July 12, 2010 - Lilly Touting Blood Test To Boost Effient Sales.

The New York Times (7/12, Pollack) "Prescriptions" blog reported, "Eli Lilly is about to try a new tack to help flagging sales of its new anti-clotting drug, Effient [prasugrel]." The drugmaker "will urge doctors to" administer "a blood test" developed by Accumetrics to "patients taking a rival drug, Plavix [clopidogrel bisulfate], to see if it is working," and "if it isn't, doctors would presumably switch patients to Effient." According to the Times, the "collaboration is an example of how pharmaceutical companies and diagnostics companies can work together for mutual advantage." Recent studies have demonstrated that effectiveness of clopidogrel may be impaired by using Proton Pump Inhibitor medications.

July 12, 2010 - Texas Monitors Psychotropic Drug Prescribing in Medicaid.

The Texas Tribune (7/12, Ramshaw) reported that in Texas, "officials with the state Health and Human Services Commission say psychotropic drugs represent just two percent of the 30 million Medicaid prescriptions filled every year." However, "they acknowledge the drugs are powerful and need close monitoring, particularly in children. Agency spokeswoman Stephanie Goodman wouldn't say whether Health and Human Services is investigating any particular doctors for overprescribing antipsychotics, but warned that 'any doctor prescribing far more drugs than his counterparts should expect to be on our radar.'"

July 12, 2010 - Actos Vastly Outsells Avandia In US.

The New York Times (7/12, Wilson) "Prescriptions" blog reported, "Avandia had lost a lot of ground in the market to Actos as a medicine for type 2 diabetes, even before the latest round of negative information as the Food and Drug Administration considers whether to order Avandia removed from the market." In 2009, according to IMS Health, "Avandia had $521 million in sales in the United States, compared to market leader Actos with $3.4 billion."

July 12, 2010 - FDA Panel To Review Anti-Obesity Drugs.

The Wall Street Journal (7/12, Gryta, Clark) reports that on Thursday, an FDA panel will review Vivus Inc.'s weight-loss drug Qnexa (phentermine/topiramate). Review of this and two additional formulations may be reviewed with similar criteria. The FDA said it will evaluate the drugs, which include Arena Pharmaceuticals Inc.'s lorcaserin and Orexigen Therapeutics Inc.'s Contrave (naltrexone SR/bupropion SR), under the assumption that patients will use them for the rest of their lives. The Journal notes that during the hearing for Qnexa, questions about the neurologic and psychiatric effects of topiramate, as well as the cardiovascular impact of phentermine are expected. Two of the three medications are merely reformulations of existing medications.

July 12, 2010 - Avandia Controversy May Change FDA Response To Drug-Safety Concerns.

The Wall Street Journal (7/12, Mundy) reports that the controversy surrounding Avandia may even change the way the agency responds to safety concerns surrounding medications, especially those that it has already approved. The Journal quotes former FDA Commissioner David Kessler as calling the Avandia safety discussions "a defining moment" for both Commissioner Hamburg and Deputy Commissioner Sharfstein.

July 10, 2010 - Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.

MedPage Today (7/10, Walsh) reported, "Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores."

July 10, 2010 - DC Law Designating Pharmacy Benefit Managers As Fiduciaries Rejected.

The Hill 's (7/10, Pecquet) "Healthwatch" blog said "a local law designating Pharmacy Benefit Managers as fiduciaries was struck down by the DC appeals court today" after a three-judge panel on the US Court of Appeals for the District of Columbia "found that key portions of the 2004 law were unconstitutional." The blog noted that the law never went into effect in DC "because of an injunction filed right after the law passed." The court said "PBMs are regulated exclusively by federal law," so "states and local governments can't impose other requirements."

July 10, 2010 - FDA Advisory Panel To Debate Safety Of Avandia.

USA Today (7/10, Rubin) reported, "A large clinical trial of Avandia, sponsored by its maker, 'was inadequately designed and conducted to provide any reassurance' that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday." The memo, written by Thomas Marciniak is part of a 765-page briefing document prepared by the FDA for the upcoming advisory committee meeting to review Avandia [rosiglitazone]. The New York Times (7/10, A1, Harris) reported on the front page that Dr. Marciniak "found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study's tally of adverse events. Such repeated mistakes 'should not be found even as single occurrences' and 'suggest serious flaws with trial conduct,' Dr. Marciniak wrote." The Washington Post (7/10, Stein) reported that “agency experts remained split over the drug." The Wall Street Journal (7/10, Dooren), HealthDay (7/9, Gardner), MedPage Today (7/9, Phend), and MedPage Today (7/9, Walker) also covered the story.

July 9, 2010 – State Medicaid Programs Could Save $100 Million By Mandating Use Of Generics.

The Boston Globe's (7/9, Cooney) "White Coat Notes" blog reports that a study from Health Affairs found that some states are able to switch patients from brand-name to generic drugs more quickly than others when the drugs lose patent protection. "The difference has implications for expanding Medicaid coverage to more people after the national healthcare overhaul takes effect." For the study, researchers "looked at what happened when the patent for Zocor [simvastatin] expired in 2006 and generic versions...became available," and found that for "states that did not require patient consent for substituting" the generic, "98 percent of prescriptions were filled with the generic drug." The authors concluded that when other drugs go off patent "in the next few years, the savings could total $100 million nationwide for Medicaid programs if policies did not require patient consent."

July 8, 2010 - FDA Cautions Against Using Quinine For Leg Cramps.

The Los Angeles Times (7/8, Maugh) reported, "The Food and Drug Administration on Thursday cautioned consumers against using quinine [Qualaquin] for" nocturnal "leg cramps, warning that the drug could cause severe side effects, including death." Indeed, "studies have shown that it can reduce the incidence of cramps by one-third to one-half." However, "as many as one in every 25 users can suffer serious side effects." The FDA issued the warning due to adverse-event reporting system, according to the Wall Street Journal (7/8, Dooren). Over three and a half years, 38 reports had been submitted. In those reports, "24 instances of serious life-threatening reactions" were noted according to MedPage Today (7/8, Petrochko). "These adverse events resulted in permanent kidney impairment and hospitalization in some people, and death in two." This warning reiterates a prior warning from 2006. Nevertheless according to the FDA, most of the quinine used in the United States continues to be for the prevention or treatment of leg cramps.

July 7, 2010 - Training Can Help Patients Better Control High Blood Pressure At Home.

HealthDay (7/7, Reinberg) reported, "With proper training, people with high blood pressure may be able to control it more effectively on their own at home than through conventional methods." In fact, "through telemonitoring of their blood pressure and adjusting their medications according to guidelines agreed upon in advance, patients assigned to self-managed care saw greater reductions in blood pressure after six and 12 months than patients receiving standard care through health professionals," according to a paper in The Lancet.

July 7, 2010 - Rheumatologists Claim Intimidation From Maker Over Criticism Of Colcrys.

The Wall Street Journal (7/7, Rockoff) reports that last year after the FDA approved URL Pharma, Inc.'s gout treatment, Colcrys (colchicine), several physicians criticized both the drugmaker and the FDA online, and some urged fellow rheumatologists to instead use the generic version which costs pennies a pill, as opposed to Colcrys, which costs $5. URL responded by sending letters to the physicians, warning them that their posts could lead to lawsuits. Several of the physicians, who are members of a discussion group sponsored by the American College of Rheumatology, say that URL is attempting to intimidate them.

July 7,2010 - FDA Approves AD/HD Patch For Adolescent Use.

Businessweek (7/7) reports, "Shire PLC said Tuesday that US regulators approved its attention deficit hyperactivity disorder patch Daytrana [methylphenidate transdermal] for use in adolescents age 13 to 17." The FDA previously "approved Daytrana in April 2006 for use in children age six to 12." The patch "is sold in strengths of 10 milligrams, 15 milligrams, 20 milligrams, and 30 milligrams, and is designed to be worn for nine hours." The Philadelphia Inquirer (7/7, Rudolph) also reported on this story.

July 7, 2010 - FDA Warns Cornerstone Over Zyflo CR Promotional Materials.

Businessweek (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."

July 6, 2010 - Testosterone Gel Trial Halted Due To High Number Of Heart Attacks.

The New York Times (7/6, D7, Rabin) reports, "A federally financed study to see if testosterone gel helps frail elderly men build muscle and strength was abruptly halted late last year after participants taking it suffered a disproportionate number of heart attacks and other serious cardiac problems, and one died of what was apparently a heart attack." The Times says that "researchers were taken aback by the high rate of adverse heart problems." The FDA "has approved it for use only in men with hypogonadism, whose sex glands produce extremely low amounts of testosterone or none at all because of an underlying disorder," yet, "off-label use has increased in recent years."

July 6, 2010 - STD Rates Higher Among Men Taking ED Drugs.

Bloomberg News (7/6, Ostrow) reports, users of medicines for erectile dysfunction (ED) “showed almost triple the rate of sexually transmitted diseases compared with those not taking the medications." In fact, the "higher rate of infections was seen in the year before and after the men started taking the prescription medicines," Harvard researchers explained. Investigators "looked at health insurance claims from 44 large US employers from 1997, one year before Viagra [sildenafil] was introduced, through 2006." The "most frequently reported STD was HIV/AIDS, followed by chlamydia," HealthDay (7/5, Behen) noted. The findings "suggest a need for greater responsibility in prescribing ED medications." The Boston Globe (7/5, Cooney) "White Coat Notes" blog also covered the study.

July 5, 2010 - Study Finds Drug Prices In Europe Comparable To Those In US.

The Financial Times (7/5, Jack) reported on a study from the London School of Economics to be published in Health Economics, Policy and Law. The study shows that despite claims by US pharmaceutical manufacturers, the prices for patented medicines in the US are comparable to those in other OECD nations. The Times considered the report particularly damaging to arguments made by PhRMA, which has long claimed that European policies, such as regulation and price controls, make the continent less appealing to researchers. The new data suggest that drug maker profits, and prices, in the US are only marginally higher than in Europe.

July 2, 2010 - FDA Approves Prograf Generic

Watson Pharmaceuticals Inc. announced it received approval to sell a generic version of the drug Prograf [tacrolimus], which is used to prevent rejection of transplanted organs." The FDA approved the drug "in 5-milligram capsules," and Watson "said it will start shipping the drug immediately."

June 2010 - Week 5 News

June 28, 2010 - Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News (6/28, story 7, 2:20, Sawyer), CBS Evening News (6/28, story 10, 0:30, Smith), and NBC Nightly News (6/28, story 8, 0:20, Williams) reported on two studies providing additional evidence of cardiovascular disease associated with Avandia [rosiglitazone] use in advance of a scheduled FDA committee meeting to review safety data. The Washington Post (6/29, Stein) reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times (6/29, Roan) reports that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine." USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death."

The Boston Globe (6/29, Rowland) quotes one of the study authors Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'" The New York Times (6/29, Harris) reports that "the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." Bloomberg News (6/29, Cortez), the NPR (6/28, Hensley) "Shots" blog, the Wall Street Journal (6/29, Mundy, Dooren), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner), MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story. The Hill (6/28, Pecquet) "Healthwatch" blog, and Bloomberg News (6/29, Peterson, Cortez) reported on Congressional reactions.


June 28, 2010 - Severe Headache, Migraine Patients Treated More, But Not By Guidelines.
Medscape (6/28, Gandey) reported, "A new study assessing trends in prescribing has found that, although more patients are being treated for severe headaches and migraine than ever before, they are" often receiving "more opioids, nonsteroidal anti-inflammatory drugs, benzodiazepines, muscle relaxants, and barbiturates." Opioids, benzodiazepines, muscle relaxants and barbiturates may lead to dependence and have poor evidence of effectiveness in treating headaches. They are not supported as appropriate treatment in guidelines for treating migraine. The study of "4,280 people from the National Health and Nutrition Examination Survey" also "found that although nonspecific medication use continued to increase, daily use of over-the-counter and prescription nonsteroidal anti-inflammatory drug use decreased."


June 29, 2010 - Half Of Breast Cancer Patients Stop Taking Key Medications Ahead Of Schedule.
USA Today (6/29, Szabo) reports that, according to research published online Monday in the Journal of Clinical Oncology, "half of breast cancer patients stop taking key medications ahead of schedule, a decision that can increase their risk of relapse and death." In the study of 8,769 women, researchers found that "only 49% of women took hormonal therapy pills for at least 4½ years." The study authors theorized that the length of time the prescriptions must be taken, or side effects may contribute to poor adherence or early discontinuation. The Los Angeles Times (6/28, Schiewe) "Booster Shots" blog also covered the story.


June 29, 2010 - Statins May Not Lower Death Rates Among Patients Without Heart Disease.
The Los Angeles Times (6/29, Healy) reported on the ongoing debate of the long-term benefits of cholesterol-lowering medications “that rake in some $26 billion a year for their makers.” A meta-analysis "published in the Archives of Internal Medicine found that statins do not lower death rates among patients with risk factors but no evidence of established cardiovascular disease who take them as a preventive measure." AFP (6/29) reports that the meta-analysis "involving 65,229 people questioned the wider use of statins...in patients who do not have but could develop heart disease." Researchers found that altogether, nearly 2,800 participants "died, including 1,447 in the placebo group and 1,346 in the statin group. It is not a statistically meaningful enough difference to recommend preventative treatment with statins, the authors concluded." HealthDay (6/28, Reinberg) reported that "even though the statins were doing their job and the levels of LDL...cholesterol were higher among people taking the placebo than those taking statins, there was no association between risk of dying and LDL level," the researchers found.

Meanwhile, "a study released Monday characterized as 'flawed' a widely hailed 2008 study that appeared to establish the benefit of the statin rosuvastatin (commercially marketed as Crestor) in the prevention of heart attack and stroke." Bloomberg News (6/29, Kelley) reports that the authors of the second article indicate that "nine of the 14 researchers who conducted the study, dubbed Jupiter, had financial ties to London-based AstraZeneca that may have influenced the way they did their job." Bloomberg points out that "AstraZeneca in March 2008 stopped the study early because of 'unequivocal' evidence that the pill cut deaths better than a placebo in people who had no evidence of existing heart disease." Reuters (6/29, Kelland), and MedPage Today (6/28, Bankhead) also covered the story.


June 29, 2010 - Effient Linked To Higher Cancer Risk Compared To Plavix.
Bloomberg News (6/29, Gibson) reports, "Eli Lilly's blood-thinner Effient [prasugrel] was linked to higher rates of cancer than Bristol-Myers Squibb Co.'s rival product Plavix [clopidogrel]," according to research published June 28 in the Archives of Internal Medicine. Patients "taking Effient had a 43 percent higher rate of solid tumors, excluding some skin cancers and brain tumors, than those who received Plavix." MedPage Today (6/28, Gever) reported that "potential cancer risks associated with the antiplatelet drug prasugrel (Effient) should raise clinical concerns -- and may even warrant a boxed warning." Never-published "data from the pivotal TRITON-TIMI 38 trial that tested the drug against its chief competitor, clopidogrel (Plavix), suggested that the risk of new or worsened solid-tumor cancers was increased more than 60% with prasugrel (relative risk 1.62, P=0.001)." These "findings...pointed to a greater risk than was apparent from the published results from TRITON-TIMI 38 or the FDA's own analysis, presented at a February 2009 advisory committee meeting." Although the relative risks were found to be elevated, the absolute risks of a solid tumor diagnosis was small. Of 13,600 patients only 102 were diagnosed with new cancers, and fewer only 54 trial participants died due to a pre-existing or new tumor.


June 29, 2010 - FDA Approves Arimidex Generic.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval and commercial launch of Anastrozole Tablets 1 mg, the Company's generic version of AstraZeneca's ARIMIDEX®. The product is indicated for treatment of certain forms of breast cancer in postmenopausal women." Market exclusivity periods on several of AstraZeneca's biggest-selling drugs are set to expire in the next few years.


June 29, 2010 - Heart Group Issues Statement Regarding Avandia Following New Data On Drug's Heart Risks.
The Los Angeles Times (6/29, Roan) "Booster Shots" blog reported that, following new research linking Avandia (rosiglitazone) to increased heart risks, "the American Heart Assn. weighed in Tuesday with some advice for people taking" the drug. In a statement, the group lists its "recommendations, including that the drug metformin should generally be considered the first choice for glucose-lowering drugs.” According to a Consumer Reports Insights article in the Washington Post (6/29), "For people who need a diabetes drug, Consumer Reports' free Best Buy Drugs report recommends metformin, either alone or with glipizide or glimepiride, as the first option. It has a well-established safety profile and is available as an inexpensive generic." MedPage Today (6/29, Phend) , and NPR (6/30, Knox) also reported on the story.


June 29, 2010 – Pioglitazone, Rosiglitazone May Increase Fracture Risk In Men.
Medscape (6/29, Lowry) reported that, according to research presented at the American Diabetes Association meeting, "thiazolidinediones increase fracture risk, not just in women, as is commonly believed, but in men." After analyzing "data on 212,977 people 40 years and older with type 2 diabetes to determine the number of patients who had had a fracture between 2000...and 2008," Scottish researchers found that "male thiazolidinedione users had a two-fold risk for hip fracture, with an age-adjusted incidence rate ratio of 2.23, compared with male nonusers." The study's lead author pointed out that the risk was seen "more in middle-aged men between 55 and 65 years."


June 29, 2010 - Teva's Generic Effexor XR Approved By FDA.
Teva Pharmaceutical Industries Ltd. announced "U.S. Food and Drug Administration (FDA) approval of Venlafaxine HCl ER Capsules, the Company's generic version of Wyeth's antidepressant Effexor XR®." The company said "shipment is expected to commence on July 1, 2010, as per the terms of the 2006 agreement with Wyeth." This produce, like the brand name will carry a safety warnings regarding the increased risk for suicidal thinking and behavior in children, adolescents, and young adults receiving antidepressants. HealthDay (6/29) and Reuters (6/29, Scheer) also covered the story.


June 30, 2010 - FDA Warns Shire On Overstating Benefits Of Intuniv, ADHD Medication.
Bloomberg News (6/30, Peterson) reported that, according to a June 22 letter (pdf) posted to its website, the Food and Drug Administration says that "Shire Plc overstates" in its promotional materials "the benefits of Intuniv" (guanfacine hydrochloride), its medication for attention-deficit/hyperactivity disorder in children. The letter charged that "brochures in a patient starter kit for the drug make 'unsubstantiated effectiveness claims' and 'omit and minimize important risk information.'" The FDA said that "clinical studies don't support the company's claims that the drug improves 'individual behavioral problems,' such as 'bedtime blowups,' 'homework hassles,' and 'mall meltdowns.'"


June 30, 2010 – New Emergency Contraception Option May Also Treat Uterine Fibroids.
WebMD (6/30, Mann) reported that EllaOne, a "drug used in Europe as emergency contraception, may also treat painful uterine fibroids," researchers said at the annual meeting of the European Society of Human Reproduction and Embryology. In a study "of 57 women aged 25 to 50 whose fibroids were causing symptoms, a large percentage of women who took the drug once a day for three menstrual cycles showed reductions in the size of their fibroids, compared with women who took a" placebo. In addition, during "the third month of treatment, 80% of women who took the 10 milligram dose of the new drug and 95% who took the higher 20 milligram dose experienced no menstrual bleeding."


June 30, 2010 - Metformin Use May Reduce Type 2 Diabetes Mortality.
MedPage Today (6/30, Fiore) reported that "metformin use may reduce mortality among patients with type 2 diabetes who are at risk for cardiovascular events," according to research presented at the American Diabetes Association (ADA) meeting. Investigators reported that "a large, multicenter trial found a 24% reduced risk of all-cause mortality among patients on the drug, compared with those not taking it." HeartWire (6/30, Lowry) reported that "even patients thought to have contraindications to metformin, such as those with moderate renal failure, congestive heart failure, or advanced age up to 80 years, showed benefit."


July 1, 2010 - Endo Pharmaceuticals Provides New Information On Fortesta To FDA For Extended Review.
Endo Pharmaceuticals Holdings Inc. announced that it has provided a complete response to the Food and Drug Administration regarding "its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism." According to the company, this response was a a new analysis of testosterone levels in one of the studies of Fortesta which the FDA had previously questioned. The company expects the agency to complete its review in about six months.


July 2, 2010 - House Passes Proposal Restricting "Pay To Delay" Arragements.
Bloomberg News (7/2, Bliss) reports, "The US House approved a measure restricting the ability of drugmakers to enter agreements that the Federal Trade Commission has said keep generic medicines off the market." The proposal, included in a war-funding bill, would fine companies "if the FTC and courts find they are involved in settlements that preserve a brand-name pharmaceutical firm's patent by delaying a generic- drug maker's introduction of a lower-priced product." Drug companies "are lobbying against the provision, and passage in the Senate isn't assured. At a June 9 hearing, Senators Orrin Hatch, a Utah Republican, and Arlen Specter, a Pennsylvania Democrat, said they were concerned the FTC campaign against the deals may discourage agreements that benefit consumers." Dow Jones Newswire (7/2, Boyles) says that the measure would raise $2.5 billion over 10 years, according to a senior House Democratic aide. The funds would be used to offset the cost of other domestic policy items.


July 2, 2010 - Report Says Oxycodone Was The Cause Of 1,185 Deaths In Florida Last Year.
St. Petersburg Times (7/2, Martin, Farlow) reports that data "from the Florida Department of Law Enforcement released Thursday" indicate "that oxycodone was the cause of 1,185 state deaths in 2009, a 26 percent increase from the year before and a whopping 249 percent increase from 2005." Altogether, "prescription drug deaths monitored by the state Medical Examiner's Office continued to climb to 2,488 last year." Meanwhile, "deaths caused by some illegal drugs declined."

June 2010 - Week 4 News

June 21, 2010 - FDA Approves Once-Daily Memantine Formulation For Patients With Moderate To Severe Alzheimer’s Dementia.
BusinessWire (6/21, Jeffrey) reported that Forest Laboratories, Inc and Merz Pharmaceuticals GmbH "announced...they have received approval from the US Food and Drug Administration of an extended-release formulation of memantine hydrochloride (Namenda XR) for the treatment of moderate to severe dementia of the Alzheimer's type (DAT)." This "extended-release formulation is a 28-mg, once-daily dose of memantine; the twice-daily immediate-release formulation of the drug was approved in October 2003." Medscape noted that "safety and efficacy of the new formulation were established in a randomized, double-blind, placebo-controlled trial of 677 DAT patients who were already being treated with a cholinesterase inhibitor." The previously approved dose of memantine was 10mg twice daily, other than dose frequency no additional advantages of the new formulation were identified. Market exclusivity for the original formulation is due to expire in 2015.

June 22, 2010 - Pfizer Withdraws Cancer Drug Ten Years After Accelerated Approval For Lack Benefit And Safety Concerns.
The Wall Street Journal (6/22, Dooren) reported an FDA announcement that Pfizer Inc. has withdrawn Mylotarg (gemtuzumab ozogamicin) from the US market. Despite accelerated review and approval, 10 years ago, research has indicated that the medication was not effective and was linked to safety issues, notably a potentially fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug "increased during its time on the market." The Los Angeles Times (6/21, Healy) "Booster Shots" blog reported that "although Mylotarg received accelerated FDA approval in 2000, the agency required an additional clinical trial to demonstrate its safety and effectiveness." The required trial, which did not begin until 2004, “has shown higher levels of liver toxicity in patients than seen in early trials, with no benefits to patients." Researchers found that, "compared with AML patients on standard chemotherapy alone, those on Mylotarg were more likely to die." Bloomberg News (6/22, Larkin) reports that "Mylotarg...is the first medicine to be pulled off the market that was cleared through the Food and Drug Administration's accelerated approval program, the agency said today in a statement." According to Robert Kane, acting deputy director for safety in the FDA's Division of Hematology Products, "Accelerated approval still has a place in the approval process but it's also more important that we learn over the years that the whole development plan be set up well in advance." Reuters (6/22, Richwine), and MedPage Today (6/21, Smith) also covered the story.

June 22, 2010 - High-Deductible Health-Insurance Plans Attractive To Employers, But Draw Criticism.
The Washington Post (6/22, Andrews) reported, "Rising costs make" high-deductible health plans and health savings accounts linked to them "attractive to employers because they are cheaper than comprehensive coverage." Additionally, they "are a key element in 'consumer-driven health care.'" Critics complain that requiring people to pay more "for health care encourages them to cut back on care they need." These plans are also criticized as providing "a tax shelter for healthy, affluent people who can afford to sock money away and leave it there to grow."

June 22, 2010 - HHS Report Incites Concern Over Foreign Drug Trials.
The New York Times (6/22, A14, Harris) reports that the Department of Health and Human Services has completed a report finding: "80 percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites." The DHHS Inspector General "pointed out that the [FDA] was often unaware of foreign clinical trials as they were being conducted. As a result, federal regulators have no ability to ensure that patients in these trials are being protected while the research is continuing." Rep. Rosa DeLauro (D-CT) said, "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health." The Times also noted that the FDA could not produce “clinical trial data for 29 of the 129 of the approved applications in 2008." This story was widely reported, appearing on over 100 news websites, including CBS News (6/23, Strickler).

June 22, 2010 - Osteoporosis Bisphosphonate Druvs May Be Associated With Lower Risk Of Invasive Breast Cancer.
MedPage Today (6/22, Bankhead) reported that "the risk of invasive breast cancer declined 30% to 40% among postmenopausal women using bone-preserving bisphosphonate drugs," according to two studies published online in the Journal of Clinical Oncology. In one study, researchers found that "bisphosphonate users in the Women's Health Initiative (WHI) had a 32% reduction in breast cancer risk during almost eight years of follow-up, while an Israeli study showed a 39% reduction in relative risk among women who took bisphosphonates for at least a year. Moreover, breast cancers among women taking bisphosphonates tended to have favorable prognostic characteristics."

June 22, 2010 – Lilly’s Humulin To Be Sold Through Walmart Pharmacies.
Reuters (6/22, Kelly) reported, "Eli Lilly & Co (LLY.N) will sell its Humulin insulin product in a co-branding deal with Wal-Mart Stores Inc (WMT.N) beginning in mid-September." The diabetes treatment will be sold "under the name Humulin Relion in 10 milliliter vials of Humulin R U-100, Humulin N, and Humulin 70/30 formulations." The Wall Street Journal (6/23, Kingsbury, Talley) notes that the deal is a shift for Walmart from its previous partnership with Novo Nordisk.

June 23, 2010 - Avandia Trial Sparks Dispute.
The Boston Globe (6/23, Rowland) reports on the 17 physicians "recruiting patients as subjects for a clinical trial testing the safety of Avandia [rosiglitazone], which was once the top-selling diabetes drug in the world, but has been the subject of controversy over warnings that it increases the risk of heart attack." Specialists, including some FDA officials, "contend that the drug is too dangerous to remain on the market and that the ongoing Avandia clinical trial is unethical," while defenders of the drug "say it has not been proven to be harmful." Meanwhile, on July 13, an FDA advisory panel "will publicly scrutinize Avandia safety issues, including whether the ongoing clinical trial should be suspended."

June 24, 2010 - Groups Lobbying FDA To Delay Generic Blood Thinner Have Ties To Brand Manufacturer.
The Wall Street Journal (6/24, Mundy) reported that some parties lobbying the FDA to delay approval of a generic version of the blood thinner Lovenox have undisclosed financial links to Sanofi-Aventis SA. The Journal identifies The Society of Hospital Medicine, the North American Thrombosis Forum, and researcher and professor Victor Tapson of Duke University Medical Center as being opposed to reviewing a generic alternative, and having ties to the brand manufacturer.

June 24, 2010 - Pfizer Will Not Proceed With Trial Of Antipsychotic Medication For ‘Pediatric Bipolar’ Disorder.
The Dow Jones Newswire (6/24, Gryta, Loftus) reports that Pfizer Inc. will not proceed with a study of the antipsychotic medication Geodon (ziprasidone) in young patients with bipolar disorder. However, the drugmaker still intends to seek pediatric bipolar approval of Geodon. In 2009, the FDA declined approval for this use and asked for more information. Because this and other antipsychotic medications are already widely used “off-label” in children, there may be no advantage for completing such a trial other than the additional 6-months marketing exclusivity. Additionally, the diagnosis of “pediatric bipolar disorder” is controversial and the American Psychiatric Association provides no diagnostic standard for such a condition.

June 24, 2010 - SSRIs, Amantadine May Harm Eyes Of Patients Over 65.
Two studies published in the June issue of Ophthalmology raise concerns about eye diseases and commonly used medications – specifically selective serotonin reuptake inhibitors (SSRIs) and long-term use of amantadine to treat Parkinson's disease. The first study of 18,784 cataract patients and 187,840 controls "found that SSRIs were associated with an increase in cataract risk by up to 39% in people older than 65 years." The second study, which included 169 participants, "showed corneal damage linked to the use of amantadine is dependent on the cumulative dose received."

June 24, 2010 - Merck Receives Marketing Approval For Combination Asthma Controller.
Forbes (6/24) reported, "Merck said Thursday that the U.S. Food and Drug Administration approved its inhaled asthma treatment Dulera." Dulera is a combination of previously approved inhaled asthma medicines, the steroid controller mometasone, and the long-acting bronchodilator formoterol. Like other formulation including a long-acting bronchodilator, this medicine will carry a warning of the potential for increased risk of death due to asthma. Nationwide availability is expected by the end of July. Triangle Business Journal (6/24, Vinluan), and Reuters (6/24, Sandle) also covered the story.

June 25, 2010 - Appeals Court Reviewing "Pay-To-Delay" Drug Deals Between Manufacturers.
Bloomberg News (6/25, Bliss, Decker) reports that FTC Chairman Jon Leibowitz wants a stop to the "pay-to-delay" practice of brand-name drugmakers paying generic manufacturers to keep their lower-cost version off the market, and "he could find out by August whether victory is possible." That is because "the US Court of Appeals for the Second Circuit in New York is considering whether to review an April decision by a three-judge panel of the court that upheld a 1997 deal between Bayer and Barr Pharmaceuticals, now a unit of Israel-based Teva Pharmaceutical Industries." The court is reviewing that agreement, in which "Barr dropped a patent challenge involving Cipro," and "in return, Bayer paid Barr $398 million over six years. The judges' panel urged a full-court airing, citing the 'exceptional importance' of the antitrust issues involved."

June 25, 2010 - Sanofi On Track To Double Its Diabetes Drug Sales, Company Says.
Bloomberg News (6/25, Torsoli) reports that Sanofi-Aventis SA "is 'well on track' to meet its target to double diabetes sales between 2008 and 2013, Pierre Chancel, who heads the company's diabetes division, said in an interview." Sanofi also "expects its best-selling product, the diabetes drug Lantus [insulin glargine], to maintain its lead among rival treatments." Chancel also stated the company "will continue with acquisitions and partnerships" to make its diabetes drug "pipeline more competitive."

June 2010 - Week 3 News

June 14, 2010 - Experts Propose Small Financial Incentives To Help Ensure Medication Adherence.
The New York Times (6/14, A1, Belluck) reports on its front page, "One-third to one-half of all patients do not take medication as prescribed, and up to one-quarter never fill prescriptions at all, experts say. Such lapses fuel more than $100 billion dollars in health costs annually because those patients often get sicker." But "now, a controversial, and seemingly counterintuitive, effort to tackle the problem is gaining ground: paying people money to take medicine or to comply with prescribed treatment. The idea, which is being embraced by doctors, pharmacy companies, insurers and researchers, is that paying modest financial incentives up front can save much larger costs of hospitalization." One physician noted that "although 'economically irrational'...small sums might work better than bigger ones."

June 14, 2010 - Companies Push Retiree Drug Benefits To Medicare.
The Wall Street Journal (6/14, Tita) reports that the United Auto Workers union's opposition to a plan by Navistar International Corp., a maker of trucks and engines, to shift some retirees' prescription drug benefits to the Medicare Part D program may represent the beginning of a shift among US companies looking to cut costs as federal healthcare rules change. New federal income taxes on government subsidies for company-sponsored drug coverage take effect in 2013 and benefits experts say many of the nearly 1,400 for-profit US companies that would be affected may switch retirees to Part D coverage. But the switch may result in higher premiums and reduced coverage for retirees, according to the union.

June 14, 2010 – Extended Valganciclovir May Reduce Cytomegalovirus Complications And Organ Rejection After Lung Transplant.
HealthDay (6/14, Preidt) reported, "Extended antiviral treatment after a lung transplant may help prevent dangerous complications and organ rejection," Duke researchers found after conducting a study that included 136 patients. All participants "completed three months of oral valganciclovir and then received either an additional nine months of placebo (66 patients) or an additional nine months of oral valganciclovir (70 patients)." According to the paper in the Annals of Internal Medicine, "CMV infection occurred in 10 percent of the extended treatment group, compared to 64 percent of the placebo group." What's more, "pneumonia caused by CMV virus occurred in four percent of the extended-treatment group and in 32 percent of the placebo group."


June 15, 2010 - Oregon Tightens Rules On Psychiatric Medication Use In Foster Children.
The Oregonian (6/15) reported that starting July 1, Oregon children in foster care "must have a mental health assessment before" being prescribed any antipsychotic "or more than one of another type of psychiatric" medicine. What's more, "there will...be mandatory medication reviews for children younger than six who are taking psychiatric medications and for older kids with more than two psychiatric prescriptions." Prior reporting on the change is Oregon law is found here.

June 16, 2010 - FDA Launches Drug And Vaccine Safety Website.
USA Today (6/16, Rubin) reports, "The Food and Drug Administration launched a website Tuesday where patients and healthcare professionals can find safety information about recently approved drugs and vaccines." On its Postmarketing Drug Safety Evaluations site, the FDA plans to include "what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval, or after 10,000 patients have used it, whichever comes later." Robert Boucher, an official in the FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said the agency will make a "broad sweep" of adverse-event reports, medical studies and drug utilization databases. The FDA intends to publish summary reports quarterly. Bloomberg News (6/16, Peterson) points out that the first reports will include "medications for infections, hypertension and depression, the FDA said."

June 17, 2010 - FDA Extends Review Of Application To Expand Gardasil's Use.
The Wall Street Journal (6/17, Loftus) reported that the FDA has now extended its review of an application to expand Gardasil's use to include older females. The drug's maker, Merck, now anticipates a response from the agency by year's end, according to a company spokeswoman, who declined to elaborate about why the agency has decided to extend the review timeline.

June 17, 2010 – CMS To Review Coverage Of Anemia Biologics.
Reuters (6/17) reported that the Centers for Medicare and Medicaid Services on Wednesday said it is reviewing its coverage of anemia drugs, including Amgen Inc.'s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa), after a panel of experts said the drugs could harm patients with chronic kidney disease. CMS also said it is accepting public comments through July 16 on the coverage and expects to issue a decision memo in March of 2011.

June 17, 2010 - FDA Panel Says New Morning-After Pill Is Safe, Effective.
ABC World News (6/17, story 7, 0:25, Sawyer) reported, "A new type of morning-after pill is a big step closer to going on sale in the US. Today, an FDA advisory panel voted unanimously that the pill called ellaOne [ulipristal acetate] is safe and effective." The CBS Evening News (6/17, story 8, 0:25, Couric) reported, "Studies show it can prevent pregnancy up to five days after intercourse. That's two days more than the over-the-counter Plan-B [levonorgestrel] pill." NBC Nightly News (6/17, story 5, 1:35, Holt) chief medical editor Nancy Snyderman, MD, explained that the new pill "is a close chemical cousin to the morning-after pill RU-486 [mifepristone]." The New York Times (6/18, A14, Harris) reports, "Ella blocks the effects of progesterone, a female hormone that spurs ovulation," but "some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug." The dispute focuses on "whether the drug works by delaying ovulation (as the pill's manufacturer claims) or by preventing a fertilized egg from implanting itself in the uterus (as anti-abortion advocates say)." In a head-to-head comparison of the two drugs in nearly 1,700 women, researchers found that women taking ellaOne had a less than 1 in 50 chance of becoming pregnant, while women who taking Plan B had a 1 in 40 chance, and women with neither alternative after unprotected intercourse had a 1 in 20 chance of becoming pregnant. AFP (6/18, Montet) reported that final FDA approval is "not expected for several months," but "HRA said it hopes to market Ella in the United States by the end of the year through its US partner Watson Pharmaceuticals." WebMD (6/17, DeNoon), MedPage Today (6/17, Walker), HealthDay (6/17, Gardner), USA Today (6/17), Reuters (6/18, Heavey), and The Hill (6/17, Pecquet) "Healthwatch" blog also covered the story.

June 18, 2010 - ED Visits For Pain Reliever Misuse Have Increased Over Last Five Years.
USA Today (6/18, Brophy) reported that emergency department "visits for non-medical use of pain relievers have increased at a striking rate over the last five years, according to a new study " published in Morbidity and Mortality Weekly Report. Researchers found that, "between 2004 and 2008, the estimated number of emergency department visits linked to prescription pain relievers...jumped 111%, from 144,644 visits to 305,885 visits a year, according to a study out Thursday by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control and Prevention (CDC)." Len Paulozzi, a medical epidemiologist at the CDC's Injury Center, said, "These drugs are being prescribed more often. As the number of prescriptions increase, we have seen an increase in" emergency department "visits involving the use of the drugs in a non-medical way." The Los Angeles Times (6/17, Maugh) "Booster Shots" blog reported that "the most widely abused drugs were oxycodone, which rose 152% to 105,214 visits, hydrocodone, which rose 123% to 89,051 visits and methadone, which rose 73% to 63,629 visits." The investigators "also found an 89% increase in visits for the family of anti-anxiety drugs known as benzodiazepines, with visits totaling 271,700 in 2008."

Bloomberg News (6/18, Randall) reports that, according to the researchers, "recent public health and law enforcement measures intended to prevent nonmedical use of such drugs have not prevented rate increases." Reuters (6/18, Steenhuysen) reported that in a statement, CDC Director Dr. Thomas Frieden said "We urgently need to take action." Dr. Frieden added, "These prescriptions medicines help many people, but we need to be sure they are used properly and safely." Meanwhile, SAMHSA Administrator Pamela Hyde said in a statement that "this public health threat requires an all-out effort to raise awareness of the public about proper use, storage, and disposal of these powerful drugs." The Austin American Statesman (6/17, Roser) "Salud" blog reported, "'The abuse of prescription drugs is our nation's fastest-growing drug problem. And this new study shows it is a problem that affects men and women, people under 21, and those over 21,' Office of National Drug Control Policy Director Gil Kerlikowske said in a written statement."

MedPage Today (6/17, Smith) and HealthDay (6/17, Reinberg) also covered the story.

June 18, 2010 - Celebrex May Fewer GI Events Than Diclofenac and Omeprazole.
Bloomberg News (6/18, Cortez) reported that, according to a study published online June 17 in The Lancet, Celebrex [celecoxib], an NSAID arthritis medication causes less bleeding and fewer ulcers in the gastrointestinal tract than a combination of diclofenac (an older NSAID) and omprazole (a proton pump inhibitor). In fact, the study found that "arthritis patients taking Celebrex were four times less likely to start bleeding anywhere from the stomach to the colon than those given the generic pain drug diclofenac and AstraZeneca Plc's Prilosec [omeprazole], a heartburn medicine that reduces acid production." Of course, the actual rate of “clinically significant upper or lower gastrointestinal events” was low in both groups; of approximately 2250 patients in each arm, 20 of the celecoxib and 81 of the diclofenac/omeprazole groups experienced one or more of the outcome events.

MedPage Today (6/17, Walsh) reported that an accompanying commentary said "that advice 'might be premature.'" The commentary "pointed out that the study was limited by the six month duration of treatment, so its conclusions cannot be extrapolated to long-term treatment with either celecoxib or diclofenac and, as a consequence, 'the cardiovascular data should be interpreted with caution because they might not show the true cardiovascular hazard of the two treatments.'" HealthDay (6/17, Preidt) also reported on the story.

Diclofenac may have been chosen as the comparator due to a relatively high rate of GI side effects, rather than a high prevalence of use in the population. The combination of an NSAID with omeprazole or other PPI may be common, but a more effective medication to minimize GI side effects of NSAID use is misoprostol – which is also available generically.

June 18, 2010 - Research Links Lantus To An Increased Risk Of Cancer In Patients With Diabetes.
Dow Jones Newswire (6/18, Amiel, Stovall) reported that research published in Diabetes Care links Lantus (glargine) to an increased risk of cancer in patients with diabetes. However, according to Sanofi Aventis, "The risk for cancer in subjects with diabetes has been the matter of extensive scientific debate for decades.” Reuters (6/18, Mennella, Hirschler) also covered the story.

June 2010 - Week 2 News

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.

June 2010 - Week 1 News

May 30, 2010 - Drugmaker Settlements May Not Decrease Marketing Abuses.
Time (5/30, Stier) reported that despite praise from the Justice Department of the $520 million dollars settlement paid by AstraZeneca "as a result of the off-label marketing of its blockbuster anti-psychotic drug Seroquel [quetiapine fumarate]" Critics point out that “even such large fines have yet to make a serious dent in recurring marketing abuses." Time observed that, "Since companies can roll the costs of such fines into future drug prices, the penalties become just another cost of doing business.”

May 28, 2010 – Program To Improve Prescribing Practices For Patients With Hypertension.
HealthDay (5/28, Dotinga) reported on an Academic Detailing study involving face-to-face interactions “to review current research and guidelines, doctors made small improvements in the way they prescribed medicine for patients with high blood pressure." The study was published in the Archives of Internal Medicine. Researchers found that after review of treatment guidelines, physicians “appeared to be more likely to prescribe certain blood pressure medications as recommended, with 8.7 percent prescribing the thiazide-type diuretics compared to 3.9 percent in the general population."

June 2, 2010 - FDA Approves Denosumab To Lower Fracture Risk In Postmenopausal Women.
The Wall Street Journal (6/2, Gryta), and Bloomberg News (6/2, Waters) reports that the Food and Drug Administration has approved Amgen's Prolia (denosumab) injectable medication for postmenopausal women with increased risk of fractures due to osteoporosis. Amgen is to create a clinical monitoring program to follow more than 4,500 women taking denosumab The decision immediately follows marketing authorization by the European Union according to Reuters (6/2, Berkrot).

June 2, 2010 – Low-Dose Rosiglitazone And Metformin May Slow Type 2 Diabetes Progession.
The Los Angeles Times (6/2, Maugh) "Booster Shots" blog reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online June 3 in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years.

HealthDay (6/2, Gordon) reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects. "The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin," WebMD (6/2, DeNoon) reported. But, in an email to WebMD, Steven E. Nissen, MD, of the Cleveland Clinic Foundation, said, "There is no evidence whatsoever that lower doses of [Avandia] are 'safe.'" He added, "Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best."

According to MedPage Today (6/2, Fiore), an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study. Reuters (6/3, Fox) also covered the story.

June 3, 2010 - FDA Advisory Panel Recommends Against Motavizumab Approval.
Bloomberg News (6/3, Larkin) reported, AstraZeneca Plc's MedImmune Unit "failed to win a US panel's backing to introduce an improved version of its $1 billion-a-year medicine” which is intended to reduce hospitalization for Respiratory Syncytial Virus. Motavizumab "was designed to replace Synagis [palivizumab], an older drug" that helped treat "children at risk for complications from respiratory syncytial virus." Although Synagis will lose "patent protection in 2015," the FDA advisers "recommended against approval of" the newer drug "in a 14-3 vote."

In a "report to the advisory committee," the Washington Business Journal (6/2, Sinha) reported that "a preliminary FDA review team raised three concerns with motavizumab, including technical aspects of the testing as well as the fact that the newer drug candidate had three times as many incidents of non-fatal hypersensitivity side effects in patients when compared with Synagis." Of note, the "process for gaining approval for motavizumab had already been delayed by several years after MedImmune decided to conduct a third clinical test and then again after the FDA had asked for additional data on top of the first drug application, which the local subsidiary of London-based AstraZeneca PLC had filed in January 2008."

Reuters (6/3, Heavey) reports. MedImmune continues “to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness." Sales of Synagis were impacted negatively last year by changes in national recommendations for use.

June 2, 2010 - FDA Accepts New Drug Application To Treat Obesity.
The San Diego Union-Tribune (6/2, Calbreath) reported, "San Diego's Orexigen Therapeutics said Tuesday that the Food and Drug Administration has accepted a new drug application for Contrave [naltrexone SR/bupropion SR], its proposed treatment for obesity -- becoming the latest of three drugs to enter the final stage of the agency's approval process." The FDA "is expected to decide on treatments from" Arena Pharmaceuticals and Vivus "in late October," though the "agency hasn't announced when it will have one of its panels review the drugs, prompting speculation that all three drugs might face review in September."

June 2, 2010 - GlaxoSmithKline Reaches Settlement In First Avandia Case.
The Wall Street Journal (6/2, Stovall) reported that, according to a spokeswoman from GlaxoSmithKline PLC, the drugmaker has reached a settlement in the very first Avandia [rosiglitazone] case scheduled to have been tried in Philadelphia, PA on June 1. No details of the settlement were disclosed. Reuters (6/2, Hirschler) reported that GSK still has not settled a pending multi-district suit scheduled to go to trial in October in a federal court.

June 3, 2010 - FDA Requests Revision Of Some LABA Warning Labels.
The Triangle Business Journal (6/3, Gallagher) reports, "The US Food and Drug Administration has directed drugmakers...to revise the warning labels on some of their asthma treatments." The agency said that "new warnings are needed on long-acting beta-agonists [LABAs], including GSK's Serevent [salmeterol] and Advair [fluticasone propionate], because the medication could result in severe asthma symptoms that lead to hospitalizations in children and adults or even result in death." The letters mark the eighth time the FDA has used its new power to change drug labeling since Congress granted it that authority in 2007. FDA officials stated that they wanted to see the overall use of combination products decrease as they are only needed by the most severely affected asthma patients. Dow Jones Newswire (6/3, Dooren) also covers the story.

June 4, 2010 - One In Five High School Students May Abuse Prescription Medications.
A survey (pdf) from the Centers for Disease Control and Prevention which "shows one in five high school students have taken a prescription" medication not obtained from a physician. Medications of abuse included pain medicines and medications for attention-deficit/hyperactivity disorder "used as study aids." The 2009 National Youth Risk Behavior Survey also found that "twelfth-graders had the highest likelihood of prescription" medication "abuse, at 26 percent, and ninth-graders had the lowest, at 15 percent," the CNN (6/3, Landau) "Paging Dr. Gupta" blog reported. HealthDay (6/3, Reinberg) reported that the survey of some "16,460 high school students" also revealed that "the abuse of prescription" medications "was widest among whites at 23 percent, followed by Hispanics at 17 percent, and black students at 12 percent."

The survey also asked students about drug and alcohol abuse, WebMD (6/3, Hendrick) reported. It found that "72% of high school students said they had used alcohol," while "37% said they had used marijuana, 6.4% said they had used cocaine, 4.1% said they had used methamphetamine, 6.7% said they had used ecstasy, 2.5% had used heroin, and 8% had used" hallucinogens, "such as LSD or mescaline."

June 4, 2010 - Afinitor Meets Goals In Late-Stage Study.
Novartis AG announced that its drug Afinitor [everolimus] met key treatment goals in a late-stage study involving patients with pancreatic neuroendocrine tumors. The research is scheduled to be presented at the American Society of Clinical Oncology annual meeting.

June 4, 2010 - FDA Approves Monistat Generic.
Perrigo Co. said Thursday the Food and Drug Administration approved the company's generic over-the-counter version of Johnson & Johnson's vaginal cream Monistat [miconazole]. Perrigo "was the first to file an application to make a generic version of the yeast infection treatment and the resulting patent litigation filed by Johnson & Johnson was previously dismissed."

June 4, 2010 - Amgen May Seek New Indication For Prolia Following This Week's Approvals.
The Wall Street Journal (6/4, Winslow) reported on the recent approval of Amgen's Prolia [denosumab] to treat women with osteoporosis after menopause in both the US and Europe. The Journal noted that if the drug is also approved for patients with cancer, some analysts expect sales could exceed $3 billion by 2015. Researchers at the American Society of Clinical Oncology' meeting presented new data on the drug's ability to delay fractures and other complications related to prostate cancer that has spread to the bone.