The root cause of this Opioid Epidemic is the FDA's
illegal approval of Opioids .
was first approved in 1995, it was based on science that only showed it safe
and effective when used "short-term."
But in 2001, pressured by
Big Pharma and pain sufferers, the
FDA made a fateful decision and, with no new
science to back it up, expanded the use of Oxycontin to just about anyone
with chronic ailments like arthritis and back pain.
The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for "daily, around-the-clock, long-term… treatment." And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.
Ed Thompson: A drug's label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.
Bill Whitaker: How so?
Ed Thompson: Because it allows you to then promote the drug based on the labeling.
Ed Thompson (owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma.), is suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.
Ed Thompson: You're using high-dose, long-duration opioids when they've never been designed to do that. There's no evidence that they're effective. There's extreme evidence of harms and deaths when you use them.
In a small courthouse in Welch, West Virginia, we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state's lawsuit against Purdue for deceitful marketing.
They reveal it was at those secret meetings the FDA bowed to Purdue Pharma's demands to ignore the lack of scientific data, and changed the label to, "around the clock…for an extended period of time.''
Ed Thompson: I can't think of anything more harmful ..... It opened the floodgates. It was the decision of no return for the FDA.
Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.
The FDA's responsibility is public health and the safety of drugs, and they're not doing their job. They haven't been doing their job for 20 years.
Dr. Andrew Kolodny: We found out that a group of experts and FDA and pharmaceutical companies were having private meetings, changing the rules for how opioids get approved.
He filed Freedom of Information Act Requests. In email after email between the FDA, Big Pharma and consultants, he learned of closed-door meetings at luxury hotels, like this Four Seasons in Washington, DC, where for $35,000 a piece, drug makers paid consultants to, "sit at a small table with the FDA," "hobnobbing with the regulators." Emails show one participant worrying it might be seen as "pay to play."
Dr. Andrew Kolodny: They had drugs in their pipeline, pain medicines that they wanted approved. And through these meetings, they were able to get those products on the market.
If it's not illegal, it should be illegal.
Equally suspicious but legal, the large number of key FDA regulators who went through the revolving door to jobs with drug manufacturers. The two medical officers, who originally approved Oxycontin, Curtis Wright and Douglas Kramer, went to work for the opioid maker, Purdue Pharma, not long after leaving the FDA.
The FDA bills drug companies more than $800 million a year in fees and depends on that industry money to pay the salaries of staffers who not only changed the opioid label, but also review new drugs like Dsuvia, the most powerful opioid pill ever approved.
Bill Whitaker: Just a few weeks ago the FDA approved a new opioid that is 1,000 times more powerful than morphine (fetanyl) . And this is in the middle of this opioid epidemic. How is that possible? Isn't the FDA supposed to be our watchdogs to protect us?
Only 5 people were working in a FDA division that oversaw drug promotion when this epidemic started to occur !
A system of pharmaceutical promotion ... that no one stopped.
Bill Whitaker: You say they have to do things to fix the label. The label has been in place since 2001. I-- I'm not a scientist, but that doesn't seem like that's hard to do.
Ed Thompson isn't waiting. He has now joined a growing movement of doctors, lawyers, and patient activists who want Big Pharma to kick its fixation on opioid profits. That's why he made the decision to take on his industry and the FDA.
Bill Whitaker: If you succeed, you could pull down a multibillion-dollar industry.
Ed Thompson: And if I fail, you're gonna have ever-increasing deaths every day as well. It's a pretty good decision, isn't it?
May 2016 CBS McKesson delivered 100 million opiates to a state with 1.8 million people ( in 5 years).
McKesson, the nation's largest drug distributor, is at the top of that list. The DEA, along with six states, sued McKesson in 2008 for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor their pill supply.
"Even after we charged them civilly and took civil fines , three years later, they started violating the law again," .
This time the wholesaler paid $150 million in fines and had distribution centers suspend operations in four states.
"A civil penalty of ... tens of million dollars means nothing when you're making billions of dollars," .
West Virginia is suing McKesson -- in a five-year period, McKesson delivered 100 million opiates to a state with 1.8 million people. "while West Virginia was drowning in painkillers, McKesson continued to incentivize sales... with bonuses for the sale of oxycodone and hydrocodone."
Purdue and several current and former executives pleaded guilty in
federal court and agreed to pay a total of
$635 million to settle charges they had
fraudulently marketed OxyContin as a drug that was less addictive than other narcotics and that had few side effects.
October 21st 2020 Purdue admitted to bribing doctors to
unnecessarily prescribe OxyContin and to lying to the Drug Enforcement
Administration (DEA) about controls on sales of the painkiller. It also paid
illegal kickbacks to a health records company to promote opioid prescribing
Guilty of 3 criminal charges and pay $8bn in fines and damages.
June 21st 60 MINUTES:- Insys, the Arizona-based maker of opioid painkiller Subsys, filed for bankruptcy in January 2020. Burlakoff, CEO John Kapoor and six other executives were sentenced to prison for their part in a racketeering scheme based on a conspiracy to recklessly and illegally boost profits from Subsys, a potent, fast-acting fentanyl intended for cancer pain patients. This landmark criminal case was the first to bring pharmaceutical executives to trial for their role in fueling the opioid epidemic, potentially indicating a shift in how the government approaches white collar crime. (scroll down for more)
June 21st 60 MINUTES:- In 2003, Cephalon, one of several drug companies doing business in ways that brazenly flouted FDA regulations. A former sales VP for a pharmaceutical company, who was sentenced to prison, tells 60 Minutes he bribed doctors to prescribe fentanyl drugs.
the Washington Post says: the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 came from three drugmakers (Purdue says that , according to DEA, it never accounted for more than 4% of total narcotic painkiller sales in the US. Critics dismissed that claim as a misrepresentation because the DEA statistics count only the number of individual pills sold not their strength. OxyContin, with 10 or 20 times the narcotic content of many regular painkillers, accounted for a much larger proportion of the total drug on the market reflected in sales of up to $2bn a year, more than any other opioid.):
First Major Trial in Oklahoma
( no jury) accuses
Johnson & Johnson
of overstating the benefits of opioids and understating their risks in
marketing campaigns that duped doctors into prescribing the drugs for
ailments not approved by regulators.
2019 April Insys Therapeutics founder John Kapoor Criminal Jury Trial in federal court in Boston Kapoor and his four co-defendants of bribing doctors and deceiving insurance companies.
2017 CBS 60 Minutes & Washington Post to get Congress to pass a bill to protect Drug Industry interests, in the height of an opioid epidemic, just shows how much influence Drug Companies have.”
Investigators at the DEA were aware that an inordinate number of prescription narcotics were being sent to pharmacies, and they began to bring cases against the pharmaceutical industry's powerful drug distributors.
But they hit a wall — in the form of their own attorneys. The drug industry used its money and influence to pressure the DEA's top lawyers into taking a softer approach. - Rannazzisi said
Numerous DEA agency lawyers switched sides and took high-paying jobs lobbying their former colleagues. Suddenly, DEA investigators could not get their cases through their legal office. - Novak said
As cases nearly ground to a halt at the
DEA, the drug industry began lobbying Congress
for legislation that would limit the agency's enforcement powers.
Congress passed a
Marino) that took away
the most potent tool the DEA
has — the ability to immediately freeze suspicious
shipments of prescription narcotics to keep drugs off American streets.
One of the lawmakers who introduced the bill was Pennsylvania Congressman Tom Marino. At the time of the 60 Minutes report, Marino had just been nominated to be President Donald Trump's new drug czar. Two days after the report aired, President Trump announced that Marino had withdrawn his name from consideration for the position.
DEA investigators built the biggest case the agency had ever made against a drug company: McKesson Corporation, the country's largest drug distributor
"The issue with McKesson was they were providing multi-millions of pills to countless pharmacies throughout the United States, and they did not maintain any sort of due diligence," .
But Schiller's DEA investigators hit a roadblock in Washington D.C. when they tried to hold McKesson accountable. Schiller says attorneys for the DEA and the Department of Justice were intimidated at the thought of going against McKesson and its high-powered legal team.
In the end, instead of the $1 billion fine that Schiller and his team wanted, McKesson was fined just $150 million.
"How do you do that?" Schiller told Whitaker. ".... You put the people that are responsible for dealing drugs, for breaking the law, in jail. Nobody's in jail. They wrote a check."
Drug distributors have been delivering huge numbers of pills to pharmacies, and pharmaceutical lobbyists have pressured Congress to let them off the hook.
-- then S. 483 (2016) authored by Orrin Hatch, signed by the president when it was combined with "Ensuring Patient Access" . The White House was unaware of the bill’s import when President Barack Obama signed it into law.
April 2019: Rochester Drug Co-Operative, one of the nation's 10 largest pharmaceutical distributors in the U.S., was charged with conspiracy to distribute controlled narcotics — oxycodone and fentanyl — for nonmedical reasons . Former CEO Laurence Doud and former chief of compliance William Pietruszewski and were charged with willfully failing to file suspicious order reports to the DEA.
Among the 15 largest American Drug distributors:-
paid tens of millions of dollars in fines related to the opioid epidemic in recent years.
Since 1999, more than 700,000 people in the US have died of drug overdoses, mostly driven by an increase in opioid-related deaths.
But the Washington Post says: the vast majority of the 76 billion opioid pills produced and shipped from 2006 through 2012 came from three drugmakers (Purdue wasn't even close):
|McKesson agreed to a $150 million settlement with the
Justice Department, a record for a distributor.
It was less than the $159 million retirement package the company granted its longtime chief executive, John H. Hammergren, in 2013.
At Actavis, Douglas S. Boothe rejected the DEA’s request that the company voluntarily cut its supply of oxycodone to U.S. pharmacies
Russell Portenoy, MD
Physicians had been afraid of the risks of opioids and reserved the use of opioids to cancer patients. Dr. Portenoy argued that they could also safely be taken for months or years by people suffering from chronic pain. Among the assertions he and his followers made in the 1990's was "less than 1% of opioid users became addicted", the drugs were easy to discontinue and "overdoses were extremely rare" in pain patients.
Many of those experts now say those claims were not based on sound scientific evidence. "I gave innumerable lectures in the late 1980's and 1990's about addiction that weren't true," Dr. Portenoy said in a 2010 videotaped interview with a fellow physician. Dr. Portenoy said it was "quite scary" to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. "Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do," Dr. Portenoy said in the video.
Lynn R. Webster, MD
He was quoted "Because true opioid addiction affects only about 1% of the general population and up to perhaps 5% of the chronic-pain population, it is clear that most people who take medications for pain will not become addicted to them."
Webster is also under U.S. Senate scrutiny and has the distinction of being investigated by the Drug Enforcement Agency (DEA) for unexplained deaths at his pain clinic in Utah.
Scott M. Fishman, MD
Fishman wrote a book entitled "Responsible Opioid Prescribing - A Physician's Guide" sponsored by the Federation of State Medical Boards. Fishman's book was distributed to medical boards in all 50 states and Canada and became the holy grail of prescribing opioids to physicians. One of the statements made in Fishman's book is "Another risk posed by non treatment or under treatment of pain affects the physician but not the patient directly. Physicians have been successfully sued for not treating pain aggressively." Fishman and his book is under U.S. Senate investigation as is the Federation of State Medical Boards for possibly profiting financially from pharma in the opioid epidemic.
Portenoy did have an "inkling" though to the soaring rates of addiction and
overdose deaths in the late 1980's and 1990's -- he only had to read
newspapers that covered the epidemic in every state in the country as it
spiraled out of control. So Dr. Portenoy -- you are under scrutiny of the
U.S. Senate in their investigation. Hopefully they will have an "inkling" of
your part as a trailblazer as will the medical profession you misled.
Fine is under U.S. Senate scrutiny for his ties to pharma and possible financial gain He was a "defense expert" in the cause of celebrity Anna Nicole Smith's death. Fine testified that "Smith's consuming 1,500 painkillers a month did not make her an addict".
He made a video entitled "Medications - Opioids" wherein he states "... the risk of addiction to opioids is extremely low."
Wright, along with Douglas Kramer, while employed by the FDA, were on the review panel and approved the drug OxyContin . He and Douglas Kramer subsequently left the FDA and violated their protocol by becoming employed by the maker of OxyContin, Purdue Pharma.
In 2007, Purdue
Pharma pleaded guilty in Federal Court to misleading the medical profession
about the addictive qualities of OxyContin.
J. David Haddox, DDS, MD, an executive with Purdue Pharma - maker of OxyContin.
In 1989, Haddox and another physician named Weissman, coined a word called "pseudo-addiction" which they referred to as a syndrome resulting from poorly treated pain. The term "pseudo-addiction" was as a result of one medical case -- a 17 year old teenager who was supposedly wrongly diagnosed by physicians and nurses as displaying traits of addiction to the painkillers treating his leukemia, pneumonia and chest wall pain. Haddox and Weissman wrote a case study and documented in the study that rather than addiction, the patient needed more opioids and it was not addiction, but rather "pseudo-addiction."
Keep in mind, "pseudo-addiction" was as a result of only one case study and Haddox ran with it -- to the medical profession. Pseudo-addiction took on a life of its own in the prescribing of opioids. If a patient exhibited signs of addiction, physicians were being encouraged to increase the dose of opioids -- compliments of the marketing efforts of Dr. Haddox.
In 1996, the American Academy of Pain Medicine and the American Pain Society, organizations that receive substantial funding from drug companies, issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low. This was right around the time Purdue Pharma launched their killer drug, OxyContin.
The chairman of the group that issued the statement was the infamous J. David Haddox, DDS, MD. Three years after making the chronic pain statement, Haddox became an executive with Purdue Pharma.
The American Academy of Pain Medicine and the American Pain Society are under U.S. Senate investigation to determine if they profited financially from pharma in the opioid epidemic. Unfortunately, "the gatekeeper" Haddox was not named in the U.S. Senate investigation, but hopefully they will correct this oversight and look into Haddox's lucrative marketing strategy.
J. David Haddox, DDS, MD
the FDA's three heads who were oblivious to the prescription drug epidemic:
|Margaret Hamburg Bob Rappaport DouglasThrockmorton||Bernard Schwetz, Deputy & acting Principal Commissioner Jan 2001 - Nov 2002|
|May 2009 - Apr 2015 "
The senior FDA official at the
who was head of the
opioid approval division,
angered other members by telling them there had to be “a level playing field
for business”, which was widely interpreted as
putting the right of pharmaceutical companies to make money ahead of public
DouglasThrockmorton In 2016 approved 7 extended release opioids . He sat back while 26,000 people died in 2016.”
Pain Societies financed by pharma and under U.S. Senate investigation :-