NHS to give MMR vaccine to 1m children in England

by JoelLane 26. April 2013 14:37

vaccination-publicdomain The Government has launched a ‘catch-up’ programme to give the MMR vaccine to a million children in England who lack full protection against measles.

The campaign, in which Public Health England and NHS England will work together, was provoked by the recent outbreak of measles in Swansea.

Most of the children targeted are aged 11–16, a group made vulnerable by a steep decline in uptake of the MMR vaccine following the publication of a medical paper in 1998 claiming it was linked to autism.

The paper has since been exposed as fraudulent, though its claims are still supported by some anti-NHS tabloids.

In the mid-1990s, measles had almost been eradicated in the UK. But by the year 2000, uptake of the MMR vaccine had dropped to 80%, allowing the virus to circulate widely.

In 2012, there were nearly 2,000 cases of measles in England – the highest level in two decades. This year, an outbreak in Wales has infected over 900 people.

The million children in England targeted by the new NHS campaign form three similar-sized groups: children aged 11–16 who have received no vaccine; children aged 11–16 who have received one vaccine dose without the ‘booster’ jab; and children in other age groups who lack protection.

Local area teams will use general practice case registers to identify children at risk and ensure their vaccination in schools and GP surgeries.

Mary Ramsay, Head of Immunisation at Public Health England, said that although take-up of the MMR vaccine had returned to a high level, there was a “legacy of under-vaccinated children” who needed protection.

MMR vaccines, which protect against measles, mumps and rubella, are available from GSK and Sanofi Pasteur MSD.

Vaccine R&D ‘investment’ scam busted

by JoelLane 22. January 2013 10:59

burglar_art-555px A scheme that used bogus figures for investment in vaccine research to exploit a tax loophole has been exposed by HM Revenue and Customs (HMRC).

Matrix Securities sold a scheme to investors whereby they could gain tax relief at nearly twice their level of investment, using a tax break designed to encourage medical research.

However, HMRC exposed their investment figures as fraudulent and refused most of their tax relief claim, forcing the Matrix Group into administration.

The company raised £28m from 83 investors and borrowed another £86m from banks to fund research into vaccines against HIV, influenza and hepatitis B.

It claimed a first year trading loss of £193m and £77m tax relief, of which £50m would be paid to the investors.

However, HMRC established in a tribunal that only £14m had been spent on R&D and was therefore subject to tax relief.

Matrix Securities and other members of the Matrix Group have gone into administration – though another member, Matrix Asset Management, claims to have invested £107m in the development of a universal flu vaccine.

Clients who invested in the fraudulent scheme are claiming it was misrepresented to them.

David Gauke, Exchequer Secretary to the Treasury, commented that HMRC “will take decisive action to close down schemes with the sole purpose of avoiding paying tax.”

MMR vaccine now protects nine in 10 infants

by JoelLane 27. November 2012 16:20

vaccine Uptake of the MMR vaccine in infants has passed 90% in England for the first time since the 1998 research paper questioning its safety.

The exposure of Andrew Wakefield’s study as not only flawed but based on fake data has led to renewed confidence in the MMR vaccine.

Rising incidence of measles has also helped to boost uptake of the vaccine, which is now protecting 91.6% of children under the age of two – an increase of 2.1% from 2011.

However, this still falls below the WHO target of 95%, which experts consider sufficient to prevent outbreaks of measles.

The incidence of measles in England and Wales in the first half of this year (964 cases) was nearly twice that in the first half of 2011 (497 cases), with significant outbreaks in Merseyside and Sussex.

The MMR (measles, mumps, rubella) vaccine protects against the three viral infections. It is thought to give 99% protection against measles.

Wakefield’s 1998 article claimed to prove a link between the MMR vaccine and autism. It took 12 years for flaws in his research to be uncovered, and a further year before it was exposed as fraudulent.

“Today’s report marks a significant point in the continued rise of MMR coverage since it hit a low in 2003–04,” said Tim Straughan, Chief Executive of the Health and Social Care Information Centre. “For the first time in 14 years, nine out of 10 children in England have had the MMR vaccine before they turn two.”

Dr Helen Bedford of UCL Institute of Child Health commented: “It is good news that parents have regained their confidence in this highly effective vaccine. However, some teenagers and children have never caught up with missed vaccines and remain at risk of these potentially harmful infections.”

PFI hospital bankruptcy linked to Libor fraud

by JoelLane 1. August 2012 14:48

Highwayman The recently declared bankruptcy of South London Healthcare NHS Trust has been linked to Barclays Bank’s manipulation of the interbank lending rate (Libor).

Health finance experts have called for a public investigation into the impact of the Libor fraud on hospital PFI debts.

Writing in the British Medical Journal, Allyson M. Pollock and David Price said the conflict between the trust’s falling income and its escalating PFI debts was partly due to the dependence of PFI repayment rates on financial derivatives.

Barclays Capital has been convicted of fraudulently inflating the value of derivatives in order to distort the cost of bank borrowing.

Derivatives play a key role in PFI projects: investment banks such as Barclays Capital use them to secure loans against a hospital’s future revenues.

The PFI scheme for the Princess Royal University Hospital PFI in Bromley, a major factor in the South London Healthcare NHS Trust debt, relied on interest rate ‘swaps’ that created an artificially high interest rate for the deal.

Profits from derivatives are tied to Libor, and so manipulating Libor enabled Barclays Capital to defraud the trust by indirect means, the authors claim.

They argue that “a major public inquiry” is needed “to determine the full extent to which the high interest rates, swap mechanisms and swap margins fuelling the latest round of hospital and service closures are products of Libor manipulation and fraud.”

J&J fined $1.2bn for drug marketing violations

by JoelLane 12. April 2012 14:35

Pf industry news 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.

EMA under fraud review

by emma 7. November 2011 13:08

Pharma Industry News

The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.

The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.

OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.

It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.

Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.

The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.

The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.

A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.

Pfizer pays $14.5m for illegal drug marketing

by emma 27. October 2011 16:02

Pharma Industry News

Pfizer has agreed to pay $14.5 million for illegally marketing overactive bladder drug Detrol, for males with benign prostatic hypertrophy.

The settlement resolves the last of ten whistleblower suits that were filed by the government against Pfizer, under which the company agreed to pay $2.3 billion dollars to resolve multiple civil claims and criminal charges.

Carmen Ortiz, US Attorney for the District of Massachusetts, said: “We hope and expect that this is indicative of a commitment to move forward in compliance with the law, and we will continue to watch vigilantly to ensure that Pfizer complies with the law in its sales and marketing of drugs sold to the public.”

It was filed that the company illegally marketed Detrol for treatments not approved by the FDA, marketing it for use in men suffering from benign prostatic hypertrophy and several allied conditions, including lower urinary tract symptoms and bladder outlet obstruction.

Tony West, Assistant Attorney General of the Justice Department's Civil Division, said: “Whistleblowers play an important role in protecting taxpayer funds from fraud and abuse.”

The $14.5 million fine will be divided between the US and participating state Medicaid programs, with nearly $12 million going to the federal government and $2.5 million going to state Medicaid programmes.

“Settlements like this one help maintain the integrity of FDA's drug approval process and support important federal and state health care programs,” added Mr West.

This settlement is part of the government scheme to combat healthcare fraud through the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was established in May 2009.

Nottingham Mobility owners jailed

by Joel 27. July 2011 17:18

MB medtech news

The owners of assistive technologies company Nottingham Mobility have been jailed for 12 months each after being found guilty of fraud.

Shane Johnson, 54, and Laurence Johnson, 26, took thousands of pounds from elderly customers in the Midlands and Yorkshire for mobility products that were never delivered.

The British Healthcare Trades Association (BHTA) has commented that the case highlights the need for customers to select suppliers who have signed up to an industry Code of Conduct.

According to the Johnsons’ lawyers, the father and son team breached the consumer protection laws when their company ran into financial difficulties.

Set up three years ago, Nottingham Mobility sold a range of mobility products, including scooters and stairlifts, from third-party suppliers.

The company took payments of up to £31,000 for equipment it did not deliver. It also broke promises to pay off existing finance agreements for equipment as part of the sales agreement.

One customer, May Bell (86), was forced to spend five weeks without access to her bedroom or bathroom after paying upfront for a new stairlift: the old stairlift was removed, but the new one never arrived.

Judge James Sampson told the Johnsons: “Your victims were elderly, stroke victims, polio victims, amputees, the disadvantaged and the disabled.”

The BHTA’s Director General, Ray Hodgkinson MBE, commented that elderly and disabled people are too vulnerable to fraud. “We would like to see more attention drawn to the need to buy from companies subject to the BHTA Code of Practice,” he said. “Buying from a company subject to this code safeguards people from abuses.

“All our member companies are covered by the code. They are carefully vetted and monitored to ensure adherence to it.”

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