00:15:37,360 --> 00:15:40,120
Speaker 1: two and twenty two novel therapeutics were approved, and there

307
00:15:40,160 --> 00:15:42,800
Speaker 1: were a hundred and twenty three post market safety events

308
00:15:43,000 --> 00:15:46,920
Speaker 1: involving seventy one products that required FDA action. Manufacturers needed

309
00:15:46,960 --> 00:15:49,480
Speaker 1: to add sixty one boxed warnings also commonly called a

310
00:15:49,520 --> 00:15:52,240
Speaker 1: black box warning to call attention to serious risks. In

311
00:15:52,320 --> 00:15:55,320
Speaker 1: fifty nine cases, some communication had to warn the users

312
00:15:55,320 --> 00:15:59,720
Speaker 1: about a product safety. Three therapeutics were withdrawn from the market. Now,

313
00:16:00,080 --> 00:16:03,120
Speaker 1: remember how I said that the FDA expedites approval requests

314
00:16:03,120 --> 00:16:05,000
Speaker 1: for drugs to treat illnesses where there aren't a lot

315
00:16:05,040 --> 00:16:08,040
Speaker 1: of existing treatments. That's good again, if there's like a

316
00:16:08,080 --> 00:16:10,240
Speaker 1: plague or something that you need to get out quick,

317
00:16:10,520 --> 00:16:13,120
Speaker 1: but it also means there's an extra financial incentive for

318
00:16:13,160 --> 00:16:16,080
Speaker 1: a pharmaceutical corporation to get a medicine approved to treat

319
00:16:16,080 --> 00:16:18,240
Speaker 1: an illness that doesn't have a lot of medicines for it.

320
00:16:18,760 --> 00:16:23,120
Speaker 1: This includes all of the mental illnesses, right, yeah, really

321
00:16:23,120 --> 00:16:25,400
Speaker 1: shortage of medicines because maybe in a lot of cases

322
00:16:25,440 --> 00:16:27,280
Speaker 1: medicines don't help that much. With a lot of studies,

323
00:16:27,320 --> 00:16:29,560
Speaker 1: we're fighting not not to be against medications. A lot

324
00:16:29,520 --> 00:16:31,600
Speaker 1: of great medications out there, but there's a lot of

325
00:16:31,600 --> 00:16:35,000
Speaker 1: fucking problems with mental health medications, and it's very fucking

326
00:16:35,040 --> 00:16:39,040
Speaker 1: easy to get an approval for a mental health medication. Um.

327
00:16:39,080 --> 00:16:42,840
Speaker 1: And that for a while, mental health medication was just

328
00:16:42,880 --> 00:16:46,800
Speaker 1: doing electricity on your brain. So you know, at this point,

329
00:16:46,800 --> 00:16:49,280
Speaker 1: if it's in pillform, people are like, yeah, proven you

330
00:16:49,320 --> 00:16:53,400
Speaker 1: don't you would think that it wasn't worse now, but

331
00:16:53,480 --> 00:16:57,840
Speaker 1: in some ways it is. Um so that a m

332
00:16:57,840 --> 00:17:00,440
Speaker 1: A journal report noted that drugs used for mental illness

333
00:17:00,480 --> 00:17:04,119
Speaker 1: had a higher number of events UM like negative health

334
00:17:04,160 --> 00:17:06,680
Speaker 1: and safety events. And most of these drugs, and most

335
00:17:06,720 --> 00:17:09,760
Speaker 1: of accelerated drugs are approved on trials with fewer than

336
00:17:09,800 --> 00:17:12,200
Speaker 1: a thousand patients. Because the bar is lower, they don't

337
00:17:12,200 --> 00:17:13,879
Speaker 1: need to show that it works on many people. If

338
00:17:13,920 --> 00:17:16,040
Speaker 1: you can jig a trial with a hundred people with

339
00:17:16,080 --> 00:17:18,400
Speaker 1: a thousand people and show that it works like five

340
00:17:18,760 --> 00:17:22,880
Speaker 1: people or whatnot, you can fucking get approval and expedited

341
00:17:23,000 --> 00:17:25,800
Speaker 1: as well. Yeah, yeah, you can get it done really quickly.

342
00:17:25,840 --> 00:17:27,199
Speaker 1: And there's a good book. We're not going to get

343
00:17:27,240 --> 00:17:29,560
Speaker 1: into it much because I'm kind of focusing on the FDA.

344
00:17:29,600 --> 00:17:33,040
Speaker 1: There's a whole book written about all of the different

345
00:17:33,080 --> 00:17:36,800
Speaker 1: ways in which the the medical testing industry, like the

346
00:17:36,840 --> 00:17:40,080
Speaker 1: industry that is designed to determine whether or not drugs work,

347
00:17:40,520 --> 00:17:44,199
Speaker 1: is heavily compromised because most of those studies are funded

348
00:17:44,200 --> 00:17:46,639
Speaker 1: by the pharmaceutical companies. There's all sorts of ways they

349
00:17:46,680 --> 00:17:49,480
Speaker 1: funk with the data. A lot of those scientists wind

350
00:17:49,560 --> 00:17:52,560
Speaker 1: up getting like cushy jobs afterwards and stuff with these companies.

351
00:17:52,600 --> 00:17:54,360
Speaker 1: There's all sorts of ways like that's a big part

352
00:17:54,400 --> 00:17:57,320
Speaker 1: of how a lot of very like negative like that's

353
00:17:57,320 --> 00:17:59,680
Speaker 1: how they That's how a lot of like negative aspects

354
00:17:59,720 --> 00:18:02,960
Speaker 1: of different foods like sodas and ship get hidden for

355
00:18:03,000 --> 00:18:05,879
Speaker 1: so long. Because you can kind of have a study

356
00:18:05,880 --> 00:18:08,160
Speaker 1: of five people that you control, and you can make

357
00:18:08,160 --> 00:18:10,480
Speaker 1: it kind of say whatever you want. The book is

358
00:18:10,520 --> 00:18:13,639
Speaker 1: called Unsavory Truth, How Food Companies skew the science of

359
00:18:13,680 --> 00:18:15,160
Speaker 1: what we eat, and it includes a lot of detail

360
00:18:15,200 --> 00:18:17,880
Speaker 1: on the pharmaceutical industry to It's by a woman named

361
00:18:17,920 --> 00:18:22,000
Speaker 1: Mary and Nestleie no relation to the candy people. Um again,

362
00:18:22,040 --> 00:18:25,360
Speaker 1: we're not really going to get into that, but yeah,

363
00:18:25,400 --> 00:18:27,639
Speaker 1: I I should, you know, I should read one quote

364
00:18:27,640 --> 00:18:31,080
Speaker 1: from this about the way in which industry funded research

365
00:18:31,160 --> 00:18:34,119
Speaker 1: favors the sponsors commercial interests. So I'm gonna read a

366
00:18:34,160 --> 00:18:37,360
Speaker 1: quote from that book here. Sheldon Crimsky, a Toughs University

367
00:18:37,359 --> 00:18:40,680
Speaker 1: professor who studies industry manipulation of science, dates the discovery

368
00:18:40,680 --> 00:18:43,040
Speaker 1: of this funding effect to the mid nineteen eighties, when

369
00:18:43,040 --> 00:18:45,439
Speaker 1: social scientists realized that if they knew who paid for

370
00:18:45,440 --> 00:18:48,719
Speaker 1: a study, they could predict its results. One funding effect

371
00:18:48,800 --> 00:18:51,320
Speaker 1: investigation from the late nineteen nineties looked at studies on

372
00:18:51,320 --> 00:18:54,280
Speaker 1: the safety of calcium channel blockers for reducing blood pressure.

373
00:18:54,480 --> 00:18:57,280
Speaker 1: Nearly all authors nineties percent who concluded that the drugs

374
00:18:57,280 --> 00:19:01,119
Speaker 1: were effective, reported financial ties to their manufactures. Only thirty

375
00:19:01,160 --> 00:19:04,240
Speaker 1: seven percent of authors who doubted the effectiveness had such ties,

376
00:19:04,480 --> 00:19:06,520
Speaker 1: and two thousand three a systemic review of more than

377
00:19:06,560 --> 00:19:09,680
Speaker 1: one thousand biomedical research studies came to a similar conclusion.

378
00:19:09,920 --> 00:19:13,359
Speaker 1: Investigators with industry affiliations were nearly four times more likely

379
00:19:13,400 --> 00:19:15,800
Speaker 1: to come up with pro industry conclusions than those without

380
00:19:15,840 --> 00:19:20,640
Speaker 1: such ties. See, that's why we don't trust doctors. If

381
00:19:20,640 --> 00:19:23,160
Speaker 1: you want to know why they're there's a reason people

382
00:19:23,160 --> 00:19:26,440
Speaker 1: are so distrustful about like the vaccines in the medical industry.

383
00:19:26,520 --> 00:19:31,520
Speaker 1: Like they should be distrustful, just not in this specific case. Really, yeah,

384
00:19:31,640 --> 00:19:33,960
Speaker 1: I mean, it's just it sucks because it's like every

385
00:19:34,000 --> 00:19:36,199
Speaker 1: time I hear an anti vaxer talk, I'm always like,

386
00:19:37,080 --> 00:19:41,879
Speaker 1: there's part of me that understands exactly where you're coming from,

387
00:19:42,600 --> 00:19:46,879
Speaker 1: minus the part where you're completely ignoring all subsequent data

388
00:19:47,000 --> 00:19:50,000
Speaker 1: as to the efficacy of these like vaccines. But it's

389
00:19:50,040 --> 00:19:52,520
Speaker 1: like I get it because like, yeah, nine out of

390
00:19:52,560 --> 00:19:55,680
Speaker 1: ten doctors think that this drug is good. Also, nine

391
00:19:55,680 --> 00:19:57,840
Speaker 1: out of ten doctors are paid for by the company

392
00:19:57,840 --> 00:20:01,160
Speaker 1: that makes this drug. It's just yeah, maybe a better

393
00:20:01,200 --> 00:20:03,600
Speaker 1: solution would be to tax all of the billionaires until

394
00:20:03,640 --> 00:20:07,119
Speaker 1: they're not billionaires, to dissolve all pharmaceutical corporations, and to

395
00:20:07,200 --> 00:20:09,479
Speaker 1: take all of their patents and property and money and

396
00:20:09,520 --> 00:20:13,639
Speaker 1: put it in a trust run or administered by, you know,

397
00:20:13,720 --> 00:20:17,359
Speaker 1: an agency made up of scientists who are purely paid

398
00:20:17,400 --> 00:20:20,840
Speaker 1: and supported by the taxpayer, whose job is to make

399
00:20:21,440 --> 00:20:27,600
Speaker 1: pharmaceutical stuff happen. Maybe just off the topic I did

400
00:20:27,680 --> 00:20:30,480
Speaker 1: I I I've actually invented a whole system. Um it's

401
00:20:30,480 --> 00:20:35,320
Speaker 1: called Marxist uh Robertism. Yeah, that's that's that's very heavily

402
00:20:35,359 --> 00:20:42,800
Speaker 1: based on what I what I another word, I invented socialism. Yeah. Yeah,

403
00:20:42,920 --> 00:20:45,040
Speaker 1: I'm the first person to figure this out. I have

404
00:20:45,080 --> 00:20:48,719
Speaker 1: a lot of great ideas. We're going to freeze a

405
00:20:48,720 --> 00:20:51,320
Speaker 1: lot of seeds to see if it makes them cold tolerant,

406
00:20:51,320 --> 00:20:59,000
Speaker 1: a lot of cool stuff. Try that out. Try that yeah.

407
00:20:59,760 --> 00:21:04,200
Speaker 1: So uh yeah, one area where all of this ship.

408
00:21:04,600 --> 00:21:09,040
Speaker 1: Uh this uh horrific. But so and again it's like

409
00:21:09,080 --> 00:21:12,520
Speaker 1: one of those the basic idea by which this problem

410
00:21:12,520 --> 00:21:15,000
Speaker 1: started as like reasonable, Well, these companies should have to

411
00:21:15,040 --> 00:21:17,840
Speaker 1: prove their medicine works. They should be conducting studies to

412
00:21:17,840 --> 00:21:19,360
Speaker 1: show that the stuff is safe and that it does

413
00:21:19,400 --> 00:21:22,159
Speaker 1: what it says it does. Very reasonable thing to propose

414
00:21:22,200 --> 00:21:25,720
Speaker 1: in like nineteen when it is like pushed. But you

415
00:21:25,760 --> 00:21:28,439
Speaker 1: see the obvious problem, which is that, well, they're not

416
00:21:28,520 --> 00:21:30,960
Speaker 1: gonna fun to study because they care so much, because

417
00:21:30,960 --> 00:21:33,800
Speaker 1: their primary interest is profit, their primary interest is not

418
00:21:33,880 --> 00:21:35,960
Speaker 1: helping people. A lot of the doctors and stuff, their

419
00:21:35,960 --> 00:21:37,800
Speaker 1: interest is helping people. And like one of the things

420
00:21:37,920 --> 00:21:40,520
Speaker 1: that I will say, a lot of those people who

421
00:21:40,600 --> 00:21:43,040
Speaker 1: those scientists whose results are heavily skewed by the fact

422
00:21:43,040 --> 00:21:45,320
Speaker 1: that they're being paid by pharmaceutical companies. It's not because

423
00:21:45,320 --> 00:21:47,680
Speaker 1: they're like evil or even know what they're doing. It

424
00:21:47,840 --> 00:21:51,560
Speaker 1: just happens. Um. It's likewise, I don't talk about the

425
00:21:51,600 --> 00:21:54,439
Speaker 1: fact that has an island where they allow you to

426
00:21:54,520 --> 00:21:58,200
Speaker 1: hunt children for sport very often. You know, um, because

427
00:21:58,240 --> 00:22:02,600
Speaker 1: I'm swimming in those bucks. Baby, you're just filled with

428
00:22:02,760 --> 00:22:06,800
Speaker 1: Salisbury steaks that you're gonna cook fresh tonight. They stakes

429
00:22:06,840 --> 00:22:09,399
Speaker 1: made from the children hunted on their private island. You know,

430
00:22:09,960 --> 00:22:13,960
Speaker 1: it's good stuff. You taste the fear, you know. So

431
00:22:14,119 --> 00:22:16,199
Speaker 1: one area where this whole problem may have had a

432
00:22:16,240 --> 00:22:19,040
Speaker 1: major impact both the fact that they're conducting the industry

433
00:22:19,080 --> 00:22:22,200
Speaker 1: is conducting these studies, um, and that this approval process

434
00:22:22,200 --> 00:22:24,399
Speaker 1: it's a lot easier to get mental health medication approved

435
00:22:24,480 --> 00:22:27,480
Speaker 1: is in the treatment of schizophrenia. In recent years, the

436
00:22:27,520 --> 00:22:30,720
Speaker 1: World Health Organization has released two studies which find that

437
00:22:30,840 --> 00:22:34,880
Speaker 1: long term outcomes for schizophrenia patients in three developing countries.

438
00:22:34,920 --> 00:22:36,600
Speaker 1: This is the term that they use. I don't prefer

439
00:22:36,640 --> 00:22:38,840
Speaker 1: that term, but I'm reading from a study they did

440
00:22:39,160 --> 00:22:42,520
Speaker 1: so skip long term outcomes for schizophrenia patients and three

441
00:22:42,520 --> 00:22:46,399
Speaker 1: developing countries were actually better than in the United States

442
00:22:46,480 --> 00:22:51,520
Speaker 1: and five other developed countries. Now, why how can this be? Well,

443
00:22:52,359 --> 00:22:55,399
Speaker 1: it's not entirely known, but one probably the leading theory

444
00:22:55,520 --> 00:22:58,680
Speaker 1: is that the countries with better outcomes for treating schizophrenia

445
00:22:59,000 --> 00:23:03,680
Speaker 1: only used anti psychotic meds acutely, not chronically. So they

446
00:23:03,720 --> 00:23:06,320
Speaker 1: give people They're not like rejecting this medication, but they

447
00:23:06,400 --> 00:23:08,560
Speaker 1: use it when someone is having an issue, when they're

448
00:23:08,560 --> 00:23:15,320
Speaker 1: having a psychotic breakers and not daily. You know. Um,

449
00:23:15,640 --> 00:23:18,280
Speaker 1: only sixteen percent of patients in those countries were on

450
00:23:18,359 --> 00:23:21,840
Speaker 1: regular maintenance doses of antipsychotics. Is supposed to basically everybody

451
00:23:21,880 --> 00:23:24,399
Speaker 1: with schizophrenia in the United States, right, That is the

452
00:23:24,480 --> 00:23:27,680
Speaker 1: standard of care um for most people who are dealing

453
00:23:27,680 --> 00:23:30,320
Speaker 1: with that here. And we have worse outcomes in these

454
00:23:30,320 --> 00:23:31,879
Speaker 1: countries with a lot less money to spend on their

455
00:23:31,920 --> 00:23:35,840
Speaker 1: medical system, and that maybe why. A subsequent Harvard study

456
00:23:35,880 --> 00:23:38,760
Speaker 1: found that schizophrenia outcomes for patients in the United States

457
00:23:38,920 --> 00:23:42,040
Speaker 1: have declined over the last twenty years, and at present

458
00:23:42,080 --> 00:23:44,240
Speaker 1: they are no better than they were in the nineteen twenties.

459
00:23:45,200 --> 00:23:48,760
Speaker 1: Fuck like the electrocution days, right Like, we've gone back.

460
00:23:48,800 --> 00:23:50,399
Speaker 1: We had gotten a lot better for a while, but

461
00:23:50,480 --> 00:23:54,199
Speaker 1: we we've gone back. Um journalist Robert Whittaker has investigated

462
00:23:54,200 --> 00:23:56,639
Speaker 1: the subject heavily, and he puts blame on a shamefully

463
00:23:56,720 --> 00:24:00,399
Speaker 1: lax testing process for medication for schizophrenia, the result of

464
00:24:00,400 --> 00:24:03,320
Speaker 1: all of the systems we've just discussed. Quote. When you

465
00:24:03,320 --> 00:24:06,280
Speaker 1: look at the short term studies of antidepressants and antipsychotics,

466
00:24:06,280 --> 00:24:09,480
Speaker 1: the evidence of efficacy in reducing symptoms compared to placebo

467
00:24:09,600 --> 00:24:12,280
Speaker 1: is really pretty marginal and fails to rise to the

468
00:24:12,359 --> 00:24:16,159
Speaker 1: level of a clinically meaningful benefit. Furthermore, the problem with

469
00:24:16,200 --> 00:24:18,040
Speaker 1: all of this research is that there is no real

470
00:24:18,080 --> 00:24:21,120
Speaker 1: placebo group in the studies. The placebo group is composed

471
00:24:21,119 --> 00:24:24,240
Speaker 1: of patients who have been withdrawn from their psychiatric medications

472
00:24:24,240 --> 00:24:27,720
Speaker 1: and then randomized to placebo. Thus, the placebo group is

473
00:24:27,760 --> 00:24:30,600
Speaker 1: a drug withdrawal group, and we know the withdrawal from

474
00:24:30,640 --> 00:24:34,399
Speaker 1: psychotic drugs can stir myriad negative effects a medication naive

475
00:24:34,440 --> 00:24:37,760
Speaker 1: placebo group would have a much better outcome. In short,

476
00:24:38,040 --> 00:24:40,800
Speaker 1: the research on the short term effects of psychiatric drugs

477
00:24:40,880 --> 00:24:43,800
Speaker 1: is a scientific mess. In fact, a two thousand seventeen

478
00:24:43,840 --> 00:24:45,919
Speaker 1: paper that was designed to defend the long term use

479
00:24:45,960 --> 00:24:49,600
Speaker 1: of antipsychotics nevertheless acknowledged in an off hand way that quote,

480
00:24:49,800 --> 00:24:52,760
Speaker 1: no placebo controlled trials have been reported in first episode

481
00:24:52,800 --> 00:24:56,800
Speaker 1: psychosis patients. Antipsychotics were introduced sixty five years ago, and

482
00:24:56,800 --> 00:24:59,240
Speaker 1: we still don't have good evidence that they work over

483
00:24:59,280 --> 00:25:05,000
Speaker 1: the short term in first episode patients. Still still it's

484
00:25:05,080 --> 00:25:07,800
Speaker 1: it's it's a very unlike you dig into it, it's

485
00:25:07,880 --> 00:25:10,720
Speaker 1: very messy. I should note there are researchers and scientists

486
00:25:10,760 --> 00:25:13,439
Speaker 1: who criticize Whittaker's work. Here one of the reasons I

487
00:25:13,440 --> 00:25:15,840
Speaker 1: tend to trust him number one, there's other experts that

488
00:25:15,880 --> 00:25:19,000
Speaker 1: back him. Number two. When he's interviewed by I found

489
00:25:19,000 --> 00:25:22,360
Speaker 1: this in a Scientific American article. He linked lists lengthily

490
00:25:22,440 --> 00:25:24,359
Speaker 1: all of the different criticisms of his work, and he

491
00:25:24,440 --> 00:25:26,560
Speaker 1: links to responses he's made to all of them, and

492
00:25:26,560 --> 00:25:28,040
Speaker 1: he points out the ones I think these have some

493
00:25:28,119 --> 00:25:30,119
Speaker 1: these guys have some points. I think these guys are

494
00:25:30,119 --> 00:25:33,840
Speaker 1: fascile you know. One of the reasons that I tend

495
00:25:33,880 --> 00:25:37,639
Speaker 1: to think he's probably onto something, um, because he actually

496
00:25:37,680 --> 00:25:41,240
Speaker 1: addresses the criticism and has rebuttals to it. Yeah, Yeah,

497
00:25:41,440 --> 00:25:44,520
Speaker 1: he's he's taking it seriously as as scientists as opposed

498
00:25:44,520 --> 00:25:47,080
Speaker 1: to like going for you know the thing um, And

499
00:25:47,160 --> 00:25:49,879
Speaker 1: his arguments feel extracredible to me because the same sorts

500
00:25:49,880 --> 00:25:52,560
Speaker 1: of problems that he outlies are in dimmick when you

501
00:25:52,600 --> 00:25:55,040
Speaker 1: look at other major failures of the f DA. So

502
00:25:55,119 --> 00:25:58,520
Speaker 1: it's not just with these medications he's criticizing. It happens

503
00:25:58,520 --> 00:26:01,359
Speaker 1: all over the goddamn time, um. And a strong argument

504
00:26:01,400 --> 00:26:03,359
Speaker 1: could be made that if the lidamide came before the

505
00:26:03,400 --> 00:26:06,080
Speaker 1: FDA Approval Board today, it probably would have wound up

506
00:26:06,080 --> 00:26:09,080
Speaker 1: in pharmacies across the country because there were no sleeping

507
00:26:09,080 --> 00:26:11,760
Speaker 1: medications that were safe for pregnant women. And if the

508
00:26:11,880 --> 00:26:14,480
Speaker 1: lidamide is able to get like a thousand person study

509
00:26:14,520 --> 00:26:16,280
Speaker 1: that kind of sort of shows that then yeah, then

510
00:26:16,320 --> 00:26:18,840
Speaker 1: suddenly boom, we've got a lot of philidamite up in air,

511
00:26:18,960 --> 00:26:23,199
Speaker 1: you know study and uh all know those babies who's

512
00:26:23,320 --> 00:26:25,520
Speaker 1: like arms are on their legs and legs on their arms,

513
00:26:25,560 --> 00:26:28,080
Speaker 1: that's actually just that's like part of it. They like

514
00:26:28,200 --> 00:26:32,159
Speaker 1: to They like that. Everybody likes that. Ye helps, Mr

515
00:26:32,240 --> 00:26:35,680
Speaker 1: just holding you back? Yeah exactly, it's trust me, dude,

516
00:26:35,840 --> 00:26:38,480
Speaker 1: he's into it. We're all we're Mr Potato heading on.

517
00:26:38,520 --> 00:26:40,879
Speaker 1: They don't need elbows. What do you get cooked by

518
00:26:40,920 --> 00:26:47,000
Speaker 1: an elbow? No, thank you? Straight onto the band. Oh yeah,

519
00:26:47,600 --> 00:26:51,440
Speaker 1: we've got machines for them to breathe through. It's fine. Yeah.

520
00:26:51,960 --> 00:26:54,960
Speaker 1: So this all brings me to the very sad story

521
00:26:55,119 --> 00:26:58,240
Speaker 1: of viox. Near the end of the nineteen nineties, Mirk

522
00:26:58,359 --> 00:27:00,680
Speaker 1: went to the FDA to get approof for by Ox,

523
00:27:00,760 --> 00:27:03,879
Speaker 1: a pain killer meant for patients with arthritis. They believed

524
00:27:03,880 --> 00:27:06,439
Speaker 1: it was superior to older pain killers because it had

525
00:27:06,520 --> 00:27:08,960
Speaker 1: fewer gastro intestinal side effect so they're arguing, like, this

526
00:27:09,040 --> 00:27:12,159
Speaker 1: is a safer pain killer for people with arthritis. To

527
00:27:12,200 --> 00:27:15,400
Speaker 1: support their case, they presented the FDA with eight studies

528
00:27:15,600 --> 00:27:19,160
Speaker 1: which had a grand total of fifty four hundred total subjects.

529
00:27:20,119 --> 00:27:22,800
Speaker 1: So that is well under an average of a thousand

530
00:27:22,800 --> 00:27:25,480
Speaker 1: subjects per study. Right, that's not a lot of people

531
00:27:25,800 --> 00:27:29,119
Speaker 1: to prove that your for for for number one arthritis

532
00:27:29,160 --> 00:27:32,160
Speaker 1: is very common, right, A ton of people need medication

533
00:27:32,200 --> 00:27:34,960
Speaker 1: for arthritis. That's not a shipload of subjects to prove

534
00:27:35,000 --> 00:27:37,879
Speaker 1: that a medication is safe, right, that it really is not.

535
00:27:38,640 --> 00:27:41,840
Speaker 1: In November of nine, they asked the FDA for approval.

536
00:27:42,040 --> 00:27:44,240
Speaker 1: They seem to have realized their case that it was

537
00:27:44,320 --> 00:27:47,640
Speaker 1: safer rested on pretty thin ground. So as they're going

538
00:27:47,680 --> 00:27:51,959
Speaker 1: for approval, they launched the Box gastro Intestinal Outcomes Research Study,

539
00:27:52,119 --> 00:27:55,800
Speaker 1: or VIGOR. This study would have more than eight thousand participants.

540
00:27:55,800 --> 00:27:58,399
Speaker 1: So that's good. That's almost twice as many participants as

541
00:27:58,400 --> 00:28:00,640
Speaker 1: they've had in total and all the other study. Now

542
00:28:00,640 --> 00:28:02,920
Speaker 1: we're starting to get you know that that that could

543
00:28:03,000 --> 00:28:05,359
Speaker 1: establish a broader base that to to show that this

544
00:28:05,400 --> 00:28:09,200
Speaker 1: is science here. So but this is after they start

545
00:28:09,240 --> 00:28:12,359
Speaker 1: this big study, after they've approved, or after they have

546
00:28:12,440 --> 00:28:15,160
Speaker 1: filed for approval with the FDA, and before the VIGOR

547
00:28:15,240 --> 00:28:17,920
Speaker 1: study is finished. The f d A approves by OX

548
00:28:17,960 --> 00:28:20,280
Speaker 1: in May of nineteen ninety nine off the strength of

549
00:28:20,280 --> 00:28:24,560
Speaker 1: those small studies and nothing else. Fucking roll the dice.

550
00:28:24,640 --> 00:28:29,920
Speaker 1: What do you need, right, it's their own Fuck them.

551
00:28:30,160 --> 00:28:32,960
Speaker 1: VIGOR doesn't report its first results from the study until

552
00:28:33,000 --> 00:28:36,199
Speaker 1: October of nineteen ninety nine, and they were promising VOX

553
00:28:36,280 --> 00:28:38,959
Speaker 1: patients seemed to have fewer ulcers and less bleeding than

554
00:28:39,000 --> 00:28:42,560
Speaker 1: patients taking the proxen, which was the kind of standard previously.

555
00:28:43,080 --> 00:28:46,480
Speaker 1: But then in November of nineteen ninetnine, things started to turn.

556
00:28:46,560 --> 00:28:49,120
Speaker 1: And I'm gonna quote from NPR here. At the second

557
00:28:49,160 --> 00:28:52,000
Speaker 1: meeting of the Vigor Safety Panel, the discussion focuses on

558
00:28:52,080 --> 00:28:55,840
Speaker 1: heart problems. As of November one, nineteen seventy nine patients

559
00:28:55,840 --> 00:28:58,280
Speaker 1: out of four thousand taking bax have had serious heart

560
00:28:58,280 --> 00:29:01,560
Speaker 1: problems or have died, compared with forty one taking the proxi.

561
00:29:01,600 --> 00:29:04,120
Speaker 1: In the minutes of the panel's November meeting, note that

562
00:29:04,160 --> 00:29:06,680
Speaker 1: while the trends are disconcerting, the numbers of events are small.

563
00:29:06,960 --> 00:29:08,960
Speaker 1: The panel votes to continue the study and to meet

564
00:29:08,960 --> 00:29:10,680
Speaker 1: again in a month. And this would have been fine

565
00:29:10,720 --> 00:29:13,680
Speaker 1: if the medicine hadn't already been out Right, If you're

566
00:29:13,720 --> 00:29:15,600
Speaker 1: just doing this research, sure, this is what happens. Right,

567
00:29:15,840 --> 00:29:17,840
Speaker 1: if you're studying some number of people that you test

568
00:29:17,840 --> 00:29:21,320
Speaker 1: medications on are gonna die. It's going to happen. For

569
00:29:21,720 --> 00:29:24,440
Speaker 1: you can't get medication and not have that happen from

570
00:29:24,440 --> 00:29:27,880
Speaker 1: time to time. In a by deal world, you would

571
00:29:27,880 --> 00:29:30,520
Speaker 1: not start selling it in mass until you had concluded

572
00:29:30,560 --> 00:29:34,520
Speaker 1: this research. We finished finished the project and then decide

573
00:29:34,560 --> 00:29:36,680
Speaker 1: whether or not the public can have it. So, in

574
00:29:36,720 --> 00:29:39,680
Speaker 1: December of nineteen nine, the Safety Panel has what will

575
00:29:39,680 --> 00:29:42,479
Speaker 1: be its last meeting. They're told that as of December one,

576
00:29:42,680 --> 00:29:45,360
Speaker 1: nineteen nine, the risk of serious heart problems in death

577
00:29:45,360 --> 00:29:48,440
Speaker 1: among BIOX patients is twice as high as the approxim group.

578
00:29:48,640 --> 00:29:50,600
Speaker 1: So no, it's not a safer It is twice as

579
00:29:50,640 --> 00:29:53,360
Speaker 1: likely to kill your ass. But your stomach feels better

580
00:29:53,400 --> 00:29:55,920
Speaker 1: when you're dying of a heart attack, Yeah you do,

581
00:29:55,920 --> 00:29:58,280
Speaker 1: you tell me, feels better as you as you fucking

582
00:29:58,360 --> 00:30:02,000
Speaker 1: dropped to the ground. Now, the research board monitoring this,

583
00:30:02,120 --> 00:30:04,680
Speaker 1: like safety board monitoring the study, decides to continue on,

584
00:30:04,840 --> 00:30:07,600
Speaker 1: which is a questionable decision in of itself, right, Continuing

585
00:30:07,600 --> 00:30:09,840
Speaker 1: the study at this point is like, well, but it

586
00:30:09,920 --> 00:30:12,440
Speaker 1: kills twice. Maybe that's all we need to know about this.

587
00:30:12,760 --> 00:30:15,239
Speaker 1: Bring in a thousand more guys. Let's just let's just

588
00:30:15,280 --> 00:30:18,080
Speaker 1: be sure. Let's run through some more of them. Come on,

589
00:30:19,480 --> 00:30:22,080
Speaker 1: So they did tell merk like, this board is like,

590
00:30:22,120 --> 00:30:24,680
Speaker 1: you can keep doing the study, Um, but you should

591
00:30:24,720 --> 00:30:28,280
Speaker 1: develop a plan to analyze the cardiovascular results of the

592
00:30:28,320 --> 00:30:31,000
Speaker 1: study before the study ends, right, so that you can

593
00:30:31,000 --> 00:30:33,960
Speaker 1: actually determine really what the effect on people's hearts is

594
00:30:34,000 --> 00:30:35,680
Speaker 1: as soon as the studies over, because we're seeing some

595
00:30:35,680 --> 00:30:39,160
Speaker 1: stuff that's concerning, and Mark is like, no, we're not

596
00:30:39,160 --> 00:30:41,880
Speaker 1: gonna do that. Um, we're gonna We're gonna wait, We're

597
00:30:41,880 --> 00:30:43,880
Speaker 1: gonna let a couple more studies get done within another

598
00:30:43,920 --> 00:30:46,160
Speaker 1: couple of years and then we'll see if it's bad

599
00:30:46,200 --> 00:30:49,440
Speaker 1: for people's hearts. And the safety panels like cool. That

600
00:30:49,520 --> 00:30:52,640
Speaker 1: sounds cool too. We wanted to do it now, but

601
00:30:52,680 --> 00:30:55,120
Speaker 1: it sounds fine to do it later or never. Oh no,

602
00:30:55,200 --> 00:30:57,160
Speaker 1: I never looked at it like that before, But thank

603
00:30:57,200 --> 00:30:59,360
Speaker 1: you for opening our eyes. That will just not do

604
00:30:59,440 --> 00:31:02,520
Speaker 1: with the thing. Funnily enough, Matt. The head of that

605
00:31:02,600 --> 00:31:05,120
Speaker 1: safety panel was a guy named Wine Blatt, who also

606
00:31:05,160 --> 00:31:08,400
Speaker 1: served on an advisory board for Merk, owned seventy two

607
00:31:08,280 --> 00:31:10,760
Speaker 1: th dollars in Mark stock, and worked as a paid

608
00:31:10,800 --> 00:31:15,200
Speaker 1: consultant for Mark. Yeah, he seems like he seems unbiased.

609
00:31:15,640 --> 00:31:18,960
Speaker 1: That's a legic guy. That's a that's a legit dude.

610
00:31:19,120 --> 00:31:21,000
Speaker 1: How would you like it if I read your resume

611
00:31:21,160 --> 00:31:24,000
Speaker 1: every time you're advocating for things that put money in

612
00:31:24,040 --> 00:31:27,840
Speaker 1: your pocket? H Yeah, Now the company pushed the can

613
00:31:27,880 --> 00:31:30,440
Speaker 1: down the road. And sold by Ox for nearly two years.

614
00:31:30,640 --> 00:31:34,640
Speaker 1: In January of two thousand two, epidemiological studies started coming

615
00:31:34,640 --> 00:31:37,160
Speaker 1: out that warned that biox was giving people heart attacks

616
00:31:37,160 --> 00:31:41,760
Speaker 1: and strokes and huge numbers. That's January. Nothing gets done

617
00:31:41,840 --> 00:31:44,240
Speaker 1: until September, when the weight of evidence is so high

618
00:31:44,240 --> 00:31:46,320
Speaker 1: that Mirk begins to withdraw their drug from the market.

619
00:31:46,360 --> 00:31:48,240
Speaker 1: And it's still being sold until I think like two

620
00:31:48,440 --> 00:31:50,920
Speaker 1: four to a lot of people. Jesus. By the time

621
00:31:50,960 --> 00:31:53,600
Speaker 1: they finally get it off the market, twenty million Americans

622
00:31:53,600 --> 00:31:57,120
Speaker 1: have taken it. Now, the Lancet estimates that thirty eight

623
00:31:57,160 --> 00:32:01,960
Speaker 1: thousand people at least died from taking via x. That's

624
00:32:02,000 --> 00:32:09,880
Speaker 1: a pretty good yeah, they got ked now, this estimate

625
00:32:09,960 --> 00:32:13,000
Speaker 1: is likely optimistic. Dr David Graham was a scientist at

626
00:32:13,000 --> 00:32:15,400
Speaker 1: the FDA for more than twenty years when he started

627
00:32:15,440 --> 00:32:17,560
Speaker 1: speaking out about bi ox, and he's actually still working

628
00:32:17,560 --> 00:32:19,840
Speaker 1: for the FDA when he begins doing interviews about how

629
00:32:19,880 --> 00:32:22,520
Speaker 1: this happened. Here is a right up on him from

630
00:32:22,560 --> 00:32:26,600
Speaker 1: Fraud Magazine. Quote between nine and two thousand four and

631
00:32:26,720 --> 00:32:30,080
Speaker 1: estimated twenty million Americans took by Ox, eighty million worldwide,

632
00:32:30,080 --> 00:32:32,440
Speaker 1: said Graham. The recipient of the two thousand five Cliff

633
00:32:32,520 --> 00:32:35,800
Speaker 1: Robertson Sentinel Award at the recent sixteenth Annual a c

634
00:32:35,960 --> 00:32:38,840
Speaker 1: f E Fraud Conference and Exhibition. We've estimated that up

635
00:32:38,880 --> 00:32:41,240
Speaker 1: to a hundred and forty thousand patients who took BIAX

636
00:32:41,280 --> 00:32:46,080
Speaker 1: suffered heart attacks. Of this number, sixty thousand died, said Graham.

637
00:32:46,240 --> 00:32:48,600
Speaker 1: Um Yox as a poster child for what's wrong with

638
00:32:48,600 --> 00:32:50,600
Speaker 1: the f d A and why I believe FDA reform

639
00:32:50,640 --> 00:32:53,960
Speaker 1: is so urgently needed. And if Dr Graham's calculations are correct,

640
00:32:54,000 --> 00:32:57,880
Speaker 1: if sixty people died from biox, that's too box killed

641
00:32:57,880 --> 00:33:07,320
Speaker 1: more Americans than Vietnam, like holy shit, right, and based

642
00:33:07,360 --> 00:33:09,680
Speaker 1: on just like who tends to get arthritis? Most likely

643
00:33:09,720 --> 00:33:12,520
Speaker 1: a number of the people had killed probably survived Vietnam

644
00:33:12,600 --> 00:33:16,080
Speaker 1: only get iced by biox. They got marked by biox.

645
00:33:17,840 --> 00:33:20,959
Speaker 1: They lived through a pungi stick trap. But they couldn't

646
00:33:20,960 --> 00:33:25,680
Speaker 1: make it through the new f d A. Well, you

647
00:33:25,800 --> 00:33:28,280
Speaker 1: lose to the Vietcong and then you lose to Mark

648
00:33:30,000 --> 00:33:35,600
Speaker 1: sucks Merk and the Vietcong shaking hands with killing killing Americans.

649
00:33:38,960 --> 00:33:43,360
Speaker 1: So yeah, um and Dr Graham has since claimed that

650
00:33:43,400 --> 00:33:45,920
Speaker 1: the f d A not only did they were they

651
00:33:46,000 --> 00:33:49,400
Speaker 1: lax and allowing this to happen. They actually took direct steps,

652
00:33:49,440 --> 00:33:52,320
Speaker 1: he alleges, to stop scientists from speaking out against the

653
00:33:52,360 --> 00:33:55,880
Speaker 1: drug before it could be approved. In November of last year,

654
00:33:55,920 --> 00:33:58,680
Speaker 1: Graham testified before the Senate Finance Committee that the FDA

655
00:33:58,760 --> 00:34:00,840
Speaker 1: had silenced him and his call leaks from reporting on

656
00:34:00,880 --> 00:34:03,440
Speaker 1: the risks of Box and other drugs. The FDA has

657
00:34:03,520 --> 00:34:06,480
Speaker 1: let the American people down and sadly betrayed a public trust,

658
00:34:06,560 --> 00:34:09,400
Speaker 1: Graham said during his testimony. He alleged that because the

659
00:34:09,440 --> 00:34:12,359
Speaker 1: FDA is unduly influenced by the pharmacy industry, it is

660
00:34:12,560 --> 00:34:17,480
Speaker 1: incapable of protecting America against another Box. We are virtually defenseless.

661
00:34:19,600 --> 00:34:23,080
Speaker 1: That's good. Yeah, that's nice to know, you know. Yeah,

662
00:34:23,440 --> 00:34:26,080
Speaker 1: it's good to know that they you know, they started

663
00:34:26,120 --> 00:34:30,839
Speaker 1: off good, but this is yeah, they've they've fallen into

664
00:34:30,840 --> 00:34:32,879
Speaker 1: the lava at this point, you know, there in the suit,

665
00:34:33,080 --> 00:34:42,239
Speaker 1: they're choking people to death. Yeah, there's fingerprints all over

666
00:34:42,239 --> 00:34:44,439
Speaker 1: their helmet. If you if you watch the high res

667
00:34:44,560 --> 00:34:47,800
Speaker 1: versions of the original movies, because they didn't expect TVs whatever,

668
00:34:47,840 --> 00:34:50,040
Speaker 1: get that good? Yeah? Yeah, yeah, it was supposed to good.

669
00:34:51,480 --> 00:34:55,279
Speaker 1: So this is a claim that the America is defenseless

670
00:34:55,320 --> 00:34:59,080
Speaker 1: because the FDA is fundamentally compromised by the pharmaceutical industry.

671
00:34:59,120 --> 00:35:00,600
Speaker 1: This is a claim that does is there fur their

672
00:35:00,640 --> 00:35:03,359
Speaker 1: focus to do that. We're gonna have to turn back

673
00:35:03,719 --> 00:35:06,040
Speaker 1: to the story of a drug. You might be a

674
00:35:06,080 --> 00:35:08,640
Speaker 1: fan of. I certainly am a fan of our old

675
00:35:08,680 --> 00:35:14,960
Speaker 1: buddy oxy code. Oh yeah, now, I love me samopi.

676
00:35:15,040 --> 00:35:18,760
Speaker 1: It's right, but we have to acknowledge they're a problem

677
00:35:18,840 --> 00:35:23,239
Speaker 1: for the country. There a problem for me. Yeah, yeah,

678
00:35:25,400 --> 00:35:28,200
Speaker 1: I can no longer part that is a problem for

679
00:35:28,239 --> 00:35:32,520
Speaker 1: me that I had had couldn't after I left from

680
00:35:32,600 --> 00:35:37,600
Speaker 1: Central America. Yeah, oh god, it was pretty fun just

681
00:35:37,640 --> 00:35:39,400
Speaker 1: being able to pick up a bottle of liquor and

682
00:35:39,440 --> 00:35:41,879
Speaker 1: a box of code ow like on the same trip

683
00:35:41,920 --> 00:35:45,560
Speaker 1: that I got my tortillas. God man, those are the

684
00:35:45,680 --> 00:35:50,440
Speaker 1: day you know. I for years as an addict, I

685
00:35:50,440 --> 00:35:52,399
Speaker 1: would dream of going to a place where I could

686
00:35:52,440 --> 00:35:55,080
Speaker 1: just get over the counter like morphine and whatnot. And

687
00:35:55,280 --> 00:35:57,600
Speaker 1: I mean, I do think that is how it should work.

688
00:35:57,840 --> 00:36:00,800
Speaker 1: And I think it not really a problem if you

689
00:36:00,840 --> 00:36:04,200
Speaker 1: were not getting millions of people hooked on opiates telling

690
00:36:04,239 --> 00:36:07,080
Speaker 1: them that it's going to manage their pain, when makes

691
00:36:07,080 --> 00:36:09,520
Speaker 1: the pain much worse than like makes the problems long

692
00:36:09,600 --> 00:36:13,600
Speaker 1: term much worse. Oxy OxyContin is one of the most

693
00:36:13,640 --> 00:36:17,239
Speaker 1: evil things in the world because of the fact that

694
00:36:17,360 --> 00:36:21,120
Speaker 1: it uh it sucks like it's not it's not good.

695
00:36:21,280 --> 00:36:26,560
Speaker 1: It's it's not like morphine, which has like into some

696
00:36:26,680 --> 00:36:33,560
Speaker 1: liquid morphine of fucking Now the language these actually, you know,

697
00:36:33,760 --> 00:36:36,680
Speaker 1: feel good. They will destroy your life by the whole share,

698
00:36:36,800 --> 00:36:41,320
Speaker 1: of course, lots of things will. But what's what's even

699
00:36:41,400 --> 00:36:45,560
Speaker 1: more evil about oxycontent is that like this, they got

700
00:36:45,560 --> 00:36:50,840
Speaker 1: people hooked on an opiate that sucks and better than content.

701
00:36:50,920 --> 00:36:52,640
Speaker 1: But like, yeah, that we're now we're getting into the

702
00:36:52,640 --> 00:36:56,080
Speaker 1: weeds of which ones are good and which ones are bad? Um,

703
00:36:56,200 --> 00:36:58,480
Speaker 1: all of them are better than fucking coding, which is

704
00:36:58,680 --> 00:37:04,840
Speaker 1: trash the worst and you cannot ivy uh, you can't

705
00:37:04,880 --> 00:37:07,160
Speaker 1: shoot up Cody and just let let you guys know that.

706
00:37:07,400 --> 00:37:09,759
Speaker 1: Don't even go through ANIFL access. I learned that the

707
00:37:09,800 --> 00:37:14,719
Speaker 1: hard way. I was blind for sixty seconds. Anyways, that's

708
00:37:14,760 --> 00:37:17,359
Speaker 1: the good stuff you brought me on for this one.

709
00:37:18,400 --> 00:37:22,359
Speaker 1: We're both fans. But the opiate crisis is obviously a

710
00:37:22,400 --> 00:37:26,240
Speaker 1: massive titanic tragedy that has caused um maybe more damage

711
00:37:26,280 --> 00:37:31,520
Speaker 1: than almost anything else to particularly Middle America UM and

712
00:37:31,520 --> 00:37:34,080
Speaker 1: we've got we did a two party unproduce pharmaceutical UM

713
00:37:34,080 --> 00:37:37,560
Speaker 1: in the Sackler family who profited off of this primarily.

714
00:37:37,760 --> 00:37:40,600
Speaker 1: But now it's time to talk about the FDA's complicity.

715
00:37:40,640 --> 00:37:42,560
Speaker 1: But before we do that, Matt, you know who else

716
00:37:42,640 --> 00:37:46,719
Speaker 1: is complicit? And you having a good time? All the

717
00:37:47,680 --> 00:37:53,320
Speaker 1: sponsors and products, that's right, all conspiring to make you happy.

718
00:37:53,840 --> 00:37:57,799
Speaker 1: Hell yeah, and and to push oxy codo you know,

719
00:37:58,160 --> 00:38:12,799
Speaker 1: yeah for sure? All right, we're back back maybe yeah right.

720
00:38:13,520 --> 00:38:15,680
Speaker 1: I just want to point out I am twelve years sober.

721
00:38:15,760 --> 00:38:19,799
Speaker 1: For anyone out there, for anyone out there, it was

722
00:38:19,840 --> 00:38:23,120
Speaker 1: just like I should try that lot. It has been.

723
00:38:23,160 --> 00:38:25,440
Speaker 1: I always had a rule. I would always take it

724
00:38:25,680 --> 00:38:29,320
Speaker 1: to an honestly problematic degree when I was in places

725
00:38:29,360 --> 00:38:31,319
Speaker 1: outside of the country where I could get it. I've

726
00:38:31,320 --> 00:38:33,239
Speaker 1: always had a rule where I I do not ever

727
00:38:33,320 --> 00:38:36,040
Speaker 1: purchase it in the United States. Never have, never will.

728
00:38:36,320 --> 00:38:40,120
Speaker 1: Every now and then, maybe theoretically a friend has surgery

729
00:38:40,160 --> 00:38:42,040
Speaker 1: and winds up with some extra pills and stuff. But

730
00:38:42,080 --> 00:38:45,640
Speaker 1: like I, it's I've seen it's it's too it's actually

731
00:38:45,640 --> 00:38:48,080
Speaker 1: like pretty fucking horrible. Yeah, I don't have that ability.

732
00:38:48,200 --> 00:38:52,239
Speaker 1: You're like a fucking superhero to me. I can't. I

733
00:38:52,239 --> 00:38:56,919
Speaker 1: got addicted to hookah after I got clean. Straight up, Yeah,

734
00:38:57,280 --> 00:38:59,520
Speaker 1: I got addicted to stuff. I can't help it. I

735
00:38:59,680 --> 00:39:01,719
Speaker 1: know that if I were to let myself let it

736
00:39:01,760 --> 00:39:04,400
Speaker 1: be anything but like a vacation thing, I would immediately

737
00:39:04,440 --> 00:39:07,319
Speaker 1: have a problem and it would destroy my life, right yeah,

738
00:39:07,360 --> 00:39:10,000
Speaker 1: because I have had problems with other substances before to

739
00:39:10,040 --> 00:39:11,960
Speaker 1: the point where I'm like, I, I can see you

740
00:39:12,040 --> 00:39:16,440
Speaker 1: in the rear view mirror, you know. Yeah, it's always

741
00:39:16,480 --> 00:39:19,440
Speaker 1: doing push ups in the brain. Ready, fuck your party.

742
00:39:19,719 --> 00:39:23,359
Speaker 1: That is how it works. Um, So let's talk about

743
00:39:23,400 --> 00:39:27,360
Speaker 1: the FDA's complicity in the opiate epidemic. In two thousand nineteen,

744
00:39:27,440 --> 00:39:30,160
Speaker 1: a state court in Oklahoma tied quote false, misleading, and

745
00:39:30,239 --> 00:39:35,240
Speaker 1: dangerous marketing campaigns by drug manufacturers to quote exponentially increasing

746
00:39:35,320 --> 00:39:38,400
Speaker 1: rates of addiction, overdose deaths, and baby is born exposed

747
00:39:38,400 --> 00:39:41,400
Speaker 1: to opioids. This is yet another damning black mark on

748
00:39:41,400 --> 00:39:43,759
Speaker 1: an industry whose executives should all be flung into the

749
00:39:43,760 --> 00:39:46,120
Speaker 1: sun via catapult. But as this right up from the

750
00:39:46,160 --> 00:39:49,520
Speaker 1: Journal of Ethics of the American Medical Association argues, quote,

751
00:39:50,000 --> 00:39:53,480
Speaker 1: the fact that opioid manufacturers disseminated false claims regarding the

752
00:39:53,560 --> 00:39:55,839
Speaker 1: risks and benefits of opioids for the past twenty five

753
00:39:55,920 --> 00:39:58,120
Speaker 1: years points to a dereliction of duty by the U s.

754
00:39:58,160 --> 00:40:00,960
Speaker 1: Food and Drug Administration, the f REAL agency charged with

755
00:40:01,000 --> 00:40:04,840
Speaker 1: regulating pharmaceutical companies. The FDA's regulatory failures with respect to

756
00:40:04,880 --> 00:40:07,680
Speaker 1: opioids have not gotta noticed. In two thousan seventeen, the

757
00:40:07,719 --> 00:40:10,800
Speaker 1: President's Commissioned on Combating Drug Addiction and the Opioid Crisis

758
00:40:10,800 --> 00:40:13,120
Speaker 1: found that the opioid crisis was caused in part by

759
00:40:13,320 --> 00:40:16,279
Speaker 1: inadequate oversight by the Food and Drug Administration, and the

760
00:40:16,400 --> 00:40:19,600
Speaker 1: National Academy of Sciences publicly called on the FDA to

761
00:40:19,719 --> 00:40:23,680
Speaker 1: overhaul its opioid policies. Last year, a former FDA commissioner

762
00:40:23,719 --> 00:40:26,759
Speaker 1: rebuked the agency he had previously led, saying on the

763
00:40:26,760 --> 00:40:29,239
Speaker 1: television program Sixty Minutes that the FDA it was wrong

764
00:40:29,280 --> 00:40:31,560
Speaker 1: to allow the promotion of opio d s for chronic pain.

765
00:40:32,640 --> 00:40:34,759
Speaker 1: Maybe a little late on that one, buddy, You know,

766
00:40:35,000 --> 00:40:38,560
Speaker 1: better late than never, right, you know that? In this case?

767
00:40:38,600 --> 00:40:42,440
Speaker 1: Really that's that's kind of like going drunk driving killing

768
00:40:42,480 --> 00:40:44,080
Speaker 1: six people and then getting on the news and be like,

769
00:40:44,120 --> 00:40:46,879
Speaker 1: you know what, drunk driving people shouldn't be doing that. Yeah,

770
00:40:46,920 --> 00:40:51,680
Speaker 1: it's bad. It's bad. It's like drunk driving and killing people,

771
00:40:52,000 --> 00:40:54,680
Speaker 1: hundreds of thousands of people for decades and hundreds of

772
00:40:54,680 --> 00:40:59,239
Speaker 1: thousands of people, wiping out entire towns and then just

773
00:40:59,320 --> 00:41:03,000
Speaker 1: going on TV going you know, it's bigger than just me. Yeah,

774
00:41:03,560 --> 00:41:07,000
Speaker 1: this is really a systemic problem because the roads I

775
00:41:07,080 --> 00:41:10,400
Speaker 1: use are everywhere to drive through neighborhoods. Yeah, if you

776
00:41:10,400 --> 00:41:14,560
Speaker 1: think about it, the taxpayers just as part of this,

777
00:41:14,719 --> 00:41:17,920
Speaker 1: you know, you with the making roads mean, with the

778
00:41:18,000 --> 00:41:22,320
Speaker 1: drunkenly driving through intersections and hitting groups of children, killing

779
00:41:22,440 --> 00:41:25,279
Speaker 1: up for the bus. You know, everybody's a part of

780
00:41:25,320 --> 00:41:27,959
Speaker 1: that bus driver stopping for those kids is a part

781
00:41:27,960 --> 00:41:31,720
Speaker 1: of this. You know, no one's hands are clean. Nobody stands,

782
00:41:31,880 --> 00:41:34,160
Speaker 1: So let's stop playing the blame game. You know, why

783
00:41:34,760 --> 00:41:37,000
Speaker 1: don't have to blame people every time I kill six

784
00:41:37,080 --> 00:41:42,360
Speaker 1: hundred thousand Americans. So you might expect all of this

785
00:41:42,400 --> 00:41:45,800
Speaker 1: potent criticism from like again the president pretty big names

786
00:41:45,800 --> 00:41:47,440
Speaker 1: saying the f d A has a problem with the

787
00:41:47,440 --> 00:41:49,799
Speaker 1: way it approves opioids. You might expect that to lead

788
00:41:49,800 --> 00:41:53,320
Speaker 1: the sub changes. But FDA policies for approving and labeling

789
00:41:53,320 --> 00:41:57,040
Speaker 1: opioids remain basically unmodified. As the Journal of Ethics write

790
00:41:57,080 --> 00:41:59,960
Speaker 1: up notes, the agency has refused to undertake a root

791
00:42:00,160 --> 00:42:03,440
Speaker 1: cause analysis to determine what regulatory errors contributed to the

792
00:42:03,480 --> 00:42:07,520
Speaker 1: opiate crisis. Instead, they've closed ranks and sought to defend themselves.

793
00:42:07,800 --> 00:42:11,719
Speaker 1: When Senator Maggie Hassan criticized the agency, the FDA Drug

794
00:42:11,760 --> 00:42:15,880
Speaker 1: Evaluation Director responded by claiming the agency had properly enforced

795
00:42:15,920 --> 00:42:18,800
Speaker 1: the Food, Drug and Cosmetic Act when it approved produced

796
00:42:18,840 --> 00:42:24,919
Speaker 1: new extended release oxycodone in Now that's a lie, Matt,

797
00:42:25,320 --> 00:42:27,040
Speaker 1: not just because it turned out to be bad, but

798
00:42:27,040 --> 00:42:29,319
Speaker 1: because they broke the law when they approved it. If

799
00:42:29,360 --> 00:42:31,560
Speaker 1: they had followed the law, the pills would have been

800
00:42:31,560 --> 00:42:34,560
Speaker 1: listed as having a narrow indication. Um, it's kind of

801
00:42:34,560 --> 00:42:36,560
Speaker 1: what we talked about the schizophrenia mids. This should be

802
00:42:36,680 --> 00:42:41,799
Speaker 1: used in a few specific conditions, acutely right, I only

803
00:42:41,880 --> 00:42:45,000
Speaker 1: be prescribed in limited duration for specific issues. Instead, the

804
00:42:45,080 --> 00:42:48,839
Speaker 1: drug received a broad indication, which allowed perdue to be like, oh, yeah,

805
00:42:48,880 --> 00:42:51,640
Speaker 1: this is good for back pain. You take some of

806
00:42:51,680 --> 00:42:56,120
Speaker 1: this ship Ye, you got a slight headache? Yeah, pull up,

807
00:42:56,160 --> 00:42:59,920
Speaker 1: pull up your car, we'll fill your trunk. Well Senate

808
00:43:00,040 --> 00:43:02,200
Speaker 1: direct to your house, dude, don't worry about don't worry

809
00:43:02,200 --> 00:43:06,040
Speaker 1: about it. Yeah, it's it's so fucking evil because it's like,

810
00:43:06,920 --> 00:43:12,000
Speaker 1: you know, chronic pain is a thing. Are incredibly useful

811
00:43:12,040 --> 00:43:14,800
Speaker 1: for treating people with chronic pain, and there are people

812
00:43:14,960 --> 00:43:18,680
Speaker 1: out there who do need it, and and so it's

813
00:43:18,719 --> 00:43:20,520
Speaker 1: like I'm not one of those people's like oh, putes

814
00:43:20,560 --> 00:43:23,440
Speaker 1: are all bad and whatnot. What's fucked up is to

815
00:43:24,080 --> 00:43:27,040
Speaker 1: make it into something that you would take, like you

816
00:43:27,040 --> 00:43:30,759
Speaker 1: would give it out, like it's fucking Highland. All need

817
00:43:30,760 --> 00:43:33,399
Speaker 1: it for chronic pain, most kinds of long term pain.

818
00:43:33,480 --> 00:43:35,920
Speaker 1: There's better ways to deal with it, and like you

819
00:43:35,960 --> 00:43:38,200
Speaker 1: don't actually solve that. You can actually make it better

820
00:43:38,239 --> 00:43:39,759
Speaker 1: if you go into like therapy and stuff and you

821
00:43:39,800 --> 00:43:42,600
Speaker 1: aren't medicating it away, which leads to it's yeah, there's

822
00:43:43,120 --> 00:43:46,360
Speaker 1: we talk about all this in the Sackler episodes. Um

823
00:43:46,400 --> 00:43:47,840
Speaker 1: so I'm going to quote from that a m A

824
00:43:47,920 --> 00:43:50,560
Speaker 1: Journal of Ethics right up again to talk about like

825
00:43:50,719 --> 00:43:52,759
Speaker 1: how illegal it was for the FDA to give this

826
00:43:52,800 --> 00:43:55,440
Speaker 1: broad approval. And it doesn't too face with evidence that

827
00:43:55,480 --> 00:43:59,280
Speaker 1: opioid prescribing had risen beyond levels that could be clinically warranted.

828
00:43:59,480 --> 00:44:02,600
Speaker 1: The FDA convened an advisory committee meeting of tin outside

829
00:44:02,640 --> 00:44:05,359
Speaker 1: experts and asked if the broad indication on opioid label

830
00:44:05,360 --> 00:44:08,680
Speaker 1: should be narrowed to prohibit marketing for common chronic pain conditions.

831
00:44:09,200 --> 00:44:12,600
Speaker 1: Eight of these experts had financial ties to pharmaceutical companies,

832
00:44:12,640 --> 00:44:16,280
Speaker 1: including Perdue, and advised the FDA against narrowing the indication.

833
00:44:16,600 --> 00:44:19,279
Speaker 1: An opportunity to reign in over prescribing early in the

834
00:44:19,320 --> 00:44:22,719
Speaker 1: crisis was lost, and by two thousand thirteen, enough opioids

835
00:44:22,719 --> 00:44:24,920
Speaker 1: were prescribed to provide every adult in the country with

836
00:44:24,920 --> 00:44:30,080
Speaker 1: a full pill bottle. That's so funny. So it's ridiculous

837
00:44:30,120 --> 00:44:33,359
Speaker 1: how many fucking opiates we flooded in, Like the fact

838
00:44:33,360 --> 00:44:35,160
Speaker 1: that we have a bigger problem with opiates now than

839
00:44:35,200 --> 00:44:37,719
Speaker 1: when you could buy morphine at the drug store. It

840
00:44:37,840 --> 00:44:42,320
Speaker 1: should say something. It does. I'm sorry that it says something.

841
00:44:42,520 --> 00:44:45,600
Speaker 1: It's like it's one thing to have it like available

842
00:44:45,719 --> 00:44:48,480
Speaker 1: over the counter, and people discover it and they are

843
00:44:48,520 --> 00:44:51,239
Speaker 1: able to take it. It's problems some of them will

844
00:44:53,239 --> 00:44:56,080
Speaker 1: if your doctors you have to take this forever. Now,

845
00:44:56,239 --> 00:44:58,000
Speaker 1: this is great for you to take forever, and then

846
00:44:58,040 --> 00:45:00,960
Speaker 1: you get horribly addicted, and then the doctor says, actually, no,

847
00:45:01,080 --> 00:45:02,880
Speaker 1: we found it. It's bad and you can't take it anymore,

848
00:45:03,000 --> 00:45:06,480
Speaker 1: and then you wind up buying fucking heroin, like exactly, exactly,

849
00:45:06,560 --> 00:45:11,120
Speaker 1: man um. Yeah. Now, the Food, Drug and Cosmetic Act

850
00:45:11,160 --> 00:45:14,160
Speaker 1: requires that adequate and well controlled studies be conducted before

851
00:45:14,200 --> 00:45:17,040
Speaker 1: products can be approved as safe and effective. The FDA

852
00:45:17,160 --> 00:45:21,839
Speaker 1: generally requires two randomized trials demonstrating efficacy for approval. There

853
00:45:21,880 --> 00:45:23,960
Speaker 1: are a lot of problems with this process, but it

854
00:45:24,040 --> 00:45:26,880
Speaker 1: was not even followed in the case of oxycodone. They

855
00:45:26,920 --> 00:45:30,040
Speaker 1: approved oxy for chronic pain based on a two week

856
00:45:30,120 --> 00:45:35,360
Speaker 1: clinical trial and osteoarthritis patients. Yeah, that should be enough time.

857
00:45:35,960 --> 00:45:38,520
Speaker 1: People don't live longer than two weeks, do they. It

858
00:45:38,560 --> 00:45:40,800
Speaker 1: takes me twenty four hours to realize whether or not

859
00:45:40,960 --> 00:45:44,440
Speaker 1: or opiate is good or not. I just try it out.

860
00:45:44,520 --> 00:45:47,960
Speaker 1: I have a human test subject. So yeah, you take it,

861
00:45:48,000 --> 00:45:50,640
Speaker 1: and you're like, yeah, that's good. Give it everyone, Give it.

862
00:45:50,960 --> 00:45:54,000
Speaker 1: Give it to every man, woman and child in the Midwest.

863
00:45:54,520 --> 00:45:57,600
Speaker 1: Oh my god. You know what empty the swimming public

864
00:45:57,640 --> 00:46:02,080
Speaker 1: swimming pool with pills just failing with oxy is extended release.

865
00:46:02,160 --> 00:46:05,400
Speaker 1: We'll just dive into it like a fucking junkie. Scrooge McDuck.

866
00:46:08,320 --> 00:46:11,120
Speaker 1: So for the next twenty five years is the opiate

867
00:46:11,160 --> 00:46:14,120
Speaker 1: crisis sparked off and then deepened? The FDA continued to

868
00:46:14,160 --> 00:46:17,359
Speaker 1: approve new opioid formulations for chronic pain via the same

869
00:46:17,400 --> 00:46:20,960
Speaker 1: shoddy lack daisical controls, and two thousand six the agency

870
00:46:21,000 --> 00:46:24,640
Speaker 1: moved to a new methodology for conducting efficacy trials on opiates.

871
00:46:24,680 --> 00:46:29,279
Speaker 1: This new methodology, enriched enrollment randomized withdrawal, or e er W,

872
00:46:29,719 --> 00:46:33,160
Speaker 1: became their primary method of determining evidence of opioid efficacy

873
00:46:33,200 --> 00:46:37,400
Speaker 1: for chronic pain. E er W trials are not standard

874
00:46:37,440 --> 00:46:41,000
Speaker 1: double blind, randomized controlled styles, and here's the A m

875
00:46:41,000 --> 00:46:44,560
Speaker 1: A again. In an e er W trial, Prior to

876
00:46:44,640 --> 00:46:47,399
Speaker 1: randomization for a double blind phase, all subjects are made

877
00:46:47,440 --> 00:46:50,279
Speaker 1: physiologically dependent on the opioid and a fourd to six

878
00:46:50,360 --> 00:46:53,839
Speaker 1: week open label phase. Then only the patients who tolerated

879
00:46:53,840 --> 00:46:56,239
Speaker 1: the opioid and found it helpful during the open label

880
00:46:56,239 --> 00:46:58,960
Speaker 1: phase are randomized to remain on the opioid or switched

881
00:46:58,960 --> 00:47:02,680
Speaker 1: to a placebo. Critics of vra W have have correctly

882
00:47:02,680 --> 00:47:06,520
Speaker 1: described this methodology as cooking the books for two reasons. First,

883
00:47:06,560 --> 00:47:09,200
Speaker 1: because only patients who tolerateed the opioid and found it

884
00:47:09,280 --> 00:47:12,160
Speaker 1: helpful are allowed to proceed to randomization. The study is

885
00:47:12,239 --> 00:47:15,440
Speaker 1: not representative of the general population and the results cannot

886
00:47:15,440 --> 00:47:18,759
Speaker 1: be generalized to clinical practice. Second, because daily use of

887
00:47:18,760 --> 00:47:22,840
Speaker 1: opioids causes physiological dependence, efficacy studies are skewed in favor

888
00:47:22,840 --> 00:47:25,200
Speaker 1: of the subjects who remain on the opioid. This is

889
00:47:25,239 --> 00:47:28,640
Speaker 1: because opioid dependent subjects who are switched to placebo experienced

890
00:47:28,680 --> 00:47:33,080
Speaker 1: opiate withdrawal symptoms, including increased sensitivity to pain. Moreover, switching

891
00:47:33,080 --> 00:47:37,040
Speaker 1: opioid dependent subject to placebo renders the study not double blind. Boy,

892
00:47:37,080 --> 00:47:40,720
Speaker 1: all these addicts really like opius. It seems like it works,

893
00:47:41,840 --> 00:47:44,000
Speaker 1: you know. And here's how you know it works is

894
00:47:44,040 --> 00:47:47,440
Speaker 1: when you stop giving it to them, they get fucking weird.

895
00:47:47,480 --> 00:47:50,080
Speaker 1: They don't like it at all. It must mean it's helping. Crying,

896
00:47:50,239 --> 00:47:53,759
Speaker 1: it's helping. Clearly you gotta take it or else you

897
00:47:53,840 --> 00:47:56,160
Speaker 1: start did they just start crying and being in pain? Man,

898
00:47:56,239 --> 00:48:01,879
Speaker 1: that's weird. Nanatin alcoholics says it makes them a better driver. Exactly. Man,

899
00:48:02,760 --> 00:48:05,600
Speaker 1: oh I love that. That is like such a such

900
00:48:05,880 --> 00:48:09,000
Speaker 1: like an evil thing to do. It's really fucked up, right,

901
00:48:09,480 --> 00:48:13,960
Speaker 1: So evil, Like the amount of people who like just

902
00:48:14,040 --> 00:48:16,799
Speaker 1: got addicted to this thing because they were just like,

903
00:48:17,520 --> 00:48:19,600
Speaker 1: you know, cooking the books on this test too and

904
00:48:19,880 --> 00:48:22,920
Speaker 1: fucking But I would have loved to have been a

905
00:48:22,960 --> 00:48:28,040
Speaker 1: part of that study. Yeah, yeah, I just check it

906
00:48:28,080 --> 00:48:30,640
Speaker 1: out a little bit. I don't know. So the a

907
00:48:30,800 --> 00:48:33,840
Speaker 1: m a Journal of Ethics article that blames the FDA's

908
00:48:33,880 --> 00:48:36,839
Speaker 1: decision to rely on e er W as a consequence

909
00:48:36,880 --> 00:48:39,759
Speaker 1: of their clothes, some would say, incestuous ties to the

910
00:48:39,760 --> 00:48:43,239
Speaker 1: pharmaceutical industry. It turns out that that the decision to

911
00:48:43,360 --> 00:48:45,600
Speaker 1: use e er W had been based on a series

912
00:48:45,640 --> 00:48:50,240
Speaker 1: of private meetings between FDA officials and pharmaceutical executives hosted

913
00:48:50,239 --> 00:48:53,280
Speaker 1: at a conference called Impact with two ms, it's an acronym.

914
00:48:53,320 --> 00:48:55,880
Speaker 1: You don't need to know what it's for. The drug

915
00:48:55,920 --> 00:48:59,360
Speaker 1: companies that attended Impact each paid thirty five thousand dollars

916
00:48:59,400 --> 00:49:02,560
Speaker 1: to meet directly with FDA staff. So they have a

917
00:49:02,600 --> 00:49:05,279
Speaker 1: big meeting where these guys pay, and money goes to

918
00:49:05,320 --> 00:49:08,560
Speaker 1: the FDA officials who were invited guests. I don't see

919
00:49:08,640 --> 00:49:10,520
Speaker 1: oh that's a problem, Robert. I don't see that as

920
00:49:10,560 --> 00:49:13,920
Speaker 1: a conflict of interest. No, that's totally normal. It's like,

921
00:49:14,080 --> 00:49:18,680
Speaker 1: fucking listen, it's it's a donation. Yeah, you know, and

922
00:49:18,760 --> 00:49:21,720
Speaker 1: if you don't want to donate, you don't get access. Now,

923
00:49:22,040 --> 00:49:24,880
Speaker 1: when this information dropped, there was a lot of complaints

924
00:49:24,920 --> 00:49:26,920
Speaker 1: about this is being like, oh, it seems like rank

925
00:49:27,000 --> 00:49:29,080
Speaker 1: crony ism is why this is the method by which

926
00:49:29,120 --> 00:49:32,279
Speaker 1: we determine whether or not opiates are good. Despite all this,

927
00:49:32,560 --> 00:49:34,960
Speaker 1: the FDA continues to rely on E er W for

928
00:49:35,000 --> 00:49:38,120
Speaker 1: approving opiates, and as the yeah, yeah, I know, they

929
00:49:38,120 --> 00:49:40,120
Speaker 1: ain't changed that ship, at least not as of the

930
00:49:40,120 --> 00:49:43,360
Speaker 1: writing of that article. Yeah it's cool, it's good ship.

931
00:49:43,800 --> 00:49:46,200
Speaker 1: So as the a m A Journal of Ethics details,

932
00:49:46,239 --> 00:49:49,840
Speaker 1: the crony ism does not stop here. Quote. For example,

933
00:49:49,880 --> 00:49:53,959
Speaker 1: the two principal FDA reviewers who originally approved produce oxycodon

934
00:49:54,120 --> 00:49:59,240
Speaker 1: application took both took positions at Purdue after leaving the agency. Hey,

935
00:49:59,280 --> 00:50:04,120
Speaker 1: that's just a cool. Yeah, that's just a weird kinky dink.

936
00:50:04,400 --> 00:50:07,319
Speaker 1: Listen your email and all your ex contacts and you're

937
00:50:07,400 --> 00:50:10,319
Speaker 1: just like, hey, do you have like a job with

938
00:50:10,400 --> 00:50:13,560
Speaker 1: a fucking seven figure salaries here? And I don't want

939
00:50:13,560 --> 00:50:16,600
Speaker 1: to like go in you know, if that's possible, Yeah,

940
00:50:17,600 --> 00:50:20,359
Speaker 1: if you could just you know you could. I'll write

941
00:50:20,400 --> 00:50:25,200
Speaker 1: it off of my taxes as hush money. Yeah, I'm

942
00:50:25,200 --> 00:50:28,200
Speaker 1: gonna continue that quote. Over the past twenty years, several

943
00:50:28,200 --> 00:50:31,080
Speaker 1: other FDA staff involved in opioid approvals also left the

944
00:50:31,120 --> 00:50:34,319
Speaker 1: FDA to work for opioid makers. Last January, the head

945
00:50:34,320 --> 00:50:37,279
Speaker 1: of the FDA's analgesic division retired from the FDA to

946
00:50:37,320 --> 00:50:40,760
Speaker 1: start her own consulting business, which promises drug makers help

947
00:50:41,000 --> 00:50:44,480
Speaker 1: to successfully and efficiently bring your products to market. With

948
00:50:44,760 --> 00:50:47,040
Speaker 1: more than thirty years of experience at the f D.

949
00:50:47,200 --> 00:50:51,879
Speaker 1: A but that's fine, that's legal. You know, it's good.

950
00:50:52,400 --> 00:50:54,719
Speaker 1: I mean, you know, you get the inside track on

951
00:50:54,760 --> 00:50:58,920
Speaker 1: how to get people opiates. Yeah, And obviously this is

952
00:50:58,960 --> 00:51:01,440
Speaker 1: how the whole government works, right, But it didn't used

953
00:51:01,480 --> 00:51:04,960
Speaker 1: to be how the FDA works. And I should note

954
00:51:05,000 --> 00:51:07,400
Speaker 1: that the revolving door, as this article states that states

955
00:51:07,400 --> 00:51:10,080
Speaker 1: the revolving door between the FDA and the pharmaceutical industry

956
00:51:10,160 --> 00:51:13,680
Speaker 1: is not just opiates. Two eighteen study found that eleven

957
00:51:13,760 --> 00:51:17,080
Speaker 1: of sixteen FDA medical reviewers involved in approving twenty eight

958
00:51:17,080 --> 00:51:20,840
Speaker 1: products now work for the companies whose products they regulated. Wow,

959
00:51:21,640 --> 00:51:25,239
Speaker 1: it's good stuff, right, it's fine, it's it's great. I

960
00:51:25,280 --> 00:51:30,440
Speaker 1: mean it's just it's so blatant. This is why, like I, oh,

961
00:51:30,480 --> 00:51:34,000
Speaker 1: this is every time I came on this podcast. Man,

962
00:51:34,040 --> 00:51:38,080
Speaker 1: I lose faith in humanity. But some version of this

963
00:51:38,120 --> 00:51:40,239
Speaker 1: would still be happening if they'd never moved to a

964
00:51:40,320 --> 00:51:42,480
Speaker 1: fact where like the f d A is half funded

965
00:51:42,560 --> 00:51:47,960
Speaker 1: by pharmaceutical company applications. Right, correction, it's endemic. But this

966
00:51:48,239 --> 00:51:50,200
Speaker 1: I think that really sped up the process. It's had

967
00:51:50,239 --> 00:51:53,560
Speaker 1: an impact, right, it's very clear to see in the data. Um,

968
00:51:53,640 --> 00:51:57,000
Speaker 1: And it's now the relationships are built on money already,

969
00:51:57,040 --> 00:51:59,440
Speaker 1: and you have like people, you know, it's one thing

970
00:51:59,440 --> 00:52:03,440
Speaker 1: to spend earty years like being completely fucking government funded

971
00:52:03,480 --> 00:52:05,359
Speaker 1: and just telling people no, no, no no on their

972
00:52:05,400 --> 00:52:09,120
Speaker 1: applications not you know, fucking I have no financial ties

973
00:52:09,160 --> 00:52:11,000
Speaker 1: to them. But now you have like kind of a

974
00:52:11,040 --> 00:52:13,440
Speaker 1: sugar daddy that who's going to be courting you and

975
00:52:13,960 --> 00:52:16,440
Speaker 1: has been paying my salary. You know, why shouldn't I

976
00:52:16,440 --> 00:52:18,880
Speaker 1: go to work for the right? Why is this any different?

977
00:52:18,960 --> 00:52:22,319
Speaker 1: And I know this guy, know, Roger over at fucking Fiser, Like,

978
00:52:22,680 --> 00:52:25,760
Speaker 1: wouldn't I work there? He's been paying me since fucking

979
00:52:25,840 --> 00:52:28,680
Speaker 1: day one? Yeah? Yeah, And the f d A is

980
00:52:28,760 --> 00:52:31,640
Speaker 1: complicity with both the opioid crisis and the vi X

981
00:52:31,640 --> 00:52:35,800
Speaker 1: disaster have the highest definite body counts for sure, um,

982
00:52:35,840 --> 00:52:38,319
Speaker 1: but some of the ways that they've really that the

983
00:52:38,400 --> 00:52:41,239
Speaker 1: FDA is really fucked up are less obviously deadly, but

984
00:52:41,320 --> 00:52:44,400
Speaker 1: still very unsettling. Now, if you'll remember, the whole reason

985
00:52:44,480 --> 00:52:47,280
Speaker 1: we have an FDA is because Harvey Wiley was pissed

986
00:52:47,320 --> 00:52:49,439
Speaker 1: that all kinds of foods and drugs and quack tears

987
00:52:49,640 --> 00:52:52,239
Speaker 1: were being shoved full of random horrible ship that was

988
00:52:52,280 --> 00:52:54,440
Speaker 1: not listed in the product, and people didn't know what

989
00:52:54,480 --> 00:52:56,600
Speaker 1: they were getting, right. That's why we got an f

990
00:52:56,719 --> 00:52:59,000
Speaker 1: d A. Is a bunch of people, Harvey Wiley and

991
00:52:59,000 --> 00:53:04,000
Speaker 1: others were like, this seems bad. The main, the primary

992
00:53:04,040 --> 00:53:05,719
Speaker 1: goal of the f d A was to make sure

993
00:53:05,719 --> 00:53:07,760
Speaker 1: people know what the funk they're putting in their bodies,

994
00:53:07,840 --> 00:53:09,800
Speaker 1: right at the end of the day. That's the number

995
00:53:09,840 --> 00:53:11,839
Speaker 1: one reason we have the FDA, to know what you're

996
00:53:11,840 --> 00:53:13,440
Speaker 1: putting in your body and what it does to you.

997
00:53:20,000 --> 00:53:22,279
Speaker 1: G R a S is an acronym that stands for

998
00:53:22,440 --> 00:53:25,520
Speaker 1: generally recognized as safe. This is a category the FDA

999
00:53:25,600 --> 00:53:28,040
Speaker 1: created for food additives that might be stuck in new

1000
00:53:28,080 --> 00:53:31,640
Speaker 1: products without being specifically approved but that don't need any

1001
00:53:31,680 --> 00:53:35,439
Speaker 1: specific additional approval because they're generally recognized as safe. Now,

1002
00:53:35,840 --> 00:53:38,239
Speaker 1: this starts again from a pretty reasonable place. It's so

1003
00:53:38,280 --> 00:53:40,120
Speaker 1: that like, if you're making a processed meat, you can

1004
00:53:40,160 --> 00:53:41,920
Speaker 1: add vinegar or salt to it, and you know if

1005
00:53:41,920 --> 00:53:43,960
Speaker 1: to like get approval from meat with vinegarrants because we

1006
00:53:43,960 --> 00:53:45,440
Speaker 1: know what vinegar and salt do? You know what the meat?

1007
00:53:45,640 --> 00:53:48,560
Speaker 1: It's fine, you can stick it in there right. Um,

1008
00:53:48,600 --> 00:53:51,880
Speaker 1: So I'm gonna quote from NPR again quote. Over time,

1009
00:53:51,960 --> 00:53:54,040
Speaker 1: companies have found that it's far more efficient to take

1010
00:53:54,080 --> 00:53:56,120
Speaker 1: advantage of the exemption to get their products up on

1011
00:53:56,120 --> 00:53:58,880
Speaker 1: shelves quickly. Some of these products contain additives that the

1012
00:53:58,920 --> 00:54:01,759
Speaker 1: FDA has found to post dangers, and even ingredients the

1013
00:54:01,800 --> 00:54:04,120
Speaker 1: agency has agreed r g R g r A s

1014
00:54:04,160 --> 00:54:06,920
Speaker 1: are now drawing scrutiny from scientists and consumer groups that

1015
00:54:06,960 --> 00:54:10,520
Speaker 1: dispute their safety. Critics of the system say the biggest concern, however,

1016
00:54:10,600 --> 00:54:13,920
Speaker 1: is that companies regularly introduce new additives without ever informing

1017
00:54:13,960 --> 00:54:16,480
Speaker 1: the f d A. This means people are consuming foods

1018
00:54:16,480 --> 00:54:19,120
Speaker 1: with added flavors, preservatives, and other ingredients that are not

1019
00:54:19,200 --> 00:54:21,759
Speaker 1: reviewed at all by regulators for immediate dangers or long

1020
00:54:21,880 --> 00:54:25,880
Speaker 1: term health effects. The vast majority of food additives are safe. Somehowever,

1021
00:54:25,920 --> 00:54:28,560
Speaker 1: have proved to cause serious allergic reactions or other long

1022
00:54:28,680 --> 00:54:31,480
Speaker 1: term health effects. Now a good example of this would

1023
00:54:31,520 --> 00:54:34,120
Speaker 1: be micoprotein. This is a kind of fungus product used

1024
00:54:34,120 --> 00:54:37,120
Speaker 1: to add protein to vegetarian foods. It counts as g

1025
00:54:37,320 --> 00:54:39,200
Speaker 1: R A S, but there's a bunch of lawsuits right

1026
00:54:39,239 --> 00:54:41,400
Speaker 1: now that allege a significant number of people have had

1027
00:54:41,480 --> 00:54:45,799
Speaker 1: really negative allergic reactions to microprotein, some of them anaphylactic

1028
00:54:45,800 --> 00:54:48,360
Speaker 1: shock um, which is mean nobody should take it, but

1029
00:54:48,400 --> 00:54:51,040
Speaker 1: it means like it's shouldn't be listed as generally recognized

1030
00:54:51,040 --> 00:54:52,719
Speaker 1: as ship as safe if a lot of people have

1031
00:54:52,880 --> 00:54:56,839
Speaker 1: like allergic reactions to it. And flexus is incredibly dangerous. Yeah,

1032
00:54:56,920 --> 00:55:03,960
Speaker 1: and the the FDA did eventually revoke it's g R

1033
00:55:04,000 --> 00:55:06,080
Speaker 1: A S status in two thousand eleven, but a lot

1034
00:55:06,080 --> 00:55:07,680
Speaker 1: of people had to get sick. Person. It's kind of

1035
00:55:07,680 --> 00:55:09,440
Speaker 1: an example of how like you can just kind of

1036
00:55:09,480 --> 00:55:11,680
Speaker 1: shoehorn this stuff in. It's a loophole and it's not

1037
00:55:11,800 --> 00:55:16,279
Speaker 1: watched that closely. Probably the most serious problem with though,

1038
00:55:16,360 --> 00:55:19,800
Speaker 1: is with all the weird preservatives being stuck into foods. Again,

1039
00:55:20,239 --> 00:55:23,840
Speaker 1: most are benign. Most preservatives are, as far as we know, benign.

1040
00:55:24,160 --> 00:55:26,520
Speaker 1: But g r S exemptions mean that we don't really

1041
00:55:26,560 --> 00:55:28,320
Speaker 1: have data on how a lot of this stuff affects

1042
00:55:28,400 --> 00:55:30,440
Speaker 1: children differently, or whether or not it builds up in

1043
00:55:30,440 --> 00:55:33,160
Speaker 1: the body. And I'm not trying to be like hippie dippy, like, oh,

1044
00:55:33,280 --> 00:55:36,719
Speaker 1: no preservatives in your food. Man. Stuff is necessary, but

1045
00:55:36,760 --> 00:55:39,160
Speaker 1: we should know what it does, and we shouldn't call

1046
00:55:39,200 --> 00:55:41,400
Speaker 1: it safe or put it in everything unless we have

1047
00:55:41,480 --> 00:55:44,080
Speaker 1: really good data that it's safe. Like you know, we're

1048
00:55:44,120 --> 00:55:46,759
Speaker 1: going backwards here. We already established we want to know

1049
00:55:46,840 --> 00:55:50,000
Speaker 1: what's inside. Like whiley, I'm not against preservatives or even

1050
00:55:50,239 --> 00:55:52,319
Speaker 1: chemicals and food, I eat all sorts of chemicals. We

1051
00:55:52,320 --> 00:55:56,359
Speaker 1: should know what they do. Just like it's like it's

1052
00:55:56,560 --> 00:56:01,360
Speaker 1: so important. Yeah. I found a recent study by the

1053
00:56:01,480 --> 00:56:04,640
Speaker 1: Environmental Defense Fund that looked through eight hundred and seventy

1054
00:56:04,640 --> 00:56:06,680
Speaker 1: seven g r A S notices by the f d

1055
00:56:06,760 --> 00:56:08,520
Speaker 1: A and found that only one of them was for

1056
00:56:08,600 --> 00:56:11,800
Speaker 1: an additive that the manufacturer had done a cumulative effect

1057
00:56:11,840 --> 00:56:13,880
Speaker 1: study on this is like determine whether or not it

1058
00:56:13,920 --> 00:56:16,000
Speaker 1: builds up in the body and could be harmful. One

1059
00:56:16,040 --> 00:56:17,920
Speaker 1: out of eight hundred and seventy seven had they had

1060
00:56:17,960 --> 00:56:20,960
Speaker 1: had this done. And this isn't optional, These are required

1061
00:56:21,000 --> 00:56:23,759
Speaker 1: by law. You have to do this. One out of

1062
00:56:23,760 --> 00:56:26,120
Speaker 1: eight hundred and seventy seven that the FDA had approved

1063
00:56:26,120 --> 00:56:28,640
Speaker 1: had actually done this, As the e d F notes quote,

1064
00:56:28,920 --> 00:56:31,360
Speaker 1: We found no evidence that the agency either recognized this

1065
00:56:31,440 --> 00:56:33,640
Speaker 1: single attempt to follow the law or had objected to

1066
00:56:33,680 --> 00:56:36,240
Speaker 1: the emissions and the eight hundred and seventy six other notices.

1067
00:56:36,680 --> 00:56:38,759
Speaker 1: They're just sucking Robert stabbing this ship. They don't give

1068
00:56:38,800 --> 00:56:42,560
Speaker 1: a fuck. Yeah, they don't even force them to pinky swear.

1069
00:56:43,040 --> 00:56:45,759
Speaker 1: They're just like they get money for every one of

1070
00:56:45,800 --> 00:56:48,400
Speaker 1: these applications. You know what. You don't want people to

1071
00:56:48,440 --> 00:56:50,880
Speaker 1: not send in an application if they haven't done the research.

1072
00:56:50,960 --> 00:56:55,640
Speaker 1: You want that fucking box. She's baby Jesus. Well, you

1073
00:56:55,680 --> 00:57:01,680
Speaker 1: know that's uh, it's good, that's fine, It's it's all

1074
00:57:01,800 --> 00:57:05,880
Speaker 1: really again, this is like anti f DA and that

1075
00:57:05,960 --> 00:57:08,399
Speaker 1: there's huge problems with the FDA, But like we need

1076
00:57:08,440 --> 00:57:11,359
Speaker 1: an f d A what it's called, But we need

1077
00:57:11,400 --> 00:57:13,640
Speaker 1: an agency doing that, right, Like that's why we started

1078
00:57:13,640 --> 00:57:16,560
Speaker 1: with like plamide. This is an absolutely necessary part of

1079
00:57:16,560 --> 00:57:19,280
Speaker 1: any society, vaguely similar to the one we live in.

1080
00:57:19,840 --> 00:57:23,040
Speaker 1: But we've we've broken it, We've allowed it to become broken,

1081
00:57:23,600 --> 00:57:26,680
Speaker 1: and it it doesn't work great, and it's a really

1082
00:57:26,840 --> 00:57:31,959
Speaker 1: dangerous thing to have as a corrupt organism. And again

1083
00:57:32,000 --> 00:57:34,400
Speaker 1: there's like as that we we quoted from that that

1084
00:57:34,520 --> 00:57:38,000
Speaker 1: FDA researcher who was like, you know, has been howling

1085
00:57:38,040 --> 00:57:41,480
Speaker 1: about box and stuff, and it's like, yeah, it's um,

1086
00:57:41,680 --> 00:57:44,120
Speaker 1: there's most I'm sure most of the people trying to

1087
00:57:44,120 --> 00:57:47,240
Speaker 1: do those jobs are are fucking rad and even I'm

1088
00:57:47,280 --> 00:57:49,640
Speaker 1: sure mostly people who wind up joining the pharmaceutical industry

1089
00:57:49,640 --> 00:57:52,960
Speaker 1: they're not thinking like ha ha ha no, but it's

1090
00:57:53,000 --> 00:57:56,760
Speaker 1: like they there should be a bias towards distrust and

1091
00:57:56,840 --> 00:58:00,280
Speaker 1: dislike of the pharmaceutical companies by the scientists you doing

1092
00:58:00,320 --> 00:58:03,920
Speaker 1: this right, Like they should be untrustworthy of them, you know, right,

1093
00:58:04,000 --> 00:58:07,960
Speaker 1: I expect the pharmaceutical companies to lie about ship. That's

1094
00:58:08,000 --> 00:58:10,000
Speaker 1: what they do. They're salesman, you know, they're like we

1095
00:58:10,200 --> 00:58:13,800
Speaker 1: they make they fucking patent just random compounds or like

1096
00:58:13,800 --> 00:58:17,640
Speaker 1: does that do anything. No, it's like basically just trying

1097
00:58:17,640 --> 00:58:18,960
Speaker 1: out a bunch of things to see if it makes

1098
00:58:19,000 --> 00:58:22,280
Speaker 1: your dick hard. And then eventually they'll just be like yeah,

1099
00:58:22,320 --> 00:58:24,960
Speaker 1: that makes your dick hard. You need an agency that

1100
00:58:25,360 --> 00:58:29,120
Speaker 1: takes the medication and goes like, my dick is still soft.

1101
00:58:29,920 --> 00:58:32,600
Speaker 1: You can't just pay someone to be like, yeah, I

1102
00:58:32,640 --> 00:58:35,040
Speaker 1: don't know enough. People's dicks got hard. You gotta know

1103
00:58:35,600 --> 00:58:38,680
Speaker 1: that it gets you bricked up, Robert, Yeah, it's it's

1104
00:58:38,800 --> 00:58:40,920
Speaker 1: you've got. You gotta know that. It allows you to

1105
00:58:41,000 --> 00:58:44,880
Speaker 1: fucking lay some goddamn pipe, you know pipe. That's right,

1106
00:58:45,320 --> 00:58:49,160
Speaker 1: that's right, that's what when America was great, we knew

1107
00:58:49,520 --> 00:58:53,000
Speaker 1: that was what the the FDA was for. Now, yeah,

1108
00:58:53,040 --> 00:58:57,040
Speaker 1: you goddamn right. Um, So I don't know, you know,

1109
00:58:57,240 --> 00:59:00,480
Speaker 1: I I would like to have an FDA that it

1110
00:59:00,560 --> 00:59:02,680
Speaker 1: does not have the problems of our current f d A.

1111
00:59:02,800 --> 00:59:04,720
Speaker 1: I don't think that's too much to ask of society.

1112
00:59:04,760 --> 00:59:06,680
Speaker 1: There's a lot of a lot of our problems are

1113
00:59:06,760 --> 00:59:09,480
Speaker 1: kind of intractable and difficult to figure out a solution too.

1114
00:59:09,560 --> 00:59:11,960
Speaker 1: But like, yeah, we should probably have like they should

1115
00:59:11,960 --> 00:59:15,440
Speaker 1: probably be advocates for us and not totally wing of

1116
00:59:15,440 --> 00:59:19,520
Speaker 1: the pharmaceutical industry. I mean, honestly, it's like weird for

1117
00:59:19,680 --> 00:59:23,800
Speaker 1: us to be going backwards on such like an obvious

1118
00:59:24,040 --> 00:59:27,840
Speaker 1: fucking thing. It's, uh, we don't want to drink the

1119
00:59:27,880 --> 00:59:31,720
Speaker 1: poison milk, and uh, we don't want people pushing a

1120
00:59:31,760 --> 00:59:34,200
Speaker 1: bunch of fucking drugs that don't work or funk up

1121
00:59:34,240 --> 00:59:40,520
Speaker 1: your life. Yeah, those would be you just go back

1122
00:59:40,680 --> 00:59:46,480
Speaker 1: to the Francis days. She was dope. Let's let's hire

1123
00:59:46,480 --> 00:59:48,760
Speaker 1: a bunch of people like her and give them all

1124
00:59:49,200 --> 00:59:52,960
Speaker 1: very large salaries to be distrustful of the pharmaceutical industry.

1125
00:59:53,280 --> 00:59:56,200
Speaker 1: That's like their job, that's the whole job. And we

1126
00:59:56,280 --> 00:59:58,600
Speaker 1: spend so much money on stupid ship. We could have

1127
00:59:58,640 --> 01:00:00,959
Speaker 1: a we could have a sufficient at least sized team

1128
01:00:01,000 --> 01:00:05,080
Speaker 1: of people to to to distrust the pharmaceutical industry professionally

1129
01:00:05,480 --> 01:00:07,560
Speaker 1: for the price of a couple of f thirty five

1130
01:00:07,960 --> 01:00:13,280
Speaker 1: yeah right, literally two less fucking you know, just jets

1131
01:00:13,320 --> 01:00:17,480
Speaker 1: that that bomb Yemen, you know, Yeah, and we we

1132
01:00:17,600 --> 01:00:19,720
Speaker 1: take money away from them when they let a drug

1133
01:00:19,760 --> 01:00:23,440
Speaker 1: through that kills way more people than reasonable as like

1134
01:00:23,600 --> 01:00:27,440
Speaker 1: you know, some side effects, and then then we're bribing

1135
01:00:27,480 --> 01:00:31,040
Speaker 1: them to make sure we don't die. Exactly. That's literally

1136
01:00:31,080 --> 01:00:34,800
Speaker 1: how it's supposed to work. I mean, just yeah, we

1137
01:00:34,840 --> 01:00:38,640
Speaker 1: should be you know, we should be making money off

1138
01:00:38,720 --> 01:00:42,919
Speaker 1: of UH, or the FDA should be making money off

1139
01:00:42,960 --> 01:00:46,720
Speaker 1: of destroying these pharmaceutical agencies as soon as they fuck up.

1140
01:00:47,000 --> 01:00:50,480
Speaker 1: That's what I say. Yeah, I would be sick. That's

1141
01:00:50,520 --> 01:00:55,080
Speaker 1: one way to tie it. Tie it in. Wow, Boxy

1142
01:00:55,120 --> 01:01:00,280
Speaker 1: sucks and suck it. Well, Matt, do you have any

1143
01:01:00,280 --> 01:01:06,640
Speaker 1: plugables for us? Um? Yeah, try it. I'm just kidding. Uh.

1144
01:01:07,000 --> 01:01:11,280
Speaker 1: Pod yourself a gun. Uh. The World's Only Sopranos podcasts

1145
01:01:11,360 --> 01:01:14,200
Speaker 1: and the film Drunk frodcast me and Vince Vncini talking

1146
01:01:14,200 --> 01:01:18,680
Speaker 1: about movies, talking about just life in general. Matt Leap

1147
01:01:18,760 --> 01:01:24,920
Speaker 1: jokes on Instagram. I love you guys. Oh well, you

1148
01:01:24,960 --> 01:01:27,680
Speaker 1: can find me nowhere. But I have a novel that

1149
01:01:27,760 --> 01:01:29,520
Speaker 1: you can pre order, and if you pre order it,

1150
01:01:29,560 --> 01:01:32,200
Speaker 1: you'll get assigned a copy. Just google a k press

1151
01:01:32,280 --> 01:01:35,480
Speaker 1: after the revolution, order a book now, it will come

1152
01:01:35,520 --> 01:01:39,600
Speaker 1: to you with my signature in it. That's pretty neat. Um.

1153
01:01:39,680 --> 01:01:44,520
Speaker 1: We also have a live show we do on February

1154
01:01:44,560 --> 01:01:48,920
Speaker 1: sevent The ticket info will be in the episode description,

1155
01:01:49,040 --> 01:01:53,480
Speaker 1: or you can go do allegedly. I'll do it allegedly

1156
01:01:53,680 --> 01:01:58,960
Speaker 1: in the episode description. Dot com slash pot of Bastards allegedly.

1157
01:01:59,440 --> 01:02:03,320
Speaker 1: All right, Well, until next time, you know, skim the

1158
01:02:03,320 --> 01:02:05,880
Speaker 1: cream off some milk, fill it up. With water, pour

1159
01:02:06,040 --> 01:02:09,720
Speaker 1: some worms in there, and you know, I breakfast a

1160
01:02:09,720 --> 01:02:11,960
Speaker 1: little bit of cowbrains, get some extra protein up in there.

1161
01:02:12,000 --> 01:02:16,440
Speaker 1: You know, you get to gottle grains. You think that's right,