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It is no big secret that the 3 largest drug wholesalers – who provides 80%+ of all the Rx meds to  pharmacies. They were sued by the 50 state Attorney Generals and others and did not even go to trial, but they agreed to pay BILLIONS in fines – while admitting no wrong doing – other than selling opiates and other controlled medications to pharmacies and they also agreed to REDUCE the amount of controlled meds that they sell to all American pharmacies going forward.  Around the same time, these same state AG & others sued the three largest community pharmacies (CVS, Walmart & Walgreen) and who also agreed – without admitting any wrong doing –  agreed to pay BILLION of dollars in restitution, basically for filling controlled med Rxs written by properly licensed prescribers – and also agreed to dispense FEWER Rxs for controlled meds going forward.

 

Those agreements were signed in late winter – early spring of 2023, and they are now starting to show up as more and more pts that have a valid medical need for being prescribed controlled meds or being told that their doses have to be reduced and/or the pharmacy – that they have been patronizing for years -will no longer fill their controlled Rx medications.

Ambulatory PCA (Pt controlled Administration) pumps have been around for decades. They are very similar to what millions of type one diabetics are using around the world to help control their blood sugar. These pumps will provide pain pts many advantages:

 

* They provide a constant “drip” called a basal rate, the pt has fewer “ups & downs” in pain control, if their prescriber allows it, they can also provide pt initiated “pushes” to deal with break-thru pain and/or activity induced pain.

* Because the opioid is administered like a Sub-Q shot, the opioid avoids being partially by the stomach acid  – as in taking a oral dose – & the opioid goes directly to the cell receptor site – avoiding the first pass thru the liver and being metabolized and with it some loss of potency. Resulting in the pt typically needing only 20%-25% of what mgs they had been taking orally.

* Along with those fewer mgs/day, the pt should experience fewer side effects, like dry mouth, blurred vision, constipation and other side effects.

* the CDC dosing guidelines are directed toward oral doses, but regardless, the pt’s total opioid mgs/day will be reduced with a PCA pump.

The graphic above shows an example of a butterfly needle that would be connected to the pump and be inserted in the gut and taped in place and would be changed out every few days

The link below shows JUST ONE OF MANY PCA PUMPS on the market.  I am not recommending nor endorsing this particular PCA pump, it is just as a graphic illustration of what is available.

I am hoping that since injectables are mostly used by hospitals and surgical centers, that the DEA will be exerting less controls on the pharma production quotas for injectables and will hopefully be more readily available.

As oral opioid dosing forms become less and less available, this is a discussion that many pts will be forced to have with their prescriber.

 

Click to access Ambulatory-Infusion-Pump.pdf

 

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THE MAIN CRIMINAL AT MAIN JUSTICE, AUSA KENNETH A. POLITE: THE UNCOVERING OF A CLINICAL PSYCHOPATH: PART-2

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AUSA KENNETH A. POLITE, THE MAIN CRIMINAL AT MAIN JUSTICE, THE MINDSET OF A CLINICAL PSYCHOPATH; PART-1

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Problems at understaffed CVS pharmacies are said to be widespread. The Ohio AG is taking a look

https://ohiocapitaljournal.com/2023/08/03/problems-at-understaffed-cvs-pharmacies-are-said-to-be-widespread-the-ohio-ag-is-taking-a-look/

 

CVS Health Corporation’s second-quarter results reported growth for earnings and revenue expectations, however, its latest focus on healthcare services means continued cost-cutting measures and layoffs. 

For the three months ending June 30 total revenues for CVS increased 10.3% year-over-year driven by growth across all segments. 

In the wake of news about Ohio regulators’ findings at severely understaffed CVS pharmacies, numerous current and recent CVS workers in Ohio and elsewhere have said the problems are not limited to the nine stores the Ohio Board of Pharmacy has issued reports on.

Meanwhile, Ohio Attorney General Dave Yost called the findings in the reports “very concerning” and said that his office is “collecting information” about whether some CVS practices have violated state antitrust laws.

On July 7, the Capital Journal reported on eight Ohio CVS stores where the Board of Pharmacy found rampant turnover due to understaffing in inspections that took place between 2020 and last year. Inspectors found hundreds of problems, including dirty conditions, lack of controls over dangerous drugs and wait times as long as a month for prescriptions. They also found adulterated and expired drugs on CVS pharmacy shelves.

A ninth inspection report obtained a few weeks later found similar conditions at a ninth CVS store — this one in Willoughby — and that 1,800 doses of controlled substances couldn’t be accounted for. In addition, inspectors found an instance in which a patient was made ill by being given the wrong medication. 

In responses to questions for both stories, CVS called them “isolated incidents.” But in their response to the stories, many current and recent CVS employees in Ohio and other states said the problems were far from isolated. 

Understaffed by choice

Most current employees asked to remain anonymous. But one went on record to say that short staffing at CVS is not always due to a lack of qualified people to work at the stores. Minimal staffing is a conscious policy imposed on stores from above, she said.

“Understaffing is pretty deliberate from our upper and middle management,” Iggy Aleksick, a pharmacy technician at a CVS in Bowling Green, said last month. “It’s not that we don’t have people to work, it’s that we’re not allowed to be scheduled. Even in the past couple weeks, my pharmacy manager was told to cut 36 hours from her week and it was a Thursday. It wasn’t possible for her to do.”

Others said that the district and regional managers imposing such orders get bonuses based partly on savings from limiting employee hours. When asked if that were the case, a CVS spokesman didn’t answer directly.

“Patient safety is our highest priority, and decisions about staffing, labor hours, workflow process, technology enhancements and other operational factors are made to ensure we have appropriate levels of staffing and resources in place in our pharmacies,” spokesman Matthew Blanchette said in an email.

On Tuesday, CVS announced it was laying off 5,000 employees, but it said they would be “non-customer facing positions,” CNN reported. Even before the announcement, all of the current and former CVS employees who spoke to the Capital Journal described overwork in stressful conditions that made them worry about patient safety — no matter how careful they tried to be.

Amy Gilmore was a pharmacist at CVS store No. 4401 in Centerville from 2018 until last October. She described how things grew steadily worse until she finally left. 

CVS, the largest pharmacy chain in the United States, for years has been buying out competitors, closing those stores and moving their prescriptions to the nearest CVS pharmacy.

It’s unclear if the Centerville pharmacy was affected the same way, but a pharmacist at another Dayton-area CVS told Board of Pharmacy inspectors that her store absorbed prescriptions from two other pharmacies without increasing its staff. That came after CVS in 2021 announced that it was closing 300 stores a year through 2024 — including least four in the Dayton area — and in many cases moving prescriptions at those stores to the closest CVS.

In any case, the staff at Gilmore’s Centerville CVS was so overloaded that it was in a constant scramble to catch up. She said she was faced with so many tardy prescriptions that it fell to patients to tell staffers when their needs were acute.

“We were triaging thousands of prescriptions that were all in the system as being overdue but we sadly didn’t know who needed what until the patients came,” Gilmore said. “We were trying to be transparent with our patients and told them if you need something, you have to call us because our system is not functioning the way it should because we’re so overloaded. There were other stores that weren’t that transparent with their patients, so those patients didn’t know what was going on.”

Safety concerns

Working 14-hours days with few breaks in such a situation made Gilmore worry that she couldn’t do her job properly. 

She tried to come up with a system of doublechecks to avoid mistakes, “but a lot of times I was getting interrupted. I try not to make any errors — I have an eye for detail — but as I was getting more fractured, things started happening where I was like, ‘Oh, I should have caught that.’ Thankfully, no harm came to my patients because of it.”

In its inspections, the Board of Pharmacy found several ways that understaffed CVS pharmacies might not have proper controls to ensure that employees weren’t stealing — or “diverting” — controlled substances such as narcotics. 

In one, the pharmacy staff was too busy to retrieve a drug delivery from the front of the store for nine hours. And in a Toledo CVS, they found negative numbers suspiciously entered into the inventory system, and they couldn’t know if the purpose was “to mask the diversion of drugs received on that day,” the report said.

Gilmore said that she saw some other ways dangerous drugs could be diverted from overworked pharmacies. One was by not frequently doing physical checks — “cycle counts” — against the inventory system for single-usage painkillers that are often prescribed in the emergency room or by urgent-care centers.

“At stores that weren’t keeping up with supply management, they weren’t keeping up with cycle counts, so no one was seeing that the cycle counts were off so they couldn’t tell the system that it was off,” said Gilmore, who also served as a “floater,” or pharmacist who filled in at other CVS stores.

Another way to lose track of dangerous drugs, Gilmore said, is when they sit too long in bins waiting to be picked up. Those waits can be long, other pharmacy workers said, because CVS aggressively pushes autofill for patients who often don’t need refills yet.

Gilmore explained that at the Centerville CVS where she worked there were 144 bins for scripts and each script was assigned a bin number. But sometime after 14 days if that prescription hasn’t been removed “that bin number falls off,” she said. 

When that happened, the only way to track prescriptions was to manually go through all the bins and pull all the scripts with fill dates more than two weeks earlier, Gilmore said. That’s daunting enough in a store with 144 bins, but Gilmore has subbed at stores that have 320.

“So there’s 320 bins that could have overdue narcotics that somebody could divert from,” she said, explaining that that is especially a risk if employees are aware that nobody’s really keeping track.

Asked specifically about that possibility, CVS again didn’t respond directly.

“We’re also committed to a strong culture of compliance regarding our inventory and record-keeping obligations,” Blanchette, the spokesman, said.

Same staffing, new tasks

Several current and former CVS staffers said that even as they lack time to properly consult with patients and keep them safe, constant dictates come out of corporate for them to take on new tasks, such as calling people and asking them to come pick up prescriptions or get vaccines.

“A lot of these calls are basically nonsense,” said Aleksick, who as of last week still worked at the CVS in Bowling Green.

Simon Souhrada left his job as a technician at the CVS in Mount Vernon in June. That pharmacy absorbed prescriptions from Lonsinger Pharmacy 12 miles away in Danville after buying and closing it in 2017. 

The Board of Pharmacy reported mass departures by pharmacy employees at several other CVS stores. Souhrada joined one with about eight other technicians who left in frustration — and he said he expected their pharmacy manager to follow them shortly.

“The part that did it for me was just not being able to take care of the patients; getting yelled at, but also kind of deserving it because they had reason to be mad,” Souhrada said. “Patient safety was my main issue. I don’t want to be responsible for something bad happening. I know it’s a catch 22 if I leave and make it worse.”

He said a huge frustration was that the district manager didn’t provide the help they needed, but was always foisting new tasks on them.

The tasks might be related to the corporate drive to close almost 10% of its stores and turn many of the remaining ones into “HealthHubs,” which would offer traditional pharmacy services, and “have an expanded selection of products to choose from, including more products to help with chronic conditions like diabetes.” But Souhrada said employees were drowning under the traditional pharmacy tasks they already had to perform.

His district manager “had this weird focus on all of these corporate metrics, none of which helped get medications to patients,” he said. “It was all calling people, trying to sell them on vaccines and we would get daily emails demanding that we go faster and faster on these things while the queue (of unfilled prescriptions) was piling up and there was no one to fill it. She just focused on all the wrong things and didn’t do anything to help.”

Similarly, Gilmore, the former pharmacist at the Centerville CVS, said she was made responsible for setting up CPAP machines to treat sleep apnea.

“I had no idea how to do any of that,” she said. “CVS saw it as money signs — like, ‘Hey we can get money to do this,’ — but it didn’t back up or train anybody on how to do it. It was a mix of greed from the top and information not trickling down.”

Blanchette, the CVS spokesman, said the company is trying to stay on the forefront of healthcare. 

“As the practice of pharmacy rapidly evolves, our pharmacists are keeping patients healthy through providing immunizations, adherence coaching, and clinical interventions,” he said. “To support our pharmacy teams’ ability to focus on patient-centric work, we continue to invest in technology and automation while being a leading advocate for states to increase pharmacy technician-to-pharmacist ratios.”

Aleksick, the tech at the Bowling Green CVS, doesn’t see it that way.

“I try my best to give good customer service, because that’s what my job is,” she said. “But my company does not prioritize me performing that well as part of my actual job. I’m just a profit generator for them. Which kind of sucks in a healthcare setting.” 

Cause for concern

In an interview late last month, Yost, the Ohio attorney general, said he had been keeping up with problems the Board of Pharmacy found at some CVS stores.

“It’s very concerning,” he said. “That’s why we have a pharmacy board. These kinds of things do happen all the time and they happen in all kinds of pharmacies and pharmacy chains. Like everything with human behavior, mistakes get made and controls are not observed.” 

But, Yost added, “The question is, does CVS rise to a different level from the kind of background level of mistakes that we would typically expect to see and I don’t have the answer to that.”

The attorney general’s office acts as lawyer for the pharmacy board and Yost said his office will play that role in the board’s enforcement actions against the CVS stores in which it found problems. The board will hold a hearing on Nov. 7-8 into problems found at a Canton CVS, and the board could decide to fine the store or even to revoke its license. Other hearings haven’t been scheduled yet.

But, Yost said, his office is “gathering information” on another aspect of the matter.

“There’s the whole question of the competitive marketplace and antitrust,” he said. “Healthcare is especially fraught right now in this area because as a lot of industries have previously gone through, healthcare is going through a lot of consolidation and vertical integration.”

The attorney general said it isn’t feasible to try to turn the clock back 30 years and a changing economy probably would have spelled doom for some community pharmacies even if CVS wasn’t there, trying to buy and close them.

“But on the other hand, when you buy up so many — and close them when so many were going to close anyway for economic reasons — you ought to be able to still service the patient base that you acquired through that acquisition,” Yost said. “If you buy 10 pharmacies and that represents 100,000 lives and you’re going to close all those, I would expect that the acquiring pharmacies have the ability to care for 100,000 (additional) lives.”

He added, “If they fail to do that, that is at least some evidence that this was not a market-driven issue, but predatory. It’s not dispositive and it’s not a bright line, but it’s something I’m concerned about and it’s something that we are taking measures to get information and have a better sense of what’s going on.”

Adding to antitrust concerns are long-standing allegations by community pharmacists that CVS has an inherent conflict because it owns the largest retail chain and the largest pharmacy benefit manager. The latter company, also called a PBM, decides what drugs are covered by insurance and how much to reimburse its own and its competitor pharmacies for them.

CVS maintains that it has strict firewalls between its business units. But competitor pharmacies said they saw a steep drop in CVS Caremark reimbursements in late 2016 and early 2017, followed by a flurry of letters from CVS Acquisitions offering to buy the competitors out.

Yost stressed that his office is only gathering information at this point and he didn’t discuss what an antitrust action might look like. But his office in March announced an antitrust suit against several companies, including Express Scripts, another of the big-three pharmacy benefit managers.

Louder than words

CVS spokesman Blanchette said the company wants to hear its workers’ complaints. 

“We value the feedback of our employees and provide numerous resources for them to share their suggestions and concerns, anonymously if they choose, as part of our commitment to continual improvement.”

But to many current and former pharmacy employees, those assurances ring hollow.

Souhrada, the former tech at the Mount Vernon CVS, referred to the corporation’s purchase of and closure of the Danville pharmacy in 2017 — without adequately staffing the store where it transferred the prescriptions.

“CVS is moving in and not helping the people,” he said. “It was the Mount Vernon CVS putting (the Danville pharmacy) out of business, and now people can’t get their scripts at the Mount Vernon CVS.”

And Aleksick, who as of last week still worked at the Bowling Green CVS, said it’s obvious to her what CVS’s priorities are.

“They’re really concerned with efficiency and their bottom line,” she said. “I know that those people like to say, ‘Oh, we care about our patients/customers,’ but actions speak louder than words. They do not give us enough time to give good, attentive care to people who are coming into the pharmacy.”

Gilmore, the pharmacist who left the Centerville CVS last October, said corporate practices there made her question her career choice.

“I didn’t feel I had completed a good job. Even though I’d go in, work a 14-hour day and be working the entire time without breaks, I didn’t feel like I had accomplished anything. I didn’t feel like I had an impact,” she said. “It wasn’t why I went into pharmacy. It was surviving, not thriving. A lot of times at CVS, I didn’t feel like I was doing any kind of patient care beyond hopefully checking a prescription that they needed and allowing them to have that.”

CVS its critics say the company has made careers in pharmacy less appealing. It to have had that effect on Gilmore.

“If I knew what I know about pharmacy now, I probably wouldn’t have made the choice to go to pharmacy school,” she said.

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https://www.foxnews.com/video/6312948992112

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The war on drugs/pts has seemingly taken a dramatic change in direction. The SCOTUS with a 9-0 vote in the Ruan/Kahn case in June 2022 that told the DEA that they could no longer use objective criteria when evaluating how a practitioner is treating pts dealing with subjective diseases ( pain, anxiety, depression, ADD/ADHD & large spectrum of mental health issues)  So apparently so that it would not appear that the DEA was involved, the 50 state AG’s & others, sued the 3 largest drug wholesalers – covers about 80% of Rx meds to pharmacies and the 3 largest chain pharmacies (CVS, Walgreen, Walmart).  Apparently did not even go to trial, all just settled with paying BILLIONS IN DOLLAR FINES and also agreed for the wholesalers to sell LESS control meds to ALL PHARMACIES and those chain pharmacies to dispense LESS CONTROLLED RXS.

Pts are reaching out to me with with horror stories about their pain meds being dramatically reduced or in one case on the west coast with a Independent pharmacy that was told one day that EFFECTIVELY IMMEDIATELY, their drug wholesaler would no longer sell this pharmacy ANY MORE CONTROLLED MEDS.  I am told that, this particular pharmacy had 1500 pts being prescribed controlled meds.

In the last month, I have heard about independent pharmacies that are insisting that the pt’s prescriber reduce pain meds they have been on for a long time and filling at the same pharmacy for up to decades.  More of these horror stories in the last month that I have heard from the 11-12 yrs that I have had my blog. The DOJ and others have got Krogers to part with billions in fines and I have not seen the terms of that agreement, but expect it to follow the terms of other agreements with other chains.

Morris & Dickson’s Controlled Substance License Revoked  this article is about the DEA intention to revoke this drug wholesaler’s DEA license at the end of Aug 2023. It is claimed that this drug wholesaler is the 4th largest USA wholesaler.

US sues Rite Aid for allegedly missing ‘red flags’ in unlawful prescriptions

Then there is this whistleblower lawsuit, initiated by 3 former Rite Aid Pharmacist with the DOJ and a attempt to claw back Medicaid/Medicare money from a six year period starting in 2014. Rite Aid maybe on financially “thin ice” about 5 yrs ago Rite Aid had a 20:1 reverse stock split to keep their stock from being DE-LISTED, then they sold about half the 5,000 stores to Rite Aid. At the beginning of 2021 their stock was worth about $25.00… it closed today (08/01/2023) was $1.71. and losing $17.24 per share

What is unknown – or at least I have not seen anything about this – will the control meds allocated to that wholesaler be re-allocated to other within the Rx distribution system or just “disappear” from the system.  Likewise, if the Rite Aid chain is sold or liquidated as a “fire sale” and the controlled meds allocated to those stores be re-allocated or just “disappear” from the Rx med distribution system ?

Regardless, if fewer control meds are sold by the wholesalers and few controlled meds filled by pharmacies. The DEA may have stats that would give them justification to cut pharma production quotas of controls once again .

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When Congress pass the Americans with Disability Act, they INTENTIONALLY made the law VERY VAGUE, their intention was that the ADA would be defined in our court system. Since Congress is typically 40% attorneys, the ADA could also be called … make law firms more money act.  The agency that was put in charge of enforcing the ADA was created within the Attorney General Office – the same Presidential Cabinet position that the DEA is under. I may have missed it, but I have never seen ADA agency going after some medical vendor because they denied to treat or under treat chronic pain pts.

Statement from HHS Secretary Xavier Becerra on the 33rd Anniversary of the Americans with Disabilities Act

https://www.hhs.gov/about/news/2023/07/26/statement-from-hhs-secretary-xavier-becerra-33rd-anniversary-americans-with-disabilities-act.html

 

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The top 5 PBM’s are now owned by the top 5 insurance companies, so those two industries are the largest creator of “pharmacy deserts”

CVS health: Corporate consolidation is ruining pharmacies and hurting patients

https://minnesotareformer.com/2023/07/26/cvs-hellth-corporate-consolidation-is-ruining-pharmacies-and-hurting-patients/

If you spent any time in a pharmacy on July 10 or 11, you may have noticed prescriptions were delayed, and the staff seemed even more stressed than usual.

CVS Caremark, the pharmacy benefit manager (PBM) component of CVS Health, was non-operational for multiple days, meaning when the pharmacy tried to electronically submit a claim to insurance, it did not process. Pharmacy staff were unable to determine whether any prescriptions would be covered, or what patients’ co-pays would be.

If America had a robust, competitive PBM market, perhaps this outage would have not been particularly disruptive. Unfortunately, like many markets these days, instead we have an oligopoly, and Caremark alone processes about one-third of all prescriptions in the country.

The first CVS Pharmacy in Minnesota opened in the fall of 2004, which coincidentally is exactly when I was starting pharmacy school at the University of Minnesota. As a result, I have had a front row seat to witness the effect the now sixth-largest corporation in the country has had on our state.

Earlier in 2004 in other parts of the country, CVS had already acquired rival pharmacy chain Eckerd, which continued a long pattern of CVS buying other pharmacy chains using cheap debt, most notably Revco in 1997.

Minnesota apparently did not have a local chain of pharmacies amenable to purchase by CVS, so the company was forced to expand into the state via organic growth. CVS needed to hire pharmacists to work in their new stores, so I and all my classmates were aggressively recruited as we completed our studies. The personal highlight of my recruitment store tour of the Grand Avenue location in St. Paul was a pharmacy software system that still ran on MS-DOS in 2007.

This time period also represents a clear shift in corporate strategy, as CVS began to pursue vertical integration, acquiring Minneapolis-based MinuteClinic to gain some control over prescribers of medication. But the major paradigm shift came when CVS acquired Caremark, a leading PBM negotiating prescription drug coverage and pricing for millions of insured patients. After the merger, CVS was able to control payments to their pharmacy competitors, and require insured patients covered through Caremark to use pharmacies owned by CVS.

Using this market leverage, CVS spent the intervening years consolidating its power. The most obvious local manifestation of that power was the CVS takeover of Target Pharmacy in 2015. I received so many texts and social media alerts from concerned pharmacists the day it was announced that my phone battery died before I left work. Several of my classmates had previously worked for CVS, and sought a better work environment at Target, only to be re-absorbed.

Working conditions inside CVS Pharmacies — never ideal — have steadily declined to the point of harming workers’ and patients’ health. An entire labor movement called #PizzaIsNotWorking has arisen in protest. Underpayment from Caremark has caused many non-CVS pharmacies to close, creating “pharmacy deserts” in many urban neighborhoods and rural areas.

Across Minnesota, there are 32 small towns that had a local pharmacy in 2006, but today have none. Unfortunately this list includes Harmony, my hometown, where my father was the town pharmacist for many years.

Other alleged abuses of power by CVS include contributing to the opioid epidemic, stealing money from state governments, overcharging patients’ insurance companies, abusing federal government programs, and wasting valuable local real estate.

CVS Health has been able to achieve and abuse its power through a series of mergers and acquisitions. Had our existing antitrust laws — such as the Clayton Act — been enforced correctly, this consolidation should never have been allowed.

Unfortunately, beginning in the Reagan administration, legal ideology about corporate mergers significantly changed, oriented around the thought that larger corporations would achieve “efficiencies,” which would lower prices for consumers.

The past 40 years have provided ample evidence of the dangers of unchecked corporate power, however, resulting in a new political movement to restore enforcement of our antitrust laws to their original intent when they were written and passed by Congress. Minnesota’s own Sen. Amy Klobuchar, recently published a great book on the subject.

Two of the movement’s leaders are Lina Khan and Jonathan Kanter, head of the Federal Trade Commission and the Antitrust Division of the Department of Justice, respectively. These agencies have recently proposed to update the official merger guidelines, which if adopted would make mergers and acquisitions that lessen competition — like the many that created CVS Health — less likely.

You can participate in the process.

Click here, and then select “Comment,” to send your own personal message to the FTC and DOJ on how you have been affected by any mergers and acquisitions.

These comments can be informal and are important to help law enforcers understand the issue, and guide their actions to prevent harmful monopolies.

This is not limited to CVS Health.

Did Ticketmaster charge you pointless fees for your Taylor Swift tickets at the Vikings stadium?

Did airline service and prices get worse when Delta bought Northwest Airlines?

Are you annoyed that the Gophers football stadium is named for a bank headquartered at ground zero of Buckeye fandom?

Clearly, Minnesota is at least starting to understand anticompetitive mergers, given the backlash to the proposed Sanford Health merger with Fairview Health Services.

Your life has likely been negatively affected by a monopolistic merger or acquisition. This is your chance to help prevent any industries you care about become even more dominated by one or a small group of corporations.

 

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