{"id":39212,"date":"2013-08-13T15:59:21","date_gmt":"2013-08-13T19:59:21","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=39212"},"modified":"2013-08-13T16:06:32","modified_gmt":"2013-08-13T20:06:32","slug":"the-only-point","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/08\/13\/the-only-point\/","title":{"rendered":"the only point…"},"content":{"rendered":"
This case is  about many things, but my interest is in one particular aspect – that secrecy about Clinical Trial data is justified to protect Trade Secrets. I think that is a bizarre non-argument. The only secrets being protected are that the drug’s efficacy is marginal and that its toxicity has been minimized<\/em>. Those are secrets worth revealing<\/font><\/strong>: <\/div>\n
\n
AIDS Group Wins Legal Battle With FDA Over Confidential Data<\/a><\/div>\n
Pharmalot<\/font><\/strong><\/div>\n
by Ed Silverman<\/div>\n
08\/12\/2013<\/div>\n

Over the past three years, the AIDS Healthcare Foundation waged a losing battle against Truvada, which is sold by Gilead Sciences, for AIDS prevention. The Los Angeles-based advocacy group, which also provides medical care in clinics, very vocally fought FDA approval on the grounds that prevention will unintentionally lead to riskier sexual behavior and, subsequently, more HIV infections [back story<\/a>].<\/p>\n

Last week, though, AHF won a different kind of victory against the FDA. A federal judge ruled the agency improperly withheld Truvada safety and efficacy data in response to a Freedom of Information Act requested filed by the advocacy group two years ago. The FDA had argued the data did not have to be disclosed because Gilead trade secrets and confidential information would have been compromised. As a result, the agency must provide “complete and unredacted” copies of Truvada safety and efficacy records to AHF. In her ruling, US District Court Judge Margaret Morrow wrote that the FDA failed to prove that the documents that had been withheld were “confidential” financial and commercial records or that disclosure of data summaries and analyses would cause Gilead “substantial competitive injury.”<\/font><\/strong><\/p>\n

In reaching her conclusion, Morrow noted, for instance, that the agency made unsubstantiated arguments that Gilead faced competition in the market for AIDS prevention medicines and that releasing certain information, such as statistical methods and analyses applied to third-party data that was used to obtain FDA approval for Truvada, could potentially harm Gilead [GILD] at a later date. We should note that Morrow also decided that redacted correspondence was properly withheld since the information expressed incomplete agency views not reflected in the final labeling of the product [here is the ruling<\/a>]. Of course, the initial issue that prompted AHF to seek the documents is no longer on the table – the FDA approved Truvada last year for AIDS prevention. But the advocacy group did manage to score points on a larger issue by successfully arguing against FDA efforts to make blanket determinations about releasing certain data and subsequent harm to drugmakers.<\/p>\n

The AHF, however, suggested the ruling underscores concerns that the FDA and Gilead worked surreptitiously to ensure Truvada was approved. In particular, AHF seized on statements by David Pizzuti, vp of regulatory affairs at Gilead, that the FDA and drugmaker held tlks about Truvada trials results and data submissions needed for approval. “This ruling confirms one of our deepest suspicions: the FDA colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials. [The ruling] suggests the FDA advised Gilead how to conceal unfavorable clinical trial results and coached them on what to say to get those unfavorable results spun in such a way that the FDA deemed them sufficient to approve the drug,” AHF president Michael Weinstein said in a statement…<\/div>\n<\/blockquote>\n
The FDA began life with the mandate to evaluate safety. That mandate was extended to include efficacy after the Thalidomide incident. The efficacy standards are low, requiring two Clinical Trials showing statistical separation of the drug from placebo. There’s nothing in the Clinical Trial information remotely proprietary, just the measured responses to the drug or placebo. The formula for the drug itself is widely available. Their argument that there’s some rational reason to hold the raw results of a Clinical Trial secret to protect "trade secrets" is without logic. As I said above, there are only two reasons to keep those results private – the drug’s efficacy is marginal and that its toxicity has been minimized<\/font><\/strong><\/em>. In psychiatry, both of those things have been true for the major classes of new drugs – Antidepressants, Antipsychotics, and Mood Stabilizers. There are three parameters we’d like to know about a new drug: <\/div>\n
    \n
  1. Does it statistically separate from placebo? [p<\/em><\/font><\/strong>]<\/li>\n
  2. How strong is the effect compared to placebo? [NNT<\/em><\/font><\/strong>, Odds Ratio<\/em><\/font><\/strong>, Effect Size<\/em><\/font><\/strong>] <\/li>\n
  3. How does its effect strength compare to other efficacious drugs?<\/li>\n<\/ol>\n
    All number 1. tells us is that the drug has, for example, antidepressant qualities – not how powerful the effect is. The parameters in 2. are often not published nor is the information to calculate them always available. The easiest to understand is NNT. How many patients need to be treated to get one that beats<\/em> placebo – an index of strength. And finally, there’s no requirement to go head to head against a drug with known efficacy.<\/div>\n

    With adverse effects, hiding negative things is more difficult, but the stakes are so high that the drug companies have been relatively creative in pulling it off. But even the most honest reporting is only on short term studies [6-8 weeks], and many side effects are more insidious and take longer to develop. So things like the sexual side effects of Prozac or the weight gain with Zyprexa are minimized when the drug is released only to be discovered in their true glory later.<\/p>\n

    The drug companies don’t want to make the results of the Clinical Trials available for two reasons. The first is that their competitors will use the truth against them. For that, they have my sympathy but their past behavior has brought them to the present. The second reason is that right-thinking scientists will keep them honest about the risk\/benefit ratio of their drugs. Given what has happened in psychiatry, that is now the only acceptable way forward. <\/p>\n

    The case above is as important as Ed’s article says it is. It’s a start in the campaign to restore truth to the medical literature by plugging the hole created by the secrecy of Clinical Trial results. It will hurt the pharmaceutical industry and retard new drug development. It will put an end to the blockbuster pharmaceutical economy on Wall Street. But it will improve medical care, and that’s the only<\/u> point…<\/div>\n","protected":false},"excerpt":{"rendered":"

    This case is  about many things, but my interest is in one particular aspect – that secrecy about Clinical Trial data is justified to protect Trade Secrets. I think that is a bizarre non-argument. The only secrets being protected are that the drug’s efficacy is marginal and that its toxicity has been minimized. Those are […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-39212","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/39212","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=39212"}],"version-history":[{"count":11,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/39212\/revisions"}],"predecessor-version":[{"id":39223,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/39212\/revisions\/39223"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=39212"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=39212"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=39212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}