PHARMACY

DEA statistics show painkiller sales up almost 90 percent since 1997

BY Adam Kraemer

WASHINGTON The amount of five major painkillers sold at retail establishments rose 90 percent in the eight years up to 2005, according to an Associated Press analysis of statistics from the Drug Enforcement Administration.

According to the DEA statistics more than 200,000 pounds of codeine, morphine, oxycodone, hydrocodone and meperidine were purchased at retail stores during 2005, the most recent year represented in the data.

Most of the increase can be attributed to oxycodone, the codeine derivative in Purdue Pharma’s OxyContin. Use of oxcodone jumped nearly six-fold between 1997 and 2005.

While the drug gained notoriety as “hillbilly heroin,” because of the large amount sold illegally in Appalachia, its highest rates of sale now occur in places such as suburban St. Louis, Columbus, Ohio, and Fort Lauderdale, Fla., the AP reported.

Legal sales of other pain killers are becoming more prevalent in rural and suburban areas alike. In Appalachia, retail sales of hydrocodone—sold mostly as Vicodin—are the highest in the nation. Nine of the 10 areas with the highest per-capita sales are in mostly rural parts of West Virginia, Kentucky or Tennessee. Sales of codeine, however, see some of their highest rates in communities around Kansas City, Mo., Nashville, Tenn. And throughout Long Island, N.Y.

Other findings from the Associated Press:

  • More people are abusing prescription painkillers because the medications are more available. Though the vast majority of people with prescriptions use the drugs safely, the number of emergency room visits from painkiller abuse has increased more than 160 percent since 1995, according to the government.
  • Many pain-management specialists now say they offer guidance and support to patients but will not write prescriptions, even for the sickest people. They cite high-profile arrests and prosecutions by state and federal authorities for their reluctance. The increase in painkiller retail sales continues to rise, but only barely. There was a 150 percent increase in volume in 2001. Four years later, the year-to-year increase was barely 2 percent.

The DEA cites more than 100 cases of physicians being prosecuted for illegally prescribing drugs to patients. Of those, 16 have been convicted while 83 pleaded guilty or no contest. Eight cases are still pending.

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PHARMACY

Patent office sends Pfizer “non-final” rejection letter for Lipitor

BY Adam Kraemer

NEW YORK The U.S. Patent and Trademark Office has preliminarily rejected Pfizer’s request for the reissue of a patent for its Lipitor (atorvastatin) cholesterol drug that would preserve its U.S. market exclusivity until 2011, the Wall Street Journal reported.

The U.S. Court of Appeals for the Federal Circuit invalidated in 2006 one of two patents at issue in a legal fight with generic competitor Ranbaxy, which moved up Lipitor’s June 2011 patent expiration and maintaining it instead to March 2010.

Ranbaxy had taken its case to the Supreme Court after the Federal U.S. Circuit Court of Appeals denied the company’s request to rehear the decision. The Supreme Court refused a hearing, preserving the March 2010 date.

Pfizer applied to the patent office in January to have the 2011 patent reissued, and to correct a “technical defect” in the original patent. A reissue would extend Pfizer’s market exclusivity through June 2011.

A Pfizer spokesman told the Journal on Thursday that the company was awaiting a letter from the patent office explaining the decision. Because it’s not a final rejection, Pfizer still has an opportunity to persuade the patent office to reissue the patent.

“An initial rejection is not uncommon in reissue application proceedings,” said Pfizer spokesman Bryant Haskins. “Once we receive the decision we’ll review it and respond appropriately to address any issues that were raised by the examiner.”

Lipitor is the best-selling drug in the world, with $12.9 billion in sales last year. However, it has faced pressure not only from ongoing patent challenges worldwide, but also from competition from generic versions of other anti-cholesterol drugs.

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FDA cites Novartis for distributing ‘misleading’ promotional card

BY Adam Kraemer

WASHINGTON A promotional file card Novartis has put out is “misleading” and misbrands the company’s Alzheimer’s disease drug Exelon, “suggest[ing] that Exelon is safer or more effective than has been demonstrated,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

According to the Aug. 8 warning letter, posted to the FDA’s website Aug. 14, the file card “makes unsubstantiated superiority claims for Exelon, overstates the efficacy of Exelon, includes misleading risk presentations, and recommends or suggests a combination use of Exelon that has not been approved by FDA.”

Exelon (rivastigmine tartrate) is approved to treat mild-to-moderate Alzheimer’s disease, but is “associated with numerous risks,” such as gastrointestinal adverse reactions including nausea, vomiting and weight loss; anorexia, dyspepsia, asthenia, peptic ulcers and gastrointestinal bleeding; as well as effects on the cardiovascular, pulmonary and neurological systems (i.e., seizures), and risk of urinary obstruction, the warning letter said. The package insert also contains precautions for interactions with other drugs, and warns of potential problems if a patient is given anesthesia.

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