It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.
On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory. J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.
At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.
But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra, Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.
Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.
Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.
Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine. If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.
The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.
Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.
Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: firstname.lastname@example.org.
The vast majority of medical experts in the U.S. who help formulate disease and diagnostic guidelines are taking money from the pharmaceutical industry, according to a new study.
The research published in the journal PLoS Medicine found that 75% of panelists who propose changes in disease definitions and diagnostic criteria had been paid by drug companies either as consultants, advisers or speakers.
Among those serving as chairs of these panels, 12 out of 14 were financially connected to the drug industry.
“Companies with financial relationships with the greatest proportion of panel members were marketing or developing drugs for the same conditions about which those members were making critical judgements,” Ray Moynihan, of Bond University in Robina, Australia, and colleagues wrote.
Examples cited by the researchers included GlaxoSmithKline, which had paid 20 of the 24 members of a 2009 task force that developed new definitions regarding asthma. It just so happens that the company sells the billion-dollar Advair, used to help asthma patients.
Also, Biogen, maker of the multiple sclerosis drug interferon beta-1a (Avonex), had ties to 13 of the 18 participants on a 2010 MS panel that expanded the definition to simplify diagnosis, the study revealed.
To Learn More:
Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States (by Raymond N. Moynihan, Georga P. E. Cooke, Jenny A. Doust, Lisa Bero, Suzanne Hill and Paul P. Glasziou, PLoS Medicine)
Pharma Ties Common on Guideline Panels (by David Pittman, MedPage Today)
Experts Related to Drug Makers Promote Narcotics for Seniors in Pain (by Noel Brinkerhoff, AllGov)
Doctors who Earn Hundreds of Thousands of Dollars Speaking for Drug Companies (by David Wallechinsky, AllGov)
“Yes,” According to Big Pharma Funded Doctors
How has Big Pharma managed to get so many children on expensive drug cocktails for “mental illness”? Drugs that they may not even need?
Big Pharma has spent millions on public relations campaigns that tell parents, teachers and clinicians to dose children at the first sign of problems. It knows if parents treat their kids early they will never know if the kids needed the drugs in the first place and whether residual problems are “mental illness” or drug side effects. The kids will also probably be life long customers because parents will be afraid to take them off the drugs. No wonder Pharma tells parents not to wait for “excessive energy” or “mood swings” to go away in the awareness campaigns. Ka-ching.
One “prescribe early” campaign for the atypical antipsychotic Risperdal uses a macabre abandoned wallet, a teddy bear, and keys on a barren street “to reposition a drug that was being used too late to achieve its maximum beneﬁts,” said its advertising agency, Torre Lazur McCann. Brand managers for Seroquel, a competing antipsychotic, even considered creating Winnie-the-Pooh characters like Tigger (bipolar) and Eeyore (depressed) to sell Seroquel, according to published reports, at an AstraZeneca sales meeting. Parents say they have seen toys emblazoned with Seroquel logos.
Only one child in ten thousand has pediatric schizophrenia—some say one in thirty thousand—but that doesn’t stop Gabriele Masi, MD, with the Stella Maris Institute for Child and Adolescent Neuropsychiatry at the University of Pisa in Italy from portraying it as a public health problem. In an article titled “Children with Schizophrenia: Clinical Picture and Pharmacological Treatment,” in the journal CNS Drugs, Masi writes, “Awareness of childhood- onset schizophrenia is rapidly increasing, with a more precise deﬁnition now available of the clinical picture and early signs, the outcome and the treatment strategies.”
Symptoms of childhood schizophrenia include “social deﬁcits” and “delusions . . . related to childhood themes,” writes Masi. What child doesn’t have “social deﬁcits”? Do delusions include imaginary playmates? Masi lambastes the “hesitancy on the part of clinicians to make a diagnosis of schizophrenia,” instead of prescribing early. Masi has received research funding from Eli Lilly, served as an advisor for Shire and been on speakers bureaus for Sanoﬁ Aventis, AstraZeneca, GSK, and Janssen, all of which manufacture many of the leading psychiatric drugs for children, according to the American Academy of Child & Adolescent Psychiatry.
It’s tempting to ridicule Pharma funded doctors who find mental illness and even relapses and “treatment resistance” in people who have been on the planet for forty months. But pathologizing three-year-olds isn’t funny. Both four-year-old Rebecca Riley of Hull, Massachusetts, and three-year- old Destiny Hager of Council Grove, Kansas, died in 2006 from psychiatric drugs that included Geodon and Seroquel to treat their “bipolar disorders.” And in 2009, seven-year-old Gabriel Myers of Broward County, Florida, a child in a state facility, hung himself while on Symbyax, a pill that combines Zyprexa and Prozac. If it weren’t for Big Pharma’s prescribe early campaigns, these children, and others, might still be alive.
Martha Rosenberg’s is an investigative health reporter. She is the author of Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).
It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed.
A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Like Wall Street’s bundled high risk loans, the “tide” created by Big Pharma’s high risk drugs raised many ships during the 2000s from advertising, public relations and medical communication agencies to TV and radio stations, medical journals and doctor/pitchmen who shoveled in its marketing budgets. But now the joy ride is over and Pharma is shedding jobs and settling billions in claims without changing its risky business model, like Wall Street.
In Europe, governments are no longer willing to pay the high prices for drugs that they once did say published reports and some countries are drafting laws making drug makers “prove their drugs are effective or risk having them dropped from the coverage list, or covered at a lower rate.” Imagine!
Germany has already saved 1.9 billion euros in 2011 by refusing to pay higher prices for drugs unless they are clearly superior to existing medicines, and Pharma worries that other countries will also get tough and want scientific proof for drug effectiveness instead of marketing and spin. In the U.S. and elsewhere, a drug only needs to be superior to no drug (placebo) to be approved by regulators — yet “new” is conveyed as “better than any drug to date” in advertising. Some clinicians say Haldol, an inexpensive antipsychotic, and lithium, a similar affordable bipolar drug are better than blockbuster antipyschotics and bipolar drugs that created Pharma’s 2000 bubble.
Before the Vioxx scandal and major settlements over blockbuster drugs like Zyprexa, Bextra, Celebrex, Geodon and Seroquel, being a Pharma rep was probably the next best thing to working on Wall Street. Direct-to-consumer advertising did your pre-sell for you, and all you had to do was show up with your snappy Vytorin tote bag and samples case. Some Pharma reps had their own reception room with ice water, swivel chairs, and laptop ports at medical offices, and most waltzed in to see the doctor right in front of waiting and sick patients. (It didn’t hurt that reps were usually “hotties,” both men or women).
But, by 2011, the bloom had fallen off Pharma reps’ roses. The number of prescribers willing to see most reps fell almost 20 percent, the number refusing to see all reps increased by half, and eight million sales calls were “nearly impossible to complete,” reported ZS Associates. Blockbuster drugs that were found to be unsafe after their big sales push or even withdrawn altogether, did not help the reps’ credibility with doctors. After the aggressively marketed hormone therapy was linked to high incidences of cancer, stroke and heart attack, Wyeth (now Pfizer) announced it was eliminating 1,200 jobs and closing its Rouses Point, New York plant where Prempro products were manufactured.
As government and private insurers increasingly say, “You want us to cover what?” about expensive, dangerous drugs that are not even proven effective, Pharma bubble jobs are evaporating. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. (AstraZeneca scrapped 21,600 more since 2007). Meanwhile, Pharma is outsourcing more of its operations to poor countries.
Workers and people willing to be trial subjects are both a bargain in poor countries where many can’t understand drug risks or refuse them if they did (and most can’t afford the very drugs they help sell). In January the Argentinian Federation of Health Professionals accused drug maker GlaxoSmithKline of misleading participants and pressuring poor families into joining a trial for the Synflorix vaccine, which the company says protects against bacterial pneumonia and meningitis, reported CNN. In 2010, 10 deaths occurred during Pfizer and AstraZeneca drug trials at the Bhopal Memorial Hospital and Research Centre which was ironically built for survivors of the 1984 Bhopal gas disaster, reports MSNBC. 3,878 workers perished in Bhopal when chemicals leaked at a Union Carbide pesticide plant.
Outsourcing drug manufacturing to cheap venues also contributes to Pharma’s cascade of “quality control” problems in which drugs are mislabeled, contaminated or otherwise made dangerous. It is speculated that Johnson & Johnson’s CEO William Weldon “was pushed to retire because of all of the quality issues at McNeil as well as with the company’s hip implant products, which have resulted in a raft of litigation,” reports FiercePharma.
Like the Wall Street bubble, the Pharma bubble was built on products that industry, but not the public, knew were risky, sold for quick profits. Now regulators are examining some of these “assets” more closely and with disturbing findings. The FDA now warns that bestselling statin drugs like Lipitor and Crestor, even approved for children, are linked to memory loss and diabetes associated with. The equally well selling proton pump inhibitors like Nexium and Prilosec for acid reflux disease (GERD) are now believed to increase the risk of bone fractures by 30 percent.
In March, the FDA even rejected a Merck drug that combines the active drug in Lipitor with the active drug in Zetia and Vytorin, a drug that Forbes calls Son of Vytorin. Vytorin (the father) was advertised to treat both food and family “sources of cholesterol” until results from a study that Merck and Schering-Plough appeared to withhold from regulators showed the drug had no effect on the buildup of plaque in the arteries (believed to correlate with heart attack and stroke). There was such a gap between marketing and science, Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA was approving “drugs that appear to have little to no effect in protecting lives and increasing health.”
Yet even as clouds develop over Pharma’s top-selling drugs, some say the FDA is too hard on new drugs, not too easy. “The FDA is impeding useful innovations in the U.S.,” says former FDA deputy commissioner Scott Gottlieb in the a Wall Street Journal oped and lagging behind other countries. Former FDA commissioner Andrew Von Eschenbach, also writing in the WSJ, agrees. The FDA should improve U.S. drug competitiveness by allowing drugs “to be approved based on safety, with efficacy to be proven in later trials,” while the public is already taking the drugs. Isn’t that what’s happening now?
Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, will be published in April 2012 by Amherst, New York-based Prometheus Books. She can be reached at: email@example.com.
- The drugs don’t work for AstraZeneca (independent.co.uk)
- AstraZeneca to axe 7,000 jobs as revenues slump (independent.co.uk)
- AstraZeneca appoints new chairman for troubled times (independent.co.uk)
- Shorting Candidate AstraZeneca – Seekingalpha.com (seekingalpha.com)