Posts Tagged ‘Merck’

Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Thursday, July 21st, 2011

OpEdNews – July 21, 2011
by Martha Rosenberg

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiencya.

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

There are 200 US medical education and communication companies (MECCs) who ghostwrite medical journal articles for pharma for $20,000 to $40,000 per article. Companies like Complete Healthcare Communications (CHC) whose phalanx of 50 medical writers, editors and medical directors promise a “84.5 percent acceptance rate for first-time manuscript submissions.”

Ghostwriting was behind the blockbuster Vioxx, withdrawn in 2004 for doubling the risk of heart attacks. “Merck designed the trial, paid for the trial, ran the trial,” Dr. Jeffrey R. Lisse told the New York Times about a Vioxx study he authored in the Annals of Internal Medicine that left out three cardiac deaths. Oops. “Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing.”

Medical journals themselves can make $450,000 off one such ghostwritten article, because pharma orders reprints which reps disseminate as sales pieces (“look, Doc, it says RIGHT HERE”).

Click image to watch Psychiatric Drug Side Effects Video

In 2006, the editor-in-chief of the Journal of the American Medical Association (JAMA) Dr. Catherine DeAngelis had to apologize for a pharma-tainted article that defended the use of antidepressants during pregnancy and an article linking migraines to coronary risks in women. The doctor authors, it turned out, were getting money from antidepressant and heart medication manufacturers.

But ten months later, JAMA ran a study “designed jointly by the non-Merck investigators and Merck employees” and “supported by contracts with Merck and Co” that extolled the virtues of Fosamax, a Merck bone drug. Three Merck authors on the study disclosed they potentially owned Merck “stock and/or stock options” and the article’s 11 other authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth (now Pfizer) Novartis, Procter & Gamble and Merck. Since then, the FDA has issued several warnings about Fosamax and other bone drugs.

In 2007, the AMA itself was criticized for playing both sides of the enterprise street and making $50 million a year selling the names, office addresses and practice types of its members to data miners. The AMA’s defense? Doctors could “opt out” of the privacy-invading program if they wanted to.

And then there are pharma’s “unbranded” campaigns designed to look like real public health messages or communications from grassroots groups. Who can forget PR firm Cohn and Wolfe’s faux grassroots group Freedom From Fear to sell Paxil, a pill now linked to birth defects? And the Wyeth (Pfizer) campaign, The Change You Deserve which said, whoever you are, you have depression and need Effexor?   Now, a new unbranded pharma campaign, Depression Is Real, running on radio stations, compares depression to cancer because it kills and diabetes because it doesn’t go away. Kind of like pharma’s huckstering.

http://www.opednews.com/articles/Are-You-Taking-Pills-You-D-by-Martha-Rosenberg-110721-870.html?show=votes

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Is ADHD a Fictional Disease?

Saturday, May 21st, 2011

Some psychiatrists argue that ADHD is little more than a marketing gimmick

The Mark
By Fred Baughman
May 18, 2011

Dr. Fred Baughman, Child neurologist; opponent of ADHD diagnosis

Some 5.4 million children in the United States have been diagnosed with attention-deficit hyperactivity disorder, or ADHD, with two-thirds of them taking psychiatric drugs. Sales of ADHD drugs reached $1.2 billion in 2010, a demand level so high that the U.S. is experiencing an ADHD drug shortage. But an increasingly vocal contingent of psychiatric experts is speaking up against diagnosing children with ADHD, arguing it is a non-existent condition drummed up by pharmaceutical companies to increase sales.

What makes you convinced that ADHD is not a real disease?

During my time in practice, I’ve authored papers and discovered real diseases and so on. Psychiatry in 1948 was distinguished from neurology. Neurology is the specialty dealing with physical and organic diseases of the brain and nervous system. Psychiatry is the specialty dealing with emotional and behavioural things which are not actual, physical diseases – things like depression, anxiety, panic, and so on.

Insofar as ADHD is concerned, it seems clear that in the ’50s, as the first psychiatric drugs came to market, that psychiatry – in cahoots with the pharmaceutical industry – came upon the market strategy of, “Well, we’ll call these things ‘diseases.’” And the prototypical invented disease was called ADHD.

It was initially in a 1970 congressional hearing in the U.S. that psychiatrists appeared and testified that, what was then called hyper kinetic disorder or minimal brain dysfunction, was a disease that needed diagnosing by a physician, and as a disease it justified the use of drugs to treat it. So that was the official beginning of ADHD in particular and of psychiatric diagnoses in general as being due to a disease of the brain. In every case, they say there’s a subtle chemical imbalance in the brain, which of course they never have a means of diagnosing in life and have never in scientific literature authored proof that there is in fact a disease. And yet they are allowed by [the U.S.] Food and Drug Administration to say that there is a chemical imbalance and that the drugs balance the imbalance.

So it’s been a market strategy. This lie has been allowed to be published by the drug industry and by psychiatry, by our regulatory agencies, specifically the Food and Drug Administration. So that’s where we are today.

All physicians learn in medical school that a disease is a physical abnormality. When you go to your physician, they may see a rash or they may find something microscopically abnormal, such as cancer cells. Then there are a lot of chemical diseases – diabetes being the best known. There are about a hundred examples of inborn errors of metabolism or body chemistry. These can all be tested for, they’ve all been proven, and they exist in the scientific literature – whereas there is not a single psychiatric diagnosis that exists in scientific literature of the world.

In 2008, I was counselling a young father from Kingston, Ont., who was in a divorce situation, and the mother insisted the children be seen by psychiatrists and the psychiatrist had made a number of diagnoses and had this one boy on large amounts of about five or six different types of medication. I helped the father author a letter to Health Canada asking where – in the case of ADHD or any psychiatric diagnosis – there is proof of a gross or microscopic abnormality.

This gentleman got a letter back from the director-general of Health Canada saying there is no gross, microscopic, or chemical abnormality in any psychiatric diagnosis; there is no objective way of verifying a psychiatric diagnosis as a disease.

That’s why psychiatry’s claims that their diagnoses are chemical imbalances is nothing but a lie and a deception. And yet, because of their financial might on the world scene, no one will challenge them. They have friends bought and paid for in government and in all of the governmental health-care agencies.

Here in the States, as of 2007, the Centers for Disease Control announced that 5.4 million U.S. schoolchildren five to 17 years old had ADHD. And you can be sure that they have all been on ADHD drugs, which are, for the most part, amphetamines, which are known to be addictive, dangerous, deadly.

I’ve heard estimates of 20 per cent of schoolchildren in the U.S. with a psych diagnosis and who were on psych drugs. It’s exploding, it’s increasing all the time.

Is the issue that we’re overmedicating ourselves, or that ADHD is not real?

When it’s a total fraud, you don’t call it overmedicating. There is no such thing as ADHD as a disease, so there is never justification for it. It’s a total fraud.

What is there to gain from diagnosing children with ADHD?

Ritalin has passed $1 billion a year in sales. Ritalin is no longer the top ADHD drug in the U.S. I think Adderall, which is made up of amphetamines, passed Ritalin a few years ago in market share.

It’s a complete fraud, they’ve invented diseases for which their drugs are a cure. The rate of diagnosing ADHD has been going up by a million a year in the U.S. This is a market strategy.

The book Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients [by Ray Moynihan and Alan Cassels] talks generally about inventing diseases for which to sell drugs. In the foreword of that book, the authors quote the former president of Merck Pharmaceutical Co., Henry Gadsden, who once said he was anxious to find ways to market his products to normal people, just like the Wrigley chewing gum people did. This was kind of an after-the-fact confession they were trying to market drugs to normal people, and calling all psychological dilemmas diseases for which they needed a pill. This was the strategy.

It’s almost unimaginable, it’s almost unthinkable that this has been going on, but that’s exactly what’s been going on.

How would you diagnose a child that was considered to have ADHD?

Look at the criteria that are used to call a child ADHD. They talk out of turn, they don’t sit still, they wiggle around too much in their seats, they are impulsive, disorderly, and so on. It’s a bunch of behaviours that are seen in just about every child at some stage of their life. This is by design; they have taken kind of irritating, bothersome, disruptive behaviours in children and have kind of cobbled them together and called it a disease.

They get a lot of parents to buy it because a lot of parents are now busy with their job in the workforce and there’s no longer a full-time parent in the home, and so, “Here’s why Johnny or Janey is such an irritant to me, they’ve got ADHD.” It takes the pressure entirely off the parent for not being a presence and for not being there full-time to mould the behaviour of the child, and they’re calling these behaviours a disease and saying we’ve got a pill for it. That’s very seductive. That’s a far more appealing analysis than, “Gee, you’re divorced, there’s no one in the home to discipline the child real time,” and so on.

These are not diseases, they are behaviours. Today, you hang a psychiatric label on a child, you surely stigmatize the child and these drugs are exceedingly dangerous. In 2005, there were several deaths in Canada of young children from Adderall. It was temporarily taken off the market, but then the power of the industry won out and Adderall’s back on the market. Pure amphetamines.

Read article here:  http://www.themarknews.com/articles/5193-is-adhd-a-fictional-disease?page=1

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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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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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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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Drug Firms Face Bribery Probe from US Department of Justice

Tuesday, October 5th, 2010

Justice Department, SEC Seek Information From Companies on Payments to Overseas Officials

Wall Street Journal, October 5, 2010

by Michael Rothfeld

Federal investigators are looking at ways that drug makers could be paying bribes overseas to boost sales and speed approvals, according to letters sent to the companies and people close to the matter.

Big companies—including Merck & Co., AstraZeneca PLC, Bristol-Myers Squibb Co. and GlaxoSmithKline PLC—in recent months have disclosed they are being investigated for possible violations of a 1977 law that makes it illegal for companies whose stock is traded in the U.S. to bribe government officials in other countries to get business.

[PHARMA]

The companies said they are cooperating with the government, with several adding that the investigation is industry-wide and broader than their companies specifically. Many said they have policies meant to ensure compliance with the Foreign Corrupt Practices Act.

So far, none of the companies has been accused of wrongdoing, and the investigation ultimately may not result in charges.

The Justice Department and the Securities and Exchange Commission requested that companies voluntarily report any violations of the FCPA. Some companies, including SciClone Pharmaceuticals Inc. and Eli Lilly & Co., disclosed receiving subpoenas from the SEC. Baxter International Inc. also has said it is being investigated.

The investigation is targeting transactions in Brazil, China, Germany, Italy, Poland, Russia and Saudi Arabia, people familiar with the matter said.

The Justice Department and the SEC declined to comment.

Such requests from the government typically kick off internal investigations at companies, which generally comply with the requests in order to win leniency from the government if a violation is found.

A lawyer for one drug company said the industry has been vexed because the recent requests were so broad and because the investigations, across operations in several countries, can cost millions of dollars.

“If you don’t have any specifics, a lot of this is just guesswork,” the lawyer said. “Everyone was running around to get in the door to meet with the government so they can better understand what the issues are.”

Letters from the government to one of the companies, which were reviewed by The Wall Street Journal, identified four types of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals.

People familiar with the situation said the other companies received similar letters.

The requests are similar to the government’s actions in an older bribery probe involving medical devices. In that investigation, settlement talks are ongoing with several companies, according to a person familiar with the matter.

Representatives for Merck, AstraZeneca, Bristol-Myers, Glaxo and Baxter declined to comment on the probe beyond saying they were cooperating fully with the government.

A SciClone spokeswoman declined to comment beyond the company’s SEC filings, in which it said it was subpoenaed for documents relating to its practices in China. A Lilly spokesman referred to an SEC filing in which the company said the U.S. government expanded to other countries an investigation of its Polish subsidiaries that began in 2003.

U.S. officials and European regulators have become increasingly aggressive in investigating foreign bribery cases in recent years. U.S. officials recently have threatened to file charges against executives and not just their companies.

The pharmaceutical industry is particularly vulnerable because government plays a bigger role in administering medicine in many foreign countries than it does in the U.S. and drugs are highly regulated, which creates contact with public officials. Doctors and hospital administrators often are government employees overseas.

Some of the alleged bribes could involve payments to doctors to influence drug trials, people familiar with the situation said. Justice Department officials have said publicly that drug companies also could face charges if they bribe government officials in the guise of payment for travel, meals, entertainment or speaking fees.

Read the rest of this article here: http://online.wsj.com/article/SB10001424052748704847104575532091781199092.html

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Stop the Stigma of Mental Illness? Try Stopping the Pharma Funded Campaigns & Groups Behind the “Stigmatizing”

Friday, September 17th, 2010

(Image taken from: http://herinst.org/sbeder/corppower/pharm-agenda.html)

by CCHR Int

A new study, the result of a joint collaboration between Indiana University and Columbia University, and published  by the American Journal of Psychiatry, reports that prejudice and discrimination still exists among people with serious mental illness.  Headlines include “Mental Illness Stigma Hard to Shake, Survey Finds” and “Despite Deeper Understanding of Mental Illness, Stigma Lingers.”

So what exactly is behind this study? Taking aside the fact that Columbia University is well known for its collaboration with pharmaceutical companies, its medical center having collaborated with AstraZeneca, GlaxoSmithKline, Janssen Pharmaceutica, Merck, Novartis and Pfizer. Or the fact that Indiana University received a $1 million grant from Eli Lilly.

With a seemingly altruistic agenda, the fact is the campaign to end the “stigma” of mental illness is one driven and funded by those who benefit from more and more people being labeled mentally ill—pharma, psychiatry and pharmaceutical front groups such as  NAMI and CHADD to name but a few.   For example, take NAMI’s campaign to stop the “stigma” and “end discrimination” against the mentally ill—the “Founding Sponsors” were Abbott Labs, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer, Novartis, SmithKline Beecham and Wyeth-Ayerst Labs. (For an in-depth look at what else Pharma funds and how this funding not only helps set mental health policies but campaigns such as this, read Pharmaceutical Industry Agenda Setting in Mental Health Policies at the bottom of this post)

The fact is that the  “stigmatization ” is coming from those that benefit from people being labeled/stigmatized with mental disorders that have no medical/biological evidence. Case in point, if you are rebellious, you are “stigmatized” with the label “oppositional defiant disorder.” If your kid acts like a kid he is “stigmatized” with the label “ADHD.” If you are sad, unhappy (even temporarily) you are “stigmatized” with the label “depressive” or “bi-polar disorder.” If you are shy you are “stigmatized” with the label “social anxiety disorder.” Moreover, you or your child are now stigmatized for life as this label, which is based solely on opinion, is now part of your medical record, despite the fact there is no medical evidence to prove you are “mentally ill”.

This is also true of people diagnosed “schizophrenic.” There is no medical test to verify someone has a brain abnormality or medical condition of schizophrenia. And while no one claims  people can’t become psychotic, the fact remains there is no biological evidence to support schizophrenia as a brain disease or chemical abnormality.  And consider this, if people do become psychotic, or irrational,  is it in fact caused by some  underlying medical (not psychiatric) problem?   And why did a 15-year multiple follow up study find that there was a 40% recovery rate for those diagnosed schizophrenic who did not take antipsychotics, versus a 5% rate for those who did?  What happened to their supposed “brain disease?” Did it simply vanish?  Moreover, if they could recover from such a mental state, do they deserve the “stigma” of “schizophrenia” still being part of their permanent medical record?  For life?   Think about it.  Imagine you were extremely overweight—obese.  You lose all the weight so you are no longer obese.  Yet your medical records continue to say that you are.

And if schizophrenia is in fact a “disease” despite the fact there is no medical or biological evidence (note we did not say speculation, or theories, but evidence) then why is it that psychiatrist Loren Mosher, the former Chief of Schizophrenia Research for the National Institute of Mental Health (NIMH) openly state that there is no biological condition of schizophrenia as a disease or brain malfunction? And why didn’t the mental health industry take advantage of his 2-year-outcome studies proving that those diagnosed schizophrenic could recover without the use of drugs? Is it because this proved that recovery was possible and thereby disproved the theory that something was wrong with their brain? Or was it the fact that they recovered without the use of drugs, thereby threatening a multi-billion dollar pharmaceutical industry?  Maybe this explains why Mosher was fired from his position at NIMH (http://www.moshersoteria.com/)

As a final note regarding “stigmatization,” keep in mind that psychiatrists admit there is no recovery from “mental illness.” They admit no cures. So once you are labeled—game over.

The new “study” also reports, ” more people now believe that illnesses like schizophrenia and depression are caused by chemical imbalances in the brain.”  This is marketing at its best—say people believe in a chemical imbalance so you don’t have to bother pointing out the fact that there is no chemical imbalance .  How can the layperson be sure of this? It’s simple. Find one person who has a lab test showing their chemical imbalance.  Not one of the millions of people taking drugs to cure their “chemical imbalance” has a lab test showing they have an imbalance.  Now it really doesn’t take a rocket scientist to figure that out… does it?

For more information  about pharmaceutical front groups see this:  http://www.cchrint.org/psycho-pharmaceutical-front-groups/

For an in-depth look at this topic, read Pharmaceutical Industry Agenda Setting in Mental Health Policies


Abstract: The development of political agenda-setting through the use of sophisticated public relations techniques is threatening to undermine the delicate balance of representative democracy. This has important ramifications for policies aimed at providing mental health services and the implementation of mental health laws. The principal agenda setters in this area are pharmaceutical companies with commercial reasons to promote public policies that expand the sales of their products. They have manufactured highly effective advocacy coalitions that incorporate front groups in order to set the policy agenda for mental health. However, policies tailored to their commercial purpose are not necessarily beneficial either for patients or the society at large.



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Doctors, Drug Companies, Politicians & Corruptions

Friday, August 20th, 2010

The Asian Tribune, August 21, 2010

By Shenali Waduge

They say there’s no money in healthy people. But, why is the pharmaceutical industry the most profitable industry in the world? It is because they have mastered the art of concocting the disorder, creating the drug for the disorder and then bombarding the public with advertisements to convince them they’re afflicted, leaving little choice but to get “prescribed”.

The growth in the pharmaceutical industry began to expand towards the 1970s. Pharmaceutical companies began to form mutual partnerships and began dominating the production of medicines. Advertising boomed making it possible for consumers to be enticed into believing there were miracle cures or drugs that would make people look young forever, increase sexual libido, maintain youthful looking skin with zero after effects or side effects.

Companies spend billions on “inventing” new drugs…they also spend billions on marketing them, USD53billion to be precise. But, how “innovative” are these companies? Most research and clinical trials are carried out at universities and funded by Governments. What happens thereafter is that drug companies “buy these innovations” and quickly patent them and quickly set up manufacturing plants. The only “innovation” done by these companies is to modify the existing drug something as minor as changing the color of the coating! A patented drug generally lasts for 20 years. It is only after rigorous study and testing which takes a good 10 to 15 years that Governmental authorities grant permission to market and sell drugs.

Loopholes in patent systems ensure companies are able to keep generic competitors at bay for years. These patented branded drugs naturally provides high profit margins but before the patent expires and competitors enter with a generic drug sold at far lesser prices, owners of branded drugs put out a generic version before the branded version expires…giving his company a head start in the sale of generic drugs. In 2006, the world had spent US$643billion on prescription drugs with US accounting for almost half of global pharmaceutical market. The US pharmaceutical industry is the most profitable of all businesses in the US.

It would not surprise anyone that companies spent up to $11billion annually on free samples, $6billion on sales representatives, $3billion on vague advertisements, we can only guess how many more billions is spent on bribing doctors, bribing researchers, bribing universities, bribing health officers, pharmacists, providing kickbacks and even running bogus “medical education” programs.

Essentially, what drug companies’ end up doing is using tax payer’s money to pay for medical research which they buy off, they then spend on massive advertising campaigns aimed at misleading the public about the effects of these drugs and “encourage” doctors to prescribe them!

Year in and year out drug companies end up the most successful industry with stunning profits part of which are used to buy off politicians and further promote themselves as champions of social responsibility and good corporate ethics!

There are no business ethics in the pharmaceutical industry – the industry is synonymous with money, profits, power and control. Pharmaceutical companies have mastered how to market social phobia/anxiety disorders in order to sell mind altering drugs. Does it not surprise and make you wonder why scores of people are being treated for mental disorders?

There are teenagers on anti-depressants and anti-psychotics because pharmaceutical companies want to ensure they have customers for life! Some prescription drugs are sold at more than 500,000% markup over the actual cost of their raw ingredients, naturally drug companies will do anything to sell more pills and it is why they end up inventing fictitious diseases and force parents to make addicts out of their children. There are scores of drugs available that are “habit-forming” tranquilizers?

Despite the number of drugs available why are people sicker than ever? Drugs have not helped people instead drug companies have made people addicted to drugs and suffering further from the side-affects of taking so many different combinations of drugs. In the US, over 100,000 Americans die annually from prescription drugs while a further 2million are injured by them.

The dominating companies in global pharmaceutical industry today are MERCK, Roche (fined in the US and Europe for participating in illegal price fixing cartel), Pfizer (ranked no.1, the makers of viagra the wonder drug of the 90s…. and probably soon to put out a drug that may do the opposite of viagra!), Bayer the inventor of Asprin….however hundreds and thousands of people die every year from prescription drugs? 27,000 people died of vioxx which is a nosteroidal anti-inflammatory drug which has been withdrawn over safety concerns associated with heart attacks, strokes. (though first approved in 1999 but withdrawn in 2004) It is believed that over 80m worldwide prescribed it in 2003 and its producer Merck and Co made sales revenues of US$2.5billion.

What is ironic is that there is not a single chronic disease which has been cured as a result of taking prescription drugs. What these drugs have done is to only treat the symptoms. Has chemotherapy proved scientifically accurate? It does shrink tumors but it adds nothing to a patient’s lifespan. The world is becoming sicker, fatter and more depressed than ever. The advice that people should listen to is not being given…eat healthy, avoid processed foods, avoid refined carbohydrates, avoid soft drinks etc…are rarely highlighted.

What’s more our doctors are duping us too…! In the US some mid-sized drug companies have close upon 1000 representatives lobby with companies spending over $5billion annually on sending these representatives to physician offices. The US spends $19billion annually on promotions, influencing doctors and other health professionals. As a result the physicians are lured into prescribing drugs associated with particular drug companies who ensure these physicians are well looked after and patients end up paying far more than they are required to as well as end up having to take another set of prescribed drugs to cut off the side-affects associated with the earlier drug!

Doctors are even paid to conduct fraudulent clinical trials on patients who are encouraged to take drugs for a 12month period to see its affects while the drug company profits through that particular year and the doctors enjoy the kickbacks as well. Some doctors who prescribe a particular drug company’s products and avoided competing drugs are even paid “consulting fees”. It is all a scam, and a vast majority of physicians become party to these unethical medical acts, pocketing the benefits & dosing up their patients with whatever drugs they’ve been told to prescribe. Doctors today are recipients of airfares & hotel expenses, luxury vehicles, even repairs and tyre replacements!

What is poignant and significant is that while physicians who may attend academic sessions with the thought of updating their know-how they are at the risk of being manipulated by pharmaceutical companies who pay high-profile scientists/physicians to speak on topics relevant to their products. Similarly, medical journals also help to promote specific products whose manuscripts are written by the pharmaceutical companies.

Essentially the public is at risk as a result of the direct and indirect relationships between pharmaceutical industry and the physicians. It certainly does breach professional ethics and may even bring dangers to patients.

Read the rest of this article here:  http://www.asiantribune.com/news/2010/08/21/doctors-drug-companies-politicians-corruptions

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US Department of Justice Probes Corruption in Big Pharma; Glaxo, Pfizer, Bristol-Myers Squibb, Eli Lilly & Merck

Friday, August 13th, 2010

Financial Times
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

Read entire article here:  http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
(free registration required)

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