“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
FDA’s recent approval of a controversial drug — aducanumab (Aduhelm) — to treat people living with Alzheimer’s disease shows just how broken the agency is, and reminds us that we all have to pay for it.
A series of events that has unfolded since January tells the story.
In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. The lesson was painfully clear: once the toothpaste is out of the tube it is hard to get it back in. Once doctors get used to using a therapy, pulling a drug from the market or in this case, revoking indications, is hard — even after the drugs fail to confirm benefit.
On June 7, the FDA approved aducanumab for the treatment of Alzheimer’s disease. The drug received accelerated approval because it showed it could reduce the rate of amyloid plaque on scans. What remains uncertain is whether this reduction in plaque means Alzheimer’s patients live longer or better lives — and notably, the totality of the clinical trial data do not show that. Moreover, the drug has various side effects and a whopping price tag: $56,000 a year.
In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug, quit the panel in protest. Aaron Kesselheim, MD, JD, MPH, a Harvard professor called the drug “problematic,” and argued that there was little evidence it would help patients. Writing in The Atlantic, Nicholas Bagley, JD, and Rachel Sacks, JD, MPH, estimate that if the drug is prescribed to just one-third of eligible patients, it would cost Medicare $112 billion a year — a massive figure that dwarfs any other medication.
What Is FDA Thinking?
In the last 3 months we have seen that the FDA does not have the ability to revoke accelerated approvals, even when the drugs and their sponsors fail to meet the promises made. And to wash that down, the FDA has now approved another uncertain drug for people suffering from Alzheimer’s, against the wishes of a different advisory panel. With Alzheimer’s disease affecting 6 million Americans, the financial and human implications of the approval are staggering.
FDA Has Pitched Their Tent on the Side of the Mountain
Many observers don’t fully appreciate how the FDA has taken a position that is indefensible. The agency does not guarantee that drugs that come to the U.S. market actually help Americans live longer or better lives (beyond what could be achieved without these drugs). At the same time, the FDA insists on interfering in the market and sets arbitrary standards for approval. The combined effect is the worst of all possible worlds: we don’t know if drugs work, and the companies can charge massive prices for them!
Let’s consider, two views of what the FDA could be.
One vision of the FDA — held by progressive reformers — is that the purpose of the agency is to shield desperate, sick, and vulnerable patients from making choices that may not be in their best interest. That is why we demand drugs be safe and effective, and not let any charlatan sell you any snake oil. The FDA exists to protect the American public from taking toxic drugs that don’t work. By that metric, our system has failed. The FDA often makes products available with no robust proof they are effective — such as in the case of aducanumab — and remains reluctant to withdraw the products or specific indications even when trials fail to confirm the benefit of living longer or better lives.
The other vision for the FDA is to abolish it entirely. Some libertarian policymakers argue that without the FDA, the market would work itself out. Without the agency, the barrier to sell a drug would be dramatically lowered. Small companies that cannot afford to jump through the FDA’s regulatory hoops might be able to bring small-batch products to market. Prices would tumble as drugs would flood the market and compete based on price and patient experience. In this vision, word of mouth would help clarify which drugs were effective, and some payers might conduct good randomized controlled trials to decide whether to fund products. I am not in this camp — I see dangers with this approach — but even I must concede, prices would likely fall.
Yet, instead of either of these visions, we have an agency that lives in between the two. The FDA poses a series of hurdles to get a drug to market, but none of those hurdles are an assurance a drug works or has net benefit to people. Then the agency stamps drugs with their imprimatur. Ironically, this system is ideal for medium and large pharmaceutical firms. Small firms are kept off the market, and larger firms specialize in jumping through the hoops. Once approved, costs can be astronomical, and the FDA seal of approval justifies the high price. Along the way, no one seems to ask whether patients are better off.
From this vantage, the FDA looks like an agency whose goal is to preserve pharmaceutical profits. Coincidentally, among medical reviewers at the agency, the prime destination after working at the FDA is either as a consultant for or employee of a biopharmaceutical company.
Just this week, yet another former FDA Commissioner, Stephen Hahn, MD, joined a venture capital firm in healthcare.
What is the American public to think? We have an agency that is happy to approve $100-billion-a-year drugs to a desperate and vulnerable population without knowing that patients are better off. Society pays for those costs — often through Medicare — but that same society won’t pay for a caregiver who might actually ease the burden on families who have a loved one with Alzheimer’s. If drugs approved by accelerated approval later don’t work, experts are happy to continue to keep them on the market, citing anecdotal impressions of their utility. The bar for approval is ridiculously low, but not absent altogether — a fact that facilitates high drug prices. Finally, the people who work at the FDA later go to work predominately for the companies that profit from the FDA’s lax standards. The revolving door spins so fast it might hit you in the rear.
Our system is grievously and horribly broken. I have been following it closely and my worry is that I see no signal it is getting better any time soon.
We may be seeing a “quantum leap” in the bureaucrats’ view of what has been declared as “dangerous drugs” when the Controlled Substance Act was passed in 1970 .. the bureaucratic agency that was created was the Bureau of Narcotic and Dangerous Drugs… https://en.wikipedia.org/wiki/Bureau_of_Narcotics_and_Dangerous_Drugs which evolved into the DEA in 1973.
Over the years the number of substances that ended up as been classified as controlled substances has continued to grow over the five decades since. There has been some reports that we are spending upwards of 100 billion/yr in fighting the war on drugs and we have spent nearly TWO TRILLION since 1970.
There is so many moving parts that seems to suggest that we are headed toward some weakening of the DEA… Some states – RI & NH comes to mind that have attempted to pass state laws that is trying to assure chronic pain pts get better/more appropriate pain management.. How successful they are has yet to be determined in the long run.
There is some rumors of Congress considering the legalization/decriminalization of MJ. Just imagine the impact on chronic pain pts if this happens, and it becomes a OTC med/supplement and Congress/DEA cuts the production limits of opiates by the Pharmas. The dollars that could be shifted to pts and the billions of dollars that would not be paid out by Insurance/Medicare/Medicaid. This could be viewed as necessary to cut the costs that turning Obamacare into a national healthcare insurance. This could be a option instead of putting a “sin tax” on the sale/use of MJ ?
Democrats Unveil Bill to Decriminalize Drug Possession at Federal Level, Expunge Records
A bill to end criminal penalties for drug possession at the federal level was unveiled by Democrats on Tuesday, ahead of the 50th anniversary when President Richard Nixon declared the “war on drugs.” The Drug Policy Reform Act (DPRA) would decriminalize personal use possession of all scheduled drugs—including marijuana, heroin…
In another example of misconfigured cloud services impacting security, over a billion records belonging to CVS Health have been exposed online.
On Thursday, WebsitePlanet, together with researcher Jeremiah Fowler, revealed the discovery of an online database belonging to CVS Health. The database was not password-protected and had no form of authentication in place to prevent unauthorized entry.
Upon examination of the database, the team found over one billion records that were connected to the US healthcare and pharmaceutical giant, which owns brands including CVS Pharmacy and Aetna. What people should be asking is “is meritain health the same as aetna?”
The database, 204GB in size, contained event and configuration data including production records of visitor IDs, session IDs, device access information — such as whether visitors to the firm’s domains used an iPhone or Android handset — as well as what the team calls a “blueprint” of how the logging system operated from the backend.
Search records exposed also included queries for medications, COVID-19 vaccines, and a variety of CVS products, referencing both CVS Health and CVS.com and many other additional resources to claim the orders and data of the patients. Everyone was taken aback by this incident. Contact the Canadian Pharmacy for more info.
“Hypothetically, it could have been possible to match the Session ID with what they searched for or added to the shopping cart during that session and then try to identify the customer using the exposed emails,” the report states.
The researchers say the unsecured database could be used in targeted phishing by cross-referencing some of the emails also logged in the system — likely through accidental search bar submission — or for cross-referencing other actions. Competitors, too, may have been interested in the search query data generated and stored in the system.
WebsitePlanet sent a private disclosure notice to CVS Health and quickly received a response confirming the dataset belonged to the company.
CVS Health said the database was managed by an unnamed vendor on behalf of the firm and public access was restricted following disclosure.
“In March of this year, a security researcher notified us of a publicly-accessible database that contained non-identifiable CVS Health metadata,” CVS Health told ZDNet. “We immediately investigated and determined that the database, which was hosted by a third party vendor, did not contain any personal information of our customers, members, or patients. We worked with the vendor to quickly take the database down. We’ve addressed the issue with the vendor to prevent a recurrence and we thank the researcher who notified us about this matter.”
IMO, Obamacare is now more firmly in place as the “foundation” of implementing a national health insurance and it appears that this current administration and Congress is on a “bum rush” to implement as much socialism as they can before the 2022 mid term elections. President Biden seems interested in having history look upon his administration on the same level as the two most socialist President of the last 100 years… Roosevelt (SS) and Johnson (Medicare/Medicaid). There is 50 million people on Medicare and 70 million on Medicaid – abt 38% of our population. Our bureaucrats are moving people on Medicare/Medicaid over to Medicare Advantage & Medicaid Managed Care – which is care provided by for profit insurance companies. Is this the template that will be used for a national health insurance ? Where the Feds will have a fixed cost per pt/month and the entities providing your care will be interested in paying out a lot less for care than they are being paid to provide care … so that they can produce a profit and keep their stock holders happy.
The Supreme Court dismissed a major challenge to the Affordable Care Act, upholding the national healthcare law for the third time.
The case, California v Texas, argued that after the elimination of individual penalties in 2017 for not maintaining health insurance, the entire law must be struck down. Many legal scholars viewed the argument as weak, and the justices decided that Obamacare can still exist without the penalty for lacking health coverage.
The court voted 7-2 to block the GOP-led suit saying the plaintiffs did not have the right to bring the case. Justices Neil Gorsuch and Samuel Alito were the lone dissenters.
Senate Majority Leader Chuck Schumer, D-NY, celebrated the ruling.
“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” according to CNN. “”For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”
The seven justices who voted to block the suit ruled that Texas and the other plaintiff states had no reason to sue because they are not required to pay anything under the law’s mandate and therefore had no standing, NPR reported.
“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,'” the court ruled. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”
This is a developing story. Please return for updates.
Goal: Fully investigate alleged act of animal cruelty involving acid attack on service dog.
A beloved service dog allegedly became the victim of a sadistic acid attack. Gizmo, a Shih Tsu, was found outside his caretaker’s door in visible distress. To his service companion’s horror, burns seemingly covered him. A veterinarian later reported that Gizmo had been doused with a large quantity of a cleaning chemical called boric acid. Tragically, the poor pup’s injuries were so severe that he is now blind and will likely need both of his eyes surgically removed.
The injustice did not end here, however. Although Gizmo’s caretaker harbored strong suspicions about the perpetrators and although she reported this seeming act of cruelty to authorities, no action was immediately taken. The local police department reportedly initially dismissed her complaint, telling her they did not even investigate animal cruelty cases.
Justice must be done for this innocent dog. Sign the petition below to demand authorities reevaluate their priorities in regards to this serious crime.
PETITION LETTER:
Dear Sheriff Gonzalez,
Recently, your department allegedly rebuffed a woman who claimed a vicious acid attack had been perpetrated against her service dog. If this woman’s assertions are true, you told her that the police were not in the business of investigating animal cruelty. 42.092 “Cruelty of Non-Livestock Animals” of the Texas Penal Code would say differently. Under Loco’s Law, the most heinous of crimes could be classified as a felony. A victim injured so severely that his eyes must be removed would seemingly meet the very definition of aggravated cruelty.
This living being deserved to be treated with a true understanding of the gravity of the crimes committed against him, not as a nuisance or an afterthought. You are aware that some of the most sadistic perpetrators of brutality against humans begin their “experimentation” with animals. You must take these crimes seriously. As one of the largest Sherriff’s Offices in the United States, you must set a standard for law enforcement not only locally but across the country.
Expedite an investigation into this troubling case at once.
In June of 2018, after months of intense pressure from the Ohio Pharmacists Association, Ohio state lawmakers, and Columbus Dispatch investigative journalists, the Ohio Department of Medicaid released a blockbuster report showing that PBMs working on behalf of Medicaid managed care plans charged the state $224 million in hidden spread pricing. Spread pricing is a controversial practice in which PBMs pay a pharmacy a low rate for dispensing a drug, bill a health plan a higher rate for the same transaction, and pocket the difference.
One of the overlooked controversies in the 2018 Medicaid audit in Ohio was a nugget that uncovered an additional $20 million in spread under Centene’s Ohio offering, Buckeye Health Plan. That brought the entire Ohio PBM spread-pricing haul to $244 million. The state found that while managed care plans’ PBMs captured spreads of almost $6 per prescription on average, the Buckeye plan’s total spread was almost $12 per prescription.
In one specific call-out, the Ohio lawsuit alleges that the Centene’s Buckeye Health Plan charged the state nearly $2 per prescription in dispensing fees, but instead of paying them to the pharmacies that actually dispensed the medications, Centene pocketed $1.45 per prescription for themselves.
The relentless pursuit of PBM reform continues on several fronts.
On June 14, Centene announced that it has settled litigation filed in Ohio by Yost (now the state’s attorney general) and by the state of Mississippi. Without admitting fault, Centene agreed to pay $88 million to Ohio and $55 million to Mississippi. It has set aside an additional $1.1 billion should it decide to settle similar lawsuits filed in Arkansas, Georgia, Kansas, New Mexico and several others.
The mounting scrutiny of PBMs is a welcome sight for pharmacists, and it’s gratifying in many ways that my home state Ohio continues to lead the charge.
The important thing to remember is that this is about much more than Centene and its PBM subsidiaries. Remember, out of $244 million in 1 year of Ohio Medicaid spread, Centene’s slice wasn’t even 10%. CVS Caremark and OptumRx will have their turn soon enough, but it isn’t about them, either.
The takeaway is that the United States has allowed intentional complexity and opacity to eclipse what should otherwise be a very straightforward and simple transaction. PBMs were supposed to streamline that transaction and strike a balance to create a fair payment to the pharmacies dispensing medications to patients. Instead, PBMs added unnecessary complications, layers of secrecy, and massive amounts of waste.
If PBMs are willing to engage in these kinds of dirty tricks in our Medicaid programs—intended to provide care to society’s most disadvantaged—you can only imagine what they’re doing to our small employers and seniors in Medicare.
APhA is working hard to make sure that Ohio’s work isn’t happening in isolation. Our states are making tremendous strides, and with Arkansas’s big victory in Rutledge v PCMA, this is our moment to restore order within our profession.
Stay tuned in the coming weeks to hear about APhA’s latest investments that will push our foot harder on the gas. Until then, please support our efforts.
A retired flooring contractor was watching television one night last month when he saw a news report about federal agents raiding U.S. Private Vaults, a store in a Beverly Hills strip mall that let customers rent safe deposit boxes anonymously.
He knew the place well. It’s near his home and, for years, he has rented a long, narrow box there to keep about $60,000 in cash, gold and silver. It also contained the title certificate for his pickup truck.
The 69-year-old man, who declined to be named because of privacy and safety concerns, said he has kept the stockpile of currency and precious metals since getting spooked by the 2008 financial crash. “You never know what’s going to happen, the way the world’s going today,” he said.
That financial net vanished — at least for now — in the raid.
Federal agents descended on U.S. Private Vaults in a Beverly Hills strip mall last month and seized the contents of hundreds of safe deposit boxes inside the store, on Wednesday, April 7, 2021.
(Christina House/Los Angeles Times)
Armed with a warrant, agents with the FBI and Drug Enforcement Administration pulled each of the store’s several hundred boxes out of the walls and seized all the contents. It took five days to inventory everything and take it to an undisclosed warehouse. Prosecutors said drugs, weapons and stacks of currency that drew the attention of drug-sniffing dogs were discovered.
To reclaim property, people must identify themselves to federal authorities and prove they are the rightful owners of the items — a bar that may prove challenging to clear when dealing with cash, gold, heirloom jewelry and other undocumented items.
The raid has set off legal challenges from five box holders who say the government violated the constitution’s ban on unreasonable search and seizure.
U.S. District Judge R. Gary Klausner on Tuesday declined one customer’s request for an emergency order that would have blocked prosecutors from using the boxes’ contents as evidence in the investigation. It also would have stopped the FBI from requiring box holders to identify themselves as a condition of getting their valuables back.
Klausner, however, left open the possibility that the sweeping nature of the seizures violated the box renters’ rights.
Klausner’s ruling came in the first of the five lawsuits filed by U.S. Private Vaults customers, who estimate there were 600 to 1,000 boxes in the store.
U.S. Private Vaults shut down its business in a Beverly Hills strip mall in late March after federal agents seized the contents of its safe deposit boxes during a five-day search.
(Joel Rubin / Los Angeles Times)
Prosecutors have argued in court filings that they are on solid legal footing, saying they can prove the company itself is a criminal enterprise and that most of the box holders were criminals hiding “ill-gotten wealth.” But they also acknowledged in court records that innocent people had been swept up in the case. No charges have been filed against any of the store’s customers.
Legal scholars say the U.S. attorney’s office in Los Angeles is testing constitutional restraints on the government’s power to seize private property.
“This was at bottom executing a warrant at a business,” said Orin Kerr, a UC Berkeley law professor. “What makes it different is that hundreds of customers had their own 4th Amendment protected spaces in their safe deposit boxes. That’s what makes this unusual. It’s not just the business. It’s also users storing their things — some engaging in criminal activity, others not, I assume.”
A federal grand jury indicted U.S. Private Vaults last month on three counts of conspiracy — to distribute drugs, launder money and structure cash transactions to dodge currency reporting rules. The indictment lists four unnamed people affiliated with the business as co-conspirators but has not charged them. More charges could be filed later.
In a court statement defending the seizure, FBI agent Kathryn E. Bailey said agents searching the boxes found fentanyl, OxyContin, guns, gold bullion and stacks of $100 bills. Some of the largest-sized boxes each contained more than $1 million in cash, she said.
Customers who sued the government said prosecutors had no right to seize the contents of their boxes because they had no evidence that would give them reason to suspect the customers were stashing contraband or committing some other crime.
Jeffrey B. Isaacs, an attorney for one customer, accused prosecutors of trying to force people who want their property back to reveal their names to the FBI, subject themselves to criminal investigation and prove they lawfully acquired what they stored in the boxes.
“This is as illegal a search and seizure as I’ve ever seen,” Isaacs said. “It’s rather shocking.”
His client is identified in court papers by the pseudonym James Poe. The four others who have sued are also seeking to retain their anonymity: John Doe, Charles Coe, Michael Moe and Richard Roe.
The retired Pico-Robertson contractor has not sued, but tried to file a theft report with Beverly Hills police, who refused to take it.
Klausner’s ruling rejected Doe’s request for a temporary restraining order that would have unsealed the court-approved seizure warrant; stopped inspection of any box the government has no specific justification to search; barred agents from using anything they found in such boxes in criminal investigations; and stopped the FBI from requiring personal information from people trying to retrieve their valuables.
Doe rented three boxes to store jewelry, currency and bullion, but sought a court order that applied to the whole store.
“It is possible that the government’s seizure and search of those other boxes violated the 4th Amendment rights of their owners,” Klausner wrote. But the request was “far broader than necessary” to protect Doe from harm.
The court is still considering Doe’s request for a preliminary injunction. Benjamin Gluck, his attorney, said “the government’s scheme is manifestly unconstitutional.”
In court papers filed last week, Assistant U.S. Atty. Andrew Brown said agents “seized the nests of safety deposit boxes because there was overwhelming evidence” that U.S. Private Vaults “was a criminal business.” The company’s promise of anonymity attracted criminals looking to safeguard cash, he said. Brown acknowledged some customers were “honest citizens” who should get their things back.
Standards for what makes a search legal have shifted in recent years as digital communications pose new challenges. Courts have required warrants for searches of locations where people have a “reasonable expectation of privacy.” Exceptions, however, have been made when law enforcement has sought personal data and other things that suspects have technically put in the possession of a third party like a phone company or storage facility.
In 2018, the Supreme Court narrowed those exceptions, ruling that police need a warrant to collect cellphone tracking records that can reveal everywhere a person goes. Even though the location data is kept by a private company, Chief Justice John G. Roberts wrote, “we decline to grant the state unrestricted access.”
Hadar Aviram, a UC Hastings law professor, said the warrant that remains under seal in the U.S. Private Vaults case is the key to whether prosecutors met the legal standard for breaking the box holders’ expectation of privacy. Prosecutors would need to show they had probable cause to believe evidence of criminal activity would be found in a substantial portion of the boxes — perhaps close to a third of them, she said. “There’s good cause for concern here,” she said.
Kerr, the UC Berkeley law professor, said he expected the seizure of all the boxes would ultimately hold up in court, but the legal question still did not appear “cut and dry.”
How does the 4th Amendment apply to the “U.S. Private Vaults” case, busting the Beverly Hills store where people could anonymously store guns and drugs (and anything else)?
Robert Frommer, senior attorney at the libertarian Institute for Justice in Virginia, called the seizure of the boxes “egregious.”
“Those property owners have their own independent rights to be secure in their persons and property,” he said. “The government can’t come in there and say, because the business allegedly did something wrong, those people are not entitled to the protections of the 4th Amendment.”
Attached is a link to an interesting unanimous panel decision from the Sixth Circuit Court of Appeals in an opioids case. This is the very same court that would hear appeals from cases from decisions by Judge Dan Polster, Judge of the United States District Court for the Northern District of Ohio. Judge Polster, it will be recalled, has been selected by a federal judicial panel to preside over more than 200 consolidated prescription opioid-related lawsuits in multi-district litigation (MDL).
In the instant case, the plaintiff (a pharmacist working at Walmart WMT+0.6%) sued that company and others under the federal False Claims Act (FCA). The claim is that this pharmacist received large numbers of heavy opiate prescriptions written by the same doctor. Walmart allegedly filled these prescriptions, whose small copay indicated to the plaintiff that Walmart was obtaining Medicare and/or Medicaid reimbursement. The plaintiff believed these prescriptions to be fraudulent (both because of their number and because of the high dosage) and thus that the federal reimbursement to Walmart was fraudulent. He notified his employer of his decision to file his complaint, and claims he was fired as a result (adding a retaliation count to his suit).
Typically in such cases, the federal government intervenes to support the claim of alleged fraud and the claimant (here, the pharmacist) receives a reward for his initiative. Here, though, the government expressly declined to intervene, so the pharmacist persevered alone. But Walmart and the other defendants demurred (that is, claimed that the plaintiff’s suit did not state a cause of action) and won at trial. A unanimous Circuit Court panel here confirmed.
The reasoning is interesting and potentially applicable to Judge Polster’s MDL. The panel held that the tiny amount ($1 or $2) paid by patients for each prescription was no proof that the federal government had expended any money at all, or even that any demand for federal payment had ever been made. It also held that the mere fact that doses were high was no evidence at all that they were medically “too” high. It held that the mere fact the plaintiff was discharged in no way established any causation with his FCA claim. Finally, it held that the federal government’s decision not to intervene in the case demonstrated that it too found the allegations lacking. Essentially, the panel wondered how Walmart could believe the prescriptions to be fraudulent when the government itself clearly doesn’t think so.
It’s pretty clear that bare-bones lawsuits against a seemingly fat target (Walmart in an opioids suit) are not going to be met with favor in the Sixth Circuit. Plaintiffs had better be equipped, both in individual case and in the MDL, with detailed medical expert evidence about patients’ needs and about federal fraud.
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