CJune 6, 2010 - Erbitux Provides No Benefit Among Patients With Early-Stage Colon Cancer.
The Los Angeles Times (6/6, Maugh) "Booster Shots" blog reported, "For the second time in a year, researchers have found that a drug that has proved useful in treating advanced colon cancer provides no benefit in the early stages of the disease." It is well known that "cancer drugs are typically tested first in the most advanced cases for ethical reasons, but the assumption has always been that a drug that works for advanced disease should work even better when the tumor is of a smaller, more manageable size." The new work by Mayo Clinic researchers, however, "turns that assumption on its head." Dow Jones Newswire (6/6, Dooren), HealthDay (6/6, Gardner) and Bloomberg News (6/6, Randall) also covered the story.
June 7, 2010 - Avastin May Extend Progression-Free Survival In Ovarian Cancer Patients.
The Los Angeles Times (6/7, Maugh) reported that "the cancer drug Avastin [bevacizumab] extends progression-free survival by 39% in ovarian cancer patients." This "study, reported Sunday at a Chicago meeting of the American Society of Clinical Oncology, is also the first to use the drug as first-line therapy for ovarian cancer." The New York Times (6/7, A15, Pollack) reported that the "trial involved 1,873 women with newly diagnosed Stage 3 or Stage 4 ovarian cancer who had undergone surgery to remove as much cancer as possible." Participants "received either standard chemotherapy and a placebo, standard chemotherapy and Avastin, or standard chemotherapy and Avastin followed by as many as 10 months of Avastin by itself." The researchers found that, "for those who got the extended Avastin treatment, it took a median of 14.1 months for the cancer to start worsening, compared with 10.3 months for those who received only standard chemotherapy and the placebo." This 115 day extension of progression-free survival does not imply increased cure rates.
USA Today (6/7, Szabo) reported, however, that "a short course of Avastin and chemotherapy didn't appear to offer any benefit, says study author Robert Burger of the Gynecologic Oncology Group." While previous research has "shown that Avastin can help fight relapsed ovarian cancer, this is the first" study "to show it also combats newly diagnosed disease, Burger says." The Wall Street Journal (6/7, Dooren), Bloomberg News (6/6, Waters), Reuters (6/7, Beasley), and MedPage Today (6/6, Smith) also covered the story.
June 7, 2010 – Adding Avastin May Benefit Certain Breast Cancer Patients.
MedPage Today (6/7, Susman) reported that "the addition of bevacizumab (Avastin) to most common chemotherapy regimens for metastatic breast cancer in women who have HER2-negative tumor biology appears to improve progression-free survival," according to data presented at the American Society of Clinical Oncology annual meeting. Investigators reported that "an analysis of the results of the so-called RIBBON-2 trial stratified by type of regimen showed a consistent improvement in progression-free survival with all but one of the regimens." Again, “progression-free survival” should not be confused with increased cure or prolonged survival.
June 7, 2010 - Data Suggest Two Drugs Top Gleevec For Patients With Newly Diagnosed CML.
The Wall Street Journal (6/7, Loftus) reported on findings presented at the American Society of Clinical Oncology meeting and published online in the New England Journal of Medicine suggesting that Bristol-Myers Squibb Co.'s Sprycel (dasatinib) and Novartis's Tasigna (nilotinib) may be better than Novartis AG's Gleevec (imatinib) for patients with newly diagnosed chronic myeloid leukemia. The Houston Chronicle (6/7, Ackerman) reported that "the two drugs are currently given to patients who become resistant to Gleevec."
HealthDay (6/5, Reinberg) reported that in one study, "after a year, 77 percent of the patients receiving Sprycel had a complete cytogenetic response, compared with 66 percent of the patients receiving Gleevec." In the other study, "after one year, more patients -- about 80 percent of those receiving Tasigna -- had a complete cytogenetic response, compared with 65 percent of the patients receiving Gleevec." MedPage Today (6/5, Phend) also covered the study.
June 7, 2010 - Ipilimumab Nearly Doubles Number Of Late-Stage Melanoma Patients Surviving One Year.
USA Today (6/7, Szabo) reported that "an experimental immune therapy may provide a new way to fight advanced melanoma." Specifically, "in a study of two novel treatments -- a therapeutic vaccine called gp100 and an immune stimulator called ipilimumab -- ipilimumab nearly doubled the number of patients surviving one year, found a study presented at the American Society of Clinical Oncology" meeting and published online by the New England Journal of Medicine. Approximately "25% of those given the vaccine lived one year, compared with 46% of those on ipilimumab," a drug developed by Bristol-Myers Squibb Co. In a trial of "676 patients with advanced melanoma who had failed to benefit from two treatments currently available, interleukin-2 or dacarbazine," Bloomberg News (6/5, Pettypiece) reported, "ipilimumab kept about a quarter of patients battling late-stage melanoma alive for two years -- about twice the proportion with current therapies." Those patients who took "ipilimumab alone lived an average of 10.1 months, according to the study, almost four months longer than those given the gp100 vaccine." The Chicago Sun-Times (6/5, Thomas), HealthDay (6/5, Gardner), MedPage Today (6/5, Phend), the Wall Street Journal (6/6, Loftus), Reuters (6/57, Steenhuysen), and AFP (6/6) also covered the story.
June 7, 2010 – New Desmopressin Formulation May Help Relieve Nocturnal Polyuria.
MedPage Today (6/7, Bankhead) reported, "Nocturnal polyuria and its associated adverse effects declined quickly and significantly during treatment with a quick-dissolving oral formulation of desmopressin," UCLA researchers presented findings at the American Urologic Association meeting of a 557-patient trial. They found "the frequency of nocturnal voiding declined by as much as 50%, and the voided volume of nocturnal urine decreased by as much as 40%." In addition, the "initial period of uninterrupted sleep doubled or tripled across the range of desmopressin doses, as compared with placebo." Desmopressin has been available generically as a nasal spray for many years, though because this compound can be associated with serious alterations of electrolytes, use has declined in recent years.
June 8, 2010 - FDA Panel To Consider An Emergency Contraceptive More Effective Than Plan B.
USA Today (6/8, Rubin) reported, "A Food and Drug Administration advisory committee will meet June 17 to make a recommendation for or against approval of a new emergency contraceptive shown to be more effective than Plan B [levonorgestrel], the only 'morning-after pill' on the US market." HRA Pharma of Paris "launched ulipristal acetate in October 2009 and sells it in 21 European countries under the brand name ellaOne." In a study comparing ulipristal to levonorgestrel in about 1,700 women who had sought emergency contraception at family-planning clinics in the USA, Britain and Ireland within 72 hours of having unprotected sex, 15 in the ulipristal group "ended up getting pregnant, compared with 22 who took levonorgestrel."
June 8, 2010 - FDA Grants Orphan Drug Status To CML Drug.
Medical News Today (6/8) reported, "BioSante Pharmaceuticals Inc. said Monday that regulators granted orphan drug status to its GVAX CML drug, which is intended to treat a form of leukemia." Orphan drug status provides “seven years of marketing exclusivity, tax breaks, and other benefits." Reuters (6/8, Kuber) noted that Biosante also has a pancreatic cancer vaccine and an acute myeloid leukemia vaccine that have received the orphan designation.
June 8, 2010 - Some NSAIDS May Increase Heart Risks.
NBC Nightly News (6/8, story 4, 2:40, Williams) reported that certain nonsteroidal anti-inflammatory drugs (NSAIDs) may increase heart risks, according to research published online in Circulation, Cardiovascular Quality and Outcomes. MedPage Today (6/8, Peck) reported that investigators found, "based on registry data from more than a million users of nonsteroidal anti-inflammatory drugs (NSAIDs) from 1997 through 2005," that "the two NSAIDs with the greatest increased risk of cardiovascular events were diclofenac and rofecoxib...which was withdrawn from the market in September 2004." The researchers found that "use of diclofenac" was "associated with 91% increase in the relative risk of a fatal heart attack or stroke in healthy adults, and the risk was greater at higher doses."
WebMD (6/8, DeNoon) reported that "although low doses of ibuprofen seemed to lower the risk of heart attack, the study found a trend toward increased heart attack risk with high doses." HealthDay (6/8, Edelson) reported that "the study found no increased risk of cardiovascular problems -- indeed, a slightly lower risk of death -- associated with naproxen."
June 8, 2010 - Cladribine May Reduce Signs Of MS Disease Activity.
MedPage Today (6/8, Robinson) reported that "cladribine, an oral drug already marketed for hematologic cancers under the trade name Leustatin, was superior to placebo in reducing progression and other signs of MS disease activity," according to a study presented at the Joint Consortium of Multiple Sclerosis Centers and America's Committee on Treatment and Research in Multiple Sclerosis. Researchers found that "freedom from any disease activity, including relapse, disability progression, or MRI progression, was experienced by 44.3% of patients treated with a high-dose of cladribine, and 43% of patients randomized to a low-dose regimen compared with 16% of placebo patients." This "finding emerged from a post-hoc analysis of data from a randomized, placebo-controlled study of more than 1,300 MS patients." Post-hoc analysis results are frequently reported when a clinical trial fails to demonstrate positive findings in the primary study measures. This kind of information is often used to justify “off-label” use of medications without adequate assessment of safety and effectiveness.
June 9, 2010 - Viaflex May Treat Dupuytren's Contracture Better Than Hand Surgery.
Auxilium Pharmaceuticals Inc., announced that “patients taking its Dupuytren's contracture treatment Xiaflex [collagenase clostridium histolyticum] in a two-year study had a recurrence rate of 19.3 percent," compared "with a 39 percent recurrence rate for patients undergoing a surgical procedure called fasciectomy and a recurrence rate of 85 percent with another surgical procedure, called needle fasciotomy." Collins Stewart analyst Salveen J. Kochnover also "said the launch of Xiaflex, which was approved earlier in 2010, continues to make progress, with over 1,400 physicians now approved to administer the drug. But, he added, reimbursement rates continue to remain a concern." Uptake of this treatment may be impeded not only because this is a new approach, but also because reimbursement for physicians is likely better for surgery than for medication treatment.
June 9, 2010 – First Trimester Valproic Acid Use Increases Risk For At Least Six Birth Defects.
MedPage Today (6/9, Smith) reported, "Using the antiseizure medication valproic acid in the first trimester of pregnancy significantly increased the risk of six types of birth defect," Dutch researchers found after analyzing data on "more than 98,000 pregnancies." Initially the researchers found 14 malformations were significantly more common among women who had taken valproic acid in the first trimester of pregnancy: spina bifida, microcephaly, five heart defects (including three very serious conditions), cleft palate, diaphragmatic hernia, gastroschisis, hypospadias, clubfoot, polydactyly, and craniosynostosis. To enhance reliability, the researchers designed a case control study methodology using the "European Surveillance of Congenital Anomalies (EUROCAT) antiepileptic-study database," identifying infants with the 14 birth defects, WebMD (6/9, Mann) reported. According to the paper in the New England Journal of Medicine, those babies were compared "to a group of infants with birth defects not previously connected to use of this drug and to a group of infants with chromosomal abnormalities."
The researchers eventually noted that "babies whose mothers took valproic acid during the first trimester were 12.7 times more likely to have spina bifida," HealthDay (6/9, Goodwin) reported. "Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (a heart defect); about five times as likely to have a cleft palate...or hypospadias (a penis abnormality); more than twice as likely to be born with an extra digit on the hand (polydactyly); and nearly seven times more likely to have craniosynostosis." But while "valproic acid (brand names include Depakene and Depakote) was associated with a higher relative risk of the six birth defects, the absolute risk of having a baby with any of the defects remains small."
June 9, 2010 - Metformin, Anti-Obesity Drug May Help Treat Hepatitis C Infections.
HealthDay (6/9, Preidt) reported, "The diabetes drug metformin and the anti-obesity drug AICAR may help treat hepatitis C infections, although much more study is needed." University of Leeds researchers explained that the two drugs "stimulate an enzyme called AMP kinase (AMPK)," which the "virus needs to suppress...to replicate." Thus, "by stimulating the enzyme, metformin and AICAR halt hepatitis C replication and enable cells to clear the infection."
June 9, 2010 - Warfarin May Be Safe For Patients Undergoing Heart Device Surgery.
HealthDay (6/9, Preidt) reported that "it's safe to continue giving warfarin, a blood clot inhibitor, to patients undergoing surgery to implant a heart pacemaker or defibrillator, according to a" study published in the HeartRhythm Journal. The study "included 459 patients placed on warfarin therapy." Individuals "who stopped receiving warfarin but received therapy with another blood-thinner, heparin, as a 'bridge' while having surgery to implant a cardiac device, had more bleeding complications and longer hospital stays than those who continued receiving warfarin during surgery, the US team found." Meanwhile, the researchers reported an increased TIA risk among those who received no "bridge" and who had stopped being given warfarin. The effects of warfarin can be reversed rapidly with fresh frozen plasma, or more slowly with vitamin K.
June 10, 2010 - Medicare Drug Spending Per Patient Varies Widely Nationwide.
Bloomberg News (6/10, Armstrong) reports that Medicare "spends more per patient on medicine in New York City, in Anchorage, Alaska, and in Great Falls, Montana, than anywhere else," according to a study in the New England Journal of Medicine. The researchers found that Medicare "pays 60 percent more on each beneficiary for prescription drugs in the most-expensive area, Manhattan, compared with the least costly area, in Hudson, Florida." But the study also found that there is "little connection between Medicare's drug spending in parts of the country and its outlays on hospital care or doctors." HealthDay (6/9, Reinberg) also reported on the study.
June 10, 2010 - BCBS Of Texas Sues Pfizer For "Deceptive Marketing Strategies."
The Dallas Business Journal (6/10, Bounds) reported, "Blue Cross Blue Shield of Texas, along with its parent organization and three sister health insurers, is going after the drugmaker Pfizer and four individuals over what court documents claim were 'deceptive marketing strategies' of three drugs." At issue "is that the plaintiff health insurers paid for prescriptions of the drugs -- Bextra (anti-inflammatory), Geodon (anti-psychotic), and Lyrica (anti-epileptic) -- when other medications were available that cost less and were just as safe and effective." What's more, the "defendants disseminated 'misleading' information about those three medications' safety and efficacy, and paid 'illegal kickbacks to healthcare professionals to induce them to promote and prescribe these drugs,' court documents allege."
June 11, 2010 - FDA Panel Backs Experimental MS Drug's Safety, Effectiveness.
An FDA advisory panel concluded Thursday, that an innovative multiple sclerosis drug from Novartis, called Gilenia (fingolimod), "is safe and effective for controlling tremors and other symptoms." The panel voted unanimously "that Gilenia helps reduce relapses of multiple sclerosis" and "that the proposed dose of the drug appears safe," but the panelists also "said the drug's side effects would require screening to make sure patients are healthy enough for treatment." The Wall Street Journal (6/11, A4, Dooren) also noted the panel supported Gilenia as a first-line treatment for MS. Lourdes Villalba, an FDA drug-safety senior reviewer, said that "patients need to be aware of all these possible effects and need to decide if they want to take the risks" associated with the drug, which include low heart rate, a small decline in lung function and macular edema.
Prior to the review, the Wall Street Journal (6/9, Dooren) reported on FDA findings relating to Gilenia (fingolimod), effectiveness and safety. The article noted, the drug poses "a number of safety issues," according to materials released by the agency ahead of the June 10 Advisory Committee meeting. The new medication is an oral alternative to older injectable drugs. However the side effects seen include eye disorders, heart problems, weakened lung function, and development of certain cancers. In fact, serious side effects were observed in 8.5 percent of patients taking Novartis' drug, compared with 5.8 percent using standard treatments. Bloomberg News (6/9, Lopatto, Peterson) and Reuters (6/9, Heavey) provided additional reporting.
Bloomberg News (6/11, Larkin) noted that the "panel voted 20-5 in favor of a new study testing a 0.25 milligram Gilenia pill once a day, which the FDA suggested may be 'much safer' than the 0.5 milligram proposed daily dose." A decision on marketing approval for fingolimod is expected by September. WebMD (6/10, DeNoon), MedPage Today (6/10, Frieden), HealthDay (6/10, Reinberg) and Reuters (6/11, Heavey) also covered the story.
June 11, 2010 - Avandia Linked To Increased Heart Risks In FDA Drug-Safety Study.
The Wall Street Journal (6/11, B4, Whalen, Mundy) reported that David Graham, an FDA drug-safety official concluded that the diabetes drug Avandia (rosiglitazone) may have led to thousands of preventable heart problems if other medications had been used. Graham, along with other experts, has said that drug should be removed from the market. The Journal adds that an official at the FDA said that this research would be among the data to be assessed at next month's meeting.
June 11, 2010 - Experimental Blood Thinner Trial Stopped Early On Positive Findings.
Bloomberg News (6/11, Peterson) reports that "Bristol-Myers Squibb Co. and Pfizer Inc. ended a trial of an experimental blood thinner after a panel found 'clear evidence' the drug, apixaban, helped reduce stroke risk in patients with irregular heart beats." An "independent review panel deemed apixaban more effective than aspirin in preventing strokes and embolism in patients with atrial fibrillation who can't take blood thinners such as warfarin, the companies said in a joint statement." The trial, "dubbed Averroes, was stopped early, after the interim review, and covered 5,600 patients in 36 countries, the companies said in the statement."
June 11, 2010 – Congress Investigates Wyeth For Illegal, “Off-Label” Marketing Of Transplant Drug.
Bloomberg News (6/11, Armstrong) reported that the House Oversight and Government Reform Committee "will investigate Wyeth, the drugmaker purchased last year by Pfizer, Inc., after reports the organ transplant drug Rapamune [sirolimus] was illegally marketed for unapproved uses" among black patients. The committee is investigating "whether Wyeth 'aggressively encouraged the use of Rapamune to prevent organ rejection following heart, lung, liver, pancreas, and islet cell transplants, without FDA approval,' the committee said in a statement." The drugmaker has until June 28 to respond. According to Dow Jones Newswire (6/12, Kell), the Food and Drug Administration has approved Rapamune only for the prevention of kidney rejection following transplant. Reuters (6/12, Richwine) reported that Pfizer will offer full cooperation during the FDA's inquiry.
