{"id":828,"date":"2015-09-10T15:01:30","date_gmt":"2015-09-10T15:01:30","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=828"},"modified":"2017-08-21T11:32:37","modified_gmt":"2017-08-21T11:32:37","slug":"primary-care-corner-with-geoffrey-modest-md-snake-oil","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/09\/10\/primary-care-corner-with-geoffrey-modest-md-snake-oil\/","title":{"rendered":"Primary Care Corner with Geoffrey Modest MD: Snake Oil?"},"content":{"rendered":"<p><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\"><strong>By Dr. Geoffrey Modest<\/strong><\/p>\n<p><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">I have written a\u00a0few recent blogs on the increasing laxity of regulation. One\u00a0(see\u00a0<a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/08\/27\/primary-care-corner-with-geoffrey-modest-md-implantable-cardioverter-defibrillators-in-the-hospitalized-elderly\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/08\/27\/primary-care-corner-with-geoffrey-modest-md-implantable-cardioverter-defibrillators-in-the-hospitalized-elderly\/<\/a>\u00a0) highlighted the use of implantable cardioverters, use of\u00a0which has migrated from studies documenting benefit in less elderly stable ambulatory patients to implanting them in the\u00a0unstudied\u00a0older sick\u00a0hospitalized ones, then\u00a0finding no clear clinical\u00a0benefit in this group. Another (see\u00a0<a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/08\/31\/primary-care-corner-with-geoffrey-modest-md-regulation-of-medical-devices\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/08\/31\/primary-care-corner-with-geoffrey-modest-md-regulation-of-medical-devices\/<\/a>\u00a0) looked at the approval process for medical devices, which involves minimalist premarket\u00a0studies often to be followed by FDA-required\u00a0aggressive post-marketing follow-up studies which are mostly never done\/printed. In this light, there was a truly scary article in New Engl J of Medicine this week (see\u00a0\u00a0DOI: 10.1056\/NEJMhle1506365). This article reviews the history of the FDA,\u00a0its developing much more teeth in 1962, and the erosion of its power over the past few decades, culminating in the current pharmaceutical case as below.<\/p>\n<ul>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">The current case: in May 2015 Amarin (a small Irish drug company) sued the FDA to allow it to distribute information about the usefulness of its prescription\u00a0fish oil product for an unapproved indication (lipid lowering), stating that such refusal violated its First Amendment right to free speech. The FDA replied in June with a conciliatory letter stating that most of the information was okay (also\u00a0suggesting that the drug\u00a0be reclassified as an unregulated dietary supplement&#8230; a topic for another blog). The company rejected that, went on with the lawsuit, and in August a federal judge sided with the drug company, citing\u00a0its &#8220;&#8216;considered and firm view&#8217; that\u00a0the FDA could not prevent promotion of a drug for an unapproved use if a manufacturer&#8217;s promotional statements are &#8216;truthful'&#8221;. [Note: one potential consequence is that patients might be prescribed fish oil for lipid management, without documented clinical benefit, instead of\u00a0clinically-proven therapies. And, does a small drug company sponsored study showing some\u00a0decrease in triglycerides qualify as &#8220;truthful&#8221; promotion for a clinical indication? And should that be determined in the court system?]<\/li>\n<\/ul>\n<p><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">History (in very brief &#8212; the article is quite good on this)<\/p>\n<ul>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">FDA established in 1906<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">Until 1962, drug manufacturers were not required to demonstrate that a new drug worked<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">1962 legislation: FDA was\u00a0given authority to consider any drug labeling or promotional material that was not explicitly approved by the FDA as &#8220;false or misleading&#8221; and subject to fines.\u00a0More than\u00a0$15B in fines were levied starting in the early 2000s till the present\u00a0against almost all of the\u00a0drug companies for illegal off-label promotion (e.g. promoting use of antipsychotics in elderly with dementia to control behavior). The rationale for this legislation was that neither consumers nor physicians could be expected to determine drug effectiveness or safety without an extensive evaluation by the FDA scientists and advisors\u00a0reviewing all the data<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">The erosion of FDA authority seems to have begun in 1980 (which, by the way, was when Reagan was elected&#8230;), when the Supreme\u00a0Court took on a case by compounding pharmacies trying to avoid governmental oversight, the Court finding\u00a0that the government did have a substantial interest in promoting public health by ensuring rigorous drug testing but also had an interest in facilitating patient access to the drugs. [The recent series of 11 infectious outbreaks caused by contaminated compounded meds affecting 207 and killing 17 was attributed to &#8220;inadequate regulatory controls&#8221;.]<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">There have been other recent examples:\u00a0a drug rep\u00a0successfully\u00a0sued the FDA that promoting an off-label indication for a drug (sodium oxybate) was infringing on his right to free speech.<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">The FDA itself had been undercutting its own authority, and in Feb 2014 issued a draft guidance that would make it easier for drug companies to disseminated information about non-approved drug indications. This included allowing drug reps to distribute peer-reviewed studies that describe lower risks from the meds than what was determined by the FDA.<\/li>\n<\/ul>\n<p><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">So, this brings up several issues:<\/p>\n<ul>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">The potential further degradation of the\u00a0quality of the data: those studies, for example, which might\u00a0show fewer adverse drug effects than the FDA documented\u00a0in their broad review\u00a0will\u00a0almost always be\u00a0sponsored by the drug companies (with their attendant well-documented shenanigans). \u00a0And, even if those of us in the trenches were aggressively trying to assess all of the relevant studies, we do not have access to many of them &#8212; esp the negative studies (though the FDA does)<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">A related issue\u00a0mentioned in prior blogs:\u00a0there is a huge concern\u00a0with the large numbers of clinical guidelines, with a dramatic shift from governmentally- generated (e.g. NIH) to specialty society sponsored ones. \u00a0A JAMA study (JAMA 2009; 301: 831-41) found that of 16 guidelines released by the Am\u00a0College of Cardiol and Am Heart Assn, 1\/2 of the recommendations\u00a0had evidence level C (expert opinion), and a large % of the guideline writers (i.e., experts) have significant conflicts of interest. (I am not just picking on cardiology &#8212; there are similar issues with lots of other specialty recommendations). A viewpoint in the Sept 1 2015 issue of JAMA notes that the Institute of Medicine considers the current approach to the development of clinical practice guidelines to be very\u00a0flawed, in part from these often-unreported conflicts of interest. This is another issue diluting our ability to practice the highest quality medicine based on the best evidence.<\/li>\n<li><span style=\"font-size: 11.0pt;font-family: 'Calibri',sans-serif;color: black\">And, the big issue: further erosion of FDA regulatory power, perhaps under guise of free speech for corporations (now considered to be &#8220;personlike entities&#8221; by the 2010 Citizens United case) could bring us back to the snake oil salesmen of\u00a0old, and\u00a0that neither we as providers nor the patients might be able to evaluate the studies well (pretty much all done by drug companies), which would dramatically undercut our ability to make sure that the benefit of meds are real and\u00a0outweighs their risks.\u200b<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Primary Care Corner with Geoffrey Modest MD: Snake Oil? 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