Posts Tagged ‘pharmaceutical’

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After surviving war in Iraq, U.S. troops now being killed by Big Pharma

Thursday, February 17th, 2011

Natural News, February 17, 2011

by Mike Adams, Editor, NaturalNews.com

They survived live fire, explosive devices, terror attacks and grueling desert conditions. But upon returning home to seek treatment for the mental anguish that too often accompanies war, U.S. soldiers are now being killed by the pharmaceutical industry in record numbers.

A recent example is found with the late Senior Airman Anthony Mena, who returned home from Baghdad only to be killed by a toxic cocktail of prescription medications in his apartment in the USA. As the New York Times reports, a toxicologist found eight prescription medications in his blood (http://www.nytimes.com/2011/02/13/u…).

Those drugs included painkillers, sleeping pills, antidepressants and a sedative. The medical examiner concluded that Anthony Mena died of multiple pharmaceutical toxicity. He was only 23 years old.

Big Pharma killing more soldiers than enemy combatants?

Anthony Mena is just one of a fast-rising number of U.S. soldiers who are being drugged to death by psychiatrists and physicians who dish out painkillers and psychotropic drugs with virtually no regard to their chemical interactions.

Those interactions are never tested in clinical trials (yes, never!). The position of the FDA and Big Pharma seems to be that the more drugs a person takes, the better they’ll get, and doctors are trained in med schools to keep prescribing pills with virtually no concern about the extreme toxicity of various pharmaceutical combinations. Their motto is, “For every ill, there’s another pill.”

Now the body count is rising. Today, one-third of the U.S. Army is on at least one prescription medication, and many of those are psychiatric meds used to treat PTSD.

Think about that astounding statistic for a moment: One-third of the U.S. Army is on synthetic chemicals! Some of those chemicals, by the way, have been linked to suicides and violent behavior, especially in young males. What kind of formula for warfare is that, anyway? Take a young male, put a rifle in his hands and a psychiatric medication in his head, then let him loose on the front lines and see what happens?

An Army report says that 101 soldiers have died from toxic pharmaceutical combinations in 2006 – 2009, but that report almost certainly vastly underestimates the true numbers. Most deaths are traditionally written off as organ failure of one kind or another. Very few pharmaceutically-induced deaths are ever accurately tracked back to the drugs involved… unless you’re Michael Jackson, of course.

It makes you wonder: Are more soldiers being killed by Big Pharma than by enemy combatants?

It’s not out of the question. The 9/11 terrorist attacks killed just over 3,000 Americans. Yet, according to well-researched estimates based on published scientific studies, FDA-approved prescription drugs currently kill anywhere from 98,000 – 250,000 Americans a year (http://www.naturalnews.com/009278.html). Remember, that’s every year!

Big Pharma’s link to Nazi concentration camps

Over the last decade, then, FDA-approved prescription drugs have likely killed at least one million Americans and probably many more. That’s approaching the level of a chemical holocaust. The last time so many people were killed with chemicals was in the Nazi era of World War II, when Nazi war criminals gassed Jews to death by the millions.

It’s no coincidence, by the way, that the very same chemical companies that worked for the Nazi war machine are now some of the world’s top pharmaceutical manufacturers. That’s not an internet myth, by the way: It’s an historical fact. Just Google the history of  Bayer and Nazi Germany if you want to learn more: http://www.google.com/search?q=baye…

Or check out the role of IG Farben /Bayer in Auschwitz and other German concentration camps, where this pharmaceutical company relied on slave labor to churn out chemical weapons and experimental drugs used in human medical experiments: http://archive.corporatewatch.org/p…

(You won’t read that in the New York Times, most likely…)

Fast forward to the present. Now the pharmaceutical industry is killing our young soldiers in record numbers. Much of it is due to the insanity that’s inbred throughout the psychiatric industry, which has a long and disturbing history of torturing and maiming patients in the name of “medicine.”

I strongly urge you to learn about the true history of psychiatry through the Citizens Commission on Human Rights: http://www.cchr.org/quick-facts/the…

I have walked through their museum in Los Angeles, and I’ve seen what psychiatric medicine has done to destroy the lives of countless children, adults and even soldiers. What’s happening today with psychiatric medicine is, by any honest assessment, a crime against humanity that makes the casualties of war in Iraq seem tiny by comparison.

And now, even the mainstream media is beginning to see this truth. It’s hard to deny it when young, healthy soldiers start dropping dead from following doctors’ orders and taking FDA-approved medications. These are not overdoses, folks. These are soldiers following orders and “taking their medicine” as directed.

And they’re dying from it.

The New York Times article on this issue is a great read. It’s an example of stunningly good journalism from the mainstream media, and I recommend you read it: http://www.nytimes.com/2011/02/13/u…

The NYT, of course, probably won’t go into the history of Bayer and the Nazi war crimes connection, but you can only expect the mainstream media to go so far on these stories. For the whole truth on issues like this, you have to turn to internet sites like NaturalNews which simply aren’t driven by pharmaceutical advertising money. That’s where you’ll find out the rest of the story that the MSM isn’t likely to ever report.

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Brain shrinkage seen in those taking antipsychotic medications

Monday, February 7th, 2011

Los Angeles Times, February 7, 2011

by Melissa Healy

A new study finds that one the fastest-growing classes of prescription drugs in the United States is linked to shrinkage in the brains of those who take it, raising some new questions about the widening use of antipsychotic medications.

Over a study period that spanned 14 years, 211 newly diagnosed schizophrenic patients had periodic brain scans that measured the volume of their brains overall, and of their brains’ principal component structures. Scanning each subject’s brain at least twice and as many as five times, researchers at the University of Iowa’s Carver College of Medicine sought to tease apart the factors that might contribute to a long-observed phenomenon: that patients with psychiatric disease—particularly those who suffer the delusional thinking, hallucinations and cognitive deficits of schizophrenia—appear to have smaller brains than those in good mental health.

What they found was that those whose treatment with antipsychotic medication was most “intensive”—those who took the largest doses over the longest time–had the greatest losses in brain volume. The intensity of a subject’s antipsychotic medication therapy was a far stronger predictor of brain-volume loss than was the severity of his or her psychiatric symptoms or of the extent of his or her illicit drug or alcohol abuse, the researchers found.

The volume losses were scattered throughout the brain, occurring in gray matter–the tightly packed clusters of brain cells that make up most of the brain’s lobes–as well as in the connective “white matter” that forms communication channels among the brain’s disparate regions and between its two hemispheres.

The study, published Monday in the Archives of General Psychiatry, comes against the backdrop of growing use of antipsychotic medications by younger and younger patients, as well as by patients with a wider range of psychiatric troubles, including anxiety or depression that has not yielded to first-line antidepressant drugs. Aggressive marketing of a new generation of antipsychotic drugs called the “atypicals” have made this class of drugs the top sellers in the U.S. prescription drug market, raking in $300.3 billion in sales in 2009 alone, according to IMS Health, which tracks trends in the healthcare and pharmaceutical markets.

The use of antipsychotic medications in treatment of a wider range of illnesses is also exposing more patients to these drugs, which also have been linked to metabolic changes and weight gain that can be extreme. In 2009, IMS Health estimates that U.S. consumers filled 52 million prescriptions for atypical antipsychotic medications, which account for the vast bulk of antipsychotic medications prescribed today.

“Given the sharp rise in antipsychotic utilization, especially among geriatric and pediatric populations, examining the possibility of antipsychotic brain tissue loss has important implications for assessing the risk benefit ratio in a large number of psychiatric patients,” the researchers wrote.

read the rest of the article here:  http://www.latimes.com/health/boostershots/la-heb-antipsychotic-drugs-020711,0,123296.story

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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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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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Johnny Got His Pills

Wednesday, October 27th, 2010

SF Weekly, October 27, 2010

by E.R. BILLS

After U.S. Army Sgt. Douglas Hale, Jr. finished 15 months in Iraq for his second combat tour, it was obvious that things in his life were awry. In 2007, he was diagnosed with severe depression and post-traumatic stress disorder. He began drinking heavily, and his marriage fell apart. In early 2009, Hale abandoned his post at Fort Hood. Last May, he was arrested for being absent without leave and returned to Fort Hood. Before the month was out, he tried to kill himself.

post-traumatic-stress-trap_1

The Army sent Hale for treatment at a psychiatric hospital in Denton, and it seemed to help. He spent the Fourth of July weekend with his mother, and she drove him back to Fort Hood the next day. On July 6, his mother received a text message from him that said, “I love you mom im so sorry I hope u and family and god can forgive me.” She immediately contacted Army officials at Fort Hood and started driving back. But Hale had already shot himself in the head.

Army officials are reportedly searching for solutions regarding the suicides of soldiers like Hale, but they’re not looking real hard. The answers are right under their noses.

War is hell under any circumstances. But in the case of Americans serving these days in the Middle East, it’s worse than that — it’s a planned, coordinated societal psychosis.

If you plop a normal, all-American boy or girl down in a psychotic situation for months and years at a time, tour after extended tour, psychosis or extreme disturbance is not an abnormal response. And it can lead to suicide. Especially when the nation that sent these men and women into harm’s way still hasn’t clearly justified why this madness was necessary.

I read an Associated Press story the other day that suggested that one of Big Pharma’s wonder drugs was killing American GIs. It said that many of the soldiers serving in and returning home from the wars in Afghanistan and Iraq were taking a drug called Seroquel to help them deal with chronic restlessness, severe insomnia, and constant nightmares. If I were a soldier it might have made me laugh.

Seroquel, according to the story, is a “potent antipsychotic.” Instead of reducing combat tours to reasonable timeframes, limiting the number of tours a soldier has to endure, or simply removing unstable soldiers from these ill-conceived wars indefinitely, the U.S. military is apparently using our men and women in uniform as guinea pigs for a soldier’s-little-helper pill that will supposedly desensitize them to the insanity around them.

It doesn’t cure the psychosis. It simply allows unstable soldiers to function within the insanity without being terribly bothered by it. And when you combine Seroquel with antidepressants and anti-anxiety drugs — something military officials suggest is an acceptable “standard of care” for soldiers or veterans suffering from post-traumatic stress disorder — it’s not surprising if they walk around in a cognitive fog.

In this regard, isn’t the military’s attempt to pharmaceutically abridge the humanity of our soldiers plainly evil? If you have to give someone a potent anti-psychotic to help them deal with what they’re doing or what they’ve done for you or God or country, then there’s obviously something wrong with what you’re asking them to do. It reminds me of perhaps the grimmest excerpt from Erich Maria Remarque’s All Quiet on the Western Front: “We were eighteen and had begun to love life and the world; and we had to shoot it to pieces. The first bomb, the first explosion, burst in our hearts.”

Oh, and did I mention Seroquel is more than just one of the military’s most frequently prescribed drugs? It’s also the fifth best-selling drug in the nation. So if our psychotic naiveté and ignorance ever start to really get to us, we can always knock them back with our own dose of a brain-fuddling stupefacient. In fact, we’ve already been at it.

In 2008, American emergency rooms treated a million people for abusing prescription drugs and over-the-counter medicines, roughly the same number of folks our ERs treated for heroin and cocaine overdoses or abuses of other illegal drugs — and this number doesn’t even factor in alcohol.

We’re taking the edge off our insanity any way we can. The only war more stupid and psychotic than the one in Iraq was the one on drugs. But it’s been going on so long that its mention no longer even penetrates our daze.

The military-pharmaceutical complex is making a killing or, more specifically, making a fortune off the folks we’ve asked to do the killing — and off the rest of us. They dope our unruly kids, they dope the young men and women fighting in and returning home from the war, and they dope the rest of us right here at home for being sick of wars overseas and fearful of war on the middle and lower classes and dreading the reckonings to come and being ashamed of our own sad national shadow.

And the treatment is working. Thank God we’re more susceptible to psychotropic manipulation than Sgt. Hale was.

http://www.fwweekly.com/index.php?option=com_content&view=article&id=4294:johnny-got-his-pills&catid=3:second-thought&Itemid=374

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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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Public ‘misled’ by drug trial claims

Wednesday, October 13th, 2010


Tablets
BBC NEWS
October 13, 2010
by Michelle Roberts

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.

Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective.    Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.

But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.  This is not the first time a large drug company

has come under fire about its published drug trial data.

Trial information

Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

GSK rejected claims that it improperly withheld drug trial information.

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture

The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.

They warn that the lack of all information means policy makers are unable to make informed decisions.

Read the rest of this article here:  http://www.bbc.co.uk/news/health-11521873

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GlaxoSmithKline Enters into Confidential Settlement with 200 Families Who Say Paxil Caused Birth Defects

Friday, June 25th, 2010

Fair Warning
By Lea Yu
June 25, 2010

Pharmaceutical giant GlaxoSmithKline has entered into confidential settlements with nearly 200 families who claimed that its antidepressant Paxil caused congenital birth defects.

Most of the claims alleged that babies born to mothers taking Paxil suffered heart defects. Last October, a suit filed on behalf of Lyam Kilker said he was born with three cardiac defects, including a hole between two chambers of his heart that disrupted the aorta.

Kilker’s case is the only one to have gone to trial, and a Philadelphia jury awarded Kilker’s family $2.5 million in compensatory damages. Plaintiffs argued that animal testing revealed potential problems with Paxil, but the company did not follow up with additional tests. A company memo introduced as evidence during the trial also revealed that Glaxo considered covering up any negative test results. “If neg, results can bury,” the 1997 memo said.

In 2005, the Food and Drug Administration warned doctors about a 35,000-person study that found that pregnant women on Paxil were twice as likely to have a child with defects than women taking other antidepressants.

Read entire article:  http://www.fairwarning.org/2010/06/glaxosmithkline-settles-200-birth-defects-cases-linked-to-antidepressant/

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Our Drug-Obsessed Nation: Obsessed with ‘feeling good’ & ‘forgetting our problems’—prescription drug abuse skyrockets

Monday, June 21st, 2010

Tech Jackal
June 19, 2010

Not many people would be surprised to find that drug abuse is on the increase, but they may be surprised to find that the increase is not in illegal drug abuse but pharmaceutical drug abuse.

Emergency room visits have increased 110% over the last 5 years, due to prescription drug abuse. These visits are either for overdoses or excuses to get drugs refilled. Ten years ago, emergency room visits were for heroine abuse and other illegal drugs. Today, these visits are for Oxycodone, Hydrocodone and Hydrocodone abuse. There are also many other prescription drugs, such as antidepressants, and anti-anxiety drugs.

Today, it is a popular practice for children in high school and college to take prescription drugs to help them study and focus. Some of these prescriptions are for Addeall and Xanax. Some young people are having teeth pulled and wisdom teeth extracted just so they can get a pain prescription.

Read entire article: http://www.techjackal.net/other/2010/06/19/why-are-we-a-drug-obsessed-nation/

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