Some folks will be pulling all-nighters reading the abstracts released by the American Society of Clinical Oncology this evening. (Please look here). But if you simply want to glean a few highlights, here are the latest news summaries moving over our transom…
Lilly Drug Slows Lung Cancer (The Wall Street Journal)
Rash Most Common Side Effect In Vectibix Trials (Yahoo/Reuters)
Avastin Improves Brain Cancer Survival (Yahoo/Reuters)
Herceptin Enhances Tykerb For Breast Cancer (Yahoo/Reuters)
Amgen Says Denosumab Combats Rare Bone Tumors (Yahoo/Reuters)
This is an embarassing defeat for the health care giant. A federal judge ruled today that the American Red Cross can continue using its iconic symbol, 10 months after J&J filed a lawsuit demanding the relief agency halt its use of the red cross emblem on products it sells to the public and licensed to others.
Amid a flurry of negative publicity, J&J claimed the Red Cross violated its trademark and was barred from using the symbol for commercial purposes. The health care giant claimed a congressional charter issued to the relief agency in 1900 didn’t empower the Red Cross to engage in commercial activities competing with a private business.
But US District Judge Jed Rakoff disagreed, noting that the Red Cross had used the emblem for more than a century and was authorized to do so by various Geneva Conventions and the US Congress. In his 33-page decision, Rakoff wrote the “real question” was whether the permission given by US statute to use the logo included commercial purposes. His answer? Yes.
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Right now, that call won’t go through, but an FDA advisory committee will meet tomorrow to discuss the possibility of including in televised DTC ads a statement encouraging consumers to report negative side effects to MedWatch. Right now, such statements are only required for DTC print ads.
The meeting comes amid ongoing debate over DTC ads. A growing chorus of critics say that risks are regularly minimized in favor of feel-good messages that can lead to over-prescribing. Some lawmakers and consumer advocates want toll-free phone numbers placed in the ads in hopes of helping the FDA spot warning signs sooner.
A recent Consumers Union poll found that 81 percent of Americans reported seeing or hearing an ad within 30 days of being questioned. The same poll found that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doc or hospital, but only 35 percent were aware side effects can be reported to the FDA.
Two months ago, the FDA was supposed to have given Congress a report on mandatory contact info in TV ads, but an agency spokeswoman tells the Associated Press that a final version is still being worked on. PhRMA hasn’t taken a stance, but supported adding the side-effect language in print ads.
“If it’s good enough for print, it’s good enough for TV,” Kim Witczak, founder of the WoodyMatters advocacy group, tells the AP. Her husband, Woody, committed suicide while on Pfizer’s antidepressant Zoloft. The following year FDA added warnings about risks of suicidal behavior to all depression drugs.
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The big debate about drug promotion may focus on DTC advertising, but a pair of UCLA medical school professors believes product placement should be considered a distinct form of promotion that requires new FDA guidelines.
After all, there may well be more restrictions on DTC after the presidential elections, and consumers are increasingly using TiVo and remote controls to ignore commericals. In general, the UCLA researchers note that the overall market for product placement rose 30.5 percent to $3.5 billion in 2004, according to their paper in The Journal of Public Policy & Marketing. And in 2006, there were 462 mentions of prescription meds on TV shows.
So far, placements haven’t been widely used. Examples include Pfizer’s Zoloft antidepressant showing up in The Sixth Sense and Organon’s NuvaRing contraceptive on Scrubs. Why not more often? The researchers suggest drugmakers are conservative; pharma has concerns about trivializing meds and illness by association with entertainment, and difficulties in translating meds into popular culture.
Nonetheless, they analyzed medical-themed network TV shows in 2005. For the most part, they wrote it was “impossible” to determine whether any med was a deliberate placement, except “one brand seemed unusually suspicious as a commercial drug placement” - TAP Pharmaceuticals’ Lupron, which decreases hormone production.
The drug was mentioned four times in an episode of House, and was used by the show’s docs to treat hypogonadism, which is not an FDA-approved indication. At the same time, they note that a newer version was being tested for hypogonadism for FDA approval. “”The off-label use of this product in this show and the concurrent FDA trial appear more than coincidental,” they wrote.
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A US federal court has affirmed a ruling that Sanofi-Aventis intended to deceive the US Patent & Trademark Office in its dispute over generic versions of its Lovenox blockbuster, Reuters writes. Sanofi had sued Teva and Amphastar over their attempt to sell a generic version of the best-selling blood thinner, which generated sales of $1.1 billion in this year’s first quarter.
The US Court of Appeals for the Federal Circuit ruled that Sanofi had committed “inequitable conduct” for failing to inform the patent office of info relevant to patentability. The federal court affirmed the ruling by a district court in California that there was an intent to deceive by failing to disclose dosages of the drug in certain studies, Reuters reports.
“After a trial on the matter, the district court found there was intent to deceive and held the patents unenforceable for inequitable conduct,” the court wrote. “Because we find no abuse of discretion by the district court in its holding of inequitable conduct, we affirm.”
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European antitrust investigators are expanding the scope of a major inquiry into pharma in a bid to determine whether drugmakers are blocking generic rivals from getting less-expensive meds to market quickly, Reuters reports.
Lawyers and European Union officials say that Neelie Kroes, the European Union competition commissioner, is also probing whether efforts to block competitors by extending patents were distracting them from developing new meds, Reuters continues.
Investigators, who questioned about 100 companies earlier this year, including Pfizer, Glaxo and Sanofi-Aventis, are now turning to about 80 medical organizations, including associations of doctors, patients and pharmacies, and government agencies that set the prices of prescription drugs in Europe. That could make it the broadest antitrust investigation ever in the EU, according to Reuters.
If Kroes determines that drugmakers are using unfair practices, she could impose large fines - as happened once already to AstraZeneca - and recommend changes to industry practices. “There is clearly a block in the system,” Greg Perry, who heads the European Generic Medicines Association, tells Reuters. “Access to the market in Europe still is less speedy than in the United States.”
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The 29 new drug application approvals by the FDA year to date through April represent the highest levels since 1998 and 2000. This figure is up dramatically from 16 in the year-ago period and the 10-year average of 24, writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey in a research note this morning. The results also match the four-month highs attained in 1998 and 2000.
Taken at face value, NDA approvals reflect a more active FDA in 2008. However, an increasing amount of this uptick reflects incrementalism, with 10 of the 29 approvals coming from new manufacturers for existing drugs, approvals of drugs already marketed, or new formulations of existing compounds (versus three of the 16 through the first four months of 2007). Aside from those approvals, the comparison would have been 19 year to date in 2008 versus 13 in the comparable year-ago period.
NME approvals, meanwhile, are still moribund. The three NME approvals through April match the low water mark only previously reached in 2002. The April NME approval figure was four in 2007 and an average of six over the last 10 years.
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Some people swear their restless legs won’t stop moving. Others swear the syndrome is largely invented or, at the least, hyped to incredible levels. Whatever the creepy, crawly truth, a new FDA decision could slow the onslaught of Restless Leg Syndrome ads, MSNBC writes.
Last week, the agency approved the first generic versions of Glaxo’s Requip for four manufacturers, and the move is likely to send Requip sales and advertising plummeting, industry experts predicted. At least one sleep disorder specialist expects the focus on the syndrome to fade as rapidly as the Requip television commercials - which have already been pulled from the airwaves.
“Restless legs syndrome is a great example of a suddenly out-of-the-blue disease,” Christopher Earley, an associate professor of neurology at Johns Hopkins University in Baltimore who treats the disorder, tells MSNBC. “I would anticipate there would be something of a fall-off,” Earley said, adding: “I think we need to take the kettle off the stove and let it cool down a bit.”
That prediction alarms patient advocates who have welcomed public attention for the little-known disorder first defined in 1945. “I think there certainly has been awareness about restless legs syndrome since the approval of (Reqiup) in 2005,” says Georgianna Bell, executive director of the Restless Legs Syndrome Foundation, which is funded by Glaxo and Boehringer Ingelheim.
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For years, the American Society of Clinical Oncology gave research data early to members in an embargoed book of abstracts, or summaries, that weren’t supposed to be made public until the yearly meeting began. But inevitably, the findings leaked, and the resulting insider trading caused biotech shares to fluctuate as much as 10 percent, the so-called ASCO effect, Bloomberg News writes.
The rules have changed this year, and study data will be released all at once to doctors, media and investors tonight at 9 pm EST. This means securities analysts, fund managers and others will be up all night, sorting through an unprecedented torrent of almost 5,000 studies on new cancer treatments, looking for market-moving data.
“There is always some make-or-break data with these one- product companies that leads to an explosion,” Dave Heupel, who manages $60 billion at Thrivent Financial for Lutherans, tells Bloomberg. “There are always going to be people attempting to get the data before everyone else can. It is part of what you have to endure year in and year out.”
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Diabetes meds are now the leading driver of prescription drug spending growth, displacing cholesterol pills which, thanks to generics, fell precipitously after a decade of reigning in the top position, according to a report by Medco Health Solutions, the pharmacy benefit manager.
The report shows that despite continued growth in the use of cholesterol drugs, spending fell 8.5 percent in 2007 as usage of lower-cost generic Pravachol and Zocor increased. Meanwhile, spending on diabetes drugs increased 12 percent due to shifts toward higher-cost meds, brand-name drug price inflation and moderate growth in the number of patients receiving treatment. Here’s the link to the chart to the left.
Other findings: Drug spending rose 12.3 percent in 2007, with specialty drugs accounting for 11.4 percent of all pharmacy plan spending, up 10.4 percent, thanks to autoimmune conditions, cancer, multiple sclerosis and respiratory conditions. Spending on cancer drugs is expected to increase 46 to 53 percent through 2010 on a compounded basis, driven by treatments with monthly costs that can exceed $10,000, according to Medco.
Saftey concerns had a “significant bearing” on spending and utilization on antidepressants, hormone replacement therapy, and specialty anemia treatments, Medco reports. Safety warnings on Procrit, Epogen and Aranesp, which are used to treat anemia in patients with cancer or kidney disease, led to a 15.1 percent drop in spending on this class of drugs.
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