Allergan CEO David Pyott

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.

It’s hard to know whether migraine sufferers will get behind Botox as a treatment; migraine patients are notoriously allergic to doctor visits, and many go undiagnosed. But for the worst kinds of migraines, particularly those that don’t respond to triptans or currently marketed DHEs, patients will probably be willing to try just about anything. Allergan CEO David Pyott, and MAP Pharmaceuticals CEO Tim Nelson, see headroom for growth in the category.

In 2009, the migraine market slipped into a steady decline after Imitrex, the go-to member of the triptan class, lost its patent (and blockbuster sales). Many of Imitrex’s classmates – Maxalt, Amerge, Zomig, and others – will face generic competition this year, if they aren’t facing it already. That makes Botox for migraine a difficult sell – it’s for chronic migraine, firstly, and it costs exponentially more than generic Imitrex – but during a 4Q earnings call yesterday Pyott said the migraine indication is performing “better than planned.” Around 4,600 physicians have been trained to give the injection, to date, said Pyott. “The vast majority of neurologists will inject for as long as three injection cycles,” even if they’re skeptical about the drug’s efficacy for migraine,” he Pyott. He’s hoping they’ll be convinced after that.

Branded print ads for Botox migraine will launch in women’s magazines this month, and an unbranded disease awareness campaign on television “has worked – the click-through on the website is positive,” says Pyott, adding that Allergan’s internal consumer surveys have shown “a high level of satisfaction” among patients.

After an upfront payment of $60 million last February, MAP Pharmaceuticals scored a $20 milestone payment last August, when it filed Levadex with FDA. The company could receive up to $97 million more from Allergan if all goes well with the regulatory process; the PDUFA date on Levadex is March 26. Levadex, like Valeant Pharmaceuticals’ Migranal, is a DHE, but Migranal is a nasal spray, while Levadex is inhaled. The benefit with inhalation means that the drug sidesteps first pass metabolism en route to the brain – it avoids the GI tract, and potential dilution. At JP Morgan’s 30^th Annual Healthcare Conference in January, MAP CEO Tim Nelson said that Levadex “works faster, and has fewer side effects, than the triptans.” He added that 29 million scripts for migraine were written in 2008, and close to half of them were written off-label. After triptan, “41 percent of the scripts were for opioids, and 28 percent were anti-depressants,” said Nelson. MAP will hire 50 specialty sales reps if Levadex gets the FDA go-ahead, and will expand the drug into pediatrics and other neurological conditions later on, he said.

Levadex won’t compete directly with Botox for migraine; the former is for acute migraine, the latter for chronic migraine. Nelson said Allergan’s expertise in managed care, reimbursement and experience with FDA, makes it a good partner for Levadex. MAP is also looking for “a partner in Asia, and in ex-US in general,” said Nelson.

At $40 to $80, with a ceiling at $100 per dose, though, Levadex may be as tough a sell as Botox. But then again, migraine sufferers only want one thing when the pain sets in: for it to be gone.

Buck Luce is an insider in an outsider’s field – management consultancy. As global pharmaceutical sector leader, Buck Luce is responsible for overseeing strategy, thought leadership, resourcing, learning, and solutions for E&Y’s life science clients.  In the past several years, she has overseen a series of reports called Progressions that document the turbulence of the external forces buffeting the industry and argues for a radical shift in mindset, away from selling a pill to offering a broader public health solution linked to documented improvement in patient outcomes.  The message is not always welcome in big pharma circles, and it requires an outsider’s dose of moxie to sell it.  Buck Luce alludes to this work as a “conversation” – one that has to take place.

Her selection itself represents something of a departure from the norm, given that most recent awardees have come from the big pharma “C suite” of senior managers with line responsibilities.  In that sense, Buck Luce as WOTY provides further evidence of the importance that pharma now accords to those who can interpret the business to a much broader range of stakeholders.  She enjoys a reputation as a skilled communicator whose signal mission is to impart a sense of urgency to the need for transformation, not only in the formal business model but more importantly in the practical ways that companies must change to maintain ties to customers, and ultimately the patient.  All of us who have dealt with Buck Luce know that her fiercest enemy is complacency – because time is money and the time to change is now.

In addition to her role at Ernst & Young, Buck Luce is co-chair and co-founder of The Talent Innovation Task Force and currently serves on the Mayor’s Commission on Women’s Issues in New York City, where she advises on strategies and programs to make it the best large city for women to live and work. She has also serves on the Board of Directors of the New York Women’s Foundation where she has held a variety of officer positions, most recently as chair.

“Carolyn’s accomplishments span both public and private, profit and not-profit work, and her passions for making a difference in the lives of women and children shine through everything she does,” says New York Senator Kirsten Gillibrand. “At a time when I am calling for women to get off the sidelines and join a national call to action to help this country be all it can be, I am happy to hold up Carolyn as a role model for others.”

In a long-standing partnership with the HBA, Pharmaceutical Executive devotes its cover story every April to honoring the Woman of the Year with a feature highlighting her personal and professional challenges, accomplishments, and advice to others in the industry.  It will appear in our April issue, in advance of the WOTY event on May 3.

To help shape the Woman of the Year’s priorities over the next year, Pharm Exec is interested in our online readers’ take on the following: In what new ways can the HBA drive change and diversity in the industry?  Should the focus be on women or on the broader elements of building the more diverse workforce required in a globalized business?

A day on from AstraZeneca’s announcement of 7,300 job cuts, the company was still keeping the UK in suspense with regard to a breakdown of the numbers. UK staff assembled for a meeting at 10 am on Thursday, but as of lunchtime there was still no confirmation of the  numbers , with the BBC’s Business Editor Robert Peston tweeting that it was “odd” that the drugmaker was giving “no public guidance” on the UK element of the job cuts. The expected UK losses are “not huge” — the general union GMB speculates 250 to 300, all from the R&D site in Alderley Park, Macclesfield — but other sources inform me that it could be considerably more than that. Either way, added to the company’s mooted worldwide R&D cull (2200 jobs), it very much reflects the endemic crisis plaguing pharma innovation in general.

And, globally, this is a major downsizing exercise, the third restructuring effort in five years (AZ is lighter by 21,600 global staff than it was in 2007). It also exacerbates the blow to UK R&D dealt by Pfizer’s announced closure of its Sandwich facility, just over a year ago to the day. And, coming just a day after disgraced former Royal Bank of Scotland boss Sir Fred Goodwin was belatedly stripped of his knighthood for leading RBS into financial collapse, some UK pharma bosses may be feeling a twinge of panic in light of the Royal Society of Chemistry’s Professor David Phillips’ reaction to the news: “There has to be some element of state intervention at this stage.” A few Twitter commentators wondered aloud about the former AZ head Sir Tom McKillop losing his knighthood too. Their tongues were firmly in their cheeks, but there is no getting away from the fact that this was a dark day for UK pharma.

By Marylyn Donahue, Special Projects Editor, Pharmaceutical Executive

The Patriots of biotechs is how researcher and analyst and researcher Jessica King Holden thinks of Boston’s Biogen Idec (the oldest and largest biotech in the world).

“It may have taken some hits, but it always seems to manage to come back in the end, though it might not be pretty,” says Holden. “Somehow the group takes setbacks and turns them into positives.”

The company’s new coach, I mean CEO and director, George A. Scangos, who took over almost a year ago lost no time in restructuring the pipeline, putting in his own team of top managers, and injecting his own personal brand of enthusiasm to play in an organization that was, in his words, moving too slowly and too cautiously. He is also seems blessed with of good timing.

The news last Friday was that Biogen Idec with its partner Elan Corp. won FDA approval for a label change on its controversial multiple-sclerosis drug Tysabri. Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change.  Tysabi was issued a safety recall in 2005 due to three cases of the deadly brain infection Progressive Multifocal Leukooenchepalopathy (PML) in patients taking the drug.

But wait: Can Biogen Idec now be reaping the benefits from even a side effect (how’s that for a spectacular field play?)? Tysabri, an immunosuppressant, may well lead to PML in patients who have dormant JC Virus in the brain. By testing for JC antibodies, patients can now be screened for risk of PML allowing for a wider use of Tysabri. A new test marketed by Quest Diagnostics (DGX) and developed by Biogen Idec and Elan, called Statify JCV, can test for the antibody associated with exposure to the JC Virus. If patients test positive for JC Virus antibodies, risk for PML is increased.

For the many patients then who will test negative for the antibodies, an avenue for Tysabri treatment will be open. To date, 201 cases of PML in nearly 100,000 patients taking the drug had been reported worldwide. Before Statify JCV, determining risk of developing PML in patients was not possible.

Sales of the drug, which annually produces between $1-2 billion worldwide, may double in light of the label change, according to Holden. (See Holden’s analysis here). Biogen Idec’s good news was compounded on the same day that Novartis’ announced its competing oral MS drug, Gilenya, is being investigated for potentially causing heart problems after 11 deaths had been reported in Europe. Shares of Novartis fell nearly 4% on the news.

“Novartis’ stumble also could be Biogen Idec’s benefit, as it has seemingly navigated past its own roadblock with even more in potential profits,” says Holden.

Belichick, I mean CEO Scangos’s, blessed timing was further display last October when Biogen Idec’s own oral drug MS, BG-12,  (in Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis) sparked excitement at a MS conference in Amsterdam  and quickly boosted the drug to stardom. (The big point in with these competing MS drugs is that both Novartis’s Gilenya and Biogen Idec’s BG-12 are drugs administered orally. The three older and proven existing drugs (along with Tysabi) have to be injected by the patients themselves.

Recently Citeline, an Information business unit, and the world’s leading research authority on pharmaceutical clinical trials reviewed the results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference held in Amsterdam.

The results from the CONFIRM study showed that BG-12 beat Teva’s Copaxone, which reduced the ARR by only 29 percent (p< 0.02) compared with placebo at two years.

Copaxon (the leading one of three older existing  MS drugs that have  dominated the therapeutic space for year has to be injected daily).

“With two robust and positive pivotal clinical trials that exposed BG-12 to over 2,600 patients, the drug is well positioned as a top MS therapy of choice and a formidable competitor to Gilenya from Novartis, which gained FDA approval in September 2010,” said  Dr. Heidi Chen from Citeline

And now With Gilenya’s troubles there’s an even clearer path to a touch down and market hold.

CEO Scangos might well be sporting one of Belichick’s famous hoodies this weekend as he basks in his own first year triumph in bringing his company to victory.

By Lisa Henderson, Editor-in-Chief, Applied Clinical Trials.

In December 2011, the President’s Bioethics Commission released its “Moral Science: Protecting Participants in Human Subjects Research“. The report was ordered by President Obama following an October 2010 revelation that the US Public Health Service supported unethical research in Guatemala from 1946 to 1948 that involved intentionally exposing thousands of Guatemalans to sexually transmitted diseases without their consent.

The Bioethics Commission was then tasked to oversee a thorough fact-finding investigation into the specifics of the studies, as well as assure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

The final report, available at this link and specifies 14 changes to current practice to better protect research subjects, as well as how the government should improve the tracking its over 18 federal agencies that follow the common rule for research programs with taxpayer dollars.

So again, this is specifically for government-funded studies and you can read all the different arms that receive funds, including the CIA, but of course the largest is the NIH. One of the Commission recommendations is:

“…. each federal department or agency supporting research with human subjects maintain a core set of data for their research programs that includes the title and lead investigator of each project, the location of each study, and the amount appropriated for the research. Each office should aid the public in learning more about the government’s research efforts by developing or improving publicly available electronic systems or releasing information through a government-wide system. To support these efforts, the Commission suggested that the Office for Human Research Protections or another office should administer a central web-based portal that links to each individual department or agency system. In addition, the government should consider developing a unified federal research database, which may ultimately be more cost-effective and efficient.”

Is it me or does it not sound like the “central web-based portal” or the “unified federal research database” be clinicaltrials.gov?

While the Commission could not easily identify how many research participants were enrolled in federal research (and not all of this is drug/interventional studies), they rounded it off to about 50,000 people.

So in doing the math, I’m assuming there are well over 18 biopharmaceutical companies that are conducting privately-funded research and are required by law to input this information into the clinicaltrials.gov online web database. And when these many biopharma companies fail to comply with this rule, as many critics will publicly announce as often as possible, the biopharma industry suffers another public perception setback and a trust issue.

In the meantime, wouldn’t managing 18 separate departments be akin to managing 18 privately-funded entitites? Each with their own culture, set of employees and roles, data and technology practices, and require that it happen within a certain timeframe?

I think so. I don’t think there need be separate rules for protecting human subjects in research. Nor should there be separate ways to educate the public on how to better serve their health or medical understanding. It’s everybody’s problem, private and public.

If you ever wanted to know what health economists might do with a billion dollars, the Obama Administration’s  Patient-Centered Outcomes Research Institute [PCORI] is about to tell all:  not right down to the penny, but good enough.  The congressionally funded – but independent – group has just released a document outlining priorities that will fuel a flood of research grants by mid-year. Application of that research will carry a significant impact on the evidence stream that increasingly determines Big Pharma’s access to providers and patients.
An outgrowth of the 2009 economic stimulus package, PCORI has a key role in implementing Obama’s health reform legislation with a mandate to evaluate the “comparative clinical effectiveness” of a vast array of health interventions, from drugs, diagnostics and devices to structural programs geared to prevention or wellness.  Congress authorized $1.1 billion for this task, a figure that dwarfs what other countries currently spend on all forms of effectiveness research.  It follows that the PCORI priorities will carry influence outside the US.  And there is an even larger effect should PCORI end up enabling  research that industry has traditionally eschewed, such as head-to-head drug comparisons and broad, population-based observational studies.

PCORI’s Draft National Priorities for Research, unveiled on January 23, strikes a tentative tone.  It repeatedly states the document is unfinished, and the sub-head to the title refers to  the proposed research agenda as “version one.”  Much of the text is devoted to how PCORI intends to consult widely with a broad array of stakeholders – led by patients, care-givers and their representatives – prior to final action by the group’s governing Board, probably in April.  PCORI staff will initiate the outreach through private meetings and focus groups, but there is also an all-day, open-to-the-public consultation scheduled for February 27 near the PCORI headquarters in Washington.  The comment period on the draft continues to March 15.

The five priorities set forward in the document are also very broad and will likely be read differently by different stakeholders.  The first, comparative assessment of prevention, diagnosis and treatment options, is arguably the most important. In fact, PCORI intends to devote 40 per cent of its time and resources to this area.  The goal here is research to evaluate alternatives to designate those products and practices that produce superior patient outcomes.  Although cost is not an intended path of inquiry, PCORI does have the right under law to fix priorities that take into account “the effect on national health expenditures associated with a health care treatment.”  Hence there is some risk that activities under this priority, which focuses on new technology and product interventions, could range further afield than clinical aspects alone.

Ranking behind this are two priorities that will take another 40 per cent of the PCORI budget:  improving health care systems; and accelerating patient-centered methodological research.  In the first case, this entails examining changes in health services and infrastructure, including the impact on efficiency of changes in the way these services are delivered, and by whom.  The research in methodologies priority will support work to improve the quality and usefulness of clinical data, as well as developing standards for new forms of research like patient registries, observational studies and meta-analyses.   It is hoped these new standards will promote better decision-making around rare diseases – where, it should be noted, current treatments are quite costly, with drugs leading the way.

Some 20 per cent of resources will be spent around the two final priorities:  investigating health disparities; and communication and dissemination. The disparities agenda is politically popular and focuses on revealing areas of implicit bias in the health system, from gender and race to age and social parameters, where practice patterns differ and outcomes can suffer because of them.  Expect from this an upswing in attention to the social determinants of health.  The latter priority is geared to raising patient compliance rates with treatment, improving patient understanding of options they have in treatment and promoting better patient-clinician communication, and evaluating the promise and success of electronic health records and other new information technologies.

The patient interest is the common thread running through each priority.  Patient representatives will not only be formally consulted as specific projects are developed, they will serve on in-progress review committees and will be asked weigh in on results.

Word to the Wise..
While PCORI has taken pains to consult and to avoid stepping into the minefield of cost and “value,” industry has good reason to be wary as its ambitious work plan moves forward.   The high level of inclusiveness given to the patient community may end up politicizing the process and interfere with the integrity and robustness of the research protocols. Raising this is prudent given the level of aggressiveness that patient advocates show in rallying support for their disease.   Even with a billion dollars to spend, prioritization means that while some will be let in, others will be left out.  The temptation will be for some groups to ask Congress to intercede – few scientists or researchers, of any stripe, want that.

Likewise, PCORI’s interpretative skills will be tested if it proceeds with proposals to  “synthesize” existing studies to “create a more cohesive body of evidence.”  There will invariably be disagreements in rendering judgments from different studies and it entails the risk that important clinical decisions will proceed without acknowledgment of methodological gaps and important disease variations in the populations under study.  In fact, PCORI funding for more meta analyses in place of clinical trials raises questions of encouraging population bias, particularly as the technological capacity to expand the data set to millions of people becomes commonplace.   PCORI’s Methodological Committee has not publicly weighed in on this yet, but when it does the discussion is bound to be controversial.

In a country where mere mention of the word “rationing” spawns howls of protest, PCORI is probably right in framing any document it publishes in the vaguest possible terms.  But this may in time damage its effectiveness in facilitating superior health outcomes.  I ask:  can an organization that calls itself “patient centric” still be scientifically pure and empathy free?  In the messy politics of health care, isn’t that the same as being  tone deaf?

PCORI’s online survey to gauge reaction to the strategy document can be accessed here.

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics.

Roche, perhaps, more than any other pharmaceutical company, is banking heavily on the combination of diagnostics and drug development to drive pharmaceutical innovation. In reporting its 2010 results in February 2011, Roche reported that it had 12 new molecular entities in late-stage development, of which six were potential personalized healthcare medicines with planned companion diagnostic tests, which included Zelboraf (vemurafenib) and its companion diagnostic for BRAF mutation-positive metastatic melanoma. FDA approved Zelboraf for treating BRAF V600E mutation-positive, inoperable, or metastatic melanoma and the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche, in August 2011.

Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended that Zelboraf be granted full marketing authorization as a monotherapy for treating adult patients with BRAF V600 mutation-positive unresectable or metastatic melanom. The corresponding European Commission decision on the marketing authorization of Zelboraf is expected in February 2012. Marketing authorization submissions for Zelboraf also are under review by health authorities in Australia, New Zealand, Brazil, India, Mexico, Canada, and other countries worldwide.

Roche also is using its diagnostic strategy to support new indications for existing drugs. Last month, it reported that the cobas EGFR Mutation Test was CE-marked, an indicator of a product’s conformity with EU requirements, and is now commercially availabile in Europe and other countries that recognize the CE mark. The cobas EGFR Mutation Test is a companion diagnostic to identify patients with non-small-cell lung cancer (NSCLC) who harbor mutations in the EGFR (epidermal growth factor receptor) gene and who may benefit from treatment with anti-EGFR tyrosine kinase inhibitors, such as Roche’ Tarceva (erlotinib). Tarceva, an oral EGFR inhibitor, was first approved in September 2004 to treat locally advanced or metastatic NSCLC after failure of at least one other chemotherapy treatment. It later was approved by the European Commission in September 2011 as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR-activating mutations.

Other companies also are reporting success with certain personalized medicines. In August 2011, FDA approved Pfizer’s Xalkori (crizotinib) for treating locally advanced or metastatic NSCLC that expresses the abnormal anaplastic lymphoma kinase (ALK) as detected by an FDA-approved test. The agency approved the drug along with a diagnostic test for the ALK gene abnormality, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit. Up to 7% of those patients with NSCLC, typically patients without a history of smoking, have the gene abnormality.

Although personalized medicines will likely hold only a small part of the overall pharmaceutical market by value and volume in the near term, these successes portend of a changing paradigm in drug development.

Julian Mosquera

The pharmaceuticals industry is undergoing major disruption and every comparative benchmark indicates that the sector needs to make a step change in asset performance, with working capital targeted for direct improvement. All players are planning major reconfigurations of their supply and distribution operations, from end to end, in a bid to improve cost and service efficiency. This challenge is all the more prescient with a large number of blockbusters coming off patent over the next five years, opening the door to generic producers, who are actively “forging strategic alliances” to secure the rights to produce cheaper copies, according to researchers at Frost & Sullivan. While expenditure on new medicine has risen dramatically over the past decade, regulatory approval for new drugs has declined. Where big pharma could turn to blockbusters in the past, they are now looking to smarter portfolio management for competitive advantage.

Historical margins meant pharma paid little attention to their supply chains. However, over the last decade such complacency has become unacceptable to boards. Directors in the current environment are looking to their COOs and supply chain directors to build resilience into supply chain networks, to protect against market volatility and to drive real cost reduction.

The industry’s manufacturing footprint is increasingly challenged by significant overcapacity. Efficiency, agility and flexibility are priorities, with slow moving/low volume production calling for a different supply approach. Now, more than ever, companies should look to increase product speed through the supply chain, challenging inventory touch and holding points in every market in which they operate.
Managing the chill chain is producing real challenges for the sector. As part of a much wider traceability issue, the sector has been slow to adopt the necessary technology and levels of control that may be expected of such a high-value, sensitive product line. Reliance on third parties to introduce such capabilities has had limited success. It is time for the sector to upgrade its capabilities as the new pharma supply chains emerge over the next decade, where chill control and traceability challenges will be far more critical.

There is an opportunity for companies to better leverage scale through structural change, working towards best practices, and most notably by improving and integrating sales and operations planning — something that is commonplace in other industries such as FMCG. Competition is becoming fierce, putting emphasis onto accurate forecasting and supply chain visibility.

Supply chain cost management is now a priority. Having leveraged scale and rationalised productive capacity businesses are looking for further cost-savings. The global nature of distribution has given rise to over-complex and under-managed supply chains, which are now recognised as a source of major cost reductions. Without a clear framework for delivering these savings, businesses are at risk of compromising service and the integrity of supply.

In this context, it is alarming how few pharma businesses know with any accuracy their ‘Cost to Serve’. Which products, distribution channels, customers or regions need more attention, and which need less? How should stock holding policies be tuned to these different groups? Where can lead times or touch points be reduced? Cost to Serve allows companies to calculate the true cost of servicing any combination of customer, product or market and takes a truly end-to-end approach (materials sourcing, manufacturing, logistics, distribution and consumption). By establishing clear policies for customer-product groupings, alongside disciplined, systematic control, it is possible to realise dramatic and permanent cost reductions.

Julian Mosquera is a Director at LCP Consulting, a specialist in customer-driven supply chain management.

Responses on the value of eDetails compared with in-person details differed significantly across the four practice areas covered – family medicine, oncology, cardiovascular and allergy/immunology – and suggest that biopharmaceutical companies have an opportunity to adjust the promotional mix for stronger returns.

Over the last two years, in-person visits to oncologists decreased by 14%, but eDetails for the group only increased by 4%. Allergy/Immunology docs saw a 5% decrease in rep visits, but eDetailing grew by 8%. Still, allergy/immunology docs only received 1.8 eDetails per week, on average, but would like to see 3.3 eDetails per week, according to the survey results.

In terms of perceived value, in-person reps ranked higher across the board. However, oncologists and family medicine practitioners said they were better educated by eDetails, whereas cardiologists and allergy/immunology docs said in-person reps provided a better education.

Regardless of whether a physician prefers eDetails or traditional sales calls, the kinds of material preferences included in a detail also vary by practice area. “If you go into a cardiology detail without referencing clinical trial data, they’re going to feel like something’s missing,” says Kevin Olson, CEO at Industry Standard Research, publisher of the survey. Oncologists, on the other hand, “don’t tell us the same thing” about clinical trial data, says Olson. Oncologists (39%) cited the ability to answer product-related questions as the most important aspect of a detail, followed by the inclusion of information that is “sufficiently patient focused,” at 30%. Fifty percent of cardiologists said clinical trial data is most important.

Samples remain a critical part of the in-person detail experience, according to survey results, despite the fact that many eDetailing platforms provide an easy way to request samples. Asked what is lost when in-person details go the way of the dodo bird, Olson says that distribution of samples was “one of the biggest results,” although it’s “pretty clear in our data that physicians do receive value” from the opportunity to dialogue with a human being. Asked about some of the more surprising results of the survey, Olson says one question asked about the importance of key opinion leader (KOL) content; he was surprised to learn that it did not rank highly in comparison to other aspects of the detail.

The 130-page report, titled eDetailing vs. In-person Detailing: A head-to-head comparison of Volume, Time, Value, and Outcomes, surveyed 118 practicing U.S. physicians during the fourth quarter of 2011. Participants completed a 15-minute web-based quantitative survey.

A magazine ad for Boniva, fronted by actor Sally Field, generated the DDMAC (now the Office of Prescription Drug Promotion, or OPDP) Untitled Letter last year due to following phrase: “After one year on Boniva, 9 out of 10 women stopped and reversed their bone loss.” That didn’t jibe with the scientific data, DDMAC said in the letter, before requesting that all ads containing the phrase be removed from the campaign.

Genentech went a step further. In September of last year, the company began running corrective magazine ads addressing the overstated claim. The corrective ad states that the violative ad “may have given you the wrong impression.” It goes on to state that “Boniva has not been proven to stop and reverse bone loss in 9 out of 10 women and is not a cure for postmenopausal osteoporosis.” The corrective ads will run though April 2012.

Unlike their mild-mannered, Untitled Letter cousins, Warning Letters are considered more severe, and they typically mandate corrective ads to clear up any overstated claims or minimized risk information. Given that Genentech received the former communique and not the latter, it’s notable that the company chose to run corrective ads without a mandate.

After speaking with DDMAC about the Untitled Letter, Genentech worked with the agency to create and then “voluntarily” launch the corrective ads last September, according to Chris Vancheri, director, public affairs, at Genentech.

In a statement, Genentech said that in addition to the corrective advertisements – which are running in several women’s magazines, including Weight Watchers and this month’s WebMD the Magazine – “our clinical specialists have reached out to health care providers” to inform them about the corrective ads, which intend to “clarify the benefits and risks of Boniva in women suffering from post-menopausal osteoporosis.”

Sally Field was the face of Boniva beginning in 2006, but Vancheri says Field is “no longer engaged” on the campaign. GlaxoSmithKline signed a co-promotion deal with Roche on Boniva in 2001, but the companies broke the partnership in 2010.