Report: Seniors Face Drug Cost Spikes.
By jeremyc | August 30, 2010
Source: DIA Daily
BusinessWeek /HealthDay (8/26) reported, “In 2009, the prices of the most popular brand-name drugs used by American seniors rose 8.3 percent, according to AARP researchers who looked at 217 brand-name drugs. They also noted that the price of those medications increased seven percent in 2008, and that the retail price of brand-name drugs climbed 41.5 percent between 2004 and 2009, while the consumer price index rose only 13.3 percent during the same period.” These “increases mean that a person who takes three brand-name drugs now pays an average of $1,900 more each year for medicine. … ‘Something is out of whack here about no increases in the rest of the economy and very substantial (increases) with pharmaceuticals,’ said AARP’s John Rother.” The study pointed out that “a growing number of Americans are turning to generic drugs.”
Branded Drug Price Hikes Considered Routine. Matthew Herper’s writes in his Forbes (8/27) blog, “The AARP is out with its annual survey showing that the prices of commonly used branded drugs increased. This year, those prices, measured at retail, rose 8% even though inflation was negative. … Prices for branded drugs always rise in our healthcare system.” Herper says, “Brands can’t compete with generics. If a cheaper knockoff version is available, it rarely pays to get in a price war. … This seems to be what happened with AARP’s worst offender, Flomax from Boehringer Ingelheim.” Herper concludes, “When AARP trumpets that ‘All but six of the 217 brand name prescription drugs studied by AARP had retail price increases exceeding general inflation last year. Each of the top 25-selling brand name drugs had price increases, with most jumping more than five percent,’ an informed reader should reply, ‘Of course.’”
Topics: Big Pharma | No Comments »
Reduced Plavix Efficacy Associated With Specific Gene Variants Confirmed In Two New Analyses, But Not In A Third.
By jeremyc | August 30, 2010
Source: DIA Daily
The Wall Street Journal (8/30, Winslow) reports that for patients with acute coronary syndrome, physicians often turn to Sanofi-Aventis and Bristol-Myers Squibb’s Plavix (clopidogrel) to prevent clot-induced strokes and heart attacks. However, a significant number of patients carry genetic variations that impede the drug’s effectiveness. While some believe a genetic test could help physicians make more accurate treatment decisions, others are wary. Cardiologist Spencer King, former president of the American College of Cardiology, added, “You can’t do a genetic test on an acute patient and get a result in time to change your mind.”
Now, two new studies are providing evidence that genetic testing may have limited value when considering a Plavix prescription, according to Reuters (8/30, Hirschler). The trials are especially significant because of the recent arrivals of Plavix generics to the market. There are no clear winners yet, however, as a third trial indicates that Plavix may indeed benefit patients who were previously thought to imperfect candidates due to their genetic make-up.
Still, Bloomberg News (8/30, Kresge) reports, Alfred Bove, the “immediate past president of the American College of Cardiology,” said, “Physicians don’t like complications.” He added, “If I told you there was an alternative to clopidogrel that worked the same way without the variations, they would jump on it.” But, after analyzing “gene variations in more than 10,000 patients who participated in the PLATO study,” an international team of researchers found that Brilinta (ticagrelor) “cut the risk of heart attacks, strokes, and death linked to heart disease more than Plavix, at a higher risk of spontaneous major bleeding, regardless of genetic variations.” In the second study, “funded by Lilly and Daiichi Sankyo” and also published in The Lancet, Harvard “researchers analyzed patients from the 2007 Triton trial to find that a genetic variation that diminished the effectiveness of Plavix didn’t have the same effect on Effient’s [prasugrel] potency.”
However, “in the CURE trial of patients with acute coronary syndromes without ST-segment elevation, clopidogrel significantly reduced the rate of cardiovascular death, MI, or stroke compared with placebo, regardless of CYP2C19 genotype (HR 0.71, 95% CI 0.60 to 0.84),” MedPage Today (8/29, Neale) reported. The paper published in the New England Journal of Medicine “contradicts previous findings leading the FDA to mandate a boxed warning on clopidogrel in March, about carriers of these variants who poorly metabolize the drug at standard doses and have higher cardiovascular event rates.” Nevertheless, “genotype-related efficacy issues may take a back seat to adherence as the main concern for clinicians,” Bove “said, pointing out that many patients on long-term clopidogrel treatment stop taking the drug.” He added, “That’s probably more of a problem than the genetic variation right now.”
The Wall Street Journal (8/30, Winslow) reports that for patients with acute coronary syndrome, physicians often turn to Sanofi-Aventis and Bristol-Myers Squibb’s Plavix (clopidogrel) to prevent clot-induced strokes and heart attacks. However, a significant number of patients carry genetic variations that impede the drug’s effectiveness. While some believe a genetic test could help physicians make more accurate treatment decisions, others are wary. Cardiologist Spencer King, former president of the American College of Cardiology, added, “You can’t do a genetic test on an acute patient and get a result in time to change your mind.”
Now, two new studies are providing evidence that genetic testing may have limited value when considering a Plavix prescription, according to Reuters (8/30, Hirschler). The trials are especially significant because of the recent arrivals of Plavix generics to the market. There are no clear winners yet, however, as a third trial indicates that Plavix may indeed benefit patients who were previously thought to imperfect candidates due to their genetic make-up.
Still, Bloomberg News (8/30, Kresge) reports, Alfred Bove, the “immediate past president of the American College of Cardiology,” said, “Physicians don’t like complications.” He added, “If I told you there was an alternative to clopidogrel that worked the same way without the variations, they would jump on it.” But, after analyzing “gene variations in more than 10,000 patients who participated in the PLATO study,” an international team of researchers found that Brilinta (ticagrelor) “cut the risk of heart attacks, strokes, and death linked to heart disease more than Plavix, at a higher risk of spontaneous major bleeding, regardless of genetic variations.” In the second study, “funded by Lilly and Daiichi Sankyo” and also published in The Lancet, Harvard “researchers analyzed patients from the 2007 Triton trial to find that a genetic variation that diminished the effectiveness of Plavix didn’t have the same effect on Effient’s [prasugrel] potency.”
However, “in the CURE trial of patients with acute coronary syndromes without ST-segment elevation, clopidogrel significantly reduced the rate of cardiovascular death, MI, or stroke compared with placebo, regardless of CYP2C19 genotype (HR 0.71, 95% CI 0.60 to 0.84),” MedPage Today (8/29, Neale) reported. The paper published in the New England Journal of Medicine “contradicts previous findings leading the FDA to mandate a boxed warning on clopidogrel in March, about carriers of these variants who poorly metabolize the drug at standard doses and have higher cardiovascular event rates.” Nevertheless, “genotype-related efficacy issues may take a back seat to adherence as the main concern for clinicians,” Bove “said, pointing out that many patients on long-term clopidogrel treatment stop taking the drug.” He added, “That’s probably more of a problem than the genetic variation right now.”
Topics: Plavix | No Comments »
High intake of green leafy vegetables lowers Type 2 diabetes risk
By jeremyc | August 20, 2010
Source: MedWire News
A high consumption of green leafy vegetables, such as spinach, kale, and lettuce, significantly reduces the risk for developing Type 2 diabetes, results from a systematic review and meta-analysis suggest.
“The findings add to the growing body of evidence that lifestyle is key for the prevention of Type 2 diabetes,” lead study author Patrice Carter (University of Leicester, UK) told MedWire News.
In total, six studies involving a total of 223,512 participants were included in the analysis. The follow-up period for the studies ranged from 4.6 to 23 years.
Prospective cohort studies that included a measure of intake of fruits, vegetables, or a combination of the two and an assessment of Type 2 diabetes risk were considered suitable for the analysis. Of the six studies identified, four also provided information on the intake of green leafy vegetables.
Pooled estimates showed that eating 1.35 (highest intake) compared with 0.20 (lowest intake) servings of green leafy vegetables per day was associated with a significant 14% reduction in risk for Type 2 diabetes.
Pooled estimates of highest versus lowest intake of fruit, vegetables, or both, did not show a significant reduction in risk for Type 2 diabetes, but there was a nonsignificant trend for improvement.
Carter emphasized that “this should not be ignored and shows more research would be beneficial.”
When asked about possible reasons for the observed risk reduction, Carter commented: “Green leafy vegetables have a number of potential benefits for reducing diabetes risk, they are high in antioxidants and magnesium. They also contain fatty acids which may increase insulin sensitivity of cells.
“Further research is needed to determine why green leafy vegetables are so important.”
The research is published in the British Medical Journal.
Topics: Diabetes | No Comments »
Modest fat gain affects blood vessel function
By jeremyc | August 20, 2010
Source: MedWire News
Gaining modest amounts of fat causes endothelial dysfunction in normal-weight adults even if their blood pressure does not change, a study suggests.
Endothelial function was only impaired with increases in visceral and not subcutaneous fat, and normal blood vessel function was recovered after the fat was lost again, the researchers report.
“Our study provides evidence that modest fat gain affects endothelial function, arguing against our cultural permissiveness toward weight gain or ‘going up a clothing size’ as a ‘normal’ phenomenon and strengthens the case for weight control as a means of attenuating cardiovascular risk,” say Virend Somers (Mayo Clinic, Rochester, Minnesota, USA) and colleagues.
The team recruited 43 healthy volunteers with a baseline body mass index of between 18.5 and 24.9 kg/m2 into their study.
After a weight maintenance period of 3 days, 35 individuals were randomly assigned to gain 3-4 kilograms of fat while eight others were asked to maintain their weight.
Those assigned to gain fat received 1000 kcal/day more than was required to maintain their weight for the first 8 weeks, after which they undertook a diet program to return to their original weight.
This group gained an average of 4.1 kg over the study period, and significantly increased their total, visceral and subcutaneous fat. However, blood pressure and overnight polysomnography remained unaltered after both fat gain and its loss.
Flow-mediated dilation of the brachial artery significantly decreased in the fat-gaining group, from 9.1% to 7.8%, but returned to baseline levels after participants shed the gained weight.
It remained unchanged during the study among participants assigned to maintain their weight.
Visceral, but not subcutaneous, fat gains were significantly correlated with flow-mediated dilation.
Reporting in the Journal of the American College of Cardiology, the researchers conclude: “Endothelial dysfunction secondary to visceral fat gain may be an important mechanism linking central obesity to increased cardiovascular morbidity and mortality.”
Topics: Cardiovascular | No Comments »
Untreated psychosis duration predicts non-remission
By jeremyc | August 19, 2010
Source: MedWire News
Duration of untreated psychosis (DUP) predicts short- and long-term failure to achieve remission in first-episode psychosis patients, researchers have found.
“Non-remission of positive psychotic symptoms is quite common in first-episode, non-affective psychosis,” explain Erik Simonsen (University of Copenhagen, Denmark) and team.
To investigate factors associated with failure to achieve remission in first-episode psychosis, the researchers studied data from 301 patients who received treatment at four psychiatric care centers in Denmark between 1997 and 2000.
Information on remission, defined as at least 1 week without psychotic symptoms, at both 3 months and 2 years after first receiving treatment was available for 299 and 293 patients, respectively.
The researchers found that 129 patients were still psychotic at 3 months, and 48 were still psychotic after 2 years.
Overall, 16.4% remained psychotic during the first 2 years of treatment, 15.5% achieved remission for less than 6 months, and 84.5% achieved remission for 6 months or longer.
The only variable that significantly differentiated these three groups was DUP, at 25.5, 14.4, and 6.0 weeks, respectively.
Logistic regression analysis revealed that longer DUP, more negative and less excitative symptoms independently predicted non-remission within the first 3 months. DUP accounted for 13.5% of the variance and negative symptoms for 6.5% in prediction of 3 months non-remission.
Longer DUP was the only significant predictor of non-remission at 2 years.
Simonsen and team conclude: “In general, long DUP, less excitative and more negative symptoms at baseline, and lack of inadequate immediate response to treatment should warn clinicians to pay attention to the more elaborate needs of these patients.”
They add: “A re-evaluation at 3 months should recognize that non-remitted patients with longer DUPs have considerable risk of continuous non-remission.”
Topics: Schizophrenia | No Comments »
Anti-inflammatory effects of HDL revealed
By jeremyc | August 19, 2010
High-density lipoprotein (HDL) particles interfere with the binding of T-cell microparticles (MPs) to human monocytes, new research suggests.
The net result is to inhibit the production of pro-inflammatory cytokines, meaning this is one mechanism by which HDL cholesterol exerts an anti-inflammatory effect.
The findings are reported by an Italian team in the open-access journal PLoS One.
Rakel Carpintero (University of Geneva, Austria) and team have previously shown that HDL inhibits the production of interleukin (IL)-1β by T-cells in response to direct cellular contact or the generation of microparticles by stimulated T-cells (MPT).
However, HDL does not inhibit the production of its natural inhibitor, the secreted form of IL-1 receptor antagonist (sIL-1Ra).
In this study, the team used labeled MPs to assess their interaction with monocytes and the effects of HDL.
They found that MPT, but not MP generated by activated endothelial cells, bound to monocytes and triggered the production of cytokines. MPT did not bind T-cells, however.
In addition, HDL-induced inhibition of interleukin (IL)-1β production correlated with the inhibition of MPT binding to monocytes, and HDL interacted with MPTrather than with monocytes, suggesting that they bound the activating factor(s) of T-cell surface.
Furthermore, the production of pro-inflammatory cytokines and chemokines was induced by MPT and inhibited by HDL.
Taken together, these observations suggest that MP generated by stimulated T-cells bind monocytes but not T-lymphocytes, and that HDL inhibits the interaction of MPT with monocytes.
“Therefore, HDL may inhibit cytokine production in human monocytes by interfering with the binding of the activating factor(s) at the surface of stimulated T cells to receptor(s) at the surface of monocytes,” say Carpinteroet al.
These results therefore “shed new light on the mechanism by which HDL [particles] display their anti-inflammatory functions,” they conclude.
Topics: Cholesterol | No Comments »
HRT breast cancer risk varies by personal characteristics
By jeremyc | August 18, 2010
Source: MedWire News
Breast cancer risk increases with increasing duration of hormone replacement therapy (HRT), with continuous combined estrogen-progestin therapy (EPT) users at the greatest risk for developing the disease, researchers report.
Women need detailed information regarding the risks associated with HRT to optimize their own risk-benefit assessments, say Giske Ursin (University of Oslo, Norway) and colleagues.
In the present study, Ursin and team investigated breast cancer risk in relation to HRT use among 56,867 peri- and postmenopausal women participating in the California Teachers Study. The researchers were particularly interested in the formulation and duration of HRT use, and how other established breast cancer risk factors might modify the risk associated with the latter.
During a mean follow-up of 9.8 years, 2857 (5%) women were diagnosed with invasive breast cancer, and the researchers found that the risk for breast cancer increased with increasing duration of estrogen therapy (ET) and EPT use.
Women reporting 15 or more years of ET use at baseline use had a 19% increased risk for breast cancer, compared with women who had never used HRT. The risk was 83% higher among women using EPT for 15 years or more.
When the researchers assessed average monthly HRT use, they found that breast cancer risk was highest among women using EPT regimens continuously. These women had a 75% increased for breast cancer compared non-users, whereas short sequential users (10 days or fewer per month) had a 40% increased risk and long sequential users (between 10 and 28 days per month) had a 49% increased risk.
Breast cancer risk also seemed dependent on body mass index (BMI). Compared with non-users, the risks associated with 15 or more years EPT and ET use were approximately doubled for women with BMIs below 29.9 kg/m2, whereas women women with a BMI of 30 kg/m2 or above had no significantly increased breast cancer risk.
Of note, elevated risks associated with EPT and ET use were confined to tumors that were positive for both estrogen and progesterone receptors, and those that were human epidermal growth factor receptor (HER)2-positive. The risk was slightly diminished for HER2-negative tumors.
“These findings, taken in context of the larger literature on this topic, continue to underscore the need to personalize risk-benefit discussions for women contemplating the use of HRT,” conclude Ursin and co-authors in the journalCancer Epidemiology Biomarkers and Prevention.
Topics: Breast cancer | No Comments »
Bills would ban drugmaker deals to delay cheap drugs
By jeremyc | August 18, 2010
Source: USA Today
Legislation that has recently gained momentum in Congress threatens to end such deals.
The House has passed a bill limiting “pay for delay” settlements, and the Senate Appropriations Committee narrowly approved a measure to ban them.
Twenty-one settlements have been made since Oct. 1, more than in any other federal fiscal year, according to the Federal Trade Commission.
Trade groups for both brand-name and generic-drug makers oppose the legislation. Bill Head, who represents the generics’ group, says the measure could hurt consumers by preventing generic makers from striking deals allowing them to introduce new drugs a few months before patent agreements expire.
The Senate bill’s key sponsor, Sen. Herb Kohl, D-Wis., says the fight about its fate is just starting.
“The drug lobby is very powerful, and obviously they don’t want something like this to happen,” says Kohl, chairman of the Senate’s Special Committee on Aging.
He vows to fight to keep the measure in a broad spending bill that the Senate will vote on later this year. Two Republicans— Sen. Charles Grassley, R-Iowa, and Sen. Susan Collins, R-Maine — are co-sponsors of Kohl’s bill.
The price of a drug falls about 85% after a competing generic is introduced, the FTC says. “Pay for delay” deals cost consumers $3.5 billion a year, it estimates.
Federal law now allows a generic to hit the market before the patent expires on a brand-name drug, if the generic’s manufacturer can prove it’s not infringing on the patent. But the brand-name company usually challenges the generic’s claim in court.
The disputes often end in settlements in which the generic company gets a large sum to drop its patent challenge and delay its drug’s launch. The FTC estimates the deals delay the availability of cost-saving generics by 17 months, on average.
Topics: Big Pharma | No Comments »
Pill May Be Linked To Increases In Certain Brain Areas.
By jeremyc | August 18, 2010
Source: DIA Daily
The UK Telegraph (8/18, Jamieson) reports that after taking “high-resolution images of men, women taking the pill, and women not taking the pill,” Austrian researchers found the “contraceptive of choice of an estimated 3.5 million British women — a quarter of all 16 to 49-year-olds — increases the size of parts of the brain by about three percent.” The “areas were those linked to ‘feminine’ skills, such as memory and conversation,” and the scientists said the “increase in size could lead to an improvement in function.”
Topics: Birth Control | No Comments »
Low HDL, high triglycerides contribute to residual CHD risk
By jeremyc | August 17, 2010
Source: MedWire News
High levels of triglycerides and low levels of high-density lipoprotein (HDL) cholesterol have a “strong and synergistic” influence on coronary heart disease (CHD) risk in the presence of well-controlled low-density lipoprotein (LDL) cholesterol, US scientists believe.
Vincent Carey (Brigham and Women’s Hospital, Boston, Massachusetts) and colleagues sought to quantify the relative contributions of triglycerides and HDL cholesterol to the residual risk for CHD after reducing LDL cholesterol to guideline-recommended levels.
From a hospital database they identified 170 patients with CHD (cases) and 175 patients without CHD (controls), all of whom had LDL cholesterol levels below 130 mg/dl (3.4 mmol/l). Specifically, the mean LDL cholesterol level was 73 mg/dl (1.9 mmol/l) in cases and 87 mg/dl (2.2 mmol/l) in controls.
Writing in the American Journal of Cardiology, Carey et al report that the risk for CHD increased by around 20% for each 23-mg/dl (0.26-mmol/l) increase in triglycerides, and decreased by around 40% for each 7.5-mg/dl (0.19-mmol/l) decrease in HDL cholesterol.
Logistic regression analysis revealed that these two risk factors interacted in a synergistic manner, such that the risk for CHD was increased around 10-fold in people in the highest quintile of triglycerides (>190 mg/dl; 2.14 mmol/l) and the lowest quintile of HDL cholesterol (<30 mg/dl; 0.78 mmol/l).
In addition, the risk for CHD associated with triglycerides and HDL cholesterol was similar in people with the lowest levels of LDL cholesterol (<70 mg/dl; 1.8 mmol/l) to that in people with higher LDL cholesterol levels.
Carey and team say their results “provide new evidence of the residual risk of disease associated with high triglycerides and low HDL cholesterol levels in the presence of LDL cholesterol control.”
They conclude: “These findings contribute to the rationale for considering low HDL and high triglyceride levels, especially when they occur together, in quantifying the risk level to select the type and intensity of treatment.”
Topics: Cholesterol | No Comments »
