Battered by the drop in Vytorin and Zetia prescriptions, as well as the unexpected rejection of its follow-up Cordaptive cholesterol pill, the drugmaker is cutting still more jobs. This comes on top of a companywide reorganization that was begun in 2005 that has since involved eliminating approximately 8,100 positions.
“Merck is taking this step as part of our previously disclosed, continuing efforts to optimize our cost base and improve Merck’s effectiveness and efficiency across all aspects of our business as part of our Plan to Win strategy,” Ken Frazier, president of the global human health unit, says in a statement.
“With eight successful launches of Merck products approved in the US since 2006 now behind us, and with an unexpected delay in a new product approval, we decided to accelerate the achievement of efficiencies we anticipate gaining as we transition to our new commercial model in the US.”
The move follows similar steps taken by most of its rivals, which are also eliminating thousands of jobs, particularly among their sales teams. Wyeth, for instance, last week announced plans to also cut 1,200 jobs after previously announcing plans to cut 1,240 sales reps. As of last December, Merck had 59,800 employees worldwide.
The new campaign appears to replace the “My Time To Quit” ads that ran after links to suicide were reported earlier this year. A Pfizer spokesman tells us the drugmaker is “exploring” advertising Chantix again in various print and TV outlets after holding talks with the FDA, and claims the ads are being revived because smoking is a public health problem and the ads prompt smokers to talk to docs about quitting.
This comes just three months after the FDA issued a health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior with Pfizer’s anti-smoking drug, new ads have started to appear. Chantix, you may recall, was associated with 491 cases of suicidal thinking or behavior, including 420 in the US. And of those there 39 suicides, including 34 in the US. Warnings about the suicidal link is mentioned in the ads.
The new ads, by the way, arrive just a few weeks after the FDA’s Patient Safety News pulled a segment about Chantix warnings. We asked an FDA spokeswoman about the removal last month and were told the disappearance was due to technical difficulties, but so far the Chantix segment still isn’t available.
Hat tip to CNBC’s Pharma Marketing blog
Some may view this as a bit of surprise - 52 percent of companies plan to boost their outsourcing spend by 6 percent or more, compared with 62 percent last year, according to Contract Pharma, which surveyed more than 175 R&D, quality control, regulatory affairs and clinical research heads, among others.
Last year, 22 percent of total respondents believed that they’d spend the same or less on outsourcing in the coming year; this year, that number dropped to 16 percent. Last year, 30 percent of respondents reported they’d increase outsourcing spending by 10 percent or more in the coming year; that number dropped to 23 percent this time around.
However, the percentage of respondents who believe that their outsourcing expenditure will increase from 1 percent to 5 percent from the previous year nearly doubled, from 17 percent in the previous survey to 32 percent this time around. The portion who will increase outsourcing spending from 6 percent to 10 percent in the coming year was nearly steady, dropping from 32 percent to 29 percent.
Look here and follow the quick instructions to glimpse the survey. Meanwhile, here’s a breakdown of respondents by company type:
Small/Mid-Tier Pharma - 25.7 percent;
Big Pharma - 23.6 percent;
Virtual Pharma - 12.1 percent;
Generic Pharma - 12.1 percent;
Emerging Biopharma - 10 percent;
Specialty Pharma - 5.7 percent;
Big Bio - 3.6 percent;
Other - 7.1 percent.
The world’s biggest retailer will offer about 350 generic meds at the low price and, according to a statement, has also added $9 meds to treat breast cancer, menopause and hormone deficiency as part of a plan to save women more than $100 million annually. Here’s the list of drugs.
The retailer, which started its $4 generic program in 2006, faces growing competition from Kmart, Walgreen, and CVS/Caremark, which are targeting Americans who lack insurance to pay for their drugs, Bloomberg News notes, adding that nearly a third of Wal-Mart’s over-the-counter drugs now sell for $4 or less.
“We are trying to help our customers through tough times,” John Agwunobi, Wal-Mart’s president of health and wellness, says today on a conference call. Some elderly couples are sharing heart meds and some consumers are delaying purchases, he continues, adding that purchasing a 90-day supply may help consumers save on co-pays and avoid mail-order delays.
Kmart, which sells three-month supplies of some generic drugs for $15, said in March it would sell over-the-counter drugs such as aspirin and decongestants for $1 each, Bloomberg points out.
More than half the 28 new members of writers of the next edition of the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry, according to the Center for Science in the Public Interest’s Integrity in Science Watch.
The conflicts of interests were posted online by the APA last week (look here). They ranged from small to extensive. Leading the pack was William Carpenter Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drugmakers, including Pfizer, Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb, according to CSPI.
APA president Carolyn B. Robinowitz claimed in a statement that “we have made every effort to ensure that DSM-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development.” The fifth DSM, which is produced in conjunction with the National Institute of Mental Health and will be published in 2012, is used by mental health professionals to classify mental illnesses, CSPI reminds us.
When J&J recently decided to woo a group of influential women who blog about family life, it spared no expense. J&J zeroed in on more than 50 women who write widely read blogs about child-raising and related topics, and invited them to “Camp Baby,” a three-day retreat held last month near its New Brunswick, New Jersey, headquarters, The Star-Ledger of New Jersey writes.
To sweeten the deal, free plane tickets and lodging were offered at the upscale Heldrich Hotel, named for a former J&J exec. Scheduled events included a wine tasting with “Queer Eye for the Straight Guy” alum Ted Allen, a dinner at a high-priced restaurant and free products, such as Neutrogena skin-care products and a Nintendo DS Lite gameplayer, for each attendee, the paper writes.
What J&J didn’t expect was a bruising backlash from mom bloggers during the run-up to the event. Some invitees were appalled to learn kids weren’t welcome, not even breastfeeding infants. What kind of company, they asked, calls an event Camp Baby…and outlaws babies? The paper cites one blogger who works in marketing and called the botched outreach a “case study in the making…I cannot imagine what J&J was thinking,” wrote Ellen Gerstein in one post. “Way to build equity with moms!” (Here’s another of her comments).
The event also conflicted with a popular business forum in New York sponsored by BlogHer, a network of women bloggers. And it wasn’t held on a weekend, when child care would have been easier to negotiate with working husbands. Trying to connect with a core group of customers, J&J came off as tone-deaf, the paper notes diplomatically.
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After the FDA rejected the drug, which was to have revived Merck’s cholesterol franchise, its shares plunged. The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a common reaction to niacin. But the drugmaker offered no insights into the rejection, leaving Wall Street to speculate - and the speculation isn’t optimistic.
In an investor note this morning, Catherine Arnold of Credit Suisse writes that the “laropiprant component of Cordaptive presumably had cardiovascular signals. Even though this may have been in very small numbers, the FDA was unable to get past the notion that Merck couldn’t explain why it happened in some patients and not in others, while the potential target population is large.”
She goes on to say the “FDA risk/benefit analysis must have given more weight to theoretical risk and possibly a small rate of actual cardiovascular events. The non-approval may have been cemented by the backdrop which includes the commercial availability of other niacin options and only small differences in study discontinuations favoring Cordaptive.’
And Arnold notes that cardiovascular signals weren’t evident in studies comparing Cordaptive versus a combination of niacin and Zocor, “we do not know if there was a signal in the monotherapy (laropiprant alone) studies, as these are not publicly available.” Here’s a study for background reading.
The upshot: New multi-year studies may be required, because an existing study called HPS2-Thrive won’t evaluate the effect of laropiprant on reducing or increasing cardiovascular signals compared with niacin alone. So Arnold sees this “potential higher burden” a good reason to push out her forecasts for Cordaptive and a combo of Cordpative and Zocor until 2012, at the earliest.
The battle to lower prescription drug costs is causing still more friction between doctors and insurers. Take the case of Lloyd Negoescu, who took Lopressor to stabilize his blood pressure, until his Medicare Part D plan changed, and his new insurer, RxAmerica, stopped paying for the brand-name med.
His doctor wrote letters to appeal, to no avail. “They wanted me to try generics first. My blood pressure went up astronomically on the new drugs,” the 57-year-old disabled man tells The Star-Ledger of New Jersey. Negoescu is an example of what’s known as step therapy - requiring patients to try and fail with lower-cost meds before insurers will pay for more expensive, brand-name, drugs.
To insurers, the practice directs patients away from costly meds and toward equally effective, established drugs, including generics. They say the effort is needed to curtail soaring drug bills and offset advertising that pushes expensive brand name treatments. In New Jersey, state guidelines prevent step therapy, but docs say insurers are finding ways around the guidelines, the paper writes.
John Ciccone, a member of a physicians group and a cardiologist, says one patient stabilized on the blood pressure medicine Atacand, but when insurance coverage switched to Aetna, he received a letter saying Aetna wouldn’t pay for Atacand unless the patient failed four other blood pressure drugs. Ciccone made the change and the patient’s pressure soared.
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