<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Drug development – Policy & Medicine</title> <atom:link href="https://www.policymed.com/tag/drug-development/feed" rel="self" type="application/rss+xml" /> <link>https://www.policymed.com</link> <description>Legal, Regulatory, and Compliance Issues</description> <lastBuildDate>Sat, 01 Feb 2025 17:02:48 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <image> <url>https://www.policymed.com/wp-content/uploads/2018/05/cropped-favicon-32x32.png</url> <title>Drug development – Policy & Medicine</title> <link>https://www.policymed.com</link> <width>32</width> <height>32</height> </image> <item> <title>John Marshall Unscripted: The Economics of Cancer Care and Inflation Reduction Act Ripple Effect</title> <link>https://www.policymed.com/2025/02/john-marshall-unscripted-the-economics-of-cancer-care-and-inflation-reduction-act-ripple-effect.html</link> <comments>https://www.policymed.com/2025/02/john-marshall-unscripted-the-economics-of-cancer-care-and-inflation-reduction-act-ripple-effect.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Sat, 01 Feb 2025 16:57:33 +0000</pubDate> <category><![CDATA[Inflation Reduction Act]]></category> <category><![CDATA[biotech startups]]></category> <category><![CDATA[Cancer Care]]></category> <category><![CDATA[Cancer Research]]></category> <category><![CDATA[drug costs]]></category> <category><![CDATA[Drug development]]></category> <category><![CDATA[Drug Pricing]]></category> <category><![CDATA[health insurance]]></category> <category><![CDATA[healthcare economics]]></category> <category><![CDATA[healthcare policy]]></category> <category><![CDATA[Healthcare Reform]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[John Marshall]]></category> <category><![CDATA[John Newby]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Oncology]]></category> <category><![CDATA[pharmaceutical advertising]]></category> <category><![CDATA[venture capital]]></category> <category><![CDATA[Virginia Biotech Association]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17651</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1114" height="606" src="https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12.jpg 1114w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-300x163.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-1024x557.jpg 1024w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-768x418.jpg 768w" sizes="(max-width: 1114px) 100vw, 1114px" /></div>In a recent episode of Oncology Unscripted, Dr. John Marshall, a renowned oncologist from Georgetown University, delves into the complex economics of cancer care in early 2025. As the new administration settles into Washington D.C., Dr. Marshall explores the challenges and potential changes in the healthcare landscape. Rising Costs of Cancer Drugs Dr. Marshall highlights […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1114" height="606" src="https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12.jpg 1114w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-300x163.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-1024x557.jpg 1024w, https://www.policymed.com/wp-content/uploads/2025/02/Oncology-Unscripted-Episode-12-768x418.jpg 768w" sizes="(max-width: 1114px) 100vw, 1114px" /></div><p>In a <a href="https://clinicalcaresolutions.net/activities/oncology/video-update12-dr-john-marshall-1/29727-74425/content">recent episode of Oncology Unscripted</a>, Dr. John Marshall, a renowned oncologist from Georgetown University, delves into the complex economics of cancer care in early 2025. As the new administration settles into Washington D.C., Dr. Marshall explores the challenges and potential changes in the healthcare landscape.</p> <p style="padding-left: 40px;"><strong>Rising Costs of Cancer Drugs</strong><br /> Dr. Marshall highlights alarming statistics about cancer drug costs:<br /> • 95% of new cancer drugs in the US cost over $100,000 per year<br /> • The median annual cost for cancer drugs is approaching $200,000 per patient<br /> • Costs are rising regardless of a treatment’s effectiveness or novelty</p> <p style="padding-left: 40px;">These escalating costs are primarily driven by new therapies, including gene and viral therapies. Interestingly, the magnitude of benefit is not connected to cost, suggesting a disconnect between pricing and efficacy.</p> <p style="padding-left: 40px;"><strong>The Impact of Advertising</strong><br /> The discussion turns to the role of pharmaceutical advertising:<br /> • Companies spent nearly $30 billion on ads in 2024<br /> • Direct-to-consumer marketing is prevalent, even for esoteric conditions<br /> • The new administration, particularly RFK Jr., is considering banning these ads</p> <p style="padding-left: 40px;">Dr. Marshall questions the efficiency of this spending, noting that at current drug prices, acquiring just one new patient might cover the cost of a national ad campaign.</p> <p style="padding-left: 40px;"><strong>The Inflation Reduction Act (IRA)</strong><br /> The IRA, signed into law in 2022, aims to address the disparity in drug pricing between the US and other countries. Dr. Marshall explains:<br /> • The act seeks to close the gap in drug pricing<br /> • It allows Medicare to negotiate drug prices<br /> • There are concerns about its impact on pharmaceutical companies’ budgets and drug development</p> <p style="padding-left: 40px;">The new administration may potentially double down on these efforts, causing uncertainty in the industry</p> <p style="padding-left: 40px;"><strong>The Insurance Model Dilemma</strong><br /> Dr. Marshall critically examines the current health insurance model:<br /> • The model has evolved from covering catastrophic events to managing chronic conditions<br /> • Patients are often disconnected from the actual costs of healthcare<br /> • This system may be creating a false economy, potentially increasing the national debt<br /> He suggests that a more transparent system might lead to competitive pricing and reduced costs</p> <p><a href="https://clinicalcaresolutions.net/activities/oncology/video-update12-dr-john-marshall-2/29759-74427/content">The IRA’s Ripple Effect: A Candid Conversation with John Newby</a></p> <p>In a follow-up segment, Dr. Marshall interviews John Newby, CEO of the Virginia Biotech Association, to explore the IRA’s impact on cancer care and drug development.</p> <p><strong>Challenges for Biotech Startups</strong></p> <p style="padding-left: 40px;"><strong>Newby highlights the difficulties faced by biotech startups:</strong><br /> • Securing funding for innovative cancer treatments has become more challenging<br /> • The risk is primarily borne by inventors and universities in the early stages of drug development<br /> • Larger companies typically step in later to acquire promising therapies</p> <p style="padding-left: 40px;"><strong>Impact of the IRA on Investment</strong><br /> The discussion reveals concerns about the IRA’s effect on investment in new therapies:<br /> • Investors are hesitant due to uncertainties introduced by the IRA<br /> • There are worries about potential budget cuts for research and development<br /> • The act may influence how pharmaceutical companies allocate resources for new drug development</p> <p style="padding-left: 40px;"><strong>The Future of Cancer Drug Development</strong><br /> Despite challenges, both Dr. Marshall and Newby express cautious optimism:<br /> • The biotech ecosystem continues to evolve<br /> • There’s a need for balance between making drugs affordable and incentivizing innovation<br /> • Collaboration between startups, universities, and larger pharmaceutical companies remains crucial for advancing cancer treatments</p> <p style="padding-left: 40px;">These episodes of <a href="https://clinicalcaresolutions.net/news">Oncology Unscripted</a> provide valuable insights into the complex interplay between economics, policy, and cancer care as the field navigates through significant changes in early 2025.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2025/02/john-marshall-unscripted-the-economics-of-cancer-care-and-inflation-reduction-act-ripple-effect.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Industry Wants Greater Transparency in FDA Meeting Decisions</title> <link>https://www.policymed.com/2024/12/industry-wants-greater-transparency-in-fda-meeting-decisions.html</link> <comments>https://www.policymed.com/2024/12/industry-wants-greater-transparency-in-fda-meeting-decisions.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 24 Dec 2024 09:26:19 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Transparency]]></category> <category><![CDATA[Artificial Intelligence]]></category> <category><![CDATA[BIO]]></category> <category><![CDATA[Biopharmaceutical Products]]></category> <category><![CDATA[Biotechnology Innovation Organization]]></category> <category><![CDATA[Clinical Development]]></category> <category><![CDATA[Drug Approval Process]]></category> <category><![CDATA[Drug development]]></category> <category><![CDATA[Drug Industry]]></category> <category><![CDATA[Drug Sponsors]]></category> <category><![CDATA[FDA Commitments]]></category> <category><![CDATA[FDA Performance]]></category> <category><![CDATA[FDA Stakeholder Comments]]></category> <category><![CDATA[FDA-Sponsor Interactions]]></category> <category><![CDATA[Food and Drug Administration]]></category> <category><![CDATA[In-person Meetings]]></category> <category><![CDATA[Meeting Agendas]]></category> <category><![CDATA[Meeting Background Packages]]></category> <category><![CDATA[Meeting Best Practices]]></category> <category><![CDATA[Meeting Management]]></category> <category><![CDATA[Meeting Minutes]]></category> <category><![CDATA[Meeting Scheduling]]></category> <category><![CDATA[PDUFA Goals]]></category> <category><![CDATA[PDUFA VII]]></category> <category><![CDATA[PhRMA]]></category> <category><![CDATA[Prescription Drug User Fee Act]]></category> <category><![CDATA[Regulatory Delays]]></category> <category><![CDATA[Regulatory Review]]></category> <category><![CDATA[Regulatory Uncertainty]]></category> <category><![CDATA[Virtual Meetings]]></category> <category><![CDATA[Written Response Only Letters]]></category> <category><![CDATA[WRO Letters]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17223</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div>Earlier this year, the United States Food and Drug Administration (FDA) sought comments on the best practices for meeting management, holding a workshop to fulfill a commitment in the Prescription Drug User Fee Act (PDUFA VII). In the workshop, FDA aimed to understand issues related to meeting requests, efficient time management, finalizing meeting agenda, development […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Earlier this year, the United States Food and Drug Administration (FDA) <a href="https://www.regulations.gov/document/FDA-2024-N-2561-0001">sought comments</a> on the best practices for meeting management, holding a workshop to fulfill a commitment in the Prescription Drug User Fee Act (PDUFA VII). In the workshop, FDA aimed to understand issues related to meeting requests, efficient time management, finalizing meeting agenda, development and submission of meeting background packages, and lessons learned from the use of virtual meeting platforms during the COVID-19 pandemic.</p> <p>The meeting was held in person and virtually on July 22, 2024, with electronic or written comments due to the FDA no later than August 22, 2024. Several industry stakeholders took the opportunity to submit written comments on the issues, including <a href="https://www.regulations.gov/comment/FDA-2024-N-2561-0007">PhRMA</a> and the <a href="https://www.regulations.gov/comment/FDA-2024-N-2561-0006">Biotechnology Innovation Organization (BIO)</a>.</p> <p>In its comments, PhRMA noted that “[m]eetings with the FDA during the drug development and regulatory review processes are extremely valuable to sponsors and provide a venue and opportunity to receive substantive feedback to help reduce regulatory uncertainty, which is critical for the development of innovative biopharmaceutical products.” The comment goes on to note that delays in scheduling meetings or receiving input from the Agency can slow or alter development times, which may impact the ultimate patient access to new medicines and treatments. PhRMA noted that “over the last several years, FDA has consistently missed negotiated PDUFA performance goals for key meeting management metrics.”</p> <p>BIO also took issue with FDA’s performance, citing FDA’s own FY2023 PDUFA performance report that found it failed to meet 9 out of 14 meeting-related commitments in FY 2022. “Given the criticality of these interactions, this level of performance may have a deleterious impact on FDA’s and industry’s shared goals of expeditiously developing and providing novel, safe, and effective therapies for patients. Establishing and implementing best practices for both industry and the agency would improve the planning and conduct of FDA/sponsor interactions, potentially improving performance against PDUFA goals.”</p> <p>PhRMA and BIO both stated their belief that there is a need for both in-person and virtual meetings regarding written response only (WRO) letters, saying sponsors often prefer direct communication with the agency to get quick responses, but are often denied such meetings and instead given WRO letters, which tends to slow down the process. PhRMA referenced statistics that showed that more than half of the interactions between FDA and sponsors through WRO letters involve clarifying questions, questions that could have been answered during an in-person or virtual meeting. BIO asked FDA to require staff provide sponsors a rationale when denying direct meetings and issuing WRO letters instead.</p> <p>For all face-to-face meetings, BIO commented that FDA and sponsors should agree to keep meeting minutes that summarize their discussions. This would help confirm agreements, minimize communication discrepancies, and ensure mutual understanding. BIO suggested that technology such as artificial intelligence could be to maintain the minutes to make the process expeditious and efficient.</p> <p>In its comments, PhRMA asked that standard meeting management best practices be adopted, including designating an FDA representative whose role will be to keep all sides focused on the agenda during meetings. Additionally, all participants should ensure that the right people are attending the meeting. To that end, “PhRMA requests that FDA proactively provide the current titles of all attendees, their function – for example, lead CMC reviewer – and the role they play in the meeting (e.g., decision-makers or observers.” said PhRMA. PhRMA believes this information should be automatically provided, instead of the current practice, which is that sponsors must request the information after receiving the list of attendees, or otherwise “independently ascertain this information.”</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2024/12/industry-wants-greater-transparency-in-fda-meeting-decisions.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA: Food and Drug Administration Safety and Innovation Act (FDASIA) and Patient Focused Drug Development</title> <link>https://www.policymed.com/2012/07/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme.html</link> <comments>https://www.policymed.com/2012/07/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 17 Jul 2012 00:26:00 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Innovation]]></category> <category><![CDATA[PDUFA]]></category> <category><![CDATA[Barack Obama]]></category> <category><![CDATA[Drug development]]></category> <category><![CDATA[FDASIA]]></category> <category><![CDATA[Food and Drug Administration]]></category> <category><![CDATA[Mullin]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Prescription Drug User Fee Act]]></category> <category><![CDATA[Risk management]]></category> <guid isPermaLink="false">http://www.policymed.com/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme/</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="400" height="300" src="https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi.jpg 400w, https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi-300x225.jpg 300w, https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi-86x64.jpg 86w" sizes="auto, (max-width: 400px) 100vw, 400px" /></div>Last week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). Among the numerous provisions contained in this Act are several provisions that will enhance and increase patient participation in medical product regulation. Specifically, Sec. 1137 of the new law will allow the agency to develop and implement strategies to […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="400" height="300" src="https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi.jpg 400w, https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi-300x225.jpg 300w, https://www.policymed.com/wp-content/uploads/2012/07/6a00e5520572bb88340167688ceca1970b-800wi-86x64.jpg 86w" sizes="auto, (max-width: 400px) 100vw, 400px" /></div><p><span style="font-family: arial,helvetica,sans-serif;">Last week, <a class="zem_slink" title="Barack Hussein Obama, Jr." href="http://www.biography.com/people/barack-obama-12782369" target="_blank" rel="biographycom noopener">President Obama</a> signed into law the <a class="zem_slink" title="Food and Drug Administration" href="http://maps.google.com/maps?ll=39.0353363,-76.9830894&spn=0.01,0.01&q=39.0353363,-76.9830894 (Food%20and%20Drug%20Administration)&t=h" target="_blank" rel="geolocation noopener">Food and Drug Administration</a> Safety and Innovation Act (FDASIA). Among the numerous provisions contained in this Act are several provisions that will enhance and increase <a class="zem_slink" title="Patient participation" href="http://en.wikipedia.org/wiki/Patient_participation" target="_blank" rel="noopener wikipedia">patient participation</a> in <a class="zem_slink" title="Medicine" href="http://en.wikipedia.org/wiki/Medicine" target="_blank" rel="noopener wikipedia">medical product</a> regulation. Specifically, Sec. 1137 of the new law will allow the agency to develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions. This will include: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Fostering participation of FDA Patient Representatives as Special Government Employees in appropriate agency meetings with medical product sponsors and investigators; and,</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Exploring means to provide for identification of FDA Patient Representatives who do not have any, or have minimal, financial interest in the medical products industry. </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">Consequently, Theresa Mullin, Ph.D. Associate Director for Planning and Informatics FDA <a class="zem_slink" title="Center for Drug Evaluation and Research" href="http://en.wikipedia.org/wiki/Center_for_Drug_Evaluation_and_Research" target="_blank" rel="noopener wikipedia">Center for Drug Evaluation and Research</a> (CDER) recently gave a <a href="http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM310754.pdf?source=govdelivery">presentation</a> on “Patient-Focused <a class="zem_slink" title="Drug development" href="http://en.wikipedia.org/wiki/Drug_development" target="_blank" rel="noopener wikipedia">Drug Development</a>.” </span></p> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Presentation</strong><strong> </strong></span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Mullin first outlined FDA’s benefit-risk (B-R) framework, which looks at five (5) key considerations: </span></p> <ol> <li><span style="font-family: arial,helvetica,sans-serif;">Severity of Condition</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Unmet Medical Need</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Benefit</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Risk</span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><a class="zem_slink" title="Risk management" href="http://en.wikipedia.org/wiki/Risk_management" target="_blank" rel="noopener wikipedia">Risk Management</a><strong> </strong></span></li> </ol> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Severity of Condition </strong>and <strong>Unmet Medical Need </strong>provide regulators with the clinical context for weighing benefits and risks and the associated uncertainties. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Benefit </strong>and <strong>Risk </strong>incorporate expert judgments based on evaluation of the efficacy and safety data. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Risk Management </strong>incorporates expert judgments on the expected impact of efforts to reduce and further characterize risks. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Assessment of a drug’s benefits and risks involves analysis of severity of condition and current state of the treatment armamentarium. Patients who live with a disease have a direct stake in drug review process and are in a unique position to contribute to drug development. As a result, FDA noted that its review process could benefit from systematic approach to obtaining patient perspective on disease severity or unmet medical need. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Mullins noted how FDASIA – the provisions reauthorizing the <a class="zem_slink" title="Prescription Drug User Fee Act" href="http://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act" target="_blank" rel="noopener wikipedia">Prescription Drug User Fee Act</a> (PDUFA) – provides resources to support additional program staff to expand activities dedicated to providing review divisions with patient input. FDA will convene meetings with participation from review divisions, the relevant patient advocacy community, and other interested parties. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">FDA will hold four public workshops per year—a total of 20 meetings over 5 years. Each meeting will focus on a different disease area, reviewing the armamentarium for that indication, and identifying areas of unmet need.<strong> </strong></span></p> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Benefit</strong><strong>‐</strong><strong><a class="zem_slink" title="Risk assessment" href="http://en.wikipedia.org/wiki/Risk_assessment" target="_blank" rel="noopener wikipedia">Risk Assessment</a> Framework: Analysis of Condition</strong> </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Assessing Evidence and Uncertainties– for a given drug for a given indication‐questions FDA considers include: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What is the treated (or prevented) condition?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What are its clinical manifestations (i.e., symptoms that are either reported or observed)?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What is known about the natural history and progression of the condition, including in specific subpopulations?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How severe is the condition for those who have it?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How does severity vary across the sub</em><em>‐</em><em>populations we have defined? (Note specific subpopulations and nature of differences.)</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What is the basis for our assessment of the condition and its severity? (Note any relevant literature, clinical experience, expert opinion, etc.)</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What are the major uncertainties in the available information? What are their implications?</em><strong> </strong></span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Benefit</strong><strong>‐</strong><strong>Risk Assessment Framework: Unmet Medical Need</strong> </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Assessing Evidence and Uncertainties –for a given drug for a given indication‐FDA considers: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What other pharmacological therapies are approved for this condition?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How effective are these alternative therapies?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How does their effectiveness vary by sub</em><em>‐</em><em>population?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How well tolerated are these alternative therapies?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How does tolerance vary by sub</em><em>‐</em><em>population?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What off</em><em>‐</em><em>label pharmacological therapies might be considered?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How effective and how well tolerated are they reported or believed to be?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What non</em><em>‐</em><em>pharmacological therapies might be considered?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>How effective and how well tolerated are they reported or believed to be?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What kinds of evidence are available about the use of alternative treatments for this condition?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What is the strength of evidence in each case?</em></span></li> <li><span style="font-family: arial,helvetica,sans-serif;"><em>What are the major uncertainties in the evidence? What are their implications?</em> </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">The presentation then discussed Patient‐Reported Outcome (PRO) Measures, which FDA defined as <strong>“</strong>any report of the status of a patient’s health condition coming directly from the patient, without interpretation by physicians or anyone, about how the patient functions or feels in relation to a health condition and its treatment.” FDA reviews PRO instruments and looks at whether the instrument measures the concept it is supposed to measure. FDA looks at whether the instrument is: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Well‐specified and reliable</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Specific for target population</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Specific for target indication</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Adequate measurement properties (e.g., content validity) </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">The presentation then noted that qualitative research can be used to establish PRO content validity. This might include: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Focus groups to generate a pool of patient outcome‐related domains and their components (e.g., What symptoms and functions or activities impacted by disease that are most important to patients)</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Surveys including a larger and more diverse sample patients with a given condition (e.g., examine the importance and relevance of domains identified by literature review, expert opinion or among a smaller set of patients, to validate these items and perhaps explore other measurement characteristics) </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">Mullins then used the example of people with chronic pain. Focus groups conducted with patients who experience chronic pain identified 19 aspects of their lives (outcome domains) that are significantly impacted by the presence of their symptoms and for which improvements were important criteria that they use in evaluating the effectiveness of any treatment. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Next Steps Patient</strong><strong>‐</strong><strong>Focused Drug Development</strong> </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Throughout the rest of this summer, FDA will develop preliminary list of 20 disease areas for public comment to inform planning for the set of 20 PDUFA V meetings. FDA will also develop a basic roadmap that could be used by patient groups interested in pursuing need for and development of PRO measures in a specific disease area. This roadmap will identify important but currently unaddressed aspects of their disease experience to potentially be considered in evaluating new therapies. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">In September 2012, FDA will publish an FR notice with the preliminary list of 20 disease areas for public comment. In October 2012, FDA will plan to hold public meeting to: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Discuss the proposed list of disease areas for the PDUFA meetings and get public input;</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Discuss strategies for getting broader public input and basic roadmap for identification of important patient outcomes and strategies for collaborative development PRO measures </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>FDA Patient Representative Program</strong><strong> </strong></span></p> <p><span style="font-family: arial,helvetica,sans-serif;">The Patient‐Focused Drug Development initiative will also add to the existing FDA programs designed to integrate patients’ perspectives. FDA’s patient advocacy programs are run by FDA’s Office of Special Health Issues. One of their main programs is the <a href="http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/patie%20ntinvolvement/ucm123858.htm">FDA Patient Representative Program</a>. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Patient Representatives provide FDA with the unique perspective of patients and family members directly affected by serious or life‐threatening disease. Patient Representatives serve in the several ways, including: </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">On Advisory Committees, where they offer the patient perspective, ask questions, and give comments to assist the committee in making recommendations.</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">As consultants for review divisions –the clinicians and scientists who review data submitted to determine whether the product’s benefits outweigh the potential risks</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">As presenters at FDA meetings and workshops on disease‐specific or regulatory and health policy issues </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">The Programs activities include:</span></p> <p><span style="font-family: arial,helvetica,sans-serif;"> </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Recruitment of New Patient Representatives</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Selection of Patient Representatives for: </span> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Advisory Committees</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Consultation with Review Division</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Conducts Training For Patient Representatives </span> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Individual FDA 101 Training</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Monthly Webinars</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Annual Workshop for Newly Recruited Patient Representatives </span></li> </ul> </li> </ul> </li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">In choosing Patient Representatives, FDA looks for someone who brings a personal viewpoint to the process and communicates a collective patient perspective. A <span style="text-decoration: underline;">patient </span>perspective is created when a person goes through personal experience with the disease. A <span style="text-decoration: underline;">collective patient </span>perspective is created when the person has knowledge of others’ disease experiences and conveys this collective patient perspective.</span></p> <p><span style="font-family: arial,helvetica,sans-serif;"> Patient Representatives provide Advisory Committee and FDA insight on issues, problems, and/or questions pertinent to the viewpoint of patients and family members living with a specific serious or life‐threatening disease. </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Personal experience with/knowledgeable about the specific illness</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Ability to articulate the perspective of patients</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Experience as a patient advocate</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Formal affiliation with a patient advocacy organization</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">The ability to identify issues through communication with patient constituencies </span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;">Patient Representatives serve on an Advisory Committee when a product or therapy related to specific illness is under review, as either voting or non‐voting member </span></p> <ul> <li><span style="font-family: arial,helvetica,sans-serif;">Voting: must be appointed as special government employees (SGEs); requires disclosure of personal financial information to the FDA in order to determine whether their financial interests pose a possible conflict of interest on an advisory committee</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">Non‐voting: may only vote on procedural matters concerning the conduct of the meeting</span></li> <li><span style="font-family: arial,helvetica,sans-serif;">In both cases: expected to provide the patient perspective, ask questions, and offer comments to assist the committee in making recommendations<strong> </strong></span></li> </ul> <p><span style="font-family: arial,helvetica,sans-serif;"><strong>Drug Development Patient Consultant Program</strong> </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">FDA also uses patients in its Drug Development Patient Consultant program. This program incorporates the perspective of patient advocates into the drug development process; allows opportunity to participate in the FDA drug review regulatory process. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">Patients are selected to participate in meetings by matching a specific illness and proposed indication for the new therapeutic drug being developed. Patients may participate in meetings (via telephone ) between the FDA and drug companies. </span></p> <p><span style="font-family: arial,helvetica,sans-serif;">The newly selected patient consultant receives training and participates in monthly telephone lecture series in preparation for these meetings. To provide consultation to both FDA and the drug company, it is important that the patient consultant have background information on the drug under review. About three weeks before each meeting, the patient consultant is mailed the meeting package containing the meeting issues and questions. The patient consultant reviews the meeting package in preparation for the meeting.</span></p> <div class="zemanta-pixie" style="margin-top: 10px; height: 15px;"><a class="zemanta-pixie-a" title="Enhanced by Zemanta" href="http://www.zemanta.com/?px"><img decoding="async" class="zemanta-pixie-img" style="float: right;" src="http://img.zemanta.com/zemified_e.png?x-id=d86e680d-2f41-446e-ad41-8e5f81e8e47e" alt="Enhanced by Zemanta" /></a></div> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2012/07/fda-food-and-drug-administration-safety-and-innovation-act-fdasia-and-patient-focused-drug-developme.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Educates Industry on Development of Orphan Drugs</title> <link>https://www.policymed.com/2010/03/fda-educates-industry-on-development-of-orphan-drugs.html</link> <comments>https://www.policymed.com/2010/03/fda-educates-industry-on-development-of-orphan-drugs.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Thu, 11 Mar 2010 02:58:14 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Pharmaceutical and Device]]></category> <category><![CDATA[Drug development]]></category> <category><![CDATA[Food and Drug Administration]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Orphan Diseases]]></category> <category><![CDATA[Orphan Drugs]]></category> <guid isPermaLink="false">http://www.policymed.com/fda-educates-industry-on-development-of-orphan-drugs/</guid> <description><![CDATA[In the complex and expensive world of research and development for drugs, there are therapies for conditions known as “orphan diseases,” those that affect fewer than 200,000 Americans. According to a recent article in the Wall Street Journal, “there are about 7,000 such maladies, most of them serious, that have few or no drugs to […]]]></description> <content:encoded><![CDATA[<p class="MsoNormal" style="MARGIN: 0in 0in 10pt; LINE-HEIGHT: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial"><img loading="lazy" decoding="async" height="243" src="http://www.fabinet.up.ac.za/blog/wp-content/uploads/2009/02/eucagen-breakfast-meeting-9-nov-2005.jpg" width="365" /></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 10pt; LINE-HEIGHT: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial">In the complex and expensive world of research and development for drugs, there are therapies for conditions known as “orphan diseases,” those that affect fewer than 200,000 Americans. According to a recent article in the </font></span><a href="http://online.wsj.com/article/SB10001424052748704145904575111943356541152.html"><span style="mso-bidi-font-family: Arial"><font color="#800080" face="Arial">Wall Street Journal</font></span></a><span style="mso-bidi-font-family: Arial"><font face="Arial">, “there are about 7,000 such maladies, most of them serious, that have few or no drugs to treat them.” <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 10pt; LINE-HEIGHT: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial">Examples of such orphan diseases range “from adenoid cystic carcinoma, a rare head and neck cancer, to Zollinger-Ellison syndrome, which is associated with a tumor that causes the production of high levels of stomach acid.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 10pt; LINE-HEIGHT: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial">Usually, the difficulty of creating enough financial support to research orphan diseases is extremely difficult however, WSJ reports that “staff members at the Food and Drug Administration are doing something unusual: leaving Washington to help drug makers take a crucial step in developing drugs for orphan diseases.”<o:p></o:p></font></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">Consequently, these “staffers are helping to administer the Orphan Drug Act, which provides incentives to create therapies for so-called orphan diseases.” As a result of these incentives, “doctors may end up prescribing drugs developed for other diseases off-label, but not all insurers will cover this kind of use.” <o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">A drug is designated as an orphan-drug once the FDA approves the medicine for sale in the U.S., which also gives the drug seven years' marketing exclusivity and tax breaks. IN 2009, only 250 requests for orphan-drug designation were filed, and 160 received it. In response to these numbers, Timothy Coté, director of the FDA's Office of Orphan Products Development noted that industry and the FDA are “barely scratching the surface." For example, there are roughly 350 orphan drugs approved, covering about 150 rare diseases.<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">One reason there are so few orphan drugs are because “most companies that are developing orphan drugs are small,” according to Tim Cunniff, vice president of global regulatory affairs at Lundbeck Inc. This trend is starting to change however, as “big companies are starting to get more interested in rare diseases.”<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">This positive shift of industry working with FDA is important, but a “key issue is the high cost of developing a drug and the typically long time it takes to move it from a lab into a clinic as a treatment that gets prescribed.” Consequently, going into the development of creating an orphan drug requires a “to feel there is a reasonable chance of making a profit. Another positive sign to get companies to start funding research on orphan drugs was when Dr. Coté's office announced “two workshops with on-the-spot regulatory advice.”<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">“The first workshop, held last month at the Keck Graduate Institute, drew 29 potential sponsors, from major drug companies to academic centers, small biotechs and even some patient advocates. In a follow-up survey, 74% said they had never before filed an application for orphan drug designation.” Such a turnout is evident of the clear benefits that industry and government relationships can help patients—no matter how rare the disease is.<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">The workshop gave participants regulatory advice, not an alternative pathway to orphan-drug designation. In fact, teams of participants met “four times over the course of two days with FDA staffers who offered advice on nine critical issues in filling out an application.”One of the crucial pieces of information discussed was “providing evidence—preferably either trial data or published reports of animal studies—that a drug exists and holds promise for treating a rare disease.” <o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">One example of the usefulness of the workshop was highlighted in Barbara Fant’s experience. As president and chief executive of Clinical Research Consultants Inc., she attended the workshop to prepare an application for a drug-company client. One of the FDA staffers who worked on her application noted parts that would have “delayed the designation process” to become an orphan drug however, because she attended the workshop, some of those problems were avoided.<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">Evidence of the success of the first two day workshop resulted in 14 submitted applications of the 29 who attended. As a result, Dr. Coté ‘s goal of doubling the number of applications this year seems well on its way, and he “considered the workshop a success.” <o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">The second workshop will be held at the University of Minnesota in August, and can accommodate up to 50 more organizations, and “Dr. Coté said he was considering a workshop in Europe.” We will try to update you on information pertaining to this workshop.<o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">Accordingly, his goal for the next workshop is to “weed out applicants who can't file at the end of two days.” While such an idea is admirable, just because “resources are still limited” should not be a reason to scare away interested entities. The alternative and better approach would be to find another form of funding, and since Congress is not likely to foot the bill, maybe a pool of private sources. <o:p></o:p></span></p> <p><span style="FONT-FAMILY: 'Arial','sans-serif'">Although there are other factors that determine final approval for marketing—such as safety and effectiveness—Dr. Coté hoped “that by increasing the pool of applicants for designation, they will increase the chances of getting more approvals.” By opening up this workshop and opportunities for industry to make smart investments his hopes are sure to bring new research and development into orphan diseases and his efforts should be applauded. <o:p></o:p></span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2010/03/fda-educates-industry-on-development-of-orphan-drugs.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>JACO: Researchers Contributions and Ties with Industry</title> <link>https://www.policymed.com/2010/01/jaco-researchers-contributions-and-ties-with-industry.html</link> <comments>https://www.policymed.com/2010/01/jaco-researchers-contributions-and-ties-with-industry.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Thu, 21 Jan 2010 01:19:00 +0000</pubDate> <category><![CDATA[Medical Journals]]></category> <category><![CDATA[Pharmaceutical and Device]]></category> <category><![CDATA[Drug development]]></category> <category><![CDATA[Industry Collaboration]]></category> <category><![CDATA[JACO]]></category> <category><![CDATA[Journal of Clinical Oncology]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Ties with Industry]]></category> <guid isPermaLink="false">http://www.policymed.com/jaco-researchers-contributions-and-ties-with-industry/</guid> <description><![CDATA[A recent study in the Journal of Oncology titled “Relationships Between Authorship Contributions and Authors’ Industry Financial Ties Among Oncology Clinical Trials”, tried to determine whether authors who play ‘key’ scientific roles in oncology clinical trials, are more likely than those who do not play such roles to have financial ties to industry.   The finding […]]]></description> <content:encoded><![CDATA[<p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><font face="Arial"><span style="mso-bidi-font-family: Arial"><img loading="lazy" decoding="async" height="161" src="http://a4miberia.com/blog/wp-content/uploads/2009/12/Cancer-Research3.jpg" width="318" /></span></font></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><font face="Arial"><span style="mso-bidi-font-family: Arial">A recent study in the Journal of Oncology titled “</span><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><a href="http://jco.ascopubs.org/cgi/content/abstract/JCO.2008.21.6606v1"><font color="#800080">Relationships Between Authorship Contributions and Authors’ Industry Financial Ties Among Oncology<o:p></o:p></font></a></span></font></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span class="MsoHyperlink"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><a href="http://jco.ascopubs.org/cgi/content/abstract/JCO.2008.21.6606v1"><font color="#800080" face="Arial">Clinical Trials</font></a></span></span><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">”, tried to determine whether authors who play ‘key’ scientific roles in oncology clinical trials, are more likely than those who do not play such roles to have financial ties to industry. <span style="mso-spacerun: yes">  </span>The finding was simple, the most productive authors (those who wrote the most papers, did the most studies) benefited from industry support.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">In other words, the study tried to determine whether doctors who do work get paid for their work. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><strong style="mso-bidi-font-weight: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial">Research Findings<o:p></o:p></font></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Of the 235 articles reviewed, 52% reported industry funding, 42% reported government funding, and 24% reported foundation funding.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Only twenty-nine percent of authors reported at least one financial tie to industry. The most common areas of funding were (12%), honoraria (11%), and consulting (10%).<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Among industry-sponsored trials, 669 (44%) of 1,518 authors reported at least one tie to a commercial entity. Of these, 94% reported at least one tie to the study sponsor. Among authors of non–industry-sponsored trials, 173 (12%) of 1,409 reported ties to a commercial entity.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">The research found that sixty-four percent of the authors — 1,881 of 2,927 — said they performed at least one key role in the study.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">The study found that such researchers “who design clinical trials, analyze or interpret the data, or play other key scientific roles are four times more likely to have financial ties to industry than their counterparts who have lesser roles in these studies, such as recruiting study subjects or collecting the data.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Limitations<o:p></o:p></font></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">The study was limited because the data were derived from articles published in a single oncology journal during a limited time between January 1, 2006, and June 30, 2007.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">The data on financial ties and on authorship contributions from the study were also limited because they were self-reported, which could lead under- or over-reporting of financial ties, or of inaccurate reporting of authorship contributions.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Another limitation included the possibility that multiple instances of authorship by an individual author could have influenced the results.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">In addition, the authors acknowledged that “the data do not directly address the causal mechanisms underlying the observed association between authorship contributions and financial relationships.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Discussion<o:p></o:p></font></span></strong></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><strong style="mso-bidi-font-weight: normal"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">The problem with this type of investigation is that it can be misconstrued despite the fact that the collaboration provides benefits to patients. The paper assert that “cancer researchers who have the greatest ability to influence research are also the researchers with the greatest financial ties to the pharmaceutical and biotechnology industries.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">Instead, the recent JCO article suggests that these financial relationships have the potential to bias the outcome of such clinical research, even though patients are improving. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">Such a suggestion harms patients, physicians and researchers because it stigmatizes important research and clinical testing on cancer drugs bases on the “potential for bias.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">But even Dr. Harlan Krumholz of Yale University, noted that "In some cases, industry-physician relationships may represent high integrity interactions between industry and academic scientists seeking knowledge about the effect of a treatment on patients. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">Another reason why the media and the authors of this article need to reconsider their claims for potential bias is because “not all types of relationships between researchers and companies are of equal concern,” according to Dr. Bernard Lo, director of the program in medical ethics at the University of California at San Francisco. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><span style="mso-bidi-font-family: Arial"><font face="Arial">For example, speaker’s bureaus, consultation, and clinical trials play totally different roles in the type of experience and value physicians and researchers gain, and the amount paid is also different. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0.1pt 0in; mso-para-margin-top: .01gd; mso-para-margin-right: 0in; mso-para-margin-bottom: .01gd; mso-para-margin-left: 0in"><font face="Arial"><span style="COLOR: blue; mso-bidi-font-family: Arial">  </span><span style="mso-bidi-font-family: Arial"><o:p></o:p></span></font></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt"><span style="mso-bidi-font-family: Arial"><font face="Arial">Journals accommodating this kind of survey non-research as scholarship, downplay the value of industry association, and allow the authors to cite only the alarmist background is extremely problematic. Moreover, the recent JCO article only displays how “disclosure” is heavily abused. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Editorial<o:p></o:p></font></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><font face="Arial"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial">In response to the study, an editorial “</span><span style="mso-bidi-font-family: Arial"><a href="http://jco.ascopubs.org/cgi/reprint/JCO.2009.26.9753v1"><font color="#800080">Authorship and Industry Financial Relationships: The Tie That Binds</font></a>”</span><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"> was also published in JACO, which noted that </span><span style="mso-bidi-font-family: Arial">“collaborations between physicians and drug companies clearly benefit society, as evidenced by the remarkable advances we have witnessed in cancer research in just the past few years.”<o:p></o:p></span></font></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">The authors of this editorial however try to downplay such collaborations by citing an Institute of Medicine (IOM) report that “concluded that such conflicts present the risk of undue influence on professional judgments and thereby may jeopardize the integrity of scientific investigations, the objectivity of medical education, the quality of patient care, and the public’s trust in medicine.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">The evidence for this ‘risk of undue influence’ is minimal at best because as the editorial states, “all authors must now report their contribution to a study’s conception and design; financial support; administrative support,” and other factors. Moreover, the editorial itself states that what Dr. Steven Joffe and other authors found “is perhaps not at all surprising given that most physicians in the United States have a financial relationship with industry.” <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt"><span style="mso-bidi-font-family: Arial"><font face="Arial">This relationship with industry is crucial for cancer research, patients and physicians because the vast majority of the clinical trials are pharma sponsored because the universities cannot afford to do investigator initiated trials. <o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt"><span style="mso-bidi-font-family: Arial"><font face="Arial">In addition, phase III and registration trials are overwhelmingly carried out by private companies, and more than 80% of medical oncology is private practice. With numbers like that, where do these authors suggest getting funding for trials on new cancer drugs, resources to recruit patients, and physicians who are willing to dedicate there valuable time for free?<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-bidi-font-family: Arial"><font face="Arial">Conclusion<o:p></o:p></font></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">The JCO study on relationships with industry stated clearly that:<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial"><span style="mso-tab-count: 1">    </span><strong style="mso-bidi-font-weight: normal">“There is a lack of solid empirical data to determine if, on balance, <span style="mso-tab-count: 1">   </span>relationships between physicians and industry ultimately harm or <span style="mso-tab-count: 1">  </span>benefit society.”<o:p></o:p></strong></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">Accordingly, the idea suggested by authors in the editorial and article that disclosure is not enough, must realize that “there are a number of ways to minimize conflicts of interests including removal, recusal, third-party evaluation, codes of ethics, and disclosure.” In fact, the American Society of Clinical Oncology guidelines, published in 2003, rely heavily on disclosure as the principal method of dealing with perceived COI.<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">The fact that “author disclosures are becoming increasingly complex and there is not a uniform system for the disclosure of financial information,” does not translate into a conflict for doctors who work with industry. Specifically, the article noted that although researchers are associated with industry sponsorship:<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><font face="Arial"><span style="mso-bidi-font-family: Arial"><span style="mso-tab-count: 1">    </span>“</span><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial">little is known about the relationship between investigators’ <span style="mso-tab-count: 2"></span>personal financial ties and study outcomes.”<o:p></o:p></span></strong></font></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><font face="Arial">Moreover, the<strong style="mso-bidi-font-weight: normal"> </strong>article “<em style="mso-bidi-font-style: normal">states that the data does not prove that authors’ financial ties are problematic, nor do they necessarily reflect efforts by sponsors to influence investigators’ work."<strong style="mso-bidi-font-weight: normal"><o:p></o:p></strong></em></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><strong style="mso-bidi-font-weight: normal"><span style="mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></strong></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">Without such data, cancer research in collaboration with industry should be continued and strengthened, especially when the JCO article stated that “most patients in cancer-research trials were not worried about financial ties between researchers or medical centers and drug companies and would still have enrolled in the trial if they had known about such financial ties.”<o:p></o:p></font></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><o:p><font face="Arial"></font></o:p></span></p> <p class="MsoNormal" style="MARGIN: 0in 0in 0pt; mso-layout-grid-align: none"><span style="mso-bidi-font-family: Arial"><font face="Arial">In the end everyone may benefit one day from improved cancer care, even the authors.<o:p></o:p></font></span></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2010/01/jaco-researchers-contributions-and-ties-with-industry.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel> </rss>