Avandia Stays on Market
July 31, 2007
An FDA advisory committee found that GSK’s diabetes drug Avandia is tied to a risk of heart attacks, but did not vote to pull the medication off the market.
Several panel members said the drug should get a new heart-risk warning in its label.The nonbinding recommendation to the Food and Drug Administration came on a 22-1 vote by the panel.
The Panel offered different ideas for what, and where, the warning labels should appear. Some suggested a black box version that would focus on target groups of patients who appeared to be at higher risk. Other panel members didn’t specify what kind of warning label the FDA should support.
Congress has cited Glaxo’s Avandia as more evidence that the FDA’s is in need of an overhaul. They have been burdened by safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to do so.
Republican Leaders Fight Expansion of Children’s Health Insurance
July 27, 2007
Republican leaders of the House and Senate on Tuesday attacked proposals that call for a major expansion of the Children’s Health Insurance Program, to be financed with higher tobacco taxes.
In a letter to colleagues, Republican Senators Trent Lott and Mitch McConnell said that the plan “imposes an open-ended financial burden on American taxpayers and takes a significant step toward a government-run health care system.”
Mr. McConnell said other Republican senators were concerned about “the size of the plan that came out of the Finance Committee and what that may portend for the future in terms of an entire government takeover of American health care and, in essence, a single-payer system down the road.” [information via New York Times]
I am a smoker. I can say now that I would not mind higher tobacco taxes knowing that It was funding a health plan that ensures ALL of America’s children have health insurance. It is a RIGHT, not a privledge.
And as far as the Republican’s concenrs that this will lead us to a government run or “single payer” universal health care system, just go see Michael Moore’s new film Sicko. Then try and tell me that it is NOT the right direction we, as a country, should head.
Tamper-resistant blanks for Medicaid Patients
July 19, 2007
A tiny provision tucked into a spending bill for Iraq requires that prescriptions for Medicaid patients be written on “tamper-resistant” pads. But most doctors do not use such pads.
The law is designed to make it harder for patients to obtain controlled drugs illegally and easier for the government to save money. The start date leaves little time to educate doctors and pharmacists.
“Our members are absolutely flabbergasted that they’re going to be put on the hook for denying prescriptions if something is not on a tamperproof pad,” said Paul Kelly, vice president of government affairs for the National Association of Chain Drug Stores. “Our biggest fear is the negative impact this could have on patient care and access to prescriptions.”
Pharmacists’ groups have asked lawmakers and the Centers for Medicare and Medicaid Services to delay putting the law in place.
“Millions of Medicaid beneficiaries may not be able to obtain their medications after Oct. 1,” they said in a recent letter to lawmakers. “This could lead to higher Medicaid costs for emergency room visits, hospitalizations and physician office visits if medication cannot be obtained in a timely manner.”
Steve Hahn, a spokesman for the centers, said the agency has no plans now to change the Oct. 1 date. In the interim, it is consulting with health care providers and preparing guidance on how to comply with the law.
Several states already require tamperproof prescription pads, Hahn noted. They usually require them only for controlled drugs, those easily subject to abuse.
But health care providers in those states often had more than a year to prepare, Kelly said. New York, for example, had 18 months.
In this instance, many doctors are not even aware of the law.
President Bush had recommended the requirement for tamperproof prescription pads in his 2008 budget. The Congressional Budget Office projected that the requirement would save taxpayers $355 million over the coming decade, mainly through preventing fraudulent prescriptions.
(Via Associated Press)
More on Avandia
July 16, 2007
Just one month after The New England Journal of Medicine published a report that showed a possible connection between Avandia and heartcomplications, there was a large increase in the number of suspected Avandia-related side effects reported to the U.S. Food and Drug Administration.
In the 35 days after the analysis, there were 90 reports of related side effects. Reports of heart-related hospitalization among Avandia patients increased from 11 to 126 according to data obtained from the FDA.
NPI/DEA Database
July 12, 2007
In response to CMS’ calls for healthcare providers to get and share their NPI numbers, NCPDP has created a special look-up tool that pharmacists can use to search for physician data.
The HCIdea Prescriber Database includes prescribers, their addresses, phone numbers, licensure, specialties, and DEA information.
Beginning in August, when NPI numbers are publicly released, the database will also include NPI numbers. The database is based on a system that NCPDP created for the Department of Defense
Pharmacies may buy an annual subscription to the database for up to $500, with discounts for multiple locations or users.
This is a fantastic tool to help identify fraudulent prescriptions.
Wal-Mart pharmacist awarded $2 million
July 10, 2007
A Massachusetts jury awarded a female pharmacist $2 million in a lawsuit against Wal-Mart. Lawyers for Cynthia Haddad said that during her 11 years working for the company she was paid less than men who worked as pharmacists in charge, and was then fired for questioning it.
Wal-Mart said they fired her not because of her gender, but because she had, on occasion, left the pharmacy with only a technician to fill prescriptions in her absence, and for other lapses in judgment.
Her lawyers, however, have pointed out that male pharmacists were guilty of worse lapses, but were never disciplined for them.
Massachusetts regulation allows the technician to remain in the pharmacy when the pharmacist is gone.
A HR expert who studied the companies Pharmacy Operations Manual testified that Wal Mart failed to communicate and enforce its policies equally or update employees on policy changes.
After deliberating for 8 hours, the jury ruled in Haddad’s favor on every count. In addition to having Wal-Mart reimburse her for lost wages, they ordered the company to pay her $95,000 in damages for improper termination, $125,000 for emotional distress, and $17,700 in financial damages. The jurors decided that Haddad was owed $733,000 in wages that she would have earned over the course of her career had she not been fired, as well as punitive damages of $1 million.
Wal-Mart said they likely will appeal.
Costs of Prescriptions discourage use.
July 5, 2007
Pushing more of the cost of prescription drugs onto consumers causes patients to cut back, sometimes with adverse health consequences, according to a review of two decades worth of studies published on Tuesday by the RAND Corporation.
Higher co-payments, monthly limits and benefit caps are “associated with lower rates of drug treatment, worse adherence among existing users, and more frequent discontinuation of therapy.”
“For each 10 percent increase in cost sharing, prescription drug spending decreases by 2 percent to 6 percent, depending on class of drug and condition of the patient” The Study added. Read more
Soften the blow of bad memories.
July 3, 2007
A US and Canadian team used is using Inderal (propranolol) to target unwanted memories, while leaving others intact.
They injected the drug while asking the patient to recall a painful memory, and The Journal of Psychiatric Research study found that this seemed to disrupt the way the memory was then stored in their brain.
The researchers, from McGill University in Montreal, and Harvard University in Boston, hope their work could lead to new treatments for patients with psychiatric conditions, such as post-traumatic stress disorder.
The researchers treated 19 crash or rape victims for 10 days with a drug, or a placebo.
A week later the researchers found that those people who were given a shot of propranolol showed fewer signs of stress, such as raised heart rate, when recalling their trauma.
The researchers believe that memories are initially stored in the brain in a malleable, fluid state before becoming hard-wired into the circuitry. Then when they are recalled they once again become fluid - and capable of being altered.
They believe propranolol disrupts the biochemical pathways that allow a memory to “harden” after it has been recalled.
