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BY LAURA WILLIAMS, The US Drug Enforcement Agency (DEA) is a colossal institutional failure. Since its founding in 1973, the DEA has intercepted a fraction of one percent of illicit drug trades. Drugs have never been stronger, cheaper, or more available. Meanwhile, the global economic and human costs of ‘enforcement’ keep rising.
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(D) Senator Dick Durbin, Springfield, Ill Chairman Senate Judiciary Committee, Sir, we have a growing crisis in our Country in healthcare delivery where the DEA has been “busy haunting and raiding doctors’ offices, seizing assets, dictating opioid dosages, curtailing various classes of opioid and prescription medications so that there are shortages.” The DEA in collusion with the United States Department of Justice is undermining healthcare in America, “turning once quality medicine into chaos.” Further, turning doctors, pharmacists, dentists into criminals, and the death toll to patients needing pain care is staggering and going virtually unreported.
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Mr. President, In remarks recorded by a DEA-employed infiltrator, Mexican cartel bigwig Jorge Roman said traffickers were grateful for the drug war, which he called “a sham put on the American tax-payer” that was “actually good for business.” Mr. President, Sir, “Except For The US Drug Enforcement Agency (DEA)!!!” Most importantly, White Physicians over 50 years of age have a 78% greater chance of being targeted and arrested by the DEA’s Opioid Task Forces; this makes absolutely no sense. This would be as if all Judges over 50 years of age were being criminalized for writing their Judicial opinions.
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The so-called opioid crisis is a tragedy unique to modern American culture. Our co-hosts ask Dr. Joshi poignant questions about how law enforcement agencies have essentially criminalized the practice of medicine by allowing due process violations, subjective interpretations of the Controlled Substance Act, and through “familiarity bias” by agents not trained in the clinical practice of health care.
The discussion continues about how patients with chronic, intractable pain are treated presently and what patients can expect in the future in light of recent Supreme Court rulings and subtle policy changes. Burden of Pain, A Physician’s Journey through the Opioid Epidemic is available at Amazon.com and Barnes & Noble.com.
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Looking at the website for Troy Medical Center, it is a 97-bed hospital servicing a six-county area in Southern Alabama. According to this https://www.rasmussen.edu/degrees/health-sciences/blog/types-of-hospitals/ a hospital with < 100 beds is classified as a “small hospital” This appears that this system encourages nursing staff to “just say no” when pts request an opioid dose, which there are prescriber’s orders for a particular pt. Does this term “improves nurse practices” means that they lowered the number of “nursing hours per pt” ? I did a word search on this article and the word PAIN did not appear ONCE in the entire text but in the text… Reducing excess.. prolonging lengths of stay and increasing the risk of readmission Is this another reference to the bottom line of the hospital ?
https://www.troymedicalcenter.com/about/
(MENAFN– PR Newswire) Indicator Sciences Highlights 20% Inpatient Opioid Reduction at Troy Regional Medical Center
BIRMINGHAM, Ala.
, June 13, 2023 /PRNewswire/ –Indicator Sciences, the provider of the CareEffects Stewardship consultative analytics service, today proudly unveils the results of a successful initiative at Troy Regional Medical Center. Implementation of the service has led to a 20% reduction in inpatient opioid use within just six months, underscoring its value and effectiveness.
CareEffects reduces inpatient opioid use by 20%, improves nurse practices & elevates patient care at Troy Medical Center
Opioids pose a challenge for hospitals in that inpatient administration can cause complications and influence outpatient utilization.
Reducing excess
opioid utilization is critical to prevent opioid-related adverse drug events, complications which occur in nearly 10% of inpatient admissions in U.S. hospitals, prolonging lengths of stay and increasing the risk of readmission.
Leveraging comprehensive context-of-care risk-adjustment analytics, CareEffects Stewardship identifies individual nurses whose practice patterns lead to increased opioid utilization compared with their peers. As nurses manage roughly 80% of inpatient opioids on a PRN (as needed) basis, there is an urgent need for closer monitoring of individual nursing practices. This pioneering approach paves the way for focused stewardship education, fostering improved patient outcomes.
Rick Smith, CEO of Troy Regional Medical Center, praises the program: “As leaders of a small hospital, we have a zero-tolerance policy towards preventable complications. CareEffects Stewardship has become an integral part of our pursuit of delivering the highest quality of patient care.”
Led by Chief Clinical Officer Amy Minor, RN, a targeted nursing intervention was conducted, focusing on approximately 5% of the inpatient nursing staff. These nurses each exhibited a significant increase in opioid use per shift compared with their peers, after risk-adjusting for context-of-care.
Minor points to a success story: “One of our nurses, initially identified as an outlier, has since evolved into a practice leader. Our non-punitive approach has not just enhanced patient safety, but also nurtured a supportive and learning-centric environment for our nursing staff.”
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https://threadreaderapp.com/thread/1523720324855914498.html
Jan 31
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After reading this, I did a “word search” for “strength” & “potency” and came up with ZERO MATCHES. The word “quality” shows up 18 times and here is a recent post on my blog How Reliable Are Your Generic Drugs From India?
Are they using the word “quality” to encompass strength or potency or give the illusion that the potency and/or strength from the testing are within FDA standards ? Am I the only one that is concerned that the FDA such quality control violations that the FDA shut down a pharma production plant …But it made an exception for 25 medications, including the cancer drugs, because of shortages. If you are dealing with cancer, and your only choice of a med provided by a pharma whose plant has been shut down because of quality control issues in the plant. Would you be concerned that if the cancer does “do you in” .. the medication might ?
U.S. military officials are so concerned about the quality of generic drugs that the Department of Defense is devising a program to test the safety of widely used medicines.
Defense officials are in talks with Valisure, an independent lab, to test the quality and safety of generic drugs it purchases for millions of military members and their families, according to several people familiar with the matter who asked not to be named as the details aren’t public.
The move raises questions about the Food and Drug Administration’s ability to adequately police generic medicines. With mounting drug shortages, most of which are caused by quality problems, military officials have gone so far as to call vulnerabilities in the drug supply chain a national security threat.
Aware of growing quality problems, the White House has convened a task force that’s exploring whether testing could be expanded more broadly in the US. If the Pentagon pilot is successful, it could serve as a model for Medicare or the Department of Veterans Affairs, people familiar with the matter said. But there are tensions in Washington: In conversations with the White House, the FDA has pushed back against additional quality checks, questioning the accuracy of third-party labs like Valisure.
The agency said it stands behind medicines sold in the US and Americans can be confident about their quality.
Drugmakers are required to test their drugs for impurities. The industry doesn’t share results with the FDA, rather companies keep files that agency inspectors comb through when they visit drug production plants once every year or two. Over the last decade, FDA inspectors have found many manipulated test results. The agency can ask a plant to shut down if it finds major problems. This can lead to or exacerbate drug shortages, which is an acute problem in the US right now.
The FDA said in 2019 that 62% of drug shortages were caused by quality issues. Sometimes even the threat of a shortage can force the US to accept drugs from low-quality suppliers that, under other conditions, would have been cut off. Drug shortages are currently at a five-year high in the US and climbing.
The idea for the Pentagon’s drug testing program was motivated by weaknesses in the pharmaceutical supply chain exposed by the Covid crisis. A recent Congressional mandate also required military officials to further investigate the threat of America’s increasing reliance on overseas manufacturers.
“They’re taking that risk very seriously,” said Valisure Chief Executive Officer David Light, who declined to comment specifically on the department’s plans to partner with his company.
The Defense Department didn’t comment on a detailed list of questions sent by Bloomberg News.
The Pentagon’s proposed program follows a similar one quietly launched by Kaiser Permanente, details of which have never been reported. Kaiser, which serves 12.7 million Americans, started working with Valisure on additional drug quality checks more than two years ago, said Sean Buhler, Kaiser’s vice president of pharmacy strategic sourcing and procurement.
If Valisure detects quality issues, Kaiser turns to other manufacturers. That data also provides an early warning system for shortages: If a drug’s quality is so bad that it could trigger a recall, the health system starts preparing.
Kaiser has pursued the testing program with Valisure as “an additional assurance for our members’ safety and care beyond the current testing that the FDA is mandating,” Buhler said.
Through its testing for Kaiser, Valisure flagged that the ingredients from one supplier contained higher levels of lead when compared with another option — though both suppliers’ lead levels fell within the FDA’s standards. This finding allowed Kaiser to avoid the drug with more lead.
University of Kentucky started a program in 2019 to test drugs purchased through the college’s network of hospitals and clinics. More than 10% of drugs have been flagged with potential problems, said Robert Lodder, a pharmaceutical sciences professor who co-leads the testing effort.
These programs aim to unearth issues that are invisible to the average person. Patients may not know if they’re repeatedly taking small amounts of a chemical that can cause cancer, as has been the case with some heart and diabetes drugs.
Valisure is known for finding dangerous chemicals in drugs and personal-care products. It hopes to become the go-to source for ingredient verification for many products on store shelves.
The FDA has repeatedly pushed back against testing programs including Valisure’s, saying third-party labs don’t use the same protocols as drug manufacturers. The agency has also warned unnecessary testing and inaccurate results could exacerbate drug shortages. The FDA does a limited amount of drug testing itself.
“Protecting patients is the highest priority of the FDA,” Jeremy Kahn, an agency spokesman, said in an email. “The FDA continues to work to build a safe, secure and agile drug supply chain so that American patients have the medications they need – medications that have been carefully reviewed by the FDA for safety, effectiveness and quality.”
In response to the FDA’s suggestion that third-party labs don’t follow the same protocols as drug companies, Valisure’s Light said the company’s tests are faster and less expensive and still accurately spot problems.
FDA inspection documents, mainly from visits to factories in India over the past year and a half, have outlined a rash of violations. Some of the more alarming findings concern Accord Healthcare, a subsidiary of India-based Intas Pharmaceuticals Ltd.
Intas makes more than 100 generic drugs approved in the US, including copycats of the cholesterol-lowering pill Lipitor and erectile-dysfunction drug Cialis, according to an FDA database.
Last November, agency inspectors visited an Intas facility in Ahmedabad, India. Workers appeared to have recently destroyed sensitive quality-control documents, according to an account of the visit written by FDA inspectors. After shredding documents before inspectors arrived, Intas workers stuffed remnants into trash bags and tossed them into a truck, throwing acid on a bag that hadn’t made it onto the truck.
Following the inspection, Intas shut down operations at the plant. The FDA required extra testing on some cancer drugs — a slow but necessary process that resulted in shortages of critical chemotherapies like cisplatin, methotrexate and carboplatin. Last week, the FDA banned the Intas factory from sending drugs to the US. But it made an exception for 25 medications, including the cancer drugs, because of shortages. Intas didn’t respond to a request for comment.
The FDA is similarly allowing Sun Pharmaceutical Industries Ltd. to send another widely used cancer drug to the US despite it being made in a factory in India that was so rife with safety violations it was banned in December from selling an undisclosed number of other treatments in the US.
Both Sun and Intas are required to get extra quality tests on the drugs they’re sending to the US from banned factories.
A Sun spokesperson said the company is “taking all necessary steps to resolve the outstanding issues as fast as possible.”
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https://www.medpagetoday.com/meetingcoverage/ama/104948
CHICAGO — The criminalization of medicine is taking its toll on physicians — and not just those who perform abortions, members of the American Medical Association (AMA) House of Delegates said here Saturday during the AMA annual meeting.
“A doctor who can’t get in trouble for malpractice because no patient has been harmed can end up in federal prison for 20-plus years because they prescribed off-guidelines,” said Stuart Gitlow, MD, MPH, MBA, of New York City, a delegate for the American Society of Addiction Medicine (ASAM). “This is unacceptable. It’s been unacceptable for more than 2 decades now. And it’s time for us to push back.”
Gitlow was speaking at an AMA reference committee meeting in favor of a resolution introduced by ASAM that called for the AMA to “study the rapidly changing environment in which the practice of medicine has been criminalized” and how that is affecting medical practice. The resolution also sought a report back to the delegates by the AMA June 2024 annual meeting. ASAM’s resolution was discussed in conjunction with a similar resolution from the New York delegation.
Gitlow noted that the Controlled Substances Act “requires that physicians who prescribe controlled substances do so by issuing the prescription for a legitimate medical purpose,” but the Justice Department sees it differently from physicians. The department “has said on multiple indictments, that if somebody departs from guidelines, such as by prescribing a medication off-label, for instance, that they are then not acting in the usual course of professional practice, and therefore, they are subject to indictment,” he said. “As a result, we have past presidents of three different state addiction societies, and multiple pain medicine societies, who are either under indictment, have been raided, or are in prison.”
Monalisa Tailor, MD, of Louisville, Kentucky, speaking for the Kentucky delegation in support of the resolution, said that when gender-affirming care came up for discussion in the Kentucky legislature this year, “there were many terrible things said about the practice of medicine and physicians in my state. This is also applied to our abortion providers and our ob/gyns … We’re going to continue to see state legislatures propose these types of laws that suggest that the practice of medicine should be criminalized — for us just taking care of our patients.”
Criminalization also increases the likelihood of violence towards physicians “because it gives people the idea that we are doing something wrong,” said Sean Figy, MD, of Omaha, Nebraska, who spoke on behalf of the Young Physicians Section and the Plastic Surgery Caucus. “And therefore, for some reason, it makes people think they can threaten us and threaten death for our families … So I do think it’s really important to help us figure out how we can make it better.”
Delegates also discussed a report by the AMA Council on Ethical and Judicial Affairs (CEJA) on ethical principles for physicians involved in practices owned by private equity firms. The report recommended that physicians who contract with these companies make sure that the contract “minimizes conflict of interest” in the way doctors are paid and doesn’t encourage undue restrictions on patient care, and that it also “does not compromise physicians’ own financial well-being or ability to provide high-quality care.”
In addition, the contract should “allow the physician to appropriately exercise professional judgment” and “enable physicians to participate in, if not outright control, decisions about practice staffing,” the report said.
Several people spoke up in favor of the report. “As we know, there is a national trend to more and more practices being taken over by private equity, with the consequent pressure on the physicians to do things not in the best interest of the patients,” said Tim Fagan, MD, alternative delegate from Arizona speaking on behalf of the PacWest delegation. “So the PacWest speaks strongly in support of this report.”
But others complained the report didn’t go far enough. “[The report] did discuss the requirement for physicians to maintain fiduciary responsibility, but does not discuss whether or not it is ethical for a corporation to take large profits out of healthcare,” said former AMA president Barbara McAneny, MD, of Albuquerque, New Mexico, a delegate from the American Society of Clinical Oncology (ASCO) who was speaking for herself.
“Private equity companies are composed of wealthy people seeking to increase their wealth; they expect to exit their investment with returns of five to 10 times the investment. And that level of profit is not going to be generated by efficiencies of delivering care or by avoiding unnecessary care,” said McAneny. “That money will come from somewhere — and the only options are that that money comes from patients, physicians, and the taxpayers who support governmental programs.” She urged the committee to “send this report back to CEJA and ask them to give us guidance on one of the more pressing issues of our time, which is whether or not private equity should be playing any role in profiteering in healthcare.”
“This is a pretty toothless report,” said Brett Coldiron, MD, an Ohio delegate from Cincinnati who spoke for the Great Lakes delegation in favor of sending the report back to CEJA. “Private equity has devastated dermatology and anesthesiology, and it’s coming your way.” When private equity-owned practices go broke, “they seize their accounts receivable and [the doctors] still have a non-compete,” he added. “So it’s a terrible situation and we need a better recommendation to work with.”
The committee will consider the delegates’ comments and then issue a report with its own recommendations, which the entire House of Delegates will vote on during its general session starting on Monday.
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ECONOMY OF SCALE: The Wall Street Journal reports that “the combined company will have significantly heightened bargaining power in negotiating with hospitals and doctors,” a factor the companies hope “will boost profits and possibly even drive down medical costs to patients.”
And it follows that “hospitals and doctors will be willing to offer more enticing price concessions in order to treat more patients.“
It was announced on our local news a few nights ago that Humana was canceling Humana gives up 1,600 downtown Louisville parking spaces
I wouldn’t put any money on doctors treating more pts, it is more likely that the mid-level practitioners to physician ratios will increase. I have read that reimbursement for services provided by mid-levels reimbursed by insurance companies is 85% of what would be paid if a physician provided the same service. Typically, mid-levels pay scale is not up to 85% of that of a physician.
United HealthCare Corp., the Minnesota-based managed care giant, yesterday announced that it is merging with “rival” Humana Inc. of Kentucky in a $6 billion deal that will create “one of the nation’s most powerful players in the managed care industry.” The AP/Minneapolis Star Tribune reports that the two companies are among the nation’s “ten largest health care corporations.” United’s headquarters will stay in Minnetonka, MN, and William McGuire, will keep his CEO and chair titles. The AP/Star Tribune reports that the merged entity will “the nation’s largest publicly held health plan company” (Howatt/Feyder, 5/29). The long-term effects of Humana’s sale to United will not be felt in Kentucky for “four to seven months,” said Humana spokesperson Tom Noland. The Lexington Herald-Leader reports that “[w]hile United HealthCare has pledged to keep ‘a significant work force’ in Louisville, job cuts are likely.” Humana is Kentucky’s sixth-largest corporate employer and has played a key role in the state’s health care reforms, the Herald-Leader reports. Humana CEO Greg Wolfe told Kentucky’s insurance commissioner that his company would participate in the state’s individual market beginning this summer (Fernandez/Sharp/Butters, 5/29).
10 Million Strong
The Wall Street Journal reports that “the combined company will have significantly heightened bargaining power in negotiating with hospitals and doctors,” a factor the companies hope “will boost profits and possibly even drive down medical costs to patients.” The new company will cover 10.4 million people nationwide, bringing in annual revenues of $27 billion, according to the Journal. “If you have a million members instead of 500,000, people will listen to you a lot more attentively,” said Kenneth Abramowitz, an analyst with Sanford Bernstein & Co. And it follows that “hospitals and doctors will be willing to offer more enticing price concessions in order to treat more patients.” The Journal reports that “United is hoping to achieve cost savings of 3% to 5% of its $4.8 billion in annual operating expenses, or nearly $200 million,” and to save another $200 million in total medical care costs through renegotiated contracts, according to United officials. The Journal notes that the companies make a good couple because they are both “regarded as industry leaders in efforts to promote quality-of-care among the doctors who participate in their health care plans” (Burton/Lipin, 5/29).
Terms Of Engagement
Under yesterday’s agreement, the New York Times reports that United will “exchange one of its shares for two shares of Humana and assume $850 million of Humana’s debt.” On the New York Stock Exchange yesterday, United shares fell $1.625 to $62.50 and Humana’s rose $3.625 to $29.875. The Times reports that based on United shares’ Wednesday closing price of $64.125, the “stock swap” is valued at $5.5 billion (Freudenheim, 5/29).
From The Mountains, To The Oceans
Humana will strengthen United’s “presence in several key states, especially Illinois, Wisconsin, Texas, Florida and Ohio,” according to the Star Tribune (5/29). The Chicago Tribune reports that the deal will “change the competitive health care landscape in Illinois,” as United is currently the state’s second largest HMO and Humana is the third largest. “The combination will knock Blue Cross and Blue Shield of Illinois … out of first place,” and in a first, the state’s “HMO markets will be dominated by a publicly traded, for-profit company based elsewhere,” the Tribune reports (Buck/Graham, 5/29). The Dallas Morning News reports that the two companies serve over 1.5 million Texas members and that the “merger caps a hectic year of repositioning among the ten largest [HMOs] serving North Texas” (Ornstein, 5/29). In Ohio, the merger “will result in Greater Cincinnati’s largest HMO changing hands twice in less than a year,” the Cincinnati Enquirer reports. The deal “will affect about 380,000 Tristate residents covered by United, Humana or ChoiceCare — the once-independent HMO that Humana acquired last year” (Bonfield, 5/29). The merger will affect 1.4 million Humana members in Florida and about 900,000 of United’s in the Sunshine State. Gary Frazier of Bear Stearns & Co. said the deal would create the nation’s third largest health plan in terms of enrollment, second only to Kaiser Permanente and Blue Cross and Blue Shield
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Once again a BENCH TRIAL, don’t know if Walgreens asked for a trial by jury and it was denied by the judge who mandated a BENCH TRIAL. So that the judge is judge and jury. This whole agreement is both interesting and a contradiction. Walgreens “agreed” to pay $500 million – while admitting no wrongdoing – for claims that Walgreens failed to stop ILLEGAL PILL SALES. Mark Pifko, attorney for the state, seems to conflate pharma Rx opioids and illegal street opioids and likewise, what is the real reason for the estimated 500,000 drug overdose deaths?
https://www.newsmax.com/newsfront/drugs-chamber/2023/06/09/id/1123052/
Walgreens Boots Alliance has agreed to pay $500 million to New Mexico to settle claims that its pharmacies helped fuel opioid addiction in the state by failing to stop illegal pill sales, lawyers for the state announced Friday.
The settlement, the largest obtained by New Mexico against a single company over opioids, came after a non-jury trial last year in the state’s lawsuit against the company. The judge overseeing that trial had not yet ruled on the state’s claims.
“We are confident that this record settlement positions New Mexico to turn the tide on this deadly epidemic,” Mark Pifko, a lawyer for the state, said in a statement.
Walgreens did not admit wrongdoing under the settlement. A spokesperson for the company declined to comment.
More than half a million people died from drug overdoses in the United States from 1999 to 2020, with opioids playing an outsized role. Overdose deaths have risen further since then, according to data from the U.S. Centers for Disease Control and Prevention
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