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2009-10-13T19:15:00.001-07:00

What is the most important information I should know about Bextra?

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Bextra was withdrawn from the U.S. market in 2005.

The manufacturer of Bextra has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (Bextra is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking Bextra.

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Bextra. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects. Serious skin reactions have occurred in patients taking Bextra. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking Bextra and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

What is Bextra?

Bextra was withdrawn from the U.S. market in 2005.

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Bextra works by reducing substances in the body that cause inflammation, pain, and fever.

Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation.

Bextra may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Bextra?

Bextra should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of Bextra in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking Bextra if you are being treated for pain associated with CABG.

Before taking Bextra, tell your doctor if you

smoke;
drink alcohol;
have an ulcer or bleeding in the stomach;
have liver disease;
have kidney disease;
have asthma;
have congestive heart failure;
have fluid retention;
have heart disease;
have high blood pressure;
have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or
are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Bextra is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Bextra should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Bextra without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Bextra passes into breast milk. Do not take Bextra without first talking to your doctor if you are breast-feeding a baby. If you are over the age of 65 years, you may be more likely to experience side effects from Bextra. You may require a lower dosage or special monitoring during your therapy.

2009-10-12T09:40:00.001-07:00

For Pfizer, a Big Deal and a Test

By DUFF WILSON

Published: January 26, 2009

After announcing the $68 billion megamerger with Wyeth on Monday morning, Pfizer’s chief executive, Jeffrey B. Kindler, did not have much time to celebrate.

In Wyeth, Pfizer Sees a Drug Pipeline (January 27, 2009)

Wyeth Deal May Slow Pfizer Biotech Acquisitions (January 27, 2009)

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There was too much gloomy news to deal with.

The companies’ combined work force of 128,000 will shed 19,000 jobs. Pfizer will slash its stock dividend in half. And Pfizer is taking a $2.3 billion charge to settle a federal investigation over illegal off-label promotion of its former painkiller, Bextra.

Investors celebrated Mr. Kindler’s big day by sending Pfizer’s stock down more than 10 percent.

And yet, for Mr. Kindler, the Wyeth deal promises a big payoff. The combined company would be the fourth largest in the United States by market value based on Monday’s stock prices, which valued Pfizer at $105 billion and Wyeth at $57 billion. Only Exxon, Wal-Mart and Procter & Gamblewould be larger than Pfizer.

And it gained control of a range of biotech drugs, vaccines, consumer products and research opportunities to try to fill the gaps in its own product pipeline.

“This is not about a single product,” Mr. Kindler, 53, said at the news conference at Pfizer headquarters in Manhattan on Monday morning where the deal was formally announced. “It is about creating a broad, diversified portfolio of businesses, ones in which the people that are great at science can do what they do best and the people that are great at providing access to customers can do what they do best. And it is just such a perfect fit.”

His counterpart, Bernard J. Poussot, 56, the Wyeth chairman, who appeared beside Mr. Kindler, also termed it a “perfect” fit. But it will be Mr. Kindler’s job to make it work. He will be chairman of the merged companies, which will be known as Pfizer, while Mr. Poussot is expected to depart if the merger is completed as planned this year.

If the Pfizer-Wyeth deal had gone into effect last year, Mr. Poussot would have been entitled to about $38 million in cash severance, pension, health benefits and other perquisites. But because of changes the Wyeth board put in place on Jan. 1, the total value of the golden parachute is worth less than half that amount — an estimated $18.3 million.

In many ways, Mr. Kindler, the Harvard-trained lawyer who has led Pfizer since July 2006, had spent the last two years preparing for a big deal. He has already cut $2.8 billion in costs and 15,000 jobs. He has turned research away from the cardiovascular medicines that helped make Pfizer a giant but whose fading glory is embodied in the $13 billion-a-year cholesterol drug, Lipitor, which will lose its United States patent in 2011.

Now, if the deal is completed, Pfizer, which had sales of $48 billion in 2007, is looking forward to absorbing Wyeth, which is based in Morristown, N.J.

As many big mainline pharmaceuticals companies face their own patent problems and the prospect of cheap generic competitors to their best-selling drugs, the Wyeth deal will help Pfizer smooth a potential patent “cliff” into a mere bump in the road, says Barbara Ryan, a Deutsche Bank analyst. A predicted 30 percent drop in revenue in four years will be only 10 percent at worst, she said.

“This just has to happen in this industry,” Ms. Ryan said in an interview. “As a scale player, Pfizer can generate dramatically more earnings out of Wyeth than Wyeth can alone.”

Two Pfizer chairmen before Mr. Kindler have made major acquisitions with grand ambitions, only to see them falter. Pfizer bought Warner-Lambert for $90 billion in 2000 mainly to gain control of Lipitor, and it bought Pharmacia for $60 billion in 2003 to get the painkiller Celebrex. But Lipitor spawned no successor drug, and Celebrex sales plummeted after a similar drug, Vioxx, made by Merck, was linked to strokes and heart attacks.

Mr. Kindler said the Wyeth purchase was different. “We have obviously learned a lot from our prior acquisitions,” he said, conceding they had “hurt morale and hurt productivity.”

To make the Wyeth deal work, Mr. Kindler promised to cut $4 billion in combined spending by 2012 and to slash 15 percent of the companies’ combined work force. But he said he would do so “thoughtfully and being very careful to protect the core asset that makes both of these companies successful.”

Pfizer also said Monday that it would cut its dividend in half, to 16 cents a share, partly to shore up credit ratings, as the company borrows $22.5 billion to help finance the deal from five banks — four of which recently received federal bailout money.

“It’s good to see banks doing what banks are supposed to be doing,” Mr. Kindler said. “I think it is really good for America to support a competitive, strong, healthy, biopharmaceutical industry.”

David Moskowitz, an analyst with Caris & Company, praised the deal for its biotechnology drugs and vaccines from Wyeth and the cost-cutting potential of combined operations. In a note to investors Monday, he predicted an “exciting” year for pharma mergers and acquisitions, with Schering-Plough and Bristol-Myers Squibb being the most likely takeover targets.

Timothy D. Anderson, an analyst for Sanford C. Bernstein, said he expected cost-cutting to be closer to $6 billion. “The next big pharma merger is likely to see a level of cost-cutting not seen before,” he wrote Monday to investors.

Certainly, Wyeth and Pfizer employees were bracing themselves for deep cuts.

Magid Abou-Gharbia, director of the Center for Drug Discovery Research at Temple University, who recently left Wyeth after 26 years as a scientist and manager, said he has been receiving calls from anxious Wyeth scientists.

“I’m trying to be a calming factor,” Mr. Abou-Gharbia said in a telephone interview Monday. “Remind them that I went through three mergers at Wyeth, and after each one, the organization emerged stronger.”

As investors digested Pfizer’s news, the stock fell 10.3 percent to $15.65 a share Monday. Wyeth held steady, down 0.8 percent to $43.39 after rising 12.6 percent Friday on the takeover rumor.

Mr. Kindler defended the dividend cut, saying the Wyeth purchase gave “clarity” to future earnings.

Pfizer also reported its fourth-quarter financial results, showing that revenue dropped 4 percent, to $12.35 billion, as it lost United States exclusivity for the allergy drug Zyrtec and the colon-cancer drug Comptosar.

Excluding special charges, Pfizer said it would have earned 65 cents a share, up from 50 cents a share in the quarter a year earlier. But Pfizer’s earnings dropped by more than 90 percent, to $266 million, or 4 cents a share, after one-time charges — the biggest being the $2.3 billion set aside to settle the Justice Department’s Bextra case.

The government had accused Pfizer of paying off doctors and making false and misleading claims about the drug to encourage its unsafe use for acute and surgical pain. The investigation has also expanded to the marketing and safety of other Pfizer drugs. A spokeswoman for Michael Sullivan, the United States attorney for Massachusetts, who is leading the investigation, did not return phone calls.

Bextra was withdrawn by Pfizer in 2005. The company settled Bextra complaints from 33 states for $60 million last October and agreed to pay $894 million to settle suits over Bextra

On any other day, the Bextra settlement might have been big news for Pfizer — which is why some analysts said the company had probably decided to disclose it on Monday.

2009-10-12T09:28:00.001-07:00

Pfizer’s $2.3 billion settlement with the government over its mismarketing of Bextra “pales” next to the company’s annual revenue, making off-label promotion “easier” in the future, according to an AP story published over the weekend:

PFE 17.08 +0.16 (+0.95% )

Quotes delayed at least 20 mins.

Pfizer’s fine is the largest health care fraud settlement in U.S. Justice Department history. But that $2.3 billion total stands small compared to the $44.2 billion in pharmaceutical sales the world’s largest drugmaker rang up last year.

“$2.3 billion looks like a lot of money,” [Dr. Adriane Fugh-Berman, a Georgetown University associate medical professor] said. “But these are highly profitable drugs. It will not take them very long to make up that deficit.”

Well, yes and no. In 2008, I made this same argument: Thatsettlements between the Department of Justice and drug companies amounted to loose change and were therefore ineffective. However, to say that the $2.3 billion Bextra fine is “loose change” is going too far. $2.3 billion is a lot of money, even in Pfizer’s universe. It reduced the company’s Q4 2009 net income by 90 percent, for instance.

But it is true to say that the stock market largely shrugs off significant settlements as if they didn’t happen. Look what happened to Pfizer stock over the period of the settlement provision being made in January and today:

Sure, the stock takes a dip, but that’s more attributable to Pfizer’s acquisition of Wyeth than it is to the fine. And already it’s made up most of its ground.

A similar situation happened when AstraZeneca announced in Julythat it was potentially facing $600 million in unpaid legal bills from its Seroquel litigation. Its Q2 profit was $2.3 billion.

If you can spot the impact of that liability on AZ’s stock, let me know.

Here’s Cephalon’s announcement that it was paying a $425 million fine for its marketing. Its net income in Q3 2008, when the fine occurred, was $112 million (although it does have a settlement reserve built into its income statement).

Sure, there’s sharp dip after the Sept. 29 disclosure, but the ground is made up within a month or so.

To do this properly, you’d need to build a database of dozens of settlements and historic stock prices and run a regression analysis. But I’d be willing to bet that the result would be that settlements are not a significant mover of stock prices compared to overall price movements generally. (Note that I haven’t said a word about the wider movement of the markets, which these companies’ prices seem to follow.)

Clearly, if you read Wall Street analysts’ reports, you often find that they regard settlements as one-off events that shouldn’t affect their overall models too much.

So there’s a self-reinforcing delusion going on here: Companies know that they can increase revenues by promoting drugs off-label. They also know that the fines can be significant. But they’re pretty sure that Wall Street will either ignore the fines, or weight the extra revenues more heavily than than the fines. So the incentives still lie in favor of off-label marketing.

Which, when you look at that $2.3 billion Bextra settlement, is a scary thing to contemplate.

Illegal Marketing of Drugs: Pfizer's Record Fine

2009-09-15T20:24:00.000-07:00

U.S. drug maker settles charges for $2 billion for pushing unapproved uses of medicines. The company has now been fined four times since 2002.Transcript of radio broadcast:
10 September 2009

This is the VOA Special English Economics Report.

The world's largest drug company has agreed to pay almost two and a half billion dollars for illegal marketing of medicines. The settlement between Pfizer and the United States Justice Department was announced last week.

Kathleen Sebelius and Associate Attorney General Tom Perrelli announce the Pfizer settlement

The settlement is the nation's largest ever in a case of health care fraud. It also includes the largest criminal fine ever in any case in the United States, more than one billion dollars. Pfizer agreed to pay another billion for violations of a civil law, the False Claims Act. Pfizer, based in New York, had sales last year of forty-eight billion dollars.

A Pfizer division, Pharmacia & Upjohn, agreed to plead guilty to a criminal violation over the painkiller Bextra. Pfizer pushed sales of Bextra for several uses unapproved by the government because of safety concerns. It also pushed for use in unapproved amounts. Pfizer withdrew Bextra from the market in two thousand five because of links to heart attacks and other problems.

Pfizer also faced civil charges over Bextra as well as an anti-psychotic drug, Geodon; an antibiotic, Zyvox; and an anti-epilepsy drug, Lyrica. Officials said Pfizer paid health care providers to prescribe these medicines for conditions other than the ones for which they are approved. This is called "off-label" use of a drug.

Doctors are permitted to try off-label uses to treat their patients. The idea is that a doctor might find other ways that a drug is effective. But federal law bars drug companies from marketing their products for unapproved uses.

Kathleen Sebelius is the secretary of health and human services.

KATHLEEN SEBELIUS: "This settlement is historic not only because it's the most money taxpayers have ever recovered from a drug company, but also because it includes the most comprehensive corporate integrity agreement that a drug company has ever signed in the United States."

Under the agreement, doctors will have a way to report abuses by Pfizer sales representatives. And officials said Pfizer will have to make "detailed disclosures" on its Web site. Pfizer announced a plan in February to publicly disclose its financial relationships with doctors, medical organizations and patient groups.

Yet this is not the company's first corporate integrity agreement with the government. Pfizer has now been fined for illegal marketing four times since two thousand two.

Prescription drugs represent only about one-tenth of all health care spending in the United States. But fast-growing demand and prices have made them part of the debate over health reform.

And that's the VOA Special English Economics Report, written by Mario Ritter. I'm Bob Doughty.

Pfizer to Settle Claims Over Bextra and Celebrex

2009-09-15T20:12:00.000-07:00

Pfizer said Friday it had agreed to set aside $894 million to settle virtually all the lawsuits related to its withdrawn painkiller Bextra as well as a similar drug that remains on the market, Celebrex, four years after concerns about cardiovascular risks of such drugs became widely publicized.

Mary Altaffer/Associated Press

The painkiller Bextra was linked to a disorder that causes sloughing of the skin.

Times Topics: Pfizer Inc.

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Celebrex is still being sold years after cardiovascular concerns were first raised.

The announcement comes approximately one year after Merckannounced a $4.85 billion reserve to settle litigation involving the similar painkiller Vioxx, which Merck pulled off the market in September 2004 after studies linked it to strokes and heart attacks.

Pfizer withdrew Bextra seven months later, but left Celebrex on the market, contending that it was less dangerous — a decision that was supported by the Food and Drug Administration on the overwhelming recommendation of a federal advisory panel.

In 2007, worldwide sales of Celebrex were $2 billion.

In a news release announcing the settlement, Pfizer’s general counsel, Amy W. Schulman, said the agreements would allow the company to focus on its core business. “Inevitably, litigation can be distracting and putting these matters behind us should better enable physicians to consider Celebrex purely on the strength of its clinical data and its ability to meet the diverse needs of patients in pain.”

Pfizer shares closed down 6 cents on Friday, at $16.91.

Plaintiffs’ lawyers had filed lawsuits at the state and federal levels against Pfizer, claiming that both drugs had harmed people who took them. Pfizer would not disclose how many total cases it was settling or what percentage of them involved Bextra, but they were believed to be the large majority.

In addition to cardiovascular risks associated with Bextra, it was linked to serious cases of Stevens-Johnson syndrome, a debilitating and sometimes fatal disorder that causes sloughing of the skin. Cases involving the rare disorder, known as SJS, were not covered in the settlement agreements announced Friday; these cases have generally already been settled.

The settlement Pfizer announced Friday follows two key court rulings in the last year that were favorable to the company, which is based in New York.

In November 2007, United States District Judge Charles R. Breyer, in San Francisco, ruled that the plaintiffs had not offered adequate scientific proof that the 200-milligram dose of Celebrex — the most commonly prescribed dose — had caused heart attacks and strokes.

As a result of that ruling and a similar state-level decision by New York Supreme Court Judge Shirley Kornreich, many lawyers dropped clients who claimed they suffered heart attacks or strokes after taking the 200-milligram dose.

That meant that Pfizer’s Celebrex liability was limited, although some patients — those who had taken the 400-milligram dose — still had claims.

Vioxx, Celebrex and Bextra all belong to a category of drugs known as Cox-2 inhibitors.

A large study led by doctors at the Cleveland Clinic and paid for by Pfizer is under way to determine whether Celebrex, the only drug in the Cox-2 inhibitor class that remains on the market, carries any more cardiovascular risk than other widely used painkillers.

The drug’s labeling information currently includes a boxed warning of possible cardiovascular risks, but similar warnings are also required on two over-the-counter painkillers: ibuprofen, sold as Advil and other brands, and naproxen, of which Aleve is perhaps the best-known brand.

Daniel Becnel, a plaintiff’s lawyer in Reserve, La., who represents more than 150 patients, said he was pleased with the Pfizer settlement.

Pfizer had discussed settling many of the cases over the last two years, but Mr. Becnel said it was not until the Feinberg Group law firm got involved that settlement discussions began in earnest. The firm, based in Washington and New York, is known for its volunteer work assigning payments from the September 11 Victims Compensation Fund.

Mr. Becnel said the Feinberg Group negotiated settlements with each lawyer involved in the case after reviewing medical records of their clients.

“The Becnel group of settlements involves 150 people and each of those were negotiated individually,” he said. “After all the records were reviewed by their team of expert lawyers, we agreed to a settlement.”

Perry Weitz, a Manhattan lawyer representing 1,700 clients, said the settlement was good for the claimants. “It means they’ll get their money sooner rather than later.”

Pfizer said the $894 million charge, to be counted against third-quarter results, which are scheduled to be announced next week, would amount to $640 million after taxes. Some of that — the company did not disclose how much — will be recouped from insurance companies. The $894 million consists of $745 million to settle personal injury claims, $89 million related to consumer fraud claims, and $60 million to settle lawsuits brought by state attorneys general.

As of the second quarter, the company had $26.3 billion in cash and short-term securities.

When Merck last year agreed to settle the Vioxx claims, it reversed the company’s long-stated position that it would litigate every one of those cases. Approximately 57,000 people have filed claims that they were injured by Vioxx. About $100 million has been paid from that Merck fund so far.

Kanye West Storms the VMAs Stage During Taylor Swift’s Speech

2009-09-14T21:28:00.000-07:00

9/13/09, 10:12 pm EST

Photo: Polk/Getty

Leave it to Kanye West to produce one of the most infamous moments in VMAs history before the 2009 show was even an hour old. It happened after Taylor Swift’s victory in the Best Female Video category for “You Belong With Me,” which beat out Beyoncé’s “Single Ladies (Put a Ring On It).” Just moments after Swift accepted the Moonman and began her acceptance speech, West stormed the stage, taking the microphone from Swift to announce Beyoncé deserved the award.

VMAs 2009 in photos: Kanye’s stage invasion, Madonna pays tribute to MJ and more.

“Thank you so much!” Swift began. “I always dreamed about what it would be like to maybe win one of these some day, but I never actually thought it would have happened. I sing country music so thank you so much for giving me a chance to win a VMA award.”

Before she could continue, West broke in. “Yo Taylor, I’m really happy for you, I’ll let you finish, but Beyoncé has one of the best videos of all time. One of the best videos of all time!” Kanye shouted to a mortified Swift and the speechless audience. And as quickly as he ran onstage — MTV cut away to show Pink applauding Taylor, and when they flashed back to Swift, West already had the mic in his hand — he was off, leaving a shocked Swift in his wake.

Everyone at the Radio City Music Hall looked stunned, as the cameras captured an astonished and horrified Beyoncé still in her seat. Soon after, the audience gave a standing ovation in support of Swift. To add insult to injury, after Kanye handed the microphone back to Swift, her time was up, and MTV cut to a video featuring Tracy Morgan and Eminem. Minutes after the incident went down, MTV Chairman and CEO Judy McGrath was feverishly typing into her phone when Diddy came up for a chat. Topic of conversation? What else but West. “Like Diddy just said, ‘It’s rock & roll,’ ” McGrath commented to RS. “And the applause for [Taylor] will be louder.”

Look back at Kanye’s other awards-show outbursts, and the most famous stage invasion in rock history.

According to sources at the VMAs, Swift was seen hysterically crying backstage after Kanye’s outburst, making it convenient that the first part of her performance of “You Belong to Me,” which immediately followed the acceptance speech, was prerecorded. (Swift emerged from the subway exit and performed atop a cab outside the venue live.) Wale, who is serving as MC for the house band, told the crowd, “You can’t fault a man for speaking his mind,” which was promptly met by boos from the Radio City Music Hall crowd. According to our sources inside Radio City, Kanye was promptly tossed from the VMAs after interrupting Swift’s speech and headed to West Village haunt the Spotted Pig. “I’m assuming based on the amount of Hennessey I saw [West] drink that he was not all there,” Fall Out Boy’s Patrick Stump toldRolling Stone backstage at the show.

Follow Rolling Stone’s live blog and all our VMAs coverage here.

Near the end of the show, Beyoncé invited Swift onstage to have the acceptance speech she deserved while picking up her own Moonman for Video of the Year. Later, West posted an apology on his blog:

“I’m sooooo sorry to taylor swift and her fans and her mom. I spoke to her mother right after and she said the same thing my mother would’ve said. She is very talented! I like the lyrics about being a cheerleader and she’s in the bleachers! …………………… i’m in the wrong for going on stage and taking away from her moment!……………. beyonce’s video was the best of this decade! I’m sorry to my fans if I let you guys down! I’m sorry to my friends at mtv. I will apologize to taylor 2mrw. welcome to the real world! everybody wanna booooo me but i’m a fan of real pop culture! No disrespect but we watchin’ the show at the crib right now cause … well you know! i’m still happy for taylor! Boooyaaawwww! you are very very talented! I gave my awards to outkast when they deserved it over me… that’s what it is!! i’m not crazy yall, i’m just real. Sorry for that! I really feel bad for taylor and i’m sincerely sorry! Much respect!!”

The Content Bubble

2009-09-14T21:18:00.000-07:00

So you’ve set up your Facebook Fan Page or Twitter profile and now you’re stuck wondering what to post.

They say content is king, and this holds true. You would be doing yourself a disservice by simply posting content without taking some time to think about the community you want to build. With the wealth of information available on just about every niche, you can create a valuable social network that people will want to follow.

This is something I like to call the content bubble.

This idea probably isn’t revolutionary, but it has helped when explaining to clients how to fully utilize content on their social networks. Basically, you start thinking about content outside of your immediate subject.

For example, lets say you have a Facebook Page for your Italian restaurant (one of my favorite foods btw).

Now your first impulse may be to use the page as a bulletin board. But, before you send a flurry of links about the menu specials, consider your subject. Italian food = Italy, and there is much more to Italy than just your restaurant.

So lets start building your content bubble:

Italian food has a rich and incredible history. Share this in your feed.
What region of Italy does your restaurant represent? Are there stories and facts which you can talk about?
Highlight specialty dishes.
Share some links about all the different grades of olive oil.
Who doesn’t want to know more about Italian desserts?
Go on YouTube and find some relative videos to post.
Talk about how certain ingredients became known. How is ricotta cheese made?
What about Italian songs or music?
Spotlight some famous Italian chefs.
Explain how all the different types of pasta come about.

Getting the idea how your content bubble can grow?

In this example, the Facebook page doesn’t focus on only the restaurant. It covers Italian history and culture. Now you are providing value while also broadening your readership. This can help with word of mouth which may lead to more potential customers.

Pfizer Whistleblower Tells His Bextra Story

2009-09-14T19:19:00.000-07:00

In pursuing a case against Pfizer for fraudulently promoting drugs that eventually led to the largest health fraud settlement in U.S. history, the feds leaned heavily on evidence supplied by a half-dozen whistleblowers.

Perhaps the most important was West Point grad John Kopchinski, hired by Pfizer as a sales rep when he left the Army in 1992. Kopchinski, 45, worked in South Florida until he was fired by the company in 2003. By then he was already talking with lawyers about evidence he had accumulated on the company's marketing of Bextra, a painkiller withdrawn from the market in 2005 amid safety concerns.

Under a law dating back to the Civil War, Kopchinski will get $51.5 million of the money recovered by the feds for his help. He'll also reap a share to be determined of money being returned to various states.

What led Kopchinski, now living in San Antonio, to blow the whistle? "You have to live with yourself when you look at yourself in the mirror," he told us in a telephone interview.

He first complained to management about aggressive promotion of Bextra far beyond the uses approved by FDA. But his concerns were brushed aside, and, over time, the "ethical line kept moving" in the wrong direction. He didn't want to go along with that, he said.

One of the things that bothered him most was a $50 bounty paid to reps when they got doctors to add Bextra to the standard care for patients before and after surgery. These care protocols would direct patients to take Bextra, often at high doses, a few days before a knee operation, for instance, and then afterward to control pain.

The FDA rejected a company application to market the drug for uses like that because the benefits didn't outweigh the risks, mainly cardiovascular problems. Bextra was approved to relieve arthritis pain (10 milligrams once a day) and menstrual pain (20 milligrams twice a day). But Pfizer touted Bextra heavily for other conditions and at higher doses anyway, Kopchinsky said, and sales reps were expected to get doctors on board.

Check out a Pfizer manager's email to Kopchinski's team of sales reps, nicknamed "The Sharks," asking where their results were in getting doctors to use Bextra for surgical patients. The second page is an example of a care protocol specifying Bextra.

These protocols and other marketing of Bextra beyond its FDA-approved uses lie at the heart of the government's fraud case against Pfizer, and the worries Kopchinski had about his job. "If you don't aggressively sell your products... you're labeled a non-team player," Kopchinski said. He said you could only achieve management's goals by selling Bextra for unapproved uses.

Another one of the practices that bothered him: encouraging doctors to start patients at high doses of Bextra--eight times the approved starting dose in the case of migraine patients, he said.

Take a look at a Pfizer script from 2002 that coached reps to tell doctors Bextra was both more effective and safer than Vioxx, a rival painkiller from Merck that was pulled from the market in 2004 because of heart risks. FDA never approved superiority claims for Bextra.

For a fuller picture of Kopchinski's allegations, see his legal complaint, originally filed under seal and now available online. You can also peruse more Pfizer document about Bextra in theexhibits here.

A Pfizer spokesman confirmed Kopchinski worked for the company during the period he claimed but wouldn't comment on the circumstances of his departure. As for Kopchinski's claims and those of the government, the company spokesman said:

We deny all of the civil allegations set forth in the qui tam complaints, including those in which DOJ intervened, with the exception that Pfizer acknowledges certain improper promotional conduct related to Zyvox and the Bextra conduct involved in the plea agreement.

PR Resources

What is the most important information I should know about Bextra?

What is Bextra?

What should I discuss with my healthcare provider before taking Bextra?

For Pfizer, a Big Deal and a Test

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