Big Pharma and the FDA
Many still trust Big Pharma and the FDA with their health, and unfortunately, like every other company in the world, the FDA can be bought. I knew the corruption in the FDA was rampant with this Covid vaccine crap, I had no idea just how deep it went. I need to thank the Hulu original series Dopesick. It made me aware of something I had no idea about, and probably because I was just a kid. It exposes the FDA’s role in one of the biggest crises our country has seen, the opiod epidemic. It all started with a man name Richard Sackler form the Sackler Group, which ran Purdue Pharma. You can see their rise to wealth here. He set out to create something that would help people in severe pain, or so they portray him that way. It is hard to think that the way he is portrayed is authentic though. This man was born into a wealthy family and lived in a huge mansion estate, at the time he was creating this drug. He was the mastermind behind the worst Opoid narcotic this country has ever seen. What is this drug you ask? Oxycontin. Prior to this drug coming out, a lot of doctors hesitated prescribing pain medication because of how addicting it was. Purdue Pharma changed all that. How you ask? Simple, they lied about everything. Next thing you will say is, but that is what the FDA is for, or so you think. They were able to get a label for this drug that made it sound like it wasn’t addicting at all. Here is what the original label said:
- “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug”
- “Iatrogenic ‘addiction’ to opioids legitimately used in the management of pain is very rare.”
So before I get into that, let’s get into some back story. Oxycontin came on the market in 1996. They more than doubled the size of their sales force, which was unheard of at that time, from 318 to 671. They created profiles of doctors and their staff and trained their reps on how to get in the door to see the doctors and sway their opinion. Let me expand on this for a moment, because this is HUGE!!! How did they do this you ask? They used a sophisticated marketing database, created by the Sackler Group and then sold off to another company, to influence physicians’ prescribing habits. How does this work? Drug companies compile prescriber profiles on the individual physicians, detailing the prescribing patterns of physicians nationwide, in an effort to influence doctors’ prescribing habits. Through these profiles, a drug company can identify the highest and lowest prescribers of particular drugs in a single zip code, county, state, or the entire country. One of the critical foundations of Purdue’s marketing plan for OxyContin was to target the physicians who were the highest prescribers for opioids across the country. The resulting database would help identify physicians with large numbers of chronic-pain patients. Unfortunately, this same database would also identify which physicians were simply the most frequent prescribers of opioids and, in some cases, the least discriminate prescribers. So what does this mean? They profiled the doctors and their patients. This is beyond disgusting behavior. I have known for quite a few years that doctors can, in fact, be bought and they do , in fact, get kick backs. I also have known that Pharmaceutical companies only care about one thing, money. This specific instance really proves that and shows you just how this all started.
Not only did they increase their sales force, but they were able to increase their physician base. They increased their total physician call list from approximately 33,400 to 44,500 to approximately 70,500 to 94,000 physicians, again more than double! Through their sales reps, Purdue used a patient starter coupon program, for OxyContin, that provided patients with a free limited-time prescription for a 7 to 30 day supply. By 2001, when the program was ended, approximately 34,000 coupons had been redeemed nationally! That is a great way to get people to try the product and of course get hooked on it.
Purdue promoted a more liberal use of opioids, particularly sustained-release opioids, among PCP’s. Primary care physicians began to prescribe OxyContin more frequently. By 2003, nearly half of all the physicians prescribing OxyContin, were primary care physicians. Some experts were concerned that primary care physicians were not sufficiently trained in pain management or addiction issues. Primary care physicians, particularly in a managed care environment of time constraints, also had the least amount of time for evaluation and follow-up of patients with complicated chronic pain.
Purdue aggressively promoted the use of opioids for use in the non-malignant pain market. A much larger market than that of cancer-related pain, the non–cancer-related pain market constituted 86% of the total opioid market in 1999. Purdue’s promotion of OxyContin for the treatment of non–cancer-related pain contributed to a nearly tenfold increase in OxyContin prescriptions for this type of pain, from about 670,000 in 1997 to about 6.2 million in 2002, whereas prescriptions for cancer-related pain increased about fourfold during that same period.
So how did they convince all these doctors? It all came down to how they trained their reps, who by the way made insane amounts of money. They trained their reps to say that “less than 1% of all patients” get addicted. They also trained them to say it was less subject to abuse and diversion than other opioids. Even I can see through this lie. There has never been a schedule 2 narcotic, that was not addicting. They claimed this was due to the extended release technology which slowly released the medication in to your body. Unlike their previous drug MS Contin, that they rolled out in the 80’s. They basically needed to rebrand themselves from that disaster. By 1990, MS Contin had become the most abused prescription opioid in one major metropolitan area. Purdue’s own testing in 1995 had demonstrated that 68% of the oxycodone could be extracted from an OxyContin tablet when crushed. They knew this, and yet they continued with their false advertising and branding. They started with rural areas like Maine, West Virginia, eastern Kentucky, southwestern Virginia, and Alabama. Why did they focus on these states first? These states had a history of prescribing opioids. They were prescribing non oxycontin opioids, such as hydrocodone, 2.5 to 5 times MORE than the national average. By 2000, these same areas had become high OxyContin prescribing areas. How much more? They were 5 to 6 times higher than the national average. These areas, in which OxyContin was highly available, were the first in the nation to witness increasing OxyContin abuse and diversion, which began surfacing in 1999 and 2000.
From 1995 to 2001, the number of patients treated for opioid abuse in Maine increased 460%, and from 1997 to 1999 the state had a 400% increase in the number of chronic hepatitis C cases reported. For those of you who don’t know, I live here in Maine. They have completely abolished the prescription of opioids. They fully embrace medical marijuana for dealing with chronic pain. I was super surprised by this when we moved here, in a good way. Of course now you have both medicinal and recreational here in the state, as of this year. In eastern Kentucky from 1995 to 2001, there was a 500% increase in the number of patients entering methadone maintenance treatment programs, about 75% of whom were OxyContin dependent (Mac Bell, administrator, Narcotics Treatment Programs, Kentucky Division of Substance Abuse, written communication, March 2002). In West Virginia, the first methadone maintenance treatment program opened in August 2000, largely in response to the increasing number of people with OxyContin dependence. By October 2003, West Virginia had 7 methadone maintenance treatment clinics with 3,040 patients in treatment (M. Moore, Office of Behavioral Health Services, Office of Alcoholism and Drug Abuse, West Virginia, written communication, March 16, 2004). In southwestern Virginia, the first methadone maintenance treatment program opened in March 2000, and within 3 years it had 1400 admissions (E. Jennings, Life Center of Galax, Galax, Virginia, written communication, March 12, 2004). I mean we all know how detrimental this stuff was.
Now that we have this background into the company, we need to realize that the FDA played a HUGE role in how all this happened. They did not do their job when it came to scrutinizing this drug. There were no studies done, that I could find, for the efficacy of this drug and how it was less addicting. As a matter of fact, they utilized 2 studies from others to come to this conclusion, or should I say they presented these studies to the FDA. They cited studies by Porter and Jick, who found iatrogenic addiction in only 4 of the 11,882 patients using opioids and by Perry and Heidrich, who found no addiction among 10,000 burn patients treated with opioids. Neither of these studies cited, actually studied long term or daily use of opioids nor did they use OxyContin in this study. Drug companies are supposed to do studies on THEIR product. So here is problem number 1.
Regulations require that ALL promotional materials, for prescription drugs, be submitted to the FDA for review, when the materials are initially disseminated or used. It is not required, however, that these materials be approved by the FDA prior to their use. This would be problem number 2. The FDA also has a limited number of staff when it comes to overseeing the enormous amount of promotional materials. In 2002, for example, 39 FDA staff members were responsible for reviewing approximately 34,000 pieces of promotional materials. This limited staffing significantly diminishes the FDA’s ability to ensure that the promotional information is truthful, balanced, and accurately communicated. Here is problem number 3. In 1998, Purdue distributed 15,000 copies of an OxyContin video to physicians, without submitting it to the FDA for review, which they claim was an oversight. It was most definitely intentional on their parts. In 2001, Purdue submitted a second version of the video to the FDA, which the FDA did not review until October 2002. They only reviewed it because the General Accounting Office inquired about its content. This is problem number 4. When OxyContin entered the market in 1996, the FDA approved its original label, which I shared above. This is problem number 5. Curtis Wright, once a director at the FDA, was the one who, at the time, oversaw evaluation for pain medication. He was the one who “Approved” OxyContin’s original label. After a year of the drug’s launch, he got a position at Purdue Pharma, making $400,000 a year! Problem number 6! This is not the first time someone from the FDA has been bough and paid for, we saw this with Pfizer’s vaccine, most recently.
After the FDA finally reviewed Perdue Pharma’s video, they concluded that the video minimized the risks from OxyContin and made unsubstantiated claims regarding its benefits to patients. So in July 2001, to reflect the available scientific evidence, the label was modified to state that the data was not available for establishing the true incidence of addiction in chronic-pain patients. The 2001 labeling also deleted the original statement that the delayed absorption of OxyContin was believed to reduce the abuse liability of the drug. But of course by this time the damage had been done. Had the FDA done their due diligence to begin with all the deaths that occurred because of this drug, would have been avoided. Neither the FDA or Perdue were ever held accountable criminally. Perdue execs did plead guilty and were sued for $634 million. Their company is now bankrupt and yet the Sackler family still retains over $10 billion dollars in assets. What happened then and what is happening now are huge miscarriages of justice. Human rights were violated then and now, as well as, going against the Nuremburg code, then and now. Why does history keep repeating itself? Why do we let it? It is time to get better educated and pay better attention to your surroundings.
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