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The Fix Wasn’t In
About fifty years ago, General Motors President Charles Wilson was quoted as having said, “What’s good for General Motors is good for the country.” This same statement could easily be attributed to the leaders of Big Pharma. One of the most arrogant of the members of this arrogant group is Purdue Pharma, the makers of legal heroin—OxyContin.
Oxycodone, the active ingredient in OxyContin, is interchangeable with heroin. Purdue Pharma released this terrible drug on the public in 1996 and has made billions of dollars off of it. The fact that they pled guilty to lying to doctors and the public about the addictive qualities of OxyContin in May of 2007 and paid a fine of $634 million was just a cost of doing business. After all, their primary obligation is not to the public but to their shareholders and this justified their actions.
According to Todd Zwillich in WebMD Medical News, “More than 12% of 18- to 25-year-olds reported using the drug (oxycodone/OxyContin) for non-medical reasons in 2006, according to federal figures. Those figures also estimate that 500,000 Americans try oxycodone recreationally for the first time each year.”
Until the recreational use of OxyContin started to become a public relations nightmare and the media began correctly comparing OxyContin to heroin, it was fine with Purdue that an estimated 50% of the OxyContin sold was actually diverted and used for recreational—not medical— purposes. These sales just increased their profits. However, even Purdue was concerned when people began attacking them for recklessly selling legal heroin. If the medical profession were to understand the true dangers of OxyContin, it would seek other alternatives for their patients and Purdue’s sales would go down.
Thinking that they need to do something to make it appear that they are concerned about the diversion of their deadly drug, Purdue filed for approval of a new formulation of OxyContin that supposedly made it more “tamper-resistant.” Imagine the disappointment of the Purdue Pharma executives at the results of the May 5, 2008 FDA hearing that was to determine if they met the standards needed for approval. They had spent millions preparing their proposal. They were an integral part of Big Pharma. They are the ones that tell the FDA what is good for America. At least that is what they thought before the hearing on May 5th.
You see, on May 5th, Purdue expected a hearing where a few of their paid employees and consultants mouthed the usual inane comments about why their drug application should be approved. The hearing would result in a recommendation of approval, even though the application was obviously deeply flawed, because that is the deference that the FDA is supposed to show to Big Pharma. In other words, business as usual. And this might have happened again, except a couple of spokespeople for some of their victims did the unthinkable—they came to the meeting and spoke the truth and exposed the lies and deception of Purdue.
Winston Churchill once said, “Attitude is a little thing that makes a big difference. “ Larry Golbom, the host of the Prescription Addiction Radio show, Pete and Ellen Jackson and many others had the attitude that the truth could overcome the webs of deceit spun by Purdue. And they were right. Not only did the FDA panel see the truth of their words but the media, Purdue’s biggest nightmare, also saw and reported the truth.
The following is taken from an article entitled Panel Has Deep Concerns About New OxyContin by Jared Favole that was issued on the Dow Jones news wires:
“A U.S. Food and Drug Administration panel on Monday expressed deep concerns about a purported abuse-resistant form of the powerful painkiller OxyContin, saying there is a ‘striking’ lack of data about the drug’s abuse-prevention qualities.
A majority of FDA panel members said that including information about the drug’s resistance to abuse on a label would likely lead to more overdoses and deaths.
“I’m fascinated with the poor scientific rigor” of the data presented by Purdue Pharma LP, maker of OxyContin, FDA panel member Jeffrey R. Kirsch said. “It’s almost insulting.”
Larry Goldbom (sic), a Florida pharmacist who hosts a radio show on prescriptions and addictions, said during the meeting that it is ludicrous for the FDA to even consider approving a new form of OxyContin.
“Every narcotics officer…every addict knows oxycodone and heroin are interchangeable. The FDA has, for 12 years, ignored that fact,” Goldbom said.
Goldbom said it is estimated that 97% of all people who die from OxyContin take it whole, meaning a tamper-resistant form would address just 3% of the deaths associated with the drug.
Ellen and Peter Jackson told the FDA panel that they shouldn’t approve the new form of OxyContin, citing statistics that OxyContin has led to numerous deaths.
“My daughter is one of those statistics and I am asking you not to turn your back on her,” Peter Jackson said. The couple’s daughter, Emily, died in 2006 after swallowing an OxyContin pill whole. A relative gave her the drug.”
In another of the many articles about the OxyContin hearing, Carol Gentry, writing for Florida Health News, said,
“In the belief that one person can make a difference, Clearwater pharmacist Larry Golbom paid his own way to appear before an FDA advisory panel in Maryland on Monday to warn against approval of a new form of OxyContin. By the time he got home late Monday night, he had reason to hope he’d had an impact.
While no vote was taken, a majority of panel members expressed concerns about the product and suggested that Purdue Pharma, the manufacturer, make changes. Golbom said it was ludicrous for FDA to even consider approving a new form of painkiller made with oxycodone, an opium-derived compound that constitutes the active ingredient in OxyContin.
The FDA is finally acknowledging that the opioids (opium-derived drugs) are creating way too many negative outcomes,” he said in an e-mail message Tuesday morning to Florida Health News. “The academics and doctors who are involved with the FDA are finally coming out of their ‘bubble.’ They don’t have a clue what to do next. But their refute of Purdue yesterday is clearly an indication that it is no longer business as usual.
Golbom said the trip cost about $500 and 10 hours of lost work at his job with a chain pharmacy. But that’s nothing compared to what it has cost him to finance a one-hour radio show, “Prescription Addiction — Breaking the Silence” each Sunday night for nearly two years. His archived shows are at prescriptionaddictionradio.com.”
It should bring a smile to everyone when they think about the outcome of the May 5th hearing. Victor Hugo said, “There is nothing more powerful than an idea whose time has come.” The idea is simple and thanks to many courageous ordinary citizens, its time has come. Instead of representing Big Pharma as their client, the idea is that the FDA must return to its original purpose—protecting the American people.
I am a believer that a person is responsible for making his or her own decisions in life. However, I have an even stronger belief that it is the responsibility of a government agency, charged with ensuring that proper information is provided to the public, to actually do their job. Obviously, Purdue, an admitted criminal company, cannot be relied on to explain the truth about OxyContin, so it falls to the FDA to speak the truth as Purdue will not.
Because opioids have some valid uses to treat short-term pain, OxyContin does not have to be removed from the market, but its use needs to be much more highly controlled. Purdue says that OxyContin already has a strong Black Box Warning—the warning required when the dangers of a drug are very serious.
However, rather than have the OxyContin Black Box warning say that the drug has “… an abuse liability similar to morphine.”, the warning should say “…an abuse liability similar to morphine and heroin.” Most people don’t really know how addictive and dangerous morphine can be but everyone knows about heroin.
Instead of the Black Box Warning saying that this drug is …”indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time,” the warning also needs to include the information contained in more and more of the medical literature: “The continued use of OxyContin is being linked to opioid- induced hyperalgesia (increased pain sensitivity) and in these cases doesn’t reduce but increases pain. If you feel that your pain is increasing and you are taking opioids then see your medical professional immediately.”
On another point, the Black Box Warning says, “OxyContin 60 mg, 80 mg, and 160 mg Tablets ARE FOR USE IN OPIOID TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.” The warning needs another sentence, “IF YOU TAKE THIS DRUG YOU MAY DIE FROM TAKING ONLY ONE PILL ONE TIME.”
Pete Jackson made a good point and would go farther. Pete said, “Kids don’t read the warning. We want to prevent kids like my daughter from taking OxyContin and thinking it is safe because it is legal. We need to make them put a skull and cross bones, the universal sign for poison, on the bottle or even better—on each pill.”
Let’s make sure that patients have the data on all prescription drugs so they can make an informed consent. All we ask is that the “business as usual” practice of not telling the full truth about these deadly drugs be changed and their use be sharply curtailed and regulated like we do with other dangerous drugs.
A final caution—the world has won a great victory on May 5th , but the war against the killing and addicting of fellow citizens is not over. Purdue’s guilty plea shows that it will stop at nothing to protect their profits, so we must be prepared to fight more and more battles. We know this war can be and must be won, but it will require vigilance and continued effort from all of us. We need to keep writing letters to the FDA and Congress. Larry G needs to keep broadcasting the truth. We need to speak out at town meetings and every chance we get.
Thanks to Larry, Pete, Ellen and many others, Purdue is now aware that they are in a tunnel and the light they see is an oncoming train. It is gaining speed and will run over them if they don’t become good citizens. Purdue also sees that this is not a train that they can stop by offering the engineer a higher paying job—like Big Pharma has done with many of their critics. This train scares Purdue and Big Pharma because it is driven by dedicated, caring people who are not going to tolerate seeing their loved ones continue to suffer and die so Purdue can make a profit.
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