Medical Articles - Medication Articles
OXYCONTIN - PAIN RELIEF VS ABUSE
Are worries over abuse having an impact on the drug's legitimate use as a painkiller? Association of American Physicians & Surgeons: "The Politics of Pain and Painkillers: Public Policy and Patient Access to Effective Pain Treatments"
By Leanna Skarnulis
WebMD Feature
Reviewed by Louise Chang, MD
From time to time, OxyContin abuse flares up as a hot topic around the water cooler. If it isn't celebrities in the news for abusing the prescription painkiller, it's reports of drug-dealing doctors and overdose deaths. Add to that a law enforcement crackdown on OxyContin, and the result is a backlash affecting legitimate use of the drug: Many chronic pain sufferers won't take OxyContin for fear of becoming addicted, and some health care providers refuse to write OxyContin prescriptions for fear of being prosecuted. WebMD talked to experts about OxyContin as a legitimate medication for moderate to severe pain, the dangers of abuse, the issue of addiction, and the climate of suspicion that restricts patients' access to the drug.
OxyContin Use and Abuse
OxyContin is the brand name for a timed-release formula of oxycodone, a narcotic analgesic (medication that reduces pain). It's used to relieve pain from injuries, arthritis, cancer, and other conditions. Oxycodone, a morphine-like drug, is found along with non-narcotic analgesics in a number of prescription drugs, such as Percodan (oxycodone and aspirin) and Percocet (oxycodone and acetaminophen). OxyContin contains between 10 and 80 milligrams of oxycodone in a timed-release formula that allows up to 12 hours of relief from chronic pain. What distinguished OxyContin from other analgesics was its long-acting formula, a blessing for patients who typically need round-the-clock relief. "If you have pain that's there all the time, four hours goes by very quickly," says cancer specialist Mary A. Simmonds, MD. "If you're not watching the clock, the pain comes back. People tend not to take their pills on time. The pain builds back up, so you're starting over. It's not very good management of pain." Simmonds gave testimony on the value of OxyContin for alleviating cancer pain at a 2002 Congressional hearing. "For moderate to severe pain, aspirin and Tylenol aren't effective. We do need opioids." It's the high content of oxycodone that makes OxyContin popular on the street. People who abuse the drug crush the tablet and swallow or snort it, or dilute it in water and inject it. This destroys the time-release mechanism so that the user gets the full effects of the narcotic. Users compare the high to the euphoria of heroin.
"What makes OxyContin dangerous is not only that it's addictive, it can also be lethal," says Drew Pinsky, MD, best known for his Loveline radio show. "It makes you feel you can tolerate more, but it can precipitate respiratory failure, especially when used with other drugs like alcohol or benzodiazepenes." Street names for OxyContin include OC, Kicker, OxyCotton, and Hillbilly Heroin. According to the U.S. Drug Enforcement Administration (DEA), oxycodone has been abused for more than 30 years. But with the introduction of OxyContin in 1996, there has been a marked escalation of abuse. According to the U.S. Department of Health and Human Services 2006 revised Substance Abuse Treatment Advisory on OxyContin, the regions most affected are eastern Kentucky, New Orleans, southern Maine, Philadelphia, southwestern Pennsylvania, southwestern Virginia, Cincinnati, and Phoenix. However, the DEA says the problem has spread across the country. While there is special concern about teens' use of OxyContin, the percentage of 12th graders who said they had abused the drug in the past year declined in the 2006 Monitoring the Future survey of the National Institute on Drug Abuse (NIDA). The information is summarized in "NIDA Infofacts: High School and Youth Trends." Abuse of OxyContin decreased for the first time since its inclusion in the survey in 2002, from 5.5% in 2005 to 4.3% in 2006.
Drug Tolerance vs. Addiction
Chronic pain patients often confuse tolerance with addiction. They become fearful when the dosage of a narcotic has to be increased, but it's normal for the body to build up tolerance over time, says Simmonds, spokeswoman for the American Cancer Society. "Patients don't get a high, and they don't get addicted." Simmonds, who is in private practice in Harrisburg, Pa., tells WebMD, "The tragedy is that any day of the week a patient will be in my office in real pain, and a family member will say, 'Don't take morphine.' Patients will suffer needlessly because they think they'll get addicted. We have to take time to educate them." Kathryn Serkes, director of policy and public affairs for the Association of American Physicians & Surgeons (AAPS) in Tucson, Ariz., agrees. She says the standard of pain management care is more aggressive today than what it was just five years ago. She disagrees with some critics who would use OxyContin only as a last resort. "The phrase 'addicted to painkillers' is used fast and loose."
click here to read the rest of the article
click here to read an article on Addiction, Tolerance, and Dependence
Are worries over abuse having an impact on the drug's legitimate use as a painkiller? Association of American Physicians & Surgeons: "The Politics of Pain and Painkillers: Public Policy and Patient Access to Effective Pain Treatments"
By Leanna Skarnulis
WebMD Feature
Reviewed by Louise Chang, MD
From time to time, OxyContin abuse flares up as a hot topic around the water cooler. If it isn't celebrities in the news for abusing the prescription painkiller, it's reports of drug-dealing doctors and overdose deaths. Add to that a law enforcement crackdown on OxyContin, and the result is a backlash affecting legitimate use of the drug: Many chronic pain sufferers won't take OxyContin for fear of becoming addicted, and some health care providers refuse to write OxyContin prescriptions for fear of being prosecuted. WebMD talked to experts about OxyContin as a legitimate medication for moderate to severe pain, the dangers of abuse, the issue of addiction, and the climate of suspicion that restricts patients' access to the drug.
OxyContin Use and Abuse
OxyContin is the brand name for a timed-release formula of oxycodone, a narcotic analgesic (medication that reduces pain). It's used to relieve pain from injuries, arthritis, cancer, and other conditions. Oxycodone, a morphine-like drug, is found along with non-narcotic analgesics in a number of prescription drugs, such as Percodan (oxycodone and aspirin) and Percocet (oxycodone and acetaminophen). OxyContin contains between 10 and 80 milligrams of oxycodone in a timed-release formula that allows up to 12 hours of relief from chronic pain. What distinguished OxyContin from other analgesics was its long-acting formula, a blessing for patients who typically need round-the-clock relief. "If you have pain that's there all the time, four hours goes by very quickly," says cancer specialist Mary A. Simmonds, MD. "If you're not watching the clock, the pain comes back. People tend not to take their pills on time. The pain builds back up, so you're starting over. It's not very good management of pain." Simmonds gave testimony on the value of OxyContin for alleviating cancer pain at a 2002 Congressional hearing. "For moderate to severe pain, aspirin and Tylenol aren't effective. We do need opioids." It's the high content of oxycodone that makes OxyContin popular on the street. People who abuse the drug crush the tablet and swallow or snort it, or dilute it in water and inject it. This destroys the time-release mechanism so that the user gets the full effects of the narcotic. Users compare the high to the euphoria of heroin.
"What makes OxyContin dangerous is not only that it's addictive, it can also be lethal," says Drew Pinsky, MD, best known for his Loveline radio show. "It makes you feel you can tolerate more, but it can precipitate respiratory failure, especially when used with other drugs like alcohol or benzodiazepenes." Street names for OxyContin include OC, Kicker, OxyCotton, and Hillbilly Heroin. According to the U.S. Drug Enforcement Administration (DEA), oxycodone has been abused for more than 30 years. But with the introduction of OxyContin in 1996, there has been a marked escalation of abuse. According to the U.S. Department of Health and Human Services 2006 revised Substance Abuse Treatment Advisory on OxyContin, the regions most affected are eastern Kentucky, New Orleans, southern Maine, Philadelphia, southwestern Pennsylvania, southwestern Virginia, Cincinnati, and Phoenix. However, the DEA says the problem has spread across the country. While there is special concern about teens' use of OxyContin, the percentage of 12th graders who said they had abused the drug in the past year declined in the 2006 Monitoring the Future survey of the National Institute on Drug Abuse (NIDA). The information is summarized in "NIDA Infofacts: High School and Youth Trends." Abuse of OxyContin decreased for the first time since its inclusion in the survey in 2002, from 5.5% in 2005 to 4.3% in 2006.
Drug Tolerance vs. Addiction
Chronic pain patients often confuse tolerance with addiction. They become fearful when the dosage of a narcotic has to be increased, but it's normal for the body to build up tolerance over time, says Simmonds, spokeswoman for the American Cancer Society. "Patients don't get a high, and they don't get addicted." Simmonds, who is in private practice in Harrisburg, Pa., tells WebMD, "The tragedy is that any day of the week a patient will be in my office in real pain, and a family member will say, 'Don't take morphine.' Patients will suffer needlessly because they think they'll get addicted. We have to take time to educate them." Kathryn Serkes, director of policy and public affairs for the Association of American Physicians & Surgeons (AAPS) in Tucson, Ariz., agrees. She says the standard of pain management care is more aggressive today than what it was just five years ago. She disagrees with some critics who would use OxyContin only as a last resort. "The phrase 'addicted to painkillers' is used fast and loose."
click here to read the rest of the article
click here to read an article on Addiction, Tolerance, and Dependence
TRIAL DATA ON ANTI-SEIZURE DRUG MIGHT HAVE BEEN MANIPULATED - NEURONTIN
US NEWS AND WORLD REPORT - MONDAY NOVEMBER 16, 2009
Study found outcome measures differed between company documents, published reports
Posted November 11, 2009
By Amanda Gardner
HealthDay Reporter
WEDNESDAY, Nov. 11 (HealthDay News) -- An unusual look at internal documents from a pharmaceutical company suggests that clinical data was manipulated to make a popular anti-seizure drug, gabapentin (Neurontin), look more effective than it actually was, thereby increasing possibilities for its off-label usage, according to a new report. "This means we're not seeing the full picture, and the picture we are seeing is suspect because perhaps there was selective reporting of outcomes so that only the positive outcomes were reported," said Kay Dickersin, senior author of a paper reporting the alleged deception in the Nov. 12 issue of the New England Journal of Medicine. But this revelation may just be the tip of the iceberg, especially given that internal company research protocols are rarely available to outsiders, stated another expert. "The reality is that a deliberate fraud is extremely difficult to unearth. If scientists and companies agree to report results in a way that wasn't initially intended, unless you have access to original documents, it is extremely difficult to actually figure out what happened and how it happened," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation in Ohio. "How many other examples like this are there out there that we simply don't know about? That's what's frightening."
Dickersin, a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health in Baltimore, gained access to internal company documents when she was asked to testify for the plaintiff in a lawsuit alleging that Pfizer and Parke-Davis (now a division of Pfizer as a result of its Warner-Lambert acquisition) illegally tried to market the drug for off-label uses. Neurontin is approved by the U.S. Food and Drug Administration to treat seizures and shingles, but is also widely used off-label to fight migraines, bipolar disorder and pain. Dickersin compared internal company documents to 20 trials funded by Pfizer and Parke-Davis, 12 of which were published. Typically, clinical trials are set up to track both primary and secondary outcomes. These initial decisions then dictate other aspects of the trial, such as how many participants will be included. And that feeds back into how valid the final results are for that specific trial design and that specific primary outcome. But here, Dickersin and her colleagues discovered that the primary outcomes specified in the early company protocols were not always the same as those appearing in later reports. "What appears to be happening is that outcomes are changing between what was planned and what was published," Dickersin said. Sometimes researchers changed what the primary outcome was (if a different outcome cast the drug in a more positive light), neglected to report the primary outcome at all, turned a secondary outcome into the primary outcome or simply added new outcomes, the report said. "This distorts the scientific evidence that's available on the benefits and risks of therapies," Nissen said.
On Tuesday, Pfizer issued a statement in response to the study, part of which read: "The suggestion that Pfizer attempted to mislead the medical community about the effectiveness of gabapentin [Neurontin] for certain off-label conditions is untrue. The review recently published in the New England Journal of Medicine, regarding the reporting of industry-sponsored trials for gabapentin for off-label use, was derived from a report created for litigation and coauthored by plaintiffs' expert witness, who was hired to produce opinions to support plaintiffs' arguments. We believe the review suffers from significant bias, insufficient data, poor methodology, and cannot pass the threshold of credible scientific research." "The safety and efficacy of gabapentin has been widely published, both by Warner-Lambert/Pfizer as well as independent researchers, and Pfizer has supported the dissemination of the results of these studies, regardless of outcome.
At Pfizer, science and medical integrity come first and foremost," the statement concluded. Although regulations require that all clinical trials be registered at some point, the study authors feel that's not enough. "We need to actually have the protocol itself available for people to look at so there aren't opportunities for people to fiddle around with what they submit," Dickersin said. One possibility would be to register the protocol itself. "This doesn't necessarily fix it, but it does mean that it's transparent, that the public has access to what people say they're going to do before they do it," she added. "The peer-reviewed scientific literature is how we write our guidelines and how we make decisions about what therapies to give patients," Nissen said. "If the material available to us is severely distorted by commercial influences, then the evidence we use to take care of patients is flawed. That is too high a price to pay."
Source
UNDERSTANDING EXTENDED RELEASE MEDICATIONS
We're often asked questions about extended-release medications and how they are used. Following are the most frequently asked questions. The questions range from how much medication is actually in an extended-release tablet to the confusion about the multiple acronyms used to identify them. Did you know there are more than a dozen different acronyms that all basically mean a medication is extended-release? Then to confuse matters even further, there are mediations like OxyContin that have no identifying acronyms!
Q: What is the difference between extended-release and regular medication?
A: The active ingredients in regular medications are usually released within 15 to 30 minutes of when they are injested. Often they are prescribed to be taken three or four times a day. The active ingredients in extended-release medications are are released over a much longer period of time and are usually taken only once or twice a day. The mechanisms by which extended-release medications are released into the body vary according to the medication. If you want to know more details about the specific mechanism used in a particular medication, ask your pharmacist. The important thing to know is that the medication is gradually released into your body so that it remains at a more constant level throughout the day. In the case of pain medications, this can be a good way to provide more consistent pain relief around the clock without the peaks and valleys often experienced when regular tablets are taken every four to six hours.
Q: Why can't I cut extended-release tablets in half if I my pain is less some days?
A: Extended-release medications should never be cut, chewed, crushed or dissolved. In most cases, tampering with the tablet damages the mechanism by which the medication is released and you could end up with an overdose because too much is released into your system at once.
Q: What acronyms are used to indicate that a medication is in extended-release form?
A: Several different acronyms may be used to indicate a medication is extended-release. Here is a list of the most commonly used:
CA – continuous action or controlled action
CR – constant release, continuous release or controlled release
CD – controlled delivery
ER – extended release
GR – gradual release
LA – long acting
LL – long lasting
LTR – long-term release
PR – programmed release, prolonged release or protracted release
PA – prolonged action
RA – repeat action
SA – slow acting
SR – slow release, spaced release or sustained release
TR – timed release
XL – extended release
XR – extended release
Which acronym is used is a decision left up the the drug manufacturers. There are no rules specifying the use of any specific acronym. In fact, some extended-release medications don't use any acronym. For example, OxyContin is extended-release but has no acronym following it. So don't take for granted that your medication is not extended-release just because you don't see an acronym in the name. Be sure to read the information sheet your pharmacist gives you or ask your pharmacist if you have any doubts.
Q: How much total medication is actually in an extended-release tablet?
A: Whatever dosage is prescribed is the total amount contained in each tablet. A portion of that dosage will be released every few hours – exactly how much and how often will depend on the specific medication. As an example, a 20 mg extended-release tablet may contain two 10 mg doses that are released approximately six hours apart.
Source
We're often asked questions about extended-release medications and how they are used. Following are the most frequently asked questions. The questions range from how much medication is actually in an extended-release tablet to the confusion about the multiple acronyms used to identify them. Did you know there are more than a dozen different acronyms that all basically mean a medication is extended-release? Then to confuse matters even further, there are mediations like OxyContin that have no identifying acronyms!
Q: What is the difference between extended-release and regular medication?
A: The active ingredients in regular medications are usually released within 15 to 30 minutes of when they are injested. Often they are prescribed to be taken three or four times a day. The active ingredients in extended-release medications are are released over a much longer period of time and are usually taken only once or twice a day. The mechanisms by which extended-release medications are released into the body vary according to the medication. If you want to know more details about the specific mechanism used in a particular medication, ask your pharmacist. The important thing to know is that the medication is gradually released into your body so that it remains at a more constant level throughout the day. In the case of pain medications, this can be a good way to provide more consistent pain relief around the clock without the peaks and valleys often experienced when regular tablets are taken every four to six hours.
Q: Why can't I cut extended-release tablets in half if I my pain is less some days?
A: Extended-release medications should never be cut, chewed, crushed or dissolved. In most cases, tampering with the tablet damages the mechanism by which the medication is released and you could end up with an overdose because too much is released into your system at once.
Q: What acronyms are used to indicate that a medication is in extended-release form?
A: Several different acronyms may be used to indicate a medication is extended-release. Here is a list of the most commonly used:
CA – continuous action or controlled action
CR – constant release, continuous release or controlled release
CD – controlled delivery
ER – extended release
GR – gradual release
LA – long acting
LL – long lasting
LTR – long-term release
PR – programmed release, prolonged release or protracted release
PA – prolonged action
RA – repeat action
SA – slow acting
SR – slow release, spaced release or sustained release
TR – timed release
XL – extended release
XR – extended release
Which acronym is used is a decision left up the the drug manufacturers. There are no rules specifying the use of any specific acronym. In fact, some extended-release medications don't use any acronym. For example, OxyContin is extended-release but has no acronym following it. So don't take for granted that your medication is not extended-release just because you don't see an acronym in the name. Be sure to read the information sheet your pharmacist gives you or ask your pharmacist if you have any doubts.
Q: How much total medication is actually in an extended-release tablet?
A: Whatever dosage is prescribed is the total amount contained in each tablet. A portion of that dosage will be released every few hours – exactly how much and how often will depend on the specific medication. As an example, a 20 mg extended-release tablet may contain two 10 mg doses that are released approximately six hours apart.
Source
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