September 14

Pharma Corrupt Practices_Glaxo / Bristol-Myers_Drug-induced Deaths / Homicides

This industry’s ethics standards have more in common with illegal business operations than with legitimate, law abiding corporations that compete fairly in the marketplace.

1. The Associated Press reports that UK pharmaceutical giant, GlsaxoSmithKline, has settled the LARGEST TAX DISPUTE in IRS HISTORY.  GSK shareholders will have to shell out $3.4 billion to settle with the IRS. The dispute involved transfer pricing, an illegal accounting scheme for evading US income tax.

2. Another pharmaceutical company, Bristol-Myers, had settled federal charges for an accounting scandal last year, costing the company $800 million. Under the agreement, charges would be dropped against the company if it met certain standards until 2007.  However, the company’s CEO and general counsel were caught engaging in yet another criminal activity. They had signed an illegal agreement with Canadian drug maker Apotex "to keep generic Plavix off the market. Plavix is Bristol-Myers’ best-selling blood thinner."

Another form of tax evasion by a pharmaceutical company is described by Dr. Peter Rost in his book, The Whistleblower: Confessions of a Healthcare
Hitman. His suit against Wyeth was for engaging in a tax evasion scheme by which governments around the world were cheated of tax income.
The pharmaceutical industry is profiteering by marketing defective drugs that cause permanent damage to liver, kidney, heart, and brain function.
More than 106,000 people die each year from adverse drug effects.  If one adds prescription drug errors, the death toll rises to 140,000. [1]

The American Academy of Anti-Aging Medicine (AAAM) has the following warning on its website: [2] "Discovering dangers of prescription drugs after they have been marketed to the medical community and public is common. Generally, 51% of FDA-approved drugs have serious adverse effects not detected prior to approval. Each year prescription drugs injure 1.5 million people so severely they require hospitalization. In addition, prescription drugs cause 100,000 deaths annually. With these numbers, how can the public be protected from dangerous drugs?"

The AAAM cites the JAMA study that examined the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. "An ADR is any harmful, unintended, or undesired effect of a drug. This definition does not include drug abuse nor intentional or accidental drug overdose. The results
of this study were conclusive: the rate of severe and deadly adverse drug reactions in U.S. hospitals was found to be extremely high-high enough that
ADRs ranked fourth, after heart disease, cancer, and stroke, as a leading cause of death in the U.S."

AAAM also notes FDA’s poor performance: "Despite FDA attempts to incorporate various drug safety measures prior to approving prescription drugs, they often overlook potentially dangerous effects. The use of prescription drugs is often crucial; however, in order to avoid potentially harmful side effects and drug-interactions, natural remedies should be incorporated whenever possible. Herbal therapies and nutritional supplements may support
the relief of many health problems without the harmful effects of prescription drugs."

Drug manufacturers charge the American consumer exorbitant prices for drugs, bankrupting healthcare budgets. What’s worse, FDA has given its seal of approval to drugs’ whose risks outweigh any proven benefits.

Internal FDA documents reveal that the government seal of approval has been give to drugs that failed most clinical trials in which they were tested.
Their effectiveness is speculated on the basis of two trials–FDA declares those minority positive trials as evidence, "proof in principle"–even if the drug failed in 5 trials–or, 25 trials or, for that matter, in 125 trials.

USA Today reported that last year the pharmaceutical industry "faced the most product liability lawsuits of any other industry." [3]  Not only does this industry aggressively market drugs that have little, if any, clinical benefit, they knowingly market drugs that induce heart attacks; [4] drugs that induce diabetes; [5] drugs that cause drug dependency; [6] and drugs that trigger violent suicidal and homicidal behavior. [7] 

Below are two current news stories involving antidepressants and homicidal acts:
One case involves a seven year old Texan boy who became homicidal and suicidal after a psychiatrist prescribed Prozac and Strattera. When the
drugs were withdrawn in hospital "the child’s agitation ended." The second case involves an 83 year old man in Washington who stabbed his wife of 60
years, almost killing her. The judge found him "not guilty by reason of insanity after agreeing his crime was motivated by an adverse reaction to the prescription antidepressant Wellbutrin."

1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15);1200-04. See also:  Bates DW. "Drugs and Adverse Drug Reactions; How Worried Should We Be? [editorial]" JAMA 1998;279 (15);

2. More drugs get slapped with lawsuits, USA TODAY 8/23/2006 .
its-usat_x.htm?   See also:

3 See: Prescription Drugs and Their Potentially Adverse Effects: The Potentially Adverse Effects of Prescription Drugs,4436.html

4. DAVID ARMSTRONG. Bitter Pill: How the New England Journal Missed Warning Signs on Vioxx, THE WALL STREET JOURNAL May 15, 2006; Page A1  See also:

5.  N. R. KLEINFIELDIn Diabetes, One More Burden for the Mentally IllTHE NEW YORK TIMES June 12, 2006 See also:

6. Moncrieff J and Cohen D. "Do Antidepressants Cure or Create Abnormal Brain States?"  PLOS Medicine, June 5.

7. David Healy, Andrew Herxheimer, and David B. Menkes.  "Antidepressants and Violence: Problems at the Interface of Medicine and Law," in PLoS
See also:

Contact: Vera Hassner Sharav

The Associated Press
Glaxo to pay $3.4B to settle biggest tax dispute in history  
9/11/2006 1

WASHINGTON (AP) – The Internal Revenue Service announced Monday that it had settled a dispute with the pharmaceutical giant GlaxoSmithKline  Holdings under which Glaxo will pay $3.4 billion in the largest tax dispute in IRS history.

The case is pending in the United States Tax Court, the agency said in a statement.

The agreement covers a transfer pricing dispute for the tax years 1989 through 2000. It also settles tax issues for the 2001-2005 period. The dispute involves intercompany transactions between Glaxo and certain of its foreign affiliates relating to various GSK pharmaceutical products.

Under the settlement, Glaxo will also abandon its claim seeking a refund of $1.8 billion in overpaid income taxes, the IRS said. "We have consistently
said that transfer pricing is one of the most significant challenges for us in the area of corporate tax administration," said Mark Everson, IRS commissioner. "The settlement of this case is an important development and sends a strong message of our resolve to continue to deal with this issue."

The IRS said transfer pricing is an accounting method requiring that related parties engage in transactions at arm’s length to ensure the proper reporting of taxable income.

At issue, IRS said, was the level of U.S. profits reported by the Glaxo after making intercompany payments that took into account product intangibles developed by and trademarks owned by its British parent. Another factor was the value of Glaxo’s marketing and other contributions in the United States.

GlaxoSmithKline Holdings is a subsidiary of British-based GlaxoSmithKline (GSK)  Under the agreement, Glaxo conceded more than 60% of the total amount at issue for the years pending in Tax Court, the IRS said.

Glaxo, in a statement, said the net cash cost will be approximately $3.1 billion, covering federal, state and local taxes, interest and also the benefit of tax relief on the payments made. It said Glaxo had previously made provision for the dispute and the settlement will not have a significant impact on the company’s reported earnings or tax rate.

"GSK was confident of the strength of its position, but in view of the size of the potential financial exposure, as well as the continued level of resource being applied to the case, GSK concluded that it was in the best interests of its shareholders to reach this settlement, thereby removing the costs and uncertainty of future litigation," the company said.

Copyright 2006 The Associated Press. All rights reserved.
September 12, 2006
Bristol Ousts Chief Executive and Chief Counsel

NEW YORK (AP) — Bristol-Myers Squibb Co. on Tuesday ousted Peter R. Dolan as chief executive at the urging of a federal monitor, who found that the drug maker’s patent deal with a generic competitor violated an agreement with prosecutors.

Bristol-Myers named board member James M. Cornelius as interim CEO effectively immediately.

Also, General Counsel Richard K. Willard will leave the company. A federal monitor recommended at a board meeting Monday that the company fire both
Dolan and Willard. Dolan has been CEO since 2001, and Willard was appointed general counsel in October.

Sandra Leung, the company’s corporate secretary, was named interim general counsel, and will be aided by former FBI Director Louis J. Freeh, a board
member and former general counsel.

Bristol-Myers Squibb shares rose $1.08, or 4.6 percent, to $24.47 in early trading on the New York Stock Exchange after the news.

The company confirmed reports that Judge Frederick B. Lacey, appointed the federal monitor under the company’s deferred prosecution agreement in an
accounting scandal, recommended the firings, and that Christopher J. Christie, U.S. Attorney for New Jersey, concurred. Both Lacey and Christie
attended a meeting of the board late Monday.

Lacey was appointed monitor of the company in June 2005 after Bristol-Myers settled federal charges for an accounting scandal that ended up costing the company $800 million. Under the agreement, charges would be dropped against the company if it met certain standards until 2007.

The apparent last straw was Dolan’s and Willard’s conduct stemming from a failed agreement with Canadian drug maker Apotex to keep generic Plavix off the market. Plavix is Bristol-Myers’ best-selling blood thinner.

Bristol-Myers’ board is expected to approve the company’s high-profile dividend. In June, the company declared a quarterly dividend of 28 cents per
share. But some analysts have suggested that lost sales of Plavix could pressure the board to cut the dividend by nearly a half.

Copyright 2006 The Associated Press
Austin psychiatrist’s medical license suspended after he is deemed a threat
Medical board said he endangered 7-year-old, household member.
By Mary Ann Roser
Wednesday, September 13, 2006

A panel of the Texas Medical Board suspended the license of an Austin psychiatrist after it said he improperly medicated a 7-year-old with Prozac and another drug and mishandled the care of a household member who overdosed on drugs he prescribed.

Dr. Sergio Silva, whom the board said is 38, could not be reached for comment Tuesday. The answering machine at his Bee Cave Road office said that
"due to circumstances beyond our control," it would not be possible to leave messages for Silva or reach him "in any way" until next week.

The temporary suspension was the strongest and fastest action to remove him from practice, medical board spokeswoman Jill Wiggins said. The three-member panel said it was necessary because Silva presented "a continuing threat to the public welfare and a real and present danger to the health of patients."

The panel’s order says Silva’s behavior last year caused the 7-year-old to be hospitalized with homicidal and suicidal thoughts and the household member to be endangered. It also says Silva lost his medical privileges at Seton Shoal Creek psychiatric hospital because of threatening and disruptive

Silva can appeal the disciplinary action. Based on the medical board’s records, which give one side of the story, board staff members allege that Silva was treating a 7-year-old boy for anxiety and attention deficit disorder in April 2005 with Prozac, which is approved for major depression and obsessive-compulsive disorder in children, and Strattera, which is used to treat attention-deficit (hyperactivity) disorder in children.

The boy’s mother told Silva that he had a reaction to Strattera, so Silva reduced the dosage. The child’s behavior did not improve, and Silva increased the Prozac dose and later boosted the Strattera, believing that the boy’s mother was not complying with his medication orders.

The boy’s behavior worsened and grew violent, causing Silva to again say the mother was not complying. She suggested that he draw the child’s blood and see for himself.

The mother said she thought the bad behavior, which later became suicidal, was a reaction to the medicine; Prozac and Strattera each warn that they can increase suicidal thoughts in children. Silva threatened to report her to Child Protective Services.

Another psychiatrist found high levels of Prozac in the boy’s blood. The new doctor hospitalized the boy, and the Prozac and Strattera were
stopped. The child’s agitation ended, and an expert hired by the board concluded that a drug-to-drug interaction had occurred.

Several months later, Silva asked the boy’s mother to contact him because he was concerned that she had misrepresented the boy’s medical history. Silva later filed a complaint against her with Child Protective Services, alleging medical neglect, the order says.

In the case alleging improper treatment of a member of his household, the order says Silva was prescribing "multiple controlled substances" for his office manager and life partner, who overdosed on Xanax, Tylenol and codeine in May 2005.

After Silva tried to take care of the man for two or three days, he was admitted to Seton Medical Center’s intensive care unit, the order says.

Silva did not kept medical records justifying the prescriptions, yelled at the ICU doctor and verbally abused the staff, the order says.; 445-3619
The Olympian
Couple allowed to reunite after yearlong nightmare
By Christian Hill

Eric and Margaret Attwood walked hand-in-hand out of Thurston County Superior Court on Tuesday, taking the first steps toward normalcy since an act of violence 11 months ago rocked their 60-year union.

A judge decided that Eric Attwood, 83, could return home for the first time since his arrest for stabbing his wife in the neck as she slept on the morning of Oct. 3. Last month, a judge found Attwood not guilty by reason of insanity after agreeing his crime was motivated by an adverse reaction to the  rescription antidepressant Wellbutrin. In the intervening months, Attwood spent time at Western State Hospital, and the health of both spouses took a turn for the worse as they endured their first time apart from one another, said Hilary Carlson, their daughter.

On Tuesday, with her husband close by her side during an interview with a television news station, Margaret Attwood savored their reunion. "I feel so
much better," she said outside the courtroom. "It’s been a long year for us, but he’s still my husband and I love him very much." "I think we’ve known
for the last several months that this day would come," added Eric Attwood, choked with emotion.

During a brief hearing, Attwood reassured Judge Richard Strophy that he would comply with all court-ordered conditions, including receiving treatment and taking all of his prescribed medications.

His attorney, Jeffery Robinson, said last month that Attwood was on a different antidepressant and has been prescribed antipsychotics. "I think you’re looking at the real Eric Attwood at this point," Robinson told Strophy, as his client stood next to him dressed in a blue suit jacket and gray pants.

Attwood has been staying at an adult family home since his release in late June from Western State Hospital in Steilacoom, where he underwent psychological evaluation. The state Department of Corrections recommended to the court that Attwood be allowed to return home. The couple had lived in their own house on their daughter’s 20-acre parcel in Yelm. They will stay with her until they can be sure he can return to the home where he nearly killed his wife.

Margaret Attwood has said she fought to survive that morning to ensure people would know something had gone terribly wrong in his mind, that her
attacker wasn’t the man she’d loved for 60 years. Carlson called her mother a hero. "She fought to validate my dad’s life," Carlson said.
The family was celebrating Tuesday afternoon.  "My dad’s walking around on our property now," she said. "It’s a glorious day."
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