Our Views

Marketing drugs for non-approved uses is standard operating procedure for Big Pharma, and the law suits, fines and multi-million-dollar settlements are apparently just a ‘cost of doing business’.

An Associated Press article analyzing the recent report from the Government Accountability Office on off-label drug marketing by pharmaceutical companies points out the serious lack of resources at the FDA to police such activity.

“When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot,” the AP story says. “When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning . . . [and] typically takes four more months for the company to fix the problem. During that time, a lot of prescriptions can be written.”

The FDA is “ill-equipped to catch even blatant marketing abuses by drug companies,” the AP story continues. No staff are assigned to monitor drug marketing for unapproved uses. Instead, less than 3-dozen people — 44 employees — who oversee print and television advertising, are expected to do the job. Last year alone, they had to analyze 68,000 ads — not much time for the complex investigation it requires to monitor all drug marketing to the medical profession. Drug marketing is not all advertising, but includes scientific papers, events, conventions, personal visits to doctors’ offices, and other avenues of communication. The GAO report found that the agency lacks even a system for tracking all the material it receives.

Sen. Charles Grassley, R-Iowa, who spearheaded the GAO audit, says federal programs like Medicare and Medicaid pay billions for questionable prescriptions, all the while lining Big Pharma’s pockets.

The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Of course, doctors are legally allowed to use their own judgment prescribing drugs. And new guidance proposed by the FDA would allow drug companies to tell doctors about scientific articles that suggest unapproved uses for medications.

But it is still illegal for drug companies to promote uses not validated by the FDA based on clinical trials. And a 2006 study suggests that more than 20 percent of prescriptions are off-label — little more than an uncontrolled experiment using patients as guinea pigs.
While some patients benefit, others do not, and some are even injured or killed by side effects from prescriptions that should never have been written.

Bristol-Myers Squibb’s $515 million settlement last year for “alleged” infractions, including fraudulently promoting Abilify for dementia-related psychosis and children, is being distributed among a couple of dozen states as well as federal agencies. And that’s just the tip of the off-label marketing iceberg.

The same kinds of suits involving other Big Pharma players have been in the news for years. Unless the FDA gets its act together and staffs up a dedicated team, the fraud, the injuries, and the deaths, will just continue.

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There’s some restless rumblings in the media, the pharma marketplace and the blogosphere, about injecting new life into the increasingly limp sales of Pfizer’s Viagra to address the sexual side effects of anti-depressants.

Pfizer denies any interest in seeking a new usage approval for Viagra to counteract the libido-squashing side effects of SSRI anti-depressants in women.

But the world’s largest drug company did pay for a recent research project on that subject by long-time psych-drug consultant, Dr. H. George Nurnberg, of the Department of Psychiatry, University of New Mexico School of Medicine.

As an aside, in his Pharma Marketing blog on this subject, John Mack reveals that Dr. Nurnberg has served as a consultant to Pfizer, Eli Lilly, SmithKline, Bristol-Myers, and Glaxo; has received grant/research support from Pfizer, Eli Lilly, SmithKline, Bristol-Myers, Abbott, Lipha, Johnson & Johnson, Parke-Davis, and Wyeth; and has served on the speakers bureau for Pfizer, Eli Lilly, SmithKline, Bristol-Myers, Abbott, Glaxo, and Wyeth. And Dr. Nurnberg already has published papers on related Pfizer-funded research on the use of Viagra for antidepressant-associated erectile dysfunction.

Jim Edwards, in his blog on the SSRI effect on libido, says: “According to Scientific American, close to 10% of Americans are on antidepressants. Let’s make it easy and say that’s 30 million of 300 million . . .. Of those, possibly 23 million are walking around in a state of sexual frustration. And they have partners — so that’s somewhere in the neighborhood of a possible 46 million of us who are inexplicably tetchy and bad tempered on most days.”

Well, really, really bad-tempered sounds a bit more like it, for those on the SSRIs. These are the folks that break out their 12-guage and a couple of 9mm handguns and shoot up the local Wal-Mart or schoolyard. And you can bet that it’s not because they don’t feel sexy enough. But that’s a whole other subject.

John Mack expands on marketing Viagra for women: “Of that 46 million, I’d hazard a guess that 70% or 32 million are women. This is potentially a tremendously huge new market for Viagra … !”

OK, there’s a huge untapped market, but I’m a bit confused. At the About.com page on the symptoms of depression, the top two are pretty much what I would have expected:

1. Depressed Mood
A person may report feeling “sad” or “empty” or may cry frequently. Children and adolescents may exhibit irritability.

2. Decreased Interest or Pleasure
A person may show markedly diminished interest or pleasure in all, or almost all, daily activities.

Well, there it is in black and white, a good description of most of the people I know, if you catch them on the wrong day.

But if I was a modern American physician, I’d whip off a quick prescription for Zoloft, Paxil, Luvox, Prozac, Lexapro, or any other SSRI anti-depressant, and call for the next miserable patient in the waiting room, my prescription pad at the ready.

And oh, how the money would roll in.

But back to anti-depressants and sex.

First off, nobody ever feels sexy when they’re “depressed”. But nobody.

But with an anti-depressant coursing through their fevered brains, according to the literature, they’re miraculously no longer depressed.

But they still don’t feel sexy! The literature explains why: depressed libido is a side effect. Wow, now that is depressing all over again!

But wait! A couple of other side effects of anti-depressants are nymphomania and erotomania. Go figure. I guess sufferers of these side-effects are the lucky ones.

Meanwhile, most depressed people I’ve met are depressed because they aren’t “getting any” — at least not from anyone they’re actually interested in.

I know, that’s shallow.

But it’s amazing how many depressed people get rapidly un-depressed when they meet a new person who can rattle their hormones. Or even better, rattle them in a more spiritual way — such as listening to them and communicating with them — and help free them from their feelings of uselessness and entrapment in an unfulfilling life.

Meanwhile, it’s probably inevitable that some millions of the tens of millions of American women on SSRIs will soon be popping Viagra or something like it to counteract the depressing anti-libido side effects of anti-depressants. Big Pharma marketers will make sure of that.

And oh, how the money will roll in.

But you can bet we’re never going to see a drug that counteracts the serious side effects of anti-depressants — violence, mania, suicides, mass murder, obsessive sex with school children, and many other gruesome results of SSRI consumption — the kinds of side effects for which Big Pharma has already paid out billions of dollars settling law suits.

That just shows where Big Pharma’s priorities are. And how Americans — including our physicians — have bought the big psych-drug lie, and will pop yet another pill. Not to stop the killing and violence. Just to feel sexy.

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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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‘Double-dose’ pills and allegations of fake drug data dramatically illustrate the lack of effective inspection, testing and control of generic drugs being prescribed across America.

Tom Lamb at DrugInjuryWatch describes in detail the need for the FDA to improve the safety of generic drugs, following recalls of two generics carelessly marketed in double the labeled dosage by pharmaceutical companies Actavis Totowa and ETHEX Corporation, and the ongoing federal investigation of Indian pharmaceutical giant Ranbaxy Laboratories for alleged fraud.

The Ranbaxy issue is potentially huge. The company, with annual sales of $1.6 billion from pharma factories in 11 locations around the world, provides many generics distributed here. According to a story in the New Jersey Star-Ledger, federal prosecutors allege a “pattern of systemic fraudulent conduct” by Ranbaxy, including the fabrication of test data at a plant in northern India and the destruction of documents in an attempt to conceal the ruse from FDA inspectors. One generic mentioned was its generic version of Zocor, Merck’s blockbuster cholesterol med.

In April, Actavis Totowa, the U.S. headquarters of the Icelandic generic drug maker, recalled Digitek, a digitalis heart medication, because it contained “twice the active ingredient.” And in June, ETHEX Corporation recalled numerous lots of morphine sulfate 60 mg and 30 mg extended release tablets, containing as much as twice the labeled morphine sulfate.

No explanations from the FDA as to how the ‘double-dose’ pills reached the market, or how Ranbaxy got away with so much for so long.

The FDA is on the job, but effective inspection before drugs reach the market would have prevented these issues. More and more generics are replacing familiar brand names, and many, maybe most of them, are sourced overseas. When the risks are debilitating or permanent injury or even death, acting after the fact is way too little, too late.

Popularity: 64% [?]

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.

Popularity: 56% [?]

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 . . .

Popularity: 48% [?]

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.

Popularity: 52% [?]

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.

Popularity: 48% [?]