Posts Tagged ‘AstraZeneca’

Profiting from mental ill-health

Tuesday, March 15th, 2011

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here:  http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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Oh That? Seroquel Marketing Undeterred by This Week’s Deceptive Marketing Settlement

Tuesday, March 15th, 2011

OpEdNews  March 15, 2011

by Martha Rosenberg

Google the word “depression” and the first search result you’ll get is for the antipsychotic Seroquel XR.

Visit WebMD and the home page hosts similar ads for Seroquel XR, above and adjacent to the lead news story.

Who would know AstraZeneca inked the largest multi-state consumer protection settlement on record relating to deceptive Seroquel marketing just this week? For $68.5 million? Only a year after inking a similar settlement related to burying side effect and safety information for $520 million with the government?

Who would know AstraZeneca has already settled nearly 25,000 personal injury lawsuits pertaining to Seroquel with more to come says ABC news?

First approved in 1997, Seroquel has enjoyed the camel-nose-under-the-tent phenomenon known as indications creep. First approved for schizophrenia, it was later approved for bipolar disorder and psychiatric conditions in children. But it was Seroquel’s 2009 approval as an add-drug for depression that helped it reach its spectacular sales of $5.3 billion in 2010 thanks to the US’ walloping depression “market” of 20 million.

Seroquel’s blood sugar, weight gain and heart side effects are well known. That’s why FDA regulators opposed its use as a first choice, stand-alone treatment for the 10 percent of the US population with depression when safer drugs exist. “I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman who chaired the FDA panel considering the depression indication. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

The drug also can cause increased mortality in elderly patients with dementia-related psychosis, suicidality, neuroleptic malignant syndrome, cataracts, seizures, increases in blood pressure and movement disorders in neonates when their mothers take it.

Seroquel’s fraud trail is also well known with more than six conflict of interest scandals swirling around Seroquel researchers and promoters. Psychiatrist Richard Borison was sentenced to a 15-year prison sentence in 1998 for a pay-to-play Seroquel research scheme which helped establish Seroquel’s original perception as safe.

But how many realize Seroquel’s cost to the individual taxpayer and health insurance consumers at a Red Book price of almost $500 per month per person?

Auditors with the Michigan Corrections Department say the state could save $350,000 a month by switching just half of its Seroquel prescriptions to another pill. (Anyone know a school that could use $350,000 a month?) And North Carolina spends $29.4 million per year on Seroquel prescriptions. Who knows how much else states and taxpayers are paying to control the metabolic side effects that emerge with Seroquel?

Reports are also starting to surface about the effect $6,000-a-year Seroquel prescriptions, many unnecessary and inappropriate, are having on rising insurance premiums themselves for private insurance holders.

In fact, the public is really paying twice for the irrepressible Seroquel marketing. First for drug purchases in state and private plans (and the advertising) and second in side effects from a drug whose safety continues to be in doubt.

http://www.opednews.com/articles/Oh-That-Seroquel-Marketin-by-Martha-Rosenberg-110315-836.html

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AstraZeneca paying $68.5M to settle off-label marketing charges for anti-psychotic Seroquel

Thursday, March 10th, 2011

ABCNews.com

by Matthew Perrone AP Health Wire, March 10,  2011

Thursday's deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that the drug developer promoted its blockbuster psychiatric drug Seroquel for insomnia, Alzheimer’s and other unapproved uses.

The New Jersey Attorney General’s Office announced the agreement Thursday, describing it as the largest multistate pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal with 36 other states and the District of Columbia as party to the settlement.

The states alleged that salespeople for AstraZeneca promoted its anti-psychotic Seroquel for off-label, or unapproved uses, and did not disclose side effects of the pill, which include weight gain and muscle spasms.

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas Calcagni, acting director of New Jersey’s division of consumer affairs.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, though the majority prescriptions are for off-label uses like insomnia. The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $5.3 billion last year. But that success has been marred by frequent allegations that the company illegally marketed the drug and downplayed its risks.

Seroquel’s side effects, including blood sugar increases, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits from patients. The drugmaker had settled nearly 25,000 personal injury lawsuits related to Seroquel at the end of 2010, with 3,950 remaining.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

London-based AstraZeneca denied any wrongdoing.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” said company spokesman Tony Jewell, in a statement.

Thursday’s deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

The new settlement stemmed from a separate three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.

Allegations of off-label drug marketing have become increasingly common in the past decade, with the drug industry eclipsing all others as the source of fraud-related settlements with the federal government. Approximately 80 percent of the $3.1 billion in penalties collected last fiscal year by the government came from the health care sector, including drugmakers, insurers and hospitals, according to Taxpayers Against Fraud.

http://abcnews.go.com/Business/wireStory?id=13105486

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Drug Industry Fraud—The Whistle Has Been Blown, But Where’s the Enforcement?

Tuesday, December 28th, 2010

Counter Punch, December 28, 2010

by Ralph Nadar

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen’s Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe’s team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry’s penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe’s study shows that the pace of penalties has picked up over the past five years. This is due to “a combination of increased violations by companies and increased law enforcement on the part of federal and state governments,” says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators’ campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the “current system of enforcement is not working.” He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says “the lack of criminal prosecution that would result in jailing of company executives.” is key. Moreover, the report notes that “a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues.”

A flicker of hope that a little change is on the way came from the Food and Drug Administration’s Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: “.unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy–.we can not expect to make progress in deterring off-label promotion.”

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

http://www.counterpunch.org/nader12282010.html

Ralph Nader is the author of Only the Super-Rich Can Save Us!, a novel.

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Once Again Psychiatrists Top the List of Top Prescribers—And Are Heavily Funded by Pharma

Wednesday, December 8th, 2010

Note from CCHR:   The reason why we repeatedly see psychiatrists on the list of top drug prescribers is pretty simple.  It’s so easy to prescribe psychiatric drugs to patients. Think about it.  It’s not like cancer or diabetes, or even high cholesterol where there’s a test to show some disease or imbalance requiring “medication” to treat it.   Sure there are medical conditions that may not have a “test” to prove anything is wrong.  There are some.  But there are no tests to prove anyone has a mental disorder.  Not one.  So psychiatrists can make a killing when it comes to writing unnecessary prescriptions.  Literally.   All while raking in the bucks from Pharma.

San Diego Union Tribune – December 8, 2010

By Christina Jewett

Three San Diego doctors who prescribe medications at the same time they are paid by drug companies as experts on the products figure into a broader national debate about whether playing both roles poses a conflict.

California Watch, a project of the independent, nonprofit Center for Investigative Reporting, compared two sets of data at the center of the debate — one a database of payments by drug companies to doctors nationwide and the other a list of the top antipsychotic prescribers in California’s Medi-Cal program for the poor and disabled.

Among California’s top prescribers, three accepted more than $20,000 in educational or speaker’s fees from the company that makes the drug they prescribe to Medi-Cal patients. All three practice in San Diego County.

Accepting drug company payments and then prescribing the products to patients is not illegal or even unethical, in and of itself. But some inside the profession and out are concerned such marketing could induce over-prescription of drugs or otherwise corrupt the process.

Two of the San Diego-area psychiatrists share a La Mesa office — Samuel O. Etchie and John W. Allen.

Allen was among the state’s top prescribers of Zyprexa, an antipsychotic drug. Allen dispensed 418 prescriptions at a cost to the state of $346,569. This year and last, the drug’s maker, Eli Lilly and Co., paid him about $27,000 to educate other medical professionals.

Allen said he conducts speeches about Zyprexa for Lilly based on information contained in the FDA-approved literature that comes with the drug. He said he speaks for a variety of drugmakers if he has done research and treated patients with the medication.

“I think it’s unfortunate that there’s in implication in articles that we’re robots for drug companies,” Allen said. “We have to have our own experience with medications and find out what works best. We’re not 5-year-olds in front of TV watching cereal and toy commercials.”

Allen said the prescribing numbers reflect the many bipolar and schizophrenic patients he treats in his practice. He said he prescribes a wide variety of medications, new and old.

“Whatever works for the patient is most important,” Allen said.

Etchie, who shares and office with Allen, prescribed Seroquel more than 1,000 times in 2009 at a cost of $449,000 to the state, according to Medi-Cal records collected by the Pro Publica news organization and provided to California Watch. The drug’s maker paid him $25,350 this year to speak to health professionals.

Etchie said he’s been paid by drug companies to give talks for about 10 years, and sees it as a way to keep himself informed about new and approved uses for medications and to share that information with colleagues who may be too busy to keep track of the research themselves. He said his presentations on Seroquel are an overview of the research drugmaker AstraZeneca has given the FDA about the medication.

“Whatever I do in the area of medicine, I want to get paid,” he said. “But my motive in doing this is to keep my knowledge base current and then to pass on that information to colleagues. Whether a doctor prescribes a medication or not is none of my business. I’m not a salesman.”

The third San Diego-area doctor is Harinder Grewal, a child psychiatrist who sees patients throughout the county.

According to Medi-Cal records, she issued nearly 3,000 prescriptions for antipsychotic medications in 2009, half of them for the drug Seroquel. This year AstraZeneca, that company that sells the drug, paid her $21,600 to educate other health workers.

Grewal did not return calls from California Watch or The San Diego Union-Tribune.

Grewal was also among the state’s top prescribers of the antipsychotic medication Geodon. That drug’s maker, Pfizer, spent $3,750 to compensate Grewal for leading an educational forum.

The three doctors showed up on a list provided by Medi-Cal officials to Sen. Charles Grassley, R-Iowa, who is reviewing prescribing rates of psychiatric and pain medications nationwide.

Grassley’s investigation comes on the heels of numerous government lawsuits that have accused pharmaceutical companies of illegally marketing drugs beyond their approved uses. California authorities who provided the information to Grassley’s office warned against viewing the data as a sign of wrongdoing.

Read the rest of the article here:  http://www.signonsandiego.com/news/2010/dec/06/paid-drug-experts-also-prescribe-products/

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Disciplined doctors receiving pharmaceutical funds

Thursday, November 18th, 2010

San Francisco Chronicle, November 18, 2010

by Victoria Colliver

About 48 of the more than 1,730 California doctors who received money from pharmaceutical companies over the past 21 months have been the subject of disciplinary action, a database compiled by the investigative news organization ProPublica found.

While that represents less than 3 percent of the California doctors who take pharmaceutical money, the fact that drug companies are paying those doctors – some of whom have multiple disciplinary actions – for their expertise calls into question how closely these companies vet the physicians who serve as the spokespeople for their drugs.

California doctors have received $28.6 million from top pharmaceutical companies since 2009, with at least three physicians collecting more than $200,000 and 36 others making more than $100,000 for promoting drug firm products. That cash flowing from drug companies to doctors has raised ethical concerns from some observers.

“If they’re getting as much money from pharmaceutical companies as they do for being a doctor, what are they really? Are they working for a pharmaceutical company, or are they being a doctor?” asked Lisa Bero, a pharmacy professor at UCSF who studies conflicts of interest in medicine and research.

Bero also questioned why drug companies – which presumably would want medical leaders who could influence prescribing patterns – would use doctors with a history of disciplinary actions.

“Are those really the most influential physicians?” she asked. “I don’t think they’re (the drug companies) on top of this.”

Company payments

Payments to doctors and other health professionals made by Eli Lilly, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson and Cephalon, some of the world’s largest drug companies, added up to more than $281.9 million in 2009 and 2010 nationwide. The figures do not include drug samples, the cost of continuing education programs, and meals brought to doctors’ offices.

In total, 384 of the approximately 17,700 health professionals in the 30 states surveyed who received some money from drug companies in ProPublica’s database, almost all of them physicians, earned more than $100,000 apiece for their promotional and consulting work on behalf of one or more of the seven companies in 2009 through Oct. 19 of this year.

ProPublica found that the seven drug companies paid $6.7 million to 290 doctors who faced disciplinary action or other regulatory sanctions in various states.

San Francisco psychiatrist Karin Hastik, for example, took $168,658 in speaking and consulting fees from Eli Lilly, AstraZeneca and GlaxoSmithKline since 2009.

But in May, the Medical Board of California placed Hastik on probation for negligence, prescribing drugs without prior examination, and failing to keep adequate records about a patient she had been caring for since 2000. Hastik did not return calls for comment.

Dr. Gerald Sacks, an anesthesiologist with offices in Los Angeles and Santa Monica, was California’s top earner in the database, receiving $249,822 from drug companies since 2009. More than half – $150,097 – came from Pfizer.

In 2003, the state medical board cited Sacks, who did not return calls for comment, for failing to maintain adequate records of a patient he treated for back pain.

Undermining trust

While the disciplinary actions in the database vary greatly – everything from failing to maintain accurate paperwork to sexual misconduct – some experts say the very act of taking large sums of money from pharmaceutical companies raises ethical concerns.

“It undermines the trust in the doctor-patient relationship,” said Maryann O’Sullivan, executive director for the Campaign for Effective Patient Care, a nonprofit based in Fairfax. O’Sullivan said patients shouldn’t have to worry if their doctors are making medication recommendations because they are beholden to drug company money.

Officials for several of the pharmaceutical firms told ProPublica that they intended to tighten and improve their selection and screening processes in light of the disciplinary results. ProPublica provided each company with lists of all speakers who had been disciplined in the 30 states and by the U.S. Food and Drug Administration.

A survey conducted in 2004 found that more than 80 percent of physicians had some relationship with the pharmaceutical industry, ranging from accepting drug samples to collecting consulting fees and participating in paid clinical trials.

Since that time, greater attention has been placed on the relationship between doctors and drug companies, and many hospitals and medical schools have adopted rules that limit these ties.

A survey published this month in the Archives of Internal Medicine found that more than 80 percent of doctors still had industry relationships, but the level of involvement had decreased. For example, the survey found the percentage of physicians receiving payment for speaking engagements and other services dropped from more than one-fourth in 2004 to 14.1 percent last year.

Several doctors who were not the subject of any disciplinary action but did take large sums from pharmaceutical companies told The Chronicle they spoke on behalf of only those drugs they believed in and thought they were performing an important educational service for other physicians.

A teaching tool

Dr. Rona Hu, clinical associate professor at Stanford University School of Medicine, said she earned more money from speaking engagements in 2009 than usual because several drugs she prescribes became available for new uses. The psychiatrist said she has since stopped getting paid by drug firms to speak because Stanford tightened its policy regarding industry gifts to staff.

One of the top earners in Northern California, Palo Alto psychiatrist Manoj Waikar, who earned $185,875 since 2009, ended his affiliation with Stanford as an adjunct professor after the school extended its ban to adjunct staff in March.

“Speaking for drug companies is a great vehicle for me for teaching. I end up reaching more people who are eager to learn, especially in rural parts of the country,” he said, adding he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns. “As much as I loved teaching at Stanford, abiding by their rules would (keep) me from teaching as many people in as many ways as I can.”

Dr. Michael Lenoir of Oakland, who collected $112,600 from GlaxoSmithKline, said he uses his speaking engagements to visit urban and underserved areas around the country to discuss the high rate of asthma in black communities and the treatment options.

A San Francisco pain doctor who has earned $176,771 since 2009 from Pfizer and Cephalon said he doesn’t believe speaking for drug companies poses a conflict because he discloses the payments to his patients.

“So far, every patient has been OK with it,” said Dr. Wayne Anderson, adding that doctors who take money from equipment manufacturers and other medical suppliers don’t fall under the same scrutiny. “I don’t get bonus payments at the end of the month. I’m not trying to do anything secretive. I have complete transparency and honesty, and I tell people when I have been paid to promote a drug.”

About this story: It was produced in partnership with ProPublica, a nonprofit investigative news organization. To read the stories in the investigation and to search the ProPublica database on pharmaceutical company payments to doctors, go to projects.propublica.org/docdollars.

Read the rest of the article here: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/11/18/MNJU1GDLRF.DTL

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Seven Ways Medical Conflicts of Interest are Disguised

Friday, November 12th, 2010

FoodConsumer, November 12, 2010
by Martha Rosenberg

“Trust me” used to be the punch line about how a certain obscenity is uttered by Hollywood agents.

It also used to govern the conflicts of interest policies at hospitals, universities, medical schools and scientific journals about doctors’ and researchers’ financial links.

But conflicts of interest (COI) at Harvard and other universities, medical journals, professional groups and at the FDA itself have ushered in a kind of disclosure fever. In addition to the Physician Payment Sunshine Act which requires drug and device makers to report physician payments yearly, medical schools are starting to reject industry money that traditionally funded Continuing Medical Education (CMEs).

Individual doctors’ COIs have also been a problem for medical groups and journals.

The American Psychiatric Association,  in its 240 page guide to its May annual meeting, “forgot” to mention the conflicts of interest of its own president Alan Schatzberg, MD. It had to print them on the newsletter circulated the third day of the meeting. Nor were names even alphabetized for easy information retrieval. (Schatzberg is financially linked to Eli Lilly, GSK, Merck, Pfizer, Forest, Takeda, Sanofi-Aventis and eight other companies.)

Joan Luby, MD, a pediatric depression expert says in the Archives of General Psychiatry in March she didn’t disclosure lectures she gave for AstraZeneca and other pharma ties “because they were not relevant to the subject of the article.” Maybe that’s why the New York Times magazine didn’t disclose Luby’s links in the August “Can Preschoolders be Depressed?” and five Wyeth links in April’s “The Estrogen Dilemma.”

And statin investigator, Harvard’s Paul Ridker, MD, apologized to JAMA readers in 2006 for an incomplete financial disclosure for an article about cardiovascular clinical trials. He thought he only had to report funding for the “study at hand” and had omitted mentioning funding from AstraZeneca, Bayer, Novartis, Roche, Sanofi-Aventis and five other pharmaceutical companies.

Disclosure is especially tricky for medical journals whose lifeblood is often drug ads and reprints of article for drug companies to pass out to physicians.

Here are some of the ways conflicts of interest are finessed.

1) Omnibus disclosure. All of a study’s authors are listed with all the pharma links in one block of solid type. Who goes with whom? You’ll never know — but the author with no links sure isn’t happy about shared guilt.

2) Initials. “R.L.T. has consulted for Merck” is set in 8 point type at the end of the article. Will readers return to the study’s start, five pages ago where there are eight authors, four with first names that begin with R?

3) Disclosures You Have To Work For. COIs of CME faculty are often given online but the information is tucked away in a pull-down, scroll menu. It is user-unfriendly like the drug side-effects found on the scrolling ads on the same site.

4) One Disclosure is Enough. When a previous article is cited in journal letters sections, the author disclosures are said to “be found with the original article.” Surely you have that issue, published four months ago, on your desk.

5) Protective Coloring. Disclosures of drug company links are embedded between government grants and charitable foundations. Government grants and charitable foundations are not conflicts of interest — though some say taking government money along with industry should be.

6) Paying Customers Only. 20 million citations of medical literature appear on the US National Library of Medicine web site. Many have author’s institutions and email. But do the abstracts show COIs? Not unless you’re a paid subscriber. Password please.

7) Paying Customers Only…Even When You Are Reading A Hard Copy. In hard copies of the August 5 New England Journal of Medicine, the disclosures of authors of “Suicide-Related Events in Patients Treated with Antiepileptic Drugs” are absent and said to be found with the “full text” of the article at NEJM.org.

When we asked Karen Pedersen Buckley, NEJM manager of media relations, why  disclosure information about doctors who challenge an 2008 FDA warning* were not available in the journal’s hard copy, she said the web site was being redesigned. “We hope that many of our readers will have access to the full text and disclosure forms through an institutional subscription at their hospital, university or library,” she added.

And for those who don’t? Trust us.

*FDA warned about seizure drugs’ suicide side effects. The authors largely find the drugs safe.

http://www.foodconsumer.org/newsite/Non-food/Healthcare/seven_ways_medical_conflicts_of_interest_are_disguised_111110061.html

See also CCHR’s expose, Shrinks For Sale: The Corrupt Alliance of the Psychiatric Pharmaceutical Industry

Joseph Biederman

Pharma Poster Boy, Psychiatrist Joseph Biederman http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

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Is this for real, or just more smoke and mirrors – Big Pharma Executive being prosecuted by DOJ for obstruction of justice & lies

Thursday, November 11th, 2010

Is Something Not Quite Right With Stan – A Mental Health Blog – November 10, 2010

The Big News in Pharma-land is that the DOJ is going after a former GSK lawyer/Exec for a myriad of crimes which could lead to a Fashionable Federal Prison Jump Suit & a very long stay at a Martha Steward Foo Foo Club Fed. The question still remains if this scum bag exec does go to trial and is convicted (or sings like a Canary); what effect this might have on the World Wide Pharmaceutical Drug Cartel Criminal business as usual model?

From the rumblings being heard around the Pharma CEO world it appears this maybe a circle the wagons strategy developing orgy with a huge PR campaign of “we need to be more open and listen themes” while prospects of huge corporate take overs, turf wars, and more profits shine like stars in their beady & greedy CEO eyes ( read here–> AstraZeneca CEO: Pharma Must Be Open, Work With Stakeholders – FoxBusiness.com and here Glaxo sees more industry consolidation - Pharma Not Well Equipped to Handle a PR Cyber Storm-VOX

For a little back story)

This all sounds like a big wonderful hug fest & one giant “can’t we all just get along” moment for all those that have been watching these corporate crimes being waged against society and humanity go unchecked for decades now. But the caution bells are ringing in distance as we have learned the hard way many times before with Big Pharma; words are always cheap, while honesty & accountability is something of an abomination to the holy pharmaceutical corporate stone tablet creed.

So as they say, the proof will lay/lie in the pudding. Will AstraZeneca finally do the right thing when it’s comes to the many thousands injured by Seroquel, will J&J make good on the Risperdal crime settlements and get clean/sober, will GSK come in with a apology mop with groveling pledges of restitution and pay outs for damage caused by Paxil, Wellbutrin, Avandia, as we just name a few of the many ongoing Big Pharma Cartel horrendous criminal actions that have seriously harmed or killed consumers.

If you believe the sweet smell of change is in the air, you might want to ask/consider why is Big Pharma trying to close the honesty door at the same time they are saying they want it to be wide open? read here–>And Here Is The SEC Whistleblower Program

Now if one was to place this in the framed context that Big Pharma is still pumping huge amounts of money into the drug influence game involving doctors and research here—> http://projects.propublica.org/docdollars/ and here–>http://www.madinamerica.com/madinamerica.com/Leo/F7BDF895-0DE9-4605-8C73-A25177CBA9FE.html

Or here where they continue funding front marketing groups – AstraZeneca Funds DBSA http://www.speakaboutdepression.com/ and AstraZeneca funds NAMI -http://www.namimi.org/astrazeneca-bipolar-journey-exhibit-appearing-2010-nami-walks as stellar examples.

One might would get the distinct impression that Big Pharma has no intention of changing their profitable criminal ways, or their seedy business as usual model.  Definitely give us all some food for thought as the DOJ finally appears on it’s face to be taking some substantive action against the world largest criminal organization.

http://bipolar-stanscroniclesandnarritive.blogspot.com/2010/11/is-this-for-real-or-just-more-smoke-and.html

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Antipsychotic Drug Seroquel— Diabetes Lawsuits Hurt AstraZeneca Profits

Monday, November 8th, 2010

LawyersandSettlements.com, November 7, 2010

by Heidi Turner

Among Seroquel side effects is a reported increased risk of Seroquel diabetes.   Lawsuits alleging patients suffered serious Seroquel side effects reportedly hurt AstraZeneca’s third-quarter results.

Seroquel Diabetes Lawsuits Hurt AstraZeneca ProfitsAccording to the UK Press Association, AstraZeneca set aside $203 million to resolve approximately 18,000 claims in the US that Seroquel, a schizophrenia treatment, caused diabetes and other serious Seroquel side effects. A further $270 million was reportedly put aside for other claims and to cover AstraZeneca’s legal costs.

In August 2010, AstraZeneca said it settled approximately 17,500 lawsuits alleging Seroquel caused diabetes and other injuries for approximately $200 million. The lawsuits alleged the drug maker failed to adequately warn patients about the drugs’ risks.

Further eroding AstraZeneca’s profits are the effects of generic competition.

According to the San Francisco Chronicle (10/28/10), AstraZeneca reported net income of $1.55 billion in the third quarter, compared with $2.12 billion in the same quarter in 2009. The Wall Street Journal (08/10/10) reports worldwide sales of Seroquel reached almost $5 billion in 2009.

Meanwhile, an advocacy group called Taxpayers Against Fraud Education Fund alleges that the pharmaceutical industry is the number one source of Department of Justice (DOJ) fraud-related settlements. Number one on the list of pharmaceutical companies to settle with the DOJ was Allergan Inc., which paid $600 million to settle allegations of illegal marketing of Botox.

Second on the list was AstraZeneca, which paid approximately $520 million for the alleged illegal marketing of Seroquel.

Marketing of drugs is not illegal. What is illegal is marketing drugs for uses that have not been approved by the US Food and Drug Administration (FDA). Although Seroquel is approved to treat schizophrenia and bipolar disorder, it is not approved for use as a sleep aid, or to treat post-traumatic stress disorder or obsessive-compulsive disorder. It is also not approved for use in children younger than age 10, according to the US FDA-approved medication guide.

A study published online in BMJ (09/22/10) suggests that Seroquel is linked to an increased risk of blood clots. According to the study, of the patients included who were diagnosed with venous thromboembolism (VTE), 8.3 percent had received an antipsychotic medication in the two years prior to diagnosis, compared with 5.3 percent of those not diagnosed with VTE. The highest risk of VTE was found in patients who took quetiapine (known by the brand name Seroquel).

http://www.lawyersandsettlements.com/articles/15347/seroquel-side-effects-diabetes-16.html

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Drug Companies Hire Troubled Doctors As Experts

Wednesday, October 20th, 2010

NPR is investigating how pharmaceutical company payments to physicians are influencing physician prescription practices in partnership with ProPublica, an independent, nonprofit newsroom that produces investigative journalism in the public interest.

This collaboration also includes The Boston Globe, the Chicago Tribune, PBS Nightly Business Report and Consumer Reports.

Pfizer Headquarters in New York City

Mark Lennihan/AP— Pfizer, one of the largest drug makers in the U.S., saw $27.8 billion in sales in 2009. Seven drug companies, including Pfizer, have disclosed information about doctors who receive payment for speaking fees related to products they sell.

by NPR Staff and ProPublica

October 19, 2010Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies’ drugs.

But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

To vet the industry’s handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

“Without question, the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

ProPublica senior reporter Charles Ornstein detailed the findings with Morning Edition‘s Renee Montagne.

NPR: Tell us a little about the database. What have you found, and who’s on it?

Charles Ornstein, ProPublica: For many years, the pharmaceutical industry has been paying doctors to speak and consult on their behalf, but the names of those doctors have largely been a secret. So, for the first time we’re seeing from the companies who they’re paying for. Now we have a chance to take a look at their backgrounds and what they’re doing for the money.

What are these 17,000 doctors listed in the database doing for the seven drug companies that have released information?

The drug companies rely on doctors to speak locally and travel around the country to educate other doctors about the risks and benefits of the drugs. And they can get paid a lot of money. In our database we found that there were 384 doctors who, over the course of just the past 18 months, have received at least $100,000 from the drug companies that have reported so far.

What kind of money are we talking about, and what is that buying the drug companies in the way of sales?

We’re talking about big money. Just from these seven companies, they’ve paid out more than $257 million in the past 18 months, and remember not all of these companies have even disclosed their payments for that whole period of time, so it’s likely going to be substantially more, just for these seven companies.

What do they get for it? They wouldn’t be spending this kind of money if they weren’t getting returns from the perspective of increasing their brand in the market, letting doctors know about it, encouraging them to prescribe it. They say that doctors’ success at increasing prescriptions is not a means in which they’re measured, but some of the lawsuits against the industry have said that prescriptions and return on investment absolutely play a role.

And you have found among those doctors a few who have backgrounds that are a bit shocking, especially considering they’re representing these drug companies and, in a sense, representing themselves as experts.

If you take a look at the pharmaceutical company websites, you see that they take great pride in that they’ve recruited the top names in the field, the leading experts and academicians to speak on behalf of their products and consult with them, and when you start looking at the backgrounds, you find some, indeed, are the top names in their fields. But some you can’t find any information about.

We found several dozen of the top speakers did not have board certifications — which means they were not certified in their medical specialties — and then we found more than 250 doctors who had some type of sanction taken against them by a state medical board. And we just looked at a sampling of states.

Some of the discipline was really quite serious. The Ohio Medical Board, for example, voted a couple of years back to revoke the license of William David Leak, whom they accused of performing unnecessary nerve tests on 20 patients and subjecting some to an excessive number of invasive procedures. Dr. Leak is appealing the penalty, and his license is still active, but since 2009 he has received $85,000 from Eli Lilly and Co.

Another one is a hospital disciplinary case out of Georgia — the state appeals court in Georgia in 2004 upheld a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. He’s an anesthesiologist, and he admitted to giving young female patients rectal and vaginal exams without documenting why. He had also been accused of exposing women’s breasts during medical procedures, and when he was confronted by a hospital official, he said, “Maybe I am a pervert; I honestly don’t know.”

Dr. Leak did not return our phone calls, but I did talk to Dr. Taylor. He said that these incidents happened long ago, that they were old news and happened in the 1990s and didn’t want to talk about them, so he didn’t comment one way or the other, but he did say that nobody raised any issue one way or the other about his medical practice. And that’s really what was most important here — that his medical practice was not called into question.

The Survey Says…

Consumer Reports conducted a survey about the promotional activities of doctors on behalf of pharmaceutical companies.

The survey, conducted in October 2010, included 1,250 randomly selected adults in the U.S.

Highlights are below:

Some doctors take payments from drug companies in exchange for promoting the benefits of those companies’ drugs to other doctors in presentations at conventions and conferences.

Do you approve or disapprove of doctors taking such payments in exchange for promoting specific drugs to other doctors?

CR Survey Q4

Over the past five years, have you been told by a doctor you saw for medical treatment that he or she has taken payments from drug companies?

CR Survey Q5

Would you feel comfortable asking a doctor who is about to prescribe a drug for you if he or she has taken payments from the drug company that manufactures that drug?

CR Survey Q6

In general, how concerned would you be about the quality of treatment or advice you would get from a doctor who took payments from drug companies? Would you be …

CR Survey Q8

In your opinion, how often do you think doctors who take payments from a drug company would be biased enough by the money taken to prescribe that company’s drug even if that drug was no better and/or more expensive than an alternative drug that was available? Would you say …

CR Survey Q10

So put it in perspective. Of all of these doctors — and you’re really talking tens of thousands doing speaking — what does this represent? A few bad apples?

When we spoke to experts about this, what came up was that Pharma essentially has their choice — they get to pick the best of the best, and they have the pick of the litter. What one Yale professor told us is that the public definitely should care, because just as you wouldn’t want your child learning from a bad teacher, you wouldn’t want your doctor learning from a bad doctor. And if that person has displayed bad judgment in the past, what does that portend for what they may be speaking about when they are talking in front of doctors?

When you presented these findings about these doctors who had some real problems in the past to the drug companies, what did the companies say to you?

We asked the drug companies how they screen their doctors, because we felt that was a really important question. For the most part, they said that they relied on the doctors to tell them if they ran into trouble, or they checked federal databases to see if their misconduct had barred them from participating in federal health programs. But we didn’t find but two of the companies that said they checked state medical board websites to see if the doctors were disciplined in those states.

Did any of them suggest they were going to change?

The companies said that they’re certainly going to look into the doctors that we brought to their attention, and they also said they would be looking at their practices. So I think time will tell whether they take a more comprehensive look at the doctors before they hire them to go out and promote their products.

In the story you wrote for ProPublica.org, you talk about doctors who defend their speaking fees as purely educational. In some cases these are experts who go to rural areas where doctors can’t always attend conferences or meetings of experts. Is it the case that some of these payments to doctors for speaking about these products are actually doing some good?

Absolutely. I think one thing that can’t get lost here is that pharmaceutical products have been innovative and have saved lives and provided treatments for diseases that in the past there haven’t been treatments for. So without question, some drugs are absolutely necessary, and the more patients who take them, the better off society will be.

I think the question that some folks have raised is whether or not the drugs that are being excessively promoted are indeed those drugs that have really the breakthrough, the groundbreaking potential. But it does make a huge difference.

To give you an example: GlaxoSmithKline — their top drug that they’re using speakers for is a drug called Avodart, which is for enlarged prostate. And over the past five years, Avodart, which is really locked in a heated battle with another drug, has seen its sales more than quadruple and its market share double. So this has a huge effect.

I think what you hear from critics of the industry is that perhaps when they’re promoting drugs, they’re not suggesting what the alternatives could be — whether it’s watchful waiting or physical therapy or changes to diet and exercise.

In the interest of allowing patients to make some of these decisions themselves, ProPublica has compiled a database so people can search for their own doctor.

We have seven companies, and we’ve combined them all into one database, which was not easy to do. The documents they put on their websites and the databases they put on their websites are not easily analyzable and in some cases you can’t download them or even find out who the top speaker is.

So we are making available access to these doctors. You can search by state, you can search by company, you can search by doctor’s name. And we’re also letting folks have the ability to tell us if one of these doctors is their doctor, and what their experience has been with them. So this is really an opportunity to interact in a two-way conversation with the public about the doctors that work with the industry and hear what the public has to say about their experiences.

Folks will easily be able to look up the names of their doctors and pretty easily find if they’ve taken money from these seven companies.

They won’t know a couple of things. First, more than 70 companies have not yet publicly reported whom they have paid to promote their drug. You won’t see those in the database quite yet. But you also won’t know exactly what they’ve done for the money and if it’s influenced their prescription practices. And I know that we’re planning to continue our reporting in the coming months to provide additional clarity on that for the public.

What’s the use someone could practically put that information to?

We have extensively talked to experts across the country with that very question, and I think what we heard time and again was, if you see your doctor as receiving money from a company that makes your drug, it’s good to ask if there are alternatives that are less expensive, if there are alternatives that have fewer side effects, and to just exercise a degree of caution — not necessarily to distrust your doctor at all, but to ask questions to make sure that this is the drug that’s best for you.

Read the rest of this article here: http://www.npr.org/templates/story/story.php?storyId=130644774&ps=cprs

Explore the database Dollars for Docs logo

Dollars for Docs: What Drug Companies are Paying Your Doctor here: http://projects.propublica.org/docdollars/


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