Pioneered supplements with Stilbosol

Eli Lilly Stilbosol’s 1957 add in the FFA National Future Farmer

stilbosol-1957
Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
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An experienced cattle feeder from Illinois ran his own Stilbosol test

Eli Lilly Stilbosol’s 1955 add in the FFA National Future Farmer

Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
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Stilbosol now helps fatten 38% of nation’s cattle

Eli Lilly Stilbosol’s first add in the FFA National Future Farmer

Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
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DiEthylStilbestrol glass prescription bottles from 1963

DES glass prescription bottles from 1963 manufactured by Eli Lilly & Co, Indianapolis, USA

diethylstilbestrol
Diethylstilbestrol glass prescription bottles from 1963 manufactured by Eli Lilly & Co, Indianapolis, USA.

DES was sold under many names including Distilbène®, Stilbetin®, Stilboestrol-Borne®, Benzestrol®, Chlorotrianisene®, Estrobene® and Estrosyn® to name just a few.

Many different companies manufactured and marketed this drug under more than 200 different brand names.

These DiEthylStilbestrol prescription glass bottles from 1963 – 1000, 500 and 100 tablets of 25 mg – were manufactured by: Eli Lilly & Co, Indianapolis, USA.

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Not all good things need be costly…

The Diethylstilbestrol drugs were very cheap to produce

DES-advert-Lilly image
In the 1950’s and 1960’s, doctors were the target for most drug advertising campaigns including DES.

Inexpensive oral doses of Diethylstilbestrol, …”
mmm looks like they just forgot to mention the terrible multiple multi-generationnal side effects…

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DiEthylStilbestrol Tablets, U.S.P. by Lilly

DES pills manufactured by Eli Lilly & Co, Indianapolis, USA

DiEthylStilbestrol-Tablets image
Watch our DES drugs album on Flickr. Image source: DES Action USA on Facebook.
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Why off-label marketing is irresistible to Big Pharma

If off-label marketing is ‘speech,’ why even have the FDA?

This post content is written by Martha Rosenberg and published by Reporting on Health, a nonprofit, nonpartisan and educational offering resources & community for journalists covering health

off-label-marketing
It has always been legal for U.S. doctors to prescribe drugs for off-label uses but marketing of off-label uses has been illegal. Image via pharmamkting.blogspot.

It has always been legal for U.S. doctors to prescribe drugs for off-label uses but marketing of off-label uses has been illegal. In August, U.S. District Judge Paul A. Engelmayer ruled that the First Amendment allows a drug company to “engage in truthful and non-misleading speech promoting the off-label use” of drugs and that the FDA cannot bar such “speech.” The ruling, pertaining to the drug Amarin, which targets high triglyceride levels, is likely to be appealed and only applies to the 2nd U.S. Circuit Court of Appeals, which includes New York, Connecticut and Vermont. But patients had better beware.

Off-label marketing is irresistible to Big Pharma because it saves years and millions spent on clinical trials which may not assure FDA approval anyway. It allows drug companies to circumvent the pesky and slow FDA altogether and get on with the business of making money– bringing their sales pitch to doctors and patients directly. Almost all major drug companies—GSK, Eli Lilly, Abbott, AstraZeneca, Pfizer, Johnson & Johnson, Amgen, Allergen, Bristol-Myers Squibb, Cephalon, Novartis and Purdue (which makes Oxycontin)––have agreed to huge settlements which include charges of off-label marketing.

In court-released confidential memos, Pfizer (then Parke-Davis) admits why it chose to off-label market Neurontin (only approved for postherpetic neuralgia and adjunctive seizure therapy) for the unapproved indication of bipolar disorder. “The U.S. market for Bipolar Disorders is an attractive commercial opportunity that warrants clinical development of Neurontin. Based on the current patent situation, an investment in full clinical development is not recommended at this time since completion of two pivotal trials and regulatory filing and approval would occur close to patent expiration,” says the memo. Translation: It would take too long to get legal approval—our patent would expire. Instead, says the memo, “it is recommended to implement only an exploratory study in outpatients with bipolar disorders with the results highlighted through a peer reviewed publication.” Translation: Let’s not do the studies and plant some info in medical journals that looks like we did.

Pfizer paid a $430 million fine and signed a corporate integrity agreement for off-label marketing of Neurontin which was linked to wrongful deaths and suicides. But that did not stop Pfizer from off-label marketing Lyrica, sometimes called “son of Neurontin,” soon afterward. Who can say incorrigible?

Nor did Eli Lilly’s guilty plea in 2009 to the off-label promotion of the antipsychotic Zyprexa deter it from requesting permission from the FDA to market Zyprexa to children three months later. The FDA said—yes! At the same time, Pfizer and AstraZeneca also requested permission to market their antipsychotics, Geodon and Seroquel respectively, to kids though both agreed to off-label marketing those exact drugs months later.

Another off-label marketing scheme centered around the selective estrogen receptor modulator Evista. Eli Lilly, its manufacturer, had noted fewer incidences of breast cancer in an Evista trial and wanted to market it not just for its approved treatment of prevention of osteoporosis but for prevention of breast cancer. A group of doctors told Lilly the anticancer marketing claims were “an egregious stretch” and that Evista’s high risk of stroke canceled out any anticancer benefits.

Undaunted, Lilly armed 1000 of its drug reps with an off-label Evista sales plan to sell the unapproved use of breast cancer prevention. Drug reps were told to hide a disclosure page that said, “The effectiveness of [Evista] in reducing the risk of breast cancer has not yet been established,” and “All of the authors were either employees or paid consultants of Eli Lilly at the time this article was written,” according to the Department of Justice.

Lilly was charged with a violation of the Food, Drug, and Cosmetic Act and ordered to pay a $36 million settlement for the off-label marketing. But Evista did receive approval to reduce the “risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.” The problem was the drug, marketed so freely for off-label uses, was far from safe. Prescribing information warned “Serious and life-threatening side effects can occur while taking EVISTA” and ads warned about “death due to stroke.” Its effectiveness was also not impressive. Patients were warned that Evista doesn’t “completely prevent breast cancer,” and “Breast examinations and mammograms should be done before starting Evista and regularly thereafter.”

Clearly, forgiveness is cheaper than permission for drug makers who consider such settlements the cost of doing business. But are drug sales pitches really “speech?” Can a “truthful and not misleading” determination really be made by the for-profit company selling the product? If drug companies’ product claims are protected under the First Amendment and they can sell directly to doctors and patients why even have an FDA?

Over 50 years ago, Big Pharma was also annoyed with the slow-paced FDA whose efforts to ensure drugs were safe cut into profits. One company even complained to an FDA official’s bosses that she was a petty bureaucrat. The company made thalidomide.

New gain-booster to other modern cost-cutting practices for livestock best profit

FFA National Future Farmer, IUPUI archives

Stilbosol-advert-1956 image
Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
Image sources
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Carlot winner cuts cost of gain $18 per steer with Stilbosol

DES advert, FFA National Future Farmer, 1956

DES-Stilbosol-1956-advert image
Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
Image sources
Related posts
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More DES DiEthylStilbestrol Resources

“Feeds with Stilbosol keep us in the cattle busine$$ today”

DES advert, FFA National Future Farmer, 1956

stilbosol-ad mage
Stilbosol patenting turned the cattle feed industry upside down in the mid 50s with its phenomenal use by farmers.
Image sources
Related posts
Related books
More DES DiEthylStilbestrol Resources