The 27th Pharmaceutical Marketing (PM) Society Advertising Awards had the largest number of entrants ever (350) and saw the event expanding into the digital and exhibition arenas.

Notable winners among the advertising agencies included Langland Advertising, which won in seven categories (with 10 commendations), and VCCP Health, which won in three categories (with two commendations).

Of 36 pharmaceutical companies competing for the PM Society Awards, the most successful was Abbott with four wins and five commendations.

Three pharmaceutical companies – Astellas, Bayer and Johnson & Johnson – won two awards each, and another five – CSL Behring, Eisai, Janssen, Sanofi Pasteur MSD and Takeda – won one each.

Neil Smith, PM Society Advertising Awards Chairman, commented: “As ever, the truly aspirational creative treatments stand head and shoulders above the rest and their success is reflected by our industry and healthcare judges.”

From over 50 campaigns entered for the Awards, the most successful on the day were Langland’s campaign for Abbott’s drug Hidrasec (four wins and one commendation); the same agency’s campaign for Bayer’s Sativex (two wins and two commendations); and Lime’s campaign for Astellas’ Protopic (one win and two commendations).

Remarkably, Concentric Advertising won both the Primary and the Secondary Care Target Awards for one advertisement.

Two of the most coveted awards were the Healthcare Industry Award, won by relative newcomer VCCP Health, and the Geoff Brook Innovation Award, snagged by the Woolley Pau Gyro agency.

New awards were presented in three digital advertising categories, and exhibition displays were recognised in a new category for the first time.

The lunchtime awards ceremony in London was hosted by broadcaster and former MP Gyles Brandreth.

The PM Society, which promotes marketing excellence in the healthcare and life science industries, is a non-profit organisation with members in over 230 UK companies.

In 2012 the Society launched Interest Groups addressing key challenges facing UK pharmaceutical marketers: market access, digital marketing, NHS partnerships, patient engagement and personal development.

The standard cognitive test used for trials of drugs for Alzheimer’s disease is not accurate, UK researchers have found.

The ADAS Cog test, which scores patients on an aggregate of 11 components (such as language use and naming objects), underestimates the progress of dementia and variance between patients.

The report suggests that some Alzheimer’s drugs, including ones that ‘failed’ clinical trials, may be more effective than was thought.

In particular, the test is unreliable as a means of tracking the early stages of dementia, where drug interventions are likely to have most impact.

Researchers from Plymouth University examined 675 ADAS Cog test results for people with mild Alzheimer’s disease at zero, six, 12, 18 and 24 months.

Analysis of the scores at component level revealed a ‘ceiling effect’ in relation to eight abilities: from 32–83% ‘passed’ the component with equivalent scores.

A follow-up study used Rasch analysis, a technique for evaluating aggregated tests, to confirm the flaw and suggest improvements: parts of the ADAS Cog need to be more difficult, and the overall scoring method needs reworking.

“It is impossible to say precisely the extent to which the ADAS Cog’s flaws have undermined the numerous clinical trials in which it has been used,” said study leader Professor Jeremy Hobart.

“It has been used, unchanged, for many years and its apparent contribution to suboptimal trials has led a number of drug companies to rethink their strategies.

“However, it is very clear that in its current form the ADAS Cog underestimates cognitive differences between people and changes over time.”

The test “is not working in people with mild Alzheimer’s disease,” he concluded.

The ADAS Cog was recently used in the ‘unsuccessful’ drug trials of Lilly’s solanezumab and Pfizer and J&J’s bapineuzumab.

Pf looks at how the pharmaceutical industry is working with WHO to transform the developing world by defeating neglected diseases such as sleeping sickness and river blindness.

In January 2012, the World Health Organisation (WHO) launched a roadmap to defeat 10 key neglected tropical diseases, with support from 13 major pharmaceutical companies. The campaign targets diseases that are widespread only in the developing world and form major barriers to the economic development of the affected countries. The companies pledged to work in partnership with WHO, governments and health and finance organisations to strengthen their drug donation programmes, support drug distribution and implementation, and increase R&D in this disease area.  

Trojan horses
Most neglected tropical diseases (NTDs) are carried by parasites (such as tsetse flies) or are parasites (such as flatworms), which makes them difficult to treat as parasites are well adapted to the biology of the host. The parasite often acts as a ‘Trojan horse’ introducing disease into the human body. While preventative measures such as sanitation are important for controlling infection, only effective drug treatment can strike at the lethal team of parasite and micro-organism. The challenge is not only to develop effective drugs, bu to ensure they reach the populations affected by the disease.

In the ‘London Declaration on Neglected Tropical Diseases’, WHO and 13 drug companies committed to these objectives for 2020: to eradicate guinea worm disease; make progress towards eliminating lymphatic filariasis, blinding trachoma, sleeping sickness and leprosy; and achieve control of schistosomiasis, river blindness, Chagas disease, visceral leishmaniasis, and soil-transmitted helminthes. The companies involved are Abbott, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Gilead, GSK, Johnson & Johnson, Merck KGaA, Merck Sharp & Dohme (MSD), Novartis, Pfizer and Sanofi.

Margaret Chan, Director General of WHO, said: “The efforts of WHO, researchers, partners, and the contributions of industry have changed the face of NTDs. These ancient diseases are now being brought to their knees with stunning speed. I am confident almost all of these diseases can be eliminated or controlled by the end of this decade.” For some of the world’s poorest nations, that means an end to a crippling burden of endemic disease.

As a Sanofi video commented, NTDs are neglected because the populations they affect are neglected. For the pharma industry, offering drug donation, training and education to defeat these diseases is an opportunity to put down roots in important future markets, as well as boosting the industry’s public image through concrete achievements. Despite the current global economic crisis, funding for neglected disease R&D has increased significantly since 2007. Corporate social responsibility is a key aspect of any global drug company’s strategy – especially for companies based in Europe
and the US, where reputation can be a difficult issue.

In May 2012, Dr Margaret Chan commented on work to fight schistosomiasis in Africa: “These Cinderella diseases, long ignored and underappreciated, are a rags-to-riches story. We can blanket this part of the world with medicines that rid every schoolchild of worms and eggs, parasites that interfere with their learning, impair cognitive development, and compromise their nutritional status.” Such achievements, which depend on the pharmaceutical industry, are of historic importance on the world stage.

River blindness
Onchocerciasis (river blindness) causes an estimated 270,000 people each year in Africa and elsewhere to lose their sight. Its biological audit trail is complex: a nematode worm enters the body through the bite of a blackfly; the worms spread through the body, carrying symbiotic bacteria; when the worms die, the bacteria trigger the human immune system, causing severe itching and damaging eye tissue. Some 37 million people are infected with river blindness.

The most successful treatment is MSD’s Mectizan (ivermectin), an oral medication that kills the parasite in its larval stage. On 11 October 2012 (World Sight Day), MSD celebrated 25 years of its programme to donate Mectizan for treatment of river blindness. Through this programme, progress has been made towards eliminating the disease in Nigeria, Uganda, Senegal, Mali and Sudan. MSD is committed to maintaining drug donations until the disease is eliminated.

The Mectizan Donation Programme has influenced the development of other initiatives to fight NDTs in two ways: its multi-sector partnership model and its use of community-directed intervention (CDI). Stakeholders working with MSD to build the programme include WHO, the World Bank, governments, NGOs and communities. The CDI strategy, whereby communities plan their own means of delivering treatment, has enabled Mectizan to be delivered to 75 million people in Africa each year.

Former US President Jimmy Carter commented: “In Africa, where it was once thought river blindness could only be controlled, strides are being made to completely eliminate the disease from a number of countries. Thanks to MSD, the commitment of endemic communities, and strong partnerships, we can now envision a world someday free of river blindness.”

A leading distributor of Mectizan in Africa is Sightsavers, an NGO committed to preventing blindness. Simon Bush, Sightsavers’ Director for NTDs, told Pf: “Sightsavers will, through its support to river blindness programmes in Africa, treat over 25 million people this year as well as playing our part in supporting a network of about one million community-directed distributors.

“We have also the proof of the elimination of transmission of the disease in Kaduna state in Nigeria, which shows that elimination of the disease can be achieved in Africa through treatment with Mectizan alone.” 
The contribution of MSD has been “vital”, Bush said: “Sightsavers would not be able to support the elimination of river blindness and blinding trachoma if it were not for the drug donation programmes. We would not have been able to go to scale.” The supply chain reaching from a major pharmaceutical company to a network of community-directed distributors, reaching through society and across the world, is expected to eliminate transmission of the disease in the targeted countries by 2021.

Blood fluke
Schistosomiasis (blood fluke) is a parasitic flatworm infestation. The larvae enter the body from fresh water sources, mature in the liver and travel through the blood vessels, laying eggs that trigger destructive immune reactions. The disease is estimated to affect 200 million people in Africa and to cause 200,000 deaths each year.

The only medicine with which all forms of schistosomiasis can be treated is Cesol (praziquantel) from Merck Serono (a division of Merck KGaA). In 2007, the company committed to donate 200 million Cesol tablets to WHO for distribution to school-age children primarily in Africa, and to support an awareness programme in schools. In January 2012, Merck Serono doubled its annual donation of tablets to 50 million, to be maintained until the disease is eliminated. It has committed to work with partners to develop a pre-school version of the drug.

Seven million children were treated with Cesol in 2012, bringing the total to 28 million. At the end of November, Merck Serono symbolically donated the 100 millionth Cesol table to WHO, and announced a new programme to distribute the medicine throughout Kenya.

The company’s CEO, Stefan Oschmann, said: “Merck Serono is committed to more effectively fighting neglected tropical diseases.” He added that partnership is the essence of the campaign: “The closer we co-ordinate the donation activities, research and development of new drugs, as well as the supply and distribution of drugs with each other, the more effectively we’ll be able to fight these diseases.”

Sleeping sickness
Trypanosomiasis (sleeping sickness) is one of the tropical world’s most feared diseases. It is spread by the bite of the tsetse fly and affects the brain, causing sleepiness, coma and death. Almost always fatal if untreated, sleeping sickness may be the real basis of the ‘zombie’ myth. But now, according to Dr Margaret Chan, “the stage is set for the elimination of sleeping sickness, a prospect that was unthinkable a decade ago”. For over ten years, Sanofi has worked with WHO to provide drugs and develop treatment protocols for the disease via the campaign ‘Human African Trypanosomiasis – Not Neglected by Sanofi’.

In 2011, Sanofi renewed its commitment to fighting sleeping sickness through a $25m donation, extending its partnership with WHO by another five years. The company donates three of the five drugs used to treat the disease. In January 2012, Sanofi announced a global partnership with Eisai and the Bill & Melinda Gates Foundation to eliminate five NTDs including sleeping sickness and lymphatic filariasis. In July, it noted that the sleeping sickness treatment programme had saved 170,000 lives and reduced the number of new cases from 30,000 in 2001 to 6,500 in 2011. By 2020, WHO has said, Africa may be clear of the disease.

Sanofi’s video from Chad illustrates the methods used to implement treatment. By funding mobile medical teams working in towns and villages, the campaign has brought daily drug therapy to people unable to travel long distances to the city hospitals. Seeing the effects of treatment within the community encourages other patients to be treated there. Sanofi is committed to providing the drugs and supporting their implementation until sleeping sickness is eliminated.

Johnson & Johnson has said it will not enforce patents on its HIV drug Prezista (darunavir) in Africa and other poor regions of the world.

The decision will ensure that many patients have access to cheaper generic versions of the drug.

However, J&J insists that generic darunavir must be of high quality, and reserves the right to enforce its patents if this is not the case.

The company has declined to join the new Medicines Patent Pool, which aims to accelerate generic drug production.

J&J came second in the Access to Medicine Index 2012, which scores major pharmaceutical companies on the access to their drugs in poorer countries – seven places higher than its 2010 placing.

Multiple generic manufacturers will now be able to produce generic darunavir for sale in sub-Saharan Africa and other ‘least developed countries’.

The drug is a second-line therapy for patients who have developed resistance to the standard antiretroviral drugs. Demand for it in Africa is increasing rapidly.

Paul Stoffels, J&J’s Head of Pharmaceuticals, said that competition between generic manufacturers would drive down the price of darunavir.

Indian pharmaceutical companies would be particularly quick to bring out generic versions of the drug, he predicted.

Stoffels defended the decision to stay out of the Medicines Patent Pool: “We want to reserve the right to reinforce patents if people are not providing the right quality of product, for example by bringing products to market that under-dose.”

Most of the leading pharmaceutical companies are improving access to their medicines in the developing world, a new report shows.

The Access to Medicine Index identifies GSK, J&J and Sanofi as the companies doing most to make their drugs available and affordable in poorer countries.

Better pricing deals and development of drugs for neglected diseases are among the areas of company activity praised by the report, but the management of drug trials in developing companies is criticised.

GSK, which topped the Index in 2010, remains in front though its overall rating is only slightly higher. J&J and Sanofi have significantly improved their ratings.

The major Japanese firms are bottom of the league, as well as being absent from such initiatives as the WHO campaign to fight neglected tropical diseases.

In its third year, the Netherlands-based Index notes that companies are showing better internal organisation in relation to drug access issues.

Of the 20 largest pharma companies, 17 have improved access to their drugs in the developing world since 2010: they are developing more relevant drugs and doing more to facilitate patient access to them.

In particular, more companies are using tiered pricing schemes to make products more affordable for certain countries or population groups – most notably Gilead, whose HIV drugs are used worldwide.

However, the Index states that companies could do more to support generic versions of their drugs and adapt drug packaging to local needs.

It also notes that the outsourcing of clinical trials to Contract Research Organisations lacks transparency and control, with only four companies (GSK, Sanofi, Eisai and Merck & Co.) saying they enforce ethical codes.

Wim Leereveld, CEO of the Index, said: “Access to medicine is a multi-faceted challenge and the pharmaceutical industry has a critical role. While it has made strides in many areas, companies that have sector-leading practices also show us there is more the industry can contribute.”

Major pharma companies are paying multi-million dollar fines for alleged bribery in emerging markets, but these markets remain highly profitable.

Recent payments by Pfizer ($60m) and Johnson & Johnson ($70m) to settle charges under the Foreign Corrupt Practices Act (FCPA) represent only a small fraction of their revenue from the countries where the alleged offences took place.

However, steep increases in FCPA fines have been threatened if evidence suggests that pharma corporations regard them as a manageable cost.

Comparable European legislation, such as the Bribery Act in the UK, is tightening the net around overseas sales operations that pander to a culture of ‘goodwill’ gifts and other inducements.

Pfizer’s income from emerging markets is predicted to reach $10bn, while J&J has reported $6.5bn sales in Brazil, Russia, India and China.

Global Data analyst Michael Leibfried said: “The $60 million fine for Pfizer to a lay person sounds like quite a bit of money, but in perspective it took less than two days of Lipitor sales during its peak. It’s really just chump change for them.”

However, according to Kara Brockmeyer, chief of FCPA investigations within the Securities and Exchange Commission, no FCPA prosecution has so far needed to be repeated.

“I would hate to think the companies view enforcement actions as the cost of doing business,” she commented. “If we find that out, it will certainly increase the size of the penalty.”

In relation to the Pfizer settlement, she noted that a number of the company’s overseas subsidiaries “had bribery entwined in their sales culture”. Pfizer has since introduced an anti-corruption audit programme.

Novo Nordisk and Teva have also undergone FCPA investigations, with Latin American markets being a particular focus.

Janssen Pharmaceuticals, a Johnson & Johnson company, has created a division to commercialise its new drug for hepatitis C in the EMEA region.

The protease inhibitor TMC435, co-developed by Janssen and Medivir AB, is currently in phase III clinical trials.

The creation of Janssen Therapeutics EMEA, based in Belgium, reflects the growth of hepatitis C as an area of unmet medical need.

Hepatitis C, caused by the HCV virus, is a life-threatening chronic disease that affects over 130 million people worldwide.

Patient responses to treatment vary depending on genetic and other factors; many patients lack effective treatment options.

Janssen Therapeutics EMEA is dedicated to bringing TMC435 to hepatitis C patients in Europe, the Middle East and Asia as a once-daily medication.

TMC435 is being investigated in combination with PegIFN/RBV and with Direct-acting Antiviral (DAA) agents in interferon-free combinations.

“The WHO describes hepatitis C as a ‘viral time bomb,’ said Jane Griffiths, Company Group Chairman for Janssen EMEA. “That is why we have created a dedicated division, which will commercialise TMC435 and help meet hepatitis C patients’ needs.”

The new division’s strategy is to work with specialist licensing partners to develop treatments for hepatitis C. It will commercialise Incivo, another protease inhibitor, separately from TMC435 via its local subsidiaries.

Johnson & Johnson’s incoming CEO, Alex Gorsky, could be ordered to give sworn testimony in a Risperdal lawsuit, according to US government lawyers.

J&J has declined to make Gorsky available for a deposition in the case, which concerns the alleged payment of ‘kickbacks’ to health provider Omnicare.

The US government claims that millions of dollars paid by J&J to Omnicare as ‘market share rebates’ were inducements to buy and recommend Risperdal.

J&J claims that the rebates and the promotion of Risperdal were ‘common commercial practices’ that did not violate any law.

The case forms part of J&J's ongoing struggle to defend its marketing of the antipsychotic drug in the US against claims that it exaggerated the drug’s benefits and downplayed or concealed its risks.

Risperdal (risperidone) is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

The company faces a cluster of lawsuits, both civil and criminal, based on allegations that it over-promoted the drug.

The US government has claimed that from 1999 to 2004, J&J gave Omnicare “market share rebate payments conditioned on Omnicare engaging in ‘active intervention’ programs for J&J drugs,” which it provided to nursing homes.

Gorsky succeeds Bill Weldon as CEO of J&J on April 26.

While with J&J subsidiary Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare (or members of Janssen’s own sales staff) that, in January 1999, the FDA had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the US filing stated.

Attorney Robert D. Keeling of Sidley & Austin, representing J&J, said that “Mr Gorsky has no reasonable connection to the subject matter of the government’s complaint,” and that the request for his testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive”.

Omnicare agreed in 2009 to pay $98m to settle civil claims by the US government and various states that it accepted kickbacks from J&J, but the company did not admit liability.

Bayer HealthCare has agreed to pay an average of $220,000 per patient to settle 500 lawsuits over the safety of its birth control pills Yaz and Yasmin (drospirenone).

The German company is accused of misleading patients and clinicians about the risk of venous thromboembolism (VTE), leading to cardiovascular events, to women taking the drug.

The settlement means Bayer will pay a minimum total charge of $110m – and if rolled out across all the current lawsuits, could cost the company over $2bn.

Safety reviews of drospirenone-containing birth control pills led to FDA’s decision to include VTE risk warnings in the product labels.

Bayer is currently facing more than 11,000 lawsuits in the US alleging harm caused by the use of Yaz, Yasmin or authorised generic equivalents.

Yaz is one of Bayer’s most successful brands, earning $1.1bn in 2011.

Rosemarie Yancosek, a spokesperson for Bayer, said: “Bayer HealthCare confirms that some cases pending in the current Yaz/Yasmin litigation in the US are being settled.”

Bayer’s settlement strategy contrasts with the more defensive approach taken by Johnson & Johnson over the marketing of its antipsychotic drug Risperdal.

Johnson & Johnson has been fined $1.2bn by an Arkansas circuit court for fraudulent marketing of its antipsychotic drug Risperdal (risperidone).

The judge said the company and its US subsidiary Janssen Pharmaceuticals had lied about the drug’s benefits and risks in order to obtain Medicare reimbursement.

The fine is among the largest ever imposed in a US state fraud case involving a drug company.

J&J, which denies any improper conduct or actual harm, is calling for a retrial.

The judge, Tim Fox, fined the companies $1.19bn for nearly 240,000 violations of the state’s Medicaid fraud law and $11m for violations of its law on deceptive practices.

To date, 11 states have prosecuted J&J over its marketing of Risperdal, which is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

Prosecutors have claimed that J&J inaccurately stated Risperdal to be more effective than generic alternatives, while concealing the increased risks of diabetes, stroke and weight gain associated with the drug.

Since reimbursement for Risperdal was available through the state-funded Medicaid system, J&J is accused of defrauding state authorities.

Arkansas attorney general Dustin McDaniel commented that the court’s verdict “sends a clear signal that big drug companies like Johnson & Johnson and Janssen Pharmaceuticals cannot lie to the FDA, patients and doctors in order to defraud Arkansas taxpayers”.

The fine was based on minimum penalties for each individual violation of state law through a prescription or marketing message – coming in this case to over 250,000 violations.

Janssen spokeswoman Teresa Mueller said the company would call for a retrial and, if that was denied, would appeal against the state verdict.

The court “did not show any Arkansas patient was ever harmed by using Risperdal” or “that any Arkansas physician or Arkansas Medicaid was ever misled by the drug’s label or package insert,” she asserted.

In the last year, J&J has reached a $158m settlement with Texas over the marketing of Risperdal and been fined $327m by South Carolina.

At the federal level, the company is in talks with the Justice Department to settle a misdemeanour criminal charge. However, the JoD has rejected a $1bn offer from J&J to settle all outstanding civil charges.