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	<title>Pharma Exec Blog &#187; Meetings</title>
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		<copyright>&#xA9;Advanstar Communications </copyright>
		<managingEditor>gkoroneos@advanstar.com (Advanstar Communications)</managingEditor>
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		<category>Pharmceuticals</category>
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		<itunes:summary>The Business of Pharmaceuticals</itunes:summary>
		<itunes:author>Advanstar Communications</itunes:author>
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		<title>The Rising Clout of the Patient</title>
		<link>http://blog.pharmexec.com/2012/01/09/the-rising-clout-of-the-patient/</link>
		<comments>http://blog.pharmexec.com/2012/01/09/the-rising-clout-of-the-patient/#comments</comments>
		<pubDate>Mon, 09 Jan 2012 19:45:03 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Events]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[e-Patient Connections Conference]]></category>
		<category><![CDATA[patient communication]]></category>
		<category><![CDATA[patient groups]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3376</guid>
		<description><![CDATA[by Sarah Krüg
In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?
In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This [...]]]></description>
			<content:encoded><![CDATA[<p><em>by Sarah Krüg</em></p>
<p>In 2011, the patient’s clout as a stakeholder was firmly established, as reflected in several industry conferences. What’s next for the patient in 2012?</p>
<p><span id="more-3376"></span>In 2011, many healthcare organizations came around to the idea that patients should be included in discussions that had customarily taken place about them, but without their direct participation. This shift was evident at several healthcare conferences last year, and bodes well for 2012 as a year when further overtures – and partnerships – will be formed with and between patients.</p>
<p><strong>Health2.0</strong></p>
<p>The Health2.0 conference in San Francisco brought a deluge of innovation and shiny, new healthcare applications. Data plus IT and innovation represent the future of healthcare, and individual patients are a critical component of this equation (not just their data). This was a key theme of the Health2.0 conference. “Patient stories” have often been highlighted at conferences, and used as bookends to infuse a dose of reality to educational sessions.  What impressed me about the Health2.0 conference was the inclusion of patients and caregivers in the conversations, allowing for bi-directional exchange. Patients2.0, an offshoot of Health2.0, is a movement that aims to revolutionize healthcare delivery around the patients. The goal is to leverage the Health2.0 phenomenon and develop a hub for patients to exchange experiences through peer-to-peer networks, to obtain information, and most importantly, to have a collective voice in healthcare decision-making. By sharing stories, co-creating health data, and aggregating issues across the healthcare spectrum, the voices of Patients2.0 are empowered to be part of the larger conversation, and to exert influence on the health system by shaping future policy. Patients are the new healthcare disruption that can help transform the landscape, and using forums such as Health2.0 to involve them every step of the way is truly ahead of the curve.</p>
<p><strong>Epatient Connections</strong></p>
<p>The key theme at the Epatient Connections, held in Philadelphia, was that “Healthcare is Social.” Physician, medical and patient communities are forming connections through various social media channels, but there are a still a few less progressive entities a step behind as they figure out how to navigate uncharted regulatory waters. As connections are made, patients are becoming further engaged in their care as they learn from what others are doing. The key is to take those connections one-step further and bridge the various pockets of connection. There needs to be further inter-connectivity between patient voices, scientific publications, medical results and records, and medical education geared towards healthcare professionals, and these need to set the stage for a longitudinal data set. Patient engagement tools that were showcased included everything from health management tools to game-ification that integrated feedback mechanisms and incentives to an Internet enabled robotic telepresence, allowing immobile patients to interact with their healthcare community.</p>
<p><strong>SXSH Unconference </strong></p>
<p>The SXSH Unconference also took place in Philadelphia (Sharing, Exchanging, Social Health). Todd Park, CTO, US Department of Health &amp; Human Services opened up the conference with an introduction to the Data Liberation initiative: New Incentives+ Information Liberation= Rocket Fuel for Innovation. Medicare, Medicaid, and the Veteran&#8217;s Administration represent the largest repository of public health data in the world. Patient data liquidity and information about the public health, stripped of personal identification, is being made available so that innovators can use it to create health-maximizing options.</p>
<p><strong>2012</strong><strong></strong></p>
<p>2011 was a year where a foundation for the “patient voice” was established as a critical component of the healthcare system. 2012 will be an even more important year, as healthcare organizations empower more patients by personalizing communications for individual patients. Patients are often overwhelmed with the amount of information they must retain to successfully manage their health. How will healthcare organizations come together to simplify navigation of the healthcare system? How will different healthcare systems, records and applications that serve different purposes connect with one another to prevent redundancy? How will patient stories be further synthesized and culminated into “patient issues” that a roundtable of healthcare sectors can further troubleshoot at future conferences? If 2011 was the year of dipping toes in the waters of “patient engagement” &#8230;2012 should be the year of swimming alongside others towards a unified goal—a year of patient engagement through an open network of inter-connectivity.</p>
<p><em>Sarah Krüg is CEO/executive director of </em>CANCER101<em>, a patient outreach and advocacy organization. She is also president-elect of </em>The Society for Participatory Medicine<em>.</em></p>
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		<title>The Rise of the Patient: Medicine 2.0</title>
		<link>http://blog.pharmexec.com/2011/10/12/the-rise-of-the-patient-medicine-2-0/</link>
		<comments>http://blog.pharmexec.com/2011/10/12/the-rise-of-the-patient-medicine-2-0/#comments</comments>
		<pubDate>Wed, 12 Oct 2011 14:56:49 +0000</pubDate>
		<dc:creator>Guest Blogger</dc:creator>
				<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Patient Communication]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[healthcare]]></category>
		<category><![CDATA[leadership]]></category>
		<category><![CDATA[patient compliance]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[patient groups]]></category>
		<category><![CDATA[patient information]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=3209</guid>
		<description><![CDATA[by Sarah Krüg
Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the Fourth World Congress on Social Media and Web 2.0 in Health Medicine) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a [...]]]></description>
			<content:encoded><![CDATA[<p><em>by Sarah Krüg</em></p>
<p>Amidst yellow sandstone arches and California Mission Revival architecture, The Medicine 2.0 +Stanford Summit (otherwise known as the <a href="http://www.medicine20congress.com/ocs/index.php/med/med2011/schedConf/program">Fourth World Congress on Social Media and Web 2.0 in Health Medicine</a>) set out on a three day journey to challenge its diverse audience to break down silos and expand beyond traditional boundaries. From a focus on research findings and scientific data to dialogue around the future of science, medicine and emerging technology, innovators and thought leaders congregated from around the globe at the state-of the-art Stanford venue, Li Ka Shing Center for Learning &amp; Knowledge. Through the congress, Stanford extended an invitation for open scientific inquiries into the pursuit of teaching, learning, and research, in alignment with its motto. <sup>1</sup></p>
<p><span id="more-3209"></span></p>
<p>The energy in the room was contagious starting with the unique conference badges that featured personal QR codes (eliminating the need for business cards), lively twitter feed and building of a #med2 community (over 5,000 tweets!), to the theatrical presentations that conveyed unconventional solutions to healthcare issues. From theory to practice&#8211;patients, healthcare professionals, academics and executives discussed and debated concepts such as participatory medicine, patient self management, behavioral change, decision making, the quantified self, communities of practice, social networking, gamification, personalized healthcare, and innovation in medical education. There were so many interesting points made at Med2.0, but I’ve captured a few highlights below:</p>
<p>Abraham Verghese, MD eloquently walked us through the bedside ritual of examining the patient as a critical but threatened skill that is the foundation to the patient-physician relationship. He explained the potential of displacing the patient during the digital age and reliance on technology during the clinical encounter —with more emphasis placed on patient data, rather than the person being treated.</p>
<p>Jennifer Aaker, PhD delivered a brilliant keynote that demonstrated the impact of social media saving lives through storytelling, collaboration, and enabling the wider community to quickly act. The story began with 2 Indian men with AML in search of bone marrow matches and ended with 20,000 South Asians registering as a result of a powerful awareness and social media campaign. Attendees had the opportunity to have their cheeks swabbed and sign up for the Be The Match Registry during the break in the corridors.</p>
<p>The eclectic BJ Fogg, PhD shared his behavior change model which shows that three elements must converge at the same moment for a behavior to occur: B = MAT (Behavior = Motivation x Ability x Trigger).</p>
<p>Susannah Fox gave the closing keynote on the impact of “peer to peer healthcare” where patients are seeking and sharing health advice online. Roadblocks included pockets of offline patients, patients not motivated to engage in their healthcare, silo tools/communities, and lack of awareness of resources. Opportunities included leveraging the power of online caregivers, engagement prompted by life changing diagnoses/events, rise of mobile adoption, and emerging focus of technology that bridges silos and allows data flow. The beacons of change in these efforts include patient, clinician, and technology leaders.</p>
<p>There was a major focus on patient self management platforms in chronic diseases, the Quantified Self and use of digital devices to collect real-time quantifiable patient data, decision support tools to make informed choices, and gaming to change behavior by rewarding patients for meeting health related goals. With all the data being collected, the question is how do you give back the data to patients, synthesize, and set context in a way they can understand?</p>
<p>The use of technology as a catalyst in healthcare improvement was prevalent.  From the use of social media and mobile health tools by physicians to communicate and improve clinical workflow to the use of virtual community platforms by patients to share experiences, understand options and obtain social support&#8211;It was clear that patients and healthcare professionals are embracing the impact of technology—although not necessarily at the same pace. Patient online usage to share and obtain healthcare information is on the rise; however a research abstract (764) demonstrating physician attitudes towards social media for their own professional education and knowledge sharing showed that usage and intent to use is fairly low. Plagued with social media privacy concerns and associated risks, traditional modes of learning, and lack of clear guidance and policies—physician usage is growing at a snail’s pace in comparison.</p>
<p>There was a spotlight on the e-patients, of which 23 received scholarships to attend the conference. Each had a compelling story to tell regarding their personal but at times unfavorable experiences with the healthcare system and how they made informed medical decisions by becoming more empowered and engaged in their healthcare. These real life interactions crystallized key themes conveyed throughout the conference.</p>
<p>Larry Chu, MD was the skilled conductor of this colorful performance, which set the bar high for future Med2.0 conferences. We were each given the opportunity to challenge both established and new orthodoxies in healthcare, infuse innovation and creativity into potential solutions, and explore collaborations among the diverse Med2.0 community to make things happen!</p>
<p>Planning for the <a href="http://www.medicine20congress.com/ocs/index.php/med/med2012">2012 Med2.0 Congress</a> is underway to be held September 15-16<sup>th</sup> at Harvard Medical School. Stanford will also debut <a href="http://medicinex.stanford.edu/">MedicineX</a> in 2012 focused on the intersection of emerging technology and the future of medicine.</p>
<p><sup>1</sup> Die Luft der Freiheit Weht-unofficial Stanford Motto, Ulrich von hutten, 16<sup>th</sup> century</p>
<p><em>Sarah Krüg is executive director at Cancer101, a patient organization. She was previously </em><em>Global Education Director in the Medical Education Group at Pfizer</em><em> </em></p>
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		<title>DIA: Social Media Guidelines are DDMAC’s &quot;Highest Priority&quot;</title>
		<link>http://blog.pharmexec.com/2011/06/22/dia-social-media-guidelines-are-ddmac%e2%80%99s-%e2%80%98highest-priority%e2%80%99/</link>
		<comments>http://blog.pharmexec.com/2011/06/22/dia-social-media-guidelines-are-ddmac%e2%80%99s-%e2%80%98highest-priority%e2%80%99/#comments</comments>
		<pubDate>Wed, 22 Jun 2011 15:51:53 +0000</pubDate>
		<dc:creator>Ben Comer</dc:creator>
				<category><![CDATA[Advertising]]></category>
		<category><![CDATA[E-Media]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[patient education]]></category>
		<category><![CDATA[social media]]></category>
		<category><![CDATA[DDMAC]]></category>
		<category><![CDATA[DIA]]></category>
		<category><![CDATA[Tom Abrams]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2796</guid>
		<description><![CDATA[Tom Abrams, director of FDA’s Division (soon to be Office) of Drug Marketing, Advertising &#38; Communications (DDMAC), said that publishing social media guidelines for industry is the division’s “highest priority,” and that the document will be “published as soon as it’s vetted.”
Abram&#8217;s comments, made during a panel this morning at the Drug Information Association’s (DIA) annual meeting [...]]]></description>
			<content:encoded><![CDATA[<p><img class="alignleft size-full wp-image-2798" title="Tom Abrams" src="http://blog.pharmexec.com/wp-content/uploads/2011/06/Tom-Abrams.jpg" alt="DDMAC Director Tom Abrams" />Tom Abrams, director of FDA’s Division (soon to be Office) of Drug Marketing, Advertising &amp; Communications (DDMAC), said that publishing social media guidelines for industry is the division’s “highest priority,” and that the document will be “published as soon as it’s vetted.”<span id="more-2796"></span></p>
<p>Abram&#8217;s comments, made during a panel this morning at the Drug Information Association’s (DIA) annual meeting in Chicago, prompted audience members to probe Abrams, and his <a href="http://www.fda.gov/AboutFDA/CentersOffices/CBER/default.htm">CBER</a> colleague Lisa Stockbridge, branch chief of the Advertising and Promotional Labeling Branch, about specific policies governing online promotion. One audience member wondered whether unbranded, educational campaigns online could link to branded sites, or if that kind of activity would generate an enforcement letter. Abrams responded that his own question, in that instance, would be, “Why are you linking to a brand site?&#8221; if a campaign is designed specifically to educate about a disease, as opposed to a branded campaign designed to sell a product. When pressed, he said an educational or awareness campaign – which isn’t required to present risk information, since no drug is being promoted – linking to a brand site would “have to be considered on a case by case basis.” Industry has been browbeating DDMAC about issuing social media guidelines <a href="http://blog.pharmexec.com/2009/06/23/live-from-dia-fda-warning-letters-stir-more-questions-than-answers/">for years</a>.</p>
<p>On FDA’s Bad Ad program, one audience member asked what sort of proof would be required to verify improper promotion by a sales rep, given that a discussion between a rep and a physician would likely be verbal and unrecorded. Abrams said that an extensive review of the complaint would happen before moving forward, and then a signed affidavit from the physician, testifying to what was said during a sales meeting, would most likely be required. John Kamp, executive director at the Coalition for Healthcare Communications, and moderator of the panel, wondered aloud about whether a sales rep making hundreds of calls a week would be able to recall exactly what was said during a specific detail. “Couldn’t a sales rep say, ‘I don’t remember what I said, but my training and common response in this situation would be X.’ Would that kind of [defense] fly?” asked Kamp. Abrams didn’t answer the question directly, but insisted that DDMAC was diligent in investigating complaints, and the circumstances surrounding a potentially illicit conversation.</p>
<p>Abrams also discussed a proposed update to Section 502(n) of the Federal Food Drug and Cosmetic Act (FDCA) dealing with “clear, conspicuous, and neutral” major statements, or legally-mandated statements on major risks associated with a given drug. The <a href="http://www.kslaw.com/Library/publication/ca033110.pdf">update</a> was announced in March of last year, and deals with DTC advertising, specifically television and radio, said Abrams. One of the four proposals put forward by DDMAC would require that an “advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of a major statement.” Anyone who has seen a drug ad on television will recognize the target of this proposal; the last seconds of a DTC ad are typically used for a voiceover announcing a drug’s “major” risks, while simultaneously providing unrelated images associated with the actors or visual narrative of the commercial.</p>
<p>DDMAC is in the process of being elevated from a division to an office, a process that is “slow even by government standards,” joked Abrams. The new office will be separated into two divisions, healthcare professional and consumer, he said.</p>
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		<title>Gift Giving Must Stop Says ProPublica</title>
		<link>http://blog.pharmexec.com/2011/05/09/propublica-says-gift-giving-must-stop/</link>
		<comments>http://blog.pharmexec.com/2011/05/09/propublica-says-gift-giving-must-stop/#comments</comments>
		<pubDate>Mon, 09 May 2011 12:48:19 +0000</pubDate>
		<dc:creator>Jennifer Ringler</dc:creator>
				<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[physicians]]></category>
		<category><![CDATA[ProPublica]]></category>
		<category><![CDATA[Sunshine Act]]></category>
		<category><![CDATA[transparency]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2609</guid>
		<description><![CDATA[According to ProPublica—though transparency has seemingly increased between pharma and physicians since the Christmastime release of its Dollars for Docs report—medical societies and organizations are still having a holiday with industry money.
Three days before Christmas last year, independent news organization ProPublica released its own “naughty and nice” list in the form of its Dollars for [...]]]></description>
			<content:encoded><![CDATA[<p><em>According to ProPublica—though transparency has seemingly increased between pharma and physicians since the Christmastime release of its Dollars for Docs report—medical societies and organizations are still having a holiday with industry money.</em></p>
<p>Three days before Christmas last year, independent news organization ProPublica released its own “naughty and nice” list in the form of its <a href="http://projects.propublica.org/docdollars/">Dollars for Docs</a> report, which compiled disclosure lists from eight pharma companies, shedding light on payments given to physicians for promoting certain branded medication. The report ignited a bit of hoopla among industry and the public.</p>
<p>Since then, the Sunshine Act (an arm of the Affordable Care Act) has been chugging along toward its goals of improving transparency and limiting “gifts” to physicians, with the Department of Health and Human Services charged with implementing regulations by October 2011 to clarify which companies will have to report what specific information, and to whom.</p>
<p>However, a <a href="http://www.usatoday.com/money/industries/health/2011-05-05-medical-societies-sell-access-to-manufacturers_n.htm">new ProPublica report</a> by Charles Ornstein and Tracy Weber, co-published with USA Today, makes the claim that pharma payoffs don’t end with docs.</p>
<p>According to the report, medical societies that represent groups of experts, such as the Heart Rhythm Society (HRS). allow (and encourage) drug and medical device manufacturers to promote their products to members at conferences and similar meetings and opportunities—for a fee. HRS is one of many “professional associations and groups that promote disease awareness and research,” says the report, and many such organizations allow sponsors—the drug and medical device companies who help pay for their events—to pitch and promote to members.</p>
<p>ProPublica bristled at the advertisement smorgasbord evident at the recent HRS conference full of cardiologists in San Francisco. Ads “adorn every hotel key card … are splashed on busses, banners, and the stairs underfoot. Logos splay across shuttle bus headrests, carpets, and cellphone-charging stations,” says the report. According to ProPublica, HRS “sold access to its members and their purchasing power,” accepting money from pharma and med tech companies in exchange for the power to promote to such an ideal target audience.</p>
<p>But for the HRS and similar research, patient advocate, and non-profit organizations, allowing sponsors to promote products is just a way of doing business—perhaps even the way they stay afloat. “Officials of the Heart Rhythm Society say industry money does not buy influence and is essential to developing new treatments,” recounts the report. Dr. Bruce Wilkoff, incoming HRS president, told ProPublica, “This is our business. We either get out of the business or we manage these relationships. That’s what we’ve chosen to do.”</p>
<p>Call it shameless promotion or kickbacks or a necessary part of sponsor-organization relations—whatever you call it, ProPublica will continue to make sure that the financial relationship between pharma and other healthcare industry players is fully transparent to all stakeholders—including the public.</p>
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		<title>Fighting Cancer &#8212; A Checklist of Change</title>
		<link>http://blog.pharmexec.com/2011/02/01/fighting-cancer-%e2%80%94-a-checklist-of-change/</link>
		<comments>http://blog.pharmexec.com/2011/02/01/fighting-cancer-%e2%80%94-a-checklist-of-change/#comments</comments>
		<pubDate>Tue, 01 Feb 2011 09:42:22 +0000</pubDate>
		<dc:creator>William Looney</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Global]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Regulatory]]></category>
		<category><![CDATA[Safety]]></category>
		<category><![CDATA[healthcare]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2310</guid>
		<description><![CDATA[Payer and regulatory pressures are likely to take some steam off of heady projections of market growth in this sensitive therapeutic area.
Against a backdrop of new figures detailing the mounting cost of fighting cancer, Pharm Exec’s sister CBI conference unit held its annual meeting — co-chaired by Alison Ayers of Pfizer and Ben Steinmetz of [...]]]></description>
			<content:encoded><![CDATA[<p><em>Payer and regulatory pressures are likely to take some steam off of heady projections of market growth in this sensitive therapeutic area.</em></p>
<p>Against a backdrop of new figures detailing the mounting cost of fighting cancer, Pharm Exec’s sister CBI conference unit held its annual meeting — co-chaired by Alison Ayers of Pfizer and Ben Steinmetz of GSK — on trends in price, reimbursement and access to oncologics in Philadelphia on January 20-21. Here are a few highlights: <span id="more-2310"></span></p>
<p>o    Latest data from the National Cancer Institute [NCI] published last month project that the US will spend $173 billion to treat cancer in 2020 – a 39 per cent increase over 2010.  New technologies will drive the bulk of these costs, with treating breast and prostate cancer rising the highest due to the positive impact of these new tools in prolonging survival among patients. Participants questioned some of the assumptions behind the spending projection, noting that growing resistance among payers to pricing of cancer medicines had not been factored in.</p>
<p>o    The era where pricing and access were simply left to the discretion of the manufacturer is over. The major precedent cited is the CMS National Coverage Assessment for the anti-cancer vaccine Provenge. The NCA discourages traditional options in pursuing broad off-label use; guidelines and other access control methods will foster strict observance to the label indication alone.   In addition, risk-based contracting is starting to take root here in the US, with the private-sector [US Oncology] taking the lead.</p>
<p>o    Regulatory hurdles are mounting and the climate for reimbursement and access long-term is unpredictable. The recent FDA decision  involving withdrawal of a marketing license for Avastin as first-line treatment for breast cancer indicates that for many future cancer therapies “fast track” approval will only mean contingent approval.  The prospect of a periodic, rolling process in maintaining license rights means that more monies must be invested in “robust data” which in cancer will mean clear evidence of an increase in overall survival rates, compared to existing therapies.   The content of related REMS commitments will also assume far more importance – getting the right terms that work for clinicians and patients as well as the patent holder will be critical to success.</p>
<p>o    The Avastin case is not an exception – increasingly it will be the rule. According to CBI conference speaker Carol Marchione, some 5 other cancer drugs now on the agenda at the next FDA Oncology Drug Advisory Committee on February 8 are going to face evaluation using similar parameters and thus could confront restricted indications going forward.</p>
<p>o    Companion diagnostic and assays that link cancer drugs to personalized therapy is no panacea to the cost challenge.   Although Roche has broken some ground in this area, several speakers emphasized their utility remains “largely unvalidated, “ not only by the industry itself but especially by regulators.  The FDA has not defined a pathway that is clear on how clinicians – let alone payers – should use such tests and a consensus on this among stakeholders is “at least ten years off.”  There is also the prickly issue of the adequacy of tissue samples required to conduct the tests and the consistency of standards that can validate them.  In the interim, diagnostics are likely to serve only as an adjunct that in some cases can strengthen the value proposition – but is that enough the justify the expense?</p>
<p>o    An issue the industry must focus on is the absence of good comparative, cross-market information on the incidence of cancer in key emerging markets.  The Globocon database administered by the Lyons-based International Agency for Research on Cancer [IARC] is acknowledged as sketchy and riddled with gaps and inaccuracies.  Until the information base improves, drug companies are forgoing opportunities for real market growth in these countries because the public health implications of improved cancer treatment cannot be quantified.  It also complicates pricing decisions in markets where there is a diverse payer base that needs to be segmented to maximize ROI.</p>
<p>o    A panel of payers was asked what they thought should be the drivers of good pricing practices three to five years from now.  Their wish list?</p>
<p>1.    Better evidence from industry on which drugs really work, particularly in moderating the huge hidden costs of side-effects.</p>
<p>2.    More consistent and widespread application of clinical practice guidelines that require use on the basis of the official label indication.</p>
<p>3.    Improvements in randomized clinical trial design, with end points centered on demonstrating real improvement in overall cancer survival rates.<br />
4.    Efficient ways to track and capture pharmacy utilization, at the point of purchase, in turn reducing reliance on high-overhead claims brokering and prior authorization activities.</p>
<p>5.    As the pipeline for cancer drugs moves more toward oral agents, effectively managing the supply chain to reduce the perverse incentives around fixed co-pays and “pill filling” not linked to patient needs.</p>
<p>6.    Defining a societal consensus on managing end of life issues.</p>
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		<title>Pharma Gets the ProPublica Treatment</title>
		<link>http://blog.pharmexec.com/2010/10/27/pharma-gets-the-propublica-treatment/</link>
		<comments>http://blog.pharmexec.com/2010/10/27/pharma-gets-the-propublica-treatment/#comments</comments>
		<pubDate>Wed, 27 Oct 2010 09:14:46 +0000</pubDate>
		<dc:creator>Walter Armstrong</dc:creator>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[Legal]]></category>
		<category><![CDATA[Medical Education]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[compliance]]></category>
		<category><![CDATA[doctor payments]]></category>
		<category><![CDATA[ethics]]></category>
		<category><![CDATA[Pharma]]></category>
		<category><![CDATA[transparency]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=2050</guid>
		<description><![CDATA[Alternative news organization and media allies investigate the industry’s payments to doctors—launching a fresh assault on the ethical status quo.
By Walter Armstrong
Last week, Big Pharma’s practice of paying doctors to do medical education, promote its products, or both was the focus of a multimedia blitz launched by ProPublica in collaboration with National Public Radio, the [...]]]></description>
			<content:encoded><![CDATA[<p><em>Alternative news organization and media allies investigate the industry’s payments to doctors—launching a fresh assault on the ethical status quo.<br />
By Walter Armstrong</em></p>
<p>Last week, Big Pharma’s practice of paying doctors to do medical education, promote its products, or both was the focus of a multimedia blitz launched by ProPublica in collaboration with National Public Radio, the PBS Nightly Business Report, the Chicago Tribune, the Boston Globe, and Consumer Reports. In what must be seen as a wake-up call for the industry on its handling of compliance issues, each of these major media outlets ran its own major story raising questions about the ethics of paying physicians to help increase sales of medicines. Whether the avalanche of data and juicy anecdotes of physician behavior found in ProPublica’s “Dollars for Docs” report actually answered any of those questions l depends on your point of view.</p>
<p><span id="more-2050"></span>That pharma sales strategies can encompass elements of fraud, kickbacks, and other funny-money exchanges isn’t exactly news. Billion-dollar settlements with the Department of Justice have become so ho-hum over the past decade that the chorus of threats of criminal prosecutions of drug-company executives by officials at Justice, HHS, and FDA is reaching almost credible levels. What is news—and ProPublica’s new contribution to the debate—is the searchable database for consumers containing the names of some 17,700 US doctors and other practitioners who raked in a total of $257.8 million in pharma payments since mid-2009, a considerable technological feat (aided by Google Refiner) given the mix and sloppiness of the data. The list remains far from complete—it records the fees for speaking, consulting, researching, or related activities paid to doctors by only seven of the top pharma firms: Pfizer, Glaxo, Merck, J&amp;J, AstraZeneca, Lilly, and Cephalon. Of the seven, only Merck and Glaxo volunteered the info; ProPublica got the rest from disclosures the other five companies were forced to make as a condition of false-claims and other settlements.</p>
<p>The sharing of its database with other news organizations (and ultimately the public) is central to ProPublica’s alternative business model. The nonprofit Internet news organization’s mission is public-interest investigative journalism—a resource-consuming enterprise increasingly viewed as nonessential by an industry in financial free-fall. Since its launch in mid-2008, the group has earned its credibility, winning many of the nation’s top journalism awards, including a Pulitzer last year for investigative reporting. It counts among its funders the Gates, MacArthur, and Ford foundations; its newsroom is led and staffed by veteran editors and reporters from the New York Times and the Wall Street Journal. By lending its pharma-physician database to other national and local news outlets—and orchestrating a simultaneous delivery—ProPublica ensured that it got maximum bang for its investigative buck. And the investigations into the pharma industry’s financial ties continue this week with a report based on research into its payments to lobbyists and to political campaigns.</p>
<p>In the week since the stories broke, many lines of debate have developed among readers, including physicians, sales reps, patients, and pharma analysts. There is the usual shouting match between the pro- and anti-pharma lobbies, but the conclusions that emerge from ProPublica’s analysis are based on data that has been independently sourced from credible third parties.  ProPublica’s analysis contradicts a  few of the pharma industry’s most frequent justifications for the practice of putting the very professionals who write prescriptions for its products on its own payroll.</p>
<p>Contrary to drug makers’ claim that they only hire thought leaders and other top specialists to move their message, the sheer volume of names in the database indicates this contingency is broadly framed. Among the 384 doctors who earned $100,000 or more during this period, more than one in nine had no board certification in any specialty at all. A search of physician licensing records in 18 states found that more than 250 doctors who accepted speaker fees, including some very high earners, had been sanctioned for misconduct, not surprisingly including inappropriately prescribing drugs. More than 40 got slapped by the FDA for research wrongs, lost hospital privileges, or had criminal convictions, while at least 20 others had two or more malpractice judgments or settlements.</p>
<p>These numbers inevitably give rise to some unsettling questions. For example, why is pharma paying anything at all to doctors who have been sanctioned for professional misbehavior?</p>
<p>When asked if background checks are done on doctors, only Cephalon and J&amp;J said that they review state websites. Nevertheless, ProPublica data base shows that one physician accused of sexual misconduct with female patients was Cephalon’s  third-highest-paid speaker in 2009.</p>
<p>Critics of the ProPublica presentation, including healthcare journalists, point out that the accounting was incomplete, even unfair, because it failed to put the final tally in perspective. Most notably, only 1.5 percent of doctors on company pay  had been sanctioned, while the average payment to a physician came to $15,000, not exactly small potatoes but not necessarily an amount worth risking your reputation over. But at the same time, in a survey by Consumer Reports that accompanied its own reporting, about half of all Americans said that they would be concerned about the quality of care from a doctor who took even as little as $500 from pharma.</p>
<p>According to Medscape, pharma paid more psychiatrists than any other specialists—they also had the highest number in the $100,000-plus club, 116 out of 384. This frequency may be explained by the fact antipsychotics topped the 2009 list of best-selling drugs, while antidepressants came in at no. 4. In addition, the off-label use of these drugs is among the highest for any category.</p>
<p>Neither ProPublica nor any of the other news organizations reports in significant detail about the content of the speaking or consulting or researching for which pharma is paying these many thousands of doctors. While PhRMA reps and many physicians have been quick to point out that all materials must strictly conform to the product label and are regulated by FDA and other agencies, it’s an open secret that many of the scripts and slides that doctors rely on are produced by agencies paid by drugmakers and never vetted by any official. Companies invest in such information in order to reach as many prescribers as possible with a message about a brand-name drug that is as positive as possible. Whether you call this medical education or product promotion is beside the point. ]</p>
<p>Starting in 2013, the new US healthcare reform law requires all drugmakers to publicly disclose the amount and date of every physician payment, the name and address of the physician, and the drug or device that the doctor helped promote. This is should help build confidence in the integrity and accuracy of the data, which some experts have questioned as leading to extreme conclusions when accessed by investigative journalists.   Until then, the ProPublica-based media blitz will continue to spark controversy and conversation over the ethics of industry practices.</p>
<p>To their credit, both Lilly and GSK responded to the ProPublica revelations that the companies had sanctioned doctors on their payroll by launching their own investigations. In a statement, GSK said “we do have criteria in place to evaluate potential speakers.  However, ProPublic has raised issues to our attention that we are investigating further. We will also use this information as we continue to improve the processes by which our speakers are evaluated.”  Likewise, Lilly noted that “reporting by ProPublica and other media outlets has raised valid and important questions about some of our processes, which we take seriously.” And over the past week, all seven of the drugmakers featured in the stories have commented on the reporting. The PBS Nightly Business Report has posted these responses on its website.  Hence the debate continues—and soomer rather than later, expect the investigations to spread to practices in other countries led by renewed regulator interest in provisions of the 1977 Foreign Corrupt Practices Act.</p>
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		<title>The Truth About Closed-Loop Marketing</title>
		<link>http://blog.pharmexec.com/2008/09/12/the-truth-about-closed-loop/</link>
		<comments>http://blog.pharmexec.com/2008/09/12/the-truth-about-closed-loop/#comments</comments>
		<pubDate>Fri, 12 Sep 2008 20:12:10 +0000</pubDate>
		<dc:creator>Brittany Agro</dc:creator>
				<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Sales]]></category>
		<category><![CDATA[AstraZeneca]]></category>
		<category><![CDATA[AZ]]></category>
		<category><![CDATA[Center for Business Intelligence]]></category>
		<category><![CDATA[closed-loop promotion]]></category>
		<category><![CDATA[conference]]></category>
		<category><![CDATA[e-detailing]]></category>
		<category><![CDATA[Matt Pammer]]></category>
		<category><![CDATA[sales force]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/?p=200</guid>
		<description><![CDATA[Pharma sales forces were out, well, in force for a two-day leadership summit put on by the Center for Business Intelligence this week in Philadelphia. As a newbie on the pharma reporting scene, I eagerly await these conference opportunitiesâ€¦especially the ones that deal with important sales management topics. This conference, in particular, presented sessions on [...]]]></description>
			<content:encoded><![CDATA[<p>Pharma sales forces were out, well, in force for a two-day leadership summit put on by the <a href="http://www.cbinet.com">Center for Business Intelligence</a> this week in Philadelphia. As a newbie on the pharma reporting scene, I eagerly await these conference opportunitiesâ€¦especially the ones that deal with important sales management topics. This conference, in particular, presented sessions on just about every topic under the sales force sunâ€”from cool new ways to reach physicians to interactive detailing and closed-loop promotion. In particular, I appreciated Matt Pammerâ€™s presentation on examining the benefits and challenges of a rep-facilitated e-detailing program, and how it can complement a sales force strategy.<span id="more-200"></span></p>
<p>Pammer, executive director, IS client engagement for <a href="http://www.astrazeneca.com">AstraZeneca</a>, led a one-hour session that not only defined closed-loop marketing for me (finally!), but also provided a rundown of six keys for successful promotion:</p>
<p>1.    Focus on digital content development. In other words, work closely with advertising agencies to identify what capabilities are appropriate for your brand. You donâ€™t want anything in your ad taking away relative information from the consumer; thereâ€™s â€œno value to the discussionâ€ if that occurs.<br />
2.    Speed the content-approval process. Ongoing education of key stakeholders is crucial. Pammer confidently admitted that AstraZeneca should have taken a more modular approach at the beginning.<br />
3.    Create and sustain marketing ownership. If you find problems flaring up in your marketing programs, take a step back and identify accountabilities.<br />
4.    Encourage sales engagement. To put it the Pammer way: â€œTame the big brother fear.â€ Itâ€™s understandable that you canâ€™t tell reps a specific way to sell. Instead, focus on usage and donâ€™t short-circuit the training either. Training technology is reinforcement.<br />
5.    Integrate and focus on technologies. There is no such thing as an â€œinsignificantâ€ change with technology.<br />
6.    Practice organization-wide investment support. Itâ€™s not cheap but itâ€™s measurable and will pave the way for future sales force technologies to follow. With the right hardware, CLP can do its job!</p>
<p>The future of closed-loop marketing is here. AstraZeneca has employed it for five years, and has reaped the benefits. By exploring trends with these capabilities in the marketplace, sales reps can produce similar results.</p>
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		<title>High-Tech Name Tags &#40;and More&#41; From re&#58;think08</title>
		<link>http://blog.pharmexec.com/2008/08/26/high-tech-name-tags-and-more-from-rethink08/</link>
		<comments>http://blog.pharmexec.com/2008/08/26/high-tech-name-tags-and-more-from-rethink08/#comments</comments>
		<pubDate>Tue, 26 Aug 2008 17:55:53 +0000</pubDate>
		<dc:creator>Brittany Agro</dc:creator>
				<category><![CDATA[Deals]]></category>
		<category><![CDATA[Meetings]]></category>
		<category><![CDATA[Strategy]]></category>
		<category><![CDATA[Technology]]></category>
		<category><![CDATA[Behance]]></category>
		<category><![CDATA[Chuck Martin]]></category>
		<category><![CDATA[Impact Unlimited]]></category>
		<category><![CDATA[ReThink]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/2008/08/26/high-tech-name-tags-and-more-from-rethink08/</guid>
		<description><![CDATA[Call me old-fashioned, but the one low-tech item I never expected to see threatened with extinction was the humble but indispensable business card. After Last Thursdayâ€™s re:think08, the fifth edition of the seminar on event marketing and team building put on by the communications company Impact Unlimited, Iâ€™m not so sure. The event had some [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: left;"><img class="size-medium wp-image-157" title="impact" src="http://blog.pharmexec.com/wp-content/uploads/impact.png" alt="Impact" width="201" height="50" align="right" />Call me old-fashioned, but the one low-tech item I never expected to see threatened with extinction was the humble but indispensable business card. After Last Thursdayâ€™s re:think08, the fifth edition of the seminar on event marketing and team building put on by the communications company <a href="http://www.impactunlimited.com">Impact Unlimited, </a>Iâ€™m not so sure. The event had some terrific speakers and ideas (more about them in a minute), but my top takeaway was  . . . the name tags.</p>
<p style="text-align: left;">Not just any name tags, of course, but nifty high-tech numbers called <a href="http://www.ntag.com/flash/demo/demo.htm">nTAGs</a> that let participants automatically swap contact info, plus data about interests and skills,<span id="more-156"></span> simply by pointing their badge at another personâ€™s badge.  The tags also track who meets who and generate statistics that can be used to improve meetings. For example, at this meeting 1,258 cards were exchanged among 119 attendees for an average of 10.6 per attendee. The top networkers in the group met 60-65 people, which means that they interacted with 50 percent of the attendees! (For examples of what you can do with this sort of numbers, see nTAG inventor Rick Borovoyâ€™s fascinating <a href="http://rick.ntag.com/">blog</a>.)</p>
<p style="text-align: left;">As for those speakers, the most invigorating was Scott Belsky, founder and CEO of <a href="http://www.behance.com">Behance</a>, who offered more than 20 tips on how to â€œmake ideas happen.â€ Belsky believes there are too many ideas in the world and not enough action. He argues against e-mail, for nagging, and he says you can never consider a task delegated until the person you delegate it to actually accepts it. At re:think he emphasized the importance of actually capturing incoming good ideas: Be sure you talk last, so you donâ€™t silence the people who work for you, he suggested. And remember that ideas come in at hectic moments; have a system for recording them. (For more Belsky tips, look <a href="http://www.behancemag.com/Tip-10-Realizations-For-Productivity-_-Making-Ideas-Happen/5745">here</a>.)</p>
<p style="text-align: left;">If Belsky was about process, Chuck Martin, author of <a href="http://www.amazon.com/Smarts-Are-We-Hardwired-Success/dp/0814409067/ref=sr_1_1?ie=UTF8&amp;s=books&amp;qid=1219774886&amp;sr=8-1">â€œSmarts: Are We Hardwired for Success?&#8221;</a> looked at behavioral skills that determine success in the workplace. His list: self-restraint, working memory, emotion control, focus, task initiation, planning/prioritization, organization, time management, defining/achieving goals, flexibility, observation, and stress tolerance. Martin is chairman and CEO of NFI Research, a firm that analyzes business and management trends. You can find a collection of his columns <a href="http://www.netfutureinstitute.com/index.php?option=com_sectionex&amp;view=category&amp;id=7&amp;Itemid=53">here,</a> including interesting pieces on the <a href="http://www.netfutureinstitute.com/index.php?option=com_content&amp;view=article&amp;id=103:talent-pool-could-be-a-new-challenge&amp;catid=126:recent-columns&amp;Itemid=53">emerging talent shortage,</a> <a href="http://www.netfutureinstitute.com/index.php?option=com_content&amp;view=article&amp;id=93:many-have-high-degree-of-stress-tolerance&amp;catid=126:recent-columns&amp;Itemid=53">stress tolerance,</a> and <a href="http://www.netfutureinstitute.com/index.php?option=com_content&amp;view=article&amp;id=100:execs-managers-need-to-take-a-vacation&amp;catid=126:recent-columns&amp;Itemid=53">why you need a vacation.</a></p>
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		<title>PRSA Day 2: Join the Conversation</title>
		<link>http://blog.pharmexec.com/2008/04/04/prsa-day-2-join-the-conversation/</link>
		<comments>http://blog.pharmexec.com/2008/04/04/prsa-day-2-join-the-conversation/#comments</comments>
		<pubDate>Fri, 04 Apr 2008 17:30:43 +0000</pubDate>
		<dc:creator>Joanna Breitstein</dc:creator>
				<category><![CDATA[E-Media]]></category>
		<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Meetings]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/2008/04/04/prsa-day-2-join-the-conversation/</guid>
		<description><![CDATA[The second dispatch from Marina Maher Communication&#8217;s healthcare guru Megan Svensen:
Itâ€™s the second day of the 19th Annual PRSA Health Academy meeting in Chicago and the morning has provided more valuable learnings.  Ed Schipul, CEO of Schipul â€“ The Web Marketing Company, gave a great analogy in his talk: He says joining the blogosphere [...]]]></description>
			<content:encoded><![CDATA[<p><em>The second dispatch from <a href="http://www.mahercomm.com/">Marina Maher Communication</a>&#8217;s healthcare guru Megan Svensen:</em></p>
<p align="left"><a href="http://blog.pharmexec.com/wp-content/uploads/2008/04/megan.jpg" title="Megan Svenson"><img src="http://blog.pharmexec.com/wp-content/uploads/2008/04/megan.thumbnail.jpg" alt="Megan Svenson" align="left" height="168" width="115" /></a>Itâ€™s the second day of the 19th Annual <a href="http://www.prsa.org/">PRSA</a> Health Academy meeting in Chicago and the morning has provided more valuable learnings.  Ed Schipul, CEO of <a href="http://www.schipul.com/">Schipul â€“ The Web Marketing Company</a>, gave a great analogy in his talk: He says joining the blogosphere after a crisis is like saying â€œI didnâ€™t kill himâ€ as you stand over a dead body. And working in pharma, we know, eventually, there will be a crisis.</p>
<p align="left">Iâ€™ve been having quite a few conversations with my pharma clients and friends about how best to join the conversation.  Many of us are doing that through vehicles that allow us more control (and therefore less risk) over the content â€“ like podcasts and e-newsletters.<span id="more-107"></span></p>
<p align="left"><img src="http://blog.pharmexec.com/wp-content/uploads/2008/04/prsathumbnail1.thumbnail.png" alt="prsathumbnail1.png" align="right" />But engaging in the blogosphere requires a dialogueâ€¦not a monologue.  As Ed mentioned in his presentation, you donâ€™t initiate a conversation by starting to lecture at someone. You canâ€™t control them or tell them to shut up.  Itâ€™s scary, but we know ignoring it isnâ€™t making it go away.</p>
<p>PR is about managing relationships â€“ with media, advocates, patients, KOLs.  I believe we need to do a better job of helping our pharma clients figure out how to initiate â€“ and then as importantly â€“ maintain an ongoing dialogue online.</p>
<p>Ed referred to PR people as Word Nerds â€“ writing in complete sentences and long paragraphs. (Loved that!) In our ever-changing communications world, weâ€™ve got to adopt â€“ and help our marketing and public affairs clients embrace â€“ the need to evolve our communication to tell better stories in the short, clear language of the social sphere.</p>
<p>Finally, we need to recognize that online communication isnâ€™t just about our words.  Visuals â€“ whether photos, graphics or video â€“ are equally important in telling an online story to consumers, physicians, legislators and everyone else we are trying to reach.  Ed said that if you canâ€™t give a visual, than you just donâ€™t care.</p>
<p>Tell me, do you?</p>
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		<title>PRSA Day 1: Talking&#8217; Cross Gen</title>
		<link>http://blog.pharmexec.com/2008/04/04/prsa-day-1-talking-cross-gen/</link>
		<comments>http://blog.pharmexec.com/2008/04/04/prsa-day-1-talking-cross-gen/#comments</comments>
		<pubDate>Fri, 04 Apr 2008 14:02:56 +0000</pubDate>
		<dc:creator>Joanna Breitstein</dc:creator>
				<category><![CDATA[Marketing]]></category>
		<category><![CDATA[Meetings]]></category>

		<guid isPermaLink="false">http://blog.pharmexec.com/2008/04/04/prsa-day-1-talking-cross-gen/</guid>
		<description><![CDATA[The discussions over the next model for pharma fall all over the map, but include one central component: a conversation with consumers. How to do it? Here, Megan Svensen, executive vice president of healthcare for Marina Maher Communications, reports in from the annual Public Relations Society of America boot camp on healthcare.
I&#8217;m coming to you [...]]]></description>
			<content:encoded><![CDATA[<p><img src="http://blog.pharmexec.com/wp-content/uploads/2008/04/prsa.thumbnail.png" alt="PRSA" align="right" /><em>The discussions over the next model for pharma fall all over the map, but include one central component: a conversation with consumers. How to do it? Here, Megan Svensen, executive vice president of healthcare for Marina Maher Communications, reports in from the annual Public Relations Society of America boot camp on healthcare.</em></p>
<p>I&#8217;m coming to you from the 19th Annual PRSA Health Academy meeting in Chicago. The topic this year is Health Care Communications Strategy: Boomers, Xers and Nexters&#8230;Communicating in a Cross-Generational/Cross-Cultural Landscape. The day began with a talk by Jane Brody, the &#8220;holy grail&#8221; of health columnists. She started off by talking about how we as PR communicators are vital to the health of the nation. I must say, it was nice of someone to notice.</p>
<p>Among her topics she talked about the need for complianceâ€”the &#8220;holy grail&#8221; of pharma execs everywhereâ€”and how we need to do a better job communicating why consumers should stay on treatment. It was the one message about how to lower our country&#8217;s healthcare costs that may be palatable to conservative industry colleagues.<span id="more-105"></span></p>
<p>And when I combine what Jane had to say with comments from a panel of communications directors from Chicago-based associations, the message I heard loud and clear is we must win back the public&#8217;s trust. But how do we do that in pharma when we keep shooting ourselves in the foot? Several of the associations on the panel took pride in the fact that they do not work with industry. While it hurts their bottom line, they felt it that was a small price to pay for credibility. Ouch!</p>
<p>Looking for solutions, I attended a session and then presented another on marketing to Baby Boomers. In looking at what information sources Boomers consider valuable, one of the presenters made the point that contentâ€”particularly in health magazinesâ€”is far more valuable than advertising. I think our jobs in PR are safe for another day. But seriously, we need to create content that can help empower Boomers (and other consumers) with the information they need to control their health, wherever their starting point and whatever their end goal. More later.</p>
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