Paxil induced suicides in US quantified_Glaxo Faces criminal action in UK over "suicide" pills_Times

Paxil induced suicides in US quantified_Glaxo Faces criminal action in UK over “suicide” pills_Times

Mon, 7 Jun

Law enforcement is finally catching up with drug companies who, for years, concealed evidence of a drug-related suicide risk for some children and adults who take an antidepressant. The law requires the companies to disclose drug risks fully to the FDA and equivalent regulators abroad. Regulators are supposed to ensure that the risks are disclosed to physicians and the public. Compelling evidence shows the companies concealed evidence of harm to boost sales.

The British medicines regulatory authority (MHRA) has announced a criminal investigation of GlaxoSmithKline, producers of Paxil (paroxetine) “to make sure the company had complied with its legal obligations under UK and European law.” This action follows in the footsteps of the NYS Attorney General, Eliot Spitzer, who filed a lawsuit against Glaxo on June 2, charging the company had “engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose” important information about the safety and efficacy of Paxil.

The Times of London reports: “Depending on its findings, the MHRA could choose to prosecute either Glaxo as a company or go after named individuals. If found guilty, the penalties could include fines or imprisonment.”

After years of denial and drawn out speculation about the validity of antidepressant-induced suicide risk-due to the concealment of evidence–the scope of that risk–in real numbers-can now, for the first time be calculated. A new and accurate method for calculating the number of patients that have taken SSRIs was developed by our colleague in the UK, Graham Aldred, a systems engineer whose wife, Rhona died just 11 days after being prescribed Paxil /Seroxat.

Mr. Aldred has designed a computer model called IMR which stands for Investigative Medication Routine. Mr. Aldred has assured us that the IMR has been extensively tested and validated and all assumptions have been critically challenged. He applied IMR to analyze actual patients (in real numbers) taking an SSRI, and calculated the number of suicides that these drugs produced.

IMR has been applied to several of the most widely used SSRIs in both the UK and the US. IMR has been presented for critical review twice to the MHRA (UK Regulator) and was reviewed by UK University experts. No flaws in the design logic or implementation have been found.

Mr. Aldred’s “Letter to America” (addressed to Cong Joe Barton and Cong James Greenwood of the House Oversight and Investigations Committee) is posted on the website of The Alliance for Human Research Protection. This original document calculates the suicide risk for 18.5 million US patients who were prescribed Paxil (paroxetine) between 1993-2002.

The number of patients is derived from the number of pills consumed in the US–a total of 5.8 billion Paxil tablets within the last 10 years. To arrive at the net rate of drug induced suicides, Mr. Aldred calculated the suicide rates from recently reported clinical trial data.

Accordingly, the results show that between 1993-2002, there were 6,000 and 19,000 persons in the US who were victims of Paxil-induced suicide. See: http://www.ahrp.org/risks/aldred0404.php#letter

Is it not fair to ask, why the FDA failed to use its authority to make a credible risk-assessment of antidepressant drugs using data available to the agency and not to others?

The IMR tool will, no doubt, be of interest to the Attorney General, and other law enforcement agencies who may want to quantify the extent of harm produced by the concealment of SSRI-related risks–such as, drug-induced akathisia, self-harm, suicide and suicide attempts, violence, and drug dependency–as demonstrated by severe withdrawal symptoms.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

http://business.timesonline.co.uk/article/0,,8209-1135320,00.html

June 06, 2004
Glaxo faces criminal action in Britain over ‘suicide’ pills
Paul Durman and Dominic Rushe

GLAXO SMITH KLINE is facing a potential criminal prosecution for allegedly failing to inform British health regulators about the suicide risks associated with Seroxat, its blockbuster anti-depressant. Officials at the Medicines and Healthcare Products Regulatory Agency (MHRA) launched an investigation into Glaxo because of concerns that Britain’s biggest pharmaceutical group had withheld important data from clinical trials.

This showed that Seroxat could cause an increased risk of suicide and “self-harm” if prescribed to depressed teenagers.

The MHRA and the Committee on Safety of Medicines only received full details of the trials in May last year. Within two weeks, the MHRA announced a ban on giving Seroxat to children under 18 – the first regulator in the world to take such a step. Shortly afterwards, the US Food and Drug Administration issued similar, though less categorical, advice to doctors.

The MHRA investigation is expected to report its findings shortly. This weekend the MHRA said it “treats very seriously any failure to comply with the law. Last year, the MHRA announced that it would investigate Glaxo to make sure the company had complied with its legal obligations under UK and European law.”

Drug companies are obliged to report new evidence that changes the balance of risks and benefits of using their products.

Depending on its findings, the MHRA could choose to prosecute either Glaxo as a company or go after named individuals. If found guilty, the penalties could include fines or imprisonment.

The MHRA action comes when Glaxo is still reeling from allegations last week that it had “engaged in repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose” important information about the safety and efficacy of Seroxat, which is known as Paxil in America. The company must defend itself against a lawsuit from Eliot Spitzer, the New York attorney-general who first came to prominence after taking on the abuses of Wall Street banks during the technology boom.

Jean-Pierre Garnier, Glaxo’s chief executive, insisted the firm had provided regulators with all trial data. “We are a high-integrity company,” he said. “We know what the rules are and we follow them. We have a policy of publishing our negative data to the authorities.”

The British case rests on some of the same evidence as that of the New York lawsuit.

Garnier said it could be dangerous to change medical advice based on a single clinical study. “Sometimes you have to wait for all studies to come in before you have some sort of conclusion.”

http://www.njinsurancefraud.org/release/2004/May/glaxo0504.htm
FOR IMMEDIATE RELEASE
FOR MORE INFORMATION CONTACT:
John R. Hagerty
Division of Criminal Justice
(609) 984-1936

Office of Insurance Fraud Prosecutor
Peter C. Harvey, Attorney General
Vaughn L. McKoy, Director, Div. of Criminal Justice
Greta Gooden Brown, Insurance Fraud Prosecutor

May 4, 2004

Attorney General Announces Glaxo SmithKline To Pay $2.1 Million To New Jersey Medicaid Program As Part Of National Settlement

TRENTON – Attorney General Peter C. Harvey announced that New Jersey’s Medicaid Program will receive more than $2.1 million as a result of a national settlement which requires pharmaceutical giant Glaxo SmithKline to pay $87 million in damages and penalties to federal and state Medicaid programs. As part of the settlement, the Division of Criminal Justice – Office of Insurance Fraud Prosecutor’s Medicaid Fraud Section separately negotiated an additional $850,608 to reimburse New Jersey’s state-operated prescription drug programs.

“This settlement returns a sizable amount of money to the State of New Jersey and to the various prescription drug programs which assist and benefit those citizens who need the aid the most. Every dollar lost to fraud or abuse is one less dollar available to help the most needy citizens of our state. The Insurance Fraud Prosecutor is committed to fighting healthcare fraud and returning much needed dollars to the state treasury,” said Attorney General Harvey.

According to Vaughn L. McKoy, Director, Division of Criminal Justice and Insurance Fraud Prosecutor Greta Gooden Brown, the national litigation alleged that Glaxo SmithKline sold pharmaceutical products to privately-operated health management organizations (HMO’s) at deeply discounted prices, concealed the transactions, and then under-reported “best price” information to the Center for Medicaid and Medicare Services (CMS). The effect of this deception diminished the amount of money the company was required to pay federal and state Medicaid programs – thus cheating the states out of significant funding for prescription drug programs.

Insurance Fraud Prosecutor Gooden Brown noted that in order to receive Medicaid reimbursement for drugs, pharmaceutical manufacturers enter into a contract under the Medicaid Drug Rebate statute which requires the return of monies to state and federal Medicaid programs in the form of rebates. In order to calculate the amount of the rebate, pharmaceutical companies must provide “best price” information to CMS – “best price” information being the lowest price that a manufacturer offers a product for sale to commercial purchasers. As a result of providing inaccurate “best price” information, Glaxo SmithKline effectively discounted the amount of rebate monies owed to the individual state Medicaid programs.

According to Supervising Deputy Attorney John Krayniak, Office of Insurance Fraud Prosecutor’s Medicaid Fraud Section, Glaxo avoided higher rebate payments by re-labeling or re-packaging certain drugs under private HMO labels. For example, under a private labeling agreement with California-based HMO Kaiser Permanente, Glaxo manufactured, packed and shipped Flonase to Kaiser, substituting Kaiser’s identification number for the Glaxo identification number. The result of the private labeling arrangement was to allow Kaiser additional price discounts on Flonase without having to report the discounted price as Glaxo’s “best price,” thus allowing Glaxo to avoid paying higher rebates to the state Medicaid programs. Similarly, Glaxo SmithKline provided Kaiser discount prices on Paxil without reporting the discounted price to CMS in order to avoid paying higher Medicaid rebates.

Krayniak said that New Jersey is one of the few states in the country that administers Medicaid as well as state-funded pharmaceutical assistance programs – the Pharmaceutical Assistance to the Aged and Disabled (PAAD) and the Senior Gold Program. As with Medicaid, the state-sponsored programs require pharmaceutical manufacturers to adhere to the same “best price” rules in order to participate in the PAAD and Senior Gold programs. Based on this requirement, the Medicaid Fraud Section of the Office of Insurance Fraud Prosecutor separately negotiated and received an additional $850,608 as part of the Glaxo SmithKline settlement.

In 2003, the Office of Insurance Fraud Prosecutor filed 5,524 civil complaints, consent orders, judgements, and/or other actions which resulted in the assessment of more than $16.2 million in sanctions, fines and restitution. A national study released by the Washington, D.C.-based Coalition Against Insurance Fraud in December reported that New Jersey’s Office of Insurance Fraud Prosecutor accounted for 86 percent of the total civil actions reported in 2002 by all 43 state insurance fraud bureaus included in the report.

The Office of Insurance Fraud Prosecutor also ranks as a national leader in the filing of criminal cases. In 2003, the Office of Insurance Fraud Prosecutor charged 337 defendants via 215 criminal indictments and accusations; compared to 225 defendants charged in 173 indictments and/or accusations in 2002.

“Insurance fraud is among our top priorities,” said Attorney General Harvey. “We have dedicated significant resources to investigating and prosecuting insurance fraud to stabilize insurance rates in New Jersey. We’re fighting insurance fraud on three fronts: criminal prosecution, civil sanctions and forfeiture of the licenses of professionals who engage in insurance fraud. We’ve used that triple threat to make our Office of Insurance Fraud Prosecutor one of the nation’s foremost fraud fighting agencies.”

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