Posts Tagged ‘GlaxoSmithKline’

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Drug-Company Tweeting: Still Awaiting FDA Rules

Wednesday, December 29th, 2010

Note from CCHR:  Let’s  see if we’ve got this straight…..last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. The company also paid $2.3 billion to settle claims that it had marketed numerous drugs for unapproved purposes.  Other corporate violators included 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.  Criminal or civil illegalities included  (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. And after all that, the FDA is going to allow Big Pharma to launch into social media?   Seriously?  The article below claims the FDA monitors drug ads –for accuracy.  No they don’t.  The FDA doesn’t bother verifying the ads big Pharma inundates us with on TV & in print, to ensure these ads are not fraudulent or misleading even though its the FDA’s job to do this, and now they’re going to let Big Pharma loose on social media?   Sounds to us  like once again,  the FDA has Big Pharma’s back instead of the general public’s.

TIME Magazine  – December 28, 2010

Tweets are supposed to be quick and to the point, but the Food and Drug Administration (FDA) is neither in its ever lengthening quest to tell the world’s drugmakers how they can promote their potions via Twitter, Facebook and other social media. More than a year ago, after criticizing 14 pharmaceutical companies for posting misleading messages on such sites, the FDA held hearings on the topic and declared it would issue rules by the end of 2010. Now it’s delaying them until sometime early next year, perhaps later.

For more than a decade, the FDA has regulated how drug companies sell their products in newspapers, magazines, television and radio. But as the rest of the business world jumps into booming social-media marketing, there are no rules yet for medicine merchants. The pharmaceutical industry had hoped the FDA would stick to its pledge and issue guidelines this year. Earlier this month, in fact, agency officials said that was still the plan. But last week, the FDA office responsible for drafting the new regs said, without elaboration, that it is going to wait at least until the first quarter of 2011 before issuing them. (See TIME’s best pictures of 2010.)

The companies wish the agency would act. “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making,” the drugmaker AstraZeneca has told the FDA. “In our absence, consumers will turn to information sources that are not regulated and not always well informed.” Not everyone agrees the companies have such altruistic aims. The Center for Digital Democracy (CDD), a consumer group based in Washington, D.C., that is focused on marketing and public-health issues, has told the FDA to take as much time as it needs. The agency, says Jeff Chester, CDD’s executive director, “needs to take a deep breath, and shouldn’t open the floodgates and allow pharmaceutical companies to purposely mislead consumers.” (See how drug companies are taking their pitch to social media.)

Despite such qualms, there’s reason to be concerned by the foot-dragging. About 60% of U.S. adults get health information online, often for a partner or child. We’re what experts call “e-patients,” who regularly march into doctors’ offices demanding prescriptions for what ails us. Many of us pore over the Internet, seeking ways to get better, and often surrender personal information to get it. The drug industry surely recognizes the value of such online contact, and is steadily increasing the share of its $4 billion annual marketing budget dedicated to online offerings.

Yet tough questions need to be answered before Big Pharma starts tweeting about our tummy aches. How can drug companies safely sell their products — which often require pages of fine print or speed-talking announcers — in a 140-character tweet? If a drug’s risks and benefits are wrongly cited in a Wikipedia entry, is the company responsible for correcting it? Does that then become advertising regulated by the FDA? Does the drug industry’s proposal to include a symbol, inside a tweet, that links consumers to more detailed information make sense? (Comment on this story.)

It’s enough to give you a headache. In which case, you may want to take two tweetless aspirin, along with a dollop of patience, while awaiting the FDA’s rules.
Read more: http://www.time.com/time/business/article/0,8599,2039794,00.html#ixzz19WlEIgcZ

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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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Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Tuesday, November 30th, 2010

Alan F. Schatzberg

Note from CCHR: The two “prominent authors” of this Pharma-funded handbook for diagnosing and drugging patients, are psychiatrists Alan F. Schatzberg and Charles Nemeroff.   Schatzberg is the former President of the American Psychiatric Association and owned $6 million equity in drug developer Corcept Therapeutics at the same time that he was principle investigator in an NIH-funded, Stanford-based study of Corcept’s drug mifepristone.

Charles Nemeroff

Charles  Nemeroff was Professor and Chairman of Psychiatry and Behavioral Sciences, Emory University School of Medicine in Atlanta. Senate investigations revealed Nemeroff failed to disclose at least $1.2 million in Pharma funding including GlaxoSmithKline.



The New York Times
November 29, 2010
by Duff Williams

Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.

From the book “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care.”

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”

The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.

The book’s listed co-authors were Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that, and Dr. Alan F. Schatzberg, who was chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.

The letter documenting the relationship between Dr. Nemeroff, a writing company and SmithKline was dated Feb. 4, 1997. It and a “preliminary draft” of the book, dated Feb. 21, 1997, and adding Dr. Schatzberg’s name were released Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr. Francis S. Collins, director of the National Institutes of Health. In the letter, Danielle Brian, executive director of the project, and Paul Thacker, an investigator, formerly with the staff of Senator Charles Grassley of Iowa, also cited other examples of what they termed ghostwriting and asked the N.I.H. for better policing of such practices.

The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.

Responding to questions by e-mail last week, Dr. Nemeroff and Dr. Schatzberg emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline “had no involvement in content,” Dr. Schatzberg said, adding, “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.”

Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”

But the writing company, Scientific Therapeutics Information of Springfield, N.J., had developed “a complete content outline” for Dr. Nemeroff’s comment, according to the 1997 letter from one of the company’s officials. The company also said it had “begun development of the text.” The writing company did not respond to requests for comment.

Kevin G. Colgan, a spokesman for GlaxoSmithKline, said the company’s role in the book was described in its preface. In recent years, he added, the company has tightened its internal guidelines for medical writers.

Ron McMillen, chief executive of American Psychiatric Publishing, which published the book, said he reviewed files on it Monday and found no evidence of influence by the writing company or GlaxoSmithKline. But Mr. McMillen also said he had been unaware of the plan outlined in the two-page letter to Dr. Nemeroff.

“This would show more involvement than we would accept,” he said after reviewing it.

The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.

Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999. Dr. Howard A. Brody, an author, blogger and professor of family medicine at the University of Texas Medical Branch at Galveston, speculated that family doctors may have had some resistance to a book from a psychiatric press.

Mr. McMillen said the book was co-published with the American Medical Association. He said it was distributed until a few years ago.

Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. “Remarkably, the book remains quite accurate and relevant to clinical practice today,” he said.

Dr. Nemeroff said he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.

Dr. Schatzberg said he had not seen the 1997 letter to Dr. Nemeroff. He termed it “a theoretical proposal that bears little, if any relationship to what actually happened.”

Dr. Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear — as peer-reviewed journals now do — whose idea it was, who wrote the first draft, and who edited. Dr. Lo and other experts said ghostwriting has receded in recent years with tougher journal standards.

Dr. Nemeroff and Dr. Schatzberg have been listed on other titles, including co-editors of the Textbook of Psychopharmacology, a book for psychiatrists and medical students, whose third edition appeared in 2003. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.

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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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Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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

Thursday, November 11th, 2010

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

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

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

For a little back story)

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

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

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

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

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

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

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

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U.S. Justice Department Charges Former GlaxoSmithKline VP — A Top Lawyer—with Fraud over Illegal Marketing of Antidepressant Wellbutrin

Wednesday, November 10th, 2010

The New York Times, November 9, 2010

by Duff Wilson

In a rare move, the Justice Department on Tuesday announced that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and obstructing a federal investigation into illegal marketing of the antidepressant Wellbutrin for weight loss.

The indictment grabbed the attention of pharmaceutical executives who have been bracing for a long-promised government crackdown on company officials — rather than the corporations themselves — in drug-fraud cases that have resulted in billions of dollars in fines and payments.

“This is absolutely precedent-setting — this is really going to set people’s hair on fire,” said Douglas B. Farquhar, a Washington lawyer who recently presided at a panel on law enforcement during a drug industry conference where federal officials warned they were focusing on individuals. “This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies.”

The indictment accuses the Glaxo official, Lauren C. Stevens of Durham, N.C., of lying to the Food and Drug Administration in 2003, by writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens “made false statements and withheld documents she recognized as incriminating,” including slides the F.D.A. had sought during its investigation, the indictment stated.

Tony West, assistant attorney general for the civil division, said in a statement, “Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations.”

Ms. Stevens has assembled a high-powered legal defense team. “She’s pleading not guilty,” said Reid H. Weingarten, one of her lawyers, who previously represented Bernard J. Ebbers, former chief executive of WorldCom, and Mark A. Belnick, former Tyco counsel. “We’re going to trial and looking forward to it, and we fully expect her to be vindicated.”

Brien T. O’Connor, a lawyer with Ropes & Gray, said in a statement, “Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with F.D.A.”

Ms. Stevens, who is 60, could not be contacted Tuesday. No one answered her home telephone.

She is retired, according to Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline. Ms. Rhyne said the company was cooperating fully with a federal investigation into allegations of illegal sales and marketing of Wellbutrin. Last year, it set aside $400 million to resolve the case, which is still pending.

Two weeks ago, in an unrelated case, GlaxoSmithKline agreed to pay $750 million to the government to settle civil and criminal complaints that it sold tainted or ineffective products from a large manufacturing facility in Puerto Rico.

The theme of the drug-law industry conference last month was “more individuals, more often.” In a presentation, Eric M. Blumberg, a deputy chief counsel at the F.D.A., warned: “If you are a corporate executive — or counsel advising such a client — do not wait for the first case to decide now is the time to comply with the law.”

“Once you threaten somebody with jail, people really start paying attention,” said Frances H. Miller, a Boston University law professor and expert on health care policy. “This fits in that framework of sending very high-profile messages very fast.”

http://www.nytimes.com/2010/11/10/health/10glaxo.html

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Drug-firm executives under new scrutiny in Medicare fraud

Tuesday, November 9th, 2010

The Washington Post, November 9, 2010

By Anna Edney

Federal inspectors want to prevent drug-company executives from doing business with the U.S. government when their companies are convicted of Medicare fraud.

Under guidelines from the Department of Health and Human Services’ Office of Inspector General, executives can be barred from contracting with federal health programs when they knew, or if the inspector general concludes they should have known, about fraud at their firms. The guidelines were posted Oct. 20 on the office’s Web site.

Authorities have been spurred by large settlements, said Robert DeConti, chief of the administrative and civil remedies branch in the inspector general’s Office of Counsel.

GlaxoSmithKline was ordered to pay $750 million on Oct. 26 for sale of defective drugs, and Pfizer agreed to pay $2.3 billion in September 2009 for fraudulent marketing of medicine. A company that employs someone barred from doing business with the government cannot receive federal payments.

That is definitely a renewed emphasis, maybe a new emphasis, on holding individuals accountable,” DeConti said in an interview last month.

Certain crimes, such as patient abuse or a felony conviction of health-care fraud, require automatic exclusion by law, according to the inspector general’s Web site.

The inspector general has the discretion to bar a person in other cases, such as a misdemeanor conviction.

Company executives might also be sanctioned if their employers are convicted of misconduct or they may be blocked from doing business with federal agencies. The inspector general has used this option 31 times since 1996. Most cases involved smaller, closely held companies such as those that make durable medical equipment, DeConti said. Twenty-eight people have been barred, he said.

Federal inspectors are targeting “complex cases that might involve global pharmaceutical manufacturers that are settling larger cases,” he said. “We have cases under development right now against individuals in that kind of company.”

In 2008, the inspector general barred three executives at Purdue Pharma. The officials at the drugmaker, based in Stamford, Conn., pleaded guilty to a misdemeanor for misbranding the painkiller OxyContin.

They were excluded from doing business with the government for 15 years. Purdue paid $634 million to settle criminal and civil claims that it misled patients and doctors about the addictiveness of OxyContin.

“An exclusion for 15 years is basically a career-ender,” said Cory Andrews, senior litigation counsel at the Washington Legal Foundation, who has criticized the Food and Drug Administration for what he calls excessive enforcement.

Pfizer has “invested substantial resources” to create a compliance program under which every employee gets mandatory training, said Christopher Loder, a spokesman for the New York-based drugmaker. He declined to comment on whether Pfizer executives might be targeted with exclusion.

Mary Anne Rhyne, a spokeswoman for London-based Glaxo, also declined to comment.

Tens of thousands of people and companies are excluded, including nurses, physicians, dentists, pharmacies and durable medical equipment suppliers.

“The current administration is feeling that they want to increase enforcement in this area, and they’re of the belief that monetary settlements aren’t sufficient, and they need to charge individuals to deter the conduct,” Jeffrey Senger, a lawyer at Sidley Austin LLP in Washington and former acting chief counsel with the FDA, said in a telephone interview.

Read the rest of the article here: http://www.washingtonpost.com/wp-dyn/content/article/2010/11/08/AR2010110805757.html

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Glaxo Failed to Warn About Paxil Risks, Lawyer Says at Philadelphia Trial

Tuesday, November 9th, 2010

Note from CCHR: Also see attorney Karen Barth Menzies interview on Paxil withdrawal effects and documents withheld from the public http://www.youtube.com/cchrint#p/c/B9EA75455D155D89/3/Mpex0n0DXuc

Bloomberg News

by Jeff Feeley, November 9, 2010

GlaxoSmithKline Plc,  the U.K.’s largest drugmaker, failed to properly warn consumers that its antidepressant drug Paxil could cause birth defects, a lawyer for the family of an injured teenager told jurors.

Glaxo officials had research from the 1980s showing Paxil caused deaths among the offspring of animal test subjects and didn’t provide clear warnings about those deaths, Kimberly Baden, a lawyer for Anna Blyth and her family, told a Philadelphia jury. Baden said the drug caused a narrowing of the aorta leading from the heart of Anna, now 14 years old.

“We believe the evidence will show Paxil caused Anna’s birth defects,” Baden said in opening statements in the trial. “We believe the warnings and instructions put out in 1995 weren’t appropriate and reasonable.”

The Blyth family’s case is the first over Paxil’s birth- defect risks to go to trial since the company agreed in July to pay more than $1 billion to settle 800 cases alleging the company failed to adequately warn consumers and their doctors about the drug’s hazards. The Blyth case wasn’t part of the settlement.

In the first Philadelphia trial, a jury ordered Glaxo in October 2009 to pay $2.5 million to the family of a 3-year-old boy born with heart defects his mother blamed on the drug.

$11.7 Billion in Sales

Glaxo officials contend Paxil played no role in Anna’s heart defects. They were most likely caused by genetics or the fact that her mother became pregnant late in life, Chilton Varner, a lawyer for the drugmaker, told jurors in her opening statement.

The deaths of Paxil animal test subjects had nothing “to do with Anna Blyth’s heart defects,” Varner said.

Approved in 1992 for U.S. use, Paxil generated about $793 million in sales in 2009, or about 1.8 percent of Glaxo’s total revenue. The company had $11.7 billion in U.S. Paxil sales over nine years starting in 1997, according to documents made public last year in a Pennsylvania trial over birth-defect claims.

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. The drugmaker said in May it plans to double revenue from India and China by 2015 as it cuts prices to match competitors in emerging markets.

The company has paid out more than $2 billion to resolve a wave of litigation over Paxil, including claims the anti- depressant caused suicides in some users and withdrawal symptoms. In July, Glaxo set aside $2.4 billion to resolve litigation over Paxil and its Avandia diabetes drug.

Second Wave

After announcing its settlement of Paxil suits this summer, the company faced a second wave of suits over the drugs, said Carl Tobias, a University of Richmond law professor who teaches classes about mass-tort cases. That’s not unusual once a big- dollar settlement is on the table, he said.

“You’ll have plaintiffs lawyers who hope to get in on a settlement by going out and finding some new cases,” Tobias said. “Glaxo probably feels it had to litigate this case to send a signal that it’s not going to settle every one of these birth-defect cases, especially if they are weak.”

Sarah Alspach, a Glaxo spokeswoman, didn’t immediately return a call for comment on how many Paxil birth-defect cases remain outstanding.

In Anna’s case, the Summerville, South Carolina, resident had to undergo two rounds of open-heart surgery within nine months of her birth, Baden told jurors.

Her mother, Marsha Blyth, had taken Paxil for a short time during her pregnancy to deal with depression, Baden noted.

Glaxo’s Paxil warning label didn’t make it clear that offspring from animals on which the drug had been tested died, she said.

Read the rest of the article here: http://www.bloomberg.com/news/2010-11-09/glaxo-failed-to-warn-about-paxil-risks-lawyer-says-at-philadelphia-trial.html

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Former GSK lawyer indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug

Tuesday, November 9th, 2010

WZCO.Com, November 9, 2010

Ex-Glaxo lawyer indicted for role in U.S. drug probe

WASHINGTON (Reuters) – A former lawyer for pharmaceutical giant GlaxoSmithKline Plc has been indicted for lying and obstructing an investigation into the company’s promotion of an anti-depressant drug, the U.S. Justice Department said on Tuesday.

The lawyer, Lauren Stevens, was indicted on four counts of making false statements, one count of obstruction of justice and one count of falsifying and concealing documents related to Glaxo’s promotion of the drug for weight loss, which had not been approved by the Food and Drug Administration.

“Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” said Tony West, head of the Justice Department’s civil division.

The Justice Department did not name the drug or Glaxo, but the company confirmed she had worked in its legal department but retired. A legal directory described Stevens as a Glaxo vice president and associate general counsel.

A lawyer for Stevens was not immediately available for a comment.

The case emerged after the FDA sought information from Glaxo in 2002 about its promotion of the drug.

A Glaxo spokeswoman declined to comment about any FDA probe of marketing of its drug for an unapproved use.

Such charges against corporate executives in these kinds of instances are rare. Justice Department officials could not immediately recall a similar case in recent years.

Stevens knew the company had sponsored programs to promote the drug for unapproved uses, including payments to doctors to give hundreds of talks to other doctors, according to the indictment.

The indictment also accused Stevens of withholding slides that were used by doctors who were paid by Glaxo to promote the drug and that she prepared a memorandum about the benefits and risks of providing the information to the FDA.

The obstruction charges carries a maximum sentence of 20 years in prison, while each false statements charge has a maximum sentence of five years in prison.

(Reporting by Jeremy Pelofsky; editing by Andre Grenon)

http://wkzo.com/news/articles/2010/nov/09/ex-glaxo-lawyer-indicted-for-role-in-us-drug-probe/

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