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.

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.

Sherilyn McCoy, vice-chairwoman of Johnson & Johnson’s pharmaceuticals division, has quit pharma to become CEO of cosmetics giant Avon.

McCoy, who has been with J&J for 30 years, was considered a leading contender for the CEO role in February but was passed over in favour of Alex Gorsky.

The pharma industry veteran will need to turn Avon around: the iconic brand has been dogged by falling profits and a bribery investigation, and recently turned down a $10bn buyout offer from fragrance company Coty.

Fred Hassan, Avon’s lead director, said: “The board conducted an extensive search among many world-class candidates, and Sheri emerged as the clear choice to take Avon into the future.”

He praised McCoy’s “strategic and finely honed operational skills, significant turnaround track record, global experience and people leadership” as well as her “consistent record of outperforming against new challenges”.

At J&J, McCoy rose through various executive roles over 27 years to become chairwoman of the pharmaceuticals division in 2009, successfully focusing it on new products in areas of unmet medical need (including stroke prevention and prostate cancer) to see it through the patent expiry of several key products.

Though widely tipped to replace Bill Weldon as CEO this year, McCoy lost out to Alex Gorsky, vice-chairman of J&J’s executive committee.

“I am extremely honored and excited to join Avon – a great company with an iconic brand and so much clear potential,” said McCoy. “I look forward to working with the team to develop and execute a roadmap to achieve the next phase of growth for the company.”

McCoy replaces Andrea Jung, the longest-serving female executive of a Fortune 500 company, who commented: “We are thrilled to have someone of Sheri’s caliber assuming the leadership of Avon.”

GlaxoSmithKline and Johnson & Johnson, in partnership with venture capital firm Index Ventures, are launching a €150m fund for biotechnology start-ups.

The money will be invested primarily in European companies with one or two significant projects under way that “have first-in-class or best-in-class mechanisms of action and target areas of unmet medical need”.

This follows the Wellcome Trust’s announcement of its £200m fund to support early-stage biotech companies in the UK and Europe.

GSK and J&J will each contribute a quarter of the €150m fund, with the rest to be invested by Index’s existing partners.

Moncef Slaoui, Head of R&D at GSK, said: “This unique collaboration shows our commitment to the biotech ecosystem and to continuously pursuing creative new ways to access groundbreaking new science.”

With its “unique platform of entrepreneurs” and “asset centric investing model”, he noted, “Index is well positioned to create an exciting pipeline.”

Paul Stoffels, Chairman of J&J’s pharmaceuticals business, commented that “new and creative approaches to funding early-stage innovation are crucial to the development of transformative medicine”.

The Wellcome Trust has created Sigma, a new business with initial capital of £200m to provide funding and guidance to emerging biotech companies.

Sir Mark Walport, Director of the Trust, said the new company has a long-term perspective, aiming “to give small and medium-sized companies the support they require to fulfil their potential”.