Buddy Holly – R.I.P.

Buddy Holly
Died 3rd February, 1959
The real creator of Rock and Roll
Still heard in every rock song ever released.

Psychiatric Drugs-the Beginning of the End

The Times-News
Modern mind medicines begin to lose luster
January 27, 2009
Hundreds of years ago, people with mental illness might be burned at the stake or locked away in a dungeon. In the early 20th century, some patients with schizophrenia were lobotomized with an ice pick to blunt emotions and reduce agitation.

Other treatments included padded cells, straitjackets, cold wet sheets and electroshock therapy. Mental institutions in the first part of the 20th century were sometimes referred to as “snake pits.”

It was in this barbaric context that the first antipsychotic drugs were developed. In 1952, when Thorazine (chlorpromazine) was first introduced, it was hailed as a breakthrough.

Other drugs such as Stelazine (trifluoperazine), Mellaril (thioridazine) and Haldol (haloperidol) followed. Although these antipsychotic medications were popular with psychiatrists, patients often thought of them as chemical straitjackets.

Such drugs helped reduce hallucinations and agitation. But there was a high price to pay for the apparent benefits. The drugs made people feel sedated and slowed them down, resulting in a zombielike shuffle.

Other side effects included dizziness, slurred speech, seizures and a variety of movement disorders such as severe neck muscle spasms causing head twitches or uncontrollable rhythmic movements such as sticking out the tongue. Urinary retention, constipation and sexual difficulties also contributed to the drugs’ unpopularity with patients, who often discontinued their medicines as soon as they were discharged.

A newer generation of schizophrenia drugs was introduced in the early 1990s with great fanfare. Drugs like Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Geodon (ziprasidone) and Abilify (aripiprazole) are known as atypical antipsychotics.

Psychiatrists hoped that these medications would be better tolerated and much more effective than older antipsychotics. Some even believed the new drugs would help schizophrenic patients return to normal.

More than $13 billion is spent on antipsychotic medications each year. They are prescribed for a range of conditions beyond schizophrenia, including Alzheimer’s and dementia, bipolar disorder, insomnia, autism, obsessive-compulsive disorder, ADHD and major depression.

Despite the initial enthusiasm, there is growing consternation about the safety and effectiveness of these powerful mind medicines. A few years ago, a study found that the newer and far pricier drugs were no more effective or less likely to cause troublesome side effects than an older antipsychotic (New England Journal of Medicine, Sept. 22, 2005). A new study in the same journal (Jan. 15, 2009) reported an alarming rate of sudden cardiac death linked to the newer drugs.

It’s no wonder that patients and families are nervous about these medicines, especially when you consider that they can cause other complications such as dramatic weight gain, diabetes, strokes and irregular heart rhythms. Children and older people may be particularly vulnerable.

People with mental illness deserve much better treatment than they have received to date. Although lobotomies and straitjackets are no longer used, modern medications leave a lot to be desired.

Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert.

Source: http://www.blueridgenow.com/article/20090127/ARTICLES/901271010?Title=Modern_mind_medicines_begin_to_lose_luster <http://www.blueridgenow.com/article/20090127/ARTICLES/901271010?Title=Modern_mind_medicines_begin_to_lose_luster

The Whistle-Blower who Blew Eli LIlly Out of the Water

He wants jail time for wrongdoing by Lilly executives regarding psych drug Zyprexa. “You have to remember, with Zyprexa,” he said, “people lost their lives.”

Letters to the editor: Inquirer.Letters@phillynews.com

Philadelphia Inquirer
Whistle-blower’s perspective on Lilly case
By Miriam Hill
Jan. 19, 2009
Robert Rudolph knew he was about to end his lucrative career at Eli Lilly & Co., but he had to say something.

Why, he asked management, was the Indianapolis pharmaceutical company marketing its antipsychotic drug Zyprexa to elderly people when the drug was not approved for that group?

Robert Rudolph was one of nine Eli Lilly workers who took allegations against the drugmaker to federal prosecutors.
Why had the company violated privacy rules by culling patient lists at doctors’ offices?

Why was the company counting drug samples as sales, which would boost the stock price?

He went on for about 10 minutes during a sales meeting in 2002. The other 25 Lilly sales representatives stared at him, stunned.

“I’d just been wrestling with this stuff for so long,” he said in a telephone interview today. “I was put in a position of breaking the law, in my view, or quitting.”

Rudolph and eight other whistle-blowers brought their allegations to federal prosecutors. That led Lilly to agree Thursday to a record $1.4 billion fine to settle charges of marketing Zyprexa illegally.

Zyprexa had been approved by the Food and Drug Administration for schizophrenia and bipolar disorder – but in 2001, the company began promoting it for other uses, such as treating anxiety, agitation and confusion in the elderly.

Drug companies are permitted to market drugs only for approved uses, though doctors may prescribe as they see fit. Lilly did an end run around the process by telling doctors Zyprexa could ease agitation, anxiety, and other everyday symptoms, according to the Philadelphia U.S. Attorney’s Office, which brought the case.

In a statement today, Lilly insisted its employees always adhered to strict ethics. “Doing things the right way at Lilly is more important than securing a prescription,” the statement said.

Rudolph and several other whistle-blowers found their way to prosecutors through their attorneys, Steve Sheller of Sheller P.C. and Michael Mustokoff of Duane Morris L.L.P., both of Philadelphia, and Gary Farmer of Florida.

Lilly’s Zyprexa marketing material included pictures of composite patients such as Martha, a confused and agitated widow.

“If you looked at it, you would say this was an Alzheimer’s dementia patient,” Rudolph said in the interview from his home in Oregon.

Other tactics bothered him, too. Company employees were allowed into doctors’ offices on weekends to collect names of patients taking certain drugs in hopes of switching them to Lilly products.

“We’re not selling soap. We’re selling chemicals that can be dangerous if they’re not used in the right way,” he said.

That was especially true of Zyprexa, which caused weight gain. And diabetes is a risk of the drug.

Rudolph, who was a pharmacist before joining Lilly in 1976, chose the company because of its sterling reputation.

But gradually, as financial markets boomed and stock options became a bigger part of executive pay, Lilly’s culture began to change, Rudolph said.

Instead of the pharmacists it had traditionally hired, Lilly started bringing in recent college graduates who had no medical background and were easy to train to parrot the company line. Instead of a profit-sharing program that all employees participated in – “even the guy who swept the floor,” Rudolph said – compensation shifted to rewards-based on sales.

“This new way of compensation kind of opened the door for a lot of unscrupulous practices, I felt,” Rudolph said.

He warned management of his concerns. Their response: “You’re not a team player.”

He began talking to other sales representatives about the issue, including Hector Rosado, another whistle-blower in the case.

As he pondered what to do, Rudolph’s son, then 15, provided a moment of clarity:

“He came up to me and said, ‘Dad, what’s wrong is wrong.’ I had taught my kids that. It was wrong, and I wanted to make it right.”

So he raised his hand at the Lilly district sales meeting in Sacramento, Calif., in January 2002.

The stress of the job had thrown him into a depression. Managers made it clear they wanted him to leave, so six months after he made his stand at the meeting, he retired from his $115,000-a-year job.

He and the eight other whistle-blowers will split $78 million to $100 million of the settlement. Rudolph, 60, says the settlement against Lilly will only go so far in changing business practices. He wants jail time for wrongdoing by companies and executives.

Zyprexa sales were about $39 billion since FDA approval in 1996. Lilly did plead to a single misdemeanor of misbranding of a drug.

“You have to remember, with Zyprexa,” he said, “people lost their lives.”

Link: http://www.philly.com/inquirer/breaking/business_breaking/20090119_Whistle-blowers_perspective_on_Lilly_case.html

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Eli Lilly Buys its Way Out of Trouble-Again

Lilly settles Zyprexa suit for $1.42 billion
Lilly to pay total of $1.42 billion to settle Zyprexa suits, pleads guilty to marketing charge

Thursday January 15, 2009, 6:48 am EST
Yahoo!
NEW YORK (AP) — Drugmaker Eli Lilly is pleading guilty to a charge that it illegally marketed anti-psychotic drug Zyprexa for off-label use, and will pay a combined $1.42 billion to settle civil suits and end the criminal investigation.

The Indianapolis-based company will pay $800 million to settle civil suits, including $438 million to the federal government and $362 million to states. It will pay $615 million to resolve the criminal probe, and plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act for promoting Zyprexa as a dementia treatment.

The company did not acknowledge any wrongdoing in the civil cases.

Eli Lilly & Co. in October said it expected to pay $1.42 billion to end the investigations.

Eli LIlly Scam-Payout Close

New York Times
Lilly Said to Be Near $1.4 Billion U.S. Settlement on Drug
By GARDINER HARRIS
January 14, 2009

Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects.

The amount of the settlement is a record sum for so-called corporate whistleblower cases, which are federal lawsuits prompted by tips from company employees or former employees. Details of the agreement were provided by people involved in the negotiations.

Among the charges, Lilly has been accused of a years-long scheme to persuade doctors to prescribe Zyprexa to two categories of patients — children and the elderly — for whom the drug was not federally approved and in whom its use was especially risky.

In one marketing effort, the company urged geriatricians to use Zyprexa to sedate unruly nursing home patients so as to reduce “nursing time and effort,” according to court documents. Like other antipsychotics, Zyprexa increases the risks of sudden death, heart failure and life-threatening infections like pneumonia in elderly patients with dementia-related psychosis.

The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared.

The case is being prosecuted by the United States Attorney’s Office for the Eastern District of Pennsylvania. Patricia Hartman, a spokeswoman for the office, declined to comment.

Angela Sekson, a Lilly spokeswoman, said she could not comment on the status of the Zyprexa negotiations. Last fall, the company, anticipating a settlement, had set aside $1.4 billion for that purpose.

Lilly executives have for years insisted that the company’s Zyprexa marketing efforts were legal and appropriate. When asked whether she could repeat those assurances, Ms. Sekson said, “It would be inappropriate for me to comment further right now.”

It could not be confirmed on Wednesday whether the company will acknowledge wrongdoing as part of the settlement. Without a settlement, Lilly risks being barred from participating in the federal Medicaid and Medicare programs — a huge part of its business — even though such bans almost unheard of for big drug makers because their products are considered so essential.

In the United States, most of Zyprexa’s sales are paid for by government programs because so many of those taking Zyprexa are indigent or disabled. Zyprexa had sales of $4.8 billion in 2007, making it the biggest seller by far for Lilly, whose revenue that year was $18.6 billion. Depending on dosage, the drug can cost as much as $25 for a daily pill.
The settlement may have little impact on how doctors actually use Zyprexa, because physicians are free to prescribe drugs as they see fit. But it is because drug makers are barred from promoting drugs for uses not specifically approved by the Food and Drug Administration that Lilly has been charged.

Zyprexa has F.D.A. approval only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.

Just about every major drug company in recent years has pleaded guilty or is under investigation for urging doctors to use medicines beyond their approved uses. The Zyprexa case and others were brought by former drug company employees using a Civil War-era whistleblower law to claim that the companies defrauded government health programs. The former employees usually share in the recovery.

The Zyprexa settlement is the largest such recovery in history, surpassing the $900 million fine that Tenet Healthcare paid in 2006 to resolve whistleblower claims that it improperly billed Medicare. In 2001, TAP Pharmaceutical agreed to pay $875 million to resolve criminal and civil charges related to pricing and marketing of its cancer drug, Lupron.
But while the fines in such cases involving drug makers have been substantial, they generally recover only a fraction of the costs associated with unapproved drug uses.

Zyprexa, for instance, has generated more than $39 billion in sales since its approval in 1996, making it one of the biggest-selling drugs in the world. As much as half of Zyprexa’s use is estimated to be for unapproved or “off label” use, the $1.4 billion fine — punishment for years of illegal marketing efforts — represent less than one year of off-label sales of the drug.

And despite mounting concern about Zyprexa’s risks and the negative publicity surrounding the legal case, sales were $3.5 billion for the first nine of 2008, 2 percent higher than in the first nine months of 2007.

Zyprexa was initially received as a significant advance over an earlier generation of antipsychotics. But a series of landmark studies in recent years have cast doubt on that long-held view and suggested that Zyprexa is no better than older drugs that sell for far less.

A government study published in September, for instance, found that Zyprexa was no more effective in children than an older medicine but caused more serious side effects. Indeed, the children receiving Zyprexa gained so much weight during the study that a safety monitoring panel ordered that they be taken off the drug.

In December 2006, The New York Times published articles detailing hundreds of internal Lilly documents and e-mail messages among top company managers that showed how the company sought for years to downplay Zyprexa’s tendency to cause severe weight gain and metabolic disorders, including diabetes, while promoting unapproved uses.

One 2000 e-mail message, for instance, described how a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes had warned the company that “unless we come clean on this, it could get much more serious than we might anticipate.”

The government’s case will remain sealed until at least Thursday, when a judge is expected to approve the settlement. People involved in the negotiations say that prosecutors pressed for a resolution in the waning days of the Bush Administration to avoid having to get another set of approvals from new bosses at the Justice Department in Washington.
While the settlement is intended to resolve all pending government claims, it is unclear whether all states, which are parties to the case through the federal-state Medicaid program, have agreed to terms.

Some of the claims and evidence in the government’s case are similar to those made in a pending California state whistleblower lawsuit in which Jaydeen Vicente, a former Lilly sales representative, described years of what she said were illegal Zyprexa marketing efforts.

Ms. Vicente claimed, for instance, that Lilly paid kickbacks to doctors who prescribed large amounts of Zyprexa by hiring them to educate other doctors through a “speaker’s program” or by sending doctors to posh resorts where they were trained to be speakers.

“The speaking engagements were frequently a mere sham,” Ms. Vicente’s lawsuit states. “Lilly-paid speakers were even paid to give pointless presentations to their colleagues at the healthcare facility with which they were affiliated.”

The drug industry continues to hire tens of thousands of doctors to serve as part-time marketing representatives, although medical schools and societies increasingly frown on the practice.

Ms. Vicente was hired in 2000 to join a 160-person “Long Term Care” sales team that focused on nursing homes “despite the lack of any clinical trials or F.D.A. approval for the use of Zyprexa in the elderly,” the lawsuit states.

Ms. Vicente and other Lilly sales representatives distributed a Lilly study contending that elderly patients who were prescribed the drug “required fewer skilled nursing staff hours than patients prescribed other competing medications” and reduced “caregiver distress,” the lawsuit states. Zyprexa often induces sleep in patients.

“In truth, this was Lilly’s thinly-veiled marketing of Zyprexa as an effective chemical restraint for demanding, vulnerable and needy patients,” the lawsuit states.

In October, Lilly agreed to pay $62 million to 32 states and the District of Columbia to settle consumer protection claims related to Zyprexa. It paid Alaska $15 million and agreed to pay $1.2 billion to 31,000 Zyprexa plaintiffs. Some private Zyprexa claims remain unresolved.

Source: http://www.nytimes.com/2009/01/15/business/15drug.html?pagewanted=1&_r=1&ref=business

Doctors ‘Conned’ by Drug Industry

Antipsychotics: Doctors ‘conned’ by drug industry
08 January 2009

Doctors and psychiatrists have been conned by the drug industry to prescribe new, or second-generation, antipsychotics for problems such as schizophrenia, two leading specialists have claimed.

The new generation of drugs, known as atypicals, were heralded as safer and more effective than the earlier antipsychotics, and for the past 20 years doctors have been ‘beguiled’ into thinking they were superior.

The claims come from Peter Tyrer and Tim Kendall from Imperial College London [psychiatrists] as a commentary on a new study that assessed the effectiveness of nine second-generation antipsychotics against earlier, typical antipsychotic drugs.

The study, conducted by Munich University, found that the second-generation drugs were not even a new class of drug at all, but were a hotchpotch made up from ingredients used in the earlier drugs. They certainly weren’t more effective or safer.

In their commentary, Tyrer and Kendall say: “The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug industry for marketing purposes and only now being exposed.”

Source: http://www.wddty.com/03363800369837226214/antipsychotics-doctors-conned-by-drug-industry.html

Reference: http://f1.grp.yahoofs.com/v1/gJNmSeUnebKX3CzzjI4zjetc862zRTfCw011ny6dFjf53qL10UiC68Qjel4GKIhnxoODOvBd6r5Gn2qCRudeag/lancet.pdf
The spurious advance of antipsychotic drug therapy
The Lancet , Volume 373 , Issue 9657 , Pages 4 – 5
Peter Tyrer, Professor of Community Psychiatry, Imperial College
Tim Kendall, MD, Royal College of Psychiatrists’ Research Unit