Getting in Your Medicine Cabinet

Have You Been Fooled by These Pharma Dirty Tricks?
How does the pharmaceutical industry get a product through development, testing and approval and onto your insurer's formulary, television set and bathroom shelf? (And Wall Street profit reports?) And how does it do it so, so seamlessly you think it's your idea? Here are some of pharma's dirtiest tricks.
Playing the Price Spread
In drug sales, the price pharmacies pay and the government reimburses are not the same. This lets pharma inflate government's Average Wholesale Price (AWP) and play the spread either for kickbacks or sales "incentives." Exploiting the price difference is so common, AWP could stand for Ain't What's Paid says Tony West, assistant attorney general for the Justice Department's civil division, because "the only purchasers who paid the inflated, reported drug price were you, the American taxpayers." Maybe the classic claim "I got it wholesale" isn't so good after all.
Double dealing at the Pharmacy
Why did pharma send letters to doctors through CVS pharmacy extolling the expensive drug Zyprexa? Even though CVS' pharmacy benefit manager, AdvancePCS, is pledged  to negotiate the lowest drug prices for its insurer and pensions plan clients? Because pharmacy benefit managers (PBMs) increasingly play both side of the street, says the Boston Globe. The extra $3,000 to $9,000 per person per year that Zyprexa costs over a generic will do a lot for Lilly stock. If you don't think about health insurance premiums.
Faux Patient Groups
Ever wonder how patient groups lobbying FDA to approve some expensive drug you've never heard of suddenly appear? Replete with tears and sob stories? The patient front groups, sometimes called astroturf, are aggregated and orchestrated by pharma. One of the largest, the "grassroots" National Alliance on Mental Illness (NAMI), lobbies Medicaid programs not to substitute less expensive drugs and was investigated by Sen. Charles Grassley for undisclosed pharma links. How can you tell an astroturf group? Its web site looks just like pharma's.
FDA Foreplay
Sometimes when pharma thinks it is sitting on a revolutionary drug, it doesn't wait for FDA approval and begins marketing directly to the public to triangulate FDA. A recent example was a drug to treat female sexual dysfunction and hopefully be a blockbuster like Viagra. What was not to like? Who could say no? But after Boehringer-Ingelheim debuted its pink Viagra for "hypoactive sexual desire disorder" (HSDD) at a medical conference last year and rolled out its elaborate Sex Brain Body: Make the Connection web site and campaign starring TV personality Lisa Rinna, FDA did say no. Seems even though Boehringer-Ingelheim was effective in "raising awareness" about female sexual dysfunction, something else wasn't effective: the drug. And when it came to foreplay, FDA had a headache.
Pharma Service Announcements
Like ghostwriting, the origins of pharma's unbranded advertising are disguised and they look legit. But when TV, radio and web messages push "awareness" of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES), be suspicious. Real diseases aren't given initials for quick recall and easy reference. Nor do they come with snappy self-quizzes and pretty patient models. Unbranded messages also pimp the PSA (public service announcement) money that media outlets have for actual public issues.
National "Interests of Health
The billions of research dollars the taxpayer-supported National Institutes of Health (NIH) allocates each year are supposed to benefit the public and be free from pharma influence. So why was a researcher stripped of an NIH grant because of hidden pharma ties, allowed to resume NIH funding at a new university? Psychiatrist Charles Nemeroff not only qualified for NIH funds when he surfaced at the University of Miami last year, he sits on the actual NIH committees which consider other researchers 'grants, reports Chronicle of Higher Education. A fox guarding the hen, or pork house.
Continuing Marketing Education
Pharma-subsidized Continuing Medical Education (CME) courses are a bonanza for pharma since doctors need the "credits" to keep their licenses. But what are they learning? A recent "course" offered by Medscape titled Quadrivalent HPV Vaccine May Be Effective in Women 24 to 45 Years Old told participants after taking the course, they would be able to "specify the currently recommended age range" for the vaccine. Especially if they could read the title! Another course offered by the Cleveland Clinic Journal of Medicine tells participates to "lobby your legislators" for pharma-related Medicare funding. No wonder, Congress recently investigated the billion dollar industry CME industry for illegal marketing. Too bad it couldn't investigate for stupidity.
Ghostwriting and Nolo Retracto
Ghostwriting — papers written by medical marketing writers with doctors only posing as authors  —  was rampant until 2008 Congressional investigations. But even though it's  now prohibited, few journals have retracted ghostwritten articles which sold Vioxx, Fen Phen, Prempro and probably Avandia. Asked about the ghostwritten papers "by" Lila Nachtigall, a professor in the Department of Obstetrics and Gynecology, Deborah Bohren, vice president for public affairs at New York University's Langone Medical Center said, "If we had received a complaint, we would have investigated." A Congressional investigation doesn't qualify as a complaint?
Crooked Books and Slanted Messages
First it was called the first completely ghostwritten book. Then it was called a completely pharma approved book. Either way, the 1999 textbook, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, was funded by an "unrestricted educational grant" from drug giant GlaxoSmithKline (GSK) to Scientific Therapeutics Information according to its own preface. Nor were its authors strangers to GSK. Alan Schatzberg is on GSK's speakers bureau and Charles Nemeroff was investigated by Congress for undeclared GSK income. Did the authors write the book themselves or was it ghostwritten by freelancers at Scientific Therapeutics Information (the group that marketed Vioxx?)  Does it matter?
May I Take Your Order?
Have you ever waited in a doctor's office with a 102 degree fever only to have pharma reps swinging Vytorin totes see the doctor first? Just because they brought free samples or lunch and are dressed for a music video? Until Congressional investigations into physician payments culminating in the Physician Payments Sunshine Act, some doctors in medical centers say they never paid for a meal. Nor did pharma largesse end there. One doctor told a reporter her entire group were jetted to a Caribbean island courtesy of her Paxil rep. Even medical students were schmoozed until the 62,000 member American Medical Student Association (AMSA) sought to end the pharma practice of gifts and free meals. Now pharma must report what it spends on doctors…and there is a longer line at the vending machine.
Trials and Fibulations
Would researchers really compromise patient safety to make a buck with clinical trials? Medical College of Georgia psychiatrist Richard Borison and his colleague Bruce Diamond did 13 years ago when they tested Zyprexa, Risperdal and 20 other drugs and ended up in jail. So did Baystate Medical Center's Scott Reuben who went to prison earlier this year for fraudulent Celebrex, Neurontin and Lyrica trials. And a Tucson facility testing asthma drugs Symbicort, Advair and Singulair doctored data and risked patients' health to net as much as $10,000 per patient according to a whistleblower and government and court documents. How many other drugs were tested for such fiscal outcomes?  Not counting recalled ones of course.
More Trials and Fibulations
Even without fraud, pharma sponsored studies can deceive. Trials that only determine that a drug is "not worse" than another one or impute safety before real data — like Vioxx and Avandia's heart attacks — are available can skew results. And some research is not meant to be accurate to begin with. The Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital was founded to "move forward the commercial goals of J.& J." according to unsealed court documents. Its head, Harvard's Joseph Biederman, promised J.& J. a proposed drug trial "will support the safety and effectiveness of risperidone [Risperdal] in this age group," before it was ever conducted. Why leave things up to science?
Overseas Adventurism
As pharma increasingly eyes poorer countries for new markets and cheaper manufacturing it also eyes them for cheaper clinical trials. In 1996, 11 Nigerian children died in trials testing Pfizer's not-yet-approved antibiotic Trovan. While Pfizer paid the Nigerian government and state of Kano millions in a settlement, Wikileaks reports that Pfizer tried to extort Nigeria's former attorney general to drop the lawsuits. Trovan was withdrawn from US markets in 2001 for liver toxicity but it sounds like "safety signals" may have appeared sooner.
Clueless Institutional Review Boards
Institutional review boards, charged with overseeing clinical trials, should catch the Borisons, Trovans and preordained Biederman trials. But a Congress and General Accountability Office sting conducted last year on a Colorado IRB raises serious doubts. When asked to oversee a study of Adhesiabloc, a product designed to reduce scar tissue that didn't exist (nor did its developer or lead researcher) Coast Independent Review Board said…when do we start?
"Previous Government Experience Desirable"
In the fight against medical fraud, the Justice Department is beginning to file criminal, not just civil, charges against pharma. More employees also are turning whistleblower thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement, in some cases. But the other side has a big advantage. As long as politicians like former Louisiana Rep. Billy Tauzin, who left government to head the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to commit a career's worth of knowledge, judgment and relationships to sell product, the government is fighting itself.

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