Cartoon Zyprexa bottle with a baby whistleblower

How Big Pharm profited by mismarketing a drug.

In January of 2009, Eli Lilly settled a case with the Department of Justice (DOJ) for 1.415 billion dollars, for improper off-label promotion of Zyprexa, a drug approved for treatment of schizophrenia and bipolar disorder. This is the fourth largest pharmaceutical company settlement with the DOJ in US history. The criminal charge notes, in part:

In September 1999, Eli Lilly began encouraging doctors to prescribe the drug for the treatment of dementia, Alzheimer’s, agitation, aggression, hostility, depression, and generalized sleep disorder. Zyprexa was not approved for use for any of these disorders, which, unlike schizophrenia, are prevalent in the elderly population. Nevertheless, Eli Lilly’s long-term care sales force promoted the use of Zyprexa in elderly populations for these symptoms.

While Eli Lilly had little choice but to pay up for its fraudulent marketing practices, lest it lose its Medicare/Medicaid business, Forbes reports just last month that nursing home patients are still receiving “dangerous antipsychotic drugs.” The manufacturer’s package insert for Zyprexa contains a black box warning that states, “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”

Lilly was aware from the beginning that its schizophrenia ‘molecule’ was not going to generate the revenue of Prozac, which would soon come off-patent. Rather than marketing Zyprexa honestly, it played to the drug’s side effect of chemical restraint. When chemical restraint meets the free market, the result is an Eighth Amendment violation that, although rationalized or otherwise couched in other terms is no different than chaining a person.

At the same time the company improperly encouraged off-label uses, it willfully downplayed voiced physician concern and study findings indicating side effects of weight gain and diabetes in patients receiving olanzapine (Zyprexa) therapy for approved use. As a whistleblower summed, “If you torture the data long enough, it’ll tell you anything you want to hear.” This practice is, to use Eli Lilly’s own internal email communication-come-court-document, “a small price to pay for the molecule.”

Ben Wallace-Wells, writing for Rolling Stone, penned an exceptional investigative journalistic article on the history and development of Zyprexa, in a piece titled Bitter Pill. He writes:

On January 15th, Lilly agreed to pay an additional $1.4 billion to settle federal charges of illegal marketing — a record settlement in a corporate whistle-blower case.

But the penalties pale in comparison to the money that Zyprexa makes for the company. In 2007, the latest year for which figures are available, the drug generated $4.78 billion in sales, accounting for 25 percent of Lilly’s total revenues. As Rosenheck reviewed the marketing history of the atypicals, he concluded that misleading data told only part of the story. ‘How did this happen?’ he wondered. ‘How did this product that’s not very advantageous wind up being marketed as a great advance?’ Part of the underlying cause, he concluded, lay in the privatization that began with the Reagan revolution. ‘Ultimately, the conservative turn — with its faith in deregulation and the virtual infallibility of markets — are at the root of what allowed this to happen,’ he says.

The 1.4 billion figure was the largest settlement at that time. Now, it is in fourth position. To be clear, no Big Pharma executives, who slither around making decisions that harm and even kill people are ever being prosecuted. These fines are occasional, set aside, and a cost of doing business and nothing more. There are no criminal consequences when laws don’t apply to certain people who are corrupt racketeering diabolical ‘just making business decisions.’ Anything goes for the One Percent.

Just last year, Eli Lilly got busted en flagrante delicto, by the Securities and Exchange Commission (SEC), which alleged, using a modicum of linguistic decency (in its press release), that the company had engaged in improper “marketing agreements,” in Russia, Brazil, China and Poland. The laundry list of SEC allegations (relating to drugs other than Zyprexa) makes one wonder what Eli Lilly didn’t actually do, but given that they shelled out a total payment of $29,398,734 without admitting any wrongdoing, one can easily surmise that they failed to pay their hookers as well. The SEC complaint press release spells out, in no uncertain terms, after all, the fake-ass offshore accounts, the spa treatments, the cash, the jewelry.

On page 7 of the actual SEC 20-page gory complaint that details business methods so sleazy it makes you want to pass out, you will find that reimbursements from falsified expense reports were used for physician-customer “visits to bath houses,” in China, “among other things.”

‘It’s a small price to pay, for The Molecule’ pretty much sums up the situation going on today with Big Pharma behaving like animals. This is a case study for predatory capitalism, where ponzi schemes and crimes have the green light with a pitch man at the helm, while the whistleblowers and the mentally ill and the poor populate our massive prison industrial complex. When regulatory oversight is all but gutted, allowing the genius of the ‘free market’ to decide, Big Pharma exhibits competence in marketing methods that are surreal and downright criminal.

Because many of these patients receive publicly funded health insurance, the government is in effect, in criminal partnership with the veneer of transparency and regulation but the reality of la mordida. Settlement fines? Get real. It’s ass backwards to vilify our truth tellers while protecting our liars. Our last hope, the ‘third rail’ that could possibly unravel this whole thing is this simple: our whistleblowers, and the internet, getting the truth in front of the passing public.

Related:

In re INJUNCTION: “No newspaper or website is directed to do anything or to refrain from doing anything. See Parts IV.F, IV.H.4, and IV.H.7, infra. No person is enjoined from expressing an opinion or speaking or writing about the documents. See Part VII, infra.”

A Bitter Pill
“Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza”

Better strategies to treat dementia

Securities and Exchange Commission v. Eli Lilly and Company, Civil Action No. 1:12-cv-02045 (D.D.C.)
The Press Release

U.S. SECURITIES AND EXCHANGE COMMISSION, :
Plaintiff, Civil Action No. —
v. COMPLAINT
ELI LILLY AND COMPANY,

note: The SEC complaint has to do with Eli Lilly business practices pertaining to drugs other than Zyprexa. pdf document.

State Lawsuits – Atypical Antipsychotics

Giant number of Zyprexa document links here, detailing through court documents and other sources, how, for example, the story made its way to the New York Times.

Image released under a Creative Commons license by Electronic Frontier Foundation.