Posts Tagged ‘Zyprexa’

Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma

Tuesday, December 7th, 2010
AlterNet — December 6, 2010
by Martha Rosenberg
Here are some of the dicey drugs many Americans are hooked on,
thanks to greedy pharmaceutical companies.

Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement — 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 — manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma’s admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the “very dynamic ADHD market” to Shire’s globalization efforts and “investments we have made in new uses for our existing products.”

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD “new starts” that are helping Shire “grow the market,” and the “co-administration market” of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. “We don’t see those patients show up again until their mid-to-late 20s,” laments Cola.

ADHD drugs, in addition to “robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors,” as Anatomy of an Epidemic author Robert Whitaker puts it, can also be deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no “real risk” and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds “are told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs,” a phenomenon also known as the co-administration market.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the last decade than direct-to-consumer advertising and Viagra put together, no pun intended: over 60 million prescriptions were filled in the US in 2007 with many patients reporting their depression lifted.

But some critics say for mild depression, SSRIs don’t work at all and are no better than placebo.

And others say they can add aggression, bizarre behavior, self-harm and suicidal thoughts to depression. In fact, there are 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988 including the well known gun massacres at Columbine (1999), Red Lake (2005), NIU and likely, Virginia Tech (2007).

SSRIs have non-behavioral perks both sides agree on: life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition, osteoporosis.

Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It’s linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sex? SSRIs are so linked to dysfunction even the pharma-identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. But there is a solution (besides going off SSRIs) says WebMD: Add another antidepressant that’s not an SSRI, like Wellbutrin!

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you’re giving a psychoactive drug for pain. “After three months of taking Savella [another SNRI], I started self-destructing and cutting myself,” writes a 40 year old woman on askapatient.com. “I don’t know why or anything, but it does similar to Prozac where it makes you think and do weird things.”

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix’s Sky Harbor airport in 2007.

SNRI’s are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. told AlterNet he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It’s also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That’s similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Read the rest of the article here: http://www.alternet.org/story/149078/nation_of_pill_poppers_19_dangerous_drugs_shamelessly_pushed_by_big_pharma?page=entire

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South Carolina Doctors Under Fraud Investigation After Writing Thousands of Antipsychotic & Painkiller Prescriptions

Monday, November 22nd, 2010
The State, November 22, 2010
By Renee Dudley

CHARLESTON — An influential U.S. senator is checking up on South Carolina doctors who have billed millions of dollars in prescriptions to the financially struggling, taxpayer-funded Medicaid program.

U.S. Sen. Charles Grassley, an Iowa Republican, requested data from each state this year listing which doctors write the most prescriptions for eight common drugs covered by Medicaid, the federal health program for the poor. The reports were intended to “ensure that taxpayer dollars are appropriately spent,” Grassley wrote in a letter to state officials.

The Palmetto State’s report, released to The (Charleston) Post and Courier, identifies a handful of doctors who have written thousands of prescriptions for painkillers and anti-psychotics over the past two years. While many of the claims are legitimate, state Department of Health and Human Services officials confirmed this week that some doctors on the list are under investigation for fraud.

  • The report detailed the top prescribers of the following drugs:

    Abilify

    Geodon

    Oxycontin

    Risperdal

    Roxicodone

    Seroquel

    Xanax

    Zyprexa

Kathleen Snider, the state agency’s compliance chief, declined to say which doctors are under review because their cases are open. State health departments are responsible for monitoring Medicaid prescription rates and billing irregularities.

Among the doctors getting the most reimbursements were a Columbia psychiatrist who wrote about 3,900 prescriptions for the drugs in question in 2008 and 2009. The doctor billed about $1.3 million to Medicaid, according to a Post and Courier review of the data.

A family doctor in Summerville billed about $635,000 for writing nearly 2,400 prescriptions for antipsychotics and painkillers during that time.

A psychiatrist with an Augusta address wrote more than 1,300 prescriptions, billing nearly $720,000 over the two years.

A Sumter family doctor billed more than $500,000 for writing about 860 prescriptions.

Grassley, a member of the Senate Finance Committee, which oversees Medicare and Medicaid, requested the state reports after discovering a Florida provider wrote 96,685 prescriptions for mental health drugs in a 21-month period.

Although the report shows no Palmetto State doctors approached that figure, Grassley took South Carolina’s data into consideration when he wrote to U.S. Secretary of Health and Human Services Kathleen Sebelius last month. His letter detailed states’ findings and encouraged the federal department to “step up efforts to monitor providers that are outliers” in both the Medicaid and Medicare systems.

A spokeswoman for Grassley said Friday Sebelius has not yet responded.

The states’ data does not indicate illegal activity, but shows that “there are very often providers that prescribe certain drugs at significantly higher rates than their peers,” Grassley wrote in his letter.

He continued, “This may be because a particular physician has a specific expertise or patient population, but it might also suggest overutilization or even health care fraud.”

Grassley also noted that the top prescriber for a particular drug often writes several times more prescriptions than the 10th highest prescriber. This was the case for several of South Carolina’s lists.

For example, a Greenville area neurologist wrote 100 prescriptions for Oxycontin in 2009 — 10 times more prescriptions that the No. 10 prescriber on the list.

The No. 1 prescriber of Xanax, a Greenville psychiatrist, wrote 1,073 prescriptions in 2009, while the number 10 prescriber wrote 63, according to the data.

Snider, of the S.C. Department of Health and Human Services, said over the past several years, the state has enacted data-mining surveillance systems to target Medicaid doctors who over-prescribe drugs.

While prescription drug abuse strains the system, Snider said other examples of fraud — billing for duplicate tests, extra hours or phantom patients — cause even more wasteful payouts because they can be harder to detect.

Read more: http://www.thestate.com/2010/11/22/1572561/medicaid-questions-raised-about.html#ixzz162671Yli

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In Indiana, Psychiatrists Once Again Top the List of Top Drug Prescribers Under Medicaid/Medicare

Monday, November 15th, 2010

IndyStar.com

by John Russell

Indiana doctors who write thousands of prescriptions a year for drugs covered by publicly funded Medicaid and Medicare programs are coming under federal scrutiny.

U.S. Sen. Charles Grassley of Iowa has launched an investigation into doctors here and around the country who are top prescribers for drugs billed to the federal program, citing concerns that expensive medications are being overprescribed. Several states, including Indiana, have already responded with lists of top prescribers.

Grassley said that some physicians are writing tens of thousands of prescriptions for costly drugs. He cited a doctor in Florida who wrote 96,685 prescriptions for mental health drugs in a 21-month period.

No Indiana doctor came close to that amount, according to a list sent to Grassley’s office by the Indiana Family & Social Services Administration. The agency compiled a list of top prescribers overall in 2008 and top prescribers for certain psychiatric medications in 2008 and 2009, including Zyprexa, Geodon, Risperdal and Abilify.

According to the list, the top overall prescriber in Indiana is Dr. Daniel Kinsey, a psychiatrist in Goshen. He wrote 2,894 prescriptions in 2008, which resulted in $791,289 in medication charges to the state.

The next highest was Dr. Melinda Weekly, a psychiatrist in Bloomington, who wrote 2,456 prescriptions in 2008, resulting in charges to Indiana of $1.16 million.

Other states have also compiled lists. In Texas, one doctor authorized 13,596 prescriptions for anxiety drug Xanax in 2008, and increased it to 14,170, according to a letter Grassley recently sent to the U.S. Department of Health and Human Services.

In Connecticut, one doctor ranked consistently as the top prescription writer across a full range of pharmaceuticals, Grassley said, writing 5,945 prescriptions in 2008 and 7,459 in 2009 for seven medications.

“I want to be clear that none of the information provided suggests any illegal or wrongful behavior,” Grassley wrote. “It merely demonstrates that across pharmaceutical brands and categories, as well as across states, there are very often providers that prescribe certain drugs at significantly higher rates than their peers.”

He continued: “This may be because a particular physician has a specific expertise or patient population, but it might also suggest overutilization or even health care fraud.”

Grassley, who is a top member of the Senate Finance Committee, urged federal authorities to look into the matter.

“The trend is found again and again across the states, suggesting that top prescribers stand out not only against other providers in their state, but against the very top prescribers in those states,” he said.

http://www.indystar.com/article/20101115/NEWS09/101115017/Inquiry-eyes-Ind-doctors-who-write-prescriptions?odyssey=tab|topnews|text|IndyStar.com|optionb|t

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Another Psychiatric Drug, Another Potential Criminal Investigation—J&J’s Antipsychotic Risperdal

Thursday, November 11th, 2010

Wall Street Journal, November 10, 2010

by Peter Loftus of Dow Jones Newswires

Johnson & Johnson (JNJ) said it’s in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal.

“Discussions are ongoing in an effort to resolve potential criminal and civil litigation arising from these matters,” J&J disclosed in a regulatory filing Wednesday. “Whether a resolution can be reached and on what terms is uncertain.”

J&J spokesman Jeff Leebaw declined further comment.

Risperdal, which is approved to treat schizophrenia and bipolar disorder, was once J&J’s best-selling drug, with global sales of about $4.9 billion in 2007, according to IMS Health, before its oral formulation lost patent protection and cleared the way for generic competition.

J&J has previously disclosed government inquiries regarding Risperdal and later, a newer antipsychotic, Invega, but hadn’t previously said it was in talks for a settlement.

In 2004, the Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena seeking documents regarding sales and marketing of Risperdal, as well as payments to physicians and clinical trials for the drug, from 1997 to 2002.

The U.S. Attorney’s Office in Philadelphia sent an additional subpoena in 2005, seeking information about Risperdal marketing and adverse reactions associated with the drug. Grand jury subpoenas have been issued seeking testimony from various witnesses.

Earlier this year, J&J, of New Brunswick, N.J., disclosed the government had served civil investigative demands seeking additional information about the marketing of Risperdal and Invega.

Other makers of popular antipsychotics have settled government probes of marketing practices in recent years. In April, AstraZeneca PLC (AZN) agreed to pay about $520 million to resolve Justice Department allegations that it promoted Seroquel off label, or for uses not approved by the Food and Drug Administration.

Last year, Eli Lilly & Co. (LLY) agreed to pay more than $1.4 billion and pleaded guilty to a criminal charge, admitting it promoted the antipsychotic Zyprexa for off-label uses including treatment of dementia in the elderly.

The drugs also have been linked to safety risks, including increased risk of death if used by elderly patients with dementia-related psychosis, as well as weight gain.

Several U.S. states have filed lawsuits against J&J seeking reimbursement of Medicaid funds used to pay for off-label uses of Risperdal, as well as compensation for treating beneficiaries for alleged adverse reactions to the drug.

In October, a jury in Louisiana awarded the state $257.7 million after concluding that J&J minimized the drug’s risk of causing weight gain leading to diabetes. J&J said it would appeal the verdict because the jury wasn’t properly told of applicable legal standards, and certain evidence was excluded. J&J said it didn’t violate the law.

Read the rest of the article here: http://online.wsj.com/article/BT-CO-20101110-717532.html

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Big Pharma executives facing legal threat; including potential fines and prison time

Sunday, October 31st, 2010

The Philadelphia Inquirer, October 31, 2010

by Christopher K. Hepp

Rats that infested a Philadelphia warehouse 40 years ago have found their way into the legal nightmares of the nation’s drug companies.Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds.

Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties.

In one area the FDA is targeting are companies that have illegally promoted products for unapproved uses, a practice know as off-label marketing.

“I don’t know when, where, or how many cases will be brought,” Blumberg told a gathering of the Food and Drug Law Institute, “but if you are a corporate executive – or counsel advising such a client – I would not wait for the first case to decide now is the time to comply with the law. They won’t get a mulligan on their conduct.”

In an interview Thursday, Blumberg was pointed.

“They need to take this seriously and find out what is going on in the marketing and sales divisions of their companies,” he said of pharmaceutical executives. “In my view, one thing that will get executives’ attention is a few cases in which we have convicted two-legged defendants.”

He singled out firms, including Pfizer Inc. and Eli Lilly & Co., that have paid multiple penalties in recent years.

Eli Lilly, for instance, was hit with a $1.4 billion fine last year for illegally marketing Zyprexa, a antipsychotic drug. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra. Neither company’s stock price suffered significantly, leading some to conclude that even massive fines are viewed by investors and executives as simply the cost of doing business. Neither firm responded to calls for comment.

“It is clear that fines are not working here,” Blumberg said. “We need to put something else on the scale to make people think twice, three times, before they promote drugs for unapproved uses.”

That something is the threat of prison and industry debarment, which could result from a successful prosecution using the Park Doctrine.

Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

It stems from a case involving John Park, president of Acme Markets Inc. in 1970, when the company was cited for rodent infestations at a warehouse here.

The FDA charged Park personally with violating sanitation laws after other rodent infestations were discovered despite a number of agency warnings.

Park argued that as company president he was too far removed from warehouse supervision to be held responsible.

The U.S. Supreme Court ultimately agreed with the FDA that Park, as president, was responsible for ensuring rodent-free warehouses.

Park got off relatively easy: a $250 fine.

Prosecutors now hope to extract stiffer penalties under the doctrine, including up to a year in prison and $100,000 fines.

Those are the possible punishments facing four executives of Synthes Inc., a West Chester firm that pleaded guilty early this month in connection with illegal clinical trials of a bone cement. Charged under the Park Doctrine by the U.S. Attorney’s Office in Philadelphia, the executives have also pleaded guilty.

The Park Doctrine can be “a very powerful tool,” said Assistant U.S. Attorney John Pease, who supervises criminal prosecutions involving pharmaceutical-industry fraud cases in eastern Pennsylvania. But it also presents prosecutors with a number of hurdles, he said.

The crimes under scrutiny have a five-year statute of limitations, for instance. Often, prosecutors are not even alerted to them for several years, he said.

“And with multinational pharmaceutical companies with billions in revenue, you find responsibility is very diffuse,” Pease said. “The real challenge is finding a person who was in a position to know about and prevent the conduct that occurred.”

Scott Gottlieb, a former FDA commissioner who is now a partner with Arcoda Capital in New York, said another challenge would be assuring that an off-label case would hold up in court, particularly if it involved executives several layers above the departments that committed the illegal acts.

“There are clearly cases where the management is so far removed from the activity, they have no direct knowledge of the issue,” he said. “To hold them criminally liable is a significant policy step that needs to be done with great care.”

He agreed, however, that bringing criminal charges against executives “would be a significant deterrent.”

read the rest of the article: http://www.philly.com/inquirer/business/20101031_Big_Pharma_executives_facing_legal_threat.html?viewAll=y

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When Big Pharma Breaks the Law—Prosecute the CEO

Tuesday, October 19th, 2010

New Scientist

October 19, 2010

Avandia's manufacturer won't release all its documents about the drug (Image: Bloomberg/Getty)
(Image: Bloomberg/Getty)

Patient safety will remain at risk until big pharma’s top executives are brought to book for their companies’ actions, says Paul Thacker

THERE have been so many stories about pharmaceutical companies promoting the misuse or abuse of their drugs that the names seem to merge – Zyprexa, Seroquel, Paxil and more.

The latest case concerns GlaxoSmithKline’s Avandia (rosiglitazone), an anti-diabetes drug linked to heart attacks. Last month, the European Medicines Agency recommended its suspension from the market, while the US Food and Drug Administration made it all but impossible for doctors to write prescriptions for the drug.

With sales worth over $3 billion in 2006, Avandia was the world’s best-selling diabetes drug until May 2007, when The New England Journal of Medicine published a study linking it to heart attacks. Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents.

As the main investigator into Avandia for the Senate committee for the past three years, I looked closely at the documents. I was appalled. From 2000, GSK pulled out all the stops to keep the drug on the market. Not all studies were provided to regulators, and it intimidated a doctor who criticised the drug. Even though GSK is in the middle of multibillion-dollar lawsuits brought by thousands of patients, it still has hundreds of documents hidden from public view under court seal – a feature of the US system that leaves documents provided under discovery accessible only to the parties involved in the litigation.

How can we stop this? One way is to slash what pharma can spend on encouraging doctors to prescribe their drugs. Companies spend billions wining and dining doctors. For instance, Forest Laboratories’ 2004 marketing plan for its antidepressant Lexapro notes it planned to spend $34.7 million to pay doctors to give lectures to their peers, and $36 million on lunches for doctors to create “an extended amount of selling time for representatives”.

In legal settlements reached with the US government, several companies have been forced to publish databases listing monies they provide to doctors. A provision in the Health Reform Bill passed this year will from 2013 require companies to disclose payments above $10 made to doctors, and explain why. This will be available in a searchable public database.

This will help, and may shame doctors into not taking handouts, but we also need professional societies to tighten ethical requirements to stop doctors accepting pharma gifts.

A second route is to reform the continuing medical education (CME) courses doctors must take every year. Of the $2 billion spent on CME in the US, pharma funds almost half. Companies claim this has no influence on prescribing practices, but internal company documents made public by the Senate finance committee contradict this. For example, Forest Laboratories’ marketing material on Lexapro discussed how CME courses could be used to push sales of the drug.

Several universities have revised rules on industry funding. Stanford University in California now requires companies to pool their money and fund a number of activities instead of funding individual courses, as is still allowed in most medical schools. The Memorial Sloan-Kettering Cancer Center in New York has ended all commercial support for CME in 2007, without ill effects.

Third, we need to penalise executives when companies are caught committing illegal acts. Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.

Paul Thacker is an investigator at the Project On Government Oversight, a non-profit organisation exposing waste, fraud and abuse in federal government. He was congressional investigator for the US Senate’s finance committee, where he was Senator Chuck Grassley’s lead investigator on Avandia

Read the rest of the article here:  http://www.newscientist.com/article/mg20827826.900-when-big-pharma-breaks-the-law-prosecute-the-ceo.html

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Prescription for prestige—Drug firms’ speaking fees flow to Harvard doctors; concerns about influence prompt new restrictions

Tuesday, October 19th, 2010

The  Boston Globe,  October 19, 2010

Liz Kowalczyk

The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs. Its allure is evident in a new analysis of all publicly reported industry payments to physicians.

Doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010 by seven pharmaceutical companies that disclosed their payments for parts of those years. The money was mostly for talking to other physicians about the companies’ drugs and the diseases they treat, but also for consulting on research and marketing.

“Companies value the cachet that comes with the name of a prestigious institution,’’ said Dr. Paul Appelbaum, director of the Division of Law, Ethics and Psychiatry at Columbia University College of Physicians and Surgeons. “Even though the institutions themselves are not in any way endorsing the presentations, the aura carries over.’’

The proportion of money going to Harvard doctors underscores why the medical school and its affiliated hospitals, concerned that certain speaking fees can compromise the independence of doctors, are clamping down on such payments.

It is not clear yet whether these restrictions are slowing payments to Harvard doctors, because the data reported publicly are incomplete. But one company, Eli Lilly, gave 50 percent of its payments in 2009 to Harvard doctors and just 33 percent during the first three months of this year.

Many hospitals and medical schools continue to permit doctors to participate in company speakers bureaus, and even at medical centers that largely ban the practice, the analysis — by ProPublica, a nonprofit, online investigative reporting organization, and the Globe — found spotty enforcement.

Consulting with industry to develop new treatments is considered part of an academic physician’s role. But participating in speakers bureaus, while legal, is controversial. Bureau speakers typically show groups of doctors company-created or approved slide presentations about specific drugs or diseases treated by a company’s products. Many of these talks, often held at fancy restaurants, have been moved out of state, doctors said, since last year, when Massachusetts banned doctors from eating the free dinners.

Pharmaceutical companies defend speakers bureaus as an important tool for educating doctors and say industry naturally relies on physicians from top academic medical centers because their peers look up to them.

While some doctors who gave speeches once or twice during 2009 and 2010 earned $2,000 to $3,000, more than two dozen Massachusetts psychiatrists, endocrinologists, and other specialists who gave frequent talks brought in $40,000 to $100,000 and, in a few cases, more. Dr. Lawrence DuBuske, an allergy specialist, earned the most: $219,775. The Globe reported earlier this year that he resigned from Brigham and Women’s Hospital largely because of its new speaking ban.

Partners HealthCare, which includes the Brigham and Massachusetts General and McLean hospitals, halted their doctors’ promotional speaking appearances in January because of concern that they could be perceived as company salespeople and were helping to drive up use of expensive drugs.

Dr. Brent Forester, a geriatric psychiatrist at McLean, was one of the Massachusetts physicians paid the most last year, when he made $73,100 for giving nearly 40 talks for Eli Lilly to colleagues about the antipsychotic Zyprexa and the antidepressant Cymbalta over dinners in restaurants and in doctors offices. He has resigned from speakers bureaus to comply with the new rules, but said he “never felt like a spokesperson for the company at all.’’

“It was an opportunity to educate primary-care doctors about the treatment of psychiatric conditions,’’ Forester said.

Christopher Clark, who oversees compliance for Partners, said his staff searched drug company websites and identified 31 of its physicians who had been hired for speakers bureaus. All but two agreed to resign from the bureaus.

Harvard Medical School itself is also prohibiting participation in speakers bureaus, effective early next year. Consulting payments will still be allowed, with certain restrictions, but will have to be disclosed to Harvard, which has been under pressure from Senator Charles Grassley of Iowa to better monitor its faculty’s relationships with industry.

“We must ensure the integrity and objectivity of all our activities,’’ said Gretchen Brodnicki, the medical school’s dean for faculty research and integrity, who added that the Harvard faculty is huge, about 24 percent of the state’s doctors.

The data on physician payments was compiled from the websites of Eli Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Merck & Co., Cephalon, and the Johnson & Johnson companies by ProPublica and analyzed for Massachusetts by the Globe.

Companies reported paying about 470 Massachusetts doctors, about 200 of them Harvard faculty, a small percentage of the physicians statewide and of those affiliated with the university.

Most drug companies, however, have not publicly reported payments. The ones that have posted the information report different types of payments for different time periods, so it is not possible to draw definitive conclusions about how many doctors received payments and how much individual doctors earned.

Read the rest of this article here:  http://www.boston.com/news/health/articles/2010/10/19/mass_doctors_earn_drug_firms_dollars/?page=full

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Pfizer ends trial after widespread overdosing of children with psych drug

Monday, October 18th, 2010

NaturalNews.com,  October 18, 2010

by David Gutierrez

Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”

“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.

Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.

Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.

In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.

Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.

Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.

Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.

Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.

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Booming Sales of Antipsychotic Drugs Often Fueled by Illegal Marketing Tactics

Wednesday, October 6th, 2010

FairWarning, October 6, 2010

By Jessica Roberts 

Antipsychotic drugs, once used to treat only the most serious mental illnesses, have emerged as the top-selling class of pharmaceuticals in the U.S., generating annual revenue of about $14.6 billion. Yet much of the sales boom has been achieved with illegal or controversial marketing tactics by major pharmaceutical companies to promote uses of the drugs that have not been approved by the U.S. Food and Drug Administration.

The result, according to an account by The New York Times, is that every major manufacturer of antipsychotic drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson  — has recently settled criminal or civil government cases for hundreds of millions of dollars or is under investigation by the Department of Justice for possible health care fraud. The criminal fines paid by Eli Lilly and Pfizer last year set records last year for the largest criminal fines ever imposed on corporations, although in the case of Pfizer, the case was built only partly on the marketing of an antipsychotic drug.

In their defense, the companies say that they follow tight business ethics guidelines and that all possible side effects of their medicines are fully disclosed. Recently, however, the government has warned that some of the drugs may be fatal for older patients and have unknown effects on children. And critics question how drugs approved by the agency for use by 1 percent of the population, to treat illnesses such as schizophrenia and bipolar mania, could have turned into top sellers, prescribed for everyone from preschoolers to octogenarians.

At least part of the answer lies in the companies’ marketing tactics. The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs.

According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles. These all are meant, federal investigators say, to promote the benefits and downplay the risks of the drugs, while encouraging off-label uses — that is, uses the FDA has not approved but which doctors, if they choose, can pursue with their patients anyway.

Drug companies skirt restrictions on promoting off-label uses by hiring consultants, researchers and educators to handle the job, delivering the marketing message verbally and through company-sponsored studies. “They can give a small hint, and people will take the bait,” Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, told the Times. “Psychiatric disorders are vaguely defined enough that you can stretch definitions.”

The Justice Department claims drug companies trained sales representatives to rebut valid medical concerns about unproved uses of antipsychotic drugs. For example, the department says, Eli Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes.

Read the rest of this article here: http://www.fairwarning.org/2010/10/booming-sales-of-antipsychotic-drugs-often-fueled-by-illegal-marketing-tactics/

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Antipschotic Drugs—Side Effects May Include Lawsuits

Monday, October 4th, 2010

The New York Times
By Duff Wilson
October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

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Department of Justice Statements on the Five Major Companies Selling Anti-Psychotic Drugs:
AstraZeneca
Bristol-Myers Squibb
Eli Lilly
Johnson and Johnson
Pfizer

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects like drowsiness, nausea, weight gain, involuntary body movements and links to diabetes are listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Tony Jewell, an AstraZeneca spokesman, said last week that the company had turned over all that material to the F.D.A. as part of the approval process and updated its label over the years to show the latest safety information.

Dr. Stefan P. Kruszewski, a Harvard-educated psychiatrist who once worked as a paid speaker for several drug makers, became a government informant and now consults for plaintiffs suing drug companies. Earlier in his career, he spoke at events for Pfizer, GlaxoSmithKline and Johnson & Johnson as an advocate of antipsychotics. He said one company offered him incentives of $1,000 or more every time he talked to an individual doctor about one of its drugs.

“When I started speaking for companies in the late 1980s and early ’90s, I was allowed to say what I thought I should say consistent with the science,” he recalls. “Then it got to the point where I was no longer allowed to do that. I was given slides and told, ‘We’ll give you a thousand dollars if you say this for a half-hour.’ And I said: ‘I can’t say that. It isn’t true.’ ”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

Read entire article:  http://www.nytimes.com/2010/10/03/business/03psych.html?_r=2

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