May 24, 2010 - Beta-Blockers May Reduce Mortality Risk, Disease Exacerbations In COPD Patients.
The Los Angeles Times (5/24, Roan) "Booster Shots" and HealthDay (5/24, Edelson) reported on a new paper appearing in the Archives of Internal Medicine "suggests that beta-blockers -- medications used to treat high blood pressure and heart rhythm disorders -- reduce respiratory infections and improve survival in people with COPD." Dutch researchers reviewed records of more than 2,200 patient and noted that COPD patients "had about a 30% reduction in deaths and disease exacerbations when treated with beta-blockers," MedPage Today (5/24, Bankhead) reported. Notably, "the results fly in the face of the conventional wisdom to avoid beta-blockers in patients with COPD." An accompanying editorial stated that the "rap against beta blockers has been that while they improve heart function, they can cause airways to contract, a problem for people with COPD." This contention was not supported in the study.
May 25, 2010 - FDA Approves Valtrex Generic.
Riverside Press Enterprise (5/25) reported Food and Drug Administration approval of a generic version of GlaxoSmithKline's herpes treatment Valtrex [valacyclovir] has been granted to Watson Pharmaceuticals, Inc. In the most recent four quarters, Valtrex sales were reported to be close to $2 billion. Watson "said it plans soon to begin shipment of Valacyclovir Hydrochloride tablets in the 500 and 1000 mg strengths."
May 25, 2010 – FDA Warns Some Uses of PPIs May Cause Bone Fractures.
Bloomberg News (5/26, Peterson), MedPage Today (5/25, Phend),and others reported on reported on a new FDA warning relating to use of proton pump inhibitors. Specifically, "high doses or long-term use … can lead to an increased risk of bone fractures," especially for those "over the age of 50." The warning "is based on a Food and Drug Administration review of several epidemiologic studies of the treatments," revealing an association with "elevated fracture risk at the hip, wrist, and spine." WebMD (5/25, DeNoon), and HealthDay (5/25, Reinberg), provided additional reporting on the story. Notably, though consumers were advised not to stop taking PPIs without discussing with their physicians, "the FDA said they should only be taken for 14 days to help ease frequent heartburn," and "under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said."
It is "not clear what the mechanism of the increased fractures is," the Los Angeles Times (5/25, Maugh) "Booster Shots" blog reported. "Most researchers believe it is due to decreased absorption of calcium from the diet because of the reduced stomach acid." It's also "possible that the drugs interfere with bone maintenance." Notably, the "drugs have previously been linked to an increased risk of contracting pneumonia and the troublesome bacterium Clostridium difficile, as well as to an increased risk of dementia." Reuters (5/26, Pierson) also covered the story.
May 26, 2010 - Experimental Drug May Boost Standard Hepatitis C Treatment Effectiveness.
The New York Times (5/26, B3, Pollack), Bloomberg News (5/26, Gibson), Dow Jones Newswire (5/26, Gryta), and Reuters (5/26, Berkrot) reported on study results of an experimental adjunct treatment for standard two drug treatment of Hepatitis C. Vertex Pharmaceuticals Inc. has developed an "experimental hepatitis C drug" that "made treatment more effective and quicker when it was added to a standard therapy," reports. The "virus was undetectable in 75 percent of patients given 12 weeks of Vertex's medicine, called telaprevir, along with a combination therapy normally used to treat the infection, the Cambridge, Massachusetts-based company said...in a statement." What's more, approximately "69 percent of patients treated for eight weeks with the telaprevir regimen were hepatitis-free after 48 weeks, compared with 44 percent of those given the standard therapy alone." It is not clear whether these responses will lead to long-term sustained virologic response, nor how this compares to the addition of metformin (an inexpensive diabetes treatment) which was also found to improve results of standard Hepatitis C treatment.
May 25, 2010 - Most Physicians Prescribe Drugs For Insomnia.
Evidence-based treatment guidelines for insomnia recommend non-drug interventions as first-line therapy for insomnia. However, researchers at the American Psychiatric Association presented a poster finding almost "three-quarters of surveyed physicians reported writing prescriptions for sleep medications as their primary course of treatment,” according to reporting in MedPage Today (5/25, Fiore).
May 27, 2010 – Roughly 1 in 6 Patients Hospitalized With Stroke Are Discharged Without a Statin.
HealthDay (5/27, Mozes) and MedPage Today (5/27, Neale) reported on research published in Stroke: Journal of the American Heart Association finding undesirable gaps in treatment of stroke patients. "Despite an increased likelihood that American stroke patients will be prescribed potentially life-saving statin medications when released from the hospital, more than 16 percent are still being discharged without such prescriptions in hand." This means “stroke patients are being unnecessarily exposed to the risk of another stroke," UCLA researchers found. The team also discovered "several factors associated with a reduced likelihood of receiving a statin at discharge, particularly female sex (OR 0.87, 95% CI 0.85 to 0.89) and treatment in the South versus the West (OR 0.66, 95% CI 0.56 to 0.78)."
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."
Saturday, May 29, 2010
Saturday, May 22, 2010
Mary 2010 - Week 3 News
May 17, 2010 - More Challenges To Biosimilar Development Than Generics.
The Wall Street Journal (5/17, Gryta) reports that Merck & Co.'s has ended its effort to copy Amgen Inc.'s Aranesp (darbepoetin alfa). The FDA is asking some companies to conduct extensive clinical trials, increasing risk of failure. This may limit the “biosimilar” industry to only the largest drug companies, the Journal notes. Biosimilar products which gain approval will likely not be automatically substitutable for biotechnology therapies, as opposed to traditional generics, which can earn the majority of market share in months.
May 18, 2010 – AARP Reports Brand-Name Drug Prices Rose 9.7% Last Year.
The Wall Street Journal (5/18, Hobson) "Health Blog" reported the AARP found widely used brand-name drug prices rose 9.7 percent in the 12 months ending in March. This represents "the biggest annual jump since the group started tracking prices in 2002." Additionally, the AARP, reported the cost of specialty drugs rose by 9.2 percent. AARP also noted that general inflation was nearly flat, and generic drug prices widely used by people in Medicare fell 9.7 percent. In a statement contesting AARP's findings as misleading. PhRMA stated, the AARP reports failed to account for "discounts and rebates generally negotiated between drug manufacturers and payers, which can significantly lower the cost of brand-name medicines, ultimately benefiting patients.” NPR (5/18, Hensley) reported the story as well.
May 20, 2010 - Rate of Prescription Drug Use Among Children Outpaced Adults Last Year.
The AP and ABC News (5/20, Murphy) reported, "Prescription drug use among children grew several times faster than for adults last year,” according to an analysis by Medco Health Solutions, Inc. "A five percent increase in prescription drug use for children contributed to a 10.8 percent spending increase last year." Overall, "prescription drug use rose 1.3 percent, and drug spending climbed 3.7 percent." Notably, "more children are being treated with cholesterol fighters or powerful anti-psychotics normally used by adults."
Reuters (5/20, Berkrot), reported a doubling of prescribing of antipsychotic medications for children since 2001. Citing the obesity epidemic, Medco chief medical officer Dr Robert Epstein also pointed out that since 2001, there's been a 50 percent increase in the number of children between 10 and 19 who use cholesterol-lowering medications, a 147 percent swell in teens taking acid reflux and heartburn remedies, and a 24 percent increase in prescriptions for blood pressure medicines. NPR (10/19, Hensley) "Shots" and The Wall Street Journal (5/19) "Health Blog" also covered the story.
May 21, 2010 - Statins May Increase Cataract, Kidney Failure, Muscle Pain And Liver Dysfunction Risks.
Bloomberg News (5/21, Cortez) reports that, according to a study published online May 20 in the British Medical Journal, statin "drugs to lower cholesterol and prevent heart disease...increase the risk of cataracts, kidney failure, muscle pain and liver dysfunction." In "a study of more than two million Britons," researchers found that "for every 10,000 people taking a statin, there were about 271 fewer cases of heart disease, eight fewer cases of esophageal cancer, 307 extra patients with cataracts, 23 additional patients with acute kidney failure, and 74 extra patients with liver dysfunction." HealthDay (5/21, Reinberg) reported, "On the more positive side, the study found no link between statin use and risks for a wide range of cancers (including stomach, colon, lung, renal, breast, or prostate malignancies), as well as no connection to Parkinson's disease, rheumatoid arthritis, blood clots, dementia, or fractures." Important to note is that "the risk for adverse effects lasted as long as the drugs were being taken, but were highest during the year when treatment was initiated, the researchers found." Reuters (5/21, Helland), BBC News (5/21), and the UK's Daily Mail (5/21, Hope) provided additional coverage.
May 21, 2010 – Chronic Chemotherapy Use May Provide Longer Remission In Multiple Myeloma and Follicular Lymphoma.
The New York Times (5/21, A17, Pollack) reported on research presented the American Society of Clinical Oncology's annual meeting showing that "use of the drug lenalidomide after stem-cell transplant sharply cut the recurrence of multiple myeloma." Another study found “two years of maintenance therapy with the drug rituximab cut the risk of cancer recurrence in half among patients with follicular lymphoma." ASCO's president-elect suggests that, "This...suggests lymphoma, like many human cancers, is a chronic disease and increasingly is likely to require chronic therapy to maintain remission." The Wall Street Journal (5/21, Dooren, Winslow), Bloomberg News (5/21, Lopatto), Reuters (5/21, Clarke), Dow Jones Newswire (5/21, Dooren, Loftus) and HealthDay (5/20, Dotinga) also covered the story. These studies will likely increase interest in continuing these relatively expensive cancer medications for extended periods of time.
May 21, 2010 – Poor Adherence to Medication Costs Over $170 Billion In The US Annually.
Pauline W. Chen, MD writes in the New York Times (5/21) Doctor and Patient column, "Like politics, religion and sex, medication nonadherence, or noncompliance, remains a topic of conversation that most of us try to avoid. …bringing the topic up in the exam room feels more like a confession or inquisition than a rational discussion." In fact, "few of us want to talk about medication nonadherence, much less admit to it." Data show that medication nonadherence costs "more than $170 billion annually in the United States alone."
The Wall Street Journal (5/17, Gryta) reports that Merck & Co.'s has ended its effort to copy Amgen Inc.'s Aranesp (darbepoetin alfa). The FDA is asking some companies to conduct extensive clinical trials, increasing risk of failure. This may limit the “biosimilar” industry to only the largest drug companies, the Journal notes. Biosimilar products which gain approval will likely not be automatically substitutable for biotechnology therapies, as opposed to traditional generics, which can earn the majority of market share in months.
May 18, 2010 – AARP Reports Brand-Name Drug Prices Rose 9.7% Last Year.
The Wall Street Journal (5/18, Hobson) "Health Blog" reported the AARP found widely used brand-name drug prices rose 9.7 percent in the 12 months ending in March. This represents "the biggest annual jump since the group started tracking prices in 2002." Additionally, the AARP, reported the cost of specialty drugs rose by 9.2 percent. AARP also noted that general inflation was nearly flat, and generic drug prices widely used by people in Medicare fell 9.7 percent. In a statement contesting AARP's findings as misleading. PhRMA stated, the AARP reports failed to account for "discounts and rebates generally negotiated between drug manufacturers and payers, which can significantly lower the cost of brand-name medicines, ultimately benefiting patients.” NPR (5/18, Hensley) reported the story as well.
May 20, 2010 - Rate of Prescription Drug Use Among Children Outpaced Adults Last Year.
The AP and ABC News (5/20, Murphy) reported, "Prescription drug use among children grew several times faster than for adults last year,” according to an analysis by Medco Health Solutions, Inc. "A five percent increase in prescription drug use for children contributed to a 10.8 percent spending increase last year." Overall, "prescription drug use rose 1.3 percent, and drug spending climbed 3.7 percent." Notably, "more children are being treated with cholesterol fighters or powerful anti-psychotics normally used by adults."
Reuters (5/20, Berkrot), reported a doubling of prescribing of antipsychotic medications for children since 2001. Citing the obesity epidemic, Medco chief medical officer Dr Robert Epstein also pointed out that since 2001, there's been a 50 percent increase in the number of children between 10 and 19 who use cholesterol-lowering medications, a 147 percent swell in teens taking acid reflux and heartburn remedies, and a 24 percent increase in prescriptions for blood pressure medicines. NPR (10/19, Hensley) "Shots" and The Wall Street Journal (5/19) "Health Blog" also covered the story.
May 21, 2010 - Statins May Increase Cataract, Kidney Failure, Muscle Pain And Liver Dysfunction Risks.
Bloomberg News (5/21, Cortez) reports that, according to a study published online May 20 in the British Medical Journal, statin "drugs to lower cholesterol and prevent heart disease...increase the risk of cataracts, kidney failure, muscle pain and liver dysfunction." In "a study of more than two million Britons," researchers found that "for every 10,000 people taking a statin, there were about 271 fewer cases of heart disease, eight fewer cases of esophageal cancer, 307 extra patients with cataracts, 23 additional patients with acute kidney failure, and 74 extra patients with liver dysfunction." HealthDay (5/21, Reinberg) reported, "On the more positive side, the study found no link between statin use and risks for a wide range of cancers (including stomach, colon, lung, renal, breast, or prostate malignancies), as well as no connection to Parkinson's disease, rheumatoid arthritis, blood clots, dementia, or fractures." Important to note is that "the risk for adverse effects lasted as long as the drugs were being taken, but were highest during the year when treatment was initiated, the researchers found." Reuters (5/21, Helland), BBC News (5/21), and the UK's Daily Mail (5/21, Hope) provided additional coverage.
May 21, 2010 – Chronic Chemotherapy Use May Provide Longer Remission In Multiple Myeloma and Follicular Lymphoma.
The New York Times (5/21, A17, Pollack) reported on research presented the American Society of Clinical Oncology's annual meeting showing that "use of the drug lenalidomide after stem-cell transplant sharply cut the recurrence of multiple myeloma." Another study found “two years of maintenance therapy with the drug rituximab cut the risk of cancer recurrence in half among patients with follicular lymphoma." ASCO's president-elect suggests that, "This...suggests lymphoma, like many human cancers, is a chronic disease and increasingly is likely to require chronic therapy to maintain remission." The Wall Street Journal (5/21, Dooren, Winslow), Bloomberg News (5/21, Lopatto), Reuters (5/21, Clarke), Dow Jones Newswire (5/21, Dooren, Loftus) and HealthDay (5/20, Dotinga) also covered the story. These studies will likely increase interest in continuing these relatively expensive cancer medications for extended periods of time.
May 21, 2010 – Poor Adherence to Medication Costs Over $170 Billion In The US Annually.
Pauline W. Chen, MD writes in the New York Times (5/21) Doctor and Patient column, "Like politics, religion and sex, medication nonadherence, or noncompliance, remains a topic of conversation that most of us try to avoid. …bringing the topic up in the exam room feels more like a confession or inquisition than a rational discussion." In fact, "few of us want to talk about medication nonadherence, much less admit to it." Data show that medication nonadherence costs "more than $170 billion annually in the United States alone."
Saturday, May 15, 2010
May 2010 - Week 2 News
May 10, 2010 - Patients Not Taking Medicine As Directed Is A National Problem.
The Boston Globe (5/10, Smith) highlights the problem of poor medication adherence reporting on a VA study of cholesterol lowering medications. The study examined the relationship between increased co-payments and other factors and affect regular medication use. Without regular use of medications for chronic conditions, patients are unlikely to receive long-term benefits in health improvement.
May 11, 2010 - Studies Link PPIs To Increased Risk Of Bacterial Infection, Bone Fracture.
The CBS Evening News (5/10, story 6, Couric) reported on proton pump inhibitors (PPIs), which are "very popular drugs used to treat acid reflux and ulcers," and generate "$13.5 billion in sales." According to the Wall Street Journal (5/11, Dooren), approximately 119 million PPI prescriptions were written in the US in 2009, making PPIs the third-largest selling class of drugs. CNN (5/10, Gardner) reported on physician concern for overprescribing and the "the risks" of taking PPIs "may outweigh the benefits for people with less serious conditions, experts say." PPIs "can have rare but serious side effects, including an increased risk of bacterial infection and bone fracture, according to several new studies in the Archives of Internal Medicine." Researchers suggest that PPI medications should be used only by patients with conditions which require these treatments.
In a large trial of postmenopausal women without a history of prior hip fracture researcher found that "over eight years of the study, there were 21,247 bone fractures" as reported in Bloomberg News (5/10, Ostrow). Even though no differences were found in the rate of hip fractures, women taking PPIs had “a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures," the Boston Globe (5/10, Cooney) "White Coat Notes" blog reported.
A number of studies and large pooled analysis associate PPI use with an increased risk of a potentially serious bacterial infection which causies diarrhea. These include: MedPage Today (5/7, Bankhead) reporting "Pooled data from the [nine] studies showed almost a threefold increased risk of C. difficile-associated diarrhea among patients taking PPIs;" HealthDay (5/10, Goodwin) reporting on analysis including more than 100,000 hospital discharges over five years – abstract here; and MedPage Today (5/10, Bankhead) reporting that a study revealed "PPI use was associated with a 42% increase in the risk of recurrent C. difficile infection, with the greatest risk among patients older than 80 and in patients treated with antibiotics that were not targeted to the bacterium."
Meanwhile, a paper written by Taiwanese scientists indicated that "high-dose PPI therapy proved to be no more effective than lower doses for controlling bleeding ulcers," while Harvard data revealed that "introduction of a standardized guideline for prescribing practices reduced inpatient use of PPIs, but only among patients who were not on PPIs at admission."
PPI medication use was previously reported to be associated with an increased risk for developing pneumonia. The Los Angeles Times (5/11, Maugh), Reuters (5/11, Steenhuysen), and WebMD (5/10, DeNoon) also provided additional coverage.
May 11, 2010 - GlaxoSmithKline Reported To Agree To Settle Some Avandia Lawsuits For $60 Million.
Bloomberg News (5/11, Feeley, Kelley) reports, "GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company's Avandia [rosiglitazone] diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say." The report stated that this will resolve 700 Avandia suits. So far, GSK faces approximately 4,000 Avandia-related lawsuits. Reuters (5/11, Hirschler) also covered the story.
May 14, 2010 - FDA Rejects Teva's Citizen Petition To Deny Approval Of Generic Copaxone.
Dow Jones Newswire (5/14, Gryta) reports the Food and Drug Administration has rejected a citizen's petition filed by Teva Pharmaceutical Industry Ltd. Seeking to halt FDA approval of generic versions of Copaxone (glatiramer), a multiple sclerosis medication. Teva has sued drugmakers Mylan Inc. and Momenta Pharmaceuticals Inc., both of which have filed to produce glatiramer. In its effort to protect its own Copaxone brand, Teva, the largest producer of generic drugs in the world, is challenging other drugmakers' ability to create a generic drug.
May 14, 2010 - Mylan Seeks To Sell Generic Version Of Sutent.
Dow Jones Newswire (5/14, Gryta) reports that Mylan Inc. is seeking FDA approval to produce a generic version of Pfizer’s cancer drug Sutent (sunitinib). Sutent is approved to treat certain types of kidney cancer and gastrointestinal tumors and generated sales of $964 million in 2009.
The Boston Globe (5/10, Smith) highlights the problem of poor medication adherence reporting on a VA study of cholesterol lowering medications. The study examined the relationship between increased co-payments and other factors and affect regular medication use. Without regular use of medications for chronic conditions, patients are unlikely to receive long-term benefits in health improvement.
May 11, 2010 - Studies Link PPIs To Increased Risk Of Bacterial Infection, Bone Fracture.
The CBS Evening News (5/10, story 6, Couric) reported on proton pump inhibitors (PPIs), which are "very popular drugs used to treat acid reflux and ulcers," and generate "$13.5 billion in sales." According to the Wall Street Journal (5/11, Dooren), approximately 119 million PPI prescriptions were written in the US in 2009, making PPIs the third-largest selling class of drugs. CNN (5/10, Gardner) reported on physician concern for overprescribing and the "the risks" of taking PPIs "may outweigh the benefits for people with less serious conditions, experts say." PPIs "can have rare but serious side effects, including an increased risk of bacterial infection and bone fracture, according to several new studies in the Archives of Internal Medicine." Researchers suggest that PPI medications should be used only by patients with conditions which require these treatments.
In a large trial of postmenopausal women without a history of prior hip fracture researcher found that "over eight years of the study, there were 21,247 bone fractures" as reported in Bloomberg News (5/10, Ostrow). Even though no differences were found in the rate of hip fractures, women taking PPIs had “a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures," the Boston Globe (5/10, Cooney) "White Coat Notes" blog reported.
A number of studies and large pooled analysis associate PPI use with an increased risk of a potentially serious bacterial infection which causies diarrhea. These include: MedPage Today (5/7, Bankhead) reporting "Pooled data from the [nine] studies showed almost a threefold increased risk of C. difficile-associated diarrhea among patients taking PPIs;" HealthDay (5/10, Goodwin) reporting on analysis including more than 100,000 hospital discharges over five years – abstract here; and MedPage Today (5/10, Bankhead) reporting that a study revealed "PPI use was associated with a 42% increase in the risk of recurrent C. difficile infection, with the greatest risk among patients older than 80 and in patients treated with antibiotics that were not targeted to the bacterium."
Meanwhile, a paper written by Taiwanese scientists indicated that "high-dose PPI therapy proved to be no more effective than lower doses for controlling bleeding ulcers," while Harvard data revealed that "introduction of a standardized guideline for prescribing practices reduced inpatient use of PPIs, but only among patients who were not on PPIs at admission."
PPI medication use was previously reported to be associated with an increased risk for developing pneumonia. The Los Angeles Times (5/11, Maugh), Reuters (5/11, Steenhuysen), and WebMD (5/10, DeNoon) also provided additional coverage.
May 11, 2010 - GlaxoSmithKline Reported To Agree To Settle Some Avandia Lawsuits For $60 Million.
Bloomberg News (5/11, Feeley, Kelley) reports, "GlaxoSmithKline Plc agreed to pay about $60 million in the first settlements of lawsuits alleging the company's Avandia [rosiglitazone] diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say." The report stated that this will resolve 700 Avandia suits. So far, GSK faces approximately 4,000 Avandia-related lawsuits. Reuters (5/11, Hirschler) also covered the story.
May 14, 2010 - FDA Rejects Teva's Citizen Petition To Deny Approval Of Generic Copaxone.
Dow Jones Newswire (5/14, Gryta) reports the Food and Drug Administration has rejected a citizen's petition filed by Teva Pharmaceutical Industry Ltd. Seeking to halt FDA approval of generic versions of Copaxone (glatiramer), a multiple sclerosis medication. Teva has sued drugmakers Mylan Inc. and Momenta Pharmaceuticals Inc., both of which have filed to produce glatiramer. In its effort to protect its own Copaxone brand, Teva, the largest producer of generic drugs in the world, is challenging other drugmakers' ability to create a generic drug.
May 14, 2010 - Mylan Seeks To Sell Generic Version Of Sutent.
Dow Jones Newswire (5/14, Gryta) reports that Mylan Inc. is seeking FDA approval to produce a generic version of Pfizer’s cancer drug Sutent (sunitinib). Sutent is approved to treat certain types of kidney cancer and gastrointestinal tumors and generated sales of $964 million in 2009.
Saturday, May 8, 2010
May 2010 - Week 1 News
May 1, 2010 - FDA Approves a Combination of Generic Naproxen and an Omeprazole Isomer For Arthritis Patients At Risk Of Gastric Ulcers.
Bloomberg News (5/1, Peterson, Larkin), MedPage Today (5/2, Peck), and Reuters (5/1) reported that the FDA has approved Vimovo (naproxen and esomeprazole magnesium) "for use in arthritis patients who are at risk of developing gastric ulcers." Approval was based on endoscopic assessment of gastric erosions compared to treatment with enteric coated naproxen. Naproxen and two other proton pump inhibitor drugs are all available inexpensively without a prescription.
May 3, 2010 - Sample Medications, DTC Advertising May Alter Physician Prescribing Patterns.
Valerie Ulene, MD, writes in the Los Angeles Times (5/3) "The MD" column, "New medications don't have to be unique or innovative to receive approval from the Food and Drug Administration." Most new medicines "provide only minor, if any, therapeutic benefit over existing medications, the agency acknowledges." Pharmaceutical companies use medication sampling and direct-to-consumer advertising to stimulate use of new medications “even when there is no evidence suggesting that a new medication works better than something tried and true.
May 3, 2010 Triple Combination Antihypertensive Pill Better At Lowering Blood Pressure Than Dual Therapies Using Its Components.
MedPage Today (5/3, Neale) reported that a combination of three currently available blood pressure medications resulted in lower blood pressure and greater percentages of patients achieving blood pressure goals than any combination of only two of the agents according to a study presented at American Society of Hypertension meeting. The combination contains high doses of two generically available medications and an Angiotensin Receptor Blocker (ARB) high blood pressure medication. The Angiotensin Receptor Blocker is currently available in a fixed combination with the diuretic. Extensive data support the long term benefit of the diuretic in reducing risk of death due to cardiovascular events. The ARB has some indication of possible benefits, though not as strong as other medications, and the calcium channel blocker medication is not associated with any long-term benefits relating to CV disease progression or survival.
May 3, 2010 – FDA Warns Certain Prostate Cancer/ Endometriosis Treatments May Increase Risk Of Diabetes, Heart Attack.
The Dow Jones Newswire (5/3, Dooren), HealthDay (5/3, Preidt), and the Los Angeles Times (5/3, Maugh) "Booster Shots" blog reported, The Food and Drug Administration is examining possible links between gonadotropin-releasing hormone (GnRH) agonists and increased risks of diabetes and heart disease. The drugs are also used by women to manage endometriosis pain, anemia associated with uterine fibroids, and as palliative treatment of advanced breast cancer. They may also be used to treat some children for precocious puberty. However, there is not evidence for increased risks in women or children. MedPage Today (5/3, Petrochko) and Bloomberg News (5/4, Larkin) also covered the story.
Bloomberg News (5/1, Peterson, Larkin), MedPage Today (5/2, Peck), and Reuters (5/1) reported that the FDA has approved Vimovo (naproxen and esomeprazole magnesium) "for use in arthritis patients who are at risk of developing gastric ulcers." Approval was based on endoscopic assessment of gastric erosions compared to treatment with enteric coated naproxen. Naproxen and two other proton pump inhibitor drugs are all available inexpensively without a prescription.
May 3, 2010 - Sample Medications, DTC Advertising May Alter Physician Prescribing Patterns.
Valerie Ulene, MD, writes in the Los Angeles Times (5/3) "The MD" column, "New medications don't have to be unique or innovative to receive approval from the Food and Drug Administration." Most new medicines "provide only minor, if any, therapeutic benefit over existing medications, the agency acknowledges." Pharmaceutical companies use medication sampling and direct-to-consumer advertising to stimulate use of new medications “even when there is no evidence suggesting that a new medication works better than something tried and true.
May 3, 2010 Triple Combination Antihypertensive Pill Better At Lowering Blood Pressure Than Dual Therapies Using Its Components.
MedPage Today (5/3, Neale) reported that a combination of three currently available blood pressure medications resulted in lower blood pressure and greater percentages of patients achieving blood pressure goals than any combination of only two of the agents according to a study presented at American Society of Hypertension meeting. The combination contains high doses of two generically available medications and an Angiotensin Receptor Blocker (ARB) high blood pressure medication. The Angiotensin Receptor Blocker is currently available in a fixed combination with the diuretic. Extensive data support the long term benefit of the diuretic in reducing risk of death due to cardiovascular events. The ARB has some indication of possible benefits, though not as strong as other medications, and the calcium channel blocker medication is not associated with any long-term benefits relating to CV disease progression or survival.
May 3, 2010 – FDA Warns Certain Prostate Cancer/ Endometriosis Treatments May Increase Risk Of Diabetes, Heart Attack.
The Dow Jones Newswire (5/3, Dooren), HealthDay (5/3, Preidt), and the Los Angeles Times (5/3, Maugh) "Booster Shots" blog reported, The Food and Drug Administration is examining possible links between gonadotropin-releasing hormone (GnRH) agonists and increased risks of diabetes and heart disease. The drugs are also used by women to manage endometriosis pain, anemia associated with uterine fibroids, and as palliative treatment of advanced breast cancer. They may also be used to treat some children for precocious puberty. However, there is not evidence for increased risks in women or children. MedPage Today (5/3, Petrochko) and Bloomberg News (5/4, Larkin) also covered the story.
Saturday, May 1, 2010
April 2010 - Week 4 News
April 24, 2010 - Metformin (an Inexpensive, Generic Diabetes Medication) May Improve Chemotherapy Effectiveness in Hormone-Resistant Prostate Cancers.
MedPage Today (4/24, Susman) reported on a study presented at the annual meeting of the American Association for Cancer Research. Researchers reported that "combining metformin with bicalutamide significantly reduces prostate cancer cell colony formation rates more effectively than either drug in monotherapy."
April 26, 2010 - Experts Tout Benefits Of Exercise For People Taking Antidepressants.
USA Today (4/26) reports on a “third choice,” other than medication or counseling for patients who are depressed. Psychologist Jasper Smits says, "It's become clear that this is a good intervention, particularly for mild to moderate depression." And, psychiatrist Michelle Riba, of the University of Michigan, "prescribes exercise to depressed patients as part of a long-term plan for healthier living that includes sleep, eating and, in many cases, weight loss. Exercise can be especially important, she says, for patients taking antidepressant medications that cause weight gain."
April 27, 2010 - Loss of Tax Breaks for Retiree Drug Benefits Could Hurt Companies' Earnings.
The New York Times (4/27, Pear) reports, "at least 40 companies have taken charges against earnings that total $3.4 billion since the [health insurance reform] law was signed." Some, including Verizon and Caterpillar, say the loss of tax breaks on prescription benefits for retirees could cause companies to this coverage for employees.
April 27, 2010 - Oral Chemotherapy Drug Access is Impeded by Reimbursement System.
Kaiser Health News (4/27, Boodman) reports that “patients are being denied access to newer oral chemotherapy drugs or are required to shoulder hefty out-of-pocket costs, sometimes thousands of dollars a month, for cancer pills with annual price tags of more than $75,000." This results from a “reimbursement system that covers IV chemotherapy as a medical benefit but considers less-invasive oral chemotherapy to be part of a patient's drug plan, which tends to be far less generous."
April 27, 2010 - AstraZeneca To Pay More Than a Half Billion Settling Charges of Illegal/Off-label Seroquel Promotion.
The New York Times (4/27, B3, Wilson) reports, AstraZeneca will pay $520 million to settle federal investigations into the marketing Seroquel [quetiapine] for unapproved uses in children and the elderly without evidence of safety and effectiveness, and allegations of kickbacks to prescribers. While acknowledging that these efforts may have jeopardized the health and safety of individual patients and cost the Federally-supported health coverage programs, the Justice Department will not pursue criminal charges. The Dow Jones Newswire (4/28, Kendall, Loftus), The Financial Times (4/28, Jack), Reuters (4/28, Pelofsky) and the AP (4/28, Yost) also covered the story.
April, 28, 2010 - Vitamin E Pills May Benefit Steatohepatitis Patients Without Diabetes.
The Los Angeles Times (4/28, Maugh) "Booster Shots" blog reported "Vitamin E may help people with nonalcoholic fatty liver disease. A study in the New England Journal of Medicine, "enrolled 247 adults with the disease but without diabetes, dividing them into three groups." Each group received either vitamin E, the diabetes drug pioglitazone, or a placebo. Two years later, investigators noted that "liver function improved in 43 percent of those in the vitamin E group, compared with 19 percent in the placebo group," Also noted was that those taking Actos [pioglitazone] improved to a lesser degree and with an average 10 pound weight gain.
April 28, 2010 - FDA Approves Novel Asthma Treatment.
HealthDay (4/28, Roberts), MedPage Today (2/28, Petrochko), and the AP (4/29) reported that the FDA has approved the "first non-drug asthma treatment." According to the developer of the Alair System, Asthmatx, the procedure known as "bronchial thermoplasty" would "only be appropriate for about two million adults with severe asthma who don't get relief from existing drugs." The device "delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release." Importantly, “as a condition of approval," the manufacturer "must conduct additional studies to evaluate the product's long-term safety and effectiveness…" Medscape (4/28, Waknine) also covered the approval.
April 29, 2010 - Risk Of Rehospitalization For MI Nearly Doubled In Patients Treated With Both PPI And Clopidogrel.
According to research published in the Archives of Internal Medicine, "the risk of rehospitalization for MI or stent placement increased by 64% in those who took both drugs [clopidogrel and a proton pump inhibitor], compared with patients who received clopidogrel alone." MedPage Today (4/29, Bankhead) also reported a doubling of rehospitalization risk, and near doubling of risk for myocardial infarction (MI) in patients treated with both a proton pump inhibitor (PPI) and clopidogrel (Plavix) after acute MI or coronary stent deployment."
April 30, 2010 - J&J Will Pay More Than $81 Million For Promotion Of Topamax for Psychiatric Conditions.
Bloomberg News (4/30, Voreacos) reports that Johnson & Johnson has agreed to pay more than $81 million settling claims relating to illegal promotion of the epilepsy drug Topamax [topiramate] for psychiatric uses, including as a “mood-stabilizer” for bipolar disorder. Ortho-McNeil Pharmaceutical admits that from 2001 to 2003 it promoted Topamax 'for certain uses not approved' by the FDA..” The Boston Herald (4/30, Grillo), the NPR (4/29, Hensley) "Shots" blog, Dow Jones Newswire (4/30, Kendall) and MedPage Today (4/29, Frieden) also covered the story
MedPage Today (4/24, Susman) reported on a study presented at the annual meeting of the American Association for Cancer Research. Researchers reported that "combining metformin with bicalutamide significantly reduces prostate cancer cell colony formation rates more effectively than either drug in monotherapy."
April 26, 2010 - Experts Tout Benefits Of Exercise For People Taking Antidepressants.
USA Today (4/26) reports on a “third choice,” other than medication or counseling for patients who are depressed. Psychologist Jasper Smits says, "It's become clear that this is a good intervention, particularly for mild to moderate depression." And, psychiatrist Michelle Riba, of the University of Michigan, "prescribes exercise to depressed patients as part of a long-term plan for healthier living that includes sleep, eating and, in many cases, weight loss. Exercise can be especially important, she says, for patients taking antidepressant medications that cause weight gain."
April 27, 2010 - Loss of Tax Breaks for Retiree Drug Benefits Could Hurt Companies' Earnings.
The New York Times (4/27, Pear) reports, "at least 40 companies have taken charges against earnings that total $3.4 billion since the [health insurance reform] law was signed." Some, including Verizon and Caterpillar, say the loss of tax breaks on prescription benefits for retirees could cause companies to this coverage for employees.
April 27, 2010 - Oral Chemotherapy Drug Access is Impeded by Reimbursement System.
Kaiser Health News (4/27, Boodman) reports that “patients are being denied access to newer oral chemotherapy drugs or are required to shoulder hefty out-of-pocket costs, sometimes thousands of dollars a month, for cancer pills with annual price tags of more than $75,000." This results from a “reimbursement system that covers IV chemotherapy as a medical benefit but considers less-invasive oral chemotherapy to be part of a patient's drug plan, which tends to be far less generous."
April 27, 2010 - AstraZeneca To Pay More Than a Half Billion Settling Charges of Illegal/Off-label Seroquel Promotion.
The New York Times (4/27, B3, Wilson) reports, AstraZeneca will pay $520 million to settle federal investigations into the marketing Seroquel [quetiapine] for unapproved uses in children and the elderly without evidence of safety and effectiveness, and allegations of kickbacks to prescribers. While acknowledging that these efforts may have jeopardized the health and safety of individual patients and cost the Federally-supported health coverage programs, the Justice Department will not pursue criminal charges. The Dow Jones Newswire (4/28, Kendall, Loftus), The Financial Times (4/28, Jack), Reuters (4/28, Pelofsky) and the AP (4/28, Yost) also covered the story.
April, 28, 2010 - Vitamin E Pills May Benefit Steatohepatitis Patients Without Diabetes.
The Los Angeles Times (4/28, Maugh) "Booster Shots" blog reported "Vitamin E may help people with nonalcoholic fatty liver disease. A study in the New England Journal of Medicine, "enrolled 247 adults with the disease but without diabetes, dividing them into three groups." Each group received either vitamin E, the diabetes drug pioglitazone, or a placebo. Two years later, investigators noted that "liver function improved in 43 percent of those in the vitamin E group, compared with 19 percent in the placebo group," Also noted was that those taking Actos [pioglitazone] improved to a lesser degree and with an average 10 pound weight gain.
April 28, 2010 - FDA Approves Novel Asthma Treatment.
HealthDay (4/28, Roberts), MedPage Today (2/28, Petrochko), and the AP (4/29) reported that the FDA has approved the "first non-drug asthma treatment." According to the developer of the Alair System, Asthmatx, the procedure known as "bronchial thermoplasty" would "only be appropriate for about two million adults with severe asthma who don't get relief from existing drugs." The device "delivers radiofrequency energy directly to the airways, heating and reducing the thickness of lung tissue and improving users' ability to breathe, the agency said in a news release." Importantly, “as a condition of approval," the manufacturer "must conduct additional studies to evaluate the product's long-term safety and effectiveness…" Medscape (4/28, Waknine) also covered the approval.
April 29, 2010 - Risk Of Rehospitalization For MI Nearly Doubled In Patients Treated With Both PPI And Clopidogrel.
According to research published in the Archives of Internal Medicine, "the risk of rehospitalization for MI or stent placement increased by 64% in those who took both drugs [clopidogrel and a proton pump inhibitor], compared with patients who received clopidogrel alone." MedPage Today (4/29, Bankhead) also reported a doubling of rehospitalization risk, and near doubling of risk for myocardial infarction (MI) in patients treated with both a proton pump inhibitor (PPI) and clopidogrel (Plavix) after acute MI or coronary stent deployment."
April 30, 2010 - J&J Will Pay More Than $81 Million For Promotion Of Topamax for Psychiatric Conditions.
Bloomberg News (4/30, Voreacos) reports that Johnson & Johnson has agreed to pay more than $81 million settling claims relating to illegal promotion of the epilepsy drug Topamax [topiramate] for psychiatric uses, including as a “mood-stabilizer” for bipolar disorder. Ortho-McNeil Pharmaceutical admits that from 2001 to 2003 it promoted Topamax 'for certain uses not approved' by the FDA..” The Boston Herald (4/30, Grillo), the NPR (4/29, Hensley) "Shots" blog, Dow Jones Newswire (4/30, Kendall) and MedPage Today (4/29, Frieden) also covered the story
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