Headline of the Day

To Keep Drug Prices High, Pharma Has Been Piling up the Patents

—Ars Technica on big Phasrma's recent orgy of rent-seeking.

This is a real-time demonstration that the US IP legal framework is broken.

The cost of healthcare in general is a debilitating, pre-existing condition for Americans. But the high prices of prescription drugs usually stand out as a pain point. While there are many insidious reasons why Americans pay more—often far more—for their medicines than people in peer countries, exploitation of the US patent system is an obvious one.

A study published Monday in JAMA highlights just how much patent exploitation has grown since 1990. In that time, researchers found that the number of patents on small-molecule drugs has more than tripled, going from an average of 2.1 patents per drug approved in 1990 to 6.9 for those approved in 2019.

Most of the growth was in “nonprimary” patents—patents that generally aren’t related to a drug’s active ingredient, but are instead for things like minor tweaks to a drug’s nonactive ingredients, updates to the way the drug is used, or the design of specialty delivery devices, such as auto-injectors. Together, those extra patents on an individual drug can create what’s called a “patent thicket,” which delays the release of affordable generics on the market, keeping drug prices higher for longer without actual clinical advancements.

The study—led by S. Sean Tu, an expert in drug and patent law at the University of Alabama—found that the increase in patents per drug extended the time in which a drug was patented from an average of two years in 1990 to an average of 6.1 years in 2019.

“Because patent protection typically determines how long brand-name firms can charge monopoly prices, the rapid growth of nonprimary patents may contribute to limited price competition that benefits patients and the health care system by helping avoid unnecessary spending,” Tu and colleagues write.

 The money is not in better drugs, it's in gaming the patent system.

Fun With Gila Monster Venom

After my two latest doctor visited showed high A1C, I was prescribed Ozempic.

I've lost a bit of weight over the past 5 weeks, high single digit, but I think that a lot of that is just a reduction in stomach contents.

I haven't so much noticed a reduction in appetite as I have noticed an increase in satiety.  I get full faster, and I stay full longer. 

Some interesting factoids at this point, first. there are preliminary indications that  GLP-1 drugs may prevent certain cancers , and second, Canada just licensed generic GLP-1 drugs.

In any case, I am definitely eating less. 

Yeah, This is Literally the Worst Thing to Do

In response to high pricing (not high cost, high prices) of pharmaceuticals, the Trump administration is writing higher drug prices into international trade deals.

This isn't lowering prices, it's just hurting other people.

The Trump administration’s position on drug prices is that Americans pay too much while other countries don’t pay nearly enough. A new trade deal with the United Kingdom is addressing that imbalance, raising prices the national health system will pay for new medicines in exchange for tariff exemptions on U.K. pharmaceutical exports valued at about $3.5 billion a year.

The deal announced Monday is an update to a broad trade deal the U.S. struck with the U.K. in May. While the countries describe this new deal as an “agreement in principle,” it sets a precedent that could shape pharmaceutical pacts the Trump administration is still pursuing with other countries.

Before the U.K.’s National Health Service (NHS) can use a new medicine, it must first be evaluated by the government’s National Institute for Health and Care Excellence (NICE), which assesses a drug’s cost effectiveness to the health service. NICE’s current cost effectiveness benchmark is a range of £20,000 to £30,000 (about $26,412 to $39,618) per quality adjusted life year. That means a cost-effective drug should lead to the equivalent of one additional year of health and improved quality of life for no greater than £20,000 to £30,000 more than the cost of the current standard of care. Consequently, a drug shown to be safe and therapeutically effective in clinical trials may end up being turned down by NICE because it is not cost effective, though the agency said it applies a higher threshold for medicines developed for ultra-rare conditions.

 This is ineluctably evil.

Not Enough Bullets

Cheaper than bullets

The folks at the Vampire Squid, aka Goldman Sachs, is wondering if, "'Curing patients a sustainable business model?"

You see, if you cure a disease, you only get paid once.  Thus you should only work on lifelong treatments.

These people should have been drowned at birth: 

Goldman Sachs analysts attempted to address a touchy subject for biotech companies, especially those involved in the pioneering "gene therapy" treatment: cures could be bad for business in the long run.

"Is curing patients a sustainable business model?" analysts ask in an April 10 report entitled "The Genome Revolution."

"The potential to deliver 'one shot cures' is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies," analyst Salveen Richter wrote in the note to clients Tuesday. "While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow."

Richter cited Gilead Sciences' treatments for hepatitis C, which achieved cure rates of more than 90 percent. The company's U.S. sales for these hepatitis C treatments peaked at $12.5 billion in 2015, but have been falling ever since. Goldman estimates the U.S. sales for these treatments will be less than $4 billion this year, according to a table in the report.

"GILD is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients," the analyst wrote. "In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise."

 Why we need socialized medicine and pharma price controls..

Signs of the Apocalypse

Sarah Huckabee Sanders has done something right.

Not only has she done something right, in signing a bill that bans Pharmacy Benefit Managers from owning pharmacies, she is the first in the nation to do this.

Governor Sanders had to choose between Big Pharma and ordinary folks, and she went with ordinary folks.

Good news, not not what I expected:

Arkansas became the first state in the nation to prevent healthcare conglomerates from operating drugstores here when Gov. Sarah Huckabee Sanders signed House Bill 1150 on Wednesday.

State law already regulates what pharmacy benefit managers (PBMs) pay to reimburse independent pharmacies, but pharmacists have complained that the companies violate the law. The state has also fined four PBMs a total of $1.47 million for paying Arkansas pharmacies below the legally required amount for prescription drugs.

PBMs negotiate prescription benefits among drug manufacturers, distributors, pharmacies and health insurance providers, and the biggest ones also own pharmacies and insurers. The Federal Trade Commission released an interim report in July 2024 saying these conglomerates are eliminating competition and increasing drug prices at the expense of patients.

HB 1150 headed to Sanders’ desk April 9 after clearing the Senate with a bipartisan 26 votes, six days after it passed the House with 89 votes. The bill generated hours of discussion and public comment in the House and Senate committees on Insurance and Commerce this month.

“These massive corporations are attacking our state because we will be the first in the country to hold them accountable for their anticompetitive actions,” Sanders said in a statement Wednesday.

This is probably the most aggressive anti-monopoly action taken by a Republican of national stature since ……… (Checks Notes) Teddy Roosevelt?  (Maybe Nixon, or William Howard Taft, but definitely a long f%$#ing time ago)

It's welcome news, but this is profoundly weird.for this to have come from Governor "Smokey Eye".

As If There Weren’t Enough Reasons to Hate Them with a White Hot Passion

It turns out that Pharmacy Benefit Managers (PBMs) extorted money from pharmaceutical companies to in furtherance of the pharma companies peddling addictive drugs.

Seriously.  Just shut them down.  Make them illegal.

In 2017, the drug industry middleman Express Scripts announced that it was taking decisive steps to curb abuse of the prescription painkillers that had fueled America’s overdose crisis. The company said it was “putting the brakes on the opioid epidemic” by making it harder to get potentially dangerous amounts of the drugs.

The announcement, which came after pressure from federal health regulators, was followed by similar declarations from the other two companies that control access to prescription drugs for most Americans.

The self-congratulatory statements, however, didn’t address an important question: Why hadn’t the middlemen, known as pharmacy benefit managers, acted sooner to address a crisis that had been building for decades?

One reason, a New York Times investigation found: Drugmakers had been paying them not to.

For years, the benefit managers, or P.B.M.s, took payments from opioid manufacturers, including Purdue Pharma, in return for not restricting the flow of pills. As tens of thousands of Americans overdosed and died from prescription painkillers, the middlemen collected billions of dollars in payments.

Let's be clear here.  PBMs did not, "Take,"  payments from big pharma, they did not, "Accept," payments from big pharma, they DEMANDED payment. 

Demanding payment from drug manufacturers and pharmacies is their whole business model.

………

The documents reviewed by The Times — including contracts, invoices, emails, memos and financial data — span more than two decades, beginning with the debut of OxyContin in 1996. Many came from a public repository of records unearthed during court cases and investigations. The Times also obtained more than 200 previously confidential documents from plaintiffs in litigation against drugmakers, P.B.M.s and others.

In the public assignment of blame for the opioid epidemic, the P.B.M.s have largely escaped notice. Drugmakers, distributors, pharmacies and doctors have paid billions of dollars to resolve lawsuits and investigations. But more recently, the largest P.B.M.s have been in the legal cross hairs.

………

But this often presented the clients with a fraught choice: If they added restrictions, they could lose the rebates that helped make coverage affordable.

In addition, documents show that P.B.M.s sometimes collaborated with opioid manufacturers to persuade insurers not to restrict access to their drugs.

Fines are not enough.  Jail the mother-f%$#ers.

Not Enough

The criminal organization/consultancy McKinsey & Company will pay at least $½ billion to settle charges that it was a criminal co-conspirator with big pharma drug pushers.

Of course, they are denying wrongdoing.  (Of course, they are lying about that)

McKinsey & Co. is nearing a deal with US prosecutors to pay at least $500 million to settle federal probes into its past work helping opioid makers boost sales, according to people familiar with the matter.

A settlement, which could be announced in the coming weeks, would resolve criminal and civil investigations by the Justice Department, said the people, who asked not to be identified discussing a confidential matter. The terms haven’t been finalized and could still change.

………

The settlement would add to penalties that McKinsey has already paid US states for its past work with drug companies that produced highly-addictive painkillers. The privately held firm, which said it generated a record $16 billion in revenue last year, agreed in 2021 to pay hundreds of millions of dollars to settle claims by states that it helped fuel the country’s opioid epidemic by providing sales analysis and marketing advice.

Note that they were doing this while they were consulting with (among others) the FDA, a clear conflict of interest.

Considering the company's long record of aiding and abetting corruption, one has to wonder why they are accredited to consult with the government.

McKinsey is to business ethics what Ebola is to French kissing.

Both Inevitable and Justified

It appears that activists are distributing information that would allow for anyone to make some of the most expensive medications in the world themselves.

A case in point is Sofosbuvir (brand name Sovaldi), which is at this point the only drug which cures Hepatitis C, which sells for $1,000.00 a pill but can be made in a relatively simple home lab for $0.87 a pill, a 114,943% markup.

This means that the treatment regimen can be had for less than $100.00, as opposed to almost $100,000.00.

Drug patents have gotten out of hand, and it needs to stop:

I’ve been video chatting with Mixæl Swan Laufer for about 30 minutes about an exciting discovery when he points out that to date, the best way he’s been able to bring attention to his organization is “the old school method of me performing a bunch of federal felonies on stage in front of a bunch of people.”

I stop him and ask: “In this case, what are the felonies?”

“Well, the list is pretty long,” he said.

Laufer is the chief spokesperson of Four Thieves Vinegar Collective, an anarchist collective that has spent the last few years teaching people how to make DIY versions of expensive pharmaceuticals at a tiny fraction of the cost. Four Thieves Vinegar Collective call what they do “right to repair for your body.”

Laufer has become well known for handing out DIY pills and medicines at hacking conferences, which include, for example, courses of the abortion drug misoprostol that can be manufactured for 89 cents (normal cost: $160) and which has become increasingly difficult to obtain in some states following the Supreme Court decision in Dobbs.

In our call, Laufer had just explained that Four Thieves’ had made some miscalculations as part of its latest project, to create instructions for replicating sofosbuvir (Sovaldi), a miracle drug that cures hepatitis C, which he planned to explain and reveal at the DEF CON hacking conference.

Unlike many other drugs that treat viruses, Sovaldi does not suppress hepatitis C, a virus that kills roughly 250,000 people around the world each year. It cures it.

“Normally you have a virus, and your body fights it off or your body fights it to a standstill and you just have it forever, basically, and hope it remains dormant more or less,” Laufer said. “The holy grail for every virologist is to find a way to drain the viral reservoir, and Sovaldi does this. You take one pill of Sovaldi a day for 12 weeks and then you don’t have hepatitis C anymore.”

The problem is that those pills are under patent, and they cost $1,000 per pill.

“Literally, if you have $84,000 then hepatitis C is not your problem anymore,” Laufer said. “But given that there are other methodologies for managing hepatitis C that are not curing it and that are cheaper, insurance typically will not cover [Sovaldi]. And so we’ve got this incredible technology and it’s sitting on the shelf except for people who are ridiculously wealthy.”

So Four Thieves Vinegar Collective set out to teach people how to make their own version of Sovaldi. Chemists at the collective thought the DIY version would cost about $300 for the entire course of medication, or about $3.57 per pill. But they were wrong. “It’s actually just a little under $70 (83 cents per pill), which just kind of blew my mind when they finally showed me the results,” Laufer said. “I was like, can we do the math here again?”

Our current IP regime, particularly with regard to pharmaceuticals does not work.

Furthermore, it runs counter to the Constitutional requirements of such a system, (Article I, Section 8, Clause 8) "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

This sort of looting and rent seeking does not promote the, "Progress of Science and useful Arts," it promotes corrupt business models.

Patent and copyright are a tax on the rest of us that is provided in order to benefit the public.

Our current IP regime does not do this.

Predictably Corrupt

The Federal Trade Commission has accused pharmacy benefit managers (PBMs) favor their affiliated pharmacies.

This disadvantages independent pharmacies, and raises costs for insurers and protesters.

The PBMs lobbying organization are arguing that the analysis is not accurate, MRDA:*

Pharmacy benefit managers (PBMs) often reimburse their own affiliated pharmacies at higher rates than they do independent pharmacies, to the disadvantage of insurers as well as taxpayers, the Federal Trade Commission (FTC) said.

"We see evidence PBMs pay their own pharmacies inflated prices," said Suzie Jing of the FTC's Office of Policy Planning, who presented interim results from the agency's report on PBMs at a commission meeting Thursday. For example, she said, in the case of generic abiraterone (Zytiga) for prostate cancer, "it costs $229 to buy the drug, but the big three PBMs pay their affiliated pharmacies about $6,000 per month on average. That's double the price paid to unaffiliated pharmacies ... This means that the PBM is overpaying itself at the expense of -- first, private insurance plans, which can lead to higher patient insurance costs; and second, at the expense of taxpayers who pay for Medicare."

Jing noted that the top six PBMs manage 94% of pharmacy claims. In addition, "based on our review to date, we find that there's often no negotiation for contract terms," she said. "The PBMs' internal memos reference 'unilateral' or 'passive' contracts, which are more like notifications -- often sent via fax -- outlining terms that take effect automatically, without the need for affirmative consent or signature. Reimbursement rates in these contracts can be unfavorable and potentially untenable, especially for local community pharmacies."

The FTC also found examples in which the PBMs' rebate contracts with drug manufacturers "are designed to limit access to affordable drugs and will exclude generic drugs from formularies ... this is disturbing," Jing said.

Seriously.  Let's just start jailing these assholes.

The whole business model is deeply corrupt and should be outlawed.

^*Well, he would say that, wouldn't he?  Seriously, know your history.

About F%$#ing Time

It looks like Lina Khan and the FTC are going after pharmacy benefits managers. (PBMs)

I knew that this would happen eventually.  PBMs are gatekeeping parasites.

Firms that serve as intermediaries to negotiate and control prescription drug access in the US "wield enormous power," largely with "extraordinarily opaque" business practices, and may be "inflating drug costs and squeezing Main Street pharmacies" for profit, according to a searing interim report released Tuesday by the Federal Trade Commission.

Amid a national focus on America's uniquely astronomical drug costs, the FTC is taking aim at firms that largely work deep in the bowels of the country's labyrinthine health care system, well hidden from public understanding and scrutiny: pharmacy benefit managers (PBMs).

PBMs were initially hired by various payors—employers, health insurance companies, government health plans, and others—to manage prescription drug benefits through various plans. But PBMs have evolved over the years to also negotiate rebates from drugmakers, set reimbursements for dispensing pharmacies, and develop drug formularies (the list of drugs that a health plan covers.) While those functions alone grant PBMs a large amount of power, consolidation and integration over recent years has concentrated that power in troubling ways, according to the FTC report.

………

In the FTC's investigation so far, the commission found evidence that PBMs are steering people toward their affiliated pharmacies—hurting small, independent pharmacies—and allowing their affiliated pharmacies to rake in payments "grossly in excess" of average drug costs. For instance, for two generic cancer drugs (one for prostate cancer and the other for leukemia), pharmacies affiliated with the top three PBMs collectively raked in nearly $1.8 billion in revenue from 2020 to 2022. That represents an excess of revenue of $1.6 billion dollars over the national average cost for the drugs. In other words, pharmacies not affiliated with the top PBMs would have otherwise seen revenue of under $200 million for the same drug dispensing.

Further, the FTC found evidence that big PBMs and big brand pharmaceutical companies make agreements to exclude cheaper drugs made by a rival manufacturer from a PBM's drug formulary in exchange for certain pricing and rebates.

Burn all the PBMs to the ground.

Not a Surprise

It turns out that the diabetes and weight loss drug Ozempic (semaglutide) which costs $1,000.00 a month, only costs the equivalent of $5.00 a month to manufacture.

What, big pharma is price gouging?  Again? 

It should be noted here that its use as a weight loss drug is off label, and diabetics, for whom the drug was actually developed are unable to find the drug, and when they do, it is ruinously expensive.

The use and expansion of exclusivity over the past 40+ years had done nothing but line the pockets of big businesses:

Ozempic could be profitably produced for less than $5 a month even as maker Novo Nordisk A/S charges almost $1,000 in the US, according to a study that revives questions about prices for top-selling treatments for diabetes and obesity.

The blockbuster drug could be manufactured for 89 cents to $4.73 for a month’s supply, figures that include a profit margin, researchers at Yale University, King’s College Hospital in London and the nonprofit Doctors Without Borders reported in the journal JAMA Network Open. That compares to the monthly US list price of $968.52 for Ozempic, a weekly injection.

………

“This outrageously high price has the potential to bankrupt Medicare, the American people and our entire health care system,” Senator Bernie Sanders, who has held hearings about high US drug prices, said in a statement after the findings came out. The Vermont independent called on Novo Nordisk to lower the list price of Ozempic to $155 a month or less, in line with what it charges in other countries.

The study extends research showing how steep US markups are for GLP-1 drugs like Ozempic and Wegovy and underlines longstanding criticism of prices for diabetes therapies, especially insulin. On a per-month basis, Ozempic generally can be produced for less than various forms of insulin, a lifesaving diabetes drug that’s been available for decades, the study found.

IP in all of its forms is a government subsidy, where the force of the state is used to sustain prices that the market would not otherwise bear.

The expansion of the scope, length, and the geographic reach of exclusivity has been a disaster, particularly for poorer nations in the world.

It has led to an orgy of unproductive rent seeking, and an expansion in inequality.

Headline of the Day

Experts: Negotiating Big Pharma's Prices Won't Stifle Innovation — They Don't Use the Money to Innovate!

—Institute for New Economic Thinking

This is true.

Big Pharma's money overwhelmingly goes to advertising, executive compensation, lobbying and stock buybacks.

………

Bottom line: big drug companies rake in enormous profits without prioritizing investments in medication development or innovation. They simply snap up drug rights that the federal government paid for (us, in other words), focus on boosting their stock prices, and overcharge the public. Surely, Americans deserve better.

Using Bayh-Dole march-in rights, which has never happened in the almost 50 years since the law passed, or better yet, repealing Bayh-Dole and having the US government retain the rights to the research which it has funded, would go a long way toward ameliorating the abusive finance driven business strategies in the pharmaceutical sector.

We would probably get more and better drugs too, because we would see fewer researchers being pressured by college administrators to create and sell blockbuster research.

The current system impedes scientific discourse and results in regulatory arbitrage, particularly through the patent and drug exclusivity process, being the primary focus of the drug companies, not research.

Burying the Lede

Maureen "Mo" Thkacic is one of my favorite reporters.

She follows the money and does good shoe leather journalism, but in the story about UnitedHealthcare's pharmacy benefit manager (PBM) Change, and the hack that took its systems offline, buries the lede.

In a 25 paragraph article, you have to wait until 'graph 21 to get this: (It's a good article otherwise)

In Utah, one of the states whose Medicaid program uses Change, the week has been oddly liberating, says Benjamin Jolley, a compounding pharmacist and self-described “anti-monopoly crusader” in the state. After working through the weekend to reach out to tens of thousands of patients with unfilled prescriptions in the system, the state decided to simply put together a simple four-question Google form for pharmacies to file requests for reimbursement until the system is back up and running. “[It’s] janky and hacky, but it does the job,” said Jolley, who has filled $1,500 in Medicaid prescriptions since the outage started and filed for reimbursement yesterday. “Presumably if anyone asks for an abnormally high figure they’ll look at their history and give them a call.”

Google docs?  Seriously? 

Based on the total kickbacks and fees received by PBMs in 2022, it looks like PBMs got something north of $700 million last year in Utah alone.

They were replaced with a single Google form.

Obviously, there are some additional state resources, the requests for reimbursements need to be reviewed by someone, but given the number of pharmacies in Utah, 1,117 at current count, the initial review could be handled by one low level full time equivalent, at less than $100,000.00 a year including benefits.

That is a 700,000% savings.

It's the looting, stupid.

Today in, "Big Fucking Deals"

While I am unimpressed with Joe Biden's mindlessly bellicose foreign policy, on domestic issues, things like labor rights, antitrust, and consumer and worker protections, I would argue that he is the best President on these issues since ……… Checks notes ……… Richard Milhaus Nixon. (Nixon created the EPA, OSHA, COLAs for Social Security, empowered the EEOC, etc.)

Well now, the Biden FDA has approved mass imports of cheaper drugs from Canada for the first time.

Not only that, they approved this for Florida, which means that much in the way of the political benefits will accrue to Ron DeSantis.

This might not be good politics, but it's good policy, and I approve of this choice:

The Food and Drug Administration has allowed Florida to import millions of dollars worth of medications from Canada at far lower prices than in the United States, overriding fierce decades-long objections from the pharmaceutical industry.

The approval, issued in a letter to Florida Friday, is a major policy shift for the United States, and supporters hope it will be a significant step forward in the long and largely unsuccessful effort to rein in drug prices. Individuals in the United States are allowed to buy directly from Canadian pharmacies, but states have long wanted to be able to purchase medicines in bulk for their Medicaid programs, government clinics and prisons from Canadian wholesalers.

Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. Other states have applied to the F.D.A. to set up similar programs.

But significant hurdles remain. Some drug manufacturers have agreements with Canadian wholesalers not to export their medicines, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.

………

Congress passed a law allowing drug importation two decades ago, but federal health officials delayed implementing it for years, citing safety concerns, one of the main arguments drug companies have used against it. In 2020, President Donald J. Trump pushed the law forward, announcing that states could submit importation proposals to the F.D.A. for review and authorization. President Biden added momentum the following year, instructing federal officials to keep working with states on importation plans.

Florida applied and later sued the F.D.A., accusing the agency of what Gov. Ron DeSantis called a “reckless delay” in approving the request. Friday’s announcement grew out of that lawsuit; a federal judge had set a Jan. 5 deadline for the F.D.A. to act on the state’s application.

………

Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin — have laws allowing for a state drug importation program, and many are seeking, or planning to seek, F.D.A. approval.

This is a win for patients and for state Medicare and Medicaid programs, and ultimately the taxpayers.

Of course, it's a lose for big Pharma, but fuck that.

 

^*Yes, I am quoting then Vice President Joe Biden.

 

Best Healthcare System in the World

Medicare now has a policy of sanctions for drugs whose price increases too rapidly.

One of drugs targeted by this policy is Flovent, whose cash price increased from  around $240 to around $340 over the past decade (Running the numbers, that is about a 3.5% annual increase, which does not sound bad, until you realize that the full cost of bringing the drug to market was likely covered in the first two years).

GlaxoSmithKline, the manufacturer of Flowvent's response was to rebrand as a generic, fluticasone, drop the price of the generic by a small amount, and stop producing the name brand, starting today.

The theory is that this sets a new baseline for the price, so they avoid penalties.

GSK opened up a whole can of worms, with insurance companies, pharmacy benefits managers, and other parasites (but I repeat my self) dragging their feet on putting the "new" generic on the approved list, because there is always time to fuck the consumer:

Earlier this year, parents trying to fill their children’s asthma prescriptions at pharmacies around the country got a jolt: The medicine was no longer covered. Soon, it would disappear from the market.

The reason: pricing.

Starting Jan. 1, drugmakers that have raised prices significantly face stiff new penalties that require them to essentially pay Medicaid for patients to use their drugs.

Drugmakers including Eli Lilly, Novo Nordisk and Sanofi are cutting prices of some insulin products by 70% or more on New Year’s Day. GlaxoSmithKline plans to cut prices for three products including its asthma and emphysema medication Advair Diskus, according to pricing data reviewed by The Wall Street Journal and confirmed by a Glaxo spokeswoman.

In June, Glaxo decided on a riskier gambit for its popular asthma inhaler Flovent HFA. It told the FDA it would pull the branded drug from the market in 2024. The company hoped patients would use a new generic version manufactured by Glaxo with a lower list price that isn’t subject to the Medicaid penalties. The maneuver would have effectively cut the price of the medication by a third.

It backfired.

Major pharmacy-benefit managers are refusing to cover the new generic product, despite a list price 35% cheaper than brand-name Flovent HFA, a favorite of pediatricians who said it is easier for children to use than other products. The skirmish between Glaxo and PBMs has left children stuck in the middle. One option is to try a different product, but not all insurers cover inhalers appropriate for children, doctors said.

Major pharmacy-benefit managers are refusing to cover the new generic product, despite a list price 35% cheaper than brand-name Flovent HFA, a favorite of pediatricians who said it is easier for children to use than other products. The skirmish between Glaxo and PBMs has left children stuck in the middle. One option is to try a different product, but not all insurers cover inhalers appropriate for children, doctors said.

………

An Express Scripts spokeswoman said Glaxo made the decision to pull Flovent HFA from the market and introduce unbranded versions at inflated prices.  

The brand, Flovent,is about (drug pricing is opaque) 35% more than their generic, fluticasone, and in Canada it is less than ⅓ of either.

I can see how the folks at Express Scripts considers the new generic overpriced.

Of course, it is the patients who are caught in the crossfire.

Another Nail in the Amyloid Plaque Theory

When the brains of Alzheimer's patients are examined post mortem, there are large amounts of deposits on the nerves in the central nervous system known as amyloid plaques.

It has been dogma in the field for almost 50 years that this is the cause of this form of dementia, but it increasingly looks like these structures are not the cause of the condition, but rather a symptom, which has the effect of invalidating 50 years of basic and pharmaceutical research into the disease:

At the start of the 20th century, psychiatrist Alois Alzheimer became the first person to notice the strange clumps and tangles in the brain of a person who had died with dementia.

These bundles of amyloid beta proteins have since become the dominant hypothesis for what causes Alzheimer's disease. And, despite decades of failed studies, finding ways to clear them away has remained an obsession.

Now, in two trials, a drug designed to eradicate these sticky plaques has failed to preserve the cognitive abilities of people with early Alzheimer's disease compared to people given a placebo.

The monoclonal antibody gantenerumab did significantly reduce the amount of amyloid beta in the brain as intended, but this did not translate into improvements in cognitive function.

"Among persons with early Alzheimer's disease, the use of gantenerumab led to a lower amyloid plaque burden than placebo at 116 weeks but was not associated with slower clinical decline," the researchers reported in their paper covering the two drug trials.

These results arrive as the amyloid hypothesis reaches a critical juncture in its history – with pharmaceutical companies controversially winning anti-amyloid drug approvals based on thin evidence.

So, it is very likely we've been wrong for the past 50+ years. 

It's time to go to work and get a better understanding of the mechanisms involved.

It's time, to quote the movie The Martian, to, "Science the sh%$ out of this."

 

Nope.

Definitely not!While I appreciate the selfless effort made by big pharma to develop treatments for erectile dysfunction, but using a spider venom that can make one's penis fall off seems to be to be a bridge too far.

Call me old school about this, but I am extremely skeptical of such a treatment:

The venom of the Brazilian wandering spider (Phoneutria nigriventer) can cause necrosis of the penis – essentially, the death of penis tissue – which can sometimes require amputation.

It's a terrifying poison best avoided, yet research suggests that in smaller amounts, the venom could hold clues to the next Viagra.

The large dose of venom dished out by the spider in nature triggers erections in mammals that are very painful and that last much too long for their primary purpose. These abnormally extended boners are technically known as priapisms, and the venom adds nausea and abdominal cramps for good measure.

P. nigriventer is also known as the banana spider because it is commonly found on banana leaves. The arachnid's body can grow up to five centimeters in length, and its leg span sometimes stretches three times further than that. It's one of the most toxic spiders there is.

Nevertheless, scientists from the Universidade Federal de Minas Gerais in Brazil have been able to develop a synthetic version of the molecule in the venom that causes the erection. It's called BZ371A, and has now been tested with some success on mice and rats: when put into a gel and spread on the groins of the animals, erections were triggered.

I'm surprised that this is being developed in Brazil.  Marketing a product as, "Giving you an erection, but your dick might fall off," seems to me to be an archetypal American marketing scheme.

I See Your Problem

This Wall Street Journal headline, "The World Needs New Antibiotics. The Problem Is, No One Can Make Them Profitably," explains the problem with the profit driven healthcare system in 14 words.

You see, if you get a treatment for something like chronic psoriasis, you have a customer for life, but for antibiotics, it's about a month and then the person is cured.

There is no money curing people:

The push for antibiotics to fight fast-evolving superbugs is snagging on a broken business model.

Six startups have won Food and Drug Administration approval for new antibiotics since 2017. All have filed for bankruptcy, been acquired or are shutting down. About 80% of the 300 scientists who worked at the companies have abandoned antibiotic development, according to Kevin Outterson, executive director of CARB-X, a government-funded group promoting research in the field.

“These companies are supposed to be the winners, but every one of them is an unhappy story,” Outterson said.

The reason, the companies say: They couldn’t sell their lifesaving products because the system that produces drugs for cancer and Alzheimer’s disease—which counts on companies selling enough of a new treatment or charging a high enough price to reward investors and make a profit—isn’t working for antibiotics.

So, there is not enough opportunity for looting, more accurately rent seeking, for the masters of the universe in finance to show interest.

Let's look at:

………

Nabriva Therapeutics terminated its 60 remaining employees this year and is seeking a buyer, four years after the FDA approved its antibiotic Xenleta for pneumonia. Nabriva priced a five-day treatment of Xenleta at over $1,000. Generic antibiotics to treat people who develop pneumonia outside of hospitals typically cost under $100. Fewer than 100 of the 800 hospitals Nabriva approached bought it.

“It was all driven by cost,” Nabriva’s former Chief Executive Officer Ted Schroeder said. 

This is compared to the (not particularly effective) Alzheimer's drug lequembi, which costs over $1,500.00 a month for the rest of the patient's life.

No problem funding that.

Am I the only one who thinks the priorities of the Best Healthcare System in the World™ are seriously f%$#ed up?

The Mask Slips

The CEO of Genentech is threatening to delay drug roll-outs over the Biden administration's (fairly pathetic) attempt to implement drug price controls.

It seems that if they cannot loot with complete impunity, they will take their marbles and go home.

This why IP in general, and drug patents in particular, should not be an unlimited license to levy economic rents:

A Swiss pharmaceutical company announced this month that it could slow-walk bringing a potentially life-saving drug to market — in order to reduce the time that it could be subject to President Joe Biden’s recently enacted federal price regulations.

Those comments were made by the CEO of Genentech, whose parent company, Roche, has reaped as much as $10 billion from Trump’s 2017 tax cuts, seeing its net income go up by an average of more than 50 percent, while its spending on research and development has increased by just 25 percent.

………

For two decades, Congress prohibited Medicare from negotiating drug prices like most other high-income countries do. As a result, pharmaceutical companies have been able to charge Americans substantially higher prices for their products than they do elsewhere. They’ve done so even though the American public subsidized research and development costs for every drug approved for sale in the U.S. between 2010-19.

Now, thanks to the new law’s drug price provisions, Medicare can begin to negotiate lower prices for 10 drugs beginning in 2026, with additional drugs added in subsequent years.

………

Earlier this month, the health news site STAT published an interview with Genentech CEO Alexander Hardy in which he said that the company could delay the release of an effective drug for ovarian cancers in order to first ensure it is approved to be sold to the largest population of patients before it is subject to the new price controls.

 Seriously, we need to put them in jail and take all their stuff.

 

Good News Everyone!

I did not expect this, but has just stayed Purdue Pharm's bankruptcy.  More specifically, it will rule on the bankruptcy discharging liability for the Sackler family as a part of this deal.

Good.

I did not expect this, but it seems to me that if corporations are people, then the bankruptcy of a corporation should not discharge any obligations of any other person. 

It is only in federal bankruptcy courts in certain districts, such as the one where Purdue relocated to just prior to their bankruptcy extend bankruptcy to right owners and it seems to me that SCOTUS would have not placed a stay on the bankruptcy unless there was significant sentiment on the court for reversing the decision of the lower court: (On edit: See Cory Doctorow here detailing how they "Moved" to White Plains, New York to get one of the 3 corrupt bankruptcy judges favored by big companies declaring bankruptcy*)

The Supreme Court blocked Purdue Pharma’s $6 billion settlement of opioid lawsuits against its Sackler family owners, agreeing to hear the Justice Department’s claim that the drugmaker’s bankruptcy plan improperly wipes out potential liability to additional parties for allegedly fueling the opioid addiction crisis.

The justices, by taking up the case and preventing Purdue from carrying out the settlement during the appeal, ensured that a sizable chunk of tens of billions of dollars pledged by the pharmaceutical industry to combat the opioid crisis will be delayed—or not paid at all. But the move eventually could open the door for parties who balked at the deal to win additional compensation.

The court’s review also will extend the long, costly litigation alleging that drug manufacturers, distributors and pharmacies oversupplied painkillers as opioid addiction grew into an epidemic.

The legal uncertainty also will continue for the Sacklers, who sought to use Purdue’s chapter 11 proceedings to resolve opioid lawsuits aimed at holding them responsible for the costs of addiction and clawing back distributions they received from the closely held manufacturer before its bankruptcy.

The idea that owners should not be liable for a company's debts is at the core of modern finance and bankruptcy law, and I generally support this, particularly for mere shareholders, though I think that it is carried to far in recent years

The difference here is the Sacklers were not just owners.  Members of the Sackler family ran the company, and this firm to aggressively pursue addiction and misuse of Oxycontin because it increased their profits.

They are criminals, and even those who just won the birth lottery and did not participate in the management of the company knew where their money came from.

I'm not optimistic about a Billy Ray Valentine scenario,^† but at the very least, the Sackler family, have to be sh%$ting their pants right now.

^*Here is the important quote:

Three judges – David Jones and Marvin Isgur of Houston and Bob Drain of New York – hear 96% of the country's large corporate bankruptcies:

https://www.creditslips.org/creditslips/2021/05/judge-shopping-in-bankruptcy.html

These judges are unbelievably horny for corporations, embracing a legal theory "that casts the invention of the limited liability corporation alongside that of the steam engine as a paradigmatic development in the pursuit of prosperity":

https://prospect.org/justice/how-do-you-solve-a-problem-like-the-sacklers-purdue-pharma-bankruptcy/

Now there are more than three bankruptcy judges in America, so how do the nation's biggest companies get their cases heard by these three enthusiastic Renfields for corporate vampirism?

They cheat.

For example: when GM was facing bankruptcy, it argued that it was a New York company on the basis that it owned a single Chevy dealership in Harlem, and got in front of Judge Drain.

The Sacklers were – characteristically – even more brazen. They really wanted to get their case in front of Judge Drain, the nation's most enthusiastic supporter of "third party releases," through which bankrupt billionaires can wipe the slate clean, securing dismissals of all claims by the people they wronged.

Drain is also uniquely hostile to independent examiners, "an independent third-party appointed by the court to investigate 'fraud, dishonesty, incompetence, misconduct, mismanagement, or irregularity…by current or former management of the debtor."

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3851339

If you're the Sacklers, hoping to keep two thirds of your billions and extinguish all claims by your victims, there is no better helpmeet than Judge Robert Drain of the Southern District of New York. So, 192 days before filing for bankruptcy, the Sacklers opened an office in White Plains, New York (a company may claim jurisdiction in a specific court once they've operated a business there for 180 days).

Then they filed a bankruptcy in which they altered the metadata on their casefile, inserting the code for a Westchester county hearing into the machine-readable, human-invisible parts of the documents they uploaded to the federal Case Management/Electronic Case Files (CM/ECF) system (they also captioned the case with "RDD, for "Robert D Drain").

They chose their judge, and the judge obliged. UCLA Law's Lynn LoPucki is one of the leading scholars of these bankruptcy "megacases," and has written extensively on why these three judges are so deferential to corporate criminals seeking to flense themselves of culpability. She sees judges like Drain motivated by "personal aggrandizement and celebrity and ability to indirectly channel to the local bankruptcy bar. The judge is the star and the ringmaster of a megacase – very appealing to certain personalities."

Thus, these judges are "willing and eager to cater to debtors to attract business…[an] assurance to debtors that…these judges will not transfer out cases with improper venue or rule against the debtor…"

https://www.fulcrum.org/concern/monographs/02870w66d

^†It comes from the movie Trading Places, "You know, it occurs to me that the best way you hurt rich people is by turning them into poor people."