Big Pharma, undeterred, racks up a half-billion dollars in regulator penalties
Big Pharma’s dubious hype of its sometimes risky products marched on last week, with the industry racking up a half-billion in regulator penalties and settlements but no seeming end to its questionable strategies and tactics:
$465 million penalty, settlement for EpiPen maker
- Mylan, the controversial maker of the EpiPen, settled with the U.S. Department Justice and other federal agencies, agreeing to pay $465 million over claims it improperly classified and overcharged Medicaid and Medicare for its anti-allergy medication injection device. The government long had warned Mylan that it could not classify the EpiPen as a generic drug. Instead, officials said it should be deemed a brand-name product, meaning Mylan should have given the government a bigger rebate when it paid for EpiPens for the poor. The company, which I have written extensively about, admitted no wrong-doing, and said this settlement should help quell the public anger at the firm, which has sent the price of the EpiPens skyrocketing. Although the firm will pay almost a half-billion in federal penalties, officials estimated the revenue on EpiPens totaled almost $1.3 billion. And while the company has lowered its earnings guidance to cover the cost of this settlement and other of its responses to the public furor over EpiPens, the company’s stock rose after the settlement announcement by as much as $3 per share in after hours trading, closing at $39.35.
$35 million penalty, settlement for Novartis over skin cream use by tots
- As part of a whistle-blower action, Novartis has agreed to pay $35 million to settle with the U.S. Department of Justice, other federal agencies, and eight states for improperly marketing a skin cream for use on children younger than age 2. That use is not approved, and health officials have issued a warning about excessive application of the Elidel skin creme on kids. They said it has undetermined effect on youngsters’ immune system, and had caused cancers in animals. A onetime Novartis salesman blew the whistle on the company (and he will be paid accordingly under whistle-blower laws almost $9 million), saying he was told to tell doctors to apply the creme liberally on kids. He said the company also trained him to take doctors and other caregivers to lavish meals, though not necessarily to discuss Elidel at those get-togethers. It’s incomprehensible how companies and their executives can sleep at night, knowing they’re profiting off of dubious practices that may harm kids. Stat, the online health news site, notes that Novartis recently agreed to a $390 million settlement over kickback allegations in the promotion of two other drugs. The company also is under fire, accused of illicit marketing or sales tactics in China, Turkey, and Korea.
In Canada, Novo Nordisk criticized for comedienne’s hype of female hormone drug
- In Canada, Novo Nordisk found itself under fire for a bizarre effort to promote a female hormone medication for use after menopause. The spokeswoman for its campaign was actress-comedienne Cathy Jones, a star of one of her nation’s longest-running hit shows, “This Hour Has 22 Minutes.” She became a stealth advocate, not disclosing her hire by the drug company, to get women to talk freely and publicly about what was termed a post-menopausal condition dubbed “vaginal atrophy.” The drug maker also hired a University of Toronto medical faculty member to go on media rounds with Jones to discuss this alleged malady, again without disclosing who had paid her. Novo Nordisk’s PR firm secured placement of an opinion-lifestyle piece by Jones in the well-respected Globe and Mail The Canadian Broadcasting Company blew the whistle on the drug maker, Jones, and the doctor. The CBC found numerous experts who denounced the failure of Novo Nordisk, Jones, and the doctor to disclose their relationship. Health experts also criticized the drug maker for hyping normal changes in women’s bodies, and hyping them as an illness that requires medication. Canadians apparently have heard this pitch before, as another Big Pharma firm sold drugs for a condition that it prudely and succinctly labeled “VA.”
A deep dig into the controversial rise of drug-maker Insys
- Forbes deserves credit for its deep dig into Insys, a company whose controversial technology, critics say, has fueled the abuse of opioid painkillers. The company has helped to make it chief a billionaire. But his rise has been filled with run-ins with regulators, as well as a skill for taking over ailing enterprises and boosting their wares with aggressive marketing. Insys is taking great heat now for its promotion of Subsys, an under the tongue, spray-delivered, exceedingly fast-acting application of the incredibly potent painkiller fentanyl. The company defends the product as effective and useful for grave pain associated with cancer. But questions persist whether the company pushed it for other uses, inviting abuse of a narcotic said to be 80 times more potent than morphine.
Why do drug prices soar? An infographic (see above) helps explain
- To illustrate why drug costs keep soaring, Julie Appleby of the Kaiser Health News and the skilled graphics staff at USAToday created the telling piece shown above and on the right. A picture’s worth a thousand words as to why Big Pharma’s prices keep going up and up and up, with middlemen adding to costs.