HSE International

Cardiac Science – At the Heart of Saving Lives®

HSE International hears how Cardiac Science extends lives by providing the public, workplace and healthcare professionals with life-saving defibrillators…

ASE Corporate Eyecare – HealthcarePlan: Corporate Eyecare Your Way

Lyn Hodges, Director of Strategic Planning at ASE Corporate Eyecare – HeathcarePlan talks optical experience, innovation and the delivery of comprehensive, corporate eyecare solutions…

Update: BSI’s role as an EU Medical Devices Notified Body

BSI’s role as an EU Notified Body will not change following the recent UK decision to leave the European Union, and is fully confident in continuing…

Popular cleanser recalled over dangerous bacteria levels

15,000 tubes of Liz Earle ‘Cleanse & Polish Hot Cloth Cleanser’, a bestselling beauty product, have been recalled after being found to contain Enterobacter gergoviae…

LloydsPharmacy repays €12m in mistaken dispensing fees

Ireland’s largest pharmacy group has repaid the fess which were incorrectly charged after irregularities were revealed by RTÉ Investigates last year.

UK farmers to cut antibiotic use to combat drug resistance

Taskforce will work with farming leaders and government to replace and reduce antibiotic use for livestock.

Evidence supports plain tobacco packaging to improve public health

Policymakers should heed the results of studies into the effect of cigarette packaging on smoking behaviour.

China vows crackdown on fake vaccines amid scandal

Chinese authorities have pledged to crack down on the black market sale of vaccines after a case was made public involving nearly $90 million (62 million pounds) worth of illegal vaccines that are suspected of being sold in dozens of provinces around the country.

The drug regulator in Shandong, the province at the heart of the scandal, said on Monday it would work with police forces and the health ministry to inspect vaccine stocks to ascertain where 570 million yuan ($88 million) worth of vaccines had ended up.

The case, which involves vaccines against meningitis, rabies and other illnesses, underlines the challenge the world’s second-largest drug market faces to regulate its fragmented supply chain, even as Beijing looks to support home-grown firms.

“We will thoroughly investigate all clues in the case and once we get to the bottom of it then we will severely punish those found to have violated the law,” the Shandong food and drug administration said in a statement posted on its website.

Local police said a mother and daughter in Shandong had illegally bought vaccines from traders and sold them on to hundreds of re-sellers around the country, according to a notice from the Shandong Public Security Department.

The vaccines, which police said were made by licensed producers, were not kept and transported in the required cold chain conditions, which could mean that patients taking them could suffer severe side effects or even death.

China‘s national food and drug regulator also called on other regions which might have bought the illegal vaccines to investigate the issue in a statement posted online on Sunday.

The case also points to frustrations aired by some doctors and patients within China, who say access to some drugs is limited due to red tape around approvals, creating demand for medicines through unapproved channels and the black market.

Pfizer Inc shut its vaccine sales business in China last year after a licence for its Prevenar vaccine, the only vaccine it sold in the country, was not renewed. Prevenar protects against pneumococcal disease, an illness that can lead to pneumonia, meningitis and sepsis.

The mother – a former doctor – and daughter were detained last April, but the case was not widely publicized until now.

(Reporting by Adam Jourdan; Editing by Richard Pullin)

Original Source: http://uk.reuters.com/article/uk-china-health-vaccine-idUKKCN0WN085

J&J must pay $72 million for cancer death linked to talcum powder

Johnson & Johnson (JNJ.N) was ordered by a Missouri state jury to pay $72 million of damages to the family of a woman whose death from ovarian cancer was linked to her use of the company’s talc-based Baby Powder and Shower to Shower for several decades.

 

In a verdict announced late Monday night, jurors in the circuit court of St. Louis awarded the family of Jacqueline Fox $10 million of actual damages and $62 million of punitive damages, according to the family’s lawyers and court records.

The verdict is the first by a U.S. jury to award damages over the claims, the lawyers said.

Johnson & Johnson faces claims that it, in an effort to boost sales, failed for decades to warn consumers that its talc-based products could cause cancer. About 1,000 cases have been filed in Missouri state court, and another 200 in New Jersey.

Fox, who lived in Birmingham, Alabama, claimed she used Baby Powder and Shower to Shower for feminine hygiene for more than 35 years before being diagnosed three years ago with ovarian cancer. She died in October at age 62.

Jurors found Johnson & Johnson liable for fraud, negligence and conspiracy, the family’s lawyers said. Deliberations lasted four hours, following a three-week trial.

Jere Beasley, a lawyer for Fox’s family, said Johnson & Johnson “knew as far back as the 1980s of the risk,” and yet resorted to “lying to the public, lying to the regulatory agencies.” He spoke on a conference call with journalists.

Carol Goodrich, a Johnson & Johnson spokeswoman, said: “We have no higher responsibility than the health and safety of consumers, and we are disappointed with the outcome of the trial. We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.”

Trials in several other talc lawsuits have been set for later this year, according to Danielle Mason, who also represented Fox’s family at trial.

In October 2013, a federal jury in Sioux Falls, South Dakota found that plaintiff Deane Berg’s use of Johnson & Johnson’s body powder products was a factor in her developing ovarian cancer. Nevertheless, it awarded no damages, court records show.

Valeant Pharmaceuticals International Inc (VRX.TO) now owns the Shower to Shower brand but was not a defendant in the Fox case.

The case is Hogans et al v. Johnson & Johnson et al, Circuit Court of the City of St. Louis, Missouri, No. 1422-CC09012.

(Reporting by Jonathan Stempel in New York. Additional reporting by Jessica Dye in New York; editing by Steve Orlofsky and Alan Crosby)

Original Source: http://www.reuters.com/article/us-johnson-johnson-verdict-idUSKCN0VW20A

One brain-dead, five hospitalised after French drug trial goes wrong

A clinical trial of a new drug in France has left one person brain-dead and another five people in hospital, in a serious condition.

The oral trial was conducted by a private laboratory in the western city of Rennes.

The trial has been suspended and the firm is recalling the volunteers. It is unclear how many people are involved.

Media reports that the drug is a cannabis-based painkiller have been denied by the health ministry.

Marisol Touraine speaks to journalists

The Paris prosecutor’s office said an investigation had been opened.

Health Minister Marisol Touraine, who was heading for Rennes on Friday, pledged to “get to the bottom… of this tragic accident”.

The trial was conducted by Biotrial, a French-based company with an international reputation which has carried out thousands of trials since it was set up in 1989.

According to the health ministry, the accident occurred on Thursday.

The worst of those affected is brain dead, it said, while the other five are described as being in a critical neurological condition.

The study was a Phase I clinical trial, in which healthy volunteers take the medication to evaluate the safety of its use, the ministry said.


Clinical Trials

Trials typically have three phases to assess a new medicine for safety and effectiveness

  • Phase I tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects
  • Phase II sees the drug given to people who have a medical condition to see if it does indeed help them
  • Phase III trials are only for medicines or devices that have already passed the first two stages, and involve them being compared to existing treatments or a placebo. The trials often last a year or more, involving several thousand patients

Has drug trial safety improved?

German medics challenge new EU clinical drug trials


Before any new medicine can be given to patients, detailed information about how it works and how safe it is must be collected.

Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.

Every year around the world thousands of people take part in clinical trials but accidents like this are very rare, the BBC’s High Schofield reports from Paris.

New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.

Original Source: http://www.bbc.co.uk/news/world-europe-35320895