FDA Hearings, OxyContin and More Big Pharma Delays

FDA Hearings, OxyContin and More Big Pharma Delays

The recent FDA hearings on May 27th and May 28th were the latest in a series of meetings conducted by the FDA to discuss the implementation of an opioid Risk Evaluation Mitigation Strategy (“REMS”). The first part of this process is to determine if opioids like OxyContin are more dangerous than beneficial. If they are found to have some legitimate medical uses but are creating many harmful effects (which they unquestionably are), then the REMS will set forth restrictions on the use of the opioids in order to reduce the harmful effects of the deadly drugs. This was the first public meeting. As they have at the previous invitation-only meetings, the members of our group, Advocates for Prescription Opioid Drug Reform (“APODR”), made a powerful emotional and medical case for the need to severely restrict the access and use of these deadly drugs.


Unless you deal with the problems created by these deadly opioid drugs, like OxyContin (legal heroin), or you experience the tragic loss created by a death or addiction from these deadly drugs, it is sometimes hard to really understand the impact these drugs are having. The following information should make it more real.


The Centers for Disease Control compile the numbers of deaths attributable to drugs in the United States. The following numbers are low not only because they are 2005 numbers but also because many states don't report the presence of prescription drugs in toxicology reports.

  • Every six minutes of every day a person is admitted into the emergency room because of an overdose of opioids.
  • Every hour of every day a person dies of an overdose of opioids.
  • By the time you have opened your email and read to this point, a person will be admitted to the emergency room because of an opioid overdose.
  • Every day that we wait to take action against these deadly opioid drugs, 240 more people go to the emergency room and 24 more people have died.


Although not just about opioids, a report issued by The National Center on Addiction and Substance Abuse (CASA) at Columbia University found:

  • Federal and state governments spend $59.83 on substance abuse and addiction for every dollar they spend on prevention and treatment;
  • States spend more on the costs of substance abuse and addiction than on any other budget item, second only to the amount they spend on elementary and secondary education.
  • The federal government spends more on the costs of substance abuse and treatment than for everything except social security, national defense, income security, Medicare and other health programs including the federal share of Medicaid.
  • 71.1 percent of total federal and state spending on costs of addiction is in two areas: health care and justice system costs.
  • The largest share of federal and state spending dealing with substance abuse and addiction is in health care costs (58.0 percent).

In an article republished in our May 18, 2009 newsletter, Senator Steve Tolman said that opioid overdose emergency room visits cost Massachusetts $200 million last year.


While it is beyond argument that these opioid drugs are causing death and destruction and costing us billions, Big Pharma and their funded groups were not bothered by the facts. They made many arguments for why restrictions on these drugs were really not needed, but these can be classified into two general types.


There was one psychiatrist who has a non-profit corporation supported by Purdue Pharma said that the only people being hurt by these opioids were addicts. He said that the drugs were safe if taken as directed. He didn't dare discuss that these drugs were interchangeable with heroin. He ignored the fact that many young people die from one OxyContin pill. They were not addicts. He ignored the fact that many people who take OxyContin as prescribed become addicted and some of these people who take OxyContin as prescribed die. There were a number of other Big Pharma-funded groups who made similar arguments.


Particularly unsettling was the argument made by some of these pain treatment advocates that any restrictions placed on these deadly drugs by the FDA must not “inconvenience” people who are taking these drugs for pain. This was probably the theme of most of the Big Pharma arguments. In the Encarta Dictionary, inconvenience is defined as “1. lack of convenience: the quality or fact of being inconvenient or causing discomfort, difficulty, or annoyance.” To them, it was inconvenient if they were forced to take a urine test or if they were delayed at the pharmacy because there were meaningful restrictions on someone getting multiple prescriptions. It was annoying. One speaker said that she has been taking OxyContin for years to deal with her pain and that it was very upsetting to her one and three year old children that their mother had to take a urine test before her doctor would renew her prescription. This was very inconvenient for her. Another said that it would be inconvenient if their doctor decided not to prescribe the opioids because of restrictions placed on their use and they had to find another doctor.


While these people may have to spend a few more minutes getting their opioids and might have to take urine tests to ensure that they are not abusing these opioids or find another doctor, there is another more serious meaning of inconvenience. Inconvenience is:

  • Getting a call that a child or spouse or friend overdosed on opioids like OxyContin and is in the emergency room;
  • Going to wake your 17 year old daughter for school only to find that she overdosed from a single OxyContin pill and will never wake up again;
  • Getting a call from your son, daughter or spouse saying that they have been arrested for breaking into a pharmacy to steal OxyContin;

What type of person can seriously say that they are not willing to add some extra time if that is going to save someone's son, daughter or spouse from going to an emergency room because of opioids? What type of person can seriously say that they are not willing to have some inconvenience if it is going to keep legal heroin out of the hands of our children and citizens?

What is a life worth?


Probably none of these drug company spokespeople really expect to be believed. However, it became obvious at this last set of meetings that Big Pharma and their paid spokespeople are primarily interested in delay. They can't deny that their drugs are killing thousands of Americans each year and destroying the lives of many thousands more and costing American taxpayers billions of dollars. They can't deny that restrictions on these deadly opioids will save lives and prevent addictions, but they hope to delay these restrictions even if thousands more die. We err when we assume that the executives of Big Pharma think like the rest of us. It is very clear that Purdue Pharma, and most other drug companies, care about only one thing—making money. Purdue Pharma is obviously not concerned that a significant percentage of OxyContin is being diverted because to them this is just more sales. You see, Purdue Pharma may sell $2.4 billion of OxyContin, legal heroin, this year. This equates to $200 million per month, $666,666 per day, $27,777 per hour and $460 per minute. No one knows how much legitimate restrictions on Purdue's sale of legal heroin will reduce their sales, but Purdue knows that if they can delay FDA action for six months, then they will make $1.2 billion. This is quite an incentive. Of course, if Purdue delays restrictions for six months, then it is certain that the number of OxyContin deaths will continue and the number of OxyContin emergency room visits will continue.


In my closing remarks to the FDA, I quoted from Dante’s Inferno. Dante said that the hottest place in hell is reserved for those who, at a time of moral crisis, do nothing. If the FDA doesn’t take action to place serious restrictions on the availability of these opioids, then there will be a lot of them spending time in a very hot place.

Here are two: “ Our family knew three young men who have died from this drug. Our oldest son (28 yrs old) was addicted and is in jail waiting to stand trial for armed robbery to obtain these drugs. He is looking at spending the rest of his life in prison leaving a wife to care for their 3 young children.”I had a friend given this drug for back pain and he became addicted to this drug. It ruined his very successful life. Please help so others will not become effected badly by this very destructive drug.” At Novus, we help people whose lives have been harmed by not only opioids like OxyContin, Vicodin, methadone and heroin, but also we help people escape from the trap created by psychoactive drugs like Xanax. Please contact us if you know someone that we can help.

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