Lawrence Golbom’s insight on how America’s 21st century opium epidemic started, 2016
Lawrence Golbom’s insight on how America’s 21st century opium epidemic started, 2016
Jeremy Spencer was 23 and graduated with a degree in Industrial Engineering in 1993. Within two years he unknowingly was in charge of producing a new miracle pain killer as powerful as heroin. The book follows his twelve year career with the most diabolical pharmaceutical company in history.
Love, loss, deceit, lies, political corruption and murder are intertwined within Jeremy’s twelve years. Not Safe As Prescribed combines a love story with revealing the time line that led to the pharmaceutical masterminds who created the biggest medical hoax since the legal introduction of heroin in 1898.
” … In Bangladesh, … the “chemical soup” that commercial shrimp are grown in threatens local workers, and pollutes their water bodies and marine life with toxic effluent. When the ponds become so polluted that even antibiotics no longer work, the operators pack up and move on to a new location… ”
” Commercial shrimp production in India, the second largest exporter of shrimp to the U.S, begins with a long list of chemicals, including urea, superphosphate and diesel. … Fish-killing chemicals like chlorine and rotenone (linked to Parkinson’s Disease), and the use of Borax and sodium tripolyphosphate (a suspected neurotoxin), are rampant in India’s shrimp production. ”
” … formalin is approved for use in U.S. shrimp production. Formalin is a parasiticide which contains formaldehyde gas. It has no mandatory withdrawal time or legal residue tolerance. Other chemicals … are “unapproved” but widely used “off-label”. “
” Thanks to the chemical, agricultural and pharmaceutical industries, and antiquated water systems, people all over the world are imbibing a witch’s brew of drugs and chemicals often without realizing it.
Associated Press reported that:
Epilepsy and anxiety drugs were found in Southern California water.
Heart and epilepsy drugs were found in Northern New Jersey water.
An antibiotic was found in Tucson drinking water.
A sex hormone was found in San Francisco drinking water. “
Read “Drugs in the Drinking Water? Don’t Ask and Officials Won’t Tell”, Truthout, 21 March, 2016.
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 childrenthree 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.
solve an everyday health problem like heartburn or high cholesterol;
have a fun or memorable ad campaign;
get social buzz;
and be sold to a large number of people quickly.
The last qualification—quick sales to millions—is crucial because Big Pharma has a small sales window before a patent runs out. But it’s also dangerous because many risks don’t emerge until millions take the drug so the public serves as unwitting guinea pigs.
When risks can’t be ignored, even if the drug is selling briskly, the drug will be unceremoniously withdrawn and seldom mentioned again. Here are some blockbusters in the drug graveyard that Big Pharma hopes we will forget about.
Darvon and Darvocet
Find out more on AlterNet:
Are We Big Pharma’s Guinea Pigs? 8 Drugs Used by Millions Before Being Pulled for Dangerous Side-Effects, AlterNet, December 2, 2014.
7 Drugs Whose Dangerous Risks Emerged Only After Big Pharma Made Its Money, AlterNet, January 2, 2014.
Pervasive use fuels concerns about impact on human health, emergence of resistant superbugs
” Major U.S. poultry firms are administering antibiotics to their flocks far more pervasively than regulators realize, posing a potential risk to human health.
Internal records examined by Reuters reveal that some of the nation’s largest poultry producers routinely feed chickens an array of antibiotics – not just when sickness strikes, but as a standard practice over most of the birds’ lives.
In every instance of antibiotic use identified by Reuters, the doses were at the low levels that scientists say are especially conducive to the growth of so-called superbugs, bacteria that gain resistance to conventional medicines used to treat people. Some of the antibiotics belong to categories considered medically important to humans. ”
The best-selling drug in America isn’t what you think—and it’s a whole lot more powerful than you’d expect
Abilify, is currently the top-selling of all prescription drugs in the U.S. marketed as a supplement to antidepressant drugs. From April 2013, through March 2014, sales of Abilify totaled almost $6.9 billion. Not only is it amazing that an antipsychotic is outselling all other drugs, no one even knows how it works to relieve depression, writes Jay Michaelson. The standardized United States Product Insert says Abilify’s method of action is “unknown” but it likely “balances” brain’s neurotransmitters – the drug is said to work “like a thermostat to restore balance”. But critics say antipsychotics don’t treat anything at all, but zone people out and produce oblivion. They also say there is a concerning rise in the prescription of antipsychotics for routine complaints like insomnia…
Sources and more information:
Mother’s Little Anti-Psychotic Is Worth $6.9 Billion A Year, thedailybeast, 11.09.14.
The most popular drug in America is an antipsychotic — and no one really knows how it works, rawstory, 16 NOV 2014.