Parker Waichman LLP Injury Alerts
OxyContin - Is this Deadly and Widely Abused Narcotic really Necessary?Mar 1, 2006
OxyContin (Generic: Oxycodone hci) is a narcotic pain killer that has been linked to physical dependence and addiction. It is primarily prescribed to treat severe pain caused by arthritis, back pain, and cancer. OxyContin is categorized as a Schedule II controlled substance.
Since its introduction in 1995, OxyContin has been linked to hundreds of deaths. Its highly addictive qualities have been compared to those of heroin. In fact, is has even been dubbed the "hillbilly heroin" because of its popularity in some of the more rural areas in the country. It has also been referred to as "the new crack."
OxyContin is both one of the best selling prescription medications and one of the most abused drugs in history. While OxyContin is intended to be prescribed for the management of moderate to severe pain, a disturbing number of reports have surfaced detailing widespread addiction to the drug. Addiction has occurred regardless of whether the user was prescribed the drug or had obtained it through illegal channels.
Users discovered that when chewed, injected, or snorted, the time-release feature was bypassed and the drug acted much more quickly and powerfully. In this way, OxyContin became another powerful narcotic drug for addicts to abuse - it joined the ranks of such illegally trafficked narcotics as heroin and morphine.
Oxycodone, the active ingredient in OxyContin tablets, has been around for almost a century. OxyContin, however, is a much more potent, time-release form of oxycodone.
In 1995, Purdue Pharma began manufacturing OxyContin tablets. For almost 6 years, the drug was grossly unregulated until July 25, 2001 when, at the urging of the FDA, Purdue Pharma added new warnings to OxyContin.
As of that date, the drug bore a black box warning on its label, the strongest type of FDA warning. The FDA also stated that OxyContin was as potentially addictive as morphine.
There have even been reports of armed robberies committed by OxyContin addicts. Prior to the label changes, there were reports of 14 robberies in the Boston area including one at a Walgreen's pharmacy where a man tried to walk away with 1,100 OxyContin pills. Other states that were hard hit by robberies and theft include Maine, Vermont, Pennsylvania, Ohio, West Virginia, Kentucky, Florida, and California. Pennsylvania had the highest number of robbery reports at 71 with Florida coming a close second at 63.
Because of the robberies, two major supermarket chains in New England, Shaws and Star Market, decided to stop carrying the drug in their pharmacy sections. Patients with prescriptions would have to wait three days for it to be filled while the pharmacy sent out for the medicine.
After the FDA involvement, Purdue issued a letter to medical professionals instructing that OxyContin only be prescribed for the most severe pain. Despite the confirmed reports of OxyContin addiction, Purdue asserts that there is no problem with the drug.
Just a few months later, in August, Purdue announced that it was working on a new version of OxyContin, one that would make it less liable to cause abuse and addiction.
Still, the number of deaths and adverse effects associated with OxyContin continues to rise.
Later that year, in October of 2001, the number of deaths attributable to OxyContin rose to 282. This information was gathered from an extensive federal review of autopsy data of individuals who had overdosed on the drug.
Following the release of this information, the vice president for research and development at Purdue Pharma said that this number was consistent with their own findings but argued that OxyContin could not be solely implicated in any of the reported deaths because other substances such as alcohol or other prescription drugs were involved.
In addition to the 282 deaths, federal officials said that they discovered that 1,010 people had died since 2000 from oxycodone overdoses. It was not determined, however, if oxycodone was responsible for every overdose report as other drugs were involved.
About 110 of these overdose deaths were directly linked to OxyContin because the drug was found in a person's stomach or there was a prescription for the drug found in the person's pocket or bag.
In March of 2002, a plaintiffs group in Washington D.C. brought legal action against Purdue Pharma and Abbott Laboratories Inc. citing that the companies had failed to provide adequate warnings to patients about the dangers of OxyContin such as side effects and addiction.
Seven people who were former addicts or relatives of addicts filed the suit. The plaintiffs contended that the sales for OxyContin, which surpassed $1 billion in the United States in 2000 alone, pointed towards an "aggressive marketing strategy" geared at promoting the drug for physicians, pharmacists, and patients.
The lawsuit also quoted a warning letter from May of 2000 from the FDA to Purdue that ordered the company to stop using a particular advertisement that did not accurately represent the drug. The advertisement called it a "first-line treatment for osteoarthritis." The plaintiffs allege that this caused a number of unnecessary prescriptions for this condition, putting more people at risk of addition to OxyContin.
Then, at the end of 2003, Rush Limbaugh, the right-wing radio personality, was discovered with a massive amount of OxyContin tablets. At first he remained quiet, not wanting to implicate himself until he knew what he was facing legally. He finally admitted to being addicted to the drug and took a leave of absence from his radio show to attend a detoxification program.
Limbaugh's drug problem was just another story of addiction, only this time it was in the public sphere for everyone to see. By January of 2004, the FDA continued its attempt to force Purdue to take responsibility for its drug. The FDA claimed that Purdue placed ads in the Journal of the American Medical Association that "grossly overstate" the drug's safety. The two ads did not indicate in the body that OxyContin can cause fatal side effects or serious addiction. That information could only be found in the fine print located at the bottom.
The ads also made it seem as if OxyContin was approved for a wider use than it really is. The FDA said that these violations were "especially egregious and alarming" since it affects the public health. A spokesperson for Purdue said that the ads were not misleading and that the FDA letter was the result of an "honest misunderstanding."
In May of 2005, U.S. Representative Stephen Lynch (D) of Boston asked Congress to rescind its FDA approval for OxyContin and remove the drug from the market. Lynch claimed that his proposed bill would be unnecessary if Purdue tried to do the right thing without having to wait for the FDA and Congress to tell them how to make their drug safer to the public.
Lynch suggested that Purdue take more responsibility for its controversial drug by redesigning it with a lower addiction rate and providing consistent and accurate updates for the warning label.
Just two months after Lynch's bill proposal, the FDA pulled Palladone XL, another time-release painkiller manufactured by Purdue, from the market, citing a potentially fatal interaction between the drug and alcohol in any amount. Purdue was once again in the public eye because of a painkiller and this time, the FDA was not just issuing a stern warning.
THE Palladone XL withdrawal is particularly instructive regarding the fact that many unnecessary (and dangerous) drugs are on the market. As the following demonstrates, Palladone is nothing more than "OxyContin on steroids" and, as such, was never needed in the first place. Moreover, since Purdue Pharma was the manufacturer of this bulked-up version of its own OxyContin, opponents of Palladone were even more incensed that it had been approved.
Palladone was ordered off the market by the FDA because of potentially fatal interactions with alcohol. In fact, the deadly combination may occur with the very first use of the drug and after as little as one alcoholic beverage.
This leads to two legitimate questions: Did the benefit of this drug somehow outweigh so deadly a risk? Was a drug like this ever really necessary? Many experts believe this was one drug that never deserved being approved in the first place.
As a service to our readers we are reproducing the FDA Public Health Advisory below:
FDA is issuing this public health advisory to inform patients and health care providers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of Palladone (hydromorphone hydrochloride, extended release capsules), a potent narcotic painkiller, because of the potential for severe side effects if Palladone is taken with alcohol.
Purdue Pharma provided FDA data that showed that drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.
FDA is announcing the following, effective immediately:
- At FDA's request, Purdue Pharma has agreed to suspend sales and marketing of Palladone.
- Patients being treated with Palladone should contact their physician to discuss appropriate alternative treatments, including immediate release hydromorphone.
- Patients who, on the advice of their physician, continue to take their current supply of Palladone should not drink alcohol, including beer, wine or distilled spirits, or take other prescription or over-the-counter-medicines that contain alcohol on days they take Palladone.
- Any unused Palladone capsules should be disposed of safely by flushing them down the toilet.
Palladone is a time-release formulation of hydromorphone, a potent narcotic painkiller. Palladone is taken once-a-day and the capsule slowly releases a steady amount of hydromorphone into the body over that whole day. Palladone is approved for treatment of moderate to severe chronic pain only in opiate-tolerant patients (that is, patients who have been taking opiate containing products for a considerable period of time). Palladone has been sold in the U.S. only since January 2005 and has been used only by a small number of patients. To date, FDA is not aware of any patients who have had life-threatening side effects from drinking alcohol while taking Palladone.
The amazing thing about this particular drug is that, even before it was approved, the FDA, Purdue Pharma, and every expert familiar with Palladone knew it had potentially fatal risks associated with alcohol interaction; use by non-opioid tolerant patients; chewing, dissolving, breaking, or chewing the capsules (because of rapid release of a fatal dose of hydromorphone); or through misuse, abuse, or diversion.
The drug was also regarded as a prime candidate for abuse by patients and as a “street drug” from the very beginning. Many consumer advocates, doctors, and relatives of victims of OxyContin opposed the approval of Palladone.
Thus, it astonishes that Palladone, which is even more powerful than the much abused, misused, and over-prescribed OxyContin (also made by Purdue Pharma), was ever approved by the FDA at all.
The issues with OxyContin continue to surface. In January of this year, the Department of Public Health began a $400,000 advertising campaign to raise awareness about OxyContin abuse and teenagers.
The radio ads consist of real-life stories from teenagers struggling with OxyContin addiction. Senator Steven Tolman (D) of Boston argued that these ads are extremely important for young people are more and more of them are trying this drug and becoming addicted.
In that same month, the Boston Herald also ran an article about the number of lawsuits that had been brought against Purdue in the past couple of years. Apparently, hundreds of lawsuits had been filed by people claiming that the company did not provide adequate warnings for consumers about the addictive nature of the drug. Purdue has also been accused of “aggressively marketing” OxyContin without discussing its dangers.
A spokesperson from Purdue said that increases in OxyContin prescriptions are not attributable to advertising alone since the company has actually reduced its advertising efforts. Purdue also claims that prescriptions for the drug have actually fallen due to competition from generic brands.
Whichever way you look at it, it is impossible to avoid seeing and hearing the facts – OxyContin is an addictive and dangerous substance. The statistics speak for themselves as well. From 1990 to 2003, the number of deaths attributable to opiates rose from 94 to 574. In addition, the number of hospital visits from opiate usage rose by 134 percent.
Doctors are prescribing the drugs without looking into the legitimacy of a patient’s pain and drug dealers are illegally selling OxyContin tablets for as much as $80 a pill. For some it is too easy to get their hands on it while others resort to crime in order to feed their addiction.
While the FDA was attempting to keep a close watch on Purdue and consumer advocacy groups and legislators were fighting to get OxyContin pulled from the market, the battle may have taken an unforeseen turn for the worse.
On July 7, 2005, the United States Court of Appeals for the Washington D.C. Circuit found, that in order to obtain patent protection for OxyContin, Purdue Pharma had intentionally deceived officials of the United States Patent Office.
The Court of Appeals agreed with United States District Court Judge Sidney H. Stein of the Southern District of New York who ad previously found that Purdue Pharma had secured its patent by implying that clinical evidence existed to show that OxyContin was easier for doctors to use to control pain when, in fact, no such data existed.
The Court also found that Purdue “failed to disclose material information that was inconsistent with its arguments for patentability.”
The ruling stripped Purdue Pharma of its patent protection for the highly profitable painkiller thereby paving the way for increased competition from generic forms of the drug.
It also raises the possibility of substantial damage awards against Purdue for the excessive profits it obtained as a result of the improper patent and the higher prices Purdue charged for OxyContin as a result of that improperly obtained patent.
Presently, 65 cases by insurers and others are pending against Purdue for that very relief. These awards could be costly for Purdue since OxyContin (under patent protection) has been a very expensive drug and because federal law allows for a potential tripling of any damage award as a means of penalizing such wrongdoing by a manufacturer. OxyContin sales have averaged $1.5 billion annually over the past 5 years.
Unfortunately, while this ruling may result in substantial penalties (in terms of monetary damages) to Purdue Pharma, the company has already made enormous profits from the drug. Moreover, the decision will actually result in more OxyContin being available for illegal trafficking since its manufacture and distribution will be more widespread and possible less regulated – hardly a promising scenario for the public to be facing.