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.

Guest blog by Reflector,

Denmark is still on the fringes of some European Union policies. Notably, it has not yet embraced the euro as a currency, and it keeps its distance from the common defence policy. But in one respect, its pharmaceutical industry has just shown that it is well abreast — and even ahead — of EU developments.

As from the start of this year, the members of its national drug industry association, LIF, have committed themselves to a new code of practice on lobbying. The code sets ethical standards for member companies’ dialogue and negotiation with authorities and politicians.

This is different from the codes in most European drug industry associations on product advertising and promotion, or on relations with patient organizations. Here we see the Danish industry responding to a more generalized European concern: that big business has too much influence over politicians. It is a theme that has repeatedly erupted in Brussels, disturbing relations between industry and the political class. And the drug industry, along with other high-tech sectors such as plant biotechnology, car makers and nanotechnology, is frequently on the receiving end of accusations of indecent behaviour and excessive arm twisting.

The Alliance for Lobbying Transparency and Ethics Regulation, a coalition of civil society groups, trade unions, academics and public affairs firms, says it is “concerned with the increasing influence exerted by corporate lobbyists on the political agenda in Europe, the resulting loss of democracy in EU decision-making and the postponement, weakening, or blockage even, of urgently needed progress on social, environmental and consumer-protection reforms.”

Under increasing pressure for greater transparency, the EU has moved over recent years towards some form of governance in this sensitive area. Its own officials are now subject to rules about accepting gifts or other favours, and both the European Commission and European Parliament have established their own registers of lobbyists, with some element of commitment to observe minimum values of fair play.
But so far the drug industry, at European level, has not taken any particular initiative.

The European Federation of Pharmaceutical Industries and Associations has a code of practice on relationships between the pharmaceutical industry and patient organizations, and a code governing the promotion of prescription-only medicines to (and interactions with) healthcare professionals. But nothing about lobbying.

This is what makes the Danish initiative interesting. LIF members have signed up to a detailed code that requires disclosure through corporate websites of companies’ use of external consultants, insists that information supplied to decision makers is updated and complete and must not contain false or misleading information, and prohibits any form of financial support, sponsorship, payment or gifts to civil servants or politicians, including to political parties or to electoral funds.

As LIF says, it is important to raise the industry’s profile in the outside world, and make clear that the industry’s lobbying activities are conducted in an open, honest, fair and credible manner. Being able to demonstrate that the industry’s dialogue with the political/administrative level is based on independence and is fully transparent will help to enhance the industry image, it remarks. It does not go on to make the related point that failure to do so is likely, in an increasingly transparency-conscious age, to land the industry with a lot more trouble.

This column has frequently drawn attention to the complexities of getting anything done in Europe. A brilliant researcher can explore visionary horizons, an ambitious entrepreneur can offer a package of goods or services of inestimable value, but the degree of control and regulation becomes more intense every year — sometimes every month or week.

This is not an argument against controls, or against the democratic system that erects them. But just as new medicines or new services are subject to scrutiny before they are released, so too should a critical eye be passed over new developments in the controls that are introduced. And this week has seen a striking example meriting some review.

The European Ombudsman — a relatively new function in the European Union — has just opened an investigation into how the European Commission conducted a study into the use for research purposes of non-human primates, such as chimpanzees. The role of ombudsman is well recognised in Europe as a buffer against state or bureaucratic abuse. It gives the ordinary citizen a right of appeal. But like any valuable instrument, it requires some precision in use.

In this case, the ombudsman has launched an inquiry into what an animal rights lobby group has described as a ‘deeply flawed and biased’ Commission report about monkeys in research. The European Coalition to End Animal Experiments alleges that the Commission working group that drew up the report “lacked expertise in the area and that it failed to take certain evidence into account”.

The ombudsman has asked the Commission for its opinion. P. Nikiforous Diamandouros, who has just been re-appointed to the post by the European Parliament, is clearly determined to assert his renewed authority. “The Ombudsman has a vital role to play in promoting effective and transparent policy-making in the EU institutions,” he says in announcing his new inquiry. And he goes on: “I expect this role to become even more important in light of the Lisbon Treaty, which strengthens the right of citizens and associations to participate in the democratic life of the Union.”

Would it be inaccurate to discern the sound of someone scrambling onto a bandwagon in this declaration of self-importance? And would it be inappropriate to speculate that the ombudsman is now determined to seize on any grist might be brought to the mill of self-aggrandisement?

Many European pharmaceutical executives will be aware that the EU is currently in the process of updating its 20-year-old rules on the use of animal in experiments. The European Commission proposed a revision last year, and the European Parliament has already given its view, and the Council of Ministers is scheduled soon to adopt its position. It is, of course, a tangled debate, because of the inherent ethical problems posed by research using animals. It combines profound technical and scientific complexity with high emotion — heightened by the increased sensitivity to biodiversity and sustainability of recent decades.

But no-one in the industry is in any doubt as to the stakes in this debate: it affects the future of research and the future of medical science. It is too important to hijack for other motives. But the ombudsman seems heedless of the complexities. He takes at face value the complaint from the European Coalition to End Animal Experiments, and “noting that this issue is of great interest for the general public” — a questionable consideration in a matter supposedly of scientific and procedural exactitude — he ploughs on with his demand for a response by 30 April, and his undertaking to “ examine whether there has been any maladministration by the Commission.” The animal activists’ complaint is that the consultation process leading up to the legislative proposal was “unfair”, and that experts drafting the legislation did not take into account “a substantial amount of evidence” they supplied.

The sad truth is that if every complaint from every disappointed lobbyist is to be elevated to the level of a formal investigation, the democratic processes on which the EU is built are themselves jeopardised. And when the criterion for elevation to formal investigation status is the degree of public interest in a subject, effective democracy collapses completely.

The public have had ample opportunity to make their views heard on the subject. The parliament and the council are the appointed bodies to make decisions in light of all that input — and the process cannot be arrested simply because some people don’t like the way the discussion is going.

Jacky Law

Pharma companies are responding swiftly to the recent earthquake in Haiti with millions of dollars in cash and drugs. GlaxoSmithKline boasted, for example, that its initial $1.2 million offering of medicines — mainly oral and topical antibiotics — was on the first airlift to the Caribbean island and that more will follow.

The UK company was not alone. By January 15, the charitable alliance, Partnership for Quality Medical  Donations (PQMD), said a total of $15.5 million (E10.8 million) had been pledged by pharma and other healthcare companies. This comprised $7.3 million in products and $4.6 million in cash, equating to one third of all corporate donations and being roughly equivalent to the £10 million pledged by the UK government.

Some pharma companies, notably Abbott Laboratories, have even been able to use the humanitarian disaster to demonstrate an altruism that extends far beyond this immediate crisis. Together with its philanthropic foundation, the Abbott Fund, the company has pledged an initial $1 million in cash and medicines to the victims of the earthquake, which comes on top of more than $34 million already donated to Haiti since 2007. The current package includes $100,000 in grants to three of its aid partners: the American Red Cross, Partners in Health and the Catholic Medical Mission Board. The company is also working with AmeriCares, Direct Relief International and other organizations to identify what drugs are most needed by the survivors.

Other biopharm companies to have responded to international calls for help include Amgen, which has said it will donate $2 million in cash. Pfizer, which has a base in the neighbouring Dominican Republic, is working with people on the ground to assess what drugs are most needed. It has also made an undisclosed cash donation and pledged to match employee contributions to the disaster fund.

Merck & Co, meanwhile, is giving $350,000 in cash and has also pledged to match employee contributions while planning an immediate shipment of $200,000 worth of medicines, including its ulcer drug, Pepcid, Coricidin cold medicine and ringworm treatment, Lotrimin. Eli Lilly is said to be donating $250,000 in cash and will match its US employees’ contributions. Bristol-Myers Squibb has shipped out a consignment of medicines, mainly antibiotics and analgesics, and donated $200,000 plus a pledge to double what its US employees give. And AstraZeneca has donated antibiotics and respiratory medicines while also giving £100,000 ($162,500) to the British Red Cross effort on the island.

Help or hindrance?
However, the lesson of Johnson & Johnson is that such generosity can be seriously undermined if it coincides with other news that doesn’t go down so well with the public.

According to PQMD, J&J is giving unspecified cash donations to relief organizations working in Haiti, as well as bandages and medicines such as Tylenol and Neosporin. But things have taken a rather sinister turn for the US company that for years has been one of the most trusted in the world. On Friday, January 15, at roughly the same time it was pledging aid for Haiti, the company’s over-the-counter (OTC) division, McNeil Consumer Healthcare, announced the recall of several hundred batches of various popular OTC medicines, including the analgesic Tylenol. This was because of a foul odour emanating from the breakdown of a chemical used to treat the wood pallets used in the storage and distribution processes. It may well be that the Tylenol on its way to Haiti is perfectly fine but the juxtaposition of events only serves to highlight the PR disasters currently plaguing this once exemplary company.

Not only did an FDA warning letter arrive on that Friday saying McNeil had known about the problems for as long as 20 months but, in an entirely separate incident, and on the same day, the US Justice Department filed charges against Johnson & Johnson for allegedly paying “tens of millions of dollars in kickbacks” to nursing home pharmacy company, Omnicare, to increase sales of its drugs, notably the blockbuster antipsychotic Risperdal.

Regarding this latter incident, Johnson & Johnson has said its actions have been “lawful and appropriate” and it looks forward to “airing the facts” in court. Nevertheless, two ‘bad’ stories coming together have the effect of compounding each other, which can cancel out the effect of one ‘good’ act if it also comes at the same time. This is because the point of altruism is to help unreservedly or, at least, for the actions to be perceived that way. Any question that a drug to relieve suffering might be tainted is not helpful.

More than 250 people were in attendance for the two-day event, which included pharma marketers, brand managers, and patient education specialists who shared a common interest: The desire to connect and engage an educated, digital savvy population of e-patients and their caregivers.

Some attendees came to hear keynote speakers such as Dennis Urbaniak from Sanofi-aventis, Joe Shields from Pfizer, and Marc Monseau from J&J share their expertise on driving change, patient adherence, and the art of tweeting, respectively. Others like Derek Rago, vice president, strategy and marketing, McKesson Patient Relationship Solutions, traveled to Philadelphia from Arizona for the opportunity to understand how social media and networking influences his clients.

“How will pharma embrace and use social media appropriately? I’m thinking it’s part of a broader marketing strategy and building an appropriate relationship with my patients and social media can play a part of it,” said Rago.

Urbaniak, vice president of innovation and new customer channels at Sanofi-aventis, kicked off Tuesday with a presentation on shifting to a customer-centric approach. “The first mindset shift is the term around patient. We need to stop thinking patient and we really need to start thinking people,” said Urbaniak. “At Sanofi-aventis, we learned that when you’re a person who is first diagnosed with cancer and given the news that you need to undergo chemotherapy, it’s a tremendous impact. We look to see what hospital and grant programs are out there, but then build a program for patients that they want like bringing chemo therapy into their homes if that’s what fits their dynamic.”

Joe Shields, product director, consumer marketing and strategy integration, Pfizer, followed with new ideas for patient adherence. “For me, success is a healthy patient,” said Shields. “The empowered patient will be a collaborator and an active participator. It’s less about the sticking to something, and more about the ‘I want to do this for my health and my family.’ Adherence is starting to elevate the role of everyone in the community, and like health care, is a team sport.”

For the duration of the conference, participants had the option of using Twitter to ask questions and continue conference discussion with tweeters near and far. The live Twitter footage was projected on a flat screen monitor for everyone to follow in the ballroom. It was only natural that J&J’s Marc Monseau was on site to discuss the popular virtual space that the company mastered under his direction.

“We saw the Twitter feed as being a news gatherer and information provider as a starting point,” said Monseau. “When we established the Twitter account, I did not want it to be a bunch of press releases.”

Here are six quick tips for getting started in Twitterland straight from the source himself:

1. Create a business case
2. Connect with other initiatives
3. Establish a personality
4. Set guides
5. Gain legal and regulatory support
6. Tweet, tweet, tweet

In addition to Twitter, Eileen O’Brien, a former digital agency veteran who led a 1:1 coaching session on SEO/SEM during lunch, said that Google’s Sidewiki was the hot topic of conversation among pharma folks. She demonstrated the tool to me, located on Google’s tool bar, by posting her own comment about the drug Allegra on www.allegra.com.

“It’s having a side conversation by posting comments,” says O’Brien, who was a fan of today’s tweeting scene. “It’s really great to see everybody here tweeting in questions and answers.”

A report published in Brussels earlier this month suggests that this judgment may be excessively harsh. Lobbyists for healthcare and pharmaceuticals score very high in the study of perceptions among politicians and senior officials in European Union institutions and member states. And industry associations score particularly highly.

Another feather for the cap of drug industry lobbyists is that they are considered to be doing a better job than lobbyists from non-governmental organizations in the healthcare sector. The report “points to a perception of greater industry effectiveness across all sectors,” and “in many cases (including energy, and healthcare and pharmaceuticals) the perceived gap in favor of industry is substantial.”

In addition, the report from Burson Marsteller’s Brussels office says: “Trade associations are seen overall as the most effective lobbyists,” followed by companies, non-governmental organizations and public affairs consultancies, and only then by think-tanks and law firms.

Lobbyists for healthcare and pharmaceuticals score very highly in a study of perceptions among politicians and senior officials in European Union institutions and member states. And industry associations score particularly highly.

Overall, the healthcare and the pharmaceutical sector come in second (after the energy sector), scoring 7.14 out of 10, on a scale where 0 is “very poor” and 10 is “very good.”

It does even better at national level in some countries, including Austria, France, and Germany. Much lower scores were achieved by consumer goods, food and drink, agriculture, transport, financial services, IT and telecommunications, chemicals, mining and natural resources, utilities and public services, and retail.

Among non-governmental organizations, healthcare and pharmaceuticals organizations do best — but their overall effectiveness rating is only 61 percent. In some countries they score better: pharmaceutical lobbying by non-governmental organizations wins 84 percent approval in Germany and Spain, and 77 percent in France.

One of the findings of the report is that politicians and officials are increasingly concerned about transparency — they want lobbyists to be clear about whom they are representing, and clear about what their positions are.

The letters stated that the drug firms must cease and desist all production and respond to FDA’s inquiry. The companies now have 60 days to stop making the drugs and 90 days to stop distribution. If they fail to comply, FDA can cease the product, get an injunction against the company, and file criminal charges.

Consumers have a right to expect that their drugs meet the FDA’s safety and effectiveness standards,” stated Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a release. “Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality.

Companies receiving warning letters include:
Boehringer Ingelheim Roxane, Cody Laboratories, Glenmark Pharmaceuticals, Lannett Company, Lehigh Valley Technologies, Mallinckrodt Pharmaceuticals Group, Physicians Total Care, Roxane Laboratories, and Xanodyne Pharmaceuticals.

The CVT board rejected Astellas’s second proposal last Friday stating that the Astellas proposal undervalued the company and is not in the best interest of the shareholders.

In a press release issued this morning Astellas stated, “While we continue to prefer to reach a negotiated agreement with CV Therapeutics’ Board, their refusal to engage with us regarding our proposal has left us with no alternative but to take our offer directly to CV Therapeutics’ stockholders. We believe our offer provides CV Therapeutics’ stockholders with immediate cash value that exceeds what the company could reasonably expect to deliver on it own, particularly given current uncertain market conditions and execution risks inherent in CV Therapeutics’ standalone strategy.”

The tender offer is a 41 percent premium to CVT’s closing share price of January 26, 2009, and a 69 percent premium to CVT’s 60-day average closing price ending on January 26th.

The bidding war began in November when Astellas made the first move to buy CVT. When the offer wasn’t accepted, Astellas made a second proposal to the board in late January, which was once again rejected by CVT on February 20th.

Meanwhile, Astellas US Holding, Inc., a subsidiary of Astellas Pharma Inc., today announced that it has filed a lawsuit in the Delaware Chancery Court against CV Therapeutics Inc. According to the press release its directors are seeking, “declaratory and injunctive relief to prevent CV Therapeutics from applying its recently amended stockholders rights plan in a way that would prevent CV Therapeutics’ stockholders from tendering their shares into the tender offer announced by Astellas today and preclude CV Therapeutics from claiming that a 2000 agreement between Astellas and CV Therapeutics has been violated by the Astellas tender offer.”

Johnson & Johnson: A perennial member of the Top Four, J&J defies the conventional wisdom; it’s a big company that still manages to grow, a sprawling, diversified company that still has focus. And along with just three other companies on our list, it created shareholder value in 2007. Bill Trombetta explains how.

What’s the best managed pharma? Each year, Professor Bill Trombetta of Saint Joseph’s University attempts to answer the question in Pharm Exec’s “Industry Audit”, applying a battery of traditional and nontraditional metrics to the largest publicly held companies.

This year, in addition to his article, Bill agreed to sit down with editor-in-chief Patrick Clinton for a conversation on the top four companies and what makes them special.

How to measure a pharma company If you want to want to truly understand how well a company is performing, you need to get past the basics of revenue, profit margin, and price earnings ratio. In this episode, Bill Trombetta explains which metrics really get at the heart of good pharma management.

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