{"id":7921,"date":"2025-01-13T10:21:01","date_gmt":"2025-01-13T10:21:01","guid":{"rendered":"http:\/\/humanityandearth.com\/wp\/?p=7921"},"modified":"2025-01-25T22:53:42","modified_gmt":"2025-01-25T22:53:42","slug":"doshi-is-a-senior-editor-at-the-bmj-and-associate-professor-of-pharmaceutical-health-services-research-at-the-university-of-maryland-school-of-pharmacy-in-july-2024-he-published-a-bmj-investigation","status":"publish","type":"post","link":"http:\/\/humanityandearth.com\/wp\/?p=7921","title":{"rendered":"Doshi is a senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. In July 2024, he published a BMJ investigation on the \u201crevolving door\u201d between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry."},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

Index:<\/a> please click on the link for the index please?<\/p>\n\n\n\n

A Florida grand jury found \u201cprofound and serious issues involving the process of vaccine development and safety surveillance in the United States,\u201d according to a report<\/a> unsealed on Tuesday.<\/p>\n\n\n\n

Gov. Ron DeSantis<\/a> convened the grand jury in December 2022 to investigate \u201cany and all wrongdoing\u201d concerning COVID-19<\/a> vaccines. Jury members reviewed documents and interviewed witnesses involved in the COVID-19 production process.<\/p>\n\n\n\n

\u201cWhile we did not find criminal activity,\u201d they wrote in their 140-page report, \u201cwe did find a pattern of deceptive and obfuscatory behavior on the part of sponsors and regulators that often straddled the line between ethical and unethical conduct.\u201d<\/p>\n\n\n\n

They added:<\/p>\n\n\n\n

\u201cMore importantly, however, not finding any indictable criminal activity does not mean we did not find any problems. On the contrary, there are profound and serious issues involving the process of vaccine development and safety surveillance in the United States.<\/p>\n\n\n\n

\u201cSome of those are acute, COVID-19-era problems that are unlikely to occur outside the context of another once-in-a-hundred-year pandemic. Others, however, are systemic; they will occur over and over until someone fixes them.\u201d<\/p>\n\n\n\n

Commenting on the jury\u2019s conclusion, Peter Doshi, Ph.D.<\/a>, told The Defender<\/a>, \u201cIt strikes me as a sober and honest appraisal of the situation.\u201d<\/p>\n\n\n\n

Doshi is a senior editor at The BMJ<\/a> and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. In July 2024, he published a Doshi is a senior editor at The BMJ<\/a> and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. In July 2024, he published a BMJ investigation<\/a> on the \u201crevolving door<\/a>\u201d between the U.S. Food and Drug Administration (FDA) and the pharmaceutical industry.<\/p>\n\n\n\n

The investigation revealed that departing FDA staff who take industry jobs are allowed to influence the FDA \u201cbehind the scenes.\u201d<\/p>\n\n\n\n

An Associated Press<\/a> (AP) story \u2014 picked up by multiple news outlets including CBS News<\/a> and MedPage Today<\/a> \u2014 ran with a headline focused on \u201cno evidence of criminal activity.\u201d<\/p>\n\n\n\n

However, those headlines contrasted with what DeSantis said on X<\/a> about the jury\u2019s findings.<\/p>\n\n\n\n

\n

This morning, the Twenty-Second Statewide Grand Jury released its final report. This Grand Jury was tasked with investigating vaccine manufacturers and their production process for vaccines following the COVID-19 pandemic.<\/p>\n\n\n\n

While we are still reading through the report and its\u2026<\/p>\n\n\n\n

\u2014 Ron DeSantis (@GovRonDeSantis) January 7, 2025<\/a><\/p>\n<\/blockquote>\n\n\n\n

DeSantis said that not only does the report reveal Big Pharma<\/a>\u2019s pattern of deception and obfuscation, it \u201calso details the frustrations of many, stating, \u2018these sponsors have taken in billions of taxpayer dollars for creating and selling their vaccines; they cannot be sued if something goes wrong with them; they have access to critical information about deaths related to a side effect of their products; and the public does not have access to that information.\u2019\u201d<\/p>\n\n\n\n

\u201cThe status quo cannot continue,\u201d DeSantis said. \u201cThe American people deserve transparency on how Big Pharma is using their federal tax dollars, and they deserve regulating entities that operate as watchdogs, not cheerleaders.\u201d<\/p>\n\n\n\n

\u2018Painful truths\u2019 about pharma and U.S. vaccine regulatory process<\/strong><\/h2>\n\n\n\n

The grand jury report highlighted \u201csome painful truths about the COVID-19 pandemic, the pharmaceutical industry and our system of vaccine approval and licensing.\u201d<\/p>\n\n\n\n

For instance, Pfizer<\/a> initially failed to publicly disclose information about adverse events that occurred among pregnant women<\/a> in one of its main clinical trials.<\/p>\n\n\n\n

\u201cThese adverse events somehow did not make it into any of the articles published in the NEJM [New England Journal of Medicine] regarding the safety and efficacy of BNT162b2,\u201d the report stated. \u201cThe public only knows about them at all because, legally, Pfizer was required to eventually publish the results of the 1001 trial on ClinicalTrials.gov.\u201d<\/p>\n\n\n\n

Also, the FDA did not enforce marketing limitations on vaccine companies as long as the advertisement promoted vaccination in general, rather than a specific vaccine.<\/p>\n\n\n\n

For example, Moderna in August 2021 ran an ad featuring a former athlete saying, \u201cWhat\u2019s our Number 1 rule? Always protect the team \u2026 with the vaccines here to help millions, we can take steps towards life as we knew it.\u201d<\/p>\n\n\n\n

Based on their findings, the jury made recommendations on how the U.S. vaccine production and regulation process should change, including:<\/p>\n\n\n\n

    \n
  1. The public must address the \u201crevolving door\u201d problem between the pharmaceutical industry and government agencies<\/a> such as the FDA and Centers for Disease Control and Prevention.<\/li>\n\n\n\n
  2. Vaccine makers must publicly disclose safety signals as soon as they are found and verified, rather than waiting until the signal has been investigated and confirmed. \u201cIt is infantilizing and paternalistic for sponsors and regulators to assume that the public cannot distinguish between \u2018we are investigating this potential problem\u2019 and \u2018we have investigated, and this is a problem,\u2019\u201d the jury said.<\/li>\n\n\n\n
  3. Conduct updated clinical trials for Pfizer and Moderna\u2019s COVID-19 shots.<\/li>\n\n\n\n
  4. Ban direct-to-consumer marketing of pharmaceutical products.<\/li>\n\n\n\n
  5. Require vaccine makers to publish anonymized individual patient data from safety and efficacy studies swiftly after receiving FDA licensure.<\/li>\n\n\n\n
  6. Remove vaccine maker\u2019s legal immunity if they fail to comply with data transparency requirements.<\/li>\n<\/ol>\n\n\n\n

    \u2018A real call for systemic change and rebalancing\u2019<\/strong><\/h2>\n\n\n\n

    The jury report authors said they don\u2019t want to take sides in the \u201cideological war that has been waged in public health, popular culture and the media\u201d over the safety and efficacy of COVID-19 vaccines.<\/p>\n\n\n\n

    Some people call the vaccines \u201ca triumph of science, technology and public health that saved countless lives,\u201d while others say they \u201cwere heedlessly licensed, excessively recommended, and even mandated to broad swathes of people that did not need them, placing their health \u2014 and sometimes their lives \u2014 at unnecessary risk.\u201d<\/p>\n\n\n\n

    Both claims hold some truth, they said.<\/p>\n\n\n\n

    Their report isn\u2019t \u201canother entry in an ideological war, but a real call for systemic change and rebalancing,\u201d they wrote.<\/p>\n\n\n\n

    \u201cIf this Final Report accomplishes nothing else, we are optimistic that it can elevate the debate around the many nuanced and specific issues involving these pharmaceuticals by clearly describing and contextualizing them.\u201d<\/p>\n\n\n\n

    Their findings and recommendations can serve as a \u201cblueprint for a larger reckoning regarding the balance of power between federal regulators, public health officials, pharmaceutical sponsors and the citizens of the United States.\u201d<\/p>\n\n\n\n

    The Defender reached out to Dr. Marty Makary<\/a>, nominated to head the FDA by incoming President Donald Trump, for comment on the jury\u2019s report but did not receive a response by the deadline.<\/p>\n\n\n\n

    <\/p>\n","protected":false},"excerpt":{"rendered":"

    Index: please click on the link for the index please? A Florida grand jury found \u201cprofound and serious issues involving the process of vaccine development and safety surveillance in the United States,\u201d according to a report unsealed on Tuesday. Gov. Ron DeSantis convened the grand jury in December 2022 to investigate \u201cany and all wrongdoing\u201d […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-7921","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/posts\/7921","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7921"}],"version-history":[{"count":2,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/posts\/7921\/revisions"}],"predecessor-version":[{"id":7964,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=\/wp\/v2\/posts\/7921\/revisions\/7964"}],"wp:attachment":[{"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7921"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7921"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/humanityandearth.com\/wp\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7921"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}