Category Archives: painkillers

FDA acts to fight opioid overdose “epidemic”

methadoneiiDrug manufactures that market opioid painkiller medications will be required to train U.S. doctors, nurses and other health care professionals in the ways of safe use of the drugs, which have caused an epidemic of overdose deaths according to the Center for Disease Control (CDC).

The FDA introduced new safety measures for extended-release and long-acting opioid medications, such as oxycodone, hydrocodone, and methadone.  It comes in the form of a mandated blueprint on best practices measures directed at upwards of 20 companies that manufacture opioid analgesics, including how best to educate physicians who prescribe the medications.

New safety measures come from the FDA after the CDC published myriad striking statistics regarding drastically rising opioid overdose deaths.

The Federal requirement handed down from the FDA comes in the wake of a failed U.S. Congressional bill that went to vote several weeks ago.

“Although many Americans don’t realize it, prescription drug abuse is our swiftest growing drug problem. Many of those abuses involve opioids,” said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration. “In 2008, nearly 15,000 Americans died where opioids were involved. In 2009, that number went up to 16,000.”

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Methadone: Public Enemy No. 1

The opioid class painkiller, methadone, is the cause of one in 3 prescription painkiller overdose deaths, despite accounting for only 2 percent of painkiller prescriptions written, reports Kristina Fiore for MedPage Today.

Methadone took center stage in a recent CDC report.  Approximately 5,000 patients died from methadone overdose in 2009, about six times more than 10 years ago.

“Methadone is riskier than other prescription painkillers … and we don’t think it has a role in the treatment of acute pain,” said Thomas Frieden, director of the CDC.

Frieden explained that the proportion of methadone to other painkiller prescriptions is on the rise because insurers have increasingly made it a top-tier drug for chronic pain since it has such a low cost.  Evidence suggests that the increase in methadone overdoses is directly related to the increased use of methadone to treat chronic pain.

It’s  “penny wise and pound foolish …with higher societal costs in terms of death and other problems that can be avoided” Frieden said adding that there are other, safer opiates that should be used for pain.

Frieden cautioned that there’s limited evidence for the efficacy of opiates on chronic pain that is not related to cancer.

I suppose this is simply another example of insurance companies using a cost/benefit analysis on human life.

Celebrex: nothing to celebrate: how Pfizer defrauded millions and made billions

Jeffrey Kindler, left, chairman and chief of PfizerThe popular nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of arthritis pain, Celebrex, has undergone intense scrutiny in a marathon securities fraud case against the manufacturer, Pfizer.  This week, The New York Times reported that thousands of internal documents were unsealed by a federal judge, and that they proved to be riddled with deliberate fraud and deception regarding not only safety concerns about the drug, but claims about the benefits as well.

In 2004, Celebrex and other COX-2-inhibitors—a class of NSAIDs thought to reduce pain and inflammation without the gastrointestinal side effects of other NSAIDs—underwent sharp examination after a similar drug, Viox, was withdrawn from the market after studies uncovered that the drug doubled the risk of heart attack and stroke.  Leading up to the release of internal documents, Pfizer has dealt with a wave of lawsuits from more than 3,000 patients who claim that Celebrex caused heart attacks and strokes.

The New York Times reported this week that blatant and unabashed deception about Pfizer’s research was detected in the documents unsealed by a federal judge.  “They swallowed our story, hook, line and sinker,” wrote a research director.  Not only was Celebrex not easier on the stomach than other NSAIDs like aspirin, but the dangers of stroke and heart attack were masked.  The only reason it appeared that the drug was safer on the stomach was because Pfizer and it’s partner, Pharmacia, cherry picked their research results by only presenting the first six months of a yearlong study.

To top off the conspiratorial nature of this case, it turns out that Pfizer stole the research that led to the discovery of Celebrex in the first place.  Last month, Pfizer settled with Brigham Young University for $450 million. A chemistry professor, Daniel L. Simmons, discovered the genetic workings of the drug in the early 1990s and the university had a research agreement for royalties with Monsanto Company which was later acquired by Pfizer.  The original agreement not honored by Pfizer was 15 percent royalty on sales of Celebrex, or about $9.7 billion.  Rather than risk losing everything in a trial by jury, BYU settled for just $450 million.

I’ll leave you to draw your own conclusions about some of the eccentricities of big pharma from this bit.

Congress hesitates to impose austere regulations on painkillers

800px-Pills_MC_inverseThe New York Times did a piece today on a bill that would have handed down stricter controls on drugs such as hydrocodone and oxycodone.  Efforts by Congress to pass the bipartisan bill were apparently impeded by a massive wave of lobbying from pharmacists and drugstore chains.  The bill ultimately fell flat yesterday.

Everyone knows about the rampant abuse of pain killers, but what struck me were some of the facts that Congress was looking at.  Apparently abuse has spiked over the past ten years.  A recent report by the federal Centers for Disease Control and Preventions said that lethal overdoses involving prescription painkillers are at “epidemic levels” and currently kill more Americans than heroin and cocaine combined.  “The death toll from overdose of prescription painkillers has more than tripled in the past decade.”  Wow!  Please everyone, be very careful with your medications!

I guess what the pharmacists and drugstores objected to was the high cost that it would take to comply with tightened security, e.g. storage would require more substantial safes, etc.  They also claimed that it would be harder for us, the patients, to get out meds, but there seems to be some contention on that point.

I personally understand the need to address the out-of-control abuse of these drugs, but I’m not sure these measures would be the best angle to attack it from.  I feel like it’s already a pain to get narcotic medications, and placing more hoops in front of people isn’t going to solve the problem.  Perhaps pain management doctors are  prescribing recklessly.  I know there aren’t really any viable alternatives, but passing the buck onto the drugstores is rather unfair.  It’s a very difficult and concerning issue to take on, and I can’t imagine many easy answers. 

I guess the moral of the story is to be careful with your meds.  Does anyone have any thoughtful comments on the issue?