In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored.

FDA told Baxter in the latest letter that it is “very concerned by your continued violative promotion of your products.” The agency requested that Baxter cease dissemination of the Araplast brochure and respond in writing about how it intends to bring its promotional material in line with the Federal Food, Drug, and Cosmetic Act.

Baxter reports that it has since sent a letter of response to FDA and put its promotional material for Araplast on hold. In a statement issued Aug. 31, the company said it “has confidence in the strength of its promotional review policies and procedures and a history of collaborating with FDA. [Baxter] will continue to work with FDA to ensure the company is in compliance with all relevant rules and regulations.”

Like it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to democratic engagement, or to giving people with a legitimate interest a legitimate voice. It’s the word I object to. Partly on aesthetic grounds, because it is an ugly coining. But much more because it is one of these words that has now been appropriated by everyone to mean exactly what they want it to mean, irrespective of what it means to anyone else. Consequently, despite its almost mandatory inclusion in every discussion of contemporary pharmaceutical affairs, it has largely lost its meaning.

The upcoming symposium of The Organization for Professionals in Regulatory Affairs (TOPRA) offers a fine example. One of the sessions, entitled ‘Better access to medicines in a changing regulatory environment,’ will look, says the programme, at “the important contribution of all stakeholders” in achieving better health outcomes and improved access. The session will doubtless provide a valuable investigation of some of the genuine challenges identified in the title. But why ‘stakeholders’?

In fact the programme goes on to spell out who TOPRA consider

s as the constituents of this group: “specifically patients, healthcare professionals, academia, pharmaceutical industry, EU institutions and regulatory agencies.” That seems a perfectly reasonable list of interested parties to debate the subject. But when it then indicates that the discussion will cover “the experiences of interaction between stakeholders and working parties at national and EU level,” the question immediately arises as to who sits on these working parties. Not stakeholders, since stakeholders are interacting with them. That — according to TOPRA’s own definition — would rule out patients, healthcare professionals, academia, pharmaceutical industry, EU institutions and regulatory agencies. So what looked like a useful exchange on an important subject is suddenly revealed as an exploration of what can only be phantom working parties consisting of people who have nothing at all to do with pharmaceuticals.

To offer only the most obvious example of the risks to the pharma industry from lazy use of words like ‘stakeholder,’ look at how the term is used by the European Public Health Alliance (EPHA) — an admirable, influential and respectable civil society organization, but no automatic supporter of the pharmaceutical industry. Its mission statement includes the pursuit of “European insti

tutions that are accountable and accessible, policy-making that is transparent and with real opportunities for stakeholder input.”

The stakeholders that EPHA are thinking of certainly do not include the pharmaceutical industry or EU institutions. For EPHA, and many of the other organizations that maintain cautious vigilance over the operations of the pharmaceutical industry, stakeholders are the public, or patients, or consumers, or organizations representing them — not, in other words, the uncritical allies of pharmaceutical companies.

So if the European pharmaceutical industry continues to use the term uncritically, it is at best muddling its message, and at worst playing into the hands of some of its most vociferous opponents. The point is not a simple question of semantics. If the pharmaceutical industry wants to win the battles for hearts and minds that it inevitably and constantly must fight across so many fronts, it is going to increase its chances by being more rigorous in its approach to debate — and it is going to decrease them by sloppy talk.  One stakeholder’s heaven may prove to be another stakeholder’s hell.

It used to be so easy. Patients listened to doctors, doctors listened to pharma and everyone was happy. There was even a time when payers listened to pharma, reimbursing their prices with very few questions asked. Now everyone is asking questions and no-one listens to anyone else.
No-one, that is, except pharma. Branded as the bad guy of healthcare, companies are nonetheless trying to learn the art of dialogue, enlisting medical liaison officers in place of reps, engaging social media experts to navigate the minefields of Facebook and YouTube, and creating whole new departments to become more conversant in health economics and patient reported outcomes.

On Facebook, where it can seem the entire world is engaged in conversation, pharma companies are seriously outcast.

But with every step they take in this new patient-centric world, their handicaps become more apparent. On Facebook, for example, where it can seem the entire world is engaged in conversation, pharma companies are seriously outcast. According to the Dose of Digital website, there are around 50 Facebook pages sponsored by pharma and healthcare companies but the vast majority of these don’t allow comments from the public, thereby scuppering any hope of dialogue before its even started.
Dose of Digital founder Jonathan Richman cites three reasons for pharma companies’ reticence to fully engage:
1. They don’t want people to post adverse events.
2. They don’t want people to post off-label information about their products.
3. They don’t want to deal with negative comments.

All good reasons but a fourth — incurring the FDA’s wrath — is arguably the most potent. This happened when the FDA sent a letter to Novartis on July 29, warning that using Facebook’s share button (ie, allowing dialogue) on its Tasigna page amounted to promotion of the leukemia drug. This should have been expected, because the regulations as they stand simply can’t handle sharing technology, where information about a drug can whizz round the net losing, at countless different junctures, the balance it must maintain in terms of risks and benefits.

Why all the talk about the benefits of social media when real dialogue is impossible until the rules change, if indeed they ever will?
So, why all the talk about the benefits of social media when real dialogue is impossible until the rules change, if indeed they ever will? One reason is the clear evidence that patients are the way forward and that they gather to talk about their conditions in ultra-convenient communities.
Patients are indeed the way forward.

In a recent international survey conducted by the Economist Intelligence Unit, the overwhelming conclusions were that patients are speaking up as never before and changing how healthcare systems work. The respondents, healthcare professionals and people from the life science industries, came from the US, the UK, Germany and India. Specifically, 52% of them said patients expect higher standards of care, 57% said they want more information about their treatment; 49% said they wanted more involvement in relevant decisions about their care; and 49% said they wanted access to the latest treatments.
But patients don’t exist exclusively on the web. Even when they choose to converse in patient communities, they usually do so on sites sponsored by patient groups, where their views and concerns are collated by people who are accessible by email, phone, even, dare I say it, in person.
Pharma could start its forays into meaningful dialogue with patients by engaging with these bodies. But the evidence suggests otherwise. Another international survey, this time conducted by PatientView into patient groups’ views of pharma, found that just 22 percent of the 665 respondent groups maintained routine contact with a pharma company.

Moreover, although many of these groups said they were opposed to working with pharma, many more told the survey they wanted to forge ties with industry but believed they were not sufficiently attractive to companies for them to be interested.
Whatever the reasons for this belief, patients are emerging as strong and natural allies of pharma and not only in terms of access to drugs. Call me old-fashioned, but given the rules effectively banning real dialogue on the web and the growing importance of patients, pharma could do a lot worse than simply picking up the phone and asking patient groups what their members want.

AstraZeneca suffered a serious setback at the start of July when the European General Court ruled that it had illegally prevented generic competition. The case dates back years, but the company – and many others in the industry – had been pinning their hopes on an appeal against a European Commission decision of June 2005 that the patent system had been misused to protect its anti-ulcer product Losec.

It isn’t just the confirmation of the €60 million fine that the Commission imposed at the time – although that is bad enough in cash-strapped times. Even more disconcerting are the broader implications for defending brand names.

As the Commission crowed triumphantly when the court issued its ruling, the judgement is significant for several reasons. It upholds the Commission’s decision on abuse of dominance in the pharmaceutical market. It also establishes that misuse of regulatory procedures, including the patent system, may constitute an infringement of EU competition rules.  The court rejected AstraZeneca’s claims that its conduct constituted normal competition and that it could be explained by errors or unauthorized behaviour by AstraZeneca’s patent agents.

The industry is still smarting from what it sees as the injustices in the Commission’s report just a year ago following the competition inquiry into the pharmaceutical sector, which threatened tough action against any attempts to stifle generic competition. Now Joaquín Almunia, the Commission Vice President who has taken over the competition policy portfolio from Neelie Kroes, is making clear he is
determined to keep up the pressure.

“Companies should not misuse the patent system and the system for authorization of medicines to extend the protection of their blockbuster products and delay the entry of generics into the market”, he said as the court judgement emerged. “Generic drugs benefit patients and governments that pay for medicines. I am determined to use competition rules whenever appropriate to fight such unfair and anticompetitive practices,” he went on.

The normally-reserved European Federation of Pharmaceutical Industries and Associations was provoked into a sharp response. EFPIA had intervened in the case because it was concerned that the Commission’s decision adopted a very narrow market definition in order to be able to demonstrate dominance. Now that this approach has been upheld by the court, EFPIA is even more concerned. The ruling “means that virtually any innovative product, even if introduced into a therapeutic area where other substitutable products can be prescribed to treat the same condition, risks being regarded as constituting its own relevant market, in which case the innovator will be assumed to be dominant”, it said in a terse statement. It went on to warn of “a chilling effect on pro-competitive commercial conduct and ultimately on innovation in Europe.”

As it that wasn’t enough bad news, just a few days later the Commission also announced that there had been a decrease in “potentially problematic patent settlements in the EU pharma sector”. In other words, brand name companies are increasingly being frightened off defending their patents in those borderline areas where the complexities of law and procedure leave scope for interpretation. The number of cases has halved, and the sums involved have dropped from more than € 200 million to less than € 1 million. “This would suggest an increased awareness of the industry of which settlement agreements might attract competition law scrutiny”, the Commission remarked, drily. It also made plain that it will “continue monitoring the sector”. It already has investigations underway into patent settlements, involving Servier and Lundbeck.

So how to respond? Two recent examples show some imagination. Among the brand name companies, Belgian biopharmaceuticals company UCB has just announced that it is reinforcing its IT teams to make better use of technology in developing treatments for patients. At a time when commodity products are becoming increasingly vulnerable to competition, UCB has made a virtue of pursuing the more elusive but potentially more profitable high-tech heights of medicines development. That still-vague concept of personalized medicine is opening up avenues that some companies are approaching on carefully-chosen fronts – and IT is becoming as central to the exploration as biochemistry.

The other example that has provoked some gasps of admiration – at the very least at the chutzpah it demonstrates – comes from the other end of the industry spectrum. This is the establishment of a chair at the University of Leuven in Belgium, by none other than the European Generics Association. The chair, entitled “European policy towards generic medicines”, will study the generic medicines policy environment in European countries. Greg Perry, the EGA director general, was as triumphant as the Commission in his speech at the inauguration: “As is recognized by all policy makers and stakeholders in the pharmaceutical market, generic medicines offer equivalent medical treatments at lower costs for healthcare systems and patients”.

Which is where we came in.

Reflector

A senior Spanish diplomat told Reflector recently that, on the face of it, the European Union is a crazy set-up. He was talking about some of its bizarre institutional arrangements — such as a Commission composed of 27 national nominees, who are allocated jobs almost at random by the Commission president, almost irrespective of their skills and background, and are then subject to a sort of inquisition by the European Parliament which can turf any or all of them out on their ear anyway.

He knew what he was talking about. He was just coming to the end of Spain’s term in the (equally bizarre) institution of the rotating presidency of the EU’s Council, where national ministers and officials meet almost every day to discuss environment or energy or economics. Spain found itself in the curious position of leading European discussions on how to restore economic stability at the very time that it was not far behind Greece as a target of criticism for massive fiscal mismanagement.

The EU has just got more bizarre. As from the beginning of July, Belgium has taken over the rotating presidency, supposedly to lead the way towards the political and economic high ground that the EU aspires to. But Belgium doesn’t even have a real government, as it hovers on the brink of domestic balkanisation. Policy and principle are being sacrificed as desperate attempts are made to cobble together a coalition, after an inconclusive election last month increased the chances of the country splitting up altogether. And its state finances are in a pitiable condition too.

Some of these curious EU characteristic were reflected in the first working meeting of the new Belgian presidency – which (readers of EPE will be relieved to learn) took the shape of an informal meeting of EU health ministers.

Laurette Onkelinx, Belgium’s caretaker health minister (and care-taker deputy prime minister, for what that is worth) spoke imperturbably and at great length about her country’s ambitions for the next six months, as if she was unaware of the fact that she might be out of a job (and her country out of funds) long before then. And John Dalli, the ex-minister from tiny Malta, who this year finds himself in charge of a huge new domain as European Commissioner for Health and Consumer Affairs, struggled manfully — but not always successfully — to rise to the challenge. His discomfort was evident when asked to give an informed view of the fight against cancer, responsibility for vaccine campaigns, or discrimination against homosexuals in blood donor programmes.

Dalli’s predicament was most obvious when he tried to explain what he planned to do about drug information to patients. When he took office earlier this year, he inherited a Commission proposal, already one year old, to allow the public wider access to information about prescription medicines. This proposal, stigmatised by critics as a licence for the pharmaceutical industry to bring direct-to-patient advertising into Europe, has languished in the Council, unloved by most member states, who smell all sorts of trouble with their electorates if they are perceived as giving free rein to drug companies.

The health commissioner says he won’t withdraw it, and aims to move forward with it. But he admits that he doesn’t like it, and wants to make it “more patient-centred”. However, he is in a bit of a trap, because he can’t do much about modifying it until he has a view from the European Parliament and the Council. The parliament discussion is dragging on slower and slower — a tentative June date for a vote has already been put back to the autumn, and could easily extend further into the winter, or even next spring. And although Onkelinx made valiant noises alongside Dalli about getting a common position out of the Council by the end of the year, the prospects of any coherent Belgian management of EU debate seem more remote by the day.

As an equally disconcerting footnote, this meeting of health ministers and officials from across Europe was remarkable for one other thing — a generalised sense of hostility and distrust towards the pharmaceutical industry. Whether on vaccine supply or drug information, the predominant tone was recriminatory and suspicious. A recent drug industry meeting in London — the annual conference of the European Federation of Pharmaceutical Industries and Associations – ambitiously explored the scope for building industry partnerships. That’s an initiative that has never been more urgently needed — and given the current European zeitgeist, couldn’t have been worst timed!

Reflector

The EMA’s Thomas Lönngren has gone public with his disquiet over organizations such as NICE. But pharma still needs more allies in fighting what it sees as the failings of the health technology assessment bodies, says

Europe’s pharmaceutical firms were never very keen on Britain’s influential National Institute for Health and Clinical Excellence (NICE). Industry has long feared that NICE’s judge-and-jury character confers an unacceptable level of unchallenged authority on the guidance it issues about what constitutes value for money. And in an area as contentious as health technology assessment, such power can be a dangerous threat to drug industry fortunes.

But now a new concern has emerged — not just from anxious pharmaceutical industry executives, but from an altogether more surprising source. Thomas Lönngren, executive director of the European Medicines Agency (EMA), has gone public with his disquiet over the role of bodies such as NICE.

His strictures extend further than the UK market, to embrace the entire EU ideal of a single market for pharmaceuticals. He says the single market has been ‘broken’ by the sort of health technology assessments typified by NICE.

Industry has long feared that NICE’s judge-and-jury character confers an unacceptable level of unchallenged authority on the guidance it issues about what constitutes value for money.

In his view, patient access is being impeded by what he sees as new product approval mechanisms based on cost-effectiveness. He insisted on the role of his agency in assessing products in terms of the criteria laid down by EU medicines legislation — of quality, safety and efficacy. Price, he made clear, does not come into the equation at the medicines agency.
Lönngren’s words are music to the ears of a pharmaceutical industry increasingly nervous about the impact of health technology assessment, and above all about its potential abuse as a fourth criterion for product approval.

Industry executives have latched even more energetically onto suggestions that Lönngren made about these value-for-money assessments undermining the work of his agency.

The agency boss has highlighted what he sees as risky moves to assess the cost-effectiveness of products in off-label use. He cited recent steps by UK health authorities to urge NICE to conduct an evaluation of off-label use of Avastin in age-related macular degeneration.

Lönngren indicated that he was unhappy with this development. How could his agency assure its responsibilities for patient safety if other authorities were encouraging use of a product in areas where no risk-benefit evaluation had been made, he asked.

The industry is repeating Lönngren’s words as widely and as often as it can — doubtless out of the same concerns for patient safety, but also conscious that assessments by NICE are already used to beat down prices for products in their authorized indications, and extending this practice into product comparisons for off-label use opens up a Pandora’s box of threats to reasonable evaluation.

An ally in Dalli?
Getting the head of EMA on the right side of the argument, however, is only part of the battle. European pharmaceutical executives face a tougher job in persuading national health and social affairs ministries of the merits of their case. They could do worse in seeking allies within the other major European Union player — the European Commission. But will the new Commissioner for Health, John Dalli, come down on the safety side of the argument, or defend the need for ever harsher scrutiny of drug bills?

Paul McClenaghan

Paul McClenaghan looks at how the UK high court’s recent decision regarding a shipment of fake Nokia phones could have serious ramifications for the transit of pharmaceuticals in Europe.

Recent complaints made by Brazil and India to the World Trade Organization regarding the seizure of generic pharmaceutical products in transit through the European Union illustrate the tension between the principles of free trade and those of intellectual property.

The conflicts involving Brazil started in 2009 when a shipment of the generic drug Losartan was seized in Rotterdam. Merck Sharp & Dohme, the owner of various European national patents for Losartan, was informed of the seizure by customs and able to detain the goods on the basis that they could infringe its intellectual property rights. The EU’s Border Measures Regulation empowers customs authorities to retain goods suspected of infringing certain IP rights in order to enable the right-holder, within a fixed term, to initiate proceedings to determine whether that right has been infringed or to settle the matter under the simplified procedure.

If the European Court agrees with the English court then drug companies will not be able to prevent fake medicines in transit through the EU.

The European Court is due to clarify this power in relation to ‘counterfeit goods,’ being branded goods that do not originate from the brand owner, after two references were made from national courts. A reference from the English High Court came about when UK customs (HMRC) stopped a consignment of fake Nokia branded phones at Heathrow en route from Hong Kong to Colombia. Nokia, as the owner of various intellectual property rights, asked HMRC to seize and retain the phones under the powers granted to it by the Border Measures Regulation but they refused. Nokia then made an application for judicial review of the decision and HMRC’s policy whereby goods travelling through the EU from one non-member state to another are not considered ‘counterfeit’ goods when they do not enter into free circulation in the EU.

The Court refused Nokia’s application, holding that the phones were not ‘counterfeit’ within the meaning set out in the Border Measures Regulation. A similar case was heard in front of the Belgian Court and a reference to the European Court also made.
Although these two references do not involve pharmaceutical products, the implications are obvious. If the European Court agrees with the English court then drug companies will not be able to prevent fake medicines in transit through the EU. Transit of such goods through Europe is increasing used by fraudsters to disguise the origin of the goods and make the goods appear more legitimate.

This has dramatic consequences for rights holders and for consumers, particularly those in the least developed countries

Paul McClenaghan is Associate, Intellectual Property Group, Stephenson Harwood. Tel.:+44 207 809 2335.

Jacky Law

Jacky Law says that news of the blockbuster’s death has been greatly exaggerated. But it may no longer be the preserve of Big Pharma.

There was a time not so long ago when people would pay good money to find out where the industry was at, let alone where it was going. Now, thanks to technology, intelligent snapshots can be obtained at the touch of a button.

The latest EvaluatePharma Yearbook, published earlier this month, is a good example. This digest of key pharma stats is based on consensus forecasts from leading analysts to 2016 and shows, among other things, that the blockbuster is far from dead.
Abbott’s anti-rheumatic, Humira, for example, is forecast to hit sales of more than $10 billion by 2016, almost double its 2009 figure of $5.6 billion (see Table 1). This impressive performance ousts Roche’s multi-purpose cancer drug, Avastin, from the number one slot it is expected to occupy by 2012 when the patent on Pfizer’s Lipitor has expired. Sales of Avastin have been downgraded following disappointing results in prostate and stomach cancers. Approved indications include colorectal, lung, breast (conditional) and kidney cancers as well as an aggressive form of brain cancer, glioblastoma.

Humira’s crown at the top of the table is not the only thing these rankings reveal. Another is the dominance of biotech (largely because of the premium prices complex biologics can command) with only two of 2016’s top-selling drugs — Crestor and Advair — being based on small molecule chemistry. A third is the dominance of certain therapeutic areas, notably anti-rheumatics and cancer, proving significant rewards are still to be had when science can deliver equally significant improvements in areas of unmet need. Of the top ten drugs, three (Humira, Enbrel and Remicade) treat the widespread condition, rheumatoid arthritis, and three treat various cancers.

The final observation from the table is that even drugs that are not yet approved can make an entry. Amgen’s osteoporosis antibody, Prolia, has, however, received a positive advisory committee review and a launch is widely anticipated this year. Indeed, of the 20 or so major product launches expected in 2010, the EvaluatePharma database forecasts that seven have the potential to generate sales of more than a billion dollars by 2014.

The blockbuster, it seems, is far from dead. However, revenues from these big-earning drugs are less likely than ever before to go into Big Pharma accounts. EvaluatePharma analysts point out, “Whereas in 2009, Big Pharma dominated the league table by being involved with 18 or the 20 biggest expected launches, this year half of the products could be commercialized by smaller and more specialized companies.”

So, the blockbuster is not only very much alive, it is breathing new life and changing an industry long dominated by a handful of extremely large companies.

For the full version of this article, click here.

Although Pfizer claimed the first and third spots on the league table, AZ emerged as the industry’s digital powerhouse with three brands in the top ten—Nexium, Crestor, and Symbicort—and four in the top 20.

While AZ maybe innovating online, L2 founder and NYU marketing professor Scott Galloway said that the industry as a whole disappoints. “Most brands offer obsolete technology, anemic content and scant social media programs.” Summing up the challenge facing pharma, PHD Network CEO Scott Hagedorn said, “Right now, there are millions of unregulated conversations taking place online regarding prescription drugs, from which the voice of pharmaceutical companies is mostly absent.

Bayer's Andreas Fibig introduces Digital Pharma Europe 2010

If anyone had any lingering doubts about an unprecedented era of inclusion and transparency promised by pharma’s newfound, if tentative, embrace of online social media, then last month’s Digital Pharma Europe conference must have gone some way to soothing them. Here, Novartis companionably took the stage with Boehringer-Ingelheim, Roche sat happily alongside AstraZeneca, and they all — along with representatives from other rival companies — were warmly welcomed into the Bayer-Schering headquarters in Berlin to swap stories, explain strategies and generally offer each other support and advice with regard to the latest phenomenon in pharma communications. Indeed, if I was less cynical a person, such a display of harmony and co-operation might have brought a tear to my eye.

But there remained a niggling doubt that echoes celebrated screenwriter William Goldman’s oft-quoted comment about Hollywood: nobody really knows anything. A scan of the conference participants’ job titles either confirms the healthy buoyancy of the industry’s approach to this revolution in patient, physician and corporate communication, or reflects the fact that everyone has their own conflicting ideas: Director of Social Media, Head of Corporate Internet Presence, Head of Digital Marketing, Lead, New Media Communications and, not forgetting, the good old Director of Corporate Communications.  Still, the very fact that the industry now has some recently re-titled Heads and Directors of Social Media underlines its long-awaited recognition of the importance, or finally its growing fear, of Web 2.0 and what it means for online strategies.

Not surprisingly, the conference saw attitudes to social media’s place in a pharma company vary fairly widely, from “social media is just another communication channel” to “no, it’s not a channel, it’s a platform” (this from speakers in the same company) to “social media shouldn’t be in our job titles, it should be ingrained in all our communication activities” and “there’s no such thing as a social media strategy.” All of which highlighted the concern expressed by more than a few members of the audience: is pharma’s engagement with Web 2.0 still an ‘experiment’ or is it a genuine attempt to spread the social media culture?

Colin Foster, Novartis’ Director of Social Media, told the conference that his role was both to experiment and to spread the culture. “But it soon becomes a question of how you embed social media into the organization,” he said. Novartis has advanced further down this path than some companies. It was one of the first companies to establish an alliance with PatientsLikeMe, an online community for people with ‘life changing conditions’ that has a current membership of around 45,000 patients and which logged over 360,000 posts last year. In 2008, it engaged PatientsLikeMe’s multiple sclerosis (MS) community to boost its registrations for its MS clinical trials. More recently, the company has helped establish an organ transplant community on the site and will use the information gleaned from its discussions in its future research.

But Gillian Tachibana, Merck Serono’s Director of Social Media, seemed to contradict Foster’s stance, saying pharma social media “is not about experimentation. Internally, it’s about education; externally it’s about having a strategy, a vision.” Merck Serono is perhaps more cautious after having had its fingers burnt by one online community it was involved with. Tachibana explained how the company “had a crisis on a message board” when someone made harsh criticisms of a rival company. “We didn’t deal with it too well,” she added. Merck Serono simply shut down the forum, a move that was soon picked up — and criticized — by the press.

As with any discussion of social media, Facebook could not be ignored. But again this was a bone of some contention. The virtues of the site as an important method to build opportunities for dialogue were duly extolled; Facebook, it was noted, has become one of the biggest drivers of traffic to websites; in some cases more so than Google. And it has over 1000 communities for people with chronic illnesses.

But Alex Butler, Communications Manager at Janssen-Cilag UK, reminded us that people on Facebook are there to have fun, not to be sold something, or even ‘educated.’ And with public trust in the industry at an all-time low, is it a good idea for Big Pharma to try and generate ‘friends’ on Facebook? “People don’t want an intimate relationship with a pharma company,” noted Alex. But what pharma does need to do on social networking sites, commented Marianne Gries, VP of Marketing at Merz Pharmaceuticals, is “listen, inform and engage.” Unfortunately, the acronym she uses to convey this message is ‘LIE.’

So, differing opinions reign. But I’ve been to enough pharma conferences in the past five years to know that inconclusiveness is usually the order of the day. I’d probably feel short-changed if I came away with any definite ideas about anything. Still, that doesn’t mean Digital Pharma Europe wasn’t a relevant and potent forum for a very healthy exchange of ideas — indeed it was.  And, in fairness, there was resounding agreement on some inescapable Web 2.0 facts and observations (with thanks to FD Santé):

• A decade ago, product launches didn’t even take account of patients; now they are at the centre of the campaign.
• Younger doctors and medical students comprise a generation that only knows online CME. Now every medical education campaign must include a social media element.
• It is pointless running a symposium unless you are going to broadcast it on the web.
• If we wait for official regulatory guidance on social media, we could be waiting forever, so industry leaders must write it themselves.

All of these topics, and more, we hope to pick up in our digital magazine, Pharmaceutical Executive Digest Europe, over the coming weeks and months. Whatever your thoughts are on where online social media sits and how it should be defined within your company, there’s no denying that it’s out there and it’s huge — and it’s not going to go away.