Our Views

At a time when Pfizer is slashing its work force around the world to save money and basically just survive, excessive executive perks are more than counterproductive.

In his Pharmalot blog, Ed Silverman breaks a fascinating story this week about Pfizer’s senior vp of human resources being asked to repay nearly $300,000 to the company for a weekly helicopter commute from her home in Maryland to corporate headquarters on East 42nd Street in Manhattan.

Silverman points out that its common for companies to pay for executive travel on corporate planes, but several staff members at the world’s largest drug company questioned whether commuting is a justifiable business expense.

CEO Jeff Kindler, who until recently was ok with these kinds of corporate perks, apparently has had a change of mind. Mary McLeod, and some other execs, have been asked to reimburse the company for portions of expenses that can’t be justified.

This would be a non-story, if it wasn’t for the fact that Pfizer, for the past few years, has been scrambling just to survive. To resurrect sagging share values in an uncertain world-wide market, the company is trying to save $1.5 billion to $2 billion by the end of this year through a brutal cost-cutting program that so far has seen the loss of 25,000 jobs, or 23 percent of its work force, since 2004, according to a Reuters report. And since 2003, nearly 50 — about half — of its factories and offices around the world have been, or will be, closed by the end of this year.

Reuters says company has begun to see some positive bottom line, and stock analysts — if not all shareholders — are upbeat. Many shareholders are upset that the stock is still running 25% below a year ago.

If I were one of the axed 25,000 employees, having listened to the woeful tale about the company’s desperate survival measures, I’d be more than a little miffed to learn that, A) the company’s head of human resources (hey, isn’t that the department responsible for me and the other 24,999 people now out of work?) has been riding the skies to work while I was out pounding the pavement looking for a job; and B) if she can pay back $300,000 just for her commutes, how the hell much money does she, and the dozens of other senior execs from the CEO down, not to mention the zillions of button-down consultants and PR flaks, take home every month?

Actually, getting even more personal, if I was one of the axed employees I’d be asking how many jobs like mine were eliminated because of the hundreds of millions of dollars poured into legal fees, damage suits, shady marketing, political lobbying and PR, all just to deal with the harm caused by our drugs.

In fact, I’d be wondering why I ever chose to work at a company, or in a system, that places profits above the safety of its ultimate customers, the patients.

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After the state Senate unanimously passed a new bill banning drug and device company gifts and meals to physicians, the House has approved a stripped down version.

The Boston Globe reports that a bill aimed at cutting soaring state health care costs has been passed by the Massachusetts House of Representatives, after being stripped of a controversial section that would have banned drug company gifts and meals to physicians.

Also removed were requirements that drug and medical device companies report payments they make to doctors for consulting and speaking to other physicians, along with a proposed $5,000 fine per violation.

The lawmakers also voted to delay until November 2009 another key section of the bill barring Big Pharma from buying data identifying doctors and their prescription records, a practice that allows Pharma’s sales people to fine-tune their sales pitches to individual physicians. The delay anticipates resolution of a similar proposition in New Hampshire, which is facing a free speech challenge in federal court.

Consumer groups and longtime gift-ban advocates are incensed, saying the relaxed regulations will drive up drug costs by allowing pharmaceutical and biotech companies to continue to manipulate doctors into prescribing new, more expensive brand-name drugs when generics often are as good, and much cheaper.

The new bill, instead of taking direct aim and pulling the trigger, now timidly requires drug companies to adopt a ‘marketing code of conduct’, similar to one announced a week earlier by the pharmaceutical industry’s trade association — interestingly, while negotiations on the Massachusetts bill were in progress between lawmakers and lobbyists.

Excuse me, but did I read that correctly? The state has asked Big Pharma to adopt a ‘marketing code of conduct’? Isn’t that like asking the wolves circling the chicken coop to adopt a ‘feeding code of conduct’?

C’mon, wolves kill and eat anything tasty, every chance they get. It’s what they do. They don’t know anything else. They’re wolves. And when in recent decades has Big Pharma ever displayed anything but wolf-like marketplace behavior?

So how did Big Pharma and the medical device makers convince the grizzled lawmakers of the Commonwealth of Massachusetts that they, Big Pharma and the medical device makers, are indeed not wolves, but just regular, reasonable folks?

They didn’t have to. True to their wolfish nature, Big Pharma threatened reduced industry investment in the state if the legislation wasn’t amended. And like the little pigs’ stick and straw houses, when the wolf huffed and puffed, the House caved in.

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J&J’s embracing of the potential for viral web marketing appears to be miles ahead of the rest of the Big Pharma family. But is this a good thing?

Mark Senak, in his Eye On FDA blog, describes the jump that Johnson & Johnson is getting on the rest of the Big Pharma family with its new online Babycenter Community social networking web site.

J&J’s original Babycenter and companion Parentcenter web sites appear to be busy, well-received sites for new parents and parents-to-be, loaded with how-to and advice articles, newsy celebrity kid-gossip, and tons of ads for J&J products. J&J says the new community site, prominently promoted on the regular Babycenter site, is the “largest parenting community online.”

As Senak points out, BabyCenter is only the latest in the company’s widening online presence, joining the J&J blog and the J&J YouTube Health Channel along with its other existing sites. Says Senak: “It seems clear as I’ve mentioned before, that J&J is executing a broad and reaching new media strategy while many other large pharmaceutical and even biotech companies are still not even sending out press releases on RSS Feeds.”

Along with the J&J product and service ads, I noticed how articles dealing with childhood or parenting problems don’t miss a chance to recommend visits to doctors and therapists — you know, the folks that write prescriptions.

Here’s the real situation as I see it:

On the one hand, we have J&J, in what could become a trend with Big Pharma, creating an unprecedented direct-to-consumer marketer’s dream — a diabolically constructed “safe and helpful” Who’s-Your-Daddy Big Pharma, connecting like never before with the population at large. Make no mistake, this is really happening through the power of the Internet. In comparison, print and TV marketing was a Neanderthal kindergarten.

Meanwhile, over here, we have thousands of respected medical, educational, justice, law-enforcement, media, marketing and treatment experts, all pointing to Big Pharma’s massively expensive direct-to-consumer print and broadcast advertising that began with FDA approval in the 1990s, as the genesis — and the continuing fuel today — for what everyone acknowledges is a prescription drug addiction and abuse epidemic that is devastating all sectors of society, from the cradle to more graves than ever.

So here’s the question I’m asking:

Should Big Pharma — a desperate, greed-driven group of ethically-challenged corporations that considers a normal cost of business paying $Billions in fines and settlements because of its inability to differentiate between right and wrong or good and bad — be allowed to create the illusion of ‘beneficent leader’ and wield the power to sway the opinions of more millions of people than ever before imagined?

My answer is, no way. But you may disagree. Feel free to comment.

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An FDA panel has voted against Black Box warnings for 11 epilepsy meds with proven increased risks of suicide, raising questions about the effectiveness of such labeling and a possible shift in the agency’s commitment to them.

The FDA has requested ‘Black Box’ label warnings, its most serious recommendation to drug makers for label warnings, many more times in recent years than in previous decades.

Then last week, after two committees unanimously agreed that 11 different epilepsy drugs can cause increased suicide risks, they turned around and voted against calling for Black Box warning labels on them.

In his Pharmalot blog, Ed Silverman poses the question: ‘Is the FDA overreacting?’ with so many label warnings recently, and suggests that the infamous Black Box may be “losing its luster” — its effectiveness — because of so many warnings.

Silverman asks his readers to vote with their opinions about whether or not the FDA has been overreacting in recent years. I voted ‘No’, but it turned out I was in a minority of 36%. The majority, 65% of voters, think the FDA has been overreacting with all the safety warnings, the net effect being less weight with physicians and possibly even patients.

One reader, claiming to be a doctor, was particularly illuminating: “Black-box warnings cause much more hand wringing among pharma marketers than they do among prescribing physicians. That said, more black boxes may dilute their intended effect (something slightly less than a skull and crossbones?), but I suspect more-so for consumers than physicians, who are much better equipped to take a very small increase in an absolute risk with the appropriate grain of salt.”

Doctors taking Black Box warnings with a grain of salt? Does this commenter even know what the expression means?

Here’s part of the definition, from Wikipedia:

“‘A grain of salt’ means that a copious measure of skepticism should be applied regarding a claim; that it should not be blindly accepted and believed without any doubt or reservation. According to the Oxford English Dictionary “to take ‘it’ with a grain of salt” means “to accept a thing less than fully”. It dates this usage back to 1647.”

Silverman points out that these drugs generated more than $10 billion in sales last year, and are taken by an estimated 10 million Americans. He suggests that the decision to forego Black Box warnings on the epilepsy medications was “a boon to several drug-makers, notably Pfizer, which sells Lyrica.”

But this observation contradicts the idea that doctors ignore label warnings, which by inference, suggests that warnings don’t affect sales.

What’s needed right now is a serious, in-depth survey of prescribing physicians across the country to ascertain just how effective Black Box labeling actually is, in terms that we can all understand. Maybe then the FDA will make more informed decisions.

Meanwhile, if physicians are indeed taking Black Box warnings with a grain of salt, patients are in even more trouble than I thought.

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Figures from various government and UN agencies, including the DEA and WHO, suggest that illicit sales of controlled drugs is big business on the internet and on the streets of towns and cities around the world. But how much business?

Have you ever wondered where all the prescription-only drugs come from that are being sold on street corners, in school yards, in bars and dance clubs, on the internet, and anywhere else, all over the world, day in and day out? Or what that trade is worth?

I wonder about it, and I can’t find out. No one seems to have a real answer.

According to what I’ve seen in the media, you can go to any city in the world, and easily find someone selling bags and bags of opioids, antidepressants, antipsychotics and stimulants of all kinds.

Where in the world are these drugs coming from?

They couldn’t all be from drug store robberies, never mind prescription bottles swiped from mommy and daddy’s medicine cabinet or scripts stolen from doctors’ offices.

Hi-jacked trucks? Well sure, that would explain some pills — like for a week in one city. It would take hi-jackings every day in every state of the Union and every city in the world to supply all the pushers, wouldn’t it? Wouldn’t we hear about that level of crime?

No, there’s just way too many millions of pills readily available, simply everywhere, that no one seems to know the source of.

I keep having this nagging suspicion that Big Pharma has a special back door next to the loading dock at its factories in those other countries where many of these drugs are actually manufactured. You know, those countries with something less than what we here in America consider ideal law enforcement, human rights and justice systems — countries that State Department brochures caution us Americans about visiting, countries where almost anything that can turn a little extra income is unofficially OK.

Also, we’re told that illicit trade in prescription drugs is a multimillion dollar industry, maybe a multibillion dollar industry. Who knows? There’s no reliable figures.

I have this other nagging suspicion, actually have had it for a long time, that Big Pharma knows exactly how much it’s worth. I fantasize about this top-secret, special section in Big Pharma’s accounting department that tracks, marks down, and accounts for all the ‘lost’ factory production runs, ‘lost’ truck-loads of pills, ‘lost’ plane-loads, boat-loads and bulging rail-car loads of drugs, that simply vanish without a trace and turn up on the streets, back alleys, and shady Internet pharmacy sites all over the world.

Well, these are just nagging suspicions, or my overactive imagination at work. There’s no way they could actually be true.

But I still wonder . . .

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The Senate Finance Committee has looked into funding of academic psychiatry, but now it wants the American Psychiatric Association to reveal all psychiatric funding from Big Pharma.

Antipsychotic and antidepressant medications are pretty much newsworthy any day of the week. That’s usually because someone taking them has either committed a violent crime, has committed suicide, or has just plain up and died — it’s pretty much the nature of the drugs. And meanwhile, Big Pharma and the psychiatrists rake in billions.

No wonder, then, that Rep. Chuck Grassley, ranking Republican on the Senate Finance Committee, is spearheading an investigation into the Niagara of cash flowing into the psychiatric community from Big Pharma. Psych drugs are news, cash-hungry psychs are news, and the news is where politicians like to be, especially in an election year.

But in this case, we’ll ignore any political ambitions, and hope for some real action. We need see an end to Big Pharma’s buckets-of-cash influence on the practice of all medicine in this country, and particularly its grotesque support of psychiatry.

We recently blogged about Grassley’s probe into three Harvard psychiatrists who received nearly $3 million from Big Pharma for “research” and other psychiatrists whose financial ties to pharma cast doubts on clinical judgment or independence of research findings.

Now, says the New York Times in a must-read article for anyone interested in health care costs and the independence of the American health system, Grassley is demanding that the American Psychiatric Association (APA), the shrinks’ professional organization, reveal its own sources of financing.

“I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Mr. Grassley said in a letter to the APA.

Amen, say I.

The Times says that in 2006, the latest year for which numbers are available, Big Pharma accounted for about 30 percent of the association’s $62.5 million in financing. About half of that money went to psych journal drug ads and annual meeting exhibits, the other half sponsoring “fellowships, conferences and industry symposiums at the annual meeting.”

The psychiatry association’s board met behind closed doors this weekend to discuss “how to respond to the increasingly intense scrutiny and questions about conflicts of interest,” the Times said.

Meanwhile, read the APA’s letter to its membership announcing Grassley’s demands, reprinted in Ed Silverman’s Pharmalot blog. APA president Nada Stotland tells members that a work group has already been formed to provide “options for ending pharmaceutical support.”

Now that is something we’d like to see. Big Pharma’s cash should be flowing into research, testing and safety, not into the pockets of academic or practicing doctors.

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Boehringer Ingelheim updated the label for Mirapex in 2005 to warn of impulse control disorders and compulsive behaviors, but it came too late to help this New York man.

There are drugs that are addictive, and drugs to treat addictions. But a former Wall Street banker claims in a suit against the makers and marketers of Mirapex (pramipexole), a drug developed to treat Parkinson’s and now also prescribed for Restless Leg Syndrome (RLS), caused his addiction to gambling.

According to a New York Daily News article, Randolph Simens, a retired executive at Prudential, says he became a compulsive gambler and lost $3 million after he began taking Mirapex for his Parkinson’s.

The man has filed suit in Manhattan Supreme Court against Boehringer Ingelheim and Pfizer, claiming his “pathological” gambling addiction was caused by the drug, and there was no warning from the drug companies that side effects could include compulsive behavior.

The drug makers “had a duty to provide adequate warnings and instruction for Mirapex, to use reasonable care to design a product that is not reasonably dangerous to users, and to adequately test their product,” the lawsuit says.

“It ruined me,” he said. “I became like a robot and I was just pissing away money.”

Simens began taking Mirapex in 2002, after being diagnosed with Parkinson’s. He says he didn’t find out about the compulsive behavior side effect until 2006 by reading an article about a film director who blamed his gambling on Mirapex. But by then he was unable to control his visiting casinos, making risky stock plays, and even raiding his kids’ bank accounts.

The drug makers say the compulsive side effects didn’t surface until long after the drug was on the market, and they acted responsibly. Label changes did come in 2005, an added caveat that reads:

“Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson’s disease and RLS.”

The wording is fascinating — “…while taking medicines, including pramipexole … etc.”, clearly suggesting that all Parkinson’s and RLS drugs cause the side effect.

If that isn’t true, then it’s a lie. And probably an attempt to create wiggle-room for lawsuits like this one.

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A Canadian appeals court has affirmed a lower court’s decision that a patients’ class-action suit can try to recover money Eli Lilly made from Zyprexa sales, rather than just seek damages, a ruling that could set a new precedent in such lawsuits.

The flesh-rending assault on Eli Lilly over side effects from its schizophrenia drug Zyprexa, including weight gain, pancreatitis and diabetes, continues unabated.

Bloomberg News reports that Lilly has lost an appeal to limit potential damages in a class-action lawsuit filed by Canadian patients who claim they developed diabetes as a result of taking Zyprexa. The Canadian appeals court, affirming a lower court decision, says the Indianapolis-based company can be sued for money it earned from sales, rather than the usual damages.

The Canadian plaintiffs initially were seeking C$900 million in damages. But with the new ruling, the sky’s the limit, considering that Zyprexa sales have been averaging multi¬billions a year for more than a decade, last year rising 9 percent to $4.76 billion, about a quarter of Lilly’s total revenue. Presumably, the suit would be limited to Lilly’s Zyprexa sales in Canada, but that aspect wasn’t reported.

This comes in bleak week for Lilly. As previously reported here and everywhere else, Lilly is accused of failing to warn the FDA and consumers that Zyprexa may cause diabetes, pancreatic inflammation, and serious weight gain.

After settling 31,000 US patients’ suits in for $1.2 billion with 1,200 patients still to go, agreeing earlier this year to pay Alaska $15 million to settle a suit there, and waiting for details on a rash of similar suits from numerous other states, this week the company was urged by a federal judge in New Jersey to negotiate settlements with insurers world-wide who are suing the drug maker for improper marketing and overcharging for Zyprexa for as much as $7.7 billion.

Meanwhile, if the Canadian suit proceeds without further appeals, it could change the legal landscape for other liability suits.

A Canadian class-action lawyer told Bloomberg that going after a company’s sales dollars is unprecedented in court. And the Canadian judge who a year ago granted Lilly the right of to appeal the action said such proceedings “have the power to make defendants liable for truly enormous amounts of money. The ramifications of exposure to this type of liability will extend beyond the parties to affect not just the pharmaceutical industry as a whole, but also the securities market.”

The ramifications are huge and potentially crippling. But many feel, and I tend to agree, that if that’s what it takes to get Big Pharma to straighten up and fly right, so be it.

Sometimes it takes a big club to get a mule’s attention.

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Although there may be no way to prove that Children’s Motrin actually caused the rare allergic reaction that blinded a 6-year-old in California, the family’s case seeks to establish whether or not drug maker Johnson & Johnson concealed adverse event risks from the FDA. It also seems unlikely the FDA didn’t know, and cautions should have been put in place much earlier.

This is another one of those tip-of-the-iceberg stories that tell us just how risky Big Pharma’s products can be, and how often too little is done about it, too late.

A California family named Johnson is suing Johnson & Johnson (J&J) for allegedly hiding evidence that its Children’s Motrin could cause Stevens-Johnson Syndrome (SJS), an extremely rare — 1 in 100,000 — allergic condition that resulted in the permanent blindness of their 6-year-old daughter, Sabrina Johnson.

Yes, I know, there are way too many Johnsons in this story. I’ll do my best to keep things as straight as possible. Just keep in mind that all the separate Johnsons have nothing to do with each other, other than commonality of name.

Sabrina Johnson, now 11, went blind in 2003 at the age of 6, after suffering a crippling attack of SJS after being given just three doses of Children’s Motrin for a mild fever. Motrin contains ibuprofen, and is marketed by the Johnson & Johnson subsidiary, McNeil Consumer Products.

At the ongoing trial in Malibu, the family’s lawyer told the jury that “. . . the FDA is only as good as the information they got, and the drug companies are responsible for giving them that information.” The contention is that J&J had information about the risk of SJS and did not report it to the FDA and did not ensure that warnings of the risk were on the label.

Backing up the family’s claim about no label warnings, a former McNeil medical director testified that the company knew that as many as 20 people had been blinded, killed or seriously injured by Children’s Motrin between the time it was put on the OTC market in the 1990s and when Sabrina became ill in 2003.

The exec said he was also aware that more than 40 more cases of Stevens-Johnson Syndrome had occurred in the years since doctors at Cedars-Sinai Medical Center first told the Johnson family that Motrin had caused Sabrina’s near-death and continued terrible pain.

He added that the company also did not add label warnings after an extensive clinical trial found that it could cause a severe allergic shock — similar to a violent bee sting reaction — in more than 5 out of every 100,000 children given the drug.

A J&J lawyer said that SJS can be caused by dozens of drugs, and there is no proof that it was J&J’s ibuprofen that harmed the girl. He said the FDA was well aware of the risk of SJS from ibuprofen. It is a medical fact the at least 50 percent of known SJS cases are drug-related reactions, and the rest may have viral or bacterial origins.

“The proof is . . . that the FDA was aware of the very-rare reports of people getting Stevens-Johnson Syndrome,” he said, “and the FDA continued to approve its use as safe and effective for children, and continues to approve it today.”

Label warnings were finally altered in 2005, after doctors petitioned the FDA to add tougher language. But descriptions of SJS symptoms were added to Children’s Motrin sold via prescription, but not the same drug sold over-the-counter, he said.

Whether or not J&J and McNeil reported the risks to the FDA, the agency must have received adverse event reports long before Sabrina was injured, and doctors at the agency had to know about the potential problems with ibuprofen. It had been hurting people for more than a decade.

It all just sounds fishy to me, just another tragic example of the horrendous lack of safety measures that continue to plague patients around the world. Until evidence is presented that changes my mind, I hold both J&J and the FDA culpable.

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Since last September, FDA has posted more than 80 short public information videos about drug safety and other issues on YouTube. The trouble is, nobody knows they’re there. But it’s an idea that holds promise, and even Big Pharma could emulate it to begin recovering its tarnished public image.

In Eye On FDA, blogger Mark Senak suggests that Big Pharma ought to follow the example of the FDA’s new YouTube public information videos, and start communicating with the public.

On its main YouTube page, the FDA has posted 70 videos since last September, and on a second YouTube page has posted nearly a dozen more, with information about the safety and usage of specific drugs and medical devices, offering data of interest to physicians as well as patients.

The videos are professionally produced are in understandable layman’s language, and clearly spell out the intended messages.

Senak says “Good job FDA!”

Well it’s at least a start. The problem is that few people know these videos exist.

Take, for example, a recent video warning that women aged 15-44 who use the Ortho Evra birth control patch are at higher risk of developing thromboembolism — blood clots in their veins — than women using birth control pills. This is serious information about a serious problem affecting millions of women.

How many people have viewed this video on YouTube? Twenty-seven — and that includes me. Most of the rest were probably people at the FDA checking out their new vid.

Compare this to a YouTube vid from something called “The National Hot Dog Sausage Council”, offering “dos and don’ts of hot dog etiquette”. It’s been viewed 188,000 times. Another video on safely handling fireworks has over 160,000 views. Others, from mashing cell phones in blenders to fake cell phone holograms have been viewed millions upon millions of times.

You have to ask, does the FDA actually want anyone to see these videos?

Online video, to go viral with big viewership, has everything to do with what the audience cares about, is already talking about, or at least is thinking about. Or in a single stroke of genius, offers a new idea that becomes the next big thing.

Tens of millions of people are already thinking and talking about the benefits versus the dangers of pharmaceuticals. And they’re wondering what the FDA is doing to protect them.

The agency should hire online video marketing specialists to revamp scripting and production values for the FDA’s dry talking-heads videos, and run a media publicity campaign to tap into these existing millions. Our “tax dollars at work” would really be working then.

Senak says: “It is rare to see a government agency move ahead of industry in embracing and utilizing communications, but in this case, that is what is happening. Wake up pharma.”

Well, as for Big Pharma jumping into the online video fray to tell its story, let’s face it: this is a challenge and a half. Big Pharma has good stories to tell, and should tell them. But the bad ones — the horror stories — can and must be presented and explained, but only in a straight-from-the-shoulder manner, no PR spin, no corporate double-speak. Only the naked truth will do.

I somehow doubt that Big Pharma has the depth, the guts, or even the simple desire to clean up its act, to really come clean to the public.

But if it was done, and done honestly and right, it could mark the beginning of a massive, much-needed turnaround in public opinion.

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