Medical Detox Programs in a stress-free environment

July 1, 2009

Unsealed Documents Reveal More Unethical Marketing By Lilly

Filed under: Big Pharma, Eli Lilly, FDA, Zyprexa — Rod Malcolm @ 9:46 am

No matter how many lawsuits against Big Pharma we’ve seen in recent years, there doesn’t seem to be any end to them in sight. Ely Lilly, the biggest maker and pusher of psychiatric drugs, is currently under the gun from health insurers alleging massive overpayments due to the company’s illegal marketing practices.

Over the past month or two, Bloomberg News has been pretty much scooping everyone else on the grisly details surrounding the gigantic overpayment lawsuit filed by health insurers against Ely Lilly, for its unethical marketing practices of its antipsychotic drug Zyprexa.

The insurers contend that Lilly should pay as much as $6.8 billion in damages for downplaying Zyprexa’s health risks, and for illegally marketing it off-label to increase profits.

So far, about 10,000 pages of internal Lilly documents have been unsealed as part of the suit, and Bloomberg’s reporters have been sifting through them in great detail.

Bloomberg has found documents fully supporting the charge that Lilly brazenly and illegally marketed its antipsychotic Zyprexa off-label for dementia, knowing full well that the drug did nothing to help the condition, and in fact was actually killing elderly patients.

Lilly has already settled with the feds and more than 30 states, pleading guilty to a criminal misdemeanor in January, over the off-label marketing of Zyprexa for use in the elderly. But these new documents remove any vestige of doubt that the company was culpable.

The documents also reveal that a subsidiary of CVS Caremark Corp., the largest U.S. drug-store chain, used its extensive access to health care providers to market Zyprexa directly to mental health prescribers — and was paid for that by Lilly — all while simultaneously under contract to bargain with Lilly on behalf of health insurers.

That’s really got the health insurers up in arms.

In an April 30 filing, Lilly said it had settled suits involving about 32,670 individual claimants alleging damages from Zyprexa, including serious weight gain and diabetes. Some 140 claims are still unsettled, but Lilly has already paid out about $1.2 billion for the individual settlements.

Whether all the suits in recent years brought against Big Pharma by patients alleging damage, by irate insurers alleging overpayment, or by state and federal governments alleging both overpayment and various civil and criminal misconducts, the suits reveal that almost all the time the charges were well-founded.

And now, along with Big Pharma, we can no longer trust our corner drug stores. Our  friendly pharmacist is now involved, however indirectly, in the endless litany of crimes against humanity that have permanently sullied Big Pharma’s reputation.

There are two things we must keep in mind if we are ever going to see real changes.

First, Big Pharma’s callous disregard for patient welfare, placing profit ahead of all else, is endemic in the industry. This fact should be trumpeted long and loud.

Second, people were killed outright by Zyprexa. The same is true for many other drugs from numerous drugmakers. Yet Lilly pleaded guilty to a “criminal misdemeanor”, and no drugmaker has spent a single day in prison for murder or manslaughter.

The problem is this: If a drug company is found guilty of a felony, the law states that they can’t do business with the federal government — so the enormous Medicare and Medicaid market is lost, meaning they are essentially out of business. However, if all Big Pharma has to do is pay a fine when they’re caught, like Purdue Pharma was over the OxyContin debacle, then it becomes just a “cost of doing business.”

But slaps on the wrist will never bring about the reform in Big Pharma that is so urgently needed. For a serious discussion of the thorny situation surrounding Big Pharma crimes, and specifically OxyContin and the FDA, please read Different Justice For A Drug Dealer, by Novus Detox director Steven Hayes.

February 24, 2009

Pfizer Follows Lilly, Merck and GSK Into The Sunshine

The Grassley-Kohl Physicians Payments Sunshine Act is not yet through Congress, but Big Pharma is jumping the gun with some transparency promises, perhaps hoping to head off the Act’s more stringent requirements.

Pfizer has announced it will start reporting financial contributions to doctors beginning in July this year. Payments for clinical trials, speeches, consulting, gifts and meals will be posted on the company’s Web site starting early next year.

Pfizer pledged to disclose payments that total more than $500 yearly, including non-monetary items whose value exceeds $25. The new Physician Payments Sunshine Act of 2009, sponsored by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI), requires pharma and biotech companies to report all payments over $100. Those that failed to comply would incur a $1 million dollar fine.

Last year Lilly, Merck, and GlaxoSmithKline also announced that they would begin reporting payments and honoraria to physicians, each with its own idea of what it is willing to divulge.

It looks like Pfizer is taking its cue from a similar transparency bill that failed to get Congressional approval back in 2007. It required a $500 reporting requirement.

According to a report at PharmaExec, Dr. Ted Epperly, president of the American Academy of Family Physicians, said the new version of the Act approaches micromanagement.

“It’s a bit regressive. It goes backwards instead of forwards in terms of reporting requirements,” said Epperly. “We agree that we ought to have transparency, openness and honesty on this, [but] there can be a point where it just crosses the line of being too burdensome.”

I can’t help wondering what Epperly is really going on about. Family physicians certainly won’t suffer any inconvenience from the Sunshine Act. Could it be that they might not get as many free lunches and pens?

And meanwhile, any micromanaging is going to be taking place over at Big Pharma’s and Biotech’s house, not the family doctor’s office.

Big Pharma won’t have a choice, says the PharmaExec report, if the bill is pushed through. With the state of the economy, and the new Obama administration promoting transparency in big business, the new Sunshine Act could gain more momentum this time.

Let’s face it. Big Pharma is jumping on the bandwagon early to dazzle Congress and head off passage of the new bill, which has more stringent requirements. The theory goes that if enough congressmen get the wacky idea that Big Pharma is willing to ‘self-police’, they’ll nix the Act and it will die like the 2007 bill.

I hope the Act makes it through Congress unscathed, and that Pfizer and the rest of Big Pharma and Biotech are made to hew to it exactly.

We all know how ethically Big Pharma plays when left unwatched in the sandbox.

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February 17, 2009

Ely Lilly CEO Was Paid $13 Million Last Year — A 39% Pay Increase

While the company’s stock price tanked and product liability suits flourished, Lilly’s top executives were rewarded with a total of $48 million compensation in 2008.

The Indianapolis Star reports that Ely Lilly’s new CEO John Lechleiter was paid $13 million last year, a 39 percent increase from 2007, according to a regulatory filing.

Lechleiter, 55, became chief executive in April and added the title of chairman last month, replaced outgoing CEO Sidney Taurel, now chairman emeritus. Taurel received a $40-million retirement package for his years of service.

FiercePharma says Lilly’s board gave Lechleiter credit for snatching ImClone Systems out from under Bristol-Myers Squibb’s nose in a $6.3 billion buyout last year, and praised him for the company’s 9 percent sales growth to $18.6 billion, although Lilly posted a $2.07 billion loss for the year largely due to the ImClone acquisition.

Here’s the rundown on Lilly’s compensation, comparing 2008 to 2007:

Eli Lilly’s 2008 proxy statement

You might or might not recall that it was an internal email from Lechleiter to his underlings several years ago, urging them to push off-label uses for Zyprexa, that added to the legal flames during the State of Alaska’s lawsuit against Lilly seeking reimbursement for medical costs of Medicaid patients who developed diabetes while taking the schizophrenia drug for off- and on-label uses. As reported in the New York Times last year, Lechleiter noted to other Lilly officials that company representatives were already promoting Strattera, another Lilly psych drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, to encourage the use of Zyprexa by children and teenagers, he said.

Ahhh, we live in interesting times.

You might also recall ImClone from the media-madness of a few years ago when fashionista-homemaker-media-maven Martha Stewart went to jail for lying to the feds about dumping her ImClone stock on the insider-advice of the company’s founder Sam Waksal, who was convinced that because of the FDA’s problems with ImClone’s cancer drug Erbitux that stock prices would tank. Oh yeah, and Waksal had also been dating Stewart’s radio-host-personality daughter Alexis, nearly 20 years his junior.

Anyway, Waksal wound up in the slammer too, for insider trading, but he also pleaded guilty to charges of securities fraud, bank fraud, obstruction of justice, perjury, conspiracy and wire fraud. Waksal became a free man just this month, but as Mike Huckman at CNBC reports, it’s ironical poetic justice that the ImClone’s cancer drug — and the company’s development pipeline — turned out to be so good, and so promising, that Lilly stepped up with the $6.3 billion buyout of ImClone in a bidding war with Bristol-Myers Squibb — long after Waksal was history at his own company.

These are the kinds of things that make Big Pharma, well, ‘Big Pharma’. Remember when doctors and their wondrous ‘miracle drugs’ were there just to help? Was it all just a dream?

January 16, 2009

Lilly’s $1.4-plus Billion Zyprexa Settlement Falls Short Of True Justice

It’s time the Justice Department started jailing criminal Big Pharma executives and send a stronger message to an industry long on cash but utterly devoid of ethics.

Who’s protecting Big Pharma from really paying for its crimes?

Admitting that its marketing of the antipsychotic Zyprexa was illegal in a civil and criminal settlement, Ely Lilly will pay nearly $1.42 billion in fines, including a $515-million criminal settlement, “the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution”, according to the Justice Department.

A CNN report says Lilly will pay up to $800 million in a civil settlement with the federal government and the states, and forfeit $100 million in assets for fines and penalties totaling $1.415 billion.

These hefty fines make it sound like the DOJ lowered the hammer on Lilly, right?

I’d have to say, Wrong.

Zyprexa sales topped $4.76 billion in just 2007 alone. That’s been going on for years with little change. And after announcing personal injury settlements of nearly $700 million in 2005, Lilly just raised the price and continued its off-label push.

The fines are far from what should be the results of an admitted criminal conspiracy that not only cost the health care system a billion dollars, but also sickened thousands of unsuspecting people, shortening their lives or outright killing them.

In any other industry, executive ringleaders of criminal actions are put on trial and receive massive personal fines and lengthy prison terms. Just swindling others out of money, with no loss of life or personal injury to others, routinely means jail time for crooked financial consultants.

The Eli Lilly execs who ran the Zyprexa scam should not only receive personal fines and jail time, they should be on trial for aggravated assault causing bodily harm, if not manslaughter, or even murder. And the same goes for all Big Pharma executives who have conspired to market drugs causing injury, illness and death.

But case after case involving drug-related injuries and deaths due to unethical marketing or withheld or doctored clinical test results are being treated in the courts like bloated multimillion-dollar speeding tickets, instead of rightly prosecuting them the same as we prosecute criminal reckless driving resulting in injury or death with jail time.

For example, the personal fines levied against three Purdue execs in 2007 for their role in misleading the public about the dangers of OxyContin was a tap on the wrist — chump change, and no jail time. One reckless driver killing one single person puts that driver in jail. Yet hundreds of deaths and thousands upon thousands of ruined lives lie in the wake of OxyContin.

So we have to ask: Who’s protecting Big Pharma?

It’s got to be all about the money. It always is.

In all the cases against Big Pharma, over the past two decades or more, none of the agencies — DOJ, FBI, SEC, FTC, etc. etc. — has ever publicly revealed the Big Pharma money trail, or even admitted trying to follow it.

To me, that’s a sure sign that Big Pharma millions are finding their way into the pockets of power brokers in Washington, the ones who pull the strings at the DOJ and all the other agencies mandated to protect Americans from criminals.

October 7, 2008

Another Top Psychiatrist Fails To Report Millions In Big Pharma Payments

Our financial transparency system for drug and device maker payments to medical consultants isn’t working, and universities are all but incapable of policing their faculty’s conflicts of interests.

A New York Times article reports this week that the ongoing Congressional inquiry into financial conflict-of-interest disclosures has revealed another influential psychiatrist violated federal research rules by failing to report income from Big Pharma.

Dr. Charles B. Nemeroff of Emory University, the Times reports, is “the most prominent example to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.”

Dr. Nemeroff earned more than $2.8 million in consulting arrangements with drug makers between 2000 and 2007, and violated federal research rules by not reporting at least $1.2 million of it to his university, according to documents provided to the Congressional investigation being spearheaded by Sen. Charles R. Grassley, Republican of Iowa.

“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Sen. Grassley said. “The current system for tracking financial relationships isn’t working.”

In one “telling example”, the Times reports, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than the federal legal limit of $10,000 a year from GlaxoSmithKline. “But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from the British drug giant — 17 times the figure he had agreed on,” says the Times.

The findings, says the Times, suggest that universities are all but incapable of policing their faculty’s conflicts of interests. Almost every major medical school and medical society is now reassessing its relationships with drug and device makers.

Not An Isolated Problem

Dr. Nemeroff isn’t the first psychiatrist the inquiry has found coming up short on financial conflict-of-interest disclosures to their institutions.

Last spring, Sen. Grassley began his investigation by questioning Dr. Melissa P. DelBello of the University of Cincinnati after the Times questioned her connections to drug makers. Although Dr. DelBello reported that she earned about $100,000 from 2005 to 2007 from eight drug makers, Sen. Grassley discovered that AstraZeneca alone paid her $238,000 during the period.

In earlier blogs, we reported on several prominent Harvard psychs, and Sen. Grassley’s growing interest in how much money from Big Pharma is flowing into the American Psychiatric Association itself. The senator also looked closely at Dr. Alan F. Schatzberg of Stanford, the APA’s president-elect, because of his $4.8 million in stock holdings in a drug development company.

Sen. Grassley is pushing the “Physician Payment Sunshine Act” that would require drug and device companies to publicly list payments made to doctors that exceed $500. Several states have already legislated similar requirements, and revelations from the Congressional investigation appear to be motivating some motion in the industry itself. Big Pharma’s trade organizations and some medical colleges say they support the Sunshine bill, and Eli Lilly and Merck announced they will publicly list doctor payments next year even without the legislation.

September 9, 2008

Judge Unseals Damning Zyprexa Documents “In Public Interest”

“Lilly’s legitimate interest in confidentiality does not outweigh the public interest in disclosure,” writes the federal judge in the Zyprexa class action case.

The New York Times reports that Judge Jack B. Weinstein of Federal District Court has unsealed confidential materials about Eli Lilly’s top-selling antipsychotic drug Zyprexa, citing “the health of hundreds of thousands of people” and “fundamental questions” about the way drugs are approved for new uses.

The judge’s decision is part of a ruling granting class-action status to a case seeking billions of dollars from Lilly by insurance companies, pension funds and unions. They contend Lilly hid Zyprexa’s side effects and marketed it for unapproved uses.

The confidential documents were placed under a protective court order shortly after Lilly provided them in a related suit by patients claiming that Zyprexa caused excessive weight gain and diabetes. In lifting the order, Judge Weinstein said Lilly’s “legitimate interest in confidentiality does not outweigh the public interest in disclosure at this stage.”

A Lilly spokesperson said the company will not appeal the decision but will appeal the certification of class action.

The issue of confidentiality arose in 2006 after the “Zyprexa papers” were secretly provided to a reporter for the Times, which ran front page articles based their contents, revealing evidence that Lilly executives suppressed the side effects.

Lilly has denied withholding the information, saying the documents were “cherry-picked” to give a biased view.

The developing situation with Lilly and Zyprexa highlights yet again how Big Pharma’s aggressive marketing practices are turning around to bite their creators in the two spots where it hurts most, the pocketbook, and public opinion.

But far more relevant to Americans, and far more serious, are the “fundamental questions” Judge Weinstein raised about how drugs are approved for new uses. The American public, health care providers and the health care industry have been clamoring for answers to these questions for over a decade.

The FDA needs to confront the issues surrounding the management of drug safety and deal with them right now, before some other new drug threatens “the health of hundreds of thousands people”.

And if the agency continues to foot-drag, play politics, and dramatize its schizophrenic relationship with Big Pharma, no less than Congress should step in and demand a complete overhaul of a system that is so flawed, in fact so barbaric, that Americans have to resort to courts of law — after the fact — to protest, and to seek compensation, for millions of injuries and deaths that could have been prevented.

July 28, 2008

Viagra: The New Ladies’ Home Companion Pill?

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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