Michael Huggins, former North America President of bone implant specialist Synthes, has received a nine-month sentence for his role in an unauthorised clinical trial of bone cement that caused three human deaths.

Three other former Synthes executives, convicted of involvement in the same criminal activity, are awaiting sentence.

The US Justice Department had prosecuted the four executives in a drive to hold individuals to account for corporate crimes.

The executives had senior roles in Synthes’ Norian unit, which manufactured osteobiological implants. Norian was purchased by US company Kensey Nash earlier this year for $22 million.

Between 2002 and 2004, the Justice Department said, Norian carried out unauthorised clinical trials of Synthes’ Norian XR bone cement in surgeries to treat vertebral compression fractures (VCF), despite a warning against such use on the product label.

Initial studies had shown that the bone cement reacted chemically with human blood in vitro, producing clots – and that when used in a pig, the cement caused blood clots in the lungs.

Synthes continued to test the product on humans until it had caused three deaths, and even then the company misled the FDA, the Justice Department said.

In April 2011, Johnson & Johnson purchased Synthes for approximately $21.3 billion to merge it with its own troubled DePuy orthopaedic device business.

Eli Lilly has won its first trial over health risks concerning its anti-psychotic drug, Zyprexa.

It is the first of 40 outstanding patient lawsuits involving the medication that claim the company concealed the drug’s side effects from patients and doctors.

Approximately 31,000 patient lawsuits were originally filed, most of which were covered by a $1.2 billion settlement, leaving 110 patient claims pending in 40 lawsuits.

The case in Los Angeles was filed by the family of a 20-year-old student who died while taking Zyprexa. They said that Lilly hid the medicine’s safety risks whilst marketing the medication for both approved and off-label uses in the US.

The lawsuit also claimed that the pharmaceutical company trained its sales representatives to counteract questions regarding risks of weight gain and diabetes linked to Zyprexa.

In addition to its settlement deal of $1.2 billion, Lilly also paid $1.42 billion for federal off-label marketing investigations and $260 million for state claims.

Bolton-based medical consumables company Vernacare has emphasised the importance of teamwork and partnership for their development of the world’s first pulp wash bowl, which won a Queen’s Award for Enterprise 2011.

The Vernacare wash bowl (pictured) is used by hospitals in more than 270 NHS Trusts and across the globe for patient care, wound and continence care, hand washing and surface cleaning.

In a study reported in the BMJ, Vernacare’s wash bowls were among a package of measures that led to a 50% fall in cases of C. difficile at Salford Royal NHS Foundation Trust over 12 months.

Karen Haslam, Chief Executive of Vernacare (pictured, left), praised the company’s team and the clinicians who had helped them to develop and trial the product. “We developed our single-use wash bowl in response to customer demand,” she said. “Nurses told us they were concerned that re-using plastic wash bowls without properly cleaning and drying was a significant infection risk.

Vernacare’s previous pulp products were permeable to warm soapy water, she added. “This was a major challenge that took our in-house team two years of painstaking research and trial and error to overcome.”

Heather Dakin, Senior Nurse Infection Control at Colchester Hospital, said of the product: “Nursing staff found that they had more time for patient care and didn’t have to worry about decontaminating plastic bowls. They also found that wards looked much tidier as the pulp can be stacked on racking provided by Vernacare rather than hanging from lockers or beds collecting dust.”

Vernacare provides single-use pulp products for patient waste management and a macerator for disposal. The products are used in over 90% of UK hospitals and more than 50 countries.

The photo shows Karen Haslam and Maria Sinfield of Royal Bolton Hospital with the Queen’s Award.

Pfizer has signed a pact worth $340 million with GlycoMimetics, in a lead drug programme for sickle cell disease.

The partnership will see Pfizer focus on the development of GMI-1070, an inflammation inhibitor for the painful vaso-occlusive crises that threaten the organs of sickle cell patients.

Yvonne Greenstreet, Senior Vice President and Head of the Medicines Development Group at Pfizer, said: “This experimental compound and partnership are emblematic of our strategy in rare disease, targeting areas of high unmet need to deliver improved patient outcomes.”

The deal states that Pfizer owns worldwide commercial rights of the treatment, with Maryland-based GlycoMimetics taking charge of the Phase II trial before passing it over to Pfizer’s development team for further studies.

GMI-1070 is also being tested in preclinical studies for other diseases, including haematologic malignancies.

Pfizer has agreed a settlement agreement with a host of pharmaceutical companies delaying the launch of generic versions of Lipitor in the UK before its patent expiry.

Teva and other companies have agreed to hold off selling the Israeli company’s generic version of cholesterol drug Lipitor (atorvastatin) until May 2012.

Pfizer submitted an injunction at the end of June 2011, with the company commenting at the time that Teva “chose to undertake an aggressive launch of a generic product on a very large scale in the UK”.

Pfizer subsequently issued a statement saying it was “fully sympathetic to the difficult position that many pharmacies find themselves in having purchased generic atorvastatin from Teva/AAH/Phoenix in good faith”.

At the time, Teva offered support to any pharmacies facing legal action over dispensing its generic version of atorvastatin.

A full trial had been arranged for November at the High Court in London to assess the case, but has now been called off. Pfizer hopes that Lipitor will not be challenged again until its patent expires in May 2011.

AstraZeneca’s Crestor has not proved as effective as Pfizer’s Lipitor at preventing cholesterol build-up in one of the arteries leading to the heart, a new study has found.

The SATURN trial’s results came as a surprise after a previous study demonstrated Crestor reversed the build-up of artery plaque, but this reduction did not reach statistical significance.

The “top-line results are not the slam dunk AstraZeneca might have been hoping for,” said Mike Mitchell, an analyst at Seymour Pierce.

The new data leads to the possibility that doctors currently prescribing Crestor will switch to a generic version of Lipitor when it becomes available.

The 104-week SATURN (Study of Coronary, Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) trial involved 1,300 patients, comparing a 40mg dose of Crestor against an 80mg dose of Lipitor.

Meanwhile, Pfizer’s legal battle with generics manufacturer Ranbaxy has ended with Ranbaxy now free to start selling the generic atorvastatin in November 2011.

Ian Read, President of Pfizer, said the deal with Ranbaxy was “a win-win-win because it is pro-patient, pro-competition and pro-intellectual property”.

Quintiles has appointed Oren Cohen (pictured) is its new Senior Vice President and Global Head of its Phase I Clinical Research division.

Mr Cohen has been promoted from his position as Chief Medical and Scientific Officer (CMSO) and will leverage the company’s clinical trial services and deep expertise in biomarker development.

Paula Brown Stafford, President of Quintiles Clinical Development, says Mr Cohen brings a “wealth of clinical and scientific expertise” after his former roles at the company.

The former medical advisor joined the company back in 2001 and was appointed CMSO in 2004.

“The Phase I clinical research space is changing rapidly, with fewer new molecules entering development and a fundamental shift in target study populations from healthy volunteers to patient groups,” said Mr Cohen.

“Biopharma companies are looking for an ally to help them manage these complexities, ensure patient safety and reduce costs, and Quintiles offers best-in-class early clinical development solutions to meet our customers’ needs.”

The launch of several new trials marks the start of a ‘golden era’ in cancer research, the head of a leading charity has said.

Harpal Kumar, Chief Executive of Cancer Research UK, says that scientists now know more than ever about the potentially fatal disease as groundbreaking trials to genetically test tumours in newly diagnosed patients are set to begin.

Although he admits there is still a great deal to be learnt, he says scientists’ “knowledge is growing exponentially” and they are learning “vast amounts more as months go by”.

The trials, backed by the DH and the charity, are set to begin in September in seven hospitals across Britain with scientists believing the results may revolutionise cancer treatment in the UK.

The two year project is intended to lead to a comprehensive genetic testing of tumours across the NHS. It aims to establish which existing treatments cancers are susceptible to, which may lead to the development of new effective medicines intended to target the genetic formation of an individual’s tumour.

The Government has recently backed an increase in genetic testing as part of the national cancer plan, which the charity says will lead in a significant change in the way cancers are treated.

“It is not hyperbolic to say that this is the future of treatment,” Mr Kumar said. “This is the future of medicine. This will not just be true in cancer but across medicine more generally.

“People have known for years that we give treatment and it is only going to work for 20% of people and we are now on the cusp of finding out what is going on.”

Genetic testing may discover which drugs work more effectively for certain individuals and decide how effect other types of treatments, such as surgery or radiotherapy, will be.

Mr Kumar says that researchers may find that old or discarded products could work on certain patients and, if scientists can discover which treatments are more effective, it may bring the price of cancer drugs down in the future.

“The problem at the moment is that it takes $1bn to get a drug to market and 15 years or more,” he added. “That is the justification for the pharmaceutical industry charging high prices.

“If on the other hand by the time you get to phase II you know exactly which patients it is going to work on, you only put those patients through and instead of 10% you get an 80% response rate.

Human papillomavirus (HPV) testing should become the primary screening tool to rule out cervical cancer, claims a new study.

The ATHENA trial recommends testing for the two most dangerous strains of HPV – HPV16 and HPV18 – as it will identify more precancerous lesions than using the current screening technology of cytology.

The study, publishing in The Lancet Oncology, states that cytology should be reserved for women who test positive for HPV, deciding which women need immediate colposcopy.

HPV testing would be an efficient option and reduce manpower requirements in laboratories, providing “potentially cost-effective and safe cervical cancer screening”, commented the authors of the study.

Guglielmo Ronco and colleagues from the Centre of Cancer Prevention in Turin, Italy said: “The results also provide useful information about triage strategies for parts of the world where high-quality cytology has been difficult to implement and combinations of HPV tests might eventually offer a more sustainable option.”

The ATHENA study aimed to evaluate the performance of HPV testing compared with liquid-based cytology, and to formulate more effective treatment ideas for HPV patients.

The trial involved more than 47,000 American women over the age of 25, who attended regular cervical screenings within a 15-month period.

HPV tests detected a considerably larger amount of existing high-grade precancers in 92% of women who had colposcopy compared to 53.3 % who were given cytology.

The study also found that a combination of HPV with cytology was of little benefit compared with HPV testing alone. The combination method improved accuracy by only 4.7%, but increased the number of screen positives by more than a third.

HPV16 and HPV18 currently account for 70% of invasive cervical cancer cases, with approximately 27% of women being infected with HPV in the US. Treatment management for HPV patients remains unclear, but HPV DNA testing is widely known to be more effective than cytology-based screening.

The FDA has approved Abbott’s stent system for the treatment of renal artery disease in patients with high blood pressure.

RX Herculink Elite is the first stent using cobalt chromium technology to gain a renal indication in the US.

Cobalt chromium allows for thin stent struts, which provides flexibility while maintaining strength to support the vessel and improves visibility during stent implantations enabling more accurate placement.

Michael R. Jaff, Medical Director of the Vascular Center and VasCore, at the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, said: “This result supports renal stenting as an important treatment option, as elevations in blood pressure can increase heart disease and stroke risk in patients with renal artery stenosis”.

The approval was based on Abbott’s HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study.

The study involved 202 patients with renal artery stenosis at 37 sites in the US, and demonstrated that the stent is safe and effective, with a significantly low restenosis (vessel re-narrowing) rate of 10.5% at nine months post-treatment.

HERCULES is a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with atherosclerotic renal artery stenosis with uncontrolled hypertension.