Posts Tagged ‘OxyContin’

The Billionaire Pill

aaaaaaaaaaaaaaaa

In a recent Forbes magazine article about this nation’s twenty richest families, the Sackler family was number sixteen on the list. The Sacklers are estimated to be richer than the Mellons, Rockefellers, and Busches. (http://www.forbes.com/sites/alexmorrell/2015/07/01/the-oxycontin-clan-the-14-billion-newcomer-to-forbes-2015-list-of-richest-u-s-families/

You say you don’t know the Sackler family? I’ll remind you. They own one-hundred percent of Purdue Pharma, a pharmaceutical company best known for manufacturing their block-buster drug OxyContin.

This is a bitter pill for me to swallow.

I started working in the field of opioid addiction treatment in 2001. At that time, nearly every opioid addict I saw was using OxyContin as their main drug. Opioid addiction in general and OxyContin addition in particular plagued many small towns and rural areas where I worked.

OxyContin was widely prescribed for pain. This powerful drug was advertised as “The one to start with and the one to stay with,” during sales pitches to rural physicians. OxyContin flooded the black market. Opioid addict quickly discovered OxyContin’s time-release coating could be easily defeated, and the pill was often snorted or injected for the rush of opioid euphoria it produced.

I was certainly not the only doctor to notice the rise of OxyContin addiction.

Barry Meier’s book Pain Killer: A “Wonder” Drug’s Trail of Addiction and Death (Rodale Books, 2003), tells the story of small town doctors trying to get the attention of Purdue Pharma, the government, or anybody else who could help change the destruction OxyContin was doing to Appalachia around that time.

I remember attending a pain and addiction conference around sometime around 2003 or 2004. At the end of the lecture explaining how opioids could be prescribe safely, a doctor from Virginia dared to ask the experts something along the lines of, “What are we going to do about OxyContin?” I thought to myself that I was glad someone had finally said what I was thinking.
This was a long time ago; I don’t remember exact words, but my memory is that he was soundly rebuffed for daring to mention one specific drug by name. He was scolded and told that the real problem was with opioids in general, and one drug company (who happened to have some of the lecturers on their payroll) should not be singled out as the problem.

I remembered wishing those experts could spend a day at my treatment program talking to the OxyContin addicts.

Eventually, the U.S. General Accounting Office asked for a report about the promotion of OxyContin by Purdue Pharma. By 2002, prescriptions written for non-cancer pain accounted for 85% of the OxyContin sold, despite a lack of data regarding the safety of this practice. By 2003, primary care doctors, with little or no training in the treatment of chronic non-cancer pain, prescribed about half of all OxyContin prescriptions written in this country. By 2003, the FDA cited Purdue Pharma twice for using misleading information in its promotional advertisements to doctors. [1, 2] Purdue Pharma also trained its sales representatives to make deceptive statements during OxyContin’s marketing to doctors. [3]

Testifying before Congress in 2002, a Purdue Pharma representative said the company was working of re-formulating OxyContin, to make it harder to use intravenously. This representative claimed it would take several years to achieve this re-formulation. The re-formulated OxyContin was finally approved by the FDA in 2010, eight years later. Currently, this medication forms a viscous hydrogel if someone attempts to inject or snort the medication. It isn’t abuse-proof; probably no opioid will ever be so, but it is much more abuse-deterrent than the original.

Did Purdue Pharma drag their feet in this re-formulation? Experts like Paul Caplan, executive director for risk management for the drug company, said there were issues about the safety of incorporating naloxone into the pill to make it less desirable to intravenous addicts. He also pointed out that some delay in approval was due to the FDA.

For comparison, Sterling Pharmaceutical, when it became widely known patients were abusing their pain medication Talwin, re-formulated within a year, adding naloxone to the medication and reducing its desirability on the black market. Since this was in the 1980’s, I would assume there was less technology to help back then, compared to 2002.

I’ll let readers draw their own conclusions.

In May of 2007, three officers of Purdue Pharma pled guilty to misleading the public about the drug’s safety. Their chief executive officer, general counsel, and chief scientific officer pled guilty as individuals to misbranding a pharmaceutical. They did no jail time but paid $34.5 million to the state of Virginia, where the lawsuit was brought.

The Purdue Pharma Company agreed to pay a fine of $600 million. Though this is one of the largest amounts paid by a drug company for illegal marketing, Purdue made 2.8 billion dollars in sales from the time of its release in 1996 until 2001.

None of the Sackler family members were charged, because they were not involved in the day to day running of the company.

And now the Sackler family is worth billions.

1. General Accounting Office OxyContin Abuse and Diversion
report GAO-04-110, 2003.
2. United States Senate. Congressional hearing of the Committee
on Health, Education, Labor, and Pensions, on Examining
the Effects of the Painkiller OxyContin, 107th Congress, Second
Session, February, 2002.
3. Washington Times, “Company Admits Painkiller Deceit,”
May 11, 2007, accessed online at http://washingtontimes.
com/news/2007/may/10/20070510-103237-4952r/prinnt/ on
12/18/2008.

Why are so many people addicted to prescription pain pills?

I was reading a great blog I’ve started visiting, http:addictionblog.org and came across an entry about why the U.S. has more pain pill addicts now than 10 years ago.

I couldn’t resist blathering on,  commenting on the blog. I wrote so much the software thought I was spamming. So I thought I’d repeat my comments here, on my blog.

This is an important issue. We now have an estimated 1.7 to 2 million people addicted to prescription pain pills. Many of the conditions that contributed to this wave of addiction have been changed – but not all.

Prescription opioid addiction has increased dramatically over the last decade, due to a combination of factors. First, there was the pain management movement, which emphasized the importance of adequate pain control. Of course that’s an admirable goal, but the risks of addiction were understated due to bad science and misinterpretation of limited data. Instead of a risk of addiction of about 1%, quoted by many pain management gurus, the true incidence is more like 10 – 45%, depending on which study you read.

Then against that backdrop, OxyContin was released and marketed to general practitioners and family docs with limited knowledge about how to identify and treat addiction. In general, medical schools and residencies have done a lousy job of educating doctors about proper prescribing of opioid medications, how to identify addiction, and where to refer people for treatment of their addiction.

 Then there was access to opioids via the internet, which actually seemed to be a bigger problem than it was. A small percentage of abused opioids came from the internet, but some people became addicted in that way. With the changing laws, these rogue internet pharmacies are less numerous.

States most heavily afflicted by pain pill addiction didn’t have prescription monitoring programs in place. These programs are essential tools to identify people who are getting pills from more than one doctor at a time, called “doctor shopping,” which is often an indication the person has an addiction that needs treatment. Fortunately, most states either have these programs now or are in the process of putting them into place.

But a big part of the problem is cultural. We share prescription medications, even controlled substances, with alarming frequency. Most people aged 18 – 24 who use pain pills nonmedically get them from friends or family, not from some nefarious dealer on the corner. Adolescents don’t realize how dangerous prescription pain pills are.

Anyone with pain pills in their medicine cabinet needs to lock them up to keep them safe, or dispose of medication when they are no longer needed. And we need to stop sharing our medications. It’s illegal, dangerous, and contributes to addiction.

Excerpt from my upcoming book: Pain Pill Addiction: Prescription for Hope

 One doctor makes work for another.  ~English Proverb

 The increase in opioid addiction coincided not only with the movement toward aggressive treatment of chronic pain with opioids, but also with the release of OxyContin by its manufacturer, Purdue Pharma, in 1996. Their other drug for pain, MS Contin, had become well-established in the treatment of severe cancer pain, but this drug was due to come off patent. This meant the other drug companies could then manufacture and sell a generic version of the same drug at a cheaper price. Purdue obviously wanted physicians to switch to their new drug, still under their patent, to maintain their share of this market.

 OxyContin was marketed aggressively to small town family doctors who didn’t have much experience treating chronic pain with powerful opioids, or with identifying and treating pain pill addiction. In rural areas, family doctors had few places they could refer patients who developed problems with their opioid pain medications.  (1)

 The drug company marketed OxyContin as an appropriate treatment for chronic, moderate to severe, non-cancer pain. In the past, such strong opioids were used only for intractable, severe pain. OxyContin was marketed as the pain medicine to “start with and stay with.” OxyContin was even prescribed for such ailments as menstrual cramps, oddly mirroring the misuse of opioids like laudanum and morphine a century earlier.

 Purdue Pharma believed OxyContin was tamper-resistant and less likely to be abused, due to its time release coating. The drug company was still touting this as a selling point in 2001, when addiction medicine doctors all over the country were seeing hundreds of OxyContin addicts. These addicts described how easy it was to moisten the pill, crush it, snort it, inject it, or just file off the coating and chew it.

 Purdue Pharma didn’t do pre-release testing of their new drug, to assess its desirability to addicts seeking to get high. At first, they didn’t have a post-market release system to monitor for signs of abuse and diversion, as other companies have done.  In fact, Purdue Pharma seemed to go out of their way to ignore early warnings and complaints about the drug. Doctors, who tried to warn the drug company about the patients they were seeing who were addicted to OxyContin, were ignored and discounted. (1)

 Purdue Pharma trained its sales representatives to make deceptive statements. Besides telling doctors that the drug was less likely to be abused, the sales representatives also gave false information about the risks of opioid withdrawal after stopping the pill. (2)

 OxyContin became such a commonly known drug to both abusers and the media that the U.S. General Accounting Office (GAO) asked for a report about the promotion of OxyContin by Purdue Pharma, information on factors affecting its abuse and diversion, and recommendations of how to curtail its misuse. This report, released in 2003, stated that by 2001, the sales of OxyContin were over 1 billion dollars per year, making it the most commonly prescribed brand of opioid medication for moderate to severe pain. (2)

 By 2002, prescriptions written for OxyContin for non-cancer pain constituted eighty-five percent of its total sales. The type of non-cancer pain for which it was prescribed included both acute pain, like kidney stones, broken bones, and post-operative pain, and chronic pain like arthritis and fibromyalgia. By 2003, primary care doctors, with little or no experience or training in the treatment of long-term pain, were prescribing about half of all the OxyContin prescriptions written in the country. By 2003, the FDA had cited Purdue Pharma twice, for using misleading information in its promotional advertisements to these doctors. (2)

 The GAO’s report recognized the unique timing of the release of OxyContin. “Fortuitous timing may have contributed to this growth, as the launching of the drug occurred during the national focus on the inadequacy of patient pain treatment and management.” (2, Page 9)

 Purdue Pharma could have re-formulated their pill, to reduce the risk of abuse and addiction. Sterling Drug, manufacturer of the pain medication Talwin, re-formulated their medication, to make it less likely to be abused. The active drug in Talwin is pentazocine, an opioid that had a brief rise in abuse when it was first released in the 1980s. To prevent intravenous injection of their drug, Sterling re-formulated Talwin within a year, adding naloxone, a drug that reverses the effects of opioids. This is the same medication used by doctors to treat opioid overdoses. Naloxone is not absorbed when taken by mouth, because it is inactivated by stomach acid. But when the pentazocine/naloxone pill is ground and injected, it puts addicts into immediate withdrawal, thus making it a much less desirable drug for intravenous addicts. This action by Sterling curtailed the abuse of Talwin/NX, their new product.

 Other manufacturers have taken different precautions, when concerned about the abuse of a prescription drug. For example, the drug Rohypnol, commonly called the date rape drug, is illegal in the U.S., but is legally prescribed in Europe and Latin America. Because they were concerned that the drug was being used illicitly, to facilitate rapes, the manufacturer, Hoffman-LaRoche, re-formulated Rohypnol so that instead of being clear, colorless and tasteless, it becomes milky white when added to any other liquid. This can warn unsuspecting people that something has been added to their drink.

 A Purdue Pharma representative testified before congress in 2002, saying that the company was working on a re-formulation of OxyContin, to make it harder to use intravenously, and that they expected to have the re-formulated pill on the market within a few years. (3)  Eight years later, there still is no such re-formulation of OxyContin. Purdue Pharma said it would take three or four years to reformulate the drug, though Sterling, with Talwin, managed to accomplish this within a year, more than a decade earlier.

 In May of 2007, three officers of Purdue Pharma, a privately held company, pled guilty to misleading the public about the drug’s safety. Their chief executive officer, general counsel, and chief scientific officer pled guilty, as individuals, to misbranding a pharmaceutical. The executives did not serve jail time. Though they plead guilty, they claimed they personally had done nothing wrong, but accepted blame under the premise that an executive is responsible for the acts of the employees working under him. (4) The three executives’ fines totaled 34.5 million dollars, to be paid to Virginia, the state that brought the lawsuit.

 The Purdue Pharma company agreed to pay a fine of $600 million. Though this is one of the largest amounts paid by a drug company for illegal marketing, Purdue made 2.8 billion dollars in sales revenue, from the time of its release in 1996 until 2001 alone.

 To be fair, the drug company and addiction specialists had data that showed the most common opioid to be abused is actually hydrocodone, a short acting opioid, often marketed under the brand names of Vicodin or Lortab. While this is technically correct, the strength of a single hydrocodone pill is usually 5, 7.5, or 10 mg, while OxyContin came in 10, 20, 40, 80, and, for a brief time, 160mg. In addition, hydrocodone is slightly weaker, milligram per milligram, than oxycodone. In other words, the opioid firepower in one OxyContin is much higher than in one hydrocodone, so they are hardly comparable. An addict would need more than eight hydrocodone 5mg pills to equal one OxyContin 40mg.

 This much opioid, packed into one pill, produces a powerful high when it’s released all at once, as it is when the time release coating is removed. Many patients I’ve talked to have said they knew OxyContin would cause problems from the first use. “After that first high, I knew I would keep using. I wanted that feeling,” is an example of a typical quote.

 Since the debacle of OxyContin, Purdue Pharma has donated money towards helping communities treat opioid addicts, and has paid money as ordered by the court. Much of the $600 million award will go to states heavily afflicted by OxyContin addiction. This money will help to establish programs to help prevent and treat opioid addiction.

 OxyContin isn’t a bad or evil drug. It’s just a drug, capable giving great benefit and relief of suffering to those people in serious pain. And it’s also capable of being misused, and can cause great suffering and even death, if not used in the right way.

 1. Barry Meier, Pain Killer: A “Wonder” Drug’s Trail of Addiction and Death (Rodale Books, 2003)

2. General Accounting Office OxyContin Abuse and Diversion report GAO-04-110, 2003.

3. United States Senate. Congressional hearing of the Committee on Health, Education, Labor, and Pensions, on Examining the Effects of the Painkiller OxyContin, 107th Congress, Second Session, February, 2002.

4. Washington Times, “Company Admits Painkiller Deceit,” May 11, 2007, accessed online at http://washingtontimes.com/news/2007/may/10/20070510-103237-4952r/prinnt/ on 12/18/2008.