“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
There’s a new nontraditional company in town purchasing physician groups: a London-based digital health company.
Babylon, which provides virtual care and health monitoring services, purchased Novato, Calif.-based Meritage Medical Network in April and plans to open a new office in Palo Alto, Calif. Meritage has 700 physicians who are now part of Babylon, which aims to continue its U.S. expansion. Click here to read more about the transaction and Babylon’s strategic plans.
Meritage, an independent practice association, cares for a population of more than 500,000 and has relationships with eight hospitals and other healthcare providers.
This acquisition furthers the trend of nontraditional companies, such as insurers or retailers, employing physicians. Optum, a division of UnitedHealth Group, has the largest physician network in the U.S. with 56,000 affiliated, contracted or employed physicians. The company is on track to reach its goal of adding 10,000 more physicians this year after purchasing the 715-person physician group Atrius Health in Newton, Mass., in March.
In April, Humana purchased Kindred at Home, the largest home health provider in the U.S., for $5.7 billion. It also rebranded its healthcare services arm in March as CenterWell, which includes 90 Conviva primary care clinics.
Walmart and CVS both also have telehealth services as well as brick-and-mortar clinics that employ healthcare providers. Amazon announced plans to broaden its telemedicine program to offer services to large U.S. employers. The nontraditional entrants are focused on bringing primary care physicians into their networks, which are often a big referral source for specialty care and ASC physicians.
As insurers, tech companies and retailers see more opportunities in healthcare, ASCs will be attractive targets as efficiently run healthcare businesses. Optum already has a chain of hundreds of ASCs, as part of Surgical Care Affiliates, and Amazon Care’s services include treatment for back, neck and joint pain.
The following comments will be submitted to the FDA. I will demonstrate why the Morphine Milligram Equivalent (MME) conversion chart, the main pillar of the CDC 2016 Prescribing Guidelines, is deeply flawed. Hence, all opioid policies are based on MMEs are likewise invalid, yet they continue to be accepted as gospel. The gospel needs to be changed.
Nearly three years ago I wrote how the science behind US opioid policies was deeply flawed, in particular, the use of Morphine Milligram Equivalents (MME) to quantify recommendations, policies, or laws. I argued that any use of MME was automatically flawed because it ignored even the most basic tenets of pharmacology, the absence of which made it impossible to rationally determine the relative strength of one drug to another. Unfortunately, it was just this methodology that became the foundation of the CDC’s catastrophic 2016 publication Prescribing Guideline for Prescribing Opioids and its use has metastasized ever since as one state after another has passed laws limiting the prescribing of opioid analgesic, often based on the Guideline’s erroneous conclusions.
It is not surprising that such a baseless document was created. First, the CDC lacks both the authority and expertise to regulate drugs; that is the function of the FDA. Second, the anti-opioid group Physicians for Responsible Opioid Prescribing (PROP), which also lacks expertise in drugs and pharmacology, has undue influence with the CDC – a relationship that remains nebulous to this day.
It was almost a foregone conclusion that the CDC “recommendations” would become law. Indeed, this is now the case in more than 30 states. Sadly, drug abusers, pain patients, and their physicians have paid a very steep price for this ill-conceived document.
Although it is years too late, it is nonetheless encouraging that the FDA is holding a workshop to examine the fundamental pharmacology of opioids. The deficiencies of the 2016 Guide need to be addressed. Here are my comments.
Table 1 forms the basis of the MME approach. Its basic premise is that different opioid drugs can be quantitatively compared and the data used to establish dosing limits for different drugs. For example, if 90 mg of morphine (90 MME) is set as the upper limit for a daily dose, then the maximum allowable doses for oxycodone and oxymorphone would be 30 mg and 45 mg, respectively. But if the assumptions in the table are incorrect then any use of them to form policy must also be incorrect.
The primary reason that the MME conversion table is inadequate is that it fails to take simple pharmacological principles into account. In order to understand this limitation, we need to examine some of the fundamental principles of pharmacokinetics – the effect of the body on the drug. Arguably, the most important parameter is our individual metabolism. It is critical in determining the fate of a drug once it enters the blood and by extension, the proper dose.
Metabolism
The purpose of metabolism, which occurs almost exclusively in the liver, is to break down and eliminate drugs and other chemicals from the blood – the body’s “detox” system. Metabolism can be subdivided into two distinct phases, based on the type of chemical transformation and the enzymes that are responsible for this transformation.
Phase 1 enzymes are members of the Cytochrome P450 enzymes (CYP family). The function of CYP enzymes is to break down drugs. In contrast, Phase 2 enzymes are not members of the CYP family; they have unique names, such as UGT and SULT, abbreviations for the enzyme carrying out a specific reaction. Phase 2 enzymes don’t break down molecules; they add to them. Although they act in different ways, the primary function of both classes is to facilitate the elimination of drugs.
Phase 1 vs Phase 2 Metabolism
The difference between the first and second phases can be illustrated by examining the metabolic fate of two simple, naturally occurring chemicals. Anisole, (aka methoxybenzene) is one of the essential oils that give licorice its flavor and scent. Phenol (aka hydroxybenzene) has antiseptic and anesthetic properties. Although they are similar in structure – differing only by one carbon atom – the two chemicals are metabolized very differently.
Figure 1. Phase 1 enzymes such as CYP2D6 and CYP3A4 catalyze the oxidation of anisole to phenol. As is common in Phase 1 reactions, a hydroxyl group (green oval) is formed.
Upon consumption, anisole is converted by Cytochrome P450 (CYP) enzymes to phenol (3) as shown in Figure 1. Note the loss of the methyl group, leaving a hydroxyl group (green oval) in its place. As is the case with anisole, Phase 1 metabolism is (normally) an oxidation reaction, in which lipophilic (fat-loving, poorly water-soluble) molecules, are broken into smaller fragments that are more hydrophilic (water-loving and water-soluble). Phase 1 metabolites often contain hydroxyl (OH) or amino (NH2) groups.
Phase 2 metabolism is fundamentally different. Phase 2 enzymes conjugate or add water-solubilizing groups to a drug or its metabolite to facilitate the elimination of the drug in the urine. One example is the sulfation of phenol shown in Figure 2.
Figure 2. Phase 2 metabolism – The PST enzyme catalyzes the conversion of phenol to phenyl sulfate (aka phenol hydrogen sulfate), which is then excreted in the urine.
The hydroxyl group in phenol acts as a chemical “handle” that allows the attachment of a water-solubilizing group, such as sulfate, that plays a critical role in conjugation and elimination. (The abbreviated name of the enzyme that promotes this reaction is PST, short for Phenol SulfoTransferase.)
What Does This Have To Do With Opioid Dosing?
Plenty. This can be seen by examining the structures of oxycodone (Figure 3, Left) and oxymorphone (Right). and their similarity in structure to anisole and phenol, respectively.
Figure 3. Anisole and oxycodone both contain methoxy groups, which makes them substrates for Phase 1 enzymes. Phenol and oxymorphone both contain hydroxyl groups, which makes them substrates for Phase 2 enzymes.
As shown in Figure 3, anisole and oxycodone are structurally similar in that they both contain a benzene ring bearing a methoxy group (shaded blue). This makes them substrates for Phase 1 CYP enzymes (oxidation). In contrast, phenol and oxymorphone are similar in that they both belong to the phenol class – a benzene ring bearing a hydroxyl group (shaded green). The phenyl hydroxyl (phenol) group makes both of these chemicals substrates for Phase 2 enzymes (conjugation/elimination). The second row in Table 2 shows the primary metabolic enzyme(s) for each drug.
Table 2. Three pharmacokinetic parameters of oxymorphone (right) and oxycodone (left). Source: Ref. (a). Ref. (b).
Direct Comparison of Opioid Drugs – the Essence of MME – is Scientifically Unsound
The two opioid drugs at the bottom of Table 1 are metabolized by a different family of enzymes and at a different rate, yet all the CDC table tells us is that one is twice as strong as the other. It’s quite tidy to state that oxycodone is 1.5-times stronger than morphine and that oxymorphone is twice that, but what does this mean? Perhaps this is true in a binding assay or even clinically in some people but the statement is, at best, oversimplified. But the metabolism of each drug is radically different, which affects the amount of drug present in the blood and brain.
Metabolism Isn’t the Only Difference: Bioavailability and half-life
Table 2 shows two other pharmacological parameters, bioavailability, and half-life, which are just as important in determining the properties of drugs.
Bioavailability measures how efficiently an orally administered dose of a drug gets absorbed into the blood. The higher the number the higher the absorption and resulting blood concentrations. Table 2, row 3 shows that the bioavailability of oxycodone (60-87%) is significantly better than oxymorphone (10%).
Half-life (Table 3, row 4) is the amount of time that it takes for the concentration of the drug to decrease by 50%, a function of our metabolism. The half-life of oxycodone is 3-4 times that of oxymorphone, so it stays in the blood much longer.
So, which is a better pill?
The CDC chart says that oxymorphone is three times as strong as morphine, but much less of it gets into the blood and when it does it is metabolized and excreted quickly. Oxycodone is supposed twice the strength of morphine, but is well absorbed and remains in the blood for considerably longer. The answer is: who knows? But it sure isn’t as simple as what the CDC guideline state – that 300 mg of morphine is equivalent to 100 mg of oxymorphone counts and 150 mg of oxycodone. Convenient? Yes. Accurate? Absolutely not.
Bottom Line
It is incomprehensible that the CDC would put out a series of guidelines without bothering to consider even the most fundamental tenets of pharmacology. But this is what happens when a woefully uninformed group like PROP feeds advice to an equally clueless CDC and lawmakers pick up the baton – a shameful and disastrous chapter in American medical history.
The failure to consider even these simple metabolic differences is a primary reason why the CDC table fails as a useful guide and why the concept of morphine milligram equivalents is scientifically faulty.
In September of 2019, Health Union (the parent company of ankylosingspondylitis.net) partnered with the US Pain Foundation for our first ever Chronic Pain in America survey to ask members of our communities about their experiences with chronic pain and what they wish others knew about their pain. 4,725 people living with chronic pain completed the survey and shared how pain impacts their life, from their work and employment status to changed relationships with family and friends. However, everyone can improve the quality of life most specially if you have enough sleep everyday. But that is only possible if you have these hospital beds of highest quality which are available at SonderCare!
More than 8 in 10 respondents shared that their life has changed significantly as a result of their pain. These life changes have a large impact on quality of life and affect both physical and mental health.
Does chronic pain ever stop?
Chronic pain is a constant companion. The levels of pain may vary day to day, but for most, at least some pain is experienced on a daily basis. Back or neck pain was the most common diagnosis, with over 2/3 of respondents having been diagnosed with this. Additionally, 78% of respondents shared that they have experienced pain for at least 5 years.
Does pain change a person’s life?
The short answer is yes. Over 8 in 10 people shared that their life has changed significantly as a result of pain. Chronic pain impacts both physical and mental health and only 24% of respondents stated that they feel control of their life despite their pain.
What does a “normal” day with pain feel like?
Unfortunately, for many, a “normal” day is still really painful. Respondents shared that the pain they experience on a normal day makes it difficult to get out of bed in the morning or to do whatever they want to accomplish that day. But for many, they don’t have a choice. They push themselves through the pain daily leaving them exhausted, only to do it all again the next day.
Pain interferes with work, relationships, and more
Pain has affected work and career for over 2/3 of people who participated in the survey. On top of that, many reported changed relationships with family or friends and limitations when it comes to new places or spending time with others. All of this has a large impact on quality of life and what they are able to do day to day.
Dealing with chronic pain
Many respondents shared what they wish they had done sooner or advice that they would give to their former selves about pain. Responses ranged from sharing that they should have asked for help sooner or taken better care of their bodies to wishing that they had better advocated for themselves. When it comes to treatment, some expressed being more assertive about early treatment whereas others wish they had been more patient in finding the right treatment.
The Chronic Pain in America 2019 survey was conducted online from mid-September through mid-October of 2019. 4,725 respondents were recruited from Health Union’s Community channels, as well as the US Pain Foundation’s member touchpoints.
Just make sure that everyone understand this… especially if you are 50+ UNITED HEALTH GROUP.. is endorsed by AARP… actually UNITED HEALTH GROUP PAYS AARP to have access to their membership mailing list and – in theory – OPENLY endorses UNITED HEALTH GROUP. Anyone can go to their website https://www.aarp.org/to see if you can find a concise mission statement… I tried and I read a lot of VERBIAGE about who they are and what they do. Maybe I over looked it… all non profits and for profit businesses – who have a mission statement – tend to have one that is just a few sentences at most.
A group of independent pharmacists plans to raise concerns over UnitedHealth Group’s [NYSE:UNH] planned acquisition of Change Healthcare [NASDAQ:CHNG] with the Department of Justice, said M. Scott Newman, president of Pharmacists United for Truth and Transparency (PUTT).
PUTT, a nonprofit industry watchdog group that specifically advocates around what it believes are harmful practices by pharmacy benefit managers, plans to send a letter to the agency outlining how the merger between UnitedHealth’s software and analytics business OptumInsight and health care technology company Change is likely to cause harmful anticompetitive effects for rivals, consumers and firms in adjacent markets, Newman said. These include the small and independent community pharmacies in PUTT’s membership and the patients they serve, he said.
Other groups and possibly state pharmacist associations are expected to help develop and co-sign the letter, Newman added.
There is widespread industry concern that the deal would further entrench the market dominance of UnitedHealth, one of the largest vertically integrated managed care and insurance conglomerates, Newman said. The merger would likely restrain other firms’ ability to compete in multiple healthcare sectors and potentially reduce UnitedHealth’s incentives to protect private patient data, he said.
OptumInsight is part of UnitedHealth’s pharmacy benefit manager and care services division Optum. In a statement to this news service, Optum said the combined company’s “distinct and complementary capabilities” will “help health care providers and payers better serve patients by more effectively connecting and simplifying key clinical, administrative and payment processes to the bene t of the health system and the people we serve.”
Last January, Optum announced its proposed acquisition of Change for USD 13bn including debt. According to the merger agreement, the parties are committed to divesting assets that account for up to USD 650m in annual revenues from the past 12-month period in order to obtain antitrust approvals. The deal is expected to close in 2H21, though its termination date can be extended to 5 April 2022. The parties, which pulled and refiled their premerger notification in February, received a second request for more information from the DOJ on 24 March, according to SEC filings.
In their deal announcement, the companies said the addition of Change Healthcare’s solutions for payment and revenue management, along with its clinical and administrative information exchange technologies, will accelerate innovation and efficiencies.
Both companies also offer services for Medicaid and state employee health plans. The Wall Street Journal reported earlier this month that multiple states are investigating possible overpayments to UnitedHealth’s PBM business. Change Healthcare provides claims administration/processing and healthcare management services to state Medicaid programs so the acquisition would potentially port those contracts into OptumInsight’s business while PBM services are provided to those same customers with OptumRx.
Two industry analysts told this news service that the combined company would also have a significant presence in healthcare clearinghouses, which act as intermediaries between providers and insurers. Both agreed that the deal could legitimately threaten the degree of competition in this space, given that the market is “somewhat esoteric” with very few big players.
The companies’ combined market share in the clearinghouse sector would exceed 50%, one of the analysts said, citing Bellevue, Washington-based Edifecs, as an independent competitor. Change Healthcare’s current clearinghouse capability was established through its combination with certain assets of McKesson [NYSE:MCK] in a deal that closed in 2017, he said.
PUTT’s concerns echo issues recently raised in letters to the DOJ from the American Hospital Association (AHA) and American Antitrust Institute (AAI) in March and May, respectively, as evidence for the need for the agency to conduct a thorough antitrust review. PUTT agrees with the doubts raised by these groups that the DOJ could address the transaction’s competitive harms by imposing behavioral remedies or ordering divestitures, Newman said.
Newman, AHA and AAI argue that the removal of Change Healthcare as a head-to-head competitor with OptumInsight’s data analytics and information exchange solutions raises horizontal competition concerns.
The second healthcare analyst agreed, adding that many physicians rely on one of these two platforms for their artificial intelligence and clinical decision-making support capabilities. These are sophisticated businesses without an overwhelming number of competitors, the analyst said. While Change Healthcare and UnitedHealth are two of the largest providers, other existing data analytics solutions providers include Experian [LON:EXPN], Health Catalyst [NASDAQ:HCAT], AllScripts Healthcare Solutions [NASDAQ:MDRX] and Ingenius Med, he said. There are also vertical competition issues, according to Newman, AHA and AAI. For example, with the addition of Change Healthcare’s data and data analytics capabilities, Optum would likely be equipped and incentivized to advantage UnitedHealth over rival insurers, as the aggregation of private patient data further entrenches the company’s dominance across the markets in which it operates.
An independent healthcare provider speaking to this news service expressed concerns that the deal could potentially provide UnitedHealth access to other types of data – fee scheduling and pricing information from other payors – which could be used anticompetitively, to inform its health insurance reimbursement rates. Newman said commitments to anonymize that data or keep it appropriately siloed with firewalls to prevent its misuse are difficult to enforce, especially considering how strong the incentives are for the companies to find a workaround. AHA and AAI made similar arguments.
UnitedHealth’s dominance over the interconnected healthcare markets it serves, even without the acquisition, warrants a breakup of the company’s businesses, so a divestiture remedy for this merger would likely fall short of what would be necessary to restore competition, Newman said.
In recent years, UnitedHealth has become one of the industry’s most active consolidators in various verticals. Deals include UnitedHealth’s acquisition of Surgical Care Affiliates in 2017, which expanded its ambulatory surgery center provider services, its purchase of Advisory Board’s healthcare division the same year, and its acquisition of DaVita Medical Group in 2019, which expanded its physician network.
Some of UnitedHealth’s previous transactions have received complaints from third parties but all were eventually approved, in some cases with conditions.
The DOJ declined to comment. Change Healthcare did not respond to a request for comment.
Even in retirement from my faculty responsibilities, my time is fully occupied with pharmacy and other activities to the point that I am challenged to keep up with email communications. As a consequence, I do not participate in or visit social media sites, although pharmacy friends faithfully forward to me social media posts in which they know I will be interested. One such friend who had been terminated by CVS and is pursuing litigation just sent me several hundred comments posted by pharmacists and pharmacy technicians, most of whom work in chain pharmacies. I read them all and they are depressing. They are highly critical of chain pharmacy management, PBMs, state boards of pharmacy, colleges of pharmacy, and pharmacy associations. The comments are characterized by stress, frustration, and even desperation, and I recognize the validity of the concerns that are voiced. As these pharmacists and technicians have experienced, concerns and recommendations I have voiced in numerous editorials have been ignored, rejected, or even ridiculed. However, they and I recognize that the issues and concerns are so important – for pharmacists, our profession, and the care and safety of the patients served – that we must continue the fight. We can’t give up, and the very fact that we continue to voice our concerns is evidence that we still care, even when many of our own colleagues have been silent. Apathy and silence are among our greatest challenges!
Rays of hope
Many of the social media posts address the devastating impact that the pharmacy benefit managers (PBMs) have had on the economic survival of community pharmacies and horrible working conditions that increase the risk of errors and jeopardize the quality and safety of services for patients. The largest PBMs have become so wealthy, powerful, and dominant that they have been able to crush dissent and challenges. However, an increasing number of individuals outside of the profession of pharmacy have become aware of the secret deals, deception, and fraud in which these PBMs are engaged. The persistence of Leslie Rutledge, the Arkansas Attorney General, was essential in achieving a U. S. Supreme Court ruling that supported pharmacy’s position with respect to activities and regulation of PBMs.
“Benefit Managers Investigated” is the title of an article in the May 12, 2021 issue of The Wall Street Journal (Anna Wilde Mathews; page A6). Excerpts from this article are provided below:
“Several states are investigating pharmacy benefit managers with some saying they are focused on whether the companies fully disclosed details about their business and potentially received overpayments under state contracts, according to state officials and documents.”
“States including Ohio, Oklahoma, Georgia, New Mexico, Kansas, Arkansas, and Mississippi, as well as the District of Columbia, are scrutinizing PBMs, according to the offices of state attorneys general and auditors…”
“Among the companies under scrutiny are units of Centene Corp, UnitedHealth Group Inc, and CVS Health Corp.”
Ohio Attorney General Dave Yost’s office which recently sued Centene, alleging it had misled the state’s Medicaid program about its pharmacy related costs, is quoted as saying, “I’m aware of many states that are looking at this” and “before this is all done, I will be surprised if we don’t have a dozen or more states” that will bring complaints against PBMs.
“At many large companies, including UnitedHealth, Centene, Cigna Corp. and CVS, the same parent owns both a PBM and a managed care operation.”
“In addition to Centene, the Ohio Medicaid program uses UnitedHealth, among others. In March, the state filed its suit against Centene, which is seeking millions of dollars in damages. Earlier, the state sued Cigna’s Express Scripts….and UnitedHealth’s OptumRx…,” alleging overcharges.
“Several states, according to publicly available contracts and state officials, have hired the same law firm, Liston and Deas, to investigate PBMs.”
There are rays of hope! Individual pharmacists and our associations must contact these and other state attorneys general to provide examples, documentation, and other support for their investigations.
On March 10 my wife made several purchases at the Rite Aid store in our community. As she was leaving she tripped and fell, and was in severe pain. I was in our car in the parking lot, and I and five other individuals quickly convened in the entranceway of the store to assist her. Several individuals wanted to call 911 but I indicated I would take her to a nearby hospital. I pulled our car into the front entrance area to the store and several men assisted me in lifting my wife into our car. Because my car was in the front entrance area, customers arriving at or leaving the store had to walk around our car. No employee of Rite Aid spoke with us.
At the hospital it was determined that my wife’s left hip was fractured and she had surgery the following day. Following 3 days in the hospital and 11 days in a rehab facility, my wife was discharged with a continued need for physical therapy and occupational therapy, and the prospect of a long period of challenging recuperation.
Soon after my wife’s visit to Rite Aid on March 10, we received via email the We Care Rite Aid Customer Satisfaction Survey, with a potential to win a cash prize of $1,000 for those who completed it. We completed the survey and noted our strong dissatisfaction with the fact that no employee at the store responded to the drama at the front entrance to speak with us then or since. The last question on the survey asked if we wanted someone to contact us. We responded “yes,” described the experience, and provided our contact information. More than two months have gone by and we have not received a response from anyone at Rite Aid. Does Rite Aid only read the positive responses on their surveys?
Perhaps we should not be shocked that Rite Aid has not responded to my wife’s experience when it continues to reject requests that it discontinue the sale of tobacco products that put their customers at risk of serious illness and death. However, it can respond promptly to rectify some errors. We receive emailed advertisements from Rite Aid on almost a daily basis. On May 12 we received an email with the message, “Mother’s Day is Sunday! Don’t Get Caught Empty-Handed!” (Mother’s Day had already been observed on March 9). When the error was recognized, Rite Aid snapped into action and issued a message the next day (May 13), “Whoops! Silly us Mother’s Day has Passed! Let’s talk about Women’s Health this Sunday with great deals on Women’s Products.”
Unsubstantiated allegations that were unaddressed for too long gained a life of their own. This website addresses questions, corrects falsehoods and sets the record straight based on publicly available, verifiable information. Judge for yourselves whether the prevailing narrative about Purdue Pharma, OxyContin and the Sackler family represents the truth.
Documents being released in Purdue’s bankruptcy show that Sackler family members who served on the company’s Board acted ethically and lawfully. The proposed resolution to the litigation, which includes the Sackler family relinquishing ownership of Purdue and also contributing $4.275 billion to address the opioid crisis, is intended to provide help rapidly for communities and people in need. The Sackler family regrets that OxyContin, which continues to help people suffering from chronic pain, unexpectedly became part of the opioid crisis.
Detailed video presentations of these facts are available on this website. This video provides an abbreviated summary of the topics discussed throughout these pages, including the false allegation that OxyContin is responsible for creating the opioid crisis even though the medicine was never more than 4% of all opioid prescriptions:
“The court of public opinion is sometimes the most powerful court.”
MIKE MOORE, PLAINTIFF’S ATTORNEY – DECEMBER 2018[2]
The strategically invented false narrative has succeeded. When plaintiffs’ lawyers decided to target Purdue and the Sackler family, they were candid about their approach and strategy. For years, the news media and plaintiffs’ lawyers have falsely blamed Purdue, OxyContin and the Sackler family for causing the opioid epidemic based on hyperbolic and sensationalized attacks that are unsupported by actual evidence.
“Litigation is a blunt instrument; it’s not a surgical tool… But it provokes interest quicker than anything I’ve ever seen.”
“Vilification of this industry has not even begun yet.”
“This litigation will vilify them. It won’t make the companies look like they’re legitimate businesspeople. It’ll make them look like they took advantage and made billions of dollars on lots of people who died from their products.”
The plaintiffs’ lawyers hired clandestine help: The most prominent, supposedly “independent” experts making misleading comments about OxyContin, Purdue and the Sackler family were actually surreptitiously being paid as litigation consultants. And some of the most prominent studies used to malign OxyContin are actually riddled with errors and incorrect.
The false narrative gained further traction in 2018 when Massachusetts became the first state to name the Sackler family specifically in lawsuits against Purdue. That lawsuit included numerous false claims that were quickly copied by other states.
How Can OxyContin Be Responsible for Opioid Crisis When the Medicine Was Never More Than 4% of Prescriptions for Opioids?
OxyContin Was Introduced in 1996, Long After Steady Increase in Prescribing Opioids
Prescription opioids have been used to treat pain since morphine[4] was invented in 1804 (and opioids have been used to treat pain since the Sumerians discovered poppy in 3400BC[5]). Beginning in the 1970s, opioid prescriptions began increasing significantly — with oxycodone increasing 40% and hydromorphone increasing 67% in just six years between 1979 and 1985.[6] Abuse of prescription opioids began increasing in the 1960s and was the basis of the film “Drugstore Cowboy” in 1989.
OxyContin: One Part in Long History of Prescription Opioids
“OxyContin” or “Oxy” Often Confused with oxycodone & Prescription Opioids Generally
Media reports and entertainment programs frequently use OxyContin as a description for all opioids — often confusing OxyContin with the generic oxycodone[7] that was first introduced in 1916. (This Apple TV description for the film “Crisis”[8] erroneously mentioned “OxyContin,” but the movie only ever said “oxycodone” or “oxy.”)
News outlets also routinely correct this mistake amid the rampant confusion between long-acting OxyContin and the generic medicine oxycodone.
Corrected description:
Original error:
Additionally, nearly every news outlet has required corrections to coverage about Purdue, OxyContin and the Sackler family:
WASHINGTON (Reuters) – A secretive U.S. Drug Enforcement Administration unit is funneling information from intelligence intercepts, wiretaps, informants and a massive database of telephone records to authorities across the nation to help them launch criminal investigations of Americans.
Although these cases rarely involve national security issues, documents reviewed by Reuters show that law enforcement agents have been directed to conceal how such investigations truly begin – not only from defense lawyers but also sometimes from prosecutors and judges.
The undated documents show that federal agents are trained to “recreate” the investigative trail to effectively cover up where the information originated, a practice that some experts say violates a defendant’s Constitutional right to a fair trial. If defendants don’t know how an investigation began, they cannot know to ask to review potential sources of exculpatory evidence – information that could reveal entrapment, mistakes or biased witnesses.
“I have never heard of anything like this at all,” said Nancy Gertner, a Harvard Law School professor who served as a federal judge from 1994 to 2011. Gertner and other legal experts said the program sounds more troubling than recent disclosures that the National Security Agency has been collecting domestic phone records. The NSA effort is geared toward stopping terrorists; the DEA program targets common criminals, primarily drug dealers.
“It is one thing to create special rules for national security,” Gertner said. “Ordinary crime is entirely different. It sounds like they are phonying up investigations.”
THE SPECIAL OPERATIONS DIVISION
The unit of the DEA that distributes the information is called the Special Operations Division, or SOD. Two dozen partner agencies comprise the unit, including the FBI, CIA, NSA, Internal Revenue Service and the Department of Homeland Security. It was created in 1994 to combat Latin American drug cartels and has grown from several dozen employees to several hundred.
Today, much of the SOD’s work is classified, and officials asked that its precise location in Virginia not be revealed. The documents reviewed by Reuters are marked “Law Enforcement Sensitive,” a government categorization that is meant to keep them confidential.
“Remember that the utilization of SOD cannot be revealed or discussed in any investigative function,” a document presented to agents reads. The document specifically directs agents to omit the SOD’s involvement from investigative reports, affidavits, discussions with prosecutors and courtroom testimony. Agents are instructed to then use “normal investigative techniques to recreate the information provided by SOD.”
A spokesman with the Department of Justice, which oversees the DEA, declined to comment.
But two senior DEA officials defended the program, and said trying to “recreate” an investigative trail is not only legal but a technique that is used almost daily.
A former federal agent in the northeastern United States who received such tips from SOD described the process. “You’d be told only, ‘Be at a certain truck stop at a certain time and look for a certain vehicle.’ And so we’d alert the state police to find an excuse to stop that vehicle, and then have a drug dog search it,” the agent said.
“PARALLEL CONSTRUCTION”
After an arrest was made, agents then pretended that their investigation began with the traffic stop, not with the SOD tip, the former agent said. The training document reviewed by Reuters refers to this process as “parallel construction.”
The two senior DEA officials, who spoke on behalf of the agency but only on condition of anonymity, said the process is kept secret to protect sources and investigative methods. “Parallel construction is a law enforcement technique we use every day,” one official said. “It’s decades old, a bedrock concept.”
A dozen current or former federal agents interviewed by Reuters confirmed they had used parallel construction during their careers. Most defended the practice; some said they understood why those outside law enforcement might be concerned.
“It’s just like laundering money – you work it backwards to make it clean,” said Finn Selander, a DEA agent from 1991 to 2008 and now a member of a group called Law Enforcement Against Prohibition, which advocates legalizing and regulating narcotics.
Some defense lawyers and former prosecutors said that using “parallel construction” may be legal to establish probable cause for an arrest. But they said employing the practice as a means of disguising how an investigation began may violate pretrial discovery rules by burying evidence that could prove useful to criminal defendants.
A QUESTION OF CONSTITUTIONALITY
“That’s outrageous,” said Tampa attorney James Felman, a vice chairman of the criminal justice section of the American Bar Association. “It strikes me as indefensible.”
Lawrence Lustberg, a New Jersey defense lawyer, said any systematic government effort to conceal the circumstances under which cases begin “would not only be alarming but pretty blatantly unconstitutional.”
Lustberg and others said the government’s use of the SOD program skirts established court procedures by which judges privately examine sensitive information, such as an informant’s identity or classified evidence, to determine whether the information is relevant to the defense.
“You can’t game the system,” said former federal prosecutor Henry E. Hockeimer Jr. “You can’t create this subterfuge. These are drug crimes, not national security cases. If you don’t draw the line here, where do you draw it?”
Some lawyers say there can be legitimate reasons for not revealing sources. Robert Spelke, a former prosecutor who spent seven years as a senior DEA lawyer, said some sources are classified. But he also said there are few reasons why unclassified evidence should be concealed at trial.
“It’s a balancing act, and they’ve doing it this way for years,” Spelke said. “Do I think it’s a good way to do it? No, because now that I’m a defense lawyer, I see how difficult it is to challenge.”
CONCEALING A TIP
One current federal prosecutor learned how agents were using SOD tips after a drug agent misled him, the prosecutor told Reuters. In a Florida drug case he was handling, the prosecutor said, a DEA agent told him the investigation of a U.S. citizen began with a tip from an informant. When the prosecutor pressed for more information, he said, a DEA supervisor intervened and revealed that the tip had actually come through the SOD and from an NSA intercept.
“I was pissed,” the prosecutor said. “Lying about where the information came from is a bad start if you’re trying to comply with the law because it can lead to all kinds of problems with discovery and candor to the court.” The prosecutor never filed charges in the case because he lost confidence in the investigation, he said.
A senior DEA official said he was not aware of the case but said the agent should not have misled the prosecutor. How often such misdirection occurs is unknown, even to the government; the DEA official said the agency does not track what happens with tips after the SOD sends them to agents in the field.
The SOD’s role providing information to agents isn’t itself a secret. It is briefly mentioned by the DEA in budget documents, albeit without any reference to how that information is used or represented when cases go to court.
The DEA has long publicly touted the SOD’s role in multi-jurisdictional and international investigations, connecting agents in separate cities who may be unwittingly investigating the same target and making sure undercover agents don’t accidentally try to arrest each other.
SOD’S BIG SUCCESSES
The unit also played a major role in a 2008 DEA sting in Thailand against Russian arms dealer Viktor Bout; he was sentenced in 2011 to 25 years in prison on charges of conspiring to sell weapons to the Colombian rebel group FARC. The SOD also recently coordinated Project Synergy, a crackdown against manufacturers, wholesalers and retailers of synthetic designer drugs that spanned 35 states and resulted in 227 arrests.
A slide from a presentation about a secretive information-sharing program run by the U.S. Drug Enforcement Administration’s Special Operations Division (SOD) is seen in this undated photo. REUTERS/John Shiffman
Since its inception, the SOD’s mandate has expanded to include narco-terrorism, organized crime and gangs. A DEA spokesman declined to comment on the unit’s annual budget. A recent LinkedIn posting on the personal page of a senior SOD official estimated it to be $125 million.
Today, the SOD offers at least three services to federal, state and local law enforcement agents: coordinating international investigations such as the Bout case; distributing tips from overseas NSA intercepts, informants, foreign law enforcement partners and domestic wiretaps; and circulating tips from a massive database known as DICE.
The DICE database contains about 1 billion records, the senior DEA officials said. The majority of the records consist of phone log and Internet data gathered legally by the DEA through subpoenas, arrests and search warrants nationwide. Records are kept for about a year and then purged, the DEA officials said.
About 10,000 federal, state and local law enforcement agents have access to the DICE database, records show. They can query it to try to link otherwise disparate clues. Recently, one of the DEA officials said, DICE linked a man who tried to smuggle $100,000 over the U.S. southwest border to a major drug case on the East Coast.
“We use it to connect the dots,” the official said.
“AN AMAZING TOOL”
Wiretap tips forwarded by the SOD usually come from foreign governments, U.S. intelligence agencies or court-authorized domestic phone recordings. Because warrantless eavesdropping on Americans is illegal, tips from intelligence agencies are generally not forwarded to the SOD until a caller’s citizenship can be verified, according to one senior law enforcement official and one former U.S. military intelligence analyst.
“They do a pretty good job of screening, but it can be a struggle to know for sure whether the person on a wiretap is American,” the senior law enforcement official said.
Tips from domestic wiretaps typically occur when agents use information gleaned from a court-ordered wiretap in one case to start a second investigation.
As a practical matter, law enforcement agents said they usually don’t worry that SOD’s involvement will be exposed in court. That’s because most drug-trafficking defendants plead guilty before trial and therefore never request to see the evidence against them. If cases did go to trial, current and former agents said, charges were sometimes dropped to avoid the risk of exposing SOD involvement.
Current and former federal agents said SOD tips aren’t always helpful – one estimated their accuracy at 60 percent. But current and former agents said tips have enabled them to catch drug smugglers who might have gotten away.
“It was an amazing tool,” said one recently retired federal agent. “Our big fear was that it wouldn’t stay secret.”
DEA officials said that the SOD process has been reviewed internally. They declined to provide Reuters with a copy of their most recent review.
