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Top Rx Club Award winners exhibit qualities that ironically juxtapose industry's paradigm (pdf)

RxClub Awards 2008:  Powerful & Simple

One robot: The Automated Lenti-Viral System, custom-built by Novartis engineers.  

» 144,000 individually coded strands of short interfering RNA: Six or seven for each of the human genome's 20,000 genes   

				» 20,000 human immune cells and an equal number of copies of HIV, the human immunodeficiency virus, accessorized with Luciferase, a light-emitting reporter virus			

				» Vast electronic databases detailing thousands upon thousands of gene ontologies and protein interactions			

This is a short list of materials used by researchers at the Salk Institute for Biological Studies, the Burnham Institute for Medical Research, and the Novartis Research Foundation's Genomics Institute to answer the question: When HIV infects a human immune cell, which of the cell's own genes play a role? 

"This study brings together two powerful new technologies: genomics and proteomics," says Burnham's Sumit Chanda, a co-author of the study published in the journal 

. "The results open a new front in the fight against HIV."  

What merits such braggadocio? All but two of the two dozen or so HIV drugs on the market take aim at the virus itself. By doing a genetic shakedown of the immune cell as it is being infected, Chanda and his colleagues have served up a feast of host-cell targets—including 295 genes, 60 of which are high-value targets—with the potential to yield new classes of HIV drugs. "Quite a few are already known to be 'druggable' by small molecules," says Salk's John Young, a study co-author. "Those rise to the top of the list in terms of priority, and we expect Big Pharma to go after them once we validate them."  

The cause of AIDS is, of course, already known—and the two French scientists who discovered HIV 25 years ago were honored with the Nobel Prize for Medicine the same week in October that this study hit. One big unknown—until now—was what Young refers to as "the flight pattern" the virus follows in its pursuit of the host cell's DNA treasure. "What's new is that we've mapped the HIV–host cell protein interactions," Chanda says. "This gives a spatial understanding of the dynamics of the two cells during infection." (See illustration.) 

With only nine genes and 15 proteins of its own, HIV (bottom left) exploits 295 of the host cell's genes to do its dirty work, triggering several hundred protein interactions in the process. Many of these may be potential drug targets. Source: Dr. John Young, Salk Institute for Biological Studies 

As significant the results and sophisticated the technology is, the actual experiment was QED: First, silence a gene in the immune cell using RNA interference, then introduce the HIV vector and wait a few days for the result. "When infection takes place, the cell glows," says Chanda, referring to Luciferase's firefly-colored light that is turned on when HIV has succeeded in hijacking the human DNA. Now repeat the experiment about 50,000 times, knocking down gene after gene after gene until the entire 20,000-gene human genome has been tested. Then repeat once (or twice) for good measure. (That's where the Novartis ALVS robot came in handy—the little guy worked nonstop for a year.) Finally, turning from test tubes to the computer, researchers combed through those massive databases to clarify the function each gene performed as well as to ID the several hundred protein interactions involved.  

Chanda and Young are eager to start screening compounds, but drug discovery is a pricey proposition. "A patent application has been put together to cover this IP," Young says. With Novartis a patent holder, the company may be planning to bolster its lackluster HIV R&D. As for the gene-silencing approach, Alnylam, Sirna, and other biotechs are trying to solve the systemic delivery problem. "We hope our study will accelerate interest in targeting HIV," says Chanda, "But the field is a few years from knowing the possibilities and limitations of RNAi therapeutics."  

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Big Science

The shakeup of top management at Novartis was one of last year's big pharma stories. Flagging sales in the wake of two serious black eyes for the Swiss giant—one for having to yank Zelnorm from the market, the other for failing to win FDA approval for Galvus—led to rumors longtime leader Daniel Vasella might be ready to retire. Instead, last October Vasela roared back with a $1.65 billion restructuring, and Joseph Jimenez, who only six months earlier had taken over as the CEO of Novartis consumer health, switched positions with the CEO of pharmaceuticals, Thomas Ebeling. Jimenez, who honed his skills at H.J. Heinz, has been charged with expanding global branding efforts while slicing away at the bureaucracy and speeding up drug development and marketing. 

 checked in with Jimenez at the one-year mark to see how he was handling his new challenges. 

How have the recent leadership changes made Novartis a different company? 

We've definitely gone through a lot in a short time. I would describe Novartis Pharma over the last 10 years as an incredibly successful model for the pharma industry as it existed. But as the world changed, I think we were slow to change. As the regulatory environment and generic competition became tougher, we were still operating in the old model. 

With new people such as myself, [Global Head of Exploratory Clinical Development] Trevor Mundel, and [Global Head of Development Franchises] Andrin Oswald, we've been able to make some significant changes that will position Novartis well for the future. For example, we've restructured the entire drug development organization into smaller, cross-functional teams—down from 30 to eight. We told them we want biotech-like intensity. At the same time, we've elevated safety. 

How are you doing things differently in terms of safety and regulatory?

We're spending more time talking to the agencies on a scientific basis. We're engaging the FDA and the EMEA more in our processes. But we're not picking up the phone every time we need something. 

Trevor Mundel is one of the big industry proponents of modeling and simulation and what that means for drug development down the road. With FDA's interest in those new technologies, we're working collaboratively with them. That's something we had not done previously. 

You have a strong consumer background. What aspects of that business do you apply to your current role?

With consumer packaged goods, you must understand the consumer at a deeply emotional level. When you transfer that to the pharmaceutical industry, you realize that we need to understand the motivations of a patient, the role of the disease in their life, and the role that the therapy plays in mitigating their disease. For example, it's very interesting for me to see how little we really understand about the causes for the lack of drug compliance. I've worked with our marketing people to take away the negatives and give the patient the positives to increase compliance with our medicines. 

Across the industry, we see changes at every level. What change has had or will have the single biggest impact at Novartis?

The external change that's had the biggest impact is the customer base—the shift away from the physician and toward the payer. The physician, in some markets, is having much less say about what's actually dispensed than even two or three years ago. And not just in the US; it's also happening in Europe and Asia Pacific. It's having a profound effect on the way we're going to have to go to market. If you look at our commercial model, it's based on visiting the physician numerous times per month with multiple sales forces. That's just not going to be effective going forward.  

We've started a few pilot tests in highly restrictive markets in the US where we have significantly reduced the number of sales reps but built up cross-functional teams—with a managing director and finance, sales, health economics, marketing, some medical—at the headquarter level of payers and healthcare providers. We're interacting now with those customers at a different level than before. 

When we found our customers, we started interacting with them and understanding what their needs were. For example, in Massachusetts one of the large physician groups was interested in helping people understand more about hypertension. We made an agreement that we would jointly screen patients for high blood pressure at a local health and fitness expo. 

Collaborating with providers and payers at the headquarter level has actually unlocked some of the restrictions—in terms of access—to the physicians. Despite the reduction of field sales reps in those markets, our business is actually performing better than it is in the rest of the US. And our sales reps in those markets have a much higher level of satisfaction because now there's access to the customers at a different level. 

Novartis' diversification strategy is a hot topic in the industry. Analysts are wondering how far the company will go. Are you using J&J as a model? 

No. I think that everything Novartis does will be science-based. For example, I don't think we'll expand into consumer healthcare products that are not based in science. Our overall strategy is to be focused in vaccines and diagnostics, in consumer health, and elements of consumer health that led to the [ophthalmology specialist] Alcon acquisition. The unreimbursed portion of over-the-counter drugs obviously provides a level of diversification that leverages the knowledge of the company in healthcare, but also mitigates some of the risk of reimbursement and other pressures the pharmaceutical side is facing. Vaccines fit into that strategy. Right now, it's a relatively small business, but if you look at vaccine growth around the world—it's in the mid-teens—it could be a nice engine.  

Like every other Big Pharma, Novartis is tackling patent expirations. Can the company fill the holes with licensing and technology—and with new initiatives?

The first thing that I did when I got to the pharmaceutical division was look at the Diovan patent expiration that's coming in 2012. As you know, Diovan is a $5 billion drug globally. I immediately went to work identifying ways to invest today in order to offset the Diovan patent expiration. 

There are a couple of areas that can help us do that. The first is our oncology franchise. If you look at the success of our late-stage pipeline, there are ways to accelerate development. For example, [there is] concurrent development of multiple indications for molecules like RAD001 [Afinitor], which we are filing this year for renal cell cancer—but which also looks very promising for breast and non-small cell lung cancer, and for neuroendocrine tumors. 

The second big area to leverage is emerging markets. There are four major markets—China, Russia, Turkey, and South Korea—where we have scale, and we can expect those businesses to grow over 20 percent annually. With the right level of investment today we can generate significant growth in the 2011 to 2013 period when Diovan comes off patent. 

A third big area is the payoff from our drug development restructuring, in terms of our general pipeline. We have formed these eight-person, cross-functional teams, and really challenged them to crash their time lines and look at what they can take out. That will accelerate growth in the critical period. So it is going to mean more investment, but it's absolutely doable.  

Emerging markets are an interesting topic. They appear to be showing rapid growth, but some critics say those markets aren't organized enough in terms of infrastructure to really deliver solid prescription growth. Do you think that's true?

We picked four countries very carefully. When I came in, we had 40 countries we called "emerging markets." One of the first things I did was separate the big, well-organized markets from the rest, so we have additional focus on those countries. Our pharmaceutical business in China, Russia, Turkey, and South Korea is getting the kind of growth that can drive sales. If we went to other markets that some people call "emerging," like India, we would not get that benefit.  

What are your biggest concerns for the company? What keeps you awake at night?

The biggest concern is that this is an industry that's changing rapidly. But the pharmaceutical industry is a good place to be. It is fundamentally going to be a growth industry over the next 20 years. When you look at how societies are going to have to cope with over a billion people who are over 65 by the year 2030, and you compare that with the capability that has been developed at companies like Novartis around discovering and developing new drugs that can mitigate the cost, there is a very strong match. 

But there are short-term issues—pricing pressure, tougher regulatory—where we need to change the way that we operate. For example, on downward pricing pressure, we have to improve health economics and outcomes research in a way that it allows us to show payers that our therapies are mitigating the cost of overall healthcare. Don't think about prescription drugs as increasing the cost. 

The thing that keeps me up at night is my ability to help move this aircraft carrier called Novartis Pharma quickly enough to adapt to that changing environment because adapting to those changes is not easy.  

 was named CEO of Novartis Pharmaceuticals in October 2007. In that position, he is charged with expanding the company's global branding efforts and speeding up drug development and marketing. For shouldering that task, the former collegiate all-American swimmer, now a father of three, pocketed $3.8 million in 2007. 

Thought Leader

It's been a year since consumer marketing master Joe Jimenez took over the top spot at Novartis Pharma. How's he faring?

No Ordinary Joe

Patients suffering from multiple sclerosis (MS) have seen their fair share of broken medical promises in recent years. Back in 2003, biopharma was on a roll, making reassuring strides in the treatment of this chronic, progressive autoimmune disorder. In the previous decade, FDA had approved five disease-modifying drugs—where previously there had been none. The future was looking even brighter, with combination therapies, oral treatments, and a powerful first-in-class monoclonal antibody (MAb) named Tysabri coming out of the pipeline. 

But the last five years have largely been a bust. Serious setbacks dampened the optimism of the 400,000 people living with MS in the US, and the 2.5 million diagnosed worldwide (see "US Patients Living With MS, 2005–2014"). The category is overdue for an infusion of innovative new products. Fortunately, according to recent AVOS Life Sciences research ("Multiple Sclerosis Agents: US Market Outlook") into the clinical and commercial dynamics that will shape the MS market through 2015, patients and their doctors can expect significant change in the form of new treatment options—largely as a result of the introduction of oral agents to a traditionally biological therapeutic category. Still, a strong sense of uncertainty permeates this medically challenging disease.  

Biogen Idec's Tysabri (natalizumab) has been the decade's big spoiler in MS. Launched in 2004 after FDA fast-tracking, the MAb was poised to disrupt the market in the best sense: It showed unprecedented efficacy in reducing the frequency of relapses suffered by MS patients. Then as now, the MS segment is characterized by biologics that require daily or weekly self-administered injections. In contrast, Tysabri offered a novel mechanism of action, less frequent dosing, fewer side effects, and greater potency than standard therapies. The drug was widely predicted to be the next gold standard in MS treatment and a sure-fire blockbuster. 

Instead, Biogen Idec was forced to yank Tysabri from the market in February 2005 after three former trial participants developed progressive multifocal leukoencephalopathy (PML), a serious brain infection; two of them died. Yet under pressure from MS patients, Tysabri made an unexpected comeback in 2006 under an FDA-approved restricted access program, on the basis that the drug's benefits outweighed the risk of developing PML.  

 US PATIENTS LIVING WITH MULTIPLE SCLEROSIS, 205-2014 

That claim is currently being tested. Biogen Idec disclosed the occurrence of two new cases of PML last July, the first since the drug's reintroduction. But given a worldwide Tysabri patient population of more than 31,000, two new cases of PML may mean that the danger of developing the brain infection while on the drug is actually lower than the previously estimated risk of  1 in 1,000 (0.1 percent). Researchers are still seeking to understand why PML occurs, what co-factors encourage PML to develop in Tysabri patients, and how to further mitigate the PML risk. But barring a breakthrough, the drug's black-box warning has dimmed its initial promise as a major treatment advance. Still, Tysabri does offer increased efficacy and quality of life, and for that reason it's likely to remain on the market. In the worst-case scenario, it will have flattened sales and end up filling a niche for patients who have failed first line treatments.  

In the wake of the Tysabri-related PML deaths, physicians have developed not only a much more conservative approach to prescribing, but also a heightened sensitivity to safety and tolerability in general and a greater appreciation of the true potency of MS drugs.  

The current MS market looks more or less like it did three years ago when Tysabri arrived on the scene. The beta interferon class, consisting of Biogen Idec's Avonex, Bayer Schering's Betaseron, and Merck Serono's Rebif, remains dominant, accounting for 69 percent of prescriptions written in the US in 2007. Avonex leads with a little more than a third of market share. Not far behind is Teva's Copaxone (glatiramer acetate), a polypeptide therapy that was introduced at almost the same time as Avonex in 1996, and that meets the need for a non-interferon treatment absent neutralizing antibodies and flulike symptoms. Copaxone has long been the market's No. 2 drug, its growth hindered by the need for daily self-injections. 

The Tysabri clinical trials demonstrated the risks of using this disease-modifying MS agent, especially in combination with beta-interferons. What had been a growing sense of confidence in the first-generation biologicals—which went so far as to compel the drugmakers to launch dual-therapy Tysabri/Avonex trials during the MAb's clinical development—was shaken when two of the three cases of PML emerged from those trials. Combination therapy is no longer recommended.  

Neurologists are also increasingly wary of switching a patient from a drug that has proved effective to a new treatment that may offer greater efficacy, but may also expose them to a new set of side effects. Doctors are demanding more extensive, longer term clinical data before endorsing a new MS drug on a broad basis. This orientation—call it the Tysabri effect—will likely slow the uptake of the new oral MS drugs as well.  

Holding Tysabri back is the physicians' understandable fear that the drug may be too "heavy-handed" for the majority of patients, who have on-ly mild-to-moderate relapse-remitting MS. (Those using Tysabri, and the ones who cried loudest for its return to the market, had more aggressive or advanced stages of the disease generally beyond the reach of the beta interferons.) Tysabri's market share is likely to reach 5 percent this year, despite the new PML scare; the MAb will gain traction through 2014, while the beta interferons slowly decline as they are bested by new treatment options (see "Future Market Trends for Current Products, 2007–2014"). 

Several late-stage oral drugs and a novel biological are poised to usher in a new, improved treatment regimen in MS—or at least promise to. A plethora of pharmas and biotechs are working to develop the next disruptive MS therapy: an oral medication. This big leap in convenience will drive a value shift in the segment as patients also seek incremental efficacy from these new mechanisms.  

FUTURE MARKET TRENDS FOR CURRENT PRODUCTS, 2007-2014 

Development delays and failures have made the expectation of an oral MS drug old news for almost a decade. In 2005, Merck Serono/Teva's cladribine and Sanofi-Aventis' teriflunomide were two oral drugs on track to launch in 2008. Since that analysis, Teva's oral formulation of the injectable Copaxone got derailed, while cladribine and teriflunomide remain in clinical trials with filings now targeted for 2009 and 2012, respectively, according to company estimates. But recent positive trial outcomes suggest that one or more oral formulations may finally reach the market by 2014. The most promising, in addition to cladribine and teriflunomide, are Teva's laquinimod and Novartis' FTY720. All are late-stage compounds that use a unique mechanism of action to achieve reductions in relapse rates, in new lesion formation in the brain, and in the risk of disability progression.  

Meanwhile, Bayer Schering and Genzyme are co-developing Campath (alemtuzumab), a biologic similar to Tysabri. Industry buzz about the drug centers on Campath's potential for short, intermittent doses to put MS into remission for a period ranging from five to 20 years. If such claims are valid, Campath will represent a milestone in the treatment of MS. On track for a 2013 launch, the MAb, which must be infused, is likely to enter a crowded MS market of orally administered competitors.  

 Even with the MS market's many unmet needs, novel treatments will increasingly be required to meet higher standards of safety and prove their value before they can gain wide market acceptance (see "Key Phase III Pipeline Products"). 

The success of next-generation MS drugs will be based chiefly on their mechanism of action—and efficacy—with oral delivery a secondary feature. Interviews by AVOS with a diverse set of MS specialists revealed that they were split in their prioritizing of ease of administration. Some physicians indicated that they and their patients are eager to obtain the first oral MS therapy and abandon injections, while other physicians expressed wariness about sacrificing stability and slowed disease progression for the sake of dosing convenience. Weaker efficacy will not be tolerated; oral treatments must prove at least as effective and safe as the beta-interferons to gain any credibility.  

THE PROS AND CONS OF KEY PHASE III PIPELINE PRODUCTS 

The oral medications are likely to be adopted initially as second or even third line treatment options. They will have to prove their utility and value in patients for whom other drugs have failed before moving to first line status. Physicians reported that they would handle patient requests to switch from injectables to orals on a case-by-case basis, but generally were not inclined to switch stable patients before long term data and usage are available—a  dynamic already evidenced in the prescribing pattern of Tysabri. 

Which compounds in the MS pipeline will deliver on their promise over the next seven years? What specific criteria will determine their success? To answer these questions, AVOS examined efficacy, safety, and administration data from the most recent clinical trials for five late-stage candidates with unique mechanisms of action, comparing the attributes to those of Avonex, the market leader and benchmark. The analysis determined that Bayer's Campath, Sanofi-Aventis' teriflunomide, and Novartis' FTY720 appear to be superior to Avonex, while Merck Serono/Teva's cladribine and Teva's laquinimod fell below the benchmark. Both Campath and FTY720 displayed better efficacy, but were marred by severe safety concerns, which are likely to require additional trials and delay their launch. The three other drugs, all orals, demonstrate weaker efficacy than that of Campath or FTY720, but fared better on administration and safety.  

US DRUG MARKET MS DRUG REVENUE BY CLASS (IN THOUSANDS) 

These new therapies will increase overall MS market growth through 2014. AVOS estimates that total revenues in the US will jump from $3.9 billion in 2008 to $5.9 billion in 2014. The worldwide market, largely identical in product offerings, will experience 67 percent revenue growth over the same period—split evenly between the US and other high-prevalence areas such as Europe and Canada. The global MS market value in 2014 is estimated to be about $10 billion (see "US Market's MS Drug Revenue by Class"). 

Interestingly, no precedent exists by which to predict how a market characterized solely by injectable biologics will react when oral pills are first introduced. The convenience of a pill is not sufficient incentive for oral therapies to change the therapeutic market overnight, the way the arrival of generics treatments do. Pricing power will also resist any massive reductions associated with the introduction of oral drugs. As long as doctors view oral formulation attributes as secondary when making a prescribing decision, an oral's ability to be priced at a premium and garner higher reimbursement rates will be dependent upon a superior clinical profile. Tysabri's significant price premium ($27,000 a year) reflects the drug's better efficacy. Convenience alone will not be the key determining factor in awarding price premiums or discounts. 

Yet it's important to remember that the success rate of bringing new MS treatments to market is poor. Only 5 percent of all MS compounds that entered clinical trials in 1995 or later won FDA approval—that's significantly less than the industry average of 12 percent. And the agency's increasingly conservative safety approach may not bode well for drugs like FTY720 and Campath that have already displayed questionable safety records marred by patient deaths in trials. 

Multiple sclerosis remains a poorly understood disease.  While its mechanisms are increasingly identified, yielding more advanced disease-modifying agents, the causal question (Why does the body's immune system start attacking the brain's myelin sheath in the first place?) continues to baffle researchers. On the bright side, the field is well funded, and the sheer volume of MS products in the pipeline (14 in Phase III and 18 in Phase II) is a strong signal that at least one new product will enter the market by 2014. Further delays, setbacks, and disappointments are inevitable, though, and the next significant treatment breakthrough in MS is still waiting to be found.

 is an associate at AVOS Life Sciences, a management consultancy and research products firm in Research Triangle Park, NC. He can be reached at 

. Requests for copies of AVOS's MS Therapeutic Market Outlook report can be e-mailed to 

A five-year forecast of the multiple-sclerosis market following the disruptions of Tysabri

The Mess in MS

The failure of a clinician to disclose nearly $1 million in industry payments has turned the spotlight on conflicts of interest in the biomedical research world. Sen. Charles Grassley (R-IA), ranking Republican on the Senate Finance Committee, recently uncovered evidence that psychiatrist Charles Nemeroff of Emory University in Atlanta ignored demands to disclose payments from GlaxoSmithKline. Even though the payments were perfectly legal, the case once again raises questions about oversight of academic consulting activities, violation of government disclosure requirements, and ultimately the validity of evidence to support new drug approval by FDA. 

As a result of such questions, senators including Grassley are seeking to enact the Physician Payment Sunshine Act, which would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors. Industry has grudgingly supported the measure as preferable to a proliferation of different state disclosure laws and ongoing investigations into conflicts of interest (COI) involving marketing and research practices.  

Elsewhere, the Institute of Medicine (IOM) has convened a blue-ribbon panel headed by University of California San Francisco professor Bernard Lo and former National Institutes of Health (NIH) official Wendy Baldwin to evaluate the role of pharmaceutical and medical product manufacturers in funding clinical research, managing publication of research results, and supporting continuing medical education (CME) of health professionals. The panel is examining disclosure policies and codes of conduct at academic medical centers, pharma companies, professional societies, and government agencies. The panel's report, due next year, will propose principles for managing COIs and for ensuring the objectivity and validity of biomedical research. 

Repeated disclosure failures and lax institutional oversight have raised doubts, however, about the enforcement of appropriate safeguards. And expanding government support for more medical evidence reviews and practice guidelines has raised alarms about even more opportunities for industry to influence medical practice. Meanwhile, universities and pharmaceutical manufacturers are revising policies and establishing new disclosure and funding practices. The University of Minnesota Medical School is weighing full disclosure of all relationships between faculty and the drug industry, as well as a ban on gifts from medical companies. Eli Lilly and Merck recently made headlines by announcing that they will voluntarily disclose all payments of more than $500 made to physicians for advice, speeches, and other services. Lilly began posting educational grants and charitable contributions last year, and will add payment information next year, followed by fees for clinicians conducting research. 

While neither manufacturers nor academic institutions are eager to cut off the more than $1 billion industry provides each year for CME, the desire to avoid any appearance of undue influence is taking a toll on industry support for medical education of doctors and health professionals. Both sides maintain that such programs are vital to keeping physicians alert to the latest disease treatments.  

But the cutoffs have already begun. Last summer, Stanford University Medical Center said it would halt direct funding of CME courses by drug and device makers. Instead of making individual grants to specific programs, medical schools now want pharma companies to fund CME through central educational funds. Pfizer adopted such an approach, and says it will end direct support of CME through commercial educational providers.  

FDA faces similar challenges in establishing partnerships with industry to support its Critical Path Initiative (CPI) for translating biomedical research and genetic discovery into new therapies. Such collaborative efforts raise concerns about industry influence over regulatory decisions, along with a host of legal issues. Congressional objections to any industry financial support for FDA programs (even user fees) have blocked federal funding of the Reagan-Udall Foundation for fear it would provide a back door for industry to influence FDA decisions on market approval for new drugs. Reagan-Udall chair Mark McClellan, a former FDA commissioner now at the Brookings Institution, is working to establish bylaws and safeguards to separate outside funders and foundation operations in order to gain budget authorization for Reagan-Udall next year. 

 Since issuing its Critical Path white paper in 2004, FDA has helped form numerous public-private partnerships (PPPs) with industry, academia, patient groups, and other government agencies. These collaborations support research on new biomarkers, disease models, data analysis methods, and data tracking systems such as FDA's Sentinel network. The aim of these partnerships is to modernize FDA's research standards and approval criteria.  

In addition, CPI is updating clinical research methods. The Clinical Trials Transformation Initiative (CTTI), a collaboration involving FDA, Duke University, and other partners, seeks to establish national standards for research functions, new review models for multi-site trials, accreditation programs for investigators and sites, and improved data management systems.  

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), says it's time to shift CPI from concept to implementation. The goal is to replicate the massive investment in research and flexible regulatory approaches that stemmed the tide of the AIDS epidemic 20 years ago. That effort produced new surrogate markers and accelerated approval processes to spur development of new treatments, recalls Mark Harrington of the Treatment Action Group. Yet that achievement was an exception, and has not been extended to research and regulation for treatment of other infectious diseases.  

Establishing those initial PPPs took months of negotiations involving data standards, information sharing, access to results, and protection of proprietary information. Lawyers had to work out approaches for dealing with conflicts of interest and intellectual property protections, as well as ensuring that collaborative groups complied with federal statutes. Neutral third parties—such as the Critical Path Institute in Arizona and the National Institutes of Health [see sidebar]—provided venues for creating partnerships that meet legal and technical requirements.  

The good news is that better biomarkers and clinical trial methods may yield new treatments. An FDA initiative, the Analgesic Clinical Trials Project (ACTP), aims to spur R&D on novel painkillers by developing new efficacy endpoints, and by evaluating innovative study designs likely to improve the success rate of clinical studies for these products. Bob Rappaport, director of CDER's Division of Anesthesia, Analgesia and Rheumatology Products, has received internal funding to re-analyze data from failed analgesic trials to assess ways to maintain study sensitivity and to explore high placebo response rates. A broader PPP will expand the scope of the project to address analgesic use in preventing chronic post-surgical pain. 

Novartis scientists are hopeful that new biomarkers for detecting liver damage from drugs could lead to market approval for its Cox-2 inhibitor Prexige. The drug is highly effective but has an "Achilles heel" of severe hepatoxicity in certain patients, explained Timothy Wright, head of translational science at Novartis, at a September DIA workshop on CPI. Last year, FDA rejected the drug, calling for additional safety data. A genetic marker that identifies patients most likely to develop liver damage from the drug might warrant additional clinical trials to support approval, Wright suggested.  

FDA has advanced these efforts to link postmarket adverse events back to clinical trials, establish biomarker data warehouses, build a knowledge base of product quality, and establish a bioinformatics platform for data standards—all with just a $20 million investment in CPI, Woodcock points out. The agency's goal over the next five years is to obtain sufficient resources to build on this expanded understanding of disease and pharmacology to ensure product quality and safety.  

"Drug development tomorrow will not look like drug development today," Woodcock predicts. 

 is Pharmaceutical Executive's Washington correspondent. She can be reached at 

Washington Report

As Congress moves to curb industry influence, support for med ed is waning

Resolving Conflicting Interests

As the 2008 election season drew to a close, the Presidential and Vice Presidential candidates framed the nature of their leadership experience to their respective political advantages. Sen. John McCain recalled his long tenure in Congress and his service in the Navy to illustrate, as the signs read, that he places "Country First." Sen. Barack Obama, meanwhile, pointed to his meteoric rise to the Democratic nomination, portraying himself as a Beltway outsider and an agent of change. As Mr. McCain regaled the country with his experience, Mr. Obama reveled in his status as a newcomer. 

On the other hand, the candidates' running mates presented the opposite paradigm. Sen. Joe Biden highlighted his years in the Senate, emphasizing the foreign policy experience he's gleaned from interacting with world leaders. Gov. Sarah Palin pointed out that many vice presidents have gotten along just fine without such experience, and like Mr. Obama, she painted herself as far enough removed from the establishment to have the good sense to clean it up. 

So what did voters learn from these candidates about the value of experience in leadership? Not much, aside from "Vote for me." 

Still, the ambiguity of the campaigns did make one thing clear: Experience is not the only thing that counts when selecting a leader. This is hardly a new idea. Psychology and management professors have dedicated years to the study of static leadership traits. Newspapers and history books are filled with stories of great leaders who ascend quickly, only to turn in exceptional performances. 

In government, there may be no better example than Theodore Roosevelt, the youngest man ever to assume the presidency. Roosevelt was just 42 when he took office, and over the next eight years, he revolutionized commercial regulation, laid the groundwork for the Food and Drug Administration, and helped bring about the end of the Russo-Japanese War. 

For leaders, relying on experience alone means leaning on prior decisions when circumstances may have changed, relying on knowledge that may be obsolete. John P. Kotter, the author of the 1990 book 

, says that the rapid acceleration of the world, particularly the business world, has created an environment so dynamic that prior experience alone is rarely enough to guide decisions. "The net result is that doing what was done yesterday, or doing it 5 percent better, is no longer a formula for success," wrote Kotter in the 

 in December 2001. "Major changes are more and more necessary to survive and compete effectively in this new environment." 

Noel Tichy and Warren Bennis, authors of 

Judgment: How Winning Leaders Make Great Calls

, say that today's leaders succeed or fail based on their ability to make judgment calls. They write: "In the face of ambiguity, uncertainty, and conflicting demands, and often under great time pressure, leaders must make decisions and take effective actions to assure the survival and success of their organizations. This is how leaders add value to their organizations." 

Tichy and Bennis cite leaders such as Joel Klein, the chancellor of the New York City Department of Education, who cut his teeth at one of the largest and most problematic school systems in the country. Mr. Klein's judgment, his ability to make difficult but informed choices in a highly volatile environment, have helped transform New York's schools. 

The counter-examples are executives like Carly Fiorina, who had 19 years of management experience in the telecom industry before becoming the CEO of Hewlett-Packard in 1999. Despite her many leadership positions, she failed to heed the warnings of her board and pushed through a controversial merger with Compaq in 2002, triggering a rough patch for the company that ended with her departure. 

Some basic experience is certainly necessary to lead, but judgment is what separates great leaders from average or even poor ones. As Wall Street reloads its boardrooms, that may be a principle worth heeding. 

 is managing partner of Flaum Partners and chairman, Fordham Graduate School of Business, Leadership Forum. He can  be reached at 

Leadership

Evaluating experience: It's what you know, not how long you know it

Size Doesn't Matter

By the time you read this, the 2008 Presidential election will have already been decided. And all the debate and discussion over the candidates' merits will instead be directed toward better understanding how the impending presidential policies will translate into action. 

But if you're like us, the discussions surrounding healthcare in the run-off left a lot to be desired. It all just seemed so, well, 

So we called up someone decidedly in the know, Tommy Thompson, who served a long career in government, most recently as the Secretary of Health and Human Services during the outgoing prez's first administration, to offer a reality check on the most pressing healthcare issues. Today, Thompson is an independent senior advisor of the Deloitte Center for Health Solutions and a partner at the law firm of Akin Gump Strauss Hauer & Feld. But perhaps his tenure in government is hard to leave behind: He backs the current system of healthcare with small changes that can have a big impact—and that have bipartisan support.  

 in October and provided some hard numbers and also some hard-to-avoid scenarios—particularly with Medicare, now on schedule to go bankrupt. The data show there are efficiencies throughout the system to be gained (including implementing a mandatory diabetes screening for seniors and an employee retention program at FDA). Indeed, in an election where "change" has been the mantra, Thompson offers some solid steps in moving the system in a new direction—toward keeping people healthy rather than treating them when they are sick.  What follows is an edited transcript of our discussion. —

People forget that you were a candidate in the current presidential race. If you were still on the stump, what would you be telling voters about healthcare?

: The first thing you have to look at is Medicare. Medicare is going broke in the 2012, and it has the potential of sinking our healthcare system just because it is so big.  

When I was secretary, we wrote into the Medicare Modernization Act a provision called the Trigger. Once Medicare in two consecutive years spends 45 percent of the cost of healthcare out of the General Fund, the president is required to put a fix-it bill in front of Congress. The two years are up, and when the next president gets sworn in on January 20, he has 90 days to put a repair bill in front of Congress. Congress doesn't have to take it up, but it will bring front and center to Congress how serious the situation is. 

Second, the continuing resolution that's keeping SCHIP [the State Children's Health Insurance Program] alive expires March 31. 

Third, there are two areas of healthcare where Democrats and Republicans have reached some agreement. The first is wellness, chronic diseases, disease prevention, and disease management. There's a bipartisan coalition developing around this area—which accounts for 75 or 80 percent of the cost of healthcare. The second is information technology—including electronic medical records. Information technology also has bipartisan support—both presidential candidates are talking about it, both parties are talking about it in Congress—and Speaker [Nancy] Pelosi says it's going to be taken up early in the next session. 

So with that, you have the areas that comprise 80 percent of the cost of healthcare, plus IT that will drive efficiencies, transparency, and more communications in the system. You've got Medicare which has to have the fix-it bill, and you have SCHIP. Those four proposals are going to be in front of Congress next year, and I absolutely believe that is going to drive the largest transformation of healthcare that any of us have ever seen. 

Now, I don't believe that Congress can handle the Medicare problem, it is so large. Right now, Medicare takes up about 3 percent of the Gross National Product. Social Security takes up about five percent. But in 75 years, Medicare goes from 3 percent to 15 percent of GNP. Social Security only goes from 5 percent to 7 percent. The second thing is, the Gross National Product in America today is $13 trillion. The unfunded liability of Social Security is about $12.5 trillion in 75 years. What do you think the unfunded liability of Medicare is going to be in 75 years? 

More than the current Gross Domestic Product?

By a large amount. The lowest estimate is $33 trillion. The highest estimate is $68 trillion. When you look at those numbers, it's impossible for Medicare to continue. Nobody's willing to talk about it in detail, but that's what's facing this country. 

First, you're going to have to means-test Medicare. The more money you make, the more you're going to have to pay for Medicare. It's not going to be free anymore. 

Second, [right now] you don't get Social Security at age 65 anymore. Every year it's extended out one or two months, so if you're 65 now, you won't get your first Social Security check until you're 66. The same kind of thing is going to have to happen with Medicare. 

And third, you're not going to have all the Medicare benefits we currently get. There are going to have to be some limitations on new medicines coming on the market or new devices that cost thousands of dollars. We're going to have to do something about the end of life because 30 percent of the cost of Medicare comes in the last year of life. 

Do you know any Republican or Democratic representative or senator who will raise any of these issues?  

I believe sincerely that the only way to fix Medicare is to handle it like a Base Closing Commission setup. Congress cannot close military bases on their own. They have to set up a Base Closing Commission, with an equal number of Republicans and Democrats. They make these tough decisions and then have Congress vote it either up or down. And that's the same type of commission that we need for Medicare. 

Next you have to take a look at where the money is being spent. It turns out that 75 to 80 percent of what we spend is for chronic illnesses. And most chronic illnesses are behavioral—meaning that you or I have some control over them. So we have to figure out a way to do wellness and prevention. For instance, we should be selling insurance to keep you from getting sick instead of insurance to pay for you after you get sick.  

One of the big drivers is tobacco. It costs us $150 billion in healthcare costs—442,000 Americans died last year from tobacco-related illness. We have to look at ways to encourage smoking cessation in America. 

There's enormous opposition to things like regulation of tobacco by FDA.

We should regulate it, without a doubt. Why not? Why should we allow a company to put out a product that kills 442,000 people each year and costs you and me $150 billion? 

The politics are going to be rough, but I'm telling you what has to be done. Healthcare is going broke. It cost us $2.4 trillion this year, and it's going to grow to $4.6 trillion by 2015. It's growing at the rate of 9 to 10 percent a year. We have to cut that to 4 to 5 percent—the rate of inflation—to maintain a healthcare system that allows us to be economically competitive. 

Next comes diabetes. Last year, 18 million Americans had Type 2 diabetes. This year, 24 million. It costs us $135 billion a year. There are 41 million more Americans who are prediabetic. And an exhaustive study by the National Institutes of Health has found that if we lost 5 to 10 percent of our body weight and walked 30 minutes a day, we could reduce the incidence of Type 2 diabetes by 60 percent. 

Another fact that most people don't know is that 30 percent of the individuals going into Medicare this year are Type 2 diabetic, and 50 percent of them don't know they are. Can you imagine how much we could save Medicare if we put the emphasis on preliminary physicals 

going into Medicare and get them started getting treatment. 

Then there's obesity. We have to recognize that in this country, we're causing it with our high fat concentrates and food consumption. Twenty-five to 30 percent of our children are overweight or obese, and we have to do something about that. This is going to be a huge emphasis next year in Congress. 

Another big topic is disease management, especially in the poorest of the poor who are on Medicaid, because 20 percent of the people on Medicaid are responsible for 70 to 75 percent of the costs. We're going to have to intensely manage them and try and get them, if nothing else, to take their medicines on a regular basis. 

People always say, "Let's adopt the European system." Well, the European system is fraught with all kinds of problems; they have self-limitations like you can't believe, and I don't think Americans would stand still for it. I'm afraid of government control. Now, a one-payer system doesn't have to be government controlled, but that usually is the way it goes, and it stifles innovation.  

In a government-controlled system like Europe, about 75 percent of the new drugs are coming out of America, because we have a market-based system. I'm afraid that if we go to a government-control or one-payer system, we will lose that innovation.  

So the market system we have is running us over the edge of the precipice, and a single-payer system is not going to work. Can we really save enough money the way you're describing?

Just having the requirement that every senior going into Medicare has to have a physical for diabetes is going to be a huge money saver. Having some kind of limitations on end-of-life care—it's going to be controversial, but Europe does it. We can save Medicare and at the same time provide for the pharmaceutical industry, the biotech industry, so that they can develop new compounds—even though I don't think they're developing them nearly as fast as they should. 

The mapping of the human genome was supposed to unleash all kinds of new targets. We had dinner last night with [NIH chief] Elias Zerhouni—he thinks that the next five, six years are going to be fantastic, and so do I. 

One of the drivers of rising healthcare costs is rising standards. It's not just inefficiencies. We keep finding ways of letting people feel better or have better lives. 

There's no question about it. That's why you've got to be able to overhaul the healthcare system completely for the new products to come out. I want that progress to continue. I want my granddaughters not to have breast cancer.  Our system in America is the best way to find cures. And that's why I believe the healthcare system we have is worth saving. 

Many of the ways you want to save money involve changing the way people live. How do you propose getting people who are a little—or a lot—apathetic to do this?

One way is by developing a new insurance policy. Right now we have insurance that pays after we get sick. I want insurance to pay to keep me from getting sick. I also want to go to corporate America. In the Deloitte Center for Health Solutions we did a poll and found that two-thirds of the Fortune 500 companies are going into wellness and prevention. Another one-third are looking at it.  

I just saw that one of the big fast food companies now is putting out calorie counters. These things are starting to come together to make people healthy. It's going to start changing human behavior. 

We're not talking about penalizing people who are sick, though?

No, with one big exception—tobacco. In my company, we charge higher insurance premiums for a smoker. But we give them a better deal. We will charge that person more—I think it's 50 bucks a month—for his or her health insurance program. But if that person will bring the whole family in for an anti-smoking program, we pay for it. And then if they quit smoking, we reimburse them their money and give them a bonus. That's the way you can change human behavior. 

Incentives get people to live healthier lives. But we still have millions of people who don't have insurance of any kind.

Forty-seven million who don't have insurance and 25 million who are underinsured. That's huge. I would require every state governor to put the uninsured into an insurable class, and then put it out for bids. Let's say the state of New York has 1 million uninsured. It's more than that, but let's call it a million. We'll put a million people out for bids and then allow any health insurance company in America to bid on it. There would be a bid for single-enrollees, for families, one with high deductibles, one with health savings accounts and HRAs [health reimbursement arrangements]. Insurance would be mandatory, but for those under 125 percent of the poverty line, the state would subsidize them or use the McCain model of $5,000 per family to buy health insurance. 

You would be absolutely amazed how competitive and reasonable those health insurance companies would bid. When you look at the composition of those that are uninsured, about one-third are between the ages of 18 and 34. They're healthy and they don't think they're ever going to get sick, so they just don't buy it. About 30 to 35 percent make over $60,000, $70,000 a year, so they're well-to-do. There are some who are going to be very sick, and you're going to have to put that in the mix, but overall the rating is going to be a reasonable class. 

When we did this on Part D, we didn't know if we were going to get any bidders. We thought that if we could get three companies to bid nationally and 10 companies to bid regionally, we would be successful. Lo and behold, our three national companies turned into 10, our regionals from 10 to 60, and some places close to 100. We had a plethora of choices, maybe too many. But people came in and bid, and drug costs for the seniors are relatively stable, and 82 percent of the seniors like Part D. Now, there is no other program in the federal government that 82 percent of any class approves of. You couldn't get 82 percent of seniors to approve of free ice cream and apple pie. And yet they like Part D. It shows that the marketplace does work. 

If you were a head of a pharmaceutical company right now, what would you do to be ready for the new world of healthcare?

The former health secretary offers a reality check on healthcare reform-and what to expect from the pols in '09

Pharm Exec Q&A: Tommy Thompson

The Internet has quietly revolutionized the world in this new century. Consumers are banking, shopping, and being entertained and informed from their personal computers. This massive shift of consumers to the Web has relevance far beyond those in the media and entertainment industries.  

Today as never before, people are researching their health, their diseases, and their medications online. According to comScore, Inc., 61 billion searches were conducted worldwide on the Internet in August 2007; nearly half (43 percent)  were medical or health related, according to Hitwise, an online competitive intelligence service. But although we see this shift of eyeballs to the Internet, drug marketing has been slow to follow.  

Those who have transitioned to online advertising have found a medium that moves at light speed and operates under rules far different from the traditional offline world. Great online content delivers targeted messages to your audience. To stake out the high ground in the ever-shifting online landscape, marketers utilize Search Engine Optimization (SEO). SEO turned into a multi-billion-dollar business almost overnight. But don't be fooled by that impressive-sounding figure. There are plenty of outfits that say they perform SEO, but most don't do it very well.  

SEO is the science behind earning first page results in a "natural search," displayed down the center column when using search engines. Natural results account for more than 80 percent of search-generated traffic. The results in the right-hand column and the very top, separated by a light pink-shaded area, are paid ads. Paid ads, known as Search Engine Marketing, are an important part of an Internet marketing campaign, but account for less than 20 percent of clicks.    

So how do you win first page placement in the natural results on Google and the other major search engines? With a click of a mouse and some important tips. 

Many people ask, "Why Google?" Simple. Google is the world's greatest search engine. Google's goal is to organize the world's information, and make it easily and instantly available to anyone with access online. This is being done by some of the brightest minds in the world and, not surprisingly, the complexity of their search algorithm is difficult to comprehend. After years of studying Google, my firm has simplified SEO into three easy-to-understand principles that I call "The three secrets to SEO."  

Until your Web site has earned the trust of Google, nothing else you do matters, and you won't rank high in searches. The most important way you earn trust is by receiving links from other trusted Web sites. When Google co-founder Larry Page created the Google algorithm called Page Rank, he looked at an existing system of qualifying papers called academic citations. If your academic paper was cited frequently, it would become trusted and used more often. Page compared a link to academic citations. The more citations or links, the more trusted the source of the content would become. Therefore, the best way you'll earn Google's trust is by making your Web site the receiver of links, or in "geek speak," back links.  

Google's trust also comes with a Web site's age. A business that has just opened its doors is less trusted than one that has been operating for years. Web sites work the same. You can't fake a Web site's age and this weighs heavily on earning Google's trust. As a result, it has created a whole new online industry of people buying, selling, and trading aged domains at online stores and auctions. 

Once you've earned Google's trust by creating a compelling reason for great Web sites to link to your site, it's time to get Google to read your text in order to understand what your site is all about.  

Most people think that if they can visibly read the text on a Web page then Google can read it. This is not always the case. For example, Google has difficulty reading Web sites created entirely in Flash, database-driven content management systems run by Java Script, and Web sites containing frames. These are just a few examples of Web sites that will probably not rank in searches; most webmasters are unaware of this. The second secret of SEO: Create content that Google can read easily. The best way to achieve this is by creating readable content and Web pages in HTML while following World Wide Web Consortium (W3C) standards.  

Many marketers want multiple messages to be sent simultaneously to their customers. Brochures and posters may contain several product offerings or messages, and some business cards list five or six things the company does. Marketers often incorrectly utilize the same strategy on a Web page. A single Web page may contain 10 different products. Now that we have implemented SEO secrets No. 1 and No. 2, we can assume that Google trusts your Web page and can read the text. If the page is about 10 different things, then Google will reward you by ranking you for all 10. The problem is that you will rank on page 100 for product one, page 1,000 for product two, page one million for product three, etc. If you're not on Google's first page search results, the majority of Internet searchers will never find you.  

In the world of search engines, keywords are powerful tools; they can be one word or a cluster of words on your Web page that identifies what the pages are about. "Cholesterol" is a single keyword. "Good cholesterol" is a keyword cluster. Single keywords are the hardest to win, but they offer the highest number of targeted visitors.  Keyword clusters are easier to win, but usually drive less traffic.  

We subscribe to numerous databases that collect information on Internet searches. They tell us how many searches are conducted daily on a given search query and how many competing Web sites are currently targeting the keyword. Two databases that I recommend are Wordtracker and Wordze. Both are reasonably priced, easy to use, and contain a wealth of valuable search-query information.   

Laser beam focus means a Web page should provide an exact match with some density to a keyword that matters to your business. Select good keywords by guessing. Brainstorm with your SEO consultants, pharmaceutical executives, and patients then create a list of product-relevant keywords that you believe people might search for. Use these keyword guesses to seek actual keyword searches on the Internet.  

Web sites are like real estate. Your domain name is a plot of land. The look, feel, and functionality of the Web site make up your hotel. Your guests represent the traffic driving there, and you want them to be able to find it. On top of that, you want guests to enjoy their visit and share the positive experience with family and friends.  

A major pharmaceutical company created a fantastic patient Web site that assisted patients in tracking their health on a daily basis. Over the course of three years, the Web site grew in popularity as nearly 60,000 patients joined the program.  

In the Internet/real estate analogy, a company purchases a piece of land and builds a great, extremely successful hotel. And just when the hotel reaches its peak performance, the company that created it brings out the wrecking ball and returns land to the city. The lesson: Every Web site is a valuable piece of property that gains customers over time. Each property can refer people to other similar and beneficial properties. It's good for businesses to own and develop several properties; create a separate Internet property for each disease that you treat.  

Most everyone would agree that an increase in a patient's education about his or her disease leads to better compliance. We know that patients are turning to the Internet by the millions, and conducting searches by the billions, to look for answers about their health. This provides the pharmaceutical industry with an unequalled opportunity to reach a targeted audience of people who are seeking education on their specific diseases. The first pharmaceutical companies that create disease-specific patient education on the Internet that is search engine optimized will empower patients within their target market to be proactive about their health. Because in the end, educated and empowered patients are more likely to get treated.  

 is president of Rank Higher and eMotion Picture Studios. He can be reached at 

Columns

When it comes to search engine optimization, here's how to earn Google's respect

All You Need to Know About SEO

Who should be in charge of inspecting foreign drug plants? There seems to be a gathering consensus that it's FDA's job, and it seems likely that Congress will turn that consensus into law sometime in the next year or two. But is that really the right answer? The current way this country handles the safety of imported drugs and active pharmaceutical ingredients is far from pretty, as a recent study from the Government Accountability Office (GAO) illustrates. But realistically, in the world of drugs, it has worked adequately. Yes, there was the heparin scandal—but by all appearances, that was a case of deliberate and rather sophisticated product adulteration. It is not at all clear that plant inspections would have caught it, or that plant inspections are the best way to prevent a recurrence of that particular problem. 

If you read the GAO report, you'll quickly see a good reason to look beyond FDA inspections for a way to regulate imported drugs. FDA, according to the report, currently inspects only about 8 percent of foreign plants each year. At that pace, it can only inspect plants about once every 13 years. That's just an estimate: FDA's databases of foreign manufacturers are in such disarray that no one really knows how many factories send drugs or APIs to the United States. When FDA has issued a warning letter to a foreign manufacturer, follow-up is slow and uncertain. Of the 15 warning letters issued between 2002 and 2007, only four resulted in a second inspection within five years—and three of those were visited not because of the letter but because they had been listed on a New Drug Application. 

Admittedly, FDA has been ramping up its inspection program, and CDER head Janet Woodcock has been quoted as saying that it will take two years and a quarter-billion dollars to get foreign plants inspected on the same schedule as US plants. But with all due respect for Janet Woodcock, she's almost certainly wrong. FDA inspections require the rarest of resources—trained and experienced people. The agency will be lucky to achieve that goal in 10 years. After all, GAO performed the same research on FDA inspections, and reached roughly the same conclusions 10 years ago. There may be a greater will to change now, but the job is still enormous. 

If we can't have these plant inspections now, then we need another plan—one that can be put in action now rather than in a decade. And if we can come up with such a plan (and of course we can), why should we follow through and make FDA the inspector of the whole world's drug manufacturing? 

So, what sort of plan? I'm sure there are a number of ways to go about it, some more palatable to the industry than others, but they will probably include two elements: The company selling the drug in the United States will take full responsibility for anything that goes wrong, giving pharma companies powerful incentives to perform their own inspections and manage their outsources meticulously. And FDA will continue with its program of reaching out to foreign drug regulating agencies to forge agreements on inspections and standards. Congress might want to take the extra step of banning imports from countries that don't have such an agreement or whose inspections don't live up to FDA standards. 

Congress needs to be realistic. It will take years for FDA to build up the capacity to inspect foreign plants. The country can't wait. And we don't need to. The right solution for this problem is the one that works now.

From the Editor

Is FDA's MO in foreign inspections too broken to fix?

Over There

The pharma industry is filled with awards that take note of the best and brightest companies have to offer. But there's one pharma award that marketing agencies seem to especially appreciate—and that's because doctors dictate the vote. This year's Doctors' Choice Awards, sponsored by the Association of Medical Media (formerly the Association of Medical Publishers), was judged by nearly 6,000 docs, who examined 327 professional ads in 13 product categories. The winning journal ads were showcased at a New York Palace Hotel gala in September. Ads were judged on their ability to communicate clearly and quickly, help with clinical decisions, prompt physicians to seek more information or re-examine treatment, generate interest, add to information provided by company sales reps, and underscore the value of the promoted product.   

 The Doctors' Choice Awards winners included (from top left): Pfizer's Chantix by Euro RSCG Life LM&P; Merck's Gardasil by JUICE; Alcon's Vigamox by Corbett Worldwide; and Takeda's Rozerem by Abelson-Taylor 			

"I think it is the most meaningful because it's not a jury of our peers or a popularity contest," says Alan Topin, president of Topin & Associates, whose agency stole the show, winning three awards for its four-page Dusa ClindaReach (Clindamycin) launch ad for acne. "[These awards] deal with ethics—so in that sense we are triply delighted with our work." 

For Robin Shapiro, senior vice president and executive creative director at Corbett Worldwide Healthcare Communications, the Doctors' Choice Awards takes the temperature of an idea's ability to break through the competitive clutter. "The fact that physicians choose the winners makes this show a favorite of many clients," she says. 

Reflecting the broader trend in drug development, an ad took first place in two categories for two different indications for the first time this year. That campaign—produced by GSW Worldwide for Lilly's Cymbalta (duloxetine)—struck a chord with physicians specializing in gastroenterology and neurology.  

Dean Tepper, senior vice president and group creative director of GSW, says that there are two reasons why the Cymbalta ads "communicated the brand's benefits in a compelling way": the target patient is clearly identified through the casting, and the use of four successive single page ads offer a chance to tell the brand's story. "It helped communicate the various problems patients face while also showing the resolution," says Tepper. 

Corbett took home two awards at the event, one for the "pink eye" treatment Vigamox (moxifloxacin), which doctors said had immediate appeal—and which Shapiro said was steeped in solid branding principles: "Our goal is to go beyond the campaign idea to build proprietary brand identities. The Vigamox work is an example of both instant communication and a proprietary brand identity." 

Medical journal advertising takes center stage at the sixth-annual Doctor's Choice Awards

Pharmaceutical Executive-11-01-2008

RxClub Awards 2008: Powerful & Simple

Big Science

No Ordinary Joe

The Mess in MS

Resolving Conflicting Interests

Size Doesn't Matter

Pharm Exec Q&A: Tommy Thompson

All You Need to Know About SEO

Over There

Docs Rock the Vote

Cash Flow Woes in EU

Making Sense of Sales

Tech Toys

Gilding Lilly