The problem we see with the polarity of views is that both sides seem to be cranking up the extrapolation machine and use single studies/data points to draw broad conclusions to gin up opinions about ACA’s success or lack thereof. With respect to investing, uncertainly caused by media/pundit noise often depresses valuations in the short run. We suggest investors avoid the extrapolation machine and stick to observing fundamentals and fact. In the context of healthcare, as we see it, this means focusing on a double bottom line: financial return potential and companies who create value improving quality or meeting a need.

The Kaiser Family Foundation (KFF) recently released a study that showed that 42% of Americans are unaware that Obamacare (the Affordable Care Act) remains the “law of the land.”  News like this seems to us, to act as a Rorschach test on how observers feel about the law. Considering 50% of Americans can’t identify New York on a map we tend not to read too much into these polls. However, according to the logic of extrapolation, since we know that the ACA remains law, we are in the elite 58% (it’s about time we made it into the elite of something).
In almost parallel to the KFF news, the New England Journal of Medicine published a follow-up study of the “Oregon experiment.” For those who haven’t been following closely, the study found that previously uninsured people who were enrolled in Medicaid did not see an improvement in clinical measures when compared to those who remained uninsured. The study did seem to show a reduction in the amount of financial distress for the insured however.

Another contentious study, another Rorschach test (example, example). In light of the fact that for most practical matters ACA doesn’t really get going until 2014, use of the extrapolation noise generator approach smacks of a lack of analytical rigor in our view. We will know soon enough how the program is doing… exchanges start enrolling on 10/1.

As investors, we should state upfront that we tend to give more weight to financial returns than what the philosopher-kings might call the political context. So what caught our eye in the Oregon study was that Medicaid recipients had higher healthcare utilization rates (and associated costs) than the uninsured. The connection between gaining insured status and healthcare utilization should not come as a surprise since there is a very extensive literature elucidating this connection.

We have noticed that many in the political community, especially where it pertains to entitlements, have taken an absolutist utilization=bad view of the world. At Poliwogg we take a more nuanced approach. We view healthcare expenditures not as a cost but as the creation of an asset. In our framework, utilization can be categorized as generating either a positive return or a negative return depending on the outcome. If the expenditure creates additional value it is good, if it does not than it is bad. We would take a good pharmaceutical over a bad diagnostic test any day despite the former often being more expensive upfront.

To be fair, it is not always easy to determine a priori whether utilization will have a positive or negative consequence longer-term. And it should be noted that the system does have significant inertia hard-wired into it (prior mis-allocation of resources, a mal-incentive based reimbursement structure and asymmetry of information, among other things) which needs to be overcome. Nevertheless, there are signs that some things have changed recently to offer some glimmers of hope of a possibility of value creation and system enhancement. Like it or not, ACA is a change-agent and it will alter the status quo. The impact of improvement in technology and telecommunication, which allows for more real-time observation of events and predictive analytics, is first being felt. And, given the downward trajectory of utilization connected to the recent economic downturn it’s a pretty good supposition that healthcare costs (after many decades of rising) are finally starting to alter behavior on the part of patients and providers.

With respect to investing, uncertainly caused by media/pundit noise often depresses valuations in the short run. We suggest investors avoid the extrapolation machine and stick to observing fundamentals and fact. In the context of healthcare, as we see it, this means focusing on a double bottom line: companies with financial return potential (at the appropriate risk level) and companies who create value through innovation either by improving quality or meeting a need (especially true in the case of therapeutics for many currently poorly-treated diseases). If investors do this they can let the extrapolation machine work for them rather than exacerbate the problem.

Morten Hjelmsoe

One of things that we’re hearing a lot about right now is big data. We’re told that we’re entering an era of big data that will come to transform business and government services alike. For data, so the thinking goes, the bigger the better. But, asks Agnitio’s Morten Hjelmsoe,  is this always the case?

There’s no doubt that big data is very useful. As organizations create and store ever more digital data, they can use it to make informed decisions on everything from product inventories to employee morale. And, through the growing use of sensors embedded in products, it’s increasingly possible to offer novel after-sales services and even proactive maintenance. That way, customers may not even notice as preventative measures are taken before a failure occurs.

It’s also thought that big data will enable an ever-narrower segmentation of customers and therefore make possible more precisely tailored products or services. But it’s here that I take issue. While we certainly do want better segmentation, crunching vast data repositories might not be the best way to get it – particularly in the pharmaceutical industry.

Big data, old paradigm
The problem is that big data actually operates using an old-fashioned paradigm. This says that we need to deal with people in groups. So we start off with data about everyone and then look for patterns; effectively chopping the data down to size and creating some more manageable groups at whom we can target our communications.

If you think about it, this big data approach is actually a little odd. In effect, we are taking data from individuals, squashing it together into a big pie and then chopping it into slices. Why would we do this if individuals have already told us what they are interested in? The process makes it less individual and therefore less relevant. Why deal with groups at all?

Small is beautiful
The reason that companies need the big data is because they don’t have the “small” data. But pharma actually does!

Like no other business, we physically see our customers, if not every week but then at least several times a year in most markets. I know of no other B2B industry that has such frequent face-to-face interaction with its customers.

This customer contact is a tremendous resource but one that until recently we haven’t been able to tap; we loaded up our reps with information but they come home empty. That individual “small” data was lost. But not any longer.

New digital technology allows our sales force to understand each healthcare professional’s personal needs and interests, keep track of it, and respond. In effect, we now don’t need to force fit customers into any kind of group. This means we can give them highly relevant information. And that means higher value for the customer.

So get your reps into play. As an industry, we are in the best position to focus on the individual and we now have the tools to make it happen. When it comes to data and the pharmaceutical industry, my advice is to go small and think big.

Morten Hjelmsoe is founder of Agnitio.

Peter Houston

You know this: digital marketing means you have the potential to get your message in front of more people than ever before; search and social media offer reach on an unparalleled scale. According to global internet analytics firm Comscore, there are 13.7 billion searches conducted on Google every month. With 60% of US consumers saying they looked for health information online in the last year, that’s a lot of potential patients.
The problem is, that reach is available to everyone else from top-10 pharma to your local Deli: We’re all publishers now.

Actually we’re not all publishers, we’re all authors. Publishers — certainly in the traditional sense of the word — would never allow most of the content on the Internet out of the slush pile. And it’s the public accessibility of that slush pile that might just provide Pharma with its best opportunity to be heard above the noise.

Content marketing — the art of creating and distributing relevant and valuable content to attract, acquire, and engage a clearly defined and understood target audience — is being hailed as the brightest hope for marketers desperate to cut through the Internet’s clutter. So far so good – Pharma has been producing quality, expert-led, evidence-based content for ever.

If you read some of the content marketing blogs you would think these geniuses had just invented the concept. But content marketing has been around almost as long as marketing.

• John Deere, America’s favourite tractor manufacturer, released the first customer magazine in 1895
• Guess what brand of flour my mother-in-law has on her kitchen shelf. Here’s a clue – she swears by her BeRo Flour cookbook first published in 1923 and now in its 40th edition.
• Have you ever wondered why the world’s leading restaurant guide is named after a tyre manufacturer? Back at the turn of the last century Michelin published its first restaurant recommendations to give drivers a good reason to burn more rubber.

What is new is the importance marketers are placing on real value delivered through content. Possibly the biggest reason for this new focus on quality is that Google, the daddy of web search, got tired of people gaming its search algorithms with sub-standard content

To combat SEO tactics that had more to do with keyword stuffing than content quality, Google changed the rules of the game with its Penguin algorithm, introduced this time last year and already headed for its third update. I won’t even begin to pretend to understand how Google’s algorithms work, but I do know they are focusing more and more on the quality and ‘shareability’ of content to improve the search experience and this puts content marketing firmly in the frame.

There’s also the added benefit that, rather than interrupt people with unwanted sales pitches, content marketing offers a non-interruptive approach to customer communication. The ideal is to create a regular stream of valued, trusted content that customers will actively seek out and share.

Pharma’s content-marketing opportunity is to make sure that when a doctor or a patient goes searching for health information — which they are doing more and more — the right content is there waiting for them. When they get exactly what they want, when they want it they’re also happy to pass it on to friends and family. The problem is pharma doesn’t like sharing.

Content marketing principles — valuable content that engages a clearly defined audience – might have been at the heart of pharma’s efforts to help HCPs and patients understand and adopt new treatments for years. Pharma should have a head start in the content marketing race, but it’s firms like Marriot, Old Spice and American Express that are getting noticed for their content marketing efforts, because they love people to share their content

“As a well-oiled content machine that knows how to build relationships, pharma should thrive in this new era,” writes Dr Candice O’Sullivan of Australia’s Wellmark agency on PharmaForum. “Here is an industry well used to the rigours of consistently producing high-quality content — the number one challenge for most content marketers — but finds it virtually impossible to ‘share’.”

O’Sullivan closes by describing Pharma as an industry “too preoccupied by the risks involved to be able to make the most of this opportunity”. Sound familiar?

Peter Houston is former Group Content Director for Advanstar Pharma Science. He is now an independent media consultant and founder of Flipping Pages.

The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help halt the epidemic of prescription drug abuse raging across the country. FDA’s decision leaves the market open to Purdue Pharma’s newer version of the drug, which the agency determined has features that make it more difficult to abuse via injection or snorting.

Purdue had stopped shipping original OxyContin in 2010 when FDA approved its reformulated, safer product, and had waged a campaign to prevent generic versions of its original product, whose patent expired April 16, 2013. After much deliberation, FDA agreed with Purdue and declared on the same day that it would “not accept or approve any generic forms of the original OxyContin ER,” according to Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research. FDA also updated the labeling of “new” OxyContin to support its abuse deterrent features.

Generic drug makers and some physicians had argued that patients need access to less costly pain treatments. But the prospect of cheap, easily abused generic painkillers flooding the market aroused strong opposition from state and federal officials struggling to control illegal prescription-drug use. FDA may approve other oxycodone extended release products with abuse-resistant features, but Purdue’s new product has a patent until 2025.

FDA has asked Purdue to conduct postmarketing studies of reformulated OxyContin to evaluate further its impact on abuse. Meanwhile, the agency is working to finalize draft guidance issued in January that maps out approaches for manufacturers to develop drugs with abuse-deterrent characteristics. A number of generics firms were poised to launch new versions of old Oxy, eager to gain a bigger share of the $10 billion U.S. painkiller market. Some are likely to challenge FDA’s decisions and contest patents of the newer painkillers.

The Obama administration’s budget plan for fiscal year 2014 apparently assumes that the pharmaceutical industry can support Medicare and other health programs through changes in drug coverage and payments. It also relies on industry fees to keep the Food and Drug Administration up and running. Meanwhile, FDA and other public health agencies are contending with the sequestration mandate, which is taking another bite out of government programs and payment policies.

Despite the the administration’s claim that its boosting 2014 funding for FDA by $821 million, that actually translates into less money for oversight of drugs and biologics. Most of the added resources will come from newly proposed user fees and previously agreed-on fee increases. Any added revenues are targeted to food safety, a new China import initiative, support for medical countermeasures and lab and building costs. The actual funds available to FDA for this year already are $117 million less than for 2012, according to the Alliance for a Stronger FDA. And without hefty new user fees, which are not likely to be approved, the numbers will go down even more for 2014. It’s pretty hard to detect what the numbers really are, but the prospects for a stable regulatory operation are not bright.

In addition to contributing more to FDA operations, the White House wants biopharmaceutical companies to shoulder more of the costs of Medicare drug benefits and to absorb some very costly policy changes. One relatively new proposal is to boost industry’s contribution to closing the Medicare Part D “donut hole.” Pharma companies already are providing 50% discounts on drugs for seniors caught in the infamous coverage gap; now Obama wants to up the discount to 75%, a change projected to cost manufacturers some $11 billion over ten years.

Another idea is to revise reimbursement for drugs provided through doctors’ offices and clinics under Medicare Part B. Here the administration wants to shift the reimbursement rate from average sales price plus 6% to ASP plus 3%. That change carries a $9 billion price tag over 10 years.

Add to the list several perennial hits on pharma. Obama proposes to extend the Medicaid drug rebate program to Medicare dual eligibles, estimated to cost industry $3 billion next year and $142 billion over a decade. Another plan is to ban brand-generic “pay for delay” agreements, which would bring in $740 million next year and $11 billion for the long term, theoretically by boosting generic drug use. And the White House also expects $3 billion in savings by reducing the exclusivity period on biosimilars from the currently approved 12 years to 7 years. That’s a particularly dicey issue for pharma and biotech companies, as they are looking to promote a 12-year protection period in new international trade agreements under negotiation.

Sequestration struggles
Add to these “reforms” the cuts already levied under budget sequestration. FDA has to absorb a 5% reduction in funds – some $200 million — on its already squeezed budget total. Agency officials say they hope to avoid staff furloughs and layoffs by going slow on new hires and new programs. But the agency is predicting fewer foreign inspections and a possible slow-down in application approvals.

It appears that the 5% hold on funds also applies to user fees anted up by industry. As user fee revenues can’t be used to pay down the national debt or support other government activities, some $80 million in fee payments may just sit in the Treasury until Congress agrees on a better strategy for curbing federal expenditures.

Sequestration also is cutting Medicare fees to providers and vendors by 2%, which applies to Medicare Part D plans  as well as to reimbursement to oncologists for chemotherapies administered under Part B. Cancer clinics made headlines a few weeks ago by reporting that they were turning away Medicare patients because they can’t afford to purchase drugs under the reduced rates.

Things are even worse at the National Institutes of Health, where the sequester means a loss of $1.6 billion on its $30 billion budget. The 2014 Obama budget gives NIH a tiny increase, but all the talk of major initiatives to map the human brain may be overwhelmed by the agency’s need to limit many activities. And that jeopardizes prospects for new research discoveries that will lead to innovative medicines for patients.

By Leela Barham.

England’s Cancer Drugs Fund (CDF) could be in its final financial year, after running in full since April 2011.  The fund covers the cost of cancer treatments either when NICE has said ‘no’, or hasn’t yet come to a view.  Companies can’t circumvent NICE though; if a company was invited to submit to NICE and refused, it’ll be refused CDF funding for its product too.  The CDF is supposed to be a ‘bridge’ to Value-Based Pricing (VBP), due to be implemented in January 2014.

Why was a fund needed?
The Fund was driven by a heady mix of a desire by the Conservatives to grab votes in the last General Election in 2010, strong political lobbying and perceived weaknesses in how England makes it’s decisions on which products to recommend for use.  The latter really means that many expensive but potentially beneficial products were simply not being recommended by NICE.

Stats illustrate this with NICE saying no in more than a third of recommendations in 87 technology appraisals of cancer medicines since the year 2000.  But that also hides the distinction between ‘recommended’ and ‘optimized’; where optimized means restricted to use in specified circumstances, so not all of the remaining two thirds are recommended to all patients.  Such stats are important; so too are the processes that lead to recommendations being made.  The concerns are many, but for cancer centre on:

• Whether tools like the EQ 5D actually pick up on what matters for those with cancer
• How people in real life trade quality and length of life versus how economic models assume they do
• Whose values count, patients, or the public or even some combination

What did the fund buy?
Up to December 2011 the fund made around 10,000 treatments available to patients, covering 34 products.  Commentators now suggest that it’s now over 28,000 patients who have benefitted.

Too much £?
The Fund is small though, starting with £50 million and now £200million a year.  It amounts to very little when compared with the £5.1 billion spend on cancer by the NHS in 2010/11. Worryingly though, there are reports that not all the money was actually spent last year. It’s not clear if that’s because there isn’t unmet need or if everyone was just overly cautious and didn’t want to bust the budget.

Move to a national approach
Change is abound in the English NHS as a result of the Health and Social Act (2012) and the CDF has not escaped reform either.  The fund is now the responsibility of NHS England, the new national agency tasked with spending some £20billion and overseeing the Clinical Commissioning Groups who will spend the rest of the over £100billion NHS budget. There’s a single approach to making decisions, and there’s a single list of products that will be funded.  That’s quite a change from the regional approach taken up to now, with 10 funds previously in operation across England.  That may be good for some; it’s less likely that there will be a different view depending on where a patient lives.  That may also be bad for others; if a companies drug doesn’t get on the national list, it has no hope to get on a list anywhere else.

And the list is more restrictive now; 28 products versus the 34 reported available under the regional approach.  There is some scope for variation from the list though, with clinicians able to ask for funding for treatments for individuals with rare cancers. Decisions on whether or not to fund these will rest with 4 panels spread across England, but they’ll have to use the same process.

Will VBP fix the problems that led to the fund in the first place?
The answer at the moment is that no-one really knows.  The details of VBP are not yet known, and maybe not even worked out.  The uncertainty that this creates is leading to widespread concerns, and headlines and concerning stats like:

Cancer Drugs Fund: Patients to Lose Out….6,427 patients every year could be denied access to the medicines

Drugs fund axe ‘will hit 16,000 cancer patients’ as experts claim access to medication will be worst in Europe

One thing is for certain though; the success or otherwise of VBP will be measured in access to cancer medicines.

Leela Barham is an economic consultant. She can be contacted via her site or at leels@btinternet.com

There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices.

Although recent legislation and regulations have greatly expanded the range of information that pharmaceutical companies have to unveil to the public, there’s an escalating demand for even more transparency.

The new “Sunshine” law — requiring drug and medical device companies to report virtually every penny they transfer to physicians and teaching hospitals, whether for conducting research, consulting, or providing free lunches — is just the tip of the iceberg.

The theory is that disclosure of financial relationships between manufacturers and prescribers will shed light on medical treatment decisions — particularly for new, more costly medicines versus older, cheaper treatments.

There’s also a broader clamor for transparency in clinical trial activities and study results. After years of reluctance, most pharma companies now post information on active clinical trials on the federal clinicaltrials.gov website. Such listings inform patients of opportunities to enroll in research, and also provide a baseline of clinical studies subject to fuller disclosure of trial result summaries after product approval. Now regulators and health advocates seek to expand disclosure to include findings on all clinical trials, even those for drugs that fail to gain market approval. Leading medical journals are working with European Union officials to promote the AllTrials effort to register and disclose results from all clinical trials around the world. Trial summaries are not enough; safety advocates and industry critics seek disclosure of patient level data and case report forms so that they can verify the sponsor’s research results and product claims.

This call for greater data transparency reflects charges that sponsors have hidden important safety information from regulators and the public. Pharma companies counter that full disclosure can raise patient privacy issues and lead to misinterpretation of findings by non-experts. Abbott’s pharma spin-off AbbVie has filed suit to prevent the European Medicines Agency from releasing patient-level clinical trial data, as has InterMune of California.

Yet, a number of pharma companies are adopting a full disclosure policy, some building on research disclosure requirements set in consent agreements negotiated with the Department of Justice and other federal and state enforcers.

In February, GlaxoSmithKline announced it would release patient-level data as part of a new “openness” policy. In addition to posting notices on new trials and result summaries, the company will make available clinical study reports for all medicines — approved and discontinued — after results are published.

Roche is taking a similar stance, partly in response to criticism over hiding clinical trial safety reports on its Tamiflu influenza treatment. Roche has formed an independent body to assess outside requests for patient data from trials supporting market applications and will make such information available after product approval in the United States and Europe.

Price transparency
An equally important goal of US transparency advocates is to reduce healthcare spending through competition generated by broader disclosure of prices for healthcare services and medical products. The new online “marketplaces” established by Obamacare for consumers to shop for health insurance will feature comparative information on plan premiums, co-pays, and benefits, along with drug formularies and pharmacy coverage policies, to help identify the best deal for an individual on coverage and costs.

Disclosure of information on drug coverage and costs has gained support from a steady supply of reports on pharma pricing issues from federal investigators. One analysis issued in February by the HHS Inspector General found millions in overpayments for drugs covered by Medicare Part B under the current average sales prices reimbursement formula. Another study criticized inadequate conflict-of-interest assessment for members of Medicare drug plan formulary committees, a factor that supposedly could bias committee judgment in drug selection decisions. The Government Accountability Office recently investigated and called for changes in how Medicare pays for drugs used in dialysis treatment.

Consumer advocates and pharma critics maintain that full disclosure of drug prices will lead to much lower costs for patients. Pharma companies counter that such transparency will only boost prices overall, especially for those customers that currently enjoy favorable rebates and discounts. Industry’s biggest fear is that some kind of national formulary will lead to reference pricing, higher rebates, and eventually drug price controls.

Social media exposure
Over the long run, though, much information on pharma research and prices will become public with the expansion of global search engines able to tap into millions of queries and postings on medical treatments and healthcare costs. A recent study by scientists at Microsoft Research, Stanford, and Columbia University, published in the Journal of the American Medical Informatics Association (March 6, 2013), found that Internet searches on drug use uncovered previously unrecognized adverse events. Here, queries from six million people in 2010 searching for information on antidepressant Paxil and cholesterol treatment Pravachol disclosed a greater incidence of high blood sugar in patients taking the two drugs.

It’s not hard to imagine similar analyses of consumer searches for lower drug prices, product safety reports, and complaints about pharma marketing and advertising from health professionals and the public.

The ultimate question is whether such disclosure enhances patient care — or adds to the complexities of innovative research.

Jill Wechsler is Pharm Exec’s Washington correspondent. She can be reached at jwechsler@advanstar.com

On April 1, India’s Supreme Court denied an appeal challenging the rejection of a patent for Novartis’s cancer drug, Glivec. The drug is a life-saving medicine for certain forms of cancer, patented in nearly 40 other countries — including many which are not noted for the strength of their intellectual property rights, such as China, Russia, and Taiwan.

Critics of the IP system have hailed this decision as a victory for patients and as likely to improve access to the medicine. In fact, the majority of patients currently taking Glivec in India will continue to receive the drug free of charge through corporate Oncology Access programmes. Yet the consequences of the ruling are damaging for India’s economy as well as for the process of creating other life-saving treatments which future patients may need.

Even before the current ruling on Glivec, India already had a low level of intellectual property protection, and not just for pharmaceuticals. A country’s IP environment is important for trade, investment and economic development. Indeed, a growing body of academic and policy research now emphasises the link between economic growth, technology transfer and stronger IPRs. OECD research, for example, has found strong links between IPRs and FDI, R&D and economic expansion. And IPRs have particular importance to the field of biomedical research, so the Indian Supreme Court’s decision is now likely to make the country a less attractive prospect for future bio-medical investment.

According to research conducted by Pugatch Consilium and published in Scientific American, India demonstrates a limited ability to compete with other countries for biopharmaceutical investment, based on a range of measures including scientific capabilities and infrastructure, clinical environment, manufacturing and logistics, regulatory framework, healthcare financing and overall market conditions. As compared to Denmark, the most competitive country surveyed (scoring 83.2), India scores only 67.3 points on the index, putting it below Israel and Poland.

A complementary piece of research shows that strong IPRs encourage pharmaceutical R&D and investment as measured by clinical trials. Based on a study published in the Journal of Biotechnology, India already has one of the lowest levels of clinical trials per capita, falling below South Africa, the Philippines, China, and Chile and well below the UK and USA. This is likely to worsen as a result of the Supreme Court decision, which weakens India’s IPR environment still further.

The simple equation promoted by activists that high prices on patented drugs deny the poor access to medicines provides a morally compelling soundbite but the reality is that weakening IPRs, as India is now doing, will not help alleviate that poverty and nor will it help India to create the medicines of the future. Instead, India’s latest decision and others like it, will only make April fools of us all.

Any complacency that the world of healthcare might be feeling about advances in the ability to treat patients suffered a head-on assault in Dublin, Ireland, last week, at a conference organized under the auspices of the Irish Presidency of the European Union and featuring a galaxy of Irish and European stars from the worlds of politics, regulation, research, industry and patients. “Crazy,” “broken,” “failing” and “haphazard” were among the less extreme accusations made.

“Healthcare systems in Europe are failing patients,” charged one highly articulate cancer patient. Failing #1, he claimed, is inadequate data collection. “We are not in a position to analyse what we don’t have — and we are told this is an information age!” Failing #2 is incompetence. “Delayed and incorrect diagnosis is still far too common — the causes are cultural, structural, and about competence in primary healthcare.” Follow-up is “haphazard,” “often poorly defined, not really understood, and its value is under-researched.” The list went on and on.

“The pharma development model is cracked,” he said. “Because it is profit driven, commercial opportunism results. We get competing agents, me-too drugs and protectionist strategies, which hinder medical practice to the dis-benefit of patients.” Meanwhile, “costs have risen at every stage in the process, which itself has got longer. There is increased regulation. Pricing has become an art form.” And the new emphasis on the search for value is an attempt at something that is “very difficult to define.”

Health technology assessment was dismissed as “fractured,” because its processes are biased against rare diseases and their treatments at the very time when genetic research is fragmenting the old histological definitions of cancer and providing many more new ones, the aggrieved patient went on. “Every cancer is now rare, every treatment is orphan,” he insisted, and “a meaningful randomized clinical trial is sometimes impossible.”

The context for drug development was also pilloried. “To compound the problems, academic peer review and journal publishing is also broken,” ran the accusations. “The academic process kills patients. They die because evidence does not get published at all, they die while journals decide whether to publish evidence, they die because academic and healthcare regulators prioritise peer reviewed publication and thus preserve a system which builds in delay.”

The patient at the forefront of these attacks was Roger Wilson, who founded Sarcoma UK, and who has good reason to know both the merits and the demerits of current treatment regimes. Since he was diagnosed with a soft tissue sarcoma 14 years ago — after initial misdiagnosis — he has experienced multiple operations, chemotherapy, and amputations, and has benefited from successive remissions, but is about to start another round of treatment after Easter.

His recommendations ranged across the full area of interventions. In diagnosis, he argued, “genetics changes everything, and we have never had a better chance of improving things.” Primary treatment could be “an evolving success story for personalised medicine — built on 200 years of skill development, innovation, new technology and some admirable pragmatism.” Follow-up, through risk modelling, nurse-led clinics, and in primary care, could deliver more benefits if they were taken more seriously. HTA bodies should “use judgement, not rigid processes, and be sensitive to social factors, not dominated by economic factors.” He said there was a need for “new systems, which are appropriate for assessing biological treatments, supported with proper use of new technologies.”

The right approach, in his view, would be to recognize that “when curative treatments with toxicity and nasty side effects are futile, healthcare systems must provide the symptom control patients need, simple therapies such as morphine.” And healthcare systems “must offer good counseling and practical support which helps families address their own needs as well as those of their loved one,” he said. “If we fail to take up this last challenge we will create expectations which result in massive dissatisfaction, despair and unhappiness.”

His approach to his audience was as direct as his message was harsh: “Let me also remind you that every one of you will die one day, and rather too many of you from cancer; so I suggest you sit up and pay attention.”

There’s a thought for Easter — one more related to entombment than resurrection.

Peter Houston

You don’t have a social media policy yet? Oh, you do, you just didn’t tell your staff?

By Peter Houston.

A few weeks back I wrote on this blog about the need for CEOs to get social. I’m realistic, I know that the majority of CEOs still don’t engage directly in social media. Mostly it’s “the team” that does it, the marketing team, or the social media team, or the whole team. Great. Have you told them what rules they’re playing by?

Back in October 2010, Pharmexec reported on a bold new initiative by Swiss drug maker Roche. They had taken the bull (maybe a cow in Switzerland) by the horns and published a set of internal guidelines on when, where, and how to apply social media tools when communicating with key stakeholders and the public.

The guidelines were a real novelty at the time, the first in the industry. Even now, almost two years later, transparent standards for online behaviour are not exactly de rigueur for Pharma… or anywhere else for that matter.

Numbers vary but there is a broad consensus that written social media policies are absent or poorly communicated. Research conducted by the Center for Marketing Research at the University of Massachusetts Dartmouth for the 2012 Inc. 500 Social Media Update found that a huge majority of INC. 500 companies plan to increase their social media spend this year, but that only 24 percent had a written policy for employees using social media tools on behalf of their company.

Late in 2011 Grant Thornton reported similar findings: More than three-quarters of 140-plus companies responding did not have a clearly defined social media policy.

More recent research from the UK seems much more positive. A study by social media consultancy Immediate Future on the adoption of social media policies showed just 19 percent of companies didn’t have a formal policy. However, whilst more than 80 percent of businesses had a policy in place, for many it was out of date, still in draft or, most important, not well communicated to employees.

Poor communication of policy is noted as a particular problem by Kirsten Liston of SAI Global’s Advisory Services team. Offering tips for developing a corporate social media policy on the Corporate Compliance Insights website, Liston says that the prevalence of social media has increased the risk of compliance violations and that it’s important that employers and employees understand those risks. Regulatory restrictions specific to Pharma are much debated, but what about more prosaic infringements. It used to be you only had to worry about employees with computers on their desk. Now, with the spread of smartphones, everyone is a potential risk. Instagram photos from the lab or the manufacturing floor anyone?

But don’t think you can throw a blanket ban over the problem; simply forbidding employee discussion of their jobs is no longer an option, at least not in the US. A recent National Labor Relations Board pronouncement says employees must be allowed to discuss working conditions freely, whether at the workplace or on Facebook.
So it’s all about striking a balance. If you think this all sounds like too much effort to mitigate a hypothetical risk, here are a couple of quick examples of corporate social media screwups.

You may have heard that UK music retailer HMV recently laid off almost 200 people earlier this year. If you did it’s probably because Poppy Rose, the community manager in charge of the company’s Twitter account, broadcast a blow-by-blow account on Twitter, including tweets like, “Mass execution, of loyal employees who love the brand”. While HMV gained 10,000 followers during the “broadcast”, the company’s management was widely pilloried for mismanagement.

Then there’s the case of Dr Amy Dunbar, an ob-gyn working at St. John’s Mercy Medical Center in St. Louis. She posted on Facebook about a patient’s tardiness. Asked why she didn’t transfer the patient, she divulged that the patient had suffered a stillbirth in the past. Dr Dunbar was not found to have breached any regulations, but criticisms of unprofessionalism and hypocrisy on the part of the hospital authorities were very public.

Would a social media policy have prevented these cases? Probably not in the case of HMV, where a judicious change of passwords ahead of the layoffs would have been much more effective. Probably yes in the St. John’s case.
The trick is to achieve the standards that you need without limiting your company’s social media potential. Roger Estafanos, director of Life Sciences for Peppers & Rogers Group’s Healthcare practice recommends pharma companies take a customer-centric approach to social media activity.  Understand your audience, the channels they use, and what they are interested in. Then, you guessed it, allow employees and the public to participate within those “rules of engagement.”

In developing your rules of engagement, remember you’re part of a heavily regulated, competitive industry, not set up for “instant unfiltered communications often seen in social media channels” as described by Snell and Wilmer on Martindale.com. Their advice is to work closely with your legal and marketing teams to maintain an up-to-date social media policy.

If you need a starting point, there are 30 policy examples on Immediate Future’s blog and Edelman SVP David Fleet offers up a long list of examples and how-to resources on his blog.

While the task of formulating a serviceable, and sustainable social media policy is daunting, the potential benefits of enhanced social media participation outweigh the challenge. Imagine you get it right and every one of your employees becomes an advocate for your brand online.

My personal advice, talk about social media regularly and keep it simple. There is a certain irony in companies publishing a social-media policy 25-pages long to regulate a 140-character tweet. How about this? “Don’t say anything online that you wouldn’t want to see quoted on CNN, be asked about by your mother or have to justify to your boss.”

I found that on Twitter; you can have it for free. You’re welcome.

Peter Houston is former Group Content Director for Advanstar Pharma Science. He is now an independent media consultant and founder of Flipping Pages.