Merck & Co (trading in Europe as MSD) has agreed to pay almost a billion dollars to settle criminal and civil claims relating to its US promotion of the arthritis drug Vioxx.

The total of $950m covers all outstanding cases in the US relating to the drug’s off-label marketing and alleged false statements regarding its safety.

Ironically, Merck’s anti-inflammatory drug has perhaps inflamed more legal trouble than any drug in recent history.

Launched in 1999, Vioxx (rofecoxib) was used worldwide for treatment of rheumatoid arthritis. Merck withdrew it from the global market in 2004, responding to evidence that it increased the risk of blood clotting and other serious cardiovascular events.

However, as early as September 2001, the FDA had sent Merck a Warning Letter directing the company to cease publishing marketing materials which it judged to be “false, lacking in fair balance, or otherwise misleading”.

The criminal charges against Merck in the USA relate to its promotion of Vioxx as a treatment for rheumatoid arthritis for three years without FDA approval. The drug was finally approved by them in that indication in 2002.

The civil charges in the USA have taken the form of thousands of private lawsuits by patients or their relatives, claiming that Merck marketed the drug in an off-label indication and/or that it made false statements to Medicaid regarding the drug’s risks.

Class actions on behalf of thousands of patients have been launched in the UK and Australia.

Merck made approximately $11bn in global revenue from Vioxx, but stands to lose most of that. The company has already paid $4.85bn to settle individual lawsuits and almost $2bn in legal costs.

Under the terms of a plea agreement with the US Department of Justice, Merck will plead guilty to a single misdemeanour for its promotion of Vioxx in the US between 199 and 2002, paying a $322m fine.

The company will settle all US civil claims with a $628m payment that covers both the off-label marketing and the claims of misleading statements. Of this payment, two-thirds will be recovered by the US Government and the rest by Medicaid.

Merck & Co commented that the civil settlement did not constitute any admission of liability or wrongdoing at the corporate level: “As part of the plea agreement, the US acknowledged that there was no basis for a finding of high-level management participation in the violation.”

The case reflects the issues facing global pharma companies concerning potential breaches of regulations by executives at lower levels.

The most dramatic allegation regarding Vioxx has come from Australia, where a court heard in 2009 that doctors had received a bogus ‘clinical research journal’ containing pro-Vioxx articles credited to non-existent doctors and written by Merck’s marketing team.

Popular painkillers or non-steroidal, anti-flammatory drugs (NSAIDs) can increase the risk of heart attack or stroke by a third, a study has found.

Researchers from the NHS, Hull York Medical School (HYMS), and the Institute for Clinical Evaluative Sciences in Canada found that patients with heart problems who used NSAIDs, including diclofenac and indomethacin, had a significantly higher risk of serious cardiovascular events compared to patients who did not.

Dr Patricia McGettigan, lead researcher of the study at HYMS said: “NSAIDs provide pain relief for millions of patients with chronic inflammatory disorders. The cardiovascular risk is well described but often overlooked.”

Even OTC drugs such as diclofenac were linked to serious cardiovascular risks, however, other common NSAIDs, including naproxen and low doses of ibuprofen do not appear to increase any risks.

The team of researchers based its results after reviewing 51 large scale studies of NSAIDs conducted in Europe, USA, Canada and Australia.

Dr McGettigan commented: “In choosing which one of the many available NSAIDs to use, patients and doctors would benefit from knowledge of the balance between benefit and harm for individual NSAIDs.”

Many people use NSAIDs in both OTC and prescription form for pain relief and for their anti-inflammatory effects to treat pains and aches.

In 2010, GPs prescribed 17 million NSAIDs in England alone, accounting for one in three people in the country. Of these, nearly 6 million were for diclofenac, 5 million were for ibuprofen and 3 million for naproxen, all of which can be bought without prescription.

FDA approval has been issued to Intersect ENT’s implant offering controlled drug delivery for patients with chronic sinusitis.

The system prevents obstruction of the ethmoid sinus following surgery, reducing the need for additional surgical procedures and systemic steroids that can have serious side effects.

David W. Kennedy, Professor of Otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, USA, said that the combination of minimally invasive techniques and local drug delivery will be “the wave of the future in sinus treatment”.

Propel, a mometason furoate implant, uses advanced corticosteroid with anti-inflammatory properties. It is inserted following endoscopic sinus surgery to stop the condition returning.

The spring-like implant expands to prop open the sinus and gradually delivers the medicine directly to the sinus tissue.

Chronic sinusitis often requires a combination of surgical and medical treatments.

It is a common condition where patients’ sinuses become swollen and inflamed, leading to difficulty in breathing, facial pain or headache, and reduced sense of smell and taste.

Each year, 500,000 US patients undergo sinus surgery to treat the condition, but the majority of patients experience recurrent symptoms within a year of surgery.

The FDA approval is based on results from three prospective clinical trials involving 205 patients in the US.

Intersect ENT is a company based in Palo Alto, California, and focuses on developing treatment alternatives to improve quality of life for ear, nose and throat patients.

NICE wants further information on Roche’s RoActemra (tocilizumab) for the treatment of systemic juvenile idiopathic arthritis (JIA) after failing to recommend it in draft guidance.

The Institute’s independent Appraisal Committee has requested a range of detailed information including comparison data to existing treatments and a revised model.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says more information is required so NICE can “fully assess the benefits that tocilizumab might provide”.

A public consultation has now been opened with responses welcomed until 1^st September.

The appraisal focused on young people aged two years and older with JIA where specific previous treatments have not produced an adequate response.

But NICE says further data is required on RoActemra when it’s used in treating systemic JIA where the individual’s condition has responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate. Information about joint damage for patients receiving RoActemra, including long-term follow-up, has also been requested.

The draft guidance also does not recommend the treatment where methotrexate has not yet been tried, but NSAIDs and systemic corticosteroids have already been used.

“In the meantime, we welcome comments from patients and their carers and families, and clinicians, as part of our public consultation on the Committee’s provisional recommendations,” said Professor Longson.

PLx Pharma has appointed Michael J. Valentino as Chairman of its Board of Directors.

Mr Valentino has previously worked for Adams Respiratory Therapeutics, Novartis AG and Warner Lambert.

Ron Zimmerman, President and CEO of PLx Pharma, said: “Mike’s exceptional industry and commercialisation experience with a range of OTC and Rx drug products will be extremely valuable”.

PLx is a pharmaceutical company developing gastrointestinal (GI) safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, ibuprofen and indomethacin for over-the-counter and prescription markets.

CROMO pharma’s Yellox (bromfenac sodium sesquihydrate) has become the first twice-daily NSAID to be approved by the European Commission.

The anti-inflammatory drug, manufactured and marketed by CROMO pharma and eye care specialists Bausch + Lomb, is indicated for the treatment of postoperative ocular inflammation following cataract extraction in adults.

The approval, which follows the recommendations of the CHMP, makes Yellox the first ocular NSAID dosed twice a day to be licensed for use in the EU.

Andreas Prinz, Managing Director, CROMA Pharma, commented: “Yellox is an innovative advance for the millions of post cataract surgical patients and offers physicians a new, powerful and convenient choice for helping to put a stop to ocular inflammation after cataract surgery.”

“Yellox is very promising for cataract surgery patients,” added Dr Cal Roberts, Chief Medical Officer, Bausch + Lomb. “The drug helps meet the unmet needs of both patients and physicians alike across a number of European markets, offering them a new choice to treat post-operative ocular inflammation following cataract extraction.”

CROMO Pharma is based in Austria and focuses on the areas of ophthalmology, osteoarthritis and aesthetic dermatology.